@prefix rdf: . @prefix rdfs: . @prefix skos: . @prefix dc: . @prefix prov: . @prefix xsd: . @prefix oa: . @prefix cml: . @prefix values: . @prefix concept: . @prefix cof: . @prefix doc: . # CML concept layer — Therapeutic Goods Act 1989 # MACHINE-DERIVED from the TEXT layer — cml:Proposed, values:HeuristicDerived. # Pending human attestation (cml:Attested / skos:exactMatch). Generated by legis2cml. a cof:Document ; dc:identifier "C2025C00525VOL02" ; prov:wasDerivedFrom ; dc:title "Therapeutic Goods Act 1989"@en ; values:category "AU" ; dc:identifier "No. 21 of 1990" ; dc:date "5 September 2025" ; prov:wasDerivedFrom ; cml:proposedBy ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-5 a cml:Concept ; skos:prefLabel "5 September 2025"@en ; cml:realizedBy doc:sec-5 ; cml:integrityHash "b68354eb76366e401f25518de6aa8b05ca7aac5c34fb38ae229b02bda15d60ba" ; skos:note "Compilation information and notes on amendments, applications, saving, transitional provisions, editorial changes, presentational changes, modifications, and self-repealing provisions." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.1" ; cml:asserts concept:therapeutic-goods-act-1989-sec-5-norm . concept:therapeutic-goods-act-1989-sec-5-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-5 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-5 cml:asserts concept:therapeutic-goods-act-1989-sec-5-logic-descriptionlogic-1 . concept:therapeutic-goods-act-1989-sec-5-logic-descriptionlogic-1 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Applicable" ; cml:logicSummary "Classifies the text as a compilation of the Therapeutic Goods Act 1989." ; cml:premiseText "The text describes itself as a compilation." ; cml:conclusionText "It is a compilation of the law." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-5 cml:asserts concept:therapeutic-goods-act-1989-sec-5-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-5-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Applicable" ; cml:logicSummary "Identifies the compilation date and contents." ; cml:premiseText "The text mentions the compilation date and contents." ; cml:conclusionText "The compilation date is September 5, 2025, and it includes sections 1-41A and 41B-69." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-5 cml:asserts concept:therapeutic-goods-act-1989-sec-5-logic-descriptionlogic-3 . concept:therapeutic-goods-act-1989-sec-5-logic-descriptionlogic-3 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Applicable" ; cml:logicSummary "Notes on amendments and uncommenced amendments." ; cml:premiseText "The text mentions uncommenced amendments." ; cml:conclusionText "Uncommenced amendments are not shown in the text of the compiled law." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-5 cml:asserts concept:therapeutic-goods-act-1989-sec-5-logic-descriptionlogic-4 . concept:therapeutic-goods-act-1989-sec-5-logic-descriptionlogic-4 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Applicable" ; cml:logicSummary "Application, saving, and transitional provisions." ; cml:premiseText "The text mentions applications, saving, and transitional provisions." ; cml:conclusionText "Details are included in the endnotes." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-5 cml:asserts concept:therapeutic-goods-act-1989-sec-5-logic-descriptionlogic-5 . concept:therapeutic-goods-act-1989-sec-5-logic-descriptionlogic-5 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Applicable" ; cml:logicSummary "Editorial changes and presentational changes." ; cml:premiseText "The text mentions editorial changes." ; cml:conclusionText "Presentational changes are applied to give a more consistent look and feel." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-5 cml:asserts concept:therapeutic-goods-act-1989-sec-5-logic-descriptionlogic-6 . concept:therapeutic-goods-act-1989-sec-5-logic-descriptionlogic-6 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Applicable" ; cml:logicSummary "Modifications and self-repealing provisions." ; cml:premiseText "The text mentions modifications." ; cml:conclusionText "The compiled law operates as modified but the modification does not amend the text of the law." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41b a cml:Concept ; skos:prefLabel "41B General"@en ; cml:realizedBy doc:sec-41b ; cml:integrityHash "6fb1546d5b2f221fc45e075216e418648b0a562af2889e9e691805ba419f3d6c" ; skos:note "Ensures safety and satisfactory performance of medical devices" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.21" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41b-norm . concept:therapeutic-goods-act-1989-sec-41b-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41b ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41b cml:asserts concept:therapeutic-goods-act-1989-sec-41b-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41b-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "ensures" ; cml:logicSummary "Guarantees safety and satisfactory performance" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ba a cml:Concept ; skos:prefLabel "41BA Requirements for medical devices (Parts 4-2 and 4-3)"@en ; cml:realizedBy doc:sec-41ba ; cml:integrityHash "dc57dd8a7d31b38ecb3d708078ea5248c704701d7c5b61eea5c2062f92908633" ; skos:note "Requirements for medical devices must conform to safety and performance standards." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.21" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ba-norm . concept:therapeutic-goods-act-1989-sec-41ba-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ba ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ba cml:asserts concept:therapeutic-goods-act-1989-sec-41ba-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41ba-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must provide requirements for medical devices." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bb a cml:Concept ; skos:prefLabel "41BB Administrative processes (Parts 4-4 to 4-10)"@en ; cml:realizedBy doc:sec-41bb ; cml:integrityHash "2817c4d28002c2863fbaa392bbef138701d0517d231fc6688466f8011ac40095" ; skos:note "List of administrative processes under this Chapter" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.21" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41bb-norm . concept:therapeutic-goods-act-1989-sec-41bb-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41bb ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bc a cml:Concept ; skos:prefLabel "41BC Enforcement (Part 4-11)"@en ; cml:realizedBy doc:sec-41bc ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.22" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41bc-norm . concept:therapeutic-goods-act-1989-sec-41bc-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41bc ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bd a cml:Concept ; skos:prefLabel "41BD What is a medical device"@en ; cml:realizedBy doc:sec-41bd ; cml:integrityHash "7ea979964f89afcf338e8d56ef3a09e11a8a3a1e450d0d0ff4e34dcc53b39b30" ; skos:note "Defines what constitutes a medical device." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.23" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41bd-norm . concept:therapeutic-goods-act-1989-sec-41bd-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41bd ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41be a cml:Concept ; skos:prefLabel "41BE Kinds of medical devices"@en ; cml:realizedBy doc:sec-41be ; cml:integrityHash "c910d474dcd724bff83ddedeb06bf1eceaf9fb3af7c76bb282be057f36e6dffa" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41be-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41be-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41be-ss-3 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.25" . concept:therapeutic-goods-act-1989-sec-41be-ss-1 a cml:Concept ; skos:prefLabel "41BE(1) Kinds of medical devices"@en ; cml:realizedBy doc:sec-41be-ss-1 ; cml:integrityHash "961ac8886fad564c5503da21f91f9e347569d95718d72083d2a62372e96443c9" ; values:partOf concept:therapeutic-goods-act-1989-sec-41be ; skos:note "Medical devices of the same kind must have the same sponsor, manufacturer, device nomenclature system code, medical device classification, and other characteristics as prescribed by regulations." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.25" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41be-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41be-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41be-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41be-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41be-ss-1-logic-alleninterval-1 . concept:therapeutic-goods-act-1989-sec-41be-ss-1-logic-alleninterval-1 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "during" ; cml:logicSummary "Characteristics prescribed by regulations apply during the same period" ; cml:premiseText "either generally or in relation to medical devices of the kind in question" ; cml:conclusionText "are of the same kind" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41be-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41be-ss-1-logic-ltl-2 . concept:therapeutic-goods-act-1989-sec-41be-ss-1-logic-ltl-2 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "until" ; cml:logicSummary "Characteristics prescribed by regulations apply until the end of the period" ; cml:premiseText "either generally or in relation to medical devices of the kind in question" ; cml:conclusionText "are of the same kind" ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41be-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41be-ss-1-logic-deontic-3 . concept:therapeutic-goods-act-1989-sec-41be-ss-1-logic-deontic-3 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "if" ; cml:logicSummary "Characteristics prescribed by regulations apply if certain conditions are met" ; cml:premiseText "(e) are the same in relation to such other characteristics as the regulations prescribe, either generally or in relation to medical devices of the kind in question." ; cml:conclusionText "are of the same kind" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41be-ss-2 a cml:Concept ; skos:prefLabel "41BE(2) Kinds of medical devices"@en ; cml:realizedBy doc:sec-41be-ss-2 ; cml:integrityHash "5d1f30d34007410354ac500daa9b0e520972beea575bca2d76dad01ee1c8e802" ; values:partOf concept:therapeutic-goods-act-1989-sec-41be ; skos:note "If a medical device is not of the same kind as any other medical device, this Chapter applies in relation to the device." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.25" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41be-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41be-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41be-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41be-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41be-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41be-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "if-then" ; cml:logicSummary "Conditional obligation" ; cml:premiseText "If a medical device is not of the same kind as any other medical device." ; cml:conclusionText "This Chapter applies in relation to the device." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41be-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41be-ss-2-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41be-ss-2-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "=" ; cml:logicSummary "Equivalence between kinds of devices" ; cml:premiseText "References in this Chapter to delivering a reasonable number of samples of the kind of device are taken to be references to delivering the device." ; cml:conclusionText "Delivering the device is equivalent to delivering a reasonable number of samples of the kind of device." ; cml:executionSurface "modalities::dl" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41be-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41be-ss-2-logic-alleninterval-3 . concept:therapeutic-goods-act-1989-sec-41be-ss-2-logic-alleninterval-3 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator ">=" ; cml:logicSummary "Temporal relation between delivering and delivering" ; cml:premiseText "References in this Chapter to delivering a reasonable number of samples of the kind of device are taken to be references to delivering the device." ; cml:conclusionText "Delivering the device is temporally related to delivering a reasonable number of samples of the kind of device." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41be-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41be-ss-2-logic-ltl-4 . concept:therapeutic-goods-act-1989-sec-41be-ss-2-logic-ltl-4 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "<=" ; cml:logicSummary "Temporal relation between delivering and delivering" ; cml:premiseText "References in this Chapter to delivering a reasonable number of samples of the kind of device are taken to be references to delivering the device." ; cml:conclusionText "Delivering the device is temporally related to delivering a reasonable number of samples of the kind of device." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41be-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41be-ss-2-logic-diffusion-5 . concept:therapeutic-goods-act-1989-sec-41be-ss-2-logic-diffusion-5 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "if-then" ; cml:logicSummary "Conditional diffusion" ; cml:premiseText "If a medical device is not of the same kind as any other medical device, this Chapter applies in relation to the device." ; cml:conclusionText "This Chapter diffuses to the device." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41be-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41be-ss-2-logic-cogai-6 . concept:therapeutic-goods-act-1989-sec-41be-ss-2-logic-cogai-6 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "=" ; cml:logicSummary "Equivalence between kinds of devices" ; cml:premiseText "References in this Chapter to delivering a reasonable number of samples of the kind of device are taken to be references to delivering the device." ; cml:conclusionText "Delivering the device is equivalent to delivering a reasonable number of samples of the kind of device." ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41be-ss-3 a cml:Concept ; skos:prefLabel "41BE(3) Kinds of medical devices"@en ; cml:realizedBy doc:sec-41be-ss-3 ; cml:integrityHash "011eaa18da19448372520e96b61e7ca5d89bf942aeb3f363d561894fb09d9895" ; values:partOf concept:therapeutic-goods-act-1989-sec-41be ; skos:note "Device nomenclature codes for medical devices may be determined by the Minister." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.25" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41be-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41be-ss-3-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41be-ss-3 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41be-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41be-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41be-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "Permission to determine device nomenclature codes" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bf a cml:Concept ; skos:prefLabel "41BF System or procedure packs"@en ; cml:realizedBy doc:sec-41bf ; cml:integrityHash "b657e94d26791d98c791bec283cfd331c76b343a6df57548bb80ea0dc9dad9b3" ; skos:note "Goods are a system or procedure pack if they are interconnected or combined for use in a medical or surgical procedure." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.26" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41bf-norm . concept:therapeutic-goods-act-1989-sec-41bf-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41bf ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bg a cml:Concept ; skos:prefLabel "41BG Manufacturers of medical devices"@en ; cml:realizedBy doc:sec-41bg ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41bg-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41bg-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41bg-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41bg-ss-4 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.26" . concept:therapeutic-goods-act-1989-sec-41bg-ss-1 a cml:Concept ; skos:prefLabel "41BG(1) Manufacturers of medical devices"@en ; cml:realizedBy doc:sec-41bg-ss-1 ; cml:integrityHash "6e8267949d0196d60cc5c48a54a2122c33f8f338ef29d6a7be4523c6d39867b9" ; values:partOf concept:therapeutic-goods-act-1989-sec-41bg ; skos:note "Manufacturer is responsible for design, production, packaging and labelling of the device." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.26" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41bg-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41bg-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41bg-ss-1 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bg-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41bg-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41bg-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "is" ; cml:logicSummary "Manufacturer is responsible" ; cml:premiseText "Design, production, packaging and labelling are operations performed by the manufacturer." ; cml:conclusionText "The manufacturer is responsible for those operations." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bg-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41bg-ss-1-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-41bg-ss-1-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "during" ; cml:logicSummary "Manufacturer's responsibility starts before device supply" ; cml:premiseText "Design, production, packaging and labelling occur before the device is supplied under the person’s name." ; cml:conclusionText "The manufacturer's responsibility for design, production, packaging and labelling begins before the device is supplied." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bg-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41bg-ss-1-logic-argumentation-3 . concept:therapeutic-goods-act-1989-sec-41bg-ss-1-logic-argumentation-3 a cml:LogicApplication ; cml:modality cml:Argumentation ; cml:operator "implies" ; cml:logicSummary "Manufacturer's responsibility implies supply of device" ; cml:premiseText "If the manufacturer is responsible for design, production, packaging and labelling, then the device must be supplied under their name." ; cml:conclusionText "The manufacturer's responsibility for design, production, packaging and labelling implies that the device must be supplied under their name." ; cml:executionSurface "modalities::argumentation" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bg-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41bg-ss-1-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-41bg-ss-1-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "implies" ; cml:logicSummary "Manufacturer's responsibility spreads to supply of device" ; cml:premiseText "The manufacturer's responsibility for design, production, packaging and labelling is not limited to the person themselves but also extends to other persons acting on their behalf." ; cml:conclusionText "The manufacturer's responsibility for design, production, packaging and labelling implies that the device must be supplied under their name or another person acting on their behalf." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bg-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41bg-ss-1-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-41bg-ss-1-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "implies" ; cml:logicSummary "Manufacturer's responsibility is a cognitive action" ; cml:premiseText "The manufacturer's responsibility for design, production, packaging and labelling involves making decisions and taking actions." ; cml:conclusionText "The manufacturer's responsibility for design, production, packaging and labelling is a cognitive action that implies the supply of the device." ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bg-ss-2 a cml:Concept ; skos:prefLabel "41BG(2) Manufacturers of medical devices"@en ; cml:realizedBy doc:sec-41bg-ss-2 ; cml:integrityHash "76f846af5ae035cb1b2a0697a4acb9b678d7b8487eecb8de77abc84c9173bb9c" ; values:partOf concept:therapeutic-goods-act-1989-sec-41bg ; skos:note "Manufacturer must provide information about the device's purpose." ; dc:description "Yes" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.26" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41bg-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41bg-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41bg-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bg-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41bg-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41bg-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must provide information." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bg-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41bg-ss-2-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41bg-ss-2-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "hasPart" ; cml:logicSummary "Device's purpose is described by the manufacturer." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bg-ss-3 a cml:Concept ; skos:prefLabel "41BG(3) Manufacturers of medical devices"@en ; cml:realizedBy doc:sec-41bg-ss-3 ; cml:integrityHash "e1255e59d9262230f97c8db65acfcf203f117497732d0240ab1535f16ac5a005" ; values:partOf concept:therapeutic-goods-act-1989-sec-41bg ; skos:note "Exemptions for individuals assembling or adapting medical devices" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.26" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41bg-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41bg-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41bg-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bg-ss-4 a cml:Concept ; skos:prefLabel "41BG(4) Manufacturers of medical devices"@en ; cml:realizedBy doc:sec-41bg-ss-4 ; cml:integrityHash "5b48feb6132b6d5ff4ab89dd9b73daa69e1e3f97b2f74e69552708f27701d63d" ; values:partOf concept:therapeutic-goods-act-1989-sec-41bg ; skos:note "Exempts individuals from being considered manufacturers of medical devices if they are part of a prescribed class." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.26" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41bg-ss-4-norm . concept:therapeutic-goods-act-1989-sec-41bg-ss-4-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41bg-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bg-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41bg-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41bg-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Exemption" ; cml:logicSummary "Exempts individuals from being considered manufacturers of medical devices." ; cml:premiseText "This section applies in relation to vaping goods that are a medical device." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bg-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41bg-ss-4-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41bg-ss-4-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Class definition" ; cml:logicSummary "Defines a class of persons prescribed by regulations for the purposes of this subsection." ; cml:premiseText "The person is not the manufacturer of a medical device if the person is included in a class of persons prescribed by the regulations." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bg-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41bg-ss-4-logic-alleninterval-3 . concept:therapeutic-goods-act-1989-sec-41bg-ss-4-logic-alleninterval-3 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Temporal exemption" ; cml:logicSummary "Exempts individuals from being considered manufacturers of medical devices during the applicable period." ; cml:premiseText "This section applies in relation to vaping goods that are a medical device." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bg-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41bg-ss-4-logic-ltl-4 . concept:therapeutic-goods-act-1989-sec-41bg-ss-4-logic-ltl-4 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Temporal exemption" ; cml:logicSummary "Exempts individuals from being considered manufacturers of medical devices during the applicable period." ; cml:premiseText "This section applies in relation to vaping goods that are a medical device." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bg-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41bg-ss-4-logic-diffusion-5 . concept:therapeutic-goods-act-1989-sec-41bg-ss-4-logic-diffusion-5 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "Knowledge dissemination" ; cml:logicSummary "Disseminates knowledge about exemptions from being considered manufacturers of medical devices." ; cml:premiseText "This section applies in relation to vaping goods that are a medical device." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bg-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41bg-ss-4-logic-cogai-6 . concept:therapeutic-goods-act-1989-sec-41bg-ss-4-logic-cogai-6 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "Artificial intelligence application" ; cml:logicSummary "Applies artificial intelligence to determine exemptions from being considered manufacturers of medical devices." ; cml:premiseText "This section applies in relation to vaping goods that are a medical device." ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bh a cml:Concept ; skos:prefLabel "41BH Meaning of compliance with essential principles"@en ; cml:realizedBy doc:sec-41bh ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41bh-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41bh-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.27" . concept:therapeutic-goods-act-1989-sec-41bh-ss-1 a cml:Concept ; skos:prefLabel "41BH(1) Meaning of compliance with essential principles"@en ; cml:realizedBy doc:sec-41bh-ss-1 ; cml:integrityHash "ea914da814d961bcda836d1172084c1cce3451c3c2952d31b0da175599231846" ; values:partOf concept:therapeutic-goods-act-1989-sec-41bh ; skos:note "A medical device complies with the essential principles if it does not contravene any of them." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.27" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41bh-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41bh-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41bh-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bh-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41bh-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41bh-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "¬" ; cml:logicSummary "Negation of a duty" ; cml:conclusionText "The device does not contravene any of the essential principles." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bh-ss-2 a cml:Concept ; skos:prefLabel "41BH(2) Meaning of compliance with essential principles"@en ; cml:realizedBy doc:sec-41bh-ss-2 ; cml:integrityHash "7ed323b589b283d900b869a93c9759043e6aeea3b057cbdd9992f4dfa60da8b3" ; values:partOf concept:therapeutic-goods-act-1989-sec-41bh ; skos:note "Compliance with medical device standards is sufficient for compliance with essential principles." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.27" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41bh-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41bh-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41bh-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bh-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41bh-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41bh-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "implies" ; cml:logicSummary "Medical device compliance with standards implies compliance with essential principles" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bi a cml:Concept ; skos:prefLabel "41BI Meaning of non-application of conformity assessment"@en ; cml:realizedBy doc:sec-41bi ; cml:integrityHash "d6447e23d6652bd9700a141845f56c0854fdc3de7a3d4610a131b5df2a58aa4b" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41bi-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41bi-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41bi-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41bi-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41bi-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41bi-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41bi-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41bi-ss-3 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.28" . concept:therapeutic-goods-act-1989-sec-41bi-ss-1 a cml:Concept ; skos:prefLabel "41BI(1) Meaning of non-application of conformity assessment"@en ; cml:realizedBy doc:sec-41bi-ss-1 ; cml:integrityHash "893e52b8d8c3ce5b7b3a3220e1c63dfd97e416e5ddad4022aa41fb2bea07bcd2" ; values:partOf concept:therapeutic-goods-act-1989-sec-41bi ; skos:note "Defines overseas regulator A conformity assessment procedure is not applied if there has been a contravention of the procedures. A requirement that is comparable to a conformity assessment procedure is not applied if there has been a contravention of the requirement." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.28" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41bi-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41bi-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41bi-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bi-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41bi-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41bi-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "not" ; cml:logicSummary "Negative obligation" ; cml:premiseText "(1) A conformity assessment procedure is taken, for the purposes of this Chapter, not to have been applied..." ; cml:conclusionText "...if there has been a contravention of the conformity assessment procedures." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bi-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41bi-ss-1-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-41bi-ss-1-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "during" ; cml:logicSummary "Temporal relation between contravention and assessment procedure" ; cml:premiseText "(a) there has been a contravention of the conformity assessment procedures; and (b) the contravention relates, wholly or partly, to that device or its manufacture." ; cml:conclusionText "...there has been a contravention of the conformity assessment procedures during which the contravention relates, wholly or partly, to that device or its manufacture." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bi-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41bi-ss-1-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-41bi-ss-1-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "during" ; cml:logicSummary "Temporal relation between contravention and assessment procedure" ; cml:premiseText "(a) there has been a contravention of the conformity assessment procedures; and (b) the contravention relates, wholly or partly, to that device or its manufacture." ; cml:conclusionText "...there has been a contravention of the conformity assessment procedures during which the contravention relates, wholly or partly, to that device or its manufacture." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bi-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41bi-ss-1-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-41bi-ss-1-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "if" ; cml:logicSummary "Conditional relation between contravention and assessment procedure" ; cml:premiseText "(a) there has been a contravention of the conformity assessment procedures; and (b) the contravention relates, wholly or partly, to that device or its manufacture." ; cml:conclusionText "...there is a diffusion from the contravention to the assessment procedure if there has been a contravention of the conformity assessment procedures during which the contravention relates, wholly or partly, to that device or its manufacture." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bi-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41bi-ss-1-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-41bi-ss-1-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "if" ; cml:logicSummary "Conditional relation between contravention and assessment procedure" ; cml:premiseText "(a) there has been a contravention of the conformity assessment procedures; and (b) the contravention relates, wholly or partly, to that device or its manufacture." ; cml:conclusionText "...there is a CogAI from the contravention to the assessment procedure if there has been a contravention of the conformity assessment procedures during which the contravention relates, wholly or partly, to that device or its manufacture." ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bi-ss-2 a cml:Concept ; skos:prefLabel "41BI(2) Meaning of non-application of conformity assessment"@en ; cml:realizedBy doc:sec-41bi-ss-2 ; cml:integrityHash "0037f5099e910a485dbab8e1cc82be0aeae8a0624bcfbc79b08811c2ad897252" ; values:partOf concept:therapeutic-goods-act-1989-sec-41bi ; skos:note "The Secretary may determine a body for the purposes of subsection (1). Exemptions from conformity assessment requirements" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.28" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41bi-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41bi-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41bi-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bi-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41bi-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41bi-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "exemption" ; cml:logicSummary "Exemptions from conformity assessment requirements" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bi-ss-3 a cml:Concept ; skos:prefLabel "41BI(3) Meaning of non-application of conformity assessment"@en ; cml:realizedBy doc:sec-41bi-ss-3 ; cml:integrityHash "f4d544392825f5fc204a56c892b78a60aa26763d361b9a575de20a555b5de1f9" ; values:partOf concept:therapeutic-goods-act-1989-sec-41bi ; skos:note "A conformity assessment standard only applies to specified parts of procedures. The Secretary may determine a body by reference to a designation, recognition, approval or authorization." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.28" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41bi-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41bi-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41bi-ss-3 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bi-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41bi-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41bi-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligate" ; cml:logicSummary "A conformity assessment standard only applies to specified parts of procedures." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bi-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41bi-ss-3-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-41bi-ss-3-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "relates to" ; cml:logicSummary "Temporal relation between intervals" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bi-ss-1 a cml:Concept ; skos:prefLabel "41BI(1) Meaning of non-application of conformity assessment"@en ; cml:realizedBy doc:sec-41bi-ss-1 ; cml:integrityHash "ca37534fd9aab92d9d7245822a9163988111ec834f03631f2bdb4bd7b52b88c3" ; values:partOf concept:therapeutic-goods-act-1989-sec-41bi ; skos:note "Defines overseas regulator A conformity assessment procedure is not applied if there has been a contravention of the procedures. A requirement that is comparable to a conformity assessment procedure is not applied if there has been a contravention of the requirement." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.28" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41bi-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41bi-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41bi-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bi-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41bi-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41bi-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "not" ; cml:logicSummary "Negative obligation" ; cml:premiseText "(1) A conformity assessment procedure is taken, for the purposes of this Chapter, not to have been applied..." ; cml:conclusionText "...if there has been a contravention of the conformity assessment procedures." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bi-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41bi-ss-1-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-41bi-ss-1-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "during" ; cml:logicSummary "Temporal relation between contravention and assessment procedure" ; cml:premiseText "(a) there has been a contravention of the conformity assessment procedures; and (b) the contravention relates, wholly or partly, to that device or its manufacture." ; cml:conclusionText "...there has been a contravention of the conformity assessment procedures during which the contravention relates, wholly or partly, to that device or its manufacture." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bi-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41bi-ss-1-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-41bi-ss-1-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "during" ; cml:logicSummary "Temporal relation between contravention and assessment procedure" ; cml:premiseText "(a) there has been a contravention of the conformity assessment procedures; and (b) the contravention relates, wholly or partly, to that device or its manufacture." ; cml:conclusionText "...there has been a contravention of the conformity assessment procedures during which the contravention relates, wholly or partly, to that device or its manufacture." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bi-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41bi-ss-1-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-41bi-ss-1-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "if" ; cml:logicSummary "Conditional relation between contravention and assessment procedure" ; cml:premiseText "(a) there has been a contravention of the conformity assessment procedures; and (b) the contravention relates, wholly or partly, to that device or its manufacture." ; cml:conclusionText "...there is a diffusion from the contravention to the assessment procedure if there has been a contravention of the conformity assessment procedures during which the contravention relates, wholly or partly, to that device or its manufacture." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bi-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41bi-ss-1-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-41bi-ss-1-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "if" ; cml:logicSummary "Conditional relation between contravention and assessment procedure" ; cml:premiseText "(a) there has been a contravention of the conformity assessment procedures; and (b) the contravention relates, wholly or partly, to that device or its manufacture." ; cml:conclusionText "...there is a CogAI from the contravention to the assessment procedure if there has been a contravention of the conformity assessment procedures during which the contravention relates, wholly or partly, to that device or its manufacture." ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bi-ss-2 a cml:Concept ; skos:prefLabel "41BI(2) Meaning of non-application of conformity assessment"@en ; cml:realizedBy doc:sec-41bi-ss-2 ; cml:integrityHash "2aa38e29c6f814ca7e871fb2caa6b3948b8b56506221cdd313191405de04a813" ; values:partOf concept:therapeutic-goods-act-1989-sec-41bi ; skos:note "The Secretary may determine a body for the purposes of subsection (1). Exemptions from conformity assessment requirements" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.28" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41bi-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41bi-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41bi-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bi-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41bi-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41bi-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "exemption" ; cml:logicSummary "Exemptions from conformity assessment requirements" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bi-ss-1 a cml:Concept ; skos:prefLabel "41BI(1) Meaning of non-application of conformity assessment"@en ; cml:realizedBy doc:sec-41bi-ss-1 ; cml:integrityHash "2e12d7771e202b463a9831a6c8e2c33841f04ddc73e2d8167f056399ac727b32" ; values:partOf concept:therapeutic-goods-act-1989-sec-41bi ; skos:note "Defines overseas regulator A conformity assessment procedure is not applied if there has been a contravention of the procedures. A requirement that is comparable to a conformity assessment procedure is not applied if there has been a contravention of the requirement." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.28" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41bi-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41bi-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41bi-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bi-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41bi-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41bi-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "not" ; cml:logicSummary "Negative obligation" ; cml:premiseText "(1) A conformity assessment procedure is taken, for the purposes of this Chapter, not to have been applied..." ; cml:conclusionText "...if there has been a contravention of the conformity assessment procedures." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bi-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41bi-ss-1-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-41bi-ss-1-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "during" ; cml:logicSummary "Temporal relation between contravention and assessment procedure" ; cml:premiseText "(a) there has been a contravention of the conformity assessment procedures; and (b) the contravention relates, wholly or partly, to that device or its manufacture." ; cml:conclusionText "...there has been a contravention of the conformity assessment procedures during which the contravention relates, wholly or partly, to that device or its manufacture." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bi-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41bi-ss-1-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-41bi-ss-1-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "during" ; cml:logicSummary "Temporal relation between contravention and assessment procedure" ; cml:premiseText "(a) there has been a contravention of the conformity assessment procedures; and (b) the contravention relates, wholly or partly, to that device or its manufacture." ; cml:conclusionText "...there has been a contravention of the conformity assessment procedures during which the contravention relates, wholly or partly, to that device or its manufacture." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bi-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41bi-ss-1-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-41bi-ss-1-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "if" ; cml:logicSummary "Conditional relation between contravention and assessment procedure" ; cml:premiseText "(a) there has been a contravention of the conformity assessment procedures; and (b) the contravention relates, wholly or partly, to that device or its manufacture." ; cml:conclusionText "...there is a diffusion from the contravention to the assessment procedure if there has been a contravention of the conformity assessment procedures during which the contravention relates, wholly or partly, to that device or its manufacture." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bi-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41bi-ss-1-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-41bi-ss-1-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "if" ; cml:logicSummary "Conditional relation between contravention and assessment procedure" ; cml:premiseText "(a) there has been a contravention of the conformity assessment procedures; and (b) the contravention relates, wholly or partly, to that device or its manufacture." ; cml:conclusionText "...there is a CogAI from the contravention to the assessment procedure if there has been a contravention of the conformity assessment procedures during which the contravention relates, wholly or partly, to that device or its manufacture." ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bi-ss-2 a cml:Concept ; skos:prefLabel "41BI(2) Meaning of non-application of conformity assessment"@en ; cml:realizedBy doc:sec-41bi-ss-2 ; cml:integrityHash "d2ed811c0d8c04d387fe3897330a16172068874086513aaa37c6a8e7b74af708" ; values:partOf concept:therapeutic-goods-act-1989-sec-41bi ; skos:note "The Secretary may determine a body for the purposes of subsection (1). Exemptions from conformity assessment requirements" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.28" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41bi-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41bi-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41bi-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bi-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41bi-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41bi-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "exemption" ; cml:logicSummary "Exemptions from conformity assessment requirements" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bi-ss-3 a cml:Concept ; skos:prefLabel "41BI(3) Meaning of non-application of conformity assessment"@en ; cml:realizedBy doc:sec-41bi-ss-3 ; cml:integrityHash "0d9ee7fe0e166737c14ac656758a1e8315c0b2d9368bce683b141437cb3d7520" ; values:partOf concept:therapeutic-goods-act-1989-sec-41bi ; skos:note "A conformity assessment standard only applies to specified parts of procedures. The Secretary may determine a body by reference to a designation, recognition, approval or authorization." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.28" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41bi-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41bi-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41bi-ss-3 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bi-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41bi-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41bi-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligate" ; cml:logicSummary "A conformity assessment standard only applies to specified parts of procedures." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bi-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41bi-ss-3-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-41bi-ss-3-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "relates to" ; cml:logicSummary "Temporal relation between intervals" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bk a cml:Concept ; skos:prefLabel "41BK Application of the Criminal Code"@en ; cml:realizedBy doc:sec-41bk ; cml:integrityHash "17095f6330023e3523619fa12132f202153702263ea4d17f0e377eda4fc235e1" ; skos:note "Chapter 2 of the Criminal Code applies to all offences against this Chapter." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.31" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41bk-norm . concept:therapeutic-goods-act-1989-sec-41bk-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41bk ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41bk cml:asserts concept:therapeutic-goods-act-1989-sec-41bk-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41bk-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "applies" ; cml:logicSummary "Chapter 2 of the Criminal Code applies to all offences against this Chapter." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41c a cml:Concept ; skos:prefLabel "41C What this Part is about"@en ; cml:realizedBy doc:sec-41c ; cml:integrityHash "e5d8fe802392df4faa97549b886f3a4204147be47326c32d26fdb3ae9f1f183f" ; skos:note "Compliance with medical device standards is not required but can be used to establish compliance with essential principles." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.32" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41c-norm . concept:therapeutic-goods-act-1989-sec-41c-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41c ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41c cml:asserts concept:therapeutic-goods-act-1989-sec-41c-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41c-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must comply with medical device standards." ; cml:premiseText "Compliance is not required." ; cml:conclusionText "Compliance can be used to establish compliance." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41c cml:asserts concept:therapeutic-goods-act-1989-sec-41c-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-41c-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator ">=" ; cml:logicSummary "The regulations may make provision for and in relation to the Secretary causing a database of unique device identifiers of medical devices to be established and maintained." ; cml:premiseText "The regulations are applicable." ; cml:conclusionText "The database must be established and maintained." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41c cml:asserts concept:therapeutic-goods-act-1989-sec-41c-logic-diffusion-3 . concept:therapeutic-goods-act-1989-sec-41c-logic-diffusion-3 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "IS_A" ; cml:logicSummary "Dealing in medical devices that do not comply with the essential principles may be an offence or contravenes a civil penalty provision." ; cml:premiseText "The regulations are applicable." ; cml:conclusionText "Dealing in non-compliant medical devices is prohibited." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41c cml:asserts concept:therapeutic-goods-act-1989-sec-41c-logic-cogai-4 . concept:therapeutic-goods-act-1989-sec-41c-logic-cogai-4 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "IS_A" ; cml:logicSummary "The therapeutic goods act regulates dealing in medical devices." ; cml:premiseText "The regulations are applicable." ; cml:conclusionText "Dealing in medical devices is regulated by the act." ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ca a cml:Concept ; skos:prefLabel "41CA Essential principles"@en ; cml:realizedBy doc:sec-41ca ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ca-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ca-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ca-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ca-ss-4 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ca-ss-5 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.33" . concept:therapeutic-goods-act-1989-sec-41ca-ss-1 a cml:Concept ; skos:prefLabel "41CA(1) Essential principles"@en ; cml:realizedBy doc:sec-41ca-ss-1 ; cml:integrityHash "3e6bc2d6309633509aa0c707034107a52cd631431f746b3e3f0ad9ad7a1bd6df" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ca ; skos:note "Requirements for medical devices may be set out by regulations." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.33" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ca-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41ca-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ca-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ca-ss-2 a cml:Concept ; skos:prefLabel "41CA(2) Essential principles"@en ; cml:realizedBy doc:sec-41ca-ss-2 ; cml:integrityHash "604c49371508ea3211c0746277f56d3cefd0cda0d533a3c14503895915a62858" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ca ; skos:note "These requirements are to be known as the essential principles." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.33" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ca-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41ca-ss-2-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ca-ss-2 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ca-ss-3 a cml:Concept ; skos:prefLabel "41CA(3) Essential principles"@en ; cml:realizedBy doc:sec-41ca-ss-3 ; cml:integrityHash "b34c8d875e99f29e16cdc172bfd97f945e3e3e03e77e3b811c5252cf050372f8" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ca ; skos:note "Requirements for unique device identifiers and medical devices in the database" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.33" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ca-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41ca-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ca-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ca-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41ca-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41ca-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "requires" ; cml:logicSummary "Requires unique device identifiers" ; cml:premiseText "(a) unique device identifiers of medical devices;" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ca-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41ca-ss-3-logic-deontic-2 . concept:therapeutic-goods-act-1989-sec-41ca-ss-3-logic-deontic-2 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "requires" ; cml:logicSummary "Requires information about medical devices" ; cml:premiseText "(b) information relating to those unique device identifiers, those medical devices or the import, export, manufacture or supply of those medical devices." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ca-ss-4 a cml:Concept ; skos:prefLabel "41CA(4) Essential principles"@en ; cml:realizedBy doc:sec-41ca-ss-4 ; cml:integrityHash "c9f2fe32302d15a9bc3f8589f2d3ae27406bbe28869d0a9f9426ab76a9c2c218" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ca ; skos:note "Subsection (3) has effect subject to subsection 41CE(2)." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.33" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ca-ss-4-norm . concept:therapeutic-goods-act-1989-sec-41ca-ss-4-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ca-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ca-ss-5 a cml:Concept ; skos:prefLabel "41CA(5) Essential principles"@en ; cml:realizedBy doc:sec-41ca-ss-5 ; cml:integrityHash "7531707ba95d473ed900e179a41dc41ef66c17fdc4bc45eac8b8edb65e828695" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ca ; skos:note "Does not limit subsection (1)" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.33" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ca-ss-5-norm . concept:therapeutic-goods-act-1989-sec-41ca-ss-5-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ca-ss-5 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41cb a cml:Concept ; skos:prefLabel "41CB Medical device standards"@en ; cml:realizedBy doc:sec-41cb ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41cb-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41cb-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41cb-ss-3 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.34" . concept:therapeutic-goods-act-1989-sec-41cb-ss-1 a cml:Concept ; skos:prefLabel "41CB(1) Medical device standards"@en ; cml:realizedBy doc:sec-41cb-ss-1 ; cml:integrityHash "9e8eff273ad318454aab11a9805fb5cfe5a2120e5fcff44522de9b5c7b908909" ; values:partOf concept:therapeutic-goods-act-1989-sec-41cb ; skos:note "The Minister may make an order determining medical device standards." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.34" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41cb-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41cb-ss-1-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41cb-ss-1 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41cb-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41cb-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41cb-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "May" ; cml:logicSummary "Permission to make an order" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41cb-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41cb-ss-1-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-41cb-ss-1-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "During" ; cml:logicSummary "Order may commence at any time" ; cml:premiseText "Note: Section 12 of the Legislation Act 2003 deals with when a legislative instrument commences." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41cb-ss-2 a cml:Concept ; skos:prefLabel "41CB(2) Medical device standards"@en ; cml:realizedBy doc:sec-41cb-ss-2 ; cml:integrityHash "7afd5ee5e461a3c4a67e086f8c1616e7047c4e563eca7c18df02752fb0b9d2e7" ; values:partOf concept:therapeutic-goods-act-1989-sec-41cb ; skos:note "Variation or revocation of orders by Minister" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.34" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41cb-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41cb-ss-2-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41cb-ss-2 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41cb-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41cb-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41cb-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "Granting permission to vary or revoke orders" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41cb-ss-3 a cml:Concept ; skos:prefLabel "41CB(3) Medical device standards"@en ; cml:realizedBy doc:sec-41cb-ss-3 ; cml:integrityHash "4c3eed0c4aaf1d570d7b20570f4287e4f37c66899758a65d78d811c3f2b532bc" ; values:partOf concept:therapeutic-goods-act-1989-sec-41cb ; skos:note "Allows for incorporation of existing instruments or writings into an order or variation thereof." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.34" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41cb-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41cb-ss-3-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41cb-ss-3 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41cc a cml:Concept ; skos:prefLabel "41CC Content of medical device standards"@en ; cml:realizedBy doc:sec-41cc ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41cc-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41cc-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.34" . concept:therapeutic-goods-act-1989-sec-41cc-ss-1 a cml:Concept ; skos:prefLabel "41CC(1) Content of medical device standards"@en ; cml:realizedBy doc:sec-41cc-ss-1 ; cml:integrityHash "355300d881e5fca51b1d54b15e4bd1da51da0b765dc27a2828be7da22fc7f4d9" ; values:partOf concept:therapeutic-goods-act-1989-sec-41cc ; skos:note "Specifies how medical device standards can be established." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.34" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41cc-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41cc-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41cc-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41cc-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41cc-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41cc-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "specifies" ; cml:logicSummary "Establishes a standard for medical devices." ; cml:premiseText "(1) Without limiting the scope of section 41CB, an order establishing a medical device standard..." ; cml:conclusionText "...may be specified by reference to..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41cc-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41cc-ss-1-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-41cc-ss-1-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "between" ; cml:logicSummary "Establishes temporal intervals." ; cml:premiseText "(f) such other matters as the Minister thinks fit." ; cml:conclusionText "...or (e) a standard published by a standards organisation; or..." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41cc-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41cc-ss-1-logic-argumentation-3 . concept:therapeutic-goods-act-1989-sec-41cc-ss-1-logic-argumentation-3 a cml:LogicApplication ; cml:modality cml:Argumentation ; cml:operator "implies" ; cml:logicSummary "Establishes implications for medical device standards." ; cml:premiseText "(1) Without limiting the scope of section 41CB, an order establishing a medical device standard..." ; cml:conclusionText "...may be specified by reference to..." ; cml:executionSurface "modalities::argumentation" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41cc-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41cc-ss-1-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-41cc-ss-1-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "diffuses" ; cml:logicSummary "Spreads information about medical device standards." ; cml:premiseText "(f) such other matters as the Minister thinks fit." ; cml:conclusionText "...or (e) a standard published by a standards organisation; or..." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41cc-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41cc-ss-1-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-41cc-ss-1-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "recognises" ; cml:logicSummary "Recognizes patterns in medical device standards." ; cml:premiseText "(f) such other matters as the Minister thinks fit." ; cml:conclusionText "...or (e) a standard published by a standards organisation; or..." ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41cc-ss-2 a cml:Concept ; skos:prefLabel "41CC(2) Content of medical device standards"@en ; cml:realizedBy doc:sec-41cc-ss-2 ; cml:integrityHash "b13d436579ba8cef3753900f5f937e7722bd089d7342eb1493af78c1d29f2b96" ; values:partOf concept:therapeutic-goods-act-1989-sec-41cc ; skos:note "List of organisations that can declare standards" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.34" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41cc-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41cc-ss-2-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41cc-ss-2 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41cd a cml:Concept ; skos:prefLabel "41CD Inconsistencies between medical device standards"@en ; cml:realizedBy doc:sec-41cd ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41cd-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41cd-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.35" . concept:therapeutic-goods-act-1989-sec-41cd-ss-1 a cml:Concept ; skos:prefLabel "41CD(1) Inconsistencies between medical device standards"@en ; cml:realizedBy doc:sec-41cd-ss-1 ; cml:integrityHash "d43d85122f7c6e83529e35a36f18583018e171a0fb3922a5cecfb8e87dd20883" ; values:partOf concept:therapeutic-goods-act-1989-sec-41cd ; skos:note "A medical device standard that is inconsistent with another standard has no effect." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.35" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41cd-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41cd-ss-1-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41cd-ss-1 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41cd-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41cd-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41cd-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits the application of inconsistent standards." ; cml:premiseText "(a) applies to a kind of medical device; and (b) is inconsistent with another medical device standard that applies only to some of the devices of that kind;" ; cml:conclusionText "is, to the extent of the inconsistency, of no effect in relation to the devices referred to in paragraph (b)." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41cd-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41cd-ss-1-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41cd-ss-1-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Classify" ; cml:logicSummary "Classifies inconsistent standards as having no effect." ; cml:premiseText "(a) applies to a kind of medical device; and (b) is inconsistent with another medical device standard that applies only to some of the devices of that kind;" ; cml:conclusionText "is, to the extent of the inconsistency, of no effect in relation to the devices referred to in paragraph (b)." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41cd-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41cd-ss-1-logic-alleninterval-3 . concept:therapeutic-goods-act-1989-sec-41cd-ss-1-logic-alleninterval-3 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Overlap" ; cml:logicSummary "Overlaps inconsistent standards." ; cml:premiseText "(a) applies to a kind of medical device; and (b) is inconsistent with another medical device standard that applies only to some of the devices of that kind;" ; cml:conclusionText "is, to the extent of the inconsistency, of no effect in relation to the devices referred to in paragraph (b)." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41cd-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41cd-ss-1-logic-ltl-4 . concept:therapeutic-goods-act-1989-sec-41cd-ss-1-logic-ltl-4 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Overlap" ; cml:logicSummary "Overlaps inconsistent standards." ; cml:premiseText "(a) applies to a kind of medical device; and (b) is inconsistent with another medical device standard that applies only to some of the devices of that kind;" ; cml:conclusionText "is, to the extent of the inconsistency, of no effect in relation to the devices referred to in paragraph (b)." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41cd-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41cd-ss-1-logic-diffusion-5 . concept:therapeutic-goods-act-1989-sec-41cd-ss-1-logic-diffusion-5 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "Influence" ; cml:logicSummary "Influences inconsistent standards." ; cml:premiseText "(a) applies to a kind of medical device; and (b) is inconsistent with another medical device standard that applies only to some of the devices of that kind;" ; cml:conclusionText "is, to the extent of the inconsistency, of no effect in relation to the devices referred to in paragraph (b)." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41cd-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41cd-ss-1-logic-cogai-6 . concept:therapeutic-goods-act-1989-sec-41cd-ss-1-logic-cogai-6 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "Classify" ; cml:logicSummary "Classifies inconsistent standards as having no effect." ; cml:premiseText "(a) applies to a kind of medical device; and (b) is inconsistent with another medical device standard that applies only to some of the devices of that kind;" ; cml:conclusionText "is, to the extent of the inconsistency, of no effect in relation to the devices referred to in paragraph (b)." ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41cd-ss-2 a cml:Concept ; skos:prefLabel "41CD(2) Inconsistencies between medical device standards"@en ; cml:realizedBy doc:sec-41cd-ss-2 ; cml:integrityHash "51437262c401bbe0350840dc034168ee555a94219c9cc9653a5713bcd018caec" ; values:partOf concept:therapeutic-goods-act-1989-sec-41cd ; skos:note "A medical device standard for a combination of component parts takes precedence over standards for individual parts." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.35" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41cd-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41cd-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41cd-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41cd-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41cd-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41cd-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "takes precedence" ; cml:logicSummary "Priority obligation" ; cml:premiseText "(2) A medical device standard..." ; cml:conclusionText "...over any medical device standard..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41cd-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41cd-ss-2-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41cd-ss-2-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "subclass hierarchy" ; cml:logicSummary "Combination of component parts as a subclass of individual parts" ; cml:premiseText "(2) A medical device standard..." ; cml:conclusionText "...applies to the component parts." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ce a cml:Concept ; skos:prefLabel "41CE Database of unique device identifiers of medical devices"@en ; cml:realizedBy doc:sec-41ce ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ce-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ce-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ce-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ce-ss-4 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ce-ss-5 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ce-ss-6 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ce-ss-7 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ce-ss-8 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.36" . concept:therapeutic-goods-act-1989-sec-41ce-ss-1 a cml:Concept ; skos:prefLabel "41CE(1) Database of unique device identifiers of medical devices"@en ; cml:realizedBy doc:sec-41ce-ss-1 ; cml:integrityHash "77256df3b448722d9c733e43502243b5c1099888ff2843fc5ab70c0fff4c74c7" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ce ; skos:note "Establishment of a database for unique device identifiers of medical devices" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.36" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ce-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41ce-ss-1-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ce-ss-1 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ce-ss-2 a cml:Concept ; skos:prefLabel "41CE(2) Database of unique device identifiers of medical devices"@en ; cml:realizedBy doc:sec-41ce-ss-2 ; cml:integrityHash "4e05992bf704b0aba6855da4b700c8ab58503df1a4bdb542bd32de75c58d65e4" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ce ; skos:note "Personal information must not be included in the database unless certain conditions are met." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.36" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ce-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41ce-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ce-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ce-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41ce-ss-2-logic-descriptionlogic-1 . concept:therapeutic-goods-act-1989-sec-41ce-ss-2-logic-descriptionlogic-1 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "=" ; cml:logicSummary "Class hierarchy for devices and representatives" ; cml:premiseText "Device → Representative" ; cml:conclusionText "Representative → Device" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ce-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41ce-ss-2-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-41ce-ss-2-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "<=" ; cml:logicSummary "Temporal relationship between device registration and personal information collection" ; cml:premiseText "Device registered → Personal Information Collection" ; cml:conclusionText "Personal Information Collection → Device Registered" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ce-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41ce-ss-2-logic-deontic-3 . concept:therapeutic-goods-act-1989-sec-41ce-ss-2-logic-deontic-3 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "=" ; cml:logicSummary "Obligation to exclude personal information from the database" ; cml:premiseText "State → Obligation to Exclude Personal Information" ; cml:conclusionText "Obligation to Exclude Personal Information → State" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ce-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41ce-ss-2-logic-ltl-4 . concept:therapeutic-goods-act-1989-sec-41ce-ss-2-logic-ltl-4 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "<=" ; cml:logicSummary "Temporal relationship between device registration and personal information collection" ; cml:premiseText "Device registered → Personal Information Collection" ; cml:conclusionText "Personal Information Collection → Device Registered" ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ce-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41ce-ss-2-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-41ce-ss-2-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "=" ; cml:logicSummary "Artificial intelligence application for device registration and personal information collection" ; cml:premiseText "Device Registration → Personal Information Collection" ; cml:conclusionText "Personal Information Collection → Device Registration" ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ce-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41ce-ss-2-logic-shacl-6 . concept:therapeutic-goods-act-1989-sec-41ce-ss-2-logic-shacl-6 a cml:LogicApplication ; cml:modality cml:SHACL ; cml:operator "=" ; cml:logicSummary "Schema-based validation for device registration and personal information collection" ; cml:premiseText "Device Registration → Personal Information Collection" ; cml:conclusionText "Personal Information Collection → Device Registration" ; cml:executionSurface "modalities::logic::shacl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ce-ss-3 a cml:Concept ; skos:prefLabel "41CE(3) Database of unique device identifiers of medical devices"@en ; cml:realizedBy doc:sec-41ce-ss-3 ; cml:integrityHash "3658ef41d5efe6c6118bfbae5fd597c56b92974a6310065bef9ecff9d578d76e" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ce ; skos:note "Regulations may provide for removal of information from database." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.36" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ce-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41ce-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ce-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ce-ss-4 a cml:Concept ; skos:prefLabel "41CE(4) Database of unique device identifiers of medical devices"@en ; cml:realizedBy doc:sec-41ce-ss-4 ; cml:integrityHash "f2558408776c8ffb85edb7a93f3171b0d7009fe0f77d1a923dd5eb2f5c71755c" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ce ; skos:note "Making the database available" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.36" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ce-ss-4-norm . concept:therapeutic-goods-act-1989-sec-41ce-ss-4-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ce-ss-4 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ce-ss-5 a cml:Concept ; skos:prefLabel "41CE(5) Database of unique device identifiers of medical devices"@en ; cml:realizedBy doc:sec-41ce-ss-5 ; cml:integrityHash "37dc8ad494c7d816b4549eb99fd6814086947bc90a48b2e002b8ca7e888c2684" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ce ; skos:note "Database of unique device identifiers of medical devices may be made available to specified persons, authorities or bodies." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.36" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ce-ss-5-norm . concept:therapeutic-goods-act-1989-sec-41ce-ss-5-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ce-ss-5 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ce-ss-6 a cml:Concept ; skos:prefLabel "41CE(6) Database of unique device identifiers of medical devices"@en ; cml:realizedBy doc:sec-41ce-ss-6 ; cml:integrityHash "1665ba29db319739e2819bdcd044aaa10d6a333bbb6c311c2c7c0965861ad7df" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ce ; skos:note "Personal information must not be made publicly available." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.36" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ce-ss-6-norm . concept:therapeutic-goods-act-1989-sec-41ce-ss-6-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ce-ss-6 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ce-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-41ce-ss-6-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41ce-ss-6-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibits public disclosure of personal information." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ce-ss-7 a cml:Concept ; skos:prefLabel "41CE(7) Database of unique device identifiers of medical devices"@en ; cml:realizedBy doc:sec-41ce-ss-7 ; cml:integrityHash "af2f04c201bfbf8ed83925213a797fced55d8d390422c72747724041ea032b77" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ce ; skos:note "Database of unique device identifiers of medical devices is not a legislative instrument." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.36" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ce-ss-7-norm . concept:therapeutic-goods-act-1989-sec-41ce-ss-7-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ce-ss-7 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ce-ss-8 a cml:Concept ; skos:prefLabel "41CE(8) Database of unique device identifiers of medical devices"@en ; cml:realizedBy doc:sec-41ce-ss-8 ; cml:integrityHash "04b6ffdae28df89b496fb8a0b2a40239a89bbac0baaa10b4aaad25a512c8893b" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ce ; skos:note "Database of unique device identifiers of medical devices is not a legislative instrument." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.36" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ce-ss-8-norm . concept:therapeutic-goods-act-1989-sec-41ce-ss-8-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ce-ss-8 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41d a cml:Concept ; skos:prefLabel "41D What this Part is about"@en ; cml:realizedBy doc:sec-41d ; cml:integrityHash "f2d950a4a205a25ba2345c7ec89d5e533df4c8d0b95edeaa02de9fbe8ef6566f" ; skos:note "Compliance with applicable conformity assessment standards is not required, but it is one way to establish that one or more parts of the conformity assessment procedures have been applied." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.38" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41d-norm . concept:therapeutic-goods-act-1989-sec-41d-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41d ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41d cml:asserts concept:therapeutic-goods-act-1989-sec-41d-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41d-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must comply with applicable standards" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41da a cml:Concept ; skos:prefLabel "41DA Conformity assessment procedures"@en ; cml:realizedBy doc:sec-41da ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41da-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41da-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41da-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41da-ss-4 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.39" . concept:therapeutic-goods-act-1989-sec-41da-ss-1 a cml:Concept ; skos:prefLabel "41DA(1) Conformity assessment procedures"@en ; cml:realizedBy doc:sec-41da-ss-1 ; cml:integrityHash "3197d12821c35fdcd4f19baa0bdae72953c02a126ffa7a881048331eaefccd3d" ; values:partOf concept:therapeutic-goods-act-1989-sec-41da ; skos:note "Manufacturers of medical devices must comply with regulations." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.39" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41da-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41da-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41da-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41da-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41da-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41da-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Expresses a duty" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41da-ss-2 a cml:Concept ; skos:prefLabel "41DA(2) Conformity assessment procedures"@en ; cml:realizedBy doc:sec-41da-ss-2 ; cml:integrityHash "badb323fd758869b373480d85486a31b72dcd74dbab440f660ef627f2a140192" ; values:partOf concept:therapeutic-goods-act-1989-sec-41da ; skos:note "Conformity assessment procedures" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.39" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41da-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41da-ss-2-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41da-ss-2 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41da-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41da-ss-2-logic-alleninterval-1 . concept:therapeutic-goods-act-1989-sec-41da-ss-2-logic-alleninterval-1 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Applicable" ; cml:logicSummary "Requires temporal intervals for conformity assessment procedures" ; cml:premiseText "Temporal interval relation" ; cml:conclusionText "Undertaking" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41da-ss-3 a cml:Concept ; skos:prefLabel "41DA(3) Conformity assessment procedures"@en ; cml:realizedBy doc:sec-41da-ss-3 ; cml:integrityHash "b2a51c867618649e1613262631e4bd86ad6040a68460766d475b6da3ba4d1652" ; values:partOf concept:therapeutic-goods-act-1989-sec-41da ; skos:note "Conformity assessment procedures may be limited or apply differently to different classifications." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.39" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41da-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41da-ss-3-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41da-ss-3 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41da-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41da-ss-3-logic-linearlogic-1 . concept:therapeutic-goods-act-1989-sec-41da-ss-3-logic-linearlogic-1 a cml:LogicApplication ; cml:modality cml:LinearLogic ; cml:operator "or" ; cml:logicSummary "Procedure may be limited or apply differently" ; cml:executionSurface "modalities::linear" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41da-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41da-ss-3-logic-deontic-2 . concept:therapeutic-goods-act-1989-sec-41da-ss-3-logic-deontic-2 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "Permission to limit procedure application" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41da-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41da-ss-3-logic-alleninterval-3 . concept:therapeutic-goods-act-1989-sec-41da-ss-3-logic-alleninterval-3 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "during" ; cml:logicSummary "Procedure may be limited in time" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41da-ss-4 a cml:Concept ; skos:prefLabel "41DA(4) Conformity assessment procedures"@en ; cml:realizedBy doc:sec-41da-ss-4 ; cml:integrityHash "a50ddd77a7df7adaa0a700a5e23e2ee25d85ec53e7cc35ac67a14013d123553d" ; values:partOf concept:therapeutic-goods-act-1989-sec-41da ; skos:note "Regulations may relate to conformity assessment procedures for medical devices." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.39" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41da-ss-4-norm . concept:therapeutic-goods-act-1989-sec-41da-ss-4-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41da-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41db a cml:Concept ; skos:prefLabel "41DB Medical device classifications"@en ; cml:realizedBy doc:sec-41db ; cml:integrityHash "ea0e7dc46f81b93af73c06af678dba71c2625ed7c78080146a087aceff6831ad" ; skos:note "Classifications and matters related to medical device classifications" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.40" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41db-norm . concept:therapeutic-goods-act-1989-sec-41db-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41db ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41dc a cml:Concept ; skos:prefLabel "41DC Conformity assessment standards"@en ; cml:realizedBy doc:sec-41dc ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41dc-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41dc-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41dc-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41dc-ss-4 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.41" . concept:therapeutic-goods-act-1989-sec-41dc-ss-1 a cml:Concept ; skos:prefLabel "41DC(1) Conformity assessment standards"@en ; cml:realizedBy doc:sec-41dc-ss-1 ; cml:integrityHash "e163d8ddd7069306298a8b56ea2d1810ee66987dec9aedfbfba7dd435ee797d0" ; values:partOf concept:therapeutic-goods-act-1989-sec-41dc ; skos:note "Minister may make an order determining conformity assessment standards." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.41" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41dc-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41dc-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41dc-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41dc-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41dc-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41dc-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "May" ; cml:logicSummary "Minister has the power to make an order." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41dc-ss-2 a cml:Concept ; skos:prefLabel "41DC(2) Conformity assessment standards"@en ; cml:realizedBy doc:sec-41dc-ss-2 ; cml:integrityHash "490dd7857c19a543d1616331878d334f9b9f0053d9f2a62d2bd94ec0f83d3535" ; values:partOf concept:therapeutic-goods-act-1989-sec-41dc ; skos:note "A conformity assessment standard may be limited to particular kinds of medical devices." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.41" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41dc-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41dc-ss-2-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41dc-ss-2 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41dc-ss-3 a cml:Concept ; skos:prefLabel "41DC(3) Conformity assessment standards"@en ; cml:realizedBy doc:sec-41dc-ss-3 ; cml:integrityHash "815c593313f9ee84ce708f1df2dfd08a7a70434fd8297c8850e9f6b74d36a7ae" ; values:partOf concept:therapeutic-goods-act-1989-sec-41dc ; skos:note "Minister may vary or revoke orders made under subsection (1)" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.41" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41dc-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41dc-ss-3-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41dc-ss-3 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41dc-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41dc-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41dc-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "May" ; cml:logicSummary "Minister may vary or revoke orders" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41dc-ss-4 a cml:Concept ; skos:prefLabel "41DC(4) Conformity assessment standards"@en ; cml:realizedBy doc:sec-41dc-ss-4 ; cml:integrityHash "f204e87118e03f338d8f942622e13fe7aa873a32b3d50a0b171d99f2a5c0c077" ; values:partOf concept:therapeutic-goods-act-1989-sec-41dc ; skos:note "Allows for provision in relation to a matter by applying, adopting or incorporating an existing instrument or writing." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.41" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41dc-ss-4-norm . concept:therapeutic-goods-act-1989-sec-41dc-ss-4-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41dc-ss-4 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41dd a cml:Concept ; skos:prefLabel "41DD Content of conformity assessment standards"@en ; cml:realizedBy doc:sec-41dd ; cml:integrityHash "c1703b55d1ca02420abfffb5cf8f3460e9e414c159b6d8d591aaca8a4001ca82" ; skos:note "Specifies how an order establishing a conformity assessment standard for a kind of medical device may be specified." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.41" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41dd-norm . concept:therapeutic-goods-act-1989-sec-41dd-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41dd ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41de a cml:Concept ; skos:prefLabel "41DE Inconsistencies between conformity assessment standards"@en ; cml:realizedBy doc:sec-41de ; cml:integrityHash "20dc965ccfe51ffcf7503baf65b1bc6a34539833a496d0f97f6a6d07bad08194" ; skos:note "Inconsistencies between conformity assessment standards are of no effect." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.42" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41de-norm . concept:therapeutic-goods-act-1989-sec-41de-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41de ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41de cml:asserts concept:therapeutic-goods-act-1989-sec-41de-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41de-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibits inconsistency between conformity assessment standards." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41e a cml:Concept ; skos:prefLabel "41E What this Part is about"@en ; cml:realizedBy doc:sec-41e ; cml:integrityHash "cfc3e5bf72bdd4739a2981ce5d04cb0b3806bdc6bf78e08dbe8cf53253ad0b83" ; skos:note "Secretary can issue conformity assessment certificate for medical devices" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.43" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41e-norm . concept:therapeutic-goods-act-1989-sec-41e-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41e ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ea a cml:Concept ; skos:prefLabel "41EA When conformity assessment certificates are required"@en ; cml:realizedBy doc:sec-41ea ; cml:integrityHash "df362d4590cd5809b9292d81039dd75e02c270c3a65fe9ad6eb2b4da5f9bc91e" ; skos:note "Regulations may prescribe requirements for manufacturers and medical devices." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.44" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ea-norm . concept:therapeutic-goods-act-1989-sec-41ea-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ea ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ea cml:asserts concept:therapeutic-goods-act-1989-sec-41ea-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41ea-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Regulations must be prescribed." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41eb a cml:Concept ; skos:prefLabel "41EB Applications"@en ; cml:realizedBy doc:sec-41eb ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41eb-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41eb-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41eb-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41eb-ss-4 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.44" . concept:therapeutic-goods-act-1989-sec-41eb-ss-1 a cml:Concept ; skos:prefLabel "41EB(1) Applications"@en ; cml:realizedBy doc:sec-41eb-ss-1 ; cml:integrityHash "84da071d80331b00a13e339cb954e55267cd4d77409fe87467d2d23a489a6036" ; values:partOf concept:therapeutic-goods-act-1989-sec-41eb ; skos:note "Application for conformity assessment certificate must be made in a specific manner." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.44" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41eb-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41eb-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41eb-ss-1 ; values:borneBy values:LegalPerson ; skos:scopeNote "borne by: LegalPerson" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41eb-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41eb-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41eb-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Application must be made in accordance with a form approved by the Secretary." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41eb-ss-2 a cml:Concept ; skos:prefLabel "41EB(2) Applications"@en ; cml:realizedBy doc:sec-41eb-ss-2 ; cml:integrityHash "18b6825f35534ed77f61254da65172ee34d1f83610b8e35bcd0a8e3ffafbd786" ; values:partOf concept:therapeutic-goods-act-1989-sec-41eb ; skos:note "Application is not effective if fee or false information is provided." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.44" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41eb-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41eb-ss-2-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41eb-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41eb-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41eb-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41eb-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Application cannot be effective." ; cml:premiseText "Prescribed fee not paid or false information in application." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41eb-ss-3 a cml:Concept ; skos:prefLabel "41EB(3) Applications"@en ; cml:realizedBy doc:sec-41eb-ss-3 ; cml:integrityHash "87da6b39abfca9e679160251c950ccb8b15aae35223b5de559d2df144a8efa33" ; values:partOf concept:therapeutic-goods-act-1989-sec-41eb ; skos:note "Application may be given in accordance with specified software requirements." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.44" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41eb-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41eb-ss-3-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41eb-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41eb-ss-4 a cml:Concept ; skos:prefLabel "41EB(4) Applications"@en ; cml:realizedBy doc:sec-41eb-ss-4 ; cml:integrityHash "c52cba30a80ef6fe666ffd4895f3d58ff65eb441f7099dc5bfcbe1ac0f639530" ; values:partOf concept:therapeutic-goods-act-1989-sec-41eb ; skos:note "Inspect premises and equipment for medical devices" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.44" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41eb-ss-4-norm . concept:therapeutic-goods-act-1989-sec-41eb-ss-4-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41eb-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41eb-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41eb-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41eb-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Allow" ; cml:logicSummary "Grant permission to inspect" ; cml:premiseText "(4) The Secretary may..." ; cml:conclusionText "...require the applicant to allow an authorised person..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41eb-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41eb-ss-4-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-41eb-ss-4-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Temporal relation" ; cml:logicSummary "Specify reasonable time for inspection" ; cml:premiseText "...at any reasonable time specified in the notice..." ; cml:conclusionText "...to inspect at that time." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ec a cml:Concept ; skos:prefLabel "41EC Considering applications"@en ; cml:realizedBy doc:sec-41ec ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ec-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ec-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ec-ss-3 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.45" . concept:therapeutic-goods-act-1989-sec-41ec-ss-1 a cml:Concept ; skos:prefLabel "41EC(1) Considering applications"@en ; cml:realizedBy doc:sec-41ec-ss-1 ; cml:integrityHash "0db1c3df32026e4fc32a4510cf46cf666444c3e4775621a72a18580b69bfb377" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ec ; skos:note "Secretary must decide whether to issue conformity assessment certificate." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.45" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ec-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41ec-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ec-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ec-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41ec-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41ec-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must decide" ; cml:conclusionText "issue conformity assessment certificate" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ec-ss-2 a cml:Concept ; skos:prefLabel "41EC(2) Considering applications"@en ; cml:realizedBy doc:sec-41ec-ss-2 ; cml:integrityHash "8e9f348a6bad7b1e37b6fb173c26c57707555cf69c3bcd7e156c2a57a7a7e1d2" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ec ; skos:note "Consider conformity assessment procedures when issuing a certificate." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.45" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ec-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41ec-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ec-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ec-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41ec-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41ec-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must consider certain aspects" ; cml:premiseText "(2) In deciding..." ; cml:conclusionText "must consider..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ec-ss-3 a cml:Concept ; skos:prefLabel "41EC(3) Considering applications"@en ; cml:realizedBy doc:sec-41ec-ss-3 ; cml:integrityHash "876c07d72714aaf74266ff26e586ad00f7d3a661274ce87d1631a04cf1f7578d" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ec ; skos:note "Consider applicant's eligibility when issuing certificate" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.45" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ec-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41ec-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ec-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ec-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41ec-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41ec-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must consider applicant's eligibility" ; cml:premiseText "(3) In deciding whether to issue the certificate, the Secretary must also..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ed a cml:Concept ; skos:prefLabel "41ED Time for making decisions on applications"@en ; cml:realizedBy doc:sec-41ed ; cml:integrityHash "f780d6beb45a45183421d233eaedb0e1dca61a4e6216564bee9edc5c9513b56c" ; skos:note "Decision on application must be made within a prescribed period." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.49" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ed-norm . concept:therapeutic-goods-act-1989-sec-41ed-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ed ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ed cml:asserts concept:therapeutic-goods-act-1989-sec-41ed-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41ed-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must provide decision within prescribed period." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ee a cml:Concept ; skos:prefLabel "41EE Procedure following making a decision whether to issue"@en ; cml:realizedBy doc:sec-41ee ; cml:integrityHash "03d66dd08835c1ca3f128cceacd1f31ac94163096b20f445ae84285bc0832d72" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ee-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ee-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ee-ss-3 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.49" . concept:therapeutic-goods-act-1989-sec-41ee-ss-1 a cml:Concept ; skos:prefLabel "41EE(1) Procedure following making a decision whether to issue"@en ; cml:realizedBy doc:sec-41ee-ss-1 ; cml:integrityHash "0242e559c47ebc263dc8c15a458cc1944e74bf6ad82449df3fdea656dbfde880" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ee ; skos:note "Secretary must notify applicant of decision within 20 working days." ; dc:description "Reasons for decision if not issuing certificate." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.49" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ee-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41ee-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ee-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ee-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41ee-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41ee-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Secretary must perform action." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ee-ss-2 a cml:Concept ; skos:prefLabel "41EE(2) Procedure following making a decision whether to issue"@en ; cml:realizedBy doc:sec-41ee-ss-2 ; cml:integrityHash "d6f88d8a47eb0e0114278185f7dcacd3916112aa9dea69a81170a85b011ed9ed" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ee ; skos:note "Manufacturer must specify covered medical devices on conformity assessment certificate." ; dc:description "Yes" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.49" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ee-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41ee-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ee-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ee-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41ee-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41ee-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Obligation to specify covered medical devices." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ee-ss-3 a cml:Concept ; skos:prefLabel "41EE(3) Procedure following making a decision whether to issue"@en ; cml:realizedBy doc:sec-41ee-ss-3 ; cml:integrityHash "dc5bbcb3eddddb045b4515f2263d377ed61d9ece61555a1e00acbf2b97e63710" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ee ; skos:note "Must contain prescribed information" ; dc:description "Yes" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.49" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ee-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41ee-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ee-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ee-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41ee-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41ee-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Obligation to provide information" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ef a cml:Concept ; skos:prefLabel "41EF Duration of certificate"@en ; cml:realizedBy doc:sec-41ef ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ef-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ef-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ef-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ef-ss-4 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ef-ss-5 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ef-ss-6 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.50" . concept:therapeutic-goods-act-1989-sec-41ef-ss-1 a cml:Concept ; skos:prefLabel "41EF(1) Duration of certificate"@en ; cml:realizedBy doc:sec-41ef-ss-1 ; cml:integrityHash "1e29325c23e3c4dd1522272376b5abf9e57d7b7510cf72df64218601c55cc299" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ef ; skos:note "Certificate commences on specified day and must be in force for no longer than 5 years." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.50" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ef-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41ef-ss-1-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ef-ss-1 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ef-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41ef-ss-1-logic-alleninterval-1 . concept:therapeutic-goods-act-1989-sec-41ef-ss-1-logic-alleninterval-1 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "during" ; cml:logicSummary "Specifies temporal interval" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ef-ss-2 a cml:Concept ; skos:prefLabel "41EF(2) Duration of certificate"@en ; cml:realizedBy doc:sec-41ef-ss-2 ; cml:integrityHash "37d1b59e7580fa236071c2528b2e414d5356ab0f77455c1508f5f3eac9c8028c" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ef ; skos:note "Certificate validity period" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.50" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ef-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41ef-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ef-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ef-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41ef-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41ef-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligate" ; cml:logicSummary "Certificate validity period" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ef-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41ef-ss-2-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-41ef-ss-2-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator ">=" ; cml:logicSummary "Temporal interval" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ef-ss-3 a cml:Concept ; skos:prefLabel "41EF(3) Duration of certificate"@en ; cml:realizedBy doc:sec-41ef-ss-3 ; cml:integrityHash "1c3a5fbdff3f593d4231c6d901b81e5bad54efd07659a07e454b9e37255d12b1" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ef ; skos:note "Secretary may extend certificate period" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.50" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ef-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41ef-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ef-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ef-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41ef-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41ef-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "Permissive obligation" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ef-ss-4 a cml:Concept ; skos:prefLabel "41EF(4) Duration of certificate"@en ; cml:realizedBy doc:sec-41ef-ss-4 ; cml:integrityHash "28e2177cb671f3378a9ed48afbdbcc91023b1134504d3f5f161795201b9b0944" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ef ; skos:note "Extension duration limit" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.50" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ef-ss-4-norm . concept:therapeutic-goods-act-1989-sec-41ef-ss-4-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ef-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ef-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41ef-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41ef-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "=" ; cml:logicSummary "Must be no longer than 12 months" ; cml:premiseText "(4) An extension must be no longer than 12 months." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ef-ss-5 a cml:Concept ; skos:prefLabel "41EF(5) Duration of certificate"@en ; cml:realizedBy doc:sec-41ef-ss-5 ; cml:integrityHash "6ca1af0e2cb395a027e3d777725c78e666e337774f7be827d6fb8841d4fad59b" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ef ; skos:note "Only one extension may be given." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.50" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ef-ss-5-norm . concept:therapeutic-goods-act-1989-sec-41ef-ss-5-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ef-ss-5 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ef-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-41ef-ss-5-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41ef-ss-5-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Single Extension" ; cml:logicSummary "Single extension obligation" ; cml:premiseText "(5) Only one extension may be given." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ef-ss-6 a cml:Concept ; skos:prefLabel "41EF(6) Duration of certificate"@en ; cml:realizedBy doc:sec-41ef-ss-6 ; cml:integrityHash "261258a93c6211fd9182d8f49c27388cb8c4cc26ab298512e1a435bb9ce7c667" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ef ; skos:note "Secretary must give notice of extension to manufacturer and applicant." ; dc:description "Notice" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.50" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ef-ss-6-norm . concept:therapeutic-goods-act-1989-sec-41ef-ss-6-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ef-ss-6 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ef-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-41ef-ss-6-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41ef-ss-6-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Secretary must give notice." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41eg a cml:Concept ; skos:prefLabel "41EG Lapsing of applications"@en ; cml:realizedBy doc:sec-41eg ; cml:integrityHash "4d0afb11c901b7cfd66016ece4ab190936c8ea886a6d5377f57392a1373057f3" ; skos:note "Failure to comply with certain requirements results in lapse of application." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.50" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41eg-norm . concept:therapeutic-goods-act-1989-sec-41eg-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41eg ; values:borneBy values:Agent ; skos:scopeNote "borne by: Agent" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41eg cml:asserts concept:therapeutic-goods-act-1989-sec-41eg-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41eg-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibition" ; cml:premiseText "Failure to comply with requirements." ; cml:conclusionText "Lapse of application." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41eg cml:asserts concept:therapeutic-goods-act-1989-sec-41eg-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41eg-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Classify" ; cml:logicSummary "Classification of applications based on compliance" ; cml:premiseText "Applications are classified as compliant or non-compliant." ; cml:conclusionText "Lapse of application if non-compliant." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41eh a cml:Concept ; skos:prefLabel "41EH Treating applications as having been refused"@en ; cml:realizedBy doc:sec-41eh ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41eh-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41eh-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41eh-ss-3 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.51" . concept:therapeutic-goods-act-1989-sec-41eh-ss-1 a cml:Concept ; skos:prefLabel "41EH(1) Treating applications as having been refused"@en ; cml:realizedBy doc:sec-41eh-ss-1 ; cml:integrityHash "75009c47e7d13c6494a39c6ce44ce9957f923ce17d4b0094127703568d4405c4" ; values:partOf concept:therapeutic-goods-act-1989-sec-41eh ; skos:note "Applicant may treat application as refused if no decision is made within a period." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.51" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41eh-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41eh-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41eh-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41eh-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41eh-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41eh-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Applicant has an obligation to treat application as refused if no decision is made within a period." ; cml:premiseText "(a) a period is prescribed under paragraph 63(2)(dc) for making a decision on the application; and (b) at the end of the period, the applicant has not been notified of a decision whether to issue the certificate." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41eh-ss-2 a cml:Concept ; skos:prefLabel "41EH(2) Treating applications as having been refused"@en ; cml:realizedBy doc:sec-41eh-ss-2 ; cml:integrityHash "bcc02e7196104a80bfa939760d14fa95d636ad01c3ffa8aca8a7b76d3fc8066a" ; values:partOf concept:therapeutic-goods-act-1989-sec-41eh ; skos:note "The notice may be given at any time before the applicant is notified of the decision." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.51" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41eh-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41eh-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41eh-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41eh-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41eh-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41eh-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MAY" ; cml:logicSummary "May be given at any time" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41eh-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41eh-ss-2-logic-epistemic-2 . concept:therapeutic-goods-act-1989-sec-41eh-ss-2-logic-epistemic-2 a cml:LogicApplication ; cml:modality cml:Epistemic ; cml:operator "ANYTIME" ; cml:logicSummary "Before applicant is notified of decision" ; cml:executionSurface "modalities::epistemic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41eh-ss-3 a cml:Concept ; skos:prefLabel "41EH(3) Treating applications as having been refused"@en ; cml:realizedBy doc:sec-41eh-ss-3 ; cml:integrityHash "8d753510a3d92eabd2a0a0519b50d45dfce85e559682994e530981e4049801e8" ; values:partOf concept:therapeutic-goods-act-1989-sec-41eh ; skos:note "Act has no effect as if notice was given" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.51" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41eh-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41eh-ss-3-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41eh-ss-3 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41eh-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41eh-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41eh-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibits the Act from having effect" ; cml:premiseText "Notice has been given" ; cml:conclusionText "Act has no effect" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ei a cml:Concept ; skos:prefLabel "41EI Criminal offences for making a false statement"@en ; cml:realizedBy doc:sec-41ei ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ei-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ei-ss-4 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ei-ss-5 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ei-ss-6 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.52" . concept:therapeutic-goods-act-1989-sec-41ei-ss-1 a cml:Concept ; skos:prefLabel "41EI(1) Criminal offences for making a false statement"@en ; cml:realizedBy doc:sec-41ei-ss-1 ; cml:integrityHash "8822ed975f5ec8b8354dc730eaa2a9a13aed713aabde37ca9c640de48526d4ae" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ei ; skos:note "Making false statements in an application for a conformity assessment certificate is prohibited." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.52" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ei-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41ei-ss-1-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ei-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ei-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41ei-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41ei-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits making false statements in an application for a conformity assessment certificate." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ei-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41ei-ss-1-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41ei-ss-1-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Classify" ; cml:logicSummary "Classifies the statement as false or misleading in a material particular." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ei-ss-4 a cml:Concept ; skos:prefLabel "41EI(4) Criminal offences for making a false statement"@en ; cml:realizedBy doc:sec-41ei-ss-4 ; cml:integrityHash "90fb6bb40296cbad08ef39f96077763b10b7b96ceb0c222f5834fefbdcfe2e5b" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ei ; skos:note "Making false statements in an application for a conformity assessment certificate is prohibited." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.52" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ei-ss-4-norm . concept:therapeutic-goods-act-1989-sec-41ei-ss-4-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ei-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ei-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41ei-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41ei-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibition of making false statements" ; cml:premiseText "The person knows that the statement is false or misleading in a material particular." ; cml:conclusionText "The person commits an offence if..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ei-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41ei-ss-4-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-41ei-ss-4-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Temporal relation" ; cml:logicSummary "Temporal relation between the making of false statements and the committing of an offence" ; cml:premiseText "(c) The person knows that the statement is false or misleading in a material particular." ; cml:conclusionText "The person commits an offence if..." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ei-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41ei-ss-4-logic-argumentation-3 . concept:therapeutic-goods-act-1989-sec-41ei-ss-4-logic-argumentation-3 a cml:LogicApplication ; cml:modality cml:Argumentation ; cml:operator "Implication" ; cml:logicSummary "Implication of making false statements on committing an offence" ; cml:premiseText "(a) The person makes a statement (whether orally, in a document or in any other way); and" ; cml:conclusionText "The person commits an offence if..." ; cml:executionSurface "modalities::argumentation" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ei-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41ei-ss-4-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-41ei-ss-4-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "Propagation" ; cml:logicSummary "Propagation of the prohibition to related statements" ; cml:premiseText "(b) The statement is in or in connection with an application for a conformity assessment certificate; and" ; cml:conclusionText "The person commits an offence if..." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ei-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41ei-ss-4-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-41ei-ss-4-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "Entity recognition" ; cml:logicSummary "Recognition of entities involved in the making of false statements" ; cml:premiseText "(a) The person makes a statement (whether orally, in a document or in any other way); and" ; cml:conclusionText "The person commits an offence if..." ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ei-ss-5 a cml:Concept ; skos:prefLabel "41EI(5) Criminal offences for making a false statement"@en ; cml:realizedBy doc:sec-41ei-ss-5 ; cml:integrityHash "1d530bffed87e77406188ab7f66779167a4bcfdb5e23eb9d034489a2c227eaff" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ei ; skos:note "Making false statements in an application for a conformity assessment certificate is prohibited." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.52" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ei-ss-5-norm . concept:therapeutic-goods-act-1989-sec-41ei-ss-5-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ei-ss-5 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ei-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-41ei-ss-5-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41ei-ss-5-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits making false statements in an application for a conformity assessment certificate." ; cml:premiseText "(5) A person commits an offence if: (a) the person makes a statement (whether orally, in a document or in any other way); and (b) the statement is in or in connection with an application for a conformity assessment certificate; and (c) the statement is false or misleading in a material particular." ; cml:conclusionText "(Penalty: 100 penalty units.)" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ei-ss-6 a cml:Concept ; skos:prefLabel "41EI(6) Criminal offences for making a false statement"@en ; cml:realizedBy doc:sec-41ei-ss-6 ; cml:integrityHash "8aca9f6b9929541ce9832f9c101208b6939102829c3a414562388d34ea7e6fc7" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ei ; skos:note "Making a false statement in an application for conformity assessment certificate is prohibited." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.52" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ei-ss-6-norm . concept:therapeutic-goods-act-1989-sec-41ei-ss-6-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ei-ss-6 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ei-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-41ei-ss-6-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41ei-ss-6-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits making a false statement in an application for conformity assessment certificate." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ej a cml:Concept ; skos:prefLabel "41EJ Automatic conditions on conformity assessment certificates"@en ; cml:realizedBy doc:sec-41ej ; cml:integrityHash "d57d24863257f78d813bb2ec53818398eb3625ff3a4def44d4e6379ee8c3a12e" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ej-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ej-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ej-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ej-ss-4 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ej-ss-5 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ej-ss-5a ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.54" . concept:therapeutic-goods-act-1989-sec-41ej-ss-1 a cml:Concept ; skos:prefLabel "41EJ(1) Automatic conditions on conformity assessment certificates"@en ; cml:realizedBy doc:sec-41ej-ss-1 ; cml:integrityHash "3594d90bd3d66ab37c66ccc04a0860fb55ae727b00260cb1f33b653931ed7455" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ej ; skos:note "Manufacturer must allow inspection and examination of premises and medical devices." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.54" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ej-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41ej-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ej-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ej-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41ej-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41ej-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Must" ; cml:logicSummary "Manufacturer must allow inspection." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ej-ss-2 a cml:Concept ; skos:prefLabel "41EJ(2) Automatic conditions on conformity assessment certificates"@en ; cml:realizedBy doc:sec-41ej-ss-2 ; cml:integrityHash "1277c3624d0fe8de37b9dcb633227226f8d37f1aa30bd397227926bb57d2787d" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ej ; skos:note "Manufacturer must cooperate in review of conformity assessment certificate" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.54" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ej-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41ej-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ej-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ej-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41ej-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41ej-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Obligation to cooperate" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ej-ss-3 a cml:Concept ; skos:prefLabel "41EJ(3) Automatic conditions on conformity assessment certificates"@en ; cml:realizedBy doc:sec-41ej-ss-3 ; cml:integrityHash "2c3d226f1964b67236eacf6a10afe98d76d902f833e352fe30360b6a98739434" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ej ; skos:note "Notify Secretary of substantial changes to quality management systems, product range, or medical device design." ; dc:description "Notification in writing" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.54" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ej-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41ej-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ej-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ej-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41ej-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41ej-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Obligation to notify" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ej-ss-4 a cml:Concept ; skos:prefLabel "41EJ(4) Automatic conditions on conformity assessment certificates"@en ; cml:realizedBy doc:sec-41ej-ss-4 ; cml:integrityHash "d99cb854cee644760b2f511369768e0c08582fdf3f33b8157e1c45cf459fd7d8" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ej ; skos:note "Applicant must pay fee for review of conformity assessment certificate" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.54" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ej-ss-4-norm . concept:therapeutic-goods-act-1989-sec-41ej-ss-4-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ej-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ej-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41ej-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41ej-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must provide payment" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ej-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41ej-ss-4-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-41ej-ss-4-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "during" ; cml:logicSummary "Fee payment occurs during review process" ; cml:premiseText "(4) A conformity assessment certificate is subject to the condition that..." ; cml:conclusionText "...when the fee becomes due and payable." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ej-ss-5 a cml:Concept ; skos:prefLabel "41EJ(5) Automatic conditions on conformity assessment certificates"@en ; cml:realizedBy doc:sec-41ej-ss-5 ; cml:integrityHash "86a42c08d4468baad771cd08f2e7d35c9c89598dbf86f6ec9a6a94f6a8308f56" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ej ; skos:note "Prescribe different levels of fees for manufacturers and medical devices." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.54" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ej-ss-5-norm . concept:therapeutic-goods-act-1989-sec-41ej-ss-5-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ej-ss-5 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ej-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-41ej-ss-5-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41ej-ss-5-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "shall" ; cml:logicSummary "Imposes a duty on the state." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ej-ss-5a a cml:Concept ; skos:prefLabel "41EJ(5A) Automatic conditions on conformity assessment certificates"@en ; cml:realizedBy doc:sec-41ej-ss-5a ; cml:integrityHash "1f896a894ce7a1fbf9b6d5468bbe81db5ac38f0b8cc53a486f06e157976a9293" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ej ; skos:note "Conformity assessment certificates are subject to conditions prescribed by regulations." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.54" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ej-ss-5a-norm . concept:therapeutic-goods-act-1989-sec-41ej-ss-5a-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ej-ss-5a ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ej-ss-5a cml:asserts concept:therapeutic-goods-act-1989-sec-41ej-ss-5a-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41ej-ss-5a-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "SUBJUNCTIVE MODO" ; cml:logicSummary "Prescription of conditions" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ek a cml:Concept ; skos:prefLabel "41EK Conditions imposed when conformity assessment certificates"@en ; cml:realizedBy doc:sec-41ek ; cml:integrityHash "eebd33e829a035b275eda36ccdeb2e59e2ebc7e277bbe4f7dd098c95d2684e50" ; skos:note "Conditions imposed on conformity assessment certificates" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.56" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ek-norm . concept:therapeutic-goods-act-1989-sec-41ek-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ek ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ek cml:asserts concept:therapeutic-goods-act-1989-sec-41ek-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41ek-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "imposes" ; cml:logicSummary "States a duty" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41el a cml:Concept ; skos:prefLabel "41EL Conditions imposed after issuing a conformity assessment"@en ; cml:realizedBy doc:sec-41el ; cml:integrityHash "03d66dd08835c1ca3f128cceacd1f31ac94163096b20f445ae84285bc0832d72" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41el-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41el-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41el-ss-3 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.56" . concept:therapeutic-goods-act-1989-sec-41el-ss-1 a cml:Concept ; skos:prefLabel "41EL(1) Conditions imposed after issuing a conformity assessment"@en ; cml:realizedBy doc:sec-41el-ss-1 ; cml:integrityHash "9d448505160c54e0f180fb1519fc7a09edca88b8fac034d2486a1a980adb19cc" ; values:partOf concept:therapeutic-goods-act-1989-sec-41el ; skos:note "Secretary may impose new conditions on a conformity assessment certificate." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.56" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41el-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41el-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41el-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41el-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41el-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41el-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "Imposes obligation on the manufacturer." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41el-ss-2 a cml:Concept ; skos:prefLabel "41EL(2) Conditions imposed after issuing a conformity assessment"@en ; cml:realizedBy doc:sec-41el-ss-2 ; cml:integrityHash "af692abab97d51cf3472951b4230ca549b1f0e000ac5ccd6f1cddf63e15d8e3e" ; values:partOf concept:therapeutic-goods-act-1989-sec-41el ; skos:note "Conditions imposed after issuing a conformity assessment take effect on the specified day." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.56" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41el-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41el-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41el-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41el-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41el-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41el-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "takesEffect" ; cml:logicSummary "Conditions take effect when specified" ; cml:premiseText "The imposition, variation or removal of a condition under this section takes effect on the day on which the notice is given to the person; or" ; cml:conclusionText "The condition takes effect on the specified day." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41el-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41el-ss-2-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-41el-ss-2-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "during" ; cml:logicSummary "Conditions occur during the specified time period" ; cml:premiseText "The imposition, variation or removal of a condition under this section takes effect on the day on which the notice is given to the person; or" ; cml:conclusionText "The condition occurs during the specified time period." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41el-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41el-ss-2-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-41el-ss-2-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "during" ; cml:logicSummary "Conditions occur during the specified time period" ; cml:premiseText "The imposition, variation or removal of a condition under this section takes effect on the day on which the notice is given to the person; or" ; cml:conclusionText "The condition occurs during the specified time period." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41el-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41el-ss-2-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-41el-ss-2-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "during" ; cml:logicSummary "Conditions occur during the specified time period" ; cml:premiseText "The imposition, variation or removal of a condition under this section takes effect on the day on which the notice is given to the person; or" ; cml:conclusionText "The condition occurs during the specified time period." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41el-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41el-ss-2-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-41el-ss-2-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "during" ; cml:logicSummary "Conditions occur during the specified time period" ; cml:premiseText "The imposition, variation or removal of a condition under this section takes effect on the day on which the notice is given to the person; or" ; cml:conclusionText "The condition occurs during the specified time period." ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41el-ss-3 a cml:Concept ; skos:prefLabel "41EL(3) Conditions imposed after issuing a conformity assessment"@en ; cml:realizedBy doc:sec-41el-ss-3 ; cml:integrityHash "9ab341489a5bf8cb5c88934696d6fc8979f886f7f964b4accda992096e6a4960" ; values:partOf concept:therapeutic-goods-act-1989-sec-41el ; skos:note "The earlier day must not be earlier than the day the notice is given to the person." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.56" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41el-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41el-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41el-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41el-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41el-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41el-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MustNot" ; cml:logicSummary "The earlier day must not be earlier than the day the notice is given to the person." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41em a cml:Concept ; skos:prefLabel "41EM Suspension of conformity assessment certificates"@en ; cml:realizedBy doc:sec-41em ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41em-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41em-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41em-ss-3 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.58" . concept:therapeutic-goods-act-1989-sec-41em-ss-1 a cml:Concept ; skos:prefLabel "41EM(1) Suspension of conformity assessment certificates"@en ; cml:realizedBy doc:sec-41em-ss-1 ; cml:integrityHash "2837462d4f0b6405c144f59bb4c8dce1885b4a328dec39ab87443d12975feb9f" ; values:partOf concept:therapeutic-goods-act-1989-sec-41em ; skos:note "Secretary may suspend conformity assessment certificate" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.58" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41em-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41em-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41em-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41em-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41em-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41em-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "Implies obligation" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41em-ss-2 a cml:Concept ; skos:prefLabel "41EM(2) Suspension of conformity assessment certificates"@en ; cml:realizedBy doc:sec-41em-ss-2 ; cml:integrityHash "04a44707a978a8d6ce51ca88f493188c737f2425b204b703a96e2c38dcdacab3" ; values:partOf concept:therapeutic-goods-act-1989-sec-41em ; skos:note "Suspension of conformity assessment certificates may be limited to some medical devices." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.58" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41em-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41em-ss-2-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41em-ss-2 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41em-ss-3 a cml:Concept ; skos:prefLabel "41EM(3) Suspension of conformity assessment certificates"@en ; cml:realizedBy doc:sec-41em-ss-3 ; cml:integrityHash "8f9e7755b6652ae1e70eb049db0e57327fef38722a3c6d1bf6dd8795a2959b22" ; values:partOf concept:therapeutic-goods-act-1989-sec-41em ; skos:note "Specify period of suspension not exceeding 6 months." ; dc:description "Notice specifying period of suspension" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.58" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41em-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41em-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41em-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41em-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41em-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41em-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Specify period of suspension" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41en a cml:Concept ; skos:prefLabel "41EN Notice of proposed suspension"@en ; cml:realizedBy doc:sec-41en ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41en-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41en-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41en-ss-3 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.58" . concept:therapeutic-goods-act-1989-sec-41en-ss-1 a cml:Concept ; skos:prefLabel "41EN(1) Notice of proposed suspension"@en ; cml:realizedBy doc:sec-41en-ss-1 ; cml:integrityHash "70f309aba95269f94fdc43a1c85a950aa3ffb2d532fee12bd1219478f93d838d" ; values:partOf concept:therapeutic-goods-act-1989-sec-41en ; skos:note "Secretary must inform person of proposed suspension and give reasonable opportunity to make submissions." ; dc:description "Notice, reasons for suspension" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.58" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41en-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41en-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41en-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41en-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41en-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41en-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Secretary must perform action" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41en-ss-2 a cml:Concept ; skos:prefLabel "41EN(2) Notice of proposed suspension"@en ; cml:realizedBy doc:sec-41en-ss-2 ; cml:integrityHash "299f2d39b86f593eff59286b20216ccd34c6a6b574bd888886e11025f0472a78" ; values:partOf concept:therapeutic-goods-act-1989-sec-41en ; skos:note "Secretary must consider submissions before making a decision." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.58" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41en-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41en-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41en-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41en-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41en-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41en-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must consider submissions" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41en-ss-3 a cml:Concept ; skos:prefLabel "41EN(3) Notice of proposed suspension"@en ; cml:realizedBy doc:sec-41en-ss-3 ; cml:integrityHash "d86f46a7770655dec213494145489b19389cbf31ae2d69161e96dfab192149c5" ; values:partOf concept:therapeutic-goods-act-1989-sec-41en ; skos:note "Exemption from section 41EN(3) if notice under section 41EM states suspension is necessary to prevent imminent risk of death, serious illness or serious injury." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.58" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41en-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41en-ss-3-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41en-ss-3 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41en-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41en-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41en-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibits section 41EN(3) application if notice under section 41EM states suspension is necessary to prevent imminent risk of death, serious illness or serious injury." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41en-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41en-ss-3-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-41en-ss-3-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Overlaps" ; cml:logicSummary "Section 41EN(3) does not apply if notice under section 41EM states suspension is necessary to prevent imminent risk of death, serious illness or serious injury." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41en-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41en-ss-3-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-41en-ss-3-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Overlaps" ; cml:logicSummary "Section 41EN(3) does not apply if notice under section 41EM states suspension is necessary to prevent imminent risk of death, serious illness or serious injury." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41en-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41en-ss-3-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-41en-ss-3-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "Overlaps" ; cml:logicSummary "Section 41EN(3) does not apply if notice under section 41EM states suspension is necessary to prevent imminent risk of death, serious illness or serious injury." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41en-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41en-ss-3-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-41en-ss-3-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "Overlaps" ; cml:logicSummary "Section 41EN(3) does not apply if notice under section 41EM states suspension is necessary to prevent imminent risk of death, serious illness or serious injury." ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41eo a cml:Concept ; skos:prefLabel "41EO Duration of suspension"@en ; cml:realizedBy doc:sec-41eo ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41eo-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41eo-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41eo-ss-3 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.59" . concept:therapeutic-goods-act-1989-sec-41eo-ss-1 a cml:Concept ; skos:prefLabel "41EO(1) Duration of suspension"@en ; cml:realizedBy doc:sec-41eo-ss-1 ; cml:integrityHash "c118404ba7204b5872342af8c8d0df6b6c3b6a7a62eada6c2976900ea9a105c0" ; values:partOf concept:therapeutic-goods-act-1989-sec-41eo ; skos:note "Suspension takes effect on specified day after notice is given." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.59" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41eo-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41eo-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41eo-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41eo-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41eo-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41eo-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "takesEffect" ; cml:logicSummary "Suspension takes effect on specified day after notice is given." ; cml:premiseText "(1) The suspension takes effect: (a) if the notice under section 41EM states that the suspension is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the notice is given to the person; or (b) in any other case—on the day specified for the purpose in the notice, being a day not earlier than 20 working days after the notice is given to the person." ; cml:conclusionText "(1) The suspension takes effect: (a) if the notice under section 41EM states that the suspension is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the notice is given to the person; or (b) in any other case—on the day specified for the purpose in the notice, being a day not earlier than 20 working days after the notice is given to the person." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41eo-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41eo-ss-1-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-41eo-ss-1-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "during" ; cml:logicSummary "Suspension takes effect on a specified day after notice is given." ; cml:premiseText "(1) The suspension takes effect: (a) if the notice under section 41EM states that the suspension is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the notice is given to the person; or (b) in any other case—on the day specified for the purpose in the notice, being a day not earlier than 20 working days after the notice is given to the person." ; cml:conclusionText "(1) The suspension takes effect: (a) if the notice under section 41EM states that the suspension is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the notice is given to the person; or (b) in any other case—on the day specified for the purpose in the notice, being a day not earlier than 20 working days after the notice is given to the person." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41eo-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41eo-ss-1-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-41eo-ss-1-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "during" ; cml:logicSummary "Suspension takes effect on a specified day after notice is given." ; cml:premiseText "(1) The suspension takes effect: (a) if the notice under section 41EM states that the suspension is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the notice is given to the person; or (b) in any other case—on the day specified for the purpose in the notice, being a day not earlier than 20 working days after the notice is given to the person." ; cml:conclusionText "(1) The suspension takes effect: (a) if the notice under section 41EM states that the suspension is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the notice is given to the person; or (b) in any other case—on the day specified for the purpose in the notice, being a day not earlier than 20 working days after the notice is given to the person." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41eo-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41eo-ss-1-logic-deontic-4 . concept:therapeutic-goods-act-1989-sec-41eo-ss-1-logic-deontic-4 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "ifThen" ; cml:logicSummary "Suspension takes effect if notice states suspension is necessary." ; cml:premiseText "(1) The suspension takes effect: (a) if the notice under section 41EM states that the suspension is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the notice is given to the person; or (b) in any other case—on the day specified for the purpose in the notice, being a day not earlier than 20 working days after the notice is given to the person." ; cml:conclusionText "(1) The suspension takes effect: (a) if the notice under section 41EM states that the suspension is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the notice is given to the person; or (b) in any other case—on the day specified for the purpose in the notice, being a day not earlier than 20 working days after the notice is given to the person." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41eo-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41eo-ss-1-logic-paraconsistent-5 . concept:therapeutic-goods-act-1989-sec-41eo-ss-1-logic-paraconsistent-5 a cml:LogicApplication ; cml:modality cml:Paraconsistent ; cml:operator "or" ; cml:logicSummary "Suspension takes effect on specified day after notice is given." ; cml:premiseText "(1) The suspension takes effect: (a) if the notice under section 41EM states that the suspension is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the notice is given to the person; or (b) in any other case—on the day specified for the purpose in the notice, being a day not earlier than 20 working days after the notice is given to the person." ; cml:conclusionText "(1) The suspension takes effect: (a) if the notice under section 41EM states that the suspension is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the notice is given to the person; or (b) in any other case—on the day specified for the purpose in the notice, being a day not earlier than 20 working days after the notice is given to the person." ; cml:executionSurface "modalities::paraconsistent" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41eo-ss-2 a cml:Concept ; skos:prefLabel "41EO(2) Duration of suspension"@en ; cml:realizedBy doc:sec-41eo-ss-2 ; cml:integrityHash "005ef4878063ee027effe5153ca5a509d46abe14f014db52388b91eaa0190b06" ; values:partOf concept:therapeutic-goods-act-1989-sec-41eo ; skos:note "Suspension duration" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.59" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41eo-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41eo-ss-2-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41eo-ss-2 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41eo-ss-3 a cml:Concept ; skos:prefLabel "41EO(3) Duration of suspension"@en ; cml:realizedBy doc:sec-41eo-ss-3 ; cml:integrityHash "b31346b6564c4702e2b0e14558620baca520515253cad055ff58ceba9d63a02c" ; values:partOf concept:therapeutic-goods-act-1989-sec-41eo ; skos:note "Extension of period for addressing grounds for revoking medical device certificate" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.59" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41eo-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41eo-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41eo-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ep a cml:Concept ; skos:prefLabel "41EP Revocation of suspension"@en ; cml:realizedBy doc:sec-41ep ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ep-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ep-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.59" . concept:therapeutic-goods-act-1989-sec-41ep-ss-1 a cml:Concept ; skos:prefLabel "41EP(1) Revocation of suspension"@en ; cml:realizedBy doc:sec-41ep-ss-1 ; cml:integrityHash "a8dd7880c35376d90cbba755983148b619aad27298bf96169fc48ce8e11bdf10" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ep ; skos:note "Must revoke suspension if grounds no longer apply and no other grounds for suspension exist." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.59" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ep-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41ep-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ep-ss-1 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ep-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41ep-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41ep-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Obligation to revoke suspension" ; cml:premiseText "(a) the ground on which the conformity assessment certificate was suspended no longer applies; and (b) there are no other grounds for suspending the certificate." ; cml:conclusionText "The Secretary must revoke the suspension." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ep-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41ep-ss-1-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-41ep-ss-1-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "BETWEEN" ; cml:logicSummary "Temporal interval of revocation obligation" ; cml:premiseText "(1) The Secretary must revoke the suspension if the Secretary is satisfied that: (a) the ground on which the conformity assessment certificate was suspended no longer applies; and (b) there are no other grounds for suspending the certificate." ; cml:conclusionText "Revocation obligation applies between specified temporal intervals" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ep-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41ep-ss-1-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-41ep-ss-1-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "BETWEEN" ; cml:logicSummary "Temporal interval of revocation obligation" ; cml:premiseText "(1) The Secretary must revoke the suspension if the Secretary is satisfied that: (a) the ground on which the conformity assessment certificate was suspended no longer applies; and (b) there are no other grounds for suspending the certificate." ; cml:conclusionText "Revocation obligation applies between specified temporal intervals" ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ep-ss-2 a cml:Concept ; skos:prefLabel "41EP(2) Revocation of suspension"@en ; cml:realizedBy doc:sec-41ep-ss-2 ; cml:integrityHash "6e77be1ae681ecae4417109d8de4f35a2b3c13f53cf82b9f5c81cf3206e499e3" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ep ; skos:note "Exercise of power to revoke suspension" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.59" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ep-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41ep-ss-2-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ep-ss-2 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41eq a cml:Concept ; skos:prefLabel "41EQ Powers of revocation of conformity assessment certificates"@en ; cml:realizedBy doc:sec-41eq ; cml:integrityHash "7298a246841d9715feeba96a04bba28f224a6389c22f90f89e3bf1c64f9bb7bc" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41eq-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41eq-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.60" . concept:therapeutic-goods-act-1989-sec-41eq-ss-1 a cml:Concept ; skos:prefLabel "41EQ(1) Powers of revocation of conformity assessment certificates"@en ; cml:realizedBy doc:sec-41eq-ss-1 ; cml:integrityHash "55270756b2c6c4bc6c3f95d398c44b690391653bf209690c9829b699e3ada48c" ; values:partOf concept:therapeutic-goods-act-1989-sec-41eq ; skos:note "Does not affect Secretary's powers to revoke conformity assessment certificates" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.60" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41eq-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41eq-ss-1-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41eq-ss-1 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41eq-ss-2 a cml:Concept ; skos:prefLabel "41EQ(2) Powers of revocation of conformity assessment certificates"@en ; cml:realizedBy doc:sec-41eq-ss-2 ; cml:integrityHash "907877fde0548372982cbca08adf7db3f8ec170dd41dbe6cdd75bb4db5c0267a" ; values:partOf concept:therapeutic-goods-act-1989-sec-41eq ; skos:note "Suspension ceases to have effect if revocation relates to conformity assessment certificate" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.60" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41eq-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41eq-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41eq-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41eq-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41eq-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41eq-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "ceases" ; cml:logicSummary "Obligation ceases" ; cml:premiseText "(2) To the extent that a suspension under this Division relates to a conformity assessment certificate to which such a revocation relates" ; cml:conclusionText "Suspension ceases to have effect" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41eq-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41eq-ss-2-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-41eq-ss-2-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "during" ; cml:logicSummary "Temporal interval relation" ; cml:premiseText "(2) To the extent that a suspension under this Division relates to a conformity assessment certificate to which such a revocation relates" ; cml:conclusionText "Suspension ceases to have effect during revocation period" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41eq-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41eq-ss-2-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-41eq-ss-2-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "during" ; cml:logicSummary "Temporal interval relation" ; cml:premiseText "(2) To the extent that a suspension under this Division relates to a conformity assessment certificate to which such a revocation relates" ; cml:conclusionText "Suspension ceases to have effect during revocation period" ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41eq-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41eq-ss-2-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-41eq-ss-2-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "if" ; cml:logicSummary "Conditional diffusion" ; cml:premiseText "(2) To the extent that a suspension under this Division relates to a conformity assessment certificate to which such a revocation relates" ; cml:conclusionText "Suspension ceases to have effect if revocation relates to conformity assessment certificate" ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41eq-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41eq-ss-2-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-41eq-ss-2-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "if" ; cml:logicSummary "Conditional CogAI" ; cml:premiseText "(2) To the extent that a suspension under this Division relates to a conformity assessment certificate to which such a revocation relates" ; cml:conclusionText "Suspension ceases to have effect if revocation relates to conformity assessment certificate" ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41er a cml:Concept ; skos:prefLabel "41ER Automatic revocation of conformity assessment certificates"@en ; cml:realizedBy doc:sec-41er ; cml:integrityHash "d388086aaf85dd8df60999f1ea4b03200759d1416fb35dbb2a831d90eec7878d" ; skos:note "Revocation of conformity assessment certificates upon expiration of suspension period" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.61" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41er-norm . concept:therapeutic-goods-act-1989-sec-41er-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41er ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41er cml:asserts concept:therapeutic-goods-act-1989-sec-41er-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41er-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibits revocation without notice" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41es a cml:Concept ; skos:prefLabel "41ES Immediate revocation of conformity assessment certificates"@en ; cml:realizedBy doc:sec-41es ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41es-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41es-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41es-ss-3 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.61" . concept:therapeutic-goods-act-1989-sec-41es-ss-1 a cml:Concept ; skos:prefLabel "41ES(1) Immediate revocation of conformity assessment certificates"@en ; cml:realizedBy doc:sec-41es-ss-1 ; cml:integrityHash "fc0f5d9c76e6fcef3d846068941754b6998f5139a1c02633a8ab3f8bda458717" ; values:partOf concept:therapeutic-goods-act-1989-sec-41es ; skos:note "Manufacturer must request revocation of certificate." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.61" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41es-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41es-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41es-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41es-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41es-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41es-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Manufacturer's request is an obligation." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41es-ss-2 a cml:Concept ; skos:prefLabel "41ES(2) Immediate revocation of conformity assessment certificates"@en ; cml:realizedBy doc:sec-41es-ss-2 ; cml:integrityHash "26e529231b0edf7ab443cb0769604a19dec4dab5999850f2bdbe76dcdc20db60" ; values:partOf concept:therapeutic-goods-act-1989-sec-41es ; skos:note "Secretary may withdraw revocation upon request and payment of fee." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.61" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41es-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41es-ss-2-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41es-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41es-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41es-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41es-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "Describes the Secretary's discretion to withdraw revocation." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41es-ss-3 a cml:Concept ; skos:prefLabel "41ES(3) Immediate revocation of conformity assessment certificates"@en ; cml:realizedBy doc:sec-41es-ss-3 ; cml:integrityHash "75b3ce082b95874acbba1a6c78f547392f635a2a2497ddcc5de2379b2aa26606" ; values:partOf concept:therapeutic-goods-act-1989-sec-41es ; skos:note "Revocation of conformity assessment certificates is taken never to have occurred if withdrawn." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.61" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41es-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41es-ss-3-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41es-ss-3 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41et a cml:Concept ; skos:prefLabel "41ET Revocation of conformity assessment certificates after notice"@en ; cml:realizedBy doc:sec-41et ; cml:integrityHash "41c56eeba96bce4446c5184c9d8fe4aa56992df1d9bc438c32aba574ff2a0e94" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41et-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41et-ss-1a ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41et-ss-1b ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41et-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.62" . concept:therapeutic-goods-act-1989-sec-41et-ss-1 a cml:Concept ; skos:prefLabel "41ET(1) Revocation of conformity assessment certificates after notice"@en ; cml:realizedBy doc:sec-41et-ss-1 ; cml:integrityHash "b8394f4590110769fdf90e81f3d27f4ae05be33d49472a1d295e959713b09cfe" ; values:partOf concept:therapeutic-goods-act-1989-sec-41et ; skos:note "Revocation of conformity assessment certificates after notice" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.62" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41et-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41et-ss-1-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41et-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41et-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41et-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41et-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibition" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41et-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41et-ss-1-logic-deontic-2 . concept:therapeutic-goods-act-1989-sec-41et-ss-1-logic-deontic-2 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Revocation for non-compliance with conditions" ; cml:premiseText "(b) the manufacturer in relation to whom the certificate is issued refuses or fails to comply with a condition to which the certificate is subject;" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41et-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41et-ss-1-logic-deontic-3 . concept:therapeutic-goods-act-1989-sec-41et-ss-1-logic-deontic-3 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Revocation for breach of conformity assessment document conditions" ; cml:premiseText "(viii) breached a condition of a conformity assessment document;" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41et-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41et-ss-1-logic-alleninterval-4 . concept:therapeutic-goods-act-1989-sec-41et-ss-1-logic-alleninterval-4 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Within" ; cml:logicSummary "Temporal interval for revocation after notice" ; cml:premiseText "within a further 10 working days from the day specified in that notice;" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41et-ss-1a a cml:Concept ; skos:prefLabel "41ET(1A) Revocation of conformity assessment certificates after notice"@en ; cml:realizedBy doc:sec-41et-ss-1a ; cml:integrityHash "a7ccd73a8675309cd6c7c0f38f97b0efd07695c3922c0869794b1e062c9952ee" ; values:partOf concept:therapeutic-goods-act-1989-sec-41et ; skos:note "A reference to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.62" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41et-ss-1a-norm . concept:therapeutic-goods-act-1989-sec-41et-ss-1a-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41et-ss-1a ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41et-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-41et-ss-1a-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41et-ss-1a-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "includes" ; cml:logicSummary "The text implies a duty on authorities to refer to persons with outstanding orders." ; cml:premiseText "Section 19B of the Crimes Act 1914 empowers courts to take action without proceeding to record a conviction." ; cml:conclusionText "A reference to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41et-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-41et-ss-1a-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41et-ss-1a-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "includes" ; cml:logicSummary "The text defines a class hierarchy for persons with outstanding orders." ; cml:premiseText "A person convicted of an offence is included in this class." ; cml:conclusionText "A reference to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41et-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-41et-ss-1a-logic-alleninterval-3 . concept:therapeutic-goods-act-1989-sec-41et-ss-1a-logic-alleninterval-3 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "includes" ; cml:logicSummary "The text implies a temporal relationship between convictions and outstanding orders." ; cml:premiseText "An order has been made relating to the offence under section 19B of the Crimes Act 1914." ; cml:conclusionText "A reference to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41et-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-41et-ss-1a-logic-ltl-4 . concept:therapeutic-goods-act-1989-sec-41et-ss-1a-logic-ltl-4 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "includes" ; cml:logicSummary "The text implies a recurring trace between convictions and outstanding orders." ; cml:premiseText "An order has been made relating to the offence under section 19B of the Crimes Act 1914." ; cml:conclusionText "A reference to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41et-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-41et-ss-1a-logic-diffusion-5 . concept:therapeutic-goods-act-1989-sec-41et-ss-1a-logic-diffusion-5 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "includes" ; cml:logicSummary "The text implies a diffusion of information between convictions and outstanding orders." ; cml:premiseText "A court that has found a person to have committed an offence can take action without proceeding to record a conviction." ; cml:conclusionText "A reference to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41et-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-41et-ss-1a-logic-cogai-6 . concept:therapeutic-goods-act-1989-sec-41et-ss-1a-logic-cogai-6 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "includes" ; cml:logicSummary "The text implies a cognitive process of referencing persons with outstanding orders." ; cml:premiseText "A court that has found a person to have committed an offence can take action without proceeding to record a conviction." ; cml:conclusionText "A reference to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence." ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41et-ss-1b a cml:Concept ; skos:prefLabel "41ET(1B) Revocation of conformity assessment certificates after notice"@en ; cml:realizedBy doc:sec-41et-ss-1b ; cml:integrityHash "6a0151983ab8c82d0d802984e05b0806c08e2302bc00e618ef7162986ef58d26" ; values:partOf concept:therapeutic-goods-act-1989-sec-41et ; skos:note "Paragraph (1)(e) does not limit paragraph (1)(f)." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.62" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41et-ss-1b-norm . concept:therapeutic-goods-act-1989-sec-41et-ss-1b-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41et-ss-1b ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41et-ss-1b cml:asserts concept:therapeutic-goods-act-1989-sec-41et-ss-1b-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41et-ss-1b-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "implies" ; cml:logicSummary "Paragraph (1)(e) implies paragraph (1)(f)" ; cml:premiseText "(1B)" ; cml:conclusionText "(1)(e)" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41et-ss-2 a cml:Concept ; skos:prefLabel "41ET(2) Revocation of conformity assessment certificates after notice"@en ; cml:realizedBy doc:sec-41et-ss-2 ; cml:integrityHash "83eea9b42b8271bc3c73f69e60f5f4ce4ae1b1ca7d2fb3573c8c6bf291504e6e" ; values:partOf concept:therapeutic-goods-act-1989-sec-41et ; skos:note "Secretary must inform and give opportunity to make submissions before revoking conformity assessment certificate." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.62" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41et-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41et-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41et-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41et-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41et-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41et-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Secretary must inform and give opportunity to make submissions before revoking conformity assessment certificate." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41et-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41et-ss-2-logic-epistemic-2 . concept:therapeutic-goods-act-1989-sec-41et-ss-2-logic-epistemic-2 a cml:LogicApplication ; cml:modality cml:Epistemic ; cml:operator "OBLIGATION" ; cml:logicSummary "Secretary has obligation to inform and give opportunity to make submissions before revoking conformity assessment certificate." ; cml:executionSurface "modalities::epistemic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41eu a cml:Concept ; skos:prefLabel "41EU Limiting revocation of conformity assessment certificates to"@en ; cml:realizedBy doc:sec-41eu ; cml:integrityHash "f8519e4b3a4e40ca9f6ff3212c99befe3a76e760cbb9726a60472c01aa2b5ba4" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41eu-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41eu-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.64" . concept:therapeutic-goods-act-1989-sec-41eu-ss-1 a cml:Concept ; skos:prefLabel "41EU(1) Limiting revocation of conformity assessment certificates to"@en ; cml:realizedBy doc:sec-41eu-ss-1 ; cml:integrityHash "298439893534c6f24fe8198a0eebd8270296836cb83f3d3faca66ae71fa4a7a2" ; values:partOf concept:therapeutic-goods-act-1989-sec-41eu ; skos:note "Limiting revocation of conformity assessment certificates to certain medical devices" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.64" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41eu-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41eu-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41eu-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41eu-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41eu-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41eu-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "limitation" ; cml:logicSummary "Limiting revocation" ; cml:premiseText "(1) If the Secretary is satisfied..." ; cml:conclusionText "...the Secretary must limit..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41eu-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41eu-ss-1-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-41eu-ss-1-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "between" ; cml:logicSummary "Temporal interval between revocation and limitation" ; cml:premiseText "(1) If the Secretary is satisfied..." ; cml:conclusionText "...the Secretary must limit...only to those medical devices" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41eu-ss-2 a cml:Concept ; skos:prefLabel "41EU(2) Limiting revocation of conformity assessment certificates to"@en ; cml:realizedBy doc:sec-41eu-ss-2 ; cml:integrityHash "cf5a21f9c5fe797d2f3a672c731032c674e6bbe7fca8d2316fd2f4e1d3123cd8" ; values:partOf concept:therapeutic-goods-act-1989-sec-41eu ; skos:note "Secretary must vary certificate to remove medical devices from scope" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.64" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41eu-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41eu-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41eu-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41eu-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41eu-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41eu-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Obligation to vary certificate" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ev a cml:Concept ; skos:prefLabel "41EV Publication of revocation etc. of conformity assessment"@en ; cml:realizedBy doc:sec-41ev ; cml:integrityHash "a9e85fa95e8e0d4c8a85e0d8d9c06c1303004da65061cfec80492023c9083d24" ; skos:note "Publish notice of revocation or variation of conformity assessment certificate." ; dc:description "Notice setting out particulars of the revocation or variation." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.64" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ev-norm . concept:therapeutic-goods-act-1989-sec-41ev-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ev ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ev cml:asserts concept:therapeutic-goods-act-1989-sec-41ev-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41ev-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Obligation to publish notice." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ew a cml:Concept ; skos:prefLabel "41EW Date of effect of revocation etc. of conformity assessment"@en ; cml:realizedBy doc:sec-41ew ; cml:integrityHash "5af45a80c2bae6b70c6569e91b434873a690d63e59bf4b21f5f0caae7c906dff" ; skos:note "Date of effect for revocation or variation of conformity assessment certificate" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.65" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ew-norm . concept:therapeutic-goods-act-1989-sec-41ew-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ew ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41f a cml:Concept ; skos:prefLabel "41F What this Part is about"@en ; cml:realizedBy doc:sec-41f ; cml:integrityHash "31cfed3971b7703e206891fb100d673a48d9b4cb7fc4c66b937209bf54730f61" ; skos:note "Medical devices must comply with certain principles and requirements to be included in the Register." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.72" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41f-norm . concept:therapeutic-goods-act-1989-sec-41f-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41f ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41f cml:asserts concept:therapeutic-goods-act-1989-sec-41f-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41f-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must comply with principles and requirements" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fa a cml:Concept ; skos:prefLabel "41FA What this Division is about"@en ; cml:realizedBy doc:sec-41fa ; cml:integrityHash "1e1d20f72fd61bf6562686ba308318d4ccdd13a027c62d7104a08dc512864d12" ; skos:note "Applications for medical devices must pass preliminary assessment." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.73" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41fa-norm . concept:therapeutic-goods-act-1989-sec-41fa-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41fa ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fa cml:asserts concept:therapeutic-goods-act-1989-sec-41fa-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41fa-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Application must pass preliminary assessment." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fa cml:asserts concept:therapeutic-goods-act-1989-sec-41fa-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41fa-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "IS_A" ; cml:logicSummary "Kind of medical device is included in the Register if application passes preliminary assessment." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fc a cml:Concept ; skos:prefLabel "41FC Making an application"@en ; cml:realizedBy doc:sec-41fc ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41fc-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41fc-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.73" . concept:therapeutic-goods-act-1989-sec-41fc-ss-1 a cml:Concept ; skos:prefLabel "41FC(1) Making an application"@en ; cml:realizedBy doc:sec-41fc-ss-1 ; cml:integrityHash "e7cb257bd7f867501a12c7c87ef50d0a03aa6897162ceedf912eba634a99a6d2" ; values:partOf concept:therapeutic-goods-act-1989-sec-41fc ; skos:note "A person may make an application to the Secretary for a kind of medical device to be included in the Register." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.73" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41fc-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41fc-ss-1-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41fc-ss-1 ; values:borneBy values:NaturalPerson ; skos:scopeNote "borne by: NaturalPerson" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fc-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41fc-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41fc-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "May" ; cml:logicSummary "Permission to make an application" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fc-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41fc-ss-1-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41fc-ss-1-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "ClassInclusion" ; cml:logicSummary "Application for a kind of medical device" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fc-ss-2 a cml:Concept ; skos:prefLabel "41FC(2) Making an application"@en ; cml:realizedBy doc:sec-41fc-ss-2 ; cml:integrityHash "3882e507e97ed7e00d03e5f6bc2ba40196dfafc6000ab75eecedd608bcfcfc75" ; values:partOf concept:therapeutic-goods-act-1989-sec-41fc ; skos:note "Application must not contain false or misleading information." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.73" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41fc-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41fc-ss-2-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41fc-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fc-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41fc-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41fc-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibition of false or misleading information" ; cml:premiseText "Application must not contain false or misleading information." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fd a cml:Concept ; skos:prefLabel "41FD Matters to be certified"@en ; cml:realizedBy doc:sec-41fd ; cml:integrityHash "f91e47bd573ce812ded32a3b98bfeffd92d9bc87fdad6538011e901c75b0e9f0" ; skos:note "Applicant must certify that devices are medical devices." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.73" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41fd-norm . concept:therapeutic-goods-act-1989-sec-41fd-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41fd ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fd cml:asserts concept:therapeutic-goods-act-1989-sec-41fd-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41fd-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must provide certification" ; cml:premiseText "Applicant must certify that devices are medical devices." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fe a cml:Concept ; skos:prefLabel "41FE Criminal offences for making a false statement"@en ; cml:realizedBy doc:sec-41fe ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41fe-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41fe-ss-4 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41fe-ss-5 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41fe-ss-6 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.78" . concept:therapeutic-goods-act-1989-sec-41fe-ss-1 a cml:Concept ; skos:prefLabel "41FE(1) Criminal offences for making a false statement"@en ; cml:realizedBy doc:sec-41fe-ss-1 ; cml:integrityHash "741eb7ed0dbd53c2eccb894fd3e788c082c9dbc6bf2b062ddfa5aeac30f19711" ; values:partOf concept:therapeutic-goods-act-1989-sec-41fe ; skos:note "Making false statements in connection with medical devices is prohibited." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.78" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41fe-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41fe-ss-1-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41fe-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fe-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41fe-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41fe-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibition of false statements" ; cml:premiseText "Statement is false or misleading" ; cml:conclusionText "Offence committed" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fe-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41fe-ss-1-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41fe-ss-1-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Classify" ; cml:logicSummary "Classification of medical devices" ; cml:premiseText "Device included in Register" ; cml:conclusionText "Device type determined" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fe-ss-4 a cml:Concept ; skos:prefLabel "41FE(4) Criminal offences for making a false statement"@en ; cml:realizedBy doc:sec-41fe-ss-4 ; cml:integrityHash "b7081dccd98deae3888496e60d7cd668059044a800cf64d5bc3764036dbb2718" ; values:partOf concept:therapeutic-goods-act-1989-sec-41fe ; skos:note "Making false statements in connection with medical device applications or certifications is prohibited." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.78" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41fe-ss-4-norm . concept:therapeutic-goods-act-1989-sec-41fe-ss-4-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41fe-ss-4 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fe-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41fe-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41fe-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits making false statements in specified contexts." ; cml:premiseText "(a) the person makes a statement (whether orally, in a document or in any other way); and (b) the person knows that the statement is false or misleading in a material particular;" ; cml:conclusionText "The person commits an offence if..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fe-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41fe-ss-4-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41fe-ss-4-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Classify" ; cml:logicSummary "Classifies statements as true or false based on knowledge." ; cml:premiseText "(b) the person knows that the statement is false or misleading in a material particular;" ; cml:conclusionText "The person knows that the statement is false or misleading in a material particular;" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fe-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41fe-ss-4-logic-alleninterval-3 . concept:therapeutic-goods-act-1989-sec-41fe-ss-4-logic-alleninterval-3 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Temporal overlap" ; cml:logicSummary "Requires temporal overlap between statements and their context." ; cml:premiseText "(c) the statement is in or in connection with: (i) an application for including a kind of medical device in the Register under this Chapter; or (ii) a certification or purported certification under section 41FD." ; cml:conclusionText "The statement is in or in connection with..." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fe-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41fe-ss-4-logic-ltl-4 . concept:therapeutic-goods-act-1989-sec-41fe-ss-4-logic-ltl-4 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Recurring trace" ; cml:logicSummary "Requires recurring traces of statements and their context." ; cml:premiseText "(c) the statement is in or in connection with: (i) an application for including a kind of medical device in the Register under this Chapter; or (ii) a certification or purported certification under section 41FD." ; cml:conclusionText "The statement is in or in connection with..." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fe-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41fe-ss-4-logic-deontic-5 . concept:therapeutic-goods-act-1989-sec-41fe-ss-4-logic-deontic-5 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Imposes an obligation to avoid making false statements in specified contexts." ; cml:premiseText "(a) the person makes a statement (whether orally, in a document or in any other way); and (b) the person knows that the statement is false or misleading in a material particular;" ; cml:conclusionText "The person commits an offence if..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fe-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41fe-ss-4-logic-deontic-6 . concept:therapeutic-goods-act-1989-sec-41fe-ss-4-logic-deontic-6 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibits making false statements in specified contexts." ; cml:premiseText "(a) the person makes a statement (whether orally, in a document or in any other way); and (b) the person knows that the statement is false or misleading in a material particular;" ; cml:conclusionText "The person commits an offence if..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fe-ss-5 a cml:Concept ; skos:prefLabel "41FE(5) Criminal offences for making a false statement"@en ; cml:realizedBy doc:sec-41fe-ss-5 ; cml:integrityHash "d88131e06caada2c090f92e0ca7ca2c33a98a4b364e69947bdbfdc6a5ccc8fd4" ; values:partOf concept:therapeutic-goods-act-1989-sec-41fe ; skos:note "Making false statements in certain contexts is an offence." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.78" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41fe-ss-5-norm . concept:therapeutic-goods-act-1989-sec-41fe-ss-5-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41fe-ss-5 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fe-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-41fe-ss-5-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41fe-ss-5-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibits making false statements in certain contexts." ; cml:premiseText "(5) A person commits an offence if..." ; cml:conclusionText "...Penalty: 100 penalty units." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fe-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-41fe-ss-5-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41fe-ss-5-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Classify" ; cml:logicSummary "Classifies the provision as a prohibition." ; cml:premiseText "A person commits an offence if..." ; cml:conclusionText "...Penalty: 100 penalty units." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fe-ss-6 a cml:Concept ; skos:prefLabel "41FE(6) Criminal offences for making a false statement"@en ; cml:realizedBy doc:sec-41fe-ss-6 ; cml:integrityHash "fded07edb2a9975502e8f6fe9f3b17aff17cfda13aa15236940e859477f08da3" ; values:partOf concept:therapeutic-goods-act-1989-sec-41fe ; skos:note "An offence against subsection (5) is an offence of strict liability." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.78" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41fe-ss-6-norm . concept:therapeutic-goods-act-1989-sec-41fe-ss-6-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41fe-ss-6 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fe-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-41fe-ss-6-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41fe-ss-6-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "is" ; cml:logicSummary "Strict liability" ; cml:premiseText "(5)" ; cml:conclusionText "(6)" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ff a cml:Concept ; skos:prefLabel "41FF Obligation to include kinds of medical devices in the Register"@en ; cml:realizedBy doc:sec-41ff ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ff-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ff-ss-1a ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ff-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ff-ss-3 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.80" . concept:therapeutic-goods-act-1989-sec-41ff-ss-1 a cml:Concept ; skos:prefLabel "41FF(1) Obligation to include kinds of medical devices in the Register"@en ; cml:realizedBy doc:sec-41ff-ss-1 ; cml:integrityHash "3935e84d41bf78398a7efd4329381b98a439414904e400ae0d51680f5cd5d628" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ff ; skos:note "Secretary must include kind of medical device in Register if application has passed preliminary assessment and not selected for audit." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.80" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ff-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41ff-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ff-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ff-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41ff-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41ff-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Obligation to include kind of medical device in Register" ; cml:premiseText "(1) If:..." ; cml:conclusionText "...the Secretary must include the kind of device in the Register in relation to the person." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ff-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41ff-ss-1-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41ff-ss-1-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "SUBCLASS OF" ; cml:logicSummary "Classifies medical devices as part of the Register" ; cml:premiseText "(1) If:..." ; cml:conclusionText "...the kind of device in the Register in relation to the person." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ff-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41ff-ss-1-logic-alleninterval-3 . concept:therapeutic-goods-act-1989-sec-41ff-ss-1-logic-alleninterval-3 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "BETWEEN" ; cml:logicSummary "Temporal interval for inclusion in Register" ; cml:premiseText "(1) If:..." ; cml:conclusionText "...the Secretary must include the kind of device in the Register in relation to the person." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ff-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41ff-ss-1-logic-argumentation-4 . concept:therapeutic-goods-act-1989-sec-41ff-ss-1-logic-argumentation-4 a cml:LogicApplication ; cml:modality cml:Argumentation ; cml:operator "IMPLIES" ; cml:logicSummary "Inference from preliminary assessment and audit selection" ; cml:premiseText "(a) an application for a kind of medical device..." ; cml:conclusionText "...the Secretary must include the kind of device in the Register in relation to the person." ; cml:executionSurface "modalities::argumentation" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ff-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41ff-ss-1-logic-diffusion-5 . concept:therapeutic-goods-act-1989-sec-41ff-ss-1-logic-diffusion-5 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "SPREADS TO" ; cml:logicSummary "Influence on audit selection and inclusion in Register" ; cml:premiseText "(b) the application has not been selected for audit under section 41FH;" ; cml:conclusionText "...the Secretary must include the kind of device in the Register in relation to the person." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ff-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41ff-ss-1-logic-cogai-6 . concept:therapeutic-goods-act-1989-sec-41ff-ss-1-logic-cogai-6 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "REQUIRES" ; cml:logicSummary "Artificial intelligence application for medical device inclusion" ; cml:premiseText "(1) If:..." ; cml:conclusionText "...the Secretary must include the kind of device in the Register in relation to the person." ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ff-ss-1a a cml:Concept ; skos:prefLabel "41FF(1A) Obligation to include kinds of medical devices in the Register"@en ; cml:realizedBy doc:sec-41ff-ss-1a ; cml:integrityHash "b128783c21371f1bc2c66fdb0e60a04284419ac0635e883b56c22358263434ae" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ff ; skos:note "The Secretary must not include a device in the Register if it is to be used exclusively for purposes specified under section 41BEA." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.80" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ff-ss-1a-norm . concept:therapeutic-goods-act-1989-sec-41ff-ss-1a-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ff-ss-1a ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ff-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-41ff-ss-1a-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41ff-ss-1a-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibits including a device in the Register if it is to be used exclusively for specified purposes." ; cml:premiseText "The Secretary must not include..." ; cml:conclusionText "...the kind of device in the Register." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ff-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-41ff-ss-1a-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41ff-ss-1a-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "ClassInclusion" ; cml:logicSummary "Includes devices that are not to be included in the Register if used exclusively for specified purposes." ; cml:premiseText "The kind of device is to be used exclusively..." ; cml:conclusionText "...the kind of device in the Register." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ff-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-41ff-ss-1a-logic-alleninterval-3 . concept:therapeutic-goods-act-1989-sec-41ff-ss-1a-logic-alleninterval-3 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "TemporalExclusion" ; cml:logicSummary "Excludes devices from the Register if they are to be used exclusively for specified purposes during a certain time period." ; cml:premiseText "The kind of device is to be used exclusively..." ; cml:conclusionText "...the kind of device in the Register." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ff-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-41ff-ss-1a-logic-ltl-4 . concept:therapeutic-goods-act-1989-sec-41ff-ss-1a-logic-ltl-4 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "TemporalExclusion" ; cml:logicSummary "Excludes devices from the Register if they are to be used exclusively for specified purposes during a certain time period." ; cml:premiseText "The kind of device is to be used exclusively..." ; cml:conclusionText "...the kind of device in the Register." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ff-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-41ff-ss-1a-logic-diffusion-5 . concept:therapeutic-goods-act-1989-sec-41ff-ss-1a-logic-diffusion-5 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "TemporalExclusion" ; cml:logicSummary "Excludes devices from the Register if they are to be used exclusively for specified purposes during a certain time period." ; cml:premiseText "The kind of device is to be used exclusively..." ; cml:conclusionText "...the kind of device in the Register." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ff-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-41ff-ss-1a-logic-cogai-6 . concept:therapeutic-goods-act-1989-sec-41ff-ss-1a-logic-cogai-6 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "TemporalExclusion" ; cml:logicSummary "Excludes devices from the Register if they are to be used exclusively for specified purposes during a certain time period." ; cml:premiseText "The kind of device is to be used exclusively..." ; cml:conclusionText "...the kind of device in the Register." ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ff-ss-2 a cml:Concept ; skos:prefLabel "41FF(2) Obligation to include kinds of medical devices in the Register"@en ; cml:realizedBy doc:sec-41ff-ss-2 ; cml:integrityHash "f1127fa868a80c7fbe5b619e79897cf27de75fa634c89743b98a801c610b6eb7" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ff ; skos:note "The Secretary must provide a certificate of inclusion to the applicant." ; dc:description "Yes" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.80" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ff-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41ff-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ff-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ff-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41ff-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41ff-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "The Secretary must provide a certificate." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ff-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41ff-ss-2-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41ff-ss-2-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "hasPartOf" ; cml:logicSummary "The Register has part of the device included." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ff-ss-3 a cml:Concept ; skos:prefLabel "41FF(3) Obligation to include kinds of medical devices in the Register"@en ; cml:realizedBy doc:sec-41ff-ss-3 ; cml:integrityHash "fc2eac3d9bd56c724c62373428fb7ee38f4700793a3384c59bcf9047b68a6f43" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ff ; skos:note "Specify commencement day for inclusion of medical devices in the Register" ; dc:description "Yes" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.80" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ff-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41ff-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ff-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ff-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41ff-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41ff-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Specify commencement day" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ff-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41ff-ss-3-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41ff-ss-3-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "SPECIFY" ; cml:logicSummary "Specify the day on which the inclusion of the kind of device in the Register commences." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fg a cml:Concept ; skos:prefLabel "41FG Notification of unsuccessful applications"@en ; cml:realizedBy doc:sec-41fg ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41fg-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41fg-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.81" . concept:therapeutic-goods-act-1989-sec-41fg-ss-1 a cml:Concept ; skos:prefLabel "41FG(1) Notification of unsuccessful applications"@en ; cml:realizedBy doc:sec-41fg-ss-1 ; cml:integrityHash "8d805aa79fa862613002fc474434673192077588e1e6d9846ae9c39f65c099bf" ; values:partOf concept:therapeutic-goods-act-1989-sec-41fg ; skos:note "Notification of unsuccessful applications for medical device inclusion in the Register" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.81" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41fg-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41fg-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41fg-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fg-ss-2 a cml:Concept ; skos:prefLabel "41FG(2) Notification of unsuccessful applications"@en ; cml:realizedBy doc:sec-41fg-ss-2 ; cml:integrityHash "1493779e679a868e7212cf78b4d93a2deafea7e8a2114684118768a674e4171b" ; values:partOf concept:therapeutic-goods-act-1989-sec-41fg ; skos:note "Secretary must notify applicant in writing within 20 working days after application is received and fee is paid." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.81" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41fg-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41fg-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41fg-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fg-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41fg-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41fg-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must notify applicant" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fh a cml:Concept ; skos:prefLabel "41FH Selecting applications for auditing"@en ; cml:realizedBy doc:sec-41fh ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41fh-ss-1a ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41fh-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41fh-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.81" . concept:therapeutic-goods-act-1989-sec-41fh-ss-1a a cml:Concept ; skos:prefLabel "41FH(1A) Selecting applications for auditing"@en ; cml:realizedBy doc:sec-41fh-ss-1a ; cml:integrityHash "44b17a58508b7e157a4b1bd964c1a726c03b848da7945158e2fd1d0b3a4bbcfa" ; values:partOf concept:therapeutic-goods-act-1989-sec-41fh ; skos:note "This section applies to applications that have passed preliminary assessment." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.81" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41fh-ss-1a-norm . concept:therapeutic-goods-act-1989-sec-41fh-ss-1a-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41fh-ss-1a ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fh-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-41fh-ss-1a-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41fh-ss-1a-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "applies" ; cml:logicSummary "Section applies to specified applications." ; cml:premiseText "(1A) This section applies to applications that have passed preliminary assessment." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fh-ss-1 a cml:Concept ; skos:prefLabel "41FH(1) Selecting applications for auditing"@en ; cml:realizedBy doc:sec-41fh-ss-1 ; cml:integrityHash "bf4d192a88b393238b07c489443701523591233e9fe78eabe5c95c036049d4f6" ; values:partOf concept:therapeutic-goods-act-1989-sec-41fh ; skos:note "Secretary must select applications for auditing." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.81" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41fh-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41fh-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41fh-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fh-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41fh-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41fh-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must select applications." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fh-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41fh-ss-1-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41fh-ss-1-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "IS_A" ; cml:logicSummary "Selects applications of a kind prescribed by regulations." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fh-ss-2 a cml:Concept ; skos:prefLabel "41FH(2) Selecting applications for auditing"@en ; cml:realizedBy doc:sec-41fh-ss-2 ; cml:integrityHash "8536d4d4f5fd77c61a573183c8f4ceda10c77683da40aa2e5111c094cbded674" ; values:partOf concept:therapeutic-goods-act-1989-sec-41fh ; skos:note "Secretary must give applicant a written notice upon selection for auditing." ; dc:description "written notice" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.81" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41fh-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41fh-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41fh-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fh-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41fh-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41fh-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Secretary must give applicant a written notice." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fi a cml:Concept ; skos:prefLabel "41FI Auditing of applications"@en ; cml:realizedBy doc:sec-41fi ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41fi-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41fi-ss-1a ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41fi-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41fi-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41fi-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41fi-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.82" . concept:therapeutic-goods-act-1989-sec-41fi-ss-1 a cml:Concept ; skos:prefLabel "41FI(1) Auditing of applications"@en ; cml:realizedBy doc:sec-41fi-ss-1 ; cml:integrityHash "e394a33370306f48b9a873bcd5bf8274cc25a74f12c4edc6d3682b10da04a48f" ; values:partOf concept:therapeutic-goods-act-1989-sec-41fi ; skos:note "The Secretary may consider certain aspects of an application during auditing. Secretary may have regard to certificate in auditing application" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.82" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41fi-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41fi-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41fi-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fi-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41fi-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41fi-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "May consider certain aspects" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fi-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41fi-ss-1-logic-deontic-2 . concept:therapeutic-goods-act-1989-sec-41fi-ss-1-logic-deontic-2 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "May" ; cml:logicSummary "Permits Secretary to consider certificate" ; cml:premiseText "(a) a section 41FC application is made for a kind of medical device..." ; cml:conclusionText "The Secretary may have regard to the certificate in auditing the application." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fi-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41fi-ss-1-logic-descriptionlogic-3 . concept:therapeutic-goods-act-1989-sec-41fi-ss-1-logic-descriptionlogic-3 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Has been issued consistently with" ; cml:logicSummary "Certificate must be consistent with conformity assessment body determination" ; cml:premiseText "(e) if the conformity assessment body determination that relates to the body is limited as mentioned in paragraph 41EWA(4)(b)—the Secretary is satisfied that the certificate has been issued..." ; cml:conclusionText "The Secretary is satisfied that the certificate has been issued consistently with the determination." ; cml:executionSurface "modalities::dl" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fi-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41fi-ss-1-logic-alleninterval-4 . concept:therapeutic-goods-act-1989-sec-41fi-ss-1-logic-alleninterval-4 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Within a specified time frame" ; cml:logicSummary "Certificate must be given to Secretary within a specified timeframe" ; cml:premiseText "(d) the certificate has been given to the Secretary;" ; cml:conclusionText "The certificate was issued within a specified timeframe." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fi-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41fi-ss-1-logic-ltl-5 . concept:therapeutic-goods-act-1989-sec-41fi-ss-1-logic-ltl-5 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Recurring trace" ; cml:logicSummary "Certificate must be audited as part of recurring audit process" ; cml:premiseText "(b) the application has been selected for audit;" ; cml:conclusionText "The certificate is part of a recurring audit process." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fi-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41fi-ss-1-logic-deontic-6 . concept:therapeutic-goods-act-1989-sec-41fi-ss-1-logic-deontic-6 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Must consider" ; cml:logicSummary "Secretary must consider certificate in auditing application" ; cml:premiseText "(1) If..." ; cml:conclusionText "The Secretary must consider the certificate in auditing the application." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fi-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41fi-ss-1-logic-descriptionlogic-7 . concept:therapeutic-goods-act-1989-sec-41fi-ss-1-logic-descriptionlogic-7 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Is a requirement for audit" ; cml:logicSummary "Certificate is a requirement for audit of section 41FC application" ; cml:premiseText "(1) If..." ; cml:conclusionText "The certificate is a requirement for the audit." ; cml:executionSurface "modalities::dl" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fi-ss-1a a cml:Concept ; skos:prefLabel "41FI(1A) Auditing of applications"@en ; cml:realizedBy doc:sec-41fi-ss-1a ; cml:integrityHash "906b4c6892dd439c50c25cd970aeb0557ae11a454e83be0635023a4f95b91127" ; values:partOf concept:therapeutic-goods-act-1989-sec-41fi ; skos:note "The applicant must deliver a reasonable number of samples within 14 days after receiving the notice." ; dc:description "Yes" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.82" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41fi-ss-1a-norm . concept:therapeutic-goods-act-1989-sec-41fi-ss-1a-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41fi-ss-1a ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fi-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-41fi-ss-1a-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41fi-ss-1a-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "The applicant must deliver samples" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fi-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-41fi-ss-1a-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41fi-ss-1a-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "hasPart" ; cml:logicSummary "The application has a part that requires delivery of samples" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fi-ss-2 a cml:Concept ; skos:prefLabel "41FI(2) Auditing of applications"@en ; cml:realizedBy doc:sec-41fi-ss-2 ; cml:integrityHash "4168657e1057e591c4eb77b234d52c101d992bbd2962820486dae0506927e9c4" ; values:partOf concept:therapeutic-goods-act-1989-sec-41fi ; skos:note "The Secretary must decide to include a device in the Register. The Secretary may have regard for matters beyond the scope of this section." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.82" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41fi-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41fi-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41fi-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fi-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41fi-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41fi-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "The Secretary must decide." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fi-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41fi-ss-2-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41fi-ss-2-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "IS_A" ; cml:logicSummary "The device is included in the Register." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fi-ss-3 a cml:Concept ; skos:prefLabel "41FI(3) Auditing of applications"@en ; cml:realizedBy doc:sec-41fi-ss-3 ; cml:integrityHash "74ad2d22f37fa181f1e1d22d0ff86285d2a4bfaa45dd2f394bd4c0aff073a7e0" ; values:partOf concept:therapeutic-goods-act-1989-sec-41fi ; skos:note "Secretary must decide not to include device in Register if not satisfied." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.82" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41fi-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41fi-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41fi-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fi-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41fi-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41fi-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Secretary must decide" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fi-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41fi-ss-3-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41fi-ss-3-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "IS_A" ; cml:logicSummary "Device type is a kind of device" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fi-ss-1 a cml:Concept ; skos:prefLabel "41FI(1) Auditing of applications"@en ; cml:realizedBy doc:sec-41fi-ss-1 ; cml:integrityHash "b8692134e7105bca16acf901c7cc6e0ca1fb92fe35ed6d08b3e5fe4f6a32b86e" ; values:partOf concept:therapeutic-goods-act-1989-sec-41fi ; skos:note "The Secretary may consider certain aspects of an application during auditing. Secretary may have regard to certificate in auditing application" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.82" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41fi-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41fi-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41fi-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fi-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41fi-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41fi-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "May consider certain aspects" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fi-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41fi-ss-1-logic-deontic-2 . concept:therapeutic-goods-act-1989-sec-41fi-ss-1-logic-deontic-2 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "May" ; cml:logicSummary "Permits Secretary to consider certificate" ; cml:premiseText "(a) a section 41FC application is made for a kind of medical device..." ; cml:conclusionText "The Secretary may have regard to the certificate in auditing the application." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fi-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41fi-ss-1-logic-descriptionlogic-3 . concept:therapeutic-goods-act-1989-sec-41fi-ss-1-logic-descriptionlogic-3 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Has been issued consistently with" ; cml:logicSummary "Certificate must be consistent with conformity assessment body determination" ; cml:premiseText "(e) if the conformity assessment body determination that relates to the body is limited as mentioned in paragraph 41EWA(4)(b)—the Secretary is satisfied that the certificate has been issued..." ; cml:conclusionText "The Secretary is satisfied that the certificate has been issued consistently with the determination." ; cml:executionSurface "modalities::dl" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fi-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41fi-ss-1-logic-alleninterval-4 . concept:therapeutic-goods-act-1989-sec-41fi-ss-1-logic-alleninterval-4 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Within a specified time frame" ; cml:logicSummary "Certificate must be given to Secretary within a specified timeframe" ; cml:premiseText "(d) the certificate has been given to the Secretary;" ; cml:conclusionText "The certificate was issued within a specified timeframe." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fi-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41fi-ss-1-logic-ltl-5 . concept:therapeutic-goods-act-1989-sec-41fi-ss-1-logic-ltl-5 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Recurring trace" ; cml:logicSummary "Certificate must be audited as part of recurring audit process" ; cml:premiseText "(b) the application has been selected for audit;" ; cml:conclusionText "The certificate is part of a recurring audit process." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fi-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41fi-ss-1-logic-deontic-6 . concept:therapeutic-goods-act-1989-sec-41fi-ss-1-logic-deontic-6 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Must consider" ; cml:logicSummary "Secretary must consider certificate in auditing application" ; cml:premiseText "(1) If..." ; cml:conclusionText "The Secretary must consider the certificate in auditing the application." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fi-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41fi-ss-1-logic-descriptionlogic-7 . concept:therapeutic-goods-act-1989-sec-41fi-ss-1-logic-descriptionlogic-7 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Is a requirement for audit" ; cml:logicSummary "Certificate is a requirement for audit of section 41FC application" ; cml:premiseText "(1) If..." ; cml:conclusionText "The certificate is a requirement for the audit." ; cml:executionSurface "modalities::dl" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fi-ss-2 a cml:Concept ; skos:prefLabel "41FI(2) Auditing of applications"@en ; cml:realizedBy doc:sec-41fi-ss-2 ; cml:integrityHash "8c8370c270ac917b9dbd6f61141f779e9ccbcc4a19b7257710f2e4a31e7e1533" ; values:partOf concept:therapeutic-goods-act-1989-sec-41fi ; skos:note "The Secretary must decide to include a device in the Register. The Secretary may have regard for matters beyond the scope of this section." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.82" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41fi-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41fi-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41fi-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fi-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41fi-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41fi-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "The Secretary must decide." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fi-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41fi-ss-2-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41fi-ss-2-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "IS_A" ; cml:logicSummary "The device is included in the Register." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fj a cml:Concept ; skos:prefLabel "41FJ Procedure following audits"@en ; cml:realizedBy doc:sec-41fj ; cml:integrityHash "0c578b05f1c711a460af00234e745f7a6d3188f0537353bbba26d6a39b8c3889" ; skos:note "Notify applicant of decision within 20 working days and state reasons for non-inclusion in Register if applicable." ; dc:description "Decision notice with reasons" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.83" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41fj-norm . concept:therapeutic-goods-act-1989-sec-41fj-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41fj ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fj cml:asserts concept:therapeutic-goods-act-1989-sec-41fj-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41fj-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Obligation to notify applicant" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fj cml:asserts concept:therapeutic-goods-act-1989-sec-41fj-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41fj-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "IS_A" ; cml:logicSummary "Definition of decision notice" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fk a cml:Concept ; skos:prefLabel "41FK Lapsing of applications"@en ; cml:realizedBy doc:sec-41fk ; cml:integrityHash "654b823b96ca904c0b00173568d87c84e5b82987f5bd012a647b6983eebe3555" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41fk-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41fk-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41fk-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41fk-ss-4 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41fk-ss-5 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.84" . concept:therapeutic-goods-act-1989-sec-41fk-ss-1 a cml:Concept ; skos:prefLabel "41FK(1) Lapsing of applications"@en ; cml:realizedBy doc:sec-41fk-ss-1 ; cml:integrityHash "1cf1a99ce980f4bc1bf2abfe5899339e4908de8350d4cad087dbdd94cb1b73ae" ; values:partOf concept:therapeutic-goods-act-1989-sec-41fk ; skos:note "Regulations may empower Secretary to make medical devices priority applicant determinations." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.84" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41fk-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41fk-ss-1-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41fk-ss-1 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fk-ss-2 a cml:Concept ; skos:prefLabel "41FK(2) Lapsing of applications"@en ; cml:realizedBy doc:sec-41fk-ss-2 ; cml:integrityHash "c2937f5ac7b008aadb8e1b078719d36302be931ab42d7afb99ae4893fcda0586" ; values:partOf concept:therapeutic-goods-act-1989-sec-41fk ; skos:note "A medical devices (priority applicant) determination is a specified person's priority applicant in relation to any section 41FC application." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.84" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41fk-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41fk-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41fk-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fk-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41fk-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41fk-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "hasPriorityApplicant" ; cml:logicSummary "Has priority applicant" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fk-ss-3 a cml:Concept ; skos:prefLabel "41FK(3) Lapsing of applications"@en ; cml:realizedBy doc:sec-41fk-ss-3 ; cml:integrityHash "ddb07a3ae8346a7a4622fda2d775e880575f0b74351dd4c3c031e7280310e914" ; values:partOf concept:therapeutic-goods-act-1989-sec-41fk ; skos:note "Regulations may make provision for and in relation to applications for medical devices." ; dc:description "specified information or documents within a specified period" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.84" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41fk-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41fk-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41fk-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fk-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41fk-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41fk-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must provide specified information or documents" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fk-ss-4 a cml:Concept ; skos:prefLabel "41FK(4) Lapsing of applications"@en ; cml:realizedBy doc:sec-41fk-ss-4 ; cml:integrityHash "d059d9fc252d67d028135dac57469a5d515eecf1848577496146dbd4bc066caf" ; values:partOf concept:therapeutic-goods-act-1989-sec-41fk ; skos:note "Regulations may revoke medical devices priority applicant determination" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.84" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41fk-ss-4-norm . concept:therapeutic-goods-act-1989-sec-41fk-ss-4-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41fk-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fk-ss-5 a cml:Concept ; skos:prefLabel "41FK(5) Lapsing of applications"@en ; cml:realizedBy doc:sec-41fk-ss-5 ; cml:integrityHash "8bce7bb1d83b91072e12d1f8e3745eaed7d486b18e91d4c434d3696b0fc4e5e4" ; values:partOf concept:therapeutic-goods-act-1989-sec-41fk ; skos:note "Subsections (3) and (4) do not limit subsection (1)." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.84" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41fk-ss-5-norm . concept:therapeutic-goods-act-1989-sec-41fk-ss-5-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41fk-ss-5 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fl a cml:Concept ; skos:prefLabel "41FL Device number"@en ; cml:realizedBy doc:sec-41fl ; cml:integrityHash "88725673f11b29f9cee023ec6ff2c2390b60a5f301c1d3d407a3b11abaf045c8" ; skos:note "Secretary must assign unique device number to included medical devices." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.86" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41fl-norm . concept:therapeutic-goods-act-1989-sec-41fl-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41fl ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fl cml:asserts concept:therapeutic-goods-act-1989-sec-41fl-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41fl-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must provide a unique device number." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fl cml:asserts concept:therapeutic-goods-act-1989-sec-41fl-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41fl-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "CLASSIFICATION" ; cml:logicSummary "Classification of medical devices in the Register." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fm a cml:Concept ; skos:prefLabel "41FM Duration of inclusion in the Register"@en ; cml:realizedBy doc:sec-41fm ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41fm-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41fm-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.87" . concept:therapeutic-goods-act-1989-sec-41fm-ss-1 a cml:Concept ; skos:prefLabel "41FM(1) Duration of inclusion in the Register"@en ; cml:realizedBy doc:sec-41fm-ss-1 ; cml:integrityHash "38db98b46e3014ffc0b7ac8c93a7dcbe03d5b725a7e175450c39ee61de4f1eb4" ; values:partOf concept:therapeutic-goods-act-1989-sec-41fm ; skos:note "Commences on a specified day" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.87" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41fm-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41fm-ss-1-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41fm-ss-1 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fm-ss-2 a cml:Concept ; skos:prefLabel "41FM(2) Duration of inclusion in the Register"@en ; cml:realizedBy doc:sec-41fm-ss-2 ; cml:integrityHash "7dde180eff88634b267877f2d265c24f5182a1289f4f9d4d441de3241a7453d8" ; values:partOf concept:therapeutic-goods-act-1989-sec-41fm ; skos:note "Device must be included in Register until cancellation or suspension." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.87" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41fm-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41fm-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41fm-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fm-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41fm-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41fm-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Device must be included in Register." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fm-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41fm-ss-2-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41fm-ss-2-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "ClassInclusion" ; cml:logicSummary "Device is included in Register." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fn a cml:Concept ; skos:prefLabel "41FN Conditions applying automatically"@en ; cml:realizedBy doc:sec-41fn ; cml:integrityHash "d57d24863257f78d813bb2ec53818398eb3625ff3a4def44d4e6379ee8c3a12e" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41fn-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41fn-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41fn-ss-3 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.88" . concept:therapeutic-goods-act-1989-sec-41fn-ss-1 a cml:Concept ; skos:prefLabel "41FN(1) Conditions applying automatically"@en ; cml:realizedBy doc:sec-41fn-ss-1 ; cml:integrityHash "ad97e685861be299317f695bf6cca9ade20bf75f0efcda21046f6679c233a3ae" ; values:partOf concept:therapeutic-goods-act-1989-sec-41fn ; skos:note "Allow authorised person to inspect premises and devices" ; dc:description "true" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.88" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41fn-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41fn-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41fn-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fn-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41fn-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41fn-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Allow" ; cml:logicSummary "Grant permission to inspect premises and devices" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fn-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41fn-ss-1-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41fn-ss-1-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Classify" ; cml:logicSummary "Classify devices into categories" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fn-ss-2 a cml:Concept ; skos:prefLabel "41FN(2) Conditions applying automatically"@en ; cml:realizedBy doc:sec-41fn-ss-2 ; cml:integrityHash "c3ec7104dc51faa8531239029ba366d8246ceb4bf4ca2f944899eb0b25759edc" ; values:partOf concept:therapeutic-goods-act-1989-sec-41fn ; skos:note "Deliver a reasonable number of samples if requested by the Secretary." ; dc:description "Yes" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.88" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41fn-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41fn-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41fn-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fn-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41fn-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41fn-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must deliver samples" ; cml:premiseText "The Secretary requests samples" ; cml:conclusionText "Deliver a reasonable number of samples" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fn-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41fn-ss-2-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41fn-ss-2-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "IS_A" ; cml:logicSummary "Condition for inclusion in the Register" ; cml:premiseText "The kind of device is included in the Register" ; cml:conclusionText "Subject to a condition" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fn-ss-3 a cml:Concept ; skos:prefLabel "41FN(3) Conditions applying automatically"@en ; cml:realizedBy doc:sec-41fn-ss-3 ; cml:integrityHash "ab4a50648c4c9c52a7884061063b0d5e3c20e3590c1c6caecbab873ded5a391b" ; values:partOf concept:therapeutic-goods-act-1989-sec-41fn ; skos:note "Conditions for inclusion of medical devices in the Register" ; dc:description "sufficient information to substantiate compliance with essential principles and conformity assessment procedures" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.88" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41fn-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41fn-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41fn-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fn-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41fn-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41fn-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "must" ; cml:logicSummary "Obligation to provide sufficient information" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fn-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41fn-ss-3-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41fn-ss-3-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "has" ; cml:logicSummary "Description of conditions for inclusion in the Register" ; cml:premiseText "(i) has available sufficient information to substantiate compliance with the essential principles; or (ii) has procedures in place, including a written agreement with the manufacturer of the kind of device, to ensure that such information can be obtained from the manufacturer within 20 working days;" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fn-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41fn-ss-3-logic-alleninterval-3 . concept:therapeutic-goods-act-1989-sec-41fn-ss-3-logic-alleninterval-3 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "within" ; cml:logicSummary "Temporal interval for obtaining information from the manufacturer" ; cml:premiseText "(ii) has procedures in place, including a written agreement with the manufacturer of the kind of device, to ensure that such information can be obtained from the manufacturer within 20 working days;" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fn-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41fn-ss-3-logic-ltl-4 . concept:therapeutic-goods-act-1989-sec-41fn-ss-3-logic-ltl-4 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "until" ; cml:logicSummary "Temporal interval for obtaining information from the manufacturer" ; cml:premiseText "(ii) has procedures in place, including a written agreement with the manufacturer of the kind of device, to ensure that such information can be obtained from the manufacturer within 20 working days;" ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fn-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41fn-ss-3-logic-deontic-5 . concept:therapeutic-goods-act-1989-sec-41fn-ss-3-logic-deontic-5 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "must" ; cml:logicSummary "Obligation to provide sufficient information for conformity assessment procedures" ; cml:premiseText "(i) has available sufficient information to substantiate that the conformity assessment procedures have been applied to the kind of medical device or that requirements, comparable to those procedures, have been applied to the kind of medical device to the satisfaction of an overseas regulator; or (ii) has procedures in place, including a written agreement with the manufacturer of the kind of device, to ensure that such information can be obtained from the manufacturer within 20 working days;" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fn-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41fn-ss-3-logic-descriptionlogic-6 . concept:therapeutic-goods-act-1989-sec-41fn-ss-3-logic-descriptionlogic-6 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "has" ; cml:logicSummary "Description of conditions for inclusion in the Register" ; cml:premiseText "(i) has available sufficient information to substantiate that the conformity assessment procedures have been applied to the kind of medical device or that requirements, comparable to those procedures, have been applied to the kind of medical device to the satisfaction of an overseas regulator; or (ii) has procedures in place, including a written agreement with the manufacturer of the kind of device, to ensure that such information can be obtained from the manufacturer within 20 working days;" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fo a cml:Concept ; skos:prefLabel "41FO Conditions imposed when kinds of medical devices are"@en ; cml:realizedBy doc:sec-41fo ; cml:integrityHash "75859b98e655040e4d3a3e95b01a30a97cf5e98446251a6e9be43cec5722c760" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41fo-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41fo-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.91" . concept:therapeutic-goods-act-1989-sec-41fo-ss-1 a cml:Concept ; skos:prefLabel "41FO(1) Conditions imposed when kinds of medical devices are"@en ; cml:realizedBy doc:sec-41fo-ss-1 ; cml:integrityHash "4aa47fc79c6f3bf2f65bc4899e61f87aa4da93fd331e3b53d9e9eb300360cd5c" ; values:partOf concept:therapeutic-goods-act-1989-sec-41fo ; skos:note "Secretary may impose conditions on medical device inclusion in Register" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.91" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41fo-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41fo-ss-1-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41fo-ss-1 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fo-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41fo-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41fo-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "May" ; cml:logicSummary "Permits Secretary to impose conditions" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fo-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41fo-ss-1-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41fo-ss-1-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Classifies" ; cml:logicSummary "Classifies medical devices by type" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fo-ss-2 a cml:Concept ; skos:prefLabel "41FO(2) Conditions imposed when kinds of medical devices are"@en ; cml:realizedBy doc:sec-41fo-ss-2 ; cml:integrityHash "81aa35475abe6907eba26eb5aca229efead4f92925b23b79b690aca4eaf6da67" ; values:partOf concept:therapeutic-goods-act-1989-sec-41fo ; skos:note "Conditions for medical devices" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.91" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41fo-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41fo-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41fo-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fo-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41fo-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41fo-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligate" ; cml:logicSummary "Conditions for medical devices" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fo-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41fo-ss-2-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-41fo-ss-2-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator ">=" ; cml:logicSummary "Temporal interval for tracking and location of devices" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fp a cml:Concept ; skos:prefLabel "41FP Conditions imposed after kinds of medical devices are"@en ; cml:realizedBy doc:sec-41fp ; cml:integrityHash "75859b98e655040e4d3a3e95b01a30a97cf5e98446251a6e9be43cec5722c760" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41fp-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41fp-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41fp-ss-3 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.92" . concept:therapeutic-goods-act-1989-sec-41fp-ss-1 a cml:Concept ; skos:prefLabel "41FP(1) Conditions imposed after kinds of medical devices are"@en ; cml:realizedBy doc:sec-41fp-ss-1 ; cml:integrityHash "e8602784d2ca7a1ebdedb948e8ee1ea8612607659a53b5d5c53850f5270c35f4" ; values:partOf concept:therapeutic-goods-act-1989-sec-41fp ; skos:note "Secretary may impose new conditions on medical devices" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.92" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41fp-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41fp-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41fp-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fp-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41fp-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41fp-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "Imposes obligation" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fp-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41fp-ss-1-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41fp-ss-1-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "includes" ; cml:logicSummary "Classifies medical devices" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fp-ss-2 a cml:Concept ; skos:prefLabel "41FP(2) Conditions imposed after kinds of medical devices are"@en ; cml:realizedBy doc:sec-41fp-ss-2 ; cml:integrityHash "22c24635143241369bd97dd2b3e24837c9d0afa4e705eba66f40d4d40272c7d9" ; values:partOf concept:therapeutic-goods-act-1989-sec-41fp ; skos:note "Conditions for imposition, variation or removal of conditions under this section" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.92" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41fp-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41fp-ss-2-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41fp-ss-2 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fp-ss-3 a cml:Concept ; skos:prefLabel "41FP(3) Conditions imposed after kinds of medical devices are"@en ; cml:realizedBy doc:sec-41fp-ss-3 ; cml:integrityHash "cc1f91a9f105ba9e0eb510145cf8f238fd07e6391924a5fcec9d72b0bceef0b6" ; values:partOf concept:therapeutic-goods-act-1989-sec-41fp ; skos:note "The earlier day must not be earlier than the day the notice is given to the person." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.92" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41fp-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41fp-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41fp-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41fp-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41fp-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41fp-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MustNot" ; cml:logicSummary "The earlier day must not be earlier than the given day." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41g a cml:Concept ; skos:prefLabel "41G What this Part is about"@en ; cml:realizedBy doc:sec-41g ; cml:integrityHash "a68f537923f96e3c1cd0a9b5629a612d08e1630ded0f256b8bfc902f33fab6f9" ; skos:note "Inclusions in the Register may be suspended or cancelled under certain circumstances." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.93" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41g-norm . concept:therapeutic-goods-act-1989-sec-41g-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41g ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41g cml:asserts concept:therapeutic-goods-act-1989-sec-41g-logic-descriptionlogic-1 . concept:therapeutic-goods-act-1989-sec-41g-logic-descriptionlogic-1 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Applicable" ; cml:logicSummary "Classifies inclusions in the Register" ; cml:premiseText "Inclusions in the Register may be suspended or cancelled." ; cml:conclusionText "Classification of inclusions is possible" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41g cml:asserts concept:therapeutic-goods-act-1989-sec-41g-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-41g-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Applicable" ; cml:logicSummary "Defines temporal intervals for suspension and cancellation" ; cml:premiseText "Suspension and cancellation occur under certain circumstances." ; cml:conclusionText "Temporal intervals are defined" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ga a cml:Concept ; skos:prefLabel "41GA Suspension of kinds of medical devices from the Register"@en ; cml:realizedBy doc:sec-41ga ; cml:integrityHash "334da9fac63999f10b5a25474cd4dd41808679e038039ae7605bc3648811ba08" ; skos:note "Suspension of medical devices from the Register" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.93" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ga-norm . concept:therapeutic-goods-act-1989-sec-41ga-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ga ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ga cml:asserts concept:therapeutic-goods-act-1989-sec-41ga-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41ga-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits suspension of medical devices" ; cml:premiseText "(1) The Secretary may, by written notice..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ga cml:asserts concept:therapeutic-goods-act-1989-sec-41ga-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41ga-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Classify" ; cml:logicSummary "Classifies medical devices into the Register" ; cml:premiseText "(a) the Secretary is satisfied that..." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gb a cml:Concept ; skos:prefLabel "41GB Notice of proposed suspension must be given in certain cases"@en ; cml:realizedBy doc:sec-41gb ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41gb-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41gb-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.94" . concept:therapeutic-goods-act-1989-sec-41gb-ss-1 a cml:Concept ; skos:prefLabel "41GB(1) Notice of proposed suspension must be given in certain cases"@en ; cml:realizedBy doc:sec-41gb-ss-1 ; cml:integrityHash "5a3d7cf881f993fc6fb4376c3a7279f4a15051590fd2a59b772d2a2c3db4595f" ; values:partOf concept:therapeutic-goods-act-1989-sec-41gb ; skos:note "Secretary must inform person of proposed suspension and give reasonable opportunity to make submissions." ; dc:description "Notice, reasons for suspension" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.94" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41gb-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41gb-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41gb-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gb-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41gb-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41gb-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Obligation to inform and provide reasons" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gb-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41gb-ss-1-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41gb-ss-1-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "SUBCLASS OF" ; cml:logicSummary "Classifies as obligation under section 41GB(1)" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gb-ss-2 a cml:Concept ; skos:prefLabel "41GB(2) Notice of proposed suspension must be given in certain cases"@en ; cml:realizedBy doc:sec-41gb-ss-2 ; cml:integrityHash "299f2d39b86f593eff59286b20216ccd34c6a6b574bd888886e11025f0472a78" ; values:partOf concept:therapeutic-goods-act-1989-sec-41gb ; skos:note "Secretary must consider submissions before making a decision on proposed suspension." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.94" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41gb-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41gb-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41gb-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gb-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41gb-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41gb-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must consider submissions" ; cml:premiseText "Secretary is not to make a decision..." ; cml:conclusionText "...until the Secretary has had regard..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gc a cml:Concept ; skos:prefLabel "41GC Duration of suspension"@en ; cml:realizedBy doc:sec-41gc ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41gc-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41gc-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41gc-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41gc-ss-4 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.94" . concept:therapeutic-goods-act-1989-sec-41gc-ss-1 a cml:Concept ; skos:prefLabel "41GC(1) Duration of suspension"@en ; cml:realizedBy doc:sec-41gc-ss-1 ; cml:integrityHash "09674d4274e8ef9d1940b6d6b5d1a3f3f242e9253a8669041c8e4dd1e7f155ce" ; values:partOf concept:therapeutic-goods-act-1989-sec-41gc ; skos:note "Suspension takes effect on specified day after notice is given to person." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.94" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41gc-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41gc-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41gc-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gc-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41gc-ss-1-logic-alleninterval-1 . concept:therapeutic-goods-act-1989-sec-41gc-ss-1-logic-alleninterval-1 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "during" ; cml:logicSummary "Suspension occurs during specified period" ; cml:conclusionText "period" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gc-ss-2 a cml:Concept ; skos:prefLabel "41GC(2) Duration of suspension"@en ; cml:realizedBy doc:sec-41gc-ss-2 ; cml:integrityHash "826672f262712e153782c704e8a46cfaa4492dbbbd809fbecd23841a0c7ecb7e" ; values:partOf concept:therapeutic-goods-act-1989-sec-41gc ; skos:note "Suspension duration" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.94" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41gc-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41gc-ss-2-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41gc-ss-2 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gc-ss-3 a cml:Concept ; skos:prefLabel "41GC(3) Duration of suspension"@en ; cml:realizedBy doc:sec-41gc-ss-3 ; cml:integrityHash "e032af2e47e11da6e3981f1ee97a9447a42db8cd13c5296a55f27e486569c0d4" ; values:partOf concept:therapeutic-goods-act-1989-sec-41gc ; skos:note "Extend period of suspension for medical device removal" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.94" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41gc-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41gc-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41gc-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gc-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41gc-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41gc-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "obligation" ; cml:logicSummary "Obligation to extend period of suspension" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gc-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41gc-ss-3-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41gc-ss-3-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "class" ; cml:logicSummary "Classifies medical devices by type" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gc-ss-4 a cml:Concept ; skos:prefLabel "41GC(4) Duration of suspension"@en ; cml:realizedBy doc:sec-41gc-ss-4 ; cml:integrityHash "ddf6c97ca30a7dfade8989ca40552082ecba04b7ee0b1fb3990b19c82fb18763" ; values:partOf concept:therapeutic-goods-act-1989-sec-41gc ; skos:note "Notice of extension publication" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.94" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41gc-ss-4-norm . concept:therapeutic-goods-act-1989-sec-41gc-ss-4-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41gc-ss-4 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gd a cml:Concept ; skos:prefLabel "41GD Revocation of suspension"@en ; cml:realizedBy doc:sec-41gd ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41gd-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41gd-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.95" . concept:therapeutic-goods-act-1989-sec-41gd-ss-1 a cml:Concept ; skos:prefLabel "41GD(1) Revocation of suspension"@en ; cml:realizedBy doc:sec-41gd-ss-1 ; cml:integrityHash "6ea793a83ad30aadb484408e519e5ea3e2b9c1052bef2fbafcab64a91b8e7ac1" ; values:partOf concept:therapeutic-goods-act-1989-sec-41gd ; skos:note "Revocation of suspension under specified conditions." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.95" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41gd-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41gd-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41gd-ss-1 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gd-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41gd-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41gd-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must revoke suspension" ; cml:premiseText "(1) The Secretary must revoke the suspension..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gd-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41gd-ss-1-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41gd-ss-1-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "IS_A" ; cml:logicSummary "Device type is a medical device" ; cml:premiseText "(a) the ground on which the kind of medical device concerned was suspended from the Register no longer applies;" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gd-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41gd-ss-1-logic-alleninterval-3 . concept:therapeutic-goods-act-1989-sec-41gd-ss-1-logic-alleninterval-3 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "BETWEEN" ; cml:logicSummary "Temporal interval for revocation" ; cml:premiseText "(1) The Secretary must revoke the suspension..." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gd-ss-2 a cml:Concept ; skos:prefLabel "41GD(2) Revocation of suspension"@en ; cml:realizedBy doc:sec-41gd-ss-2 ; cml:integrityHash "6e77be1ae681ecae4417109d8de4f35a2b3c13f53cf82b9f5c81cf3206e499e3" ; values:partOf concept:therapeutic-goods-act-1989-sec-41gd ; skos:note "Exercise of power to revoke suspension" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.95" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41gd-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41gd-ss-2-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41gd-ss-2 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ge a cml:Concept ; skos:prefLabel "41GE Treating applications for revocation as having been refused"@en ; cml:realizedBy doc:sec-41ge ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ge-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ge-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ge-ss-3 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.96" . concept:therapeutic-goods-act-1989-sec-41ge-ss-1 a cml:Concept ; skos:prefLabel "41GE(1) Treating applications for revocation as having been refused"@en ; cml:realizedBy doc:sec-41ge-ss-1 ; cml:integrityHash "dc1819b663eb84d93f32505b68b1943d367f9cba170bf6e89b868a6e7e432f25" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ge ; skos:note "Applicant can treat application as refused if Secretary fails to decide within prescribed time." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.96" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ge-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41ge-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ge-ss-1 ; values:borneBy values:Agent ; skos:scopeNote "borne by: Agent" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ge-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41ge-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41ge-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "imposes" ; cml:logicSummary "Duty to provide decision within time" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ge-ss-2 a cml:Concept ; skos:prefLabel "41GE(2) Treating applications for revocation as having been refused"@en ; cml:realizedBy doc:sec-41ge-ss-2 ; cml:integrityHash "ffe04f9a5547f6a08cc8c4c5a312863d2966e4616937a9406afc8e14c4405c62" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ge ; skos:note "Notice may be given at any time before decision on application." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.96" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ge-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41ge-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ge-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ge-ss-3 a cml:Concept ; skos:prefLabel "41GE(3) Treating applications for revocation as having been refused"@en ; cml:realizedBy doc:sec-41ge-ss-3 ; cml:integrityHash "48b78f43b36d3a58f278aae54b6bc7ae8e0c0f901dfd5d530e9fae5708a28939" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ge ; skos:note "If a notice has been given, the Act has no effect as if the Secretary had decided not to revoke the suspension." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.96" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ge-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41ge-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ge-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ge-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41ge-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41ge-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Implies" ; cml:logicSummary "If a notice has been given, then the Act has no effect as if the Secretary had decided not to revoke the suspension." ; cml:premiseText "Notice has been given." ; cml:conclusionText "The Act has no effect as if the Secretary had decided not to revoke the suspension." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ge-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41ge-ss-3-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-41ge-ss-3-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Overlaps" ; cml:logicSummary "The text describes a temporal interval where the notice being given overlaps with the day on which the Minister's decision was made." ; cml:premiseText "Notice has been given." ; cml:conclusionText "The Minister's decision had been made on the day on which notice was given to the Secretary." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ge-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41ge-ss-3-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-41ge-ss-3-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Repeats" ; cml:logicSummary "The text describes a repeating pattern where the notice being given repeats indefinitely." ; cml:premiseText "Notice has been given." ; cml:conclusionText "The Act has no effect as if the Secretary had decided not to revoke the suspension." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ge-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41ge-ss-3-logic-deontic-4 . concept:therapeutic-goods-act-1989-sec-41ge-ss-3-logic-deontic-4 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Implies" ; cml:logicSummary "If a notice has been given, then the Minister's decision is confirmed by the Secretary." ; cml:premiseText "Notice has been given." ; cml:conclusionText "The Minister's decision had been made on the day on which notice was given to the Secretary." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gf a cml:Concept ; skos:prefLabel "41GF Suspension where conformity assessment certificate"@en ; cml:realizedBy doc:sec-41gf ; cml:integrityHash "de2d423ac0393a3265f41f3dbb2ef0b7d8de3c9bcf90e777e6f9e768d351f01f" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41gf-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41gf-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41gf-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41gf-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41gf-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.97" . concept:therapeutic-goods-act-1989-sec-41gf-ss-1 a cml:Concept ; skos:prefLabel "41GF(1) Suspension where conformity assessment certificate"@en ; cml:realizedBy doc:sec-41gf-ss-1 ; cml:integrityHash "c378395cb8ce234cf0c21cc6a787fdaeb6547f9860ec036e1fd771817211483b" ; values:partOf concept:therapeutic-goods-act-1989-sec-41gf ; skos:note "Suspension of medical device from Register upon suspension of Australian conformity assessment body certificate or overseas regulator conformity assessment document. Secretary may suspend medical device from Register if conformity assessment certificate is suspended." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.97" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41gf-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41gf-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41gf-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gf-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41gf-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41gf-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibition of medical device from Register upon suspension of relevant certificates." ; cml:premiseText "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator." ; cml:conclusionText "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gf-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41gf-ss-1-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41gf-ss-1-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Classify" ; cml:logicSummary "Classification of medical devices based on suspension of relevant certificates." ; cml:premiseText "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator." ; cml:conclusionText "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gf-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41gf-ss-1-logic-alleninterval-3 . concept:therapeutic-goods-act-1989-sec-41gf-ss-1-logic-alleninterval-3 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "During" ; cml:logicSummary "Suspension occurs during suspension of relevant certificates." ; cml:premiseText "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator." ; cml:conclusionText "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gf-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41gf-ss-1-logic-ltl-4 . concept:therapeutic-goods-act-1989-sec-41gf-ss-1-logic-ltl-4 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Until" ; cml:logicSummary "Suspension continues until relevant certificates are reinstated." ; cml:premiseText "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator." ; cml:conclusionText "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gf-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41gf-ss-1-logic-diffusion-5 . concept:therapeutic-goods-act-1989-sec-41gf-ss-1-logic-diffusion-5 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "If" ; cml:logicSummary "Suspension occurs if relevant certificates are suspended." ; cml:premiseText "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator." ; cml:conclusionText "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gf-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41gf-ss-1-logic-cogai-6 . concept:therapeutic-goods-act-1989-sec-41gf-ss-1-logic-cogai-6 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "Classify" ; cml:logicSummary "Classification of medical devices based on suspension of relevant certificates." ; cml:premiseText "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator." ; cml:conclusionText "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator." ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gf-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41gf-ss-1-logic-deontic-7 . concept:therapeutic-goods-act-1989-sec-41gf-ss-1-logic-deontic-7 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "Implies obligation" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gf-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41gf-ss-1-logic-descriptionlogic-8 . concept:therapeutic-goods-act-1989-sec-41gf-ss-1-logic-descriptionlogic-8 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "is included in the Register" ; cml:logicSummary "Classifies device as part of a set" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gf-ss-2 a cml:Concept ; skos:prefLabel "41GF(2) Suspension where conformity assessment certificate"@en ; cml:realizedBy doc:sec-41gf-ss-2 ; cml:integrityHash "bbf02e053fa4c0c75216c7097e5c20fbcca633faa9a36186a30bdf657c616203" ; values:partOf concept:therapeutic-goods-act-1989-sec-41gf ; skos:note "Suspension under this section is limited to the same extent as suspension under Division 3 of Part 4-4. Secretary must take action before suspending a device from the Register" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.97" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41gf-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41gf-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41gf-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gf-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41gf-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41gf-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "implies" ; cml:logicSummary "If suspension under Division 3 of Part 4-4 is limited to some medical devices, then suspension under this section is also limited." ; cml:premiseText "Suspension under Division 3 of Part 4-4 is limited to some medical devices." ; cml:conclusionText "Suspension under this section is limited to the same extent as suspension under Division 3 of Part 4-4." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gf-ss-3 a cml:Concept ; skos:prefLabel "41GF(3) Suspension where conformity assessment certificate"@en ; cml:realizedBy doc:sec-41gf-ss-3 ; cml:integrityHash "33a6585a57e6347acb64c1d7cc8921937d87be58a1d33c8a26114f5a7136f7df" ; values:partOf concept:therapeutic-goods-act-1989-sec-41gf ; skos:note "Secretary must publish notice of suspension particulars." ; dc:description "Notice setting out particulars of the suspension." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.97" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41gf-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41gf-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41gf-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gf-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41gf-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41gf-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Secretary must publish notice." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gf-ss-1 a cml:Concept ; skos:prefLabel "41GF(1) Suspension where conformity assessment certificate"@en ; cml:realizedBy doc:sec-41gf-ss-1 ; cml:integrityHash "f31e237bc8d88a315fe3a61d1a9046c6b81da7071df38fe383a22e54ae81904e" ; values:partOf concept:therapeutic-goods-act-1989-sec-41gf ; skos:note "Suspension of medical device from Register upon suspension of Australian conformity assessment body certificate or overseas regulator conformity assessment document. Secretary may suspend medical device from Register if conformity assessment certificate is suspended." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.97" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41gf-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41gf-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41gf-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gf-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41gf-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41gf-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibition of medical device from Register upon suspension of relevant certificates." ; cml:premiseText "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator." ; cml:conclusionText "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gf-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41gf-ss-1-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41gf-ss-1-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Classify" ; cml:logicSummary "Classification of medical devices based on suspension of relevant certificates." ; cml:premiseText "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator." ; cml:conclusionText "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gf-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41gf-ss-1-logic-alleninterval-3 . concept:therapeutic-goods-act-1989-sec-41gf-ss-1-logic-alleninterval-3 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "During" ; cml:logicSummary "Suspension occurs during suspension of relevant certificates." ; cml:premiseText "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator." ; cml:conclusionText "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gf-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41gf-ss-1-logic-ltl-4 . concept:therapeutic-goods-act-1989-sec-41gf-ss-1-logic-ltl-4 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Until" ; cml:logicSummary "Suspension continues until relevant certificates are reinstated." ; cml:premiseText "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator." ; cml:conclusionText "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gf-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41gf-ss-1-logic-diffusion-5 . concept:therapeutic-goods-act-1989-sec-41gf-ss-1-logic-diffusion-5 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "If" ; cml:logicSummary "Suspension occurs if relevant certificates are suspended." ; cml:premiseText "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator." ; cml:conclusionText "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gf-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41gf-ss-1-logic-cogai-6 . concept:therapeutic-goods-act-1989-sec-41gf-ss-1-logic-cogai-6 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "Classify" ; cml:logicSummary "Classification of medical devices based on suspension of relevant certificates." ; cml:premiseText "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator." ; cml:conclusionText "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator." ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gf-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41gf-ss-1-logic-deontic-7 . concept:therapeutic-goods-act-1989-sec-41gf-ss-1-logic-deontic-7 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "Implies obligation" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gf-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41gf-ss-1-logic-descriptionlogic-8 . concept:therapeutic-goods-act-1989-sec-41gf-ss-1-logic-descriptionlogic-8 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "is included in the Register" ; cml:logicSummary "Classifies device as part of a set" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gf-ss-2 a cml:Concept ; skos:prefLabel "41GF(2) Suspension where conformity assessment certificate"@en ; cml:realizedBy doc:sec-41gf-ss-2 ; cml:integrityHash "bbf60f0055493859d0bac39a4639feeefdb2f095a0acd646e5eebff67f5f4a48" ; values:partOf concept:therapeutic-goods-act-1989-sec-41gf ; skos:note "Suspension under this section is limited to the same extent as suspension under Division 3 of Part 4-4. Secretary must take action before suspending a device from the Register" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.97" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41gf-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41gf-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41gf-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gf-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41gf-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41gf-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "implies" ; cml:logicSummary "If suspension under Division 3 of Part 4-4 is limited to some medical devices, then suspension under this section is also limited." ; cml:premiseText "Suspension under Division 3 of Part 4-4 is limited to some medical devices." ; cml:conclusionText "Suspension under this section is limited to the same extent as suspension under Division 3 of Part 4-4." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gg a cml:Concept ; skos:prefLabel "41GG Duration of suspension"@en ; cml:realizedBy doc:sec-41gg ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41gg-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41gg-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.98" . concept:therapeutic-goods-act-1989-sec-41gg-ss-1 a cml:Concept ; skos:prefLabel "41GG(1) Duration of suspension"@en ; cml:realizedBy doc:sec-41gg-ss-1 ; cml:integrityHash "72ca4ff0608a19a61baf7899c5d34c21529196a3e3d8312da2676b92cf63bd9c" ; values:partOf concept:therapeutic-goods-act-1989-sec-41gg ; skos:note "Commencement of suspension" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.98" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41gg-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41gg-ss-1-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41gg-ss-1 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gg-ss-2 a cml:Concept ; skos:prefLabel "41GG(2) Duration of suspension"@en ; cml:realizedBy doc:sec-41gg-ss-2 ; cml:integrityHash "8ad0e065f67bc10386559e386bc782b3f4ff128aa9ca9ed496671d4fa98b1e47" ; values:partOf concept:therapeutic-goods-act-1989-sec-41gg ; skos:note "Duration of suspension" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.98" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41gg-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41gg-ss-2-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41gg-ss-2 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gh a cml:Concept ; skos:prefLabel "41GH Revocation of suspension"@en ; cml:realizedBy doc:sec-41gh ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41gh-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41gh-ss-1a ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41gh-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.98" . concept:therapeutic-goods-act-1989-sec-41gh-ss-1 a cml:Concept ; skos:prefLabel "41GH(1) Revocation of suspension"@en ; cml:realizedBy doc:sec-41gh-ss-1 ; cml:integrityHash "45461ec0b92986ace18562ec383e6df8c4c07b145a2590d4e9cc49b50368987f" ; values:partOf concept:therapeutic-goods-act-1989-sec-41gh ; skos:note "Secretary must revoke suspension under certain conditions." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.98" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41gh-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41gh-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41gh-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gh-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41gh-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41gh-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Obligation to revoke suspension" ; cml:premiseText "Secretary has power to revoke suspension" ; cml:conclusionText "Suspension must be revoked" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gh-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41gh-ss-1-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41gh-ss-1-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "IS_A" ; cml:logicSummary "Definition of revocation" ; cml:premiseText "Revocation is defined as cessation of effect" ; cml:conclusionText "Cessation of effect is revocation" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gh-ss-1a a cml:Concept ; skos:prefLabel "41GH(1A) Revocation of suspension"@en ; cml:realizedBy doc:sec-41gh-ss-1a ; cml:integrityHash "d99d3a48ffa94b010bb9a55e6fbc9daa55ad5505c9207f2cb70da0cb7154783a" ; values:partOf concept:therapeutic-goods-act-1989-sec-41gh ; skos:note "The Secretary may revoke a suspension under section 41GFA if certain conditions are met." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.98" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41gh-ss-1a-norm . concept:therapeutic-goods-act-1989-sec-41gh-ss-1a-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41gh-ss-1a ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gh-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-41gh-ss-1a-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41gh-ss-1a-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "The Secretary may revoke a suspension under section 41GFA." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gh-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-41gh-ss-1a-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41gh-ss-1a-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "includes" ; cml:logicSummary "The kind of medical device is included in the Register." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gh-ss-2 a cml:Concept ; skos:prefLabel "41GH(2) Revocation of suspension"@en ; cml:realizedBy doc:sec-41gh-ss-2 ; cml:integrityHash "1de5133029405503c5c816c6c89c4ff30850a1843eeaaf6d8bd57b23e28dbe81" ; values:partOf concept:therapeutic-goods-act-1989-sec-41gh ; skos:note "Secretary must provide written notice and publish revocation notice within specified timeframe." ; dc:description "Notice of revocation, publication in Gazette or website" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.98" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41gh-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41gh-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41gh-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gh-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41gh-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41gh-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Obligation to provide notice and publish revocation" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gh-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41gh-ss-2-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41gh-ss-2-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "SUBCLASS OF" ; cml:logicSummary "Classification of revocation as a subclass of suspension" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gi a cml:Concept ; skos:prefLabel "41GI Effect of suspension"@en ; cml:realizedBy doc:sec-41gi ; cml:integrityHash "3889513ab0f22b32bcd075bf226ff0fb3a3b8c43c4acc57a2b56f0be5883f96b" ; skos:note "Medical devices of a particular kind are not included in the Register while suspension has effect." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.99" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41gi-norm . concept:therapeutic-goods-act-1989-sec-41gi-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41gi ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gi cml:asserts concept:therapeutic-goods-act-1989-sec-41gi-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41gi-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits dealing in medical devices not included in the Register." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gj a cml:Concept ; skos:prefLabel "41GJ Powers of cancellation from Register unaffected"@en ; cml:realizedBy doc:sec-41gj ; cml:integrityHash "aeed5f9971e1f789ce2ab41c7f40d24cbb3b5fd59a8eb1636856dc8f89ada54c" ; skos:note "Does not affect Secretary's powers to cancel medical device entries from Register" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.99" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41gj-norm . concept:therapeutic-goods-act-1989-sec-41gj-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41gj ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gk a cml:Concept ; skos:prefLabel "41GK Automatic cancellation of entries of kinds of medical devices"@en ; cml:realizedBy doc:sec-41gk ; cml:integrityHash "c6d86f1a6923df492080f306eb2d82402bad8a5777b2a89543a293bddc8a7a85" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41gk-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41gk-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.100" . concept:therapeutic-goods-act-1989-sec-41gk-ss-1 a cml:Concept ; skos:prefLabel "41GK(1) Automatic cancellation of entries of kinds of medical devices"@en ; cml:realizedBy doc:sec-41gk-ss-1 ; cml:integrityHash "c6d574381a9ce19824affbff7633af739935325583d3002c7924462f96fd70e0" ; values:partOf concept:therapeutic-goods-act-1989-sec-41gk ; skos:note "Secretary must cancel entry of medical device from Register under certain conditions." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.100" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41gk-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41gk-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41gk-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gk-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41gk-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41gk-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Secretary must cancel entry" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gk-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41gk-ss-1-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41gk-ss-1-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "hasPartOf" ; cml:logicSummary "Relation to Register" ; cml:premiseText "Register" ; cml:conclusionText "kind of medical device" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gk-ss-2 a cml:Concept ; skos:prefLabel "41GK(2) Automatic cancellation of entries of kinds of medical devices"@en ; cml:realizedBy doc:sec-41gk-ss-2 ; cml:integrityHash "7807d96c894396f62ebcfa222e81ce664457c57f3fd1bff8685ca87e9b82f839" ; values:partOf concept:therapeutic-goods-act-1989-sec-41gk ; skos:note "Automatic cancellation of entries of kinds of medical devices if they contravene absolute prohibitions or conditions." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.100" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41gk-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41gk-ss-2-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41gk-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gk-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41gk-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41gk-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Absolute prohibition on imports, exports, manufacture, and supplies." ; cml:premiseText "There are one or more absolute prohibitions in force for the purposes of subsection 9K(1) or (3)." ; cml:conclusionText "Imports, exports, manufacture, and supplies would contravene one or more of those prohibitions." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gk-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41gk-ss-2-logic-deontic-2 . concept:therapeutic-goods-act-1989-sec-41gk-ss-2-logic-deontic-2 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Conditioned prohibition on imports, exports, manufacture, and supplies." ; cml:premiseText "There are one or more prohibitions in force for the purposes of subsection 9K(1) or (3) that are subject to conditions." ; cml:conclusionText "Imports, exports, manufacture, and supplies would contravene one or more of those conditions." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gk-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41gk-ss-2-logic-descriptionlogic-3 . concept:therapeutic-goods-act-1989-sec-41gk-ss-2-logic-descriptionlogic-3 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Classify" ; cml:logicSummary "Classification of medical devices based on prohibitions and conditions." ; cml:premiseText "The Secretary must cancel the entry of the kind of device from the Register if..." ; cml:conclusionText "The device is classified as prohibited or subject to conditions." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gk-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41gk-ss-2-logic-alleninterval-4 . concept:therapeutic-goods-act-1989-sec-41gk-ss-2-logic-alleninterval-4 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Overlap" ; cml:logicSummary "Temporal overlap between prohibitions and device manufacture/supplies." ; cml:premiseText "If there are one or more absolute prohibitions in force for the purposes of subsection 9K(1) or (3)." ; cml:conclusionText "The device manufacture/supplies would contravene one or more of those prohibitions." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gk-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41gk-ss-2-logic-ltl-5 . concept:therapeutic-goods-act-1989-sec-41gk-ss-2-logic-ltl-5 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Recurring" ; cml:logicSummary "Recurring trace of prohibited devices." ; cml:premiseText "There are one or more prohibitions in force for the purposes of subsection 9K(1) or (3)." ; cml:conclusionText "The device would be subject to recurring prohibition." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gk-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41gk-ss-2-logic-diffusion-6 . concept:therapeutic-goods-act-1989-sec-41gk-ss-2-logic-diffusion-6 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "Spread" ; cml:logicSummary "Spread of prohibited devices through imports, exports, manufacture, and supplies." ; cml:premiseText "If there are one or more prohibitions in force for the purposes of subsection 9K(1) or (3)." ; cml:conclusionText "The device would spread to other areas." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gl a cml:Concept ; skos:prefLabel "41GL Immediate cancellation of entries of kinds of medical devices"@en ; cml:realizedBy doc:sec-41gl ; cml:integrityHash "f62153ad257d879789e6b825650e66eea86f6b11e9e471f8d23cae56d8f58dc2" ; skos:note "Cancellation of medical device entries from the Register" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.101" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41gl-norm . concept:therapeutic-goods-act-1989-sec-41gl-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41gl ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gl cml:asserts concept:therapeutic-goods-act-1989-sec-41gl-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41gl-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibition on continued inclusion of medical devices in the Register" ; cml:premiseText "The Secretary may cancel the entry of a kind of device from the Register if..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gl cml:asserts concept:therapeutic-goods-act-1989-sec-41gl-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41gl-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Classify" ; cml:logicSummary "Classification of medical devices into therapeutic goods and medical devices" ; cml:premiseText "devices of that kind are no longer therapeutic goods; or" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gm a cml:Concept ; skos:prefLabel "41GM Cancellation of entries of kinds of medical devices from the"@en ; cml:realizedBy doc:sec-41gm ; cml:integrityHash "b9e62828abfd28c6a31138351f9d2abda0a4c1b2bda3498dcc4678ba133adba5" ; skos:note "Cancellation of entries from medical device register upon non-compliance with notice." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.103" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41gm-norm . concept:therapeutic-goods-act-1989-sec-41gm-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41gm ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gm cml:asserts concept:therapeutic-goods-act-1989-sec-41gm-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41gm-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits cancellation of entries without compliance." ; cml:premiseText "Notice given under section 41JA." ; cml:conclusionText "Cancellation not permitted." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gm cml:asserts concept:therapeutic-goods-act-1989-sec-41gm-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41gm-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Classify" ; cml:logicSummary "Classifies medical devices based on non-compliance with notice." ; cml:premiseText "Person fails to comply with notice under section 41JA." ; cml:conclusionText "Device entry cancelled." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gm cml:asserts concept:therapeutic-goods-act-1989-sec-41gm-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-41gm-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Recurring" ; cml:logicSummary "Recurring trace of non-compliance leads to cancellation." ; cml:premiseText "Notice given for ascertainment purposes." ; cml:conclusionText "Cancellation upon repeated non-compliance." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gn a cml:Concept ; skos:prefLabel "41GN Cancellation of entries of kinds of medical devices from the"@en ; cml:realizedBy doc:sec-41gn ; cml:integrityHash "853a9af14612eed65a1d0763c289e120255dd5e7f9bae31bb9d9b21c83e63351" ; skos:note "The Secretary may cancel an entry of a kind of medical device from the Register under certain conditions." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.104" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41gn-norm . concept:therapeutic-goods-act-1989-sec-41gn-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41gn ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gn cml:asserts concept:therapeutic-goods-act-1989-sec-41gn-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41gn-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "can" ; cml:logicSummary "The Secretary can cancel an entry of a kind of medical device from the Register." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gn cml:asserts concept:therapeutic-goods-act-1989-sec-41gn-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41gn-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "is-a" ; cml:logicSummary "The cancellation is related to changes in the safety or performance of the device." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gn cml:asserts concept:therapeutic-goods-act-1989-sec-41gn-logic-alleninterval-3 . concept:therapeutic-goods-act-1989-sec-41gn-logic-alleninterval-3 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator ">=" ; cml:logicSummary "The cancellation must occur within a certain timeframe after notice is given." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gn cml:asserts concept:therapeutic-goods-act-1989-sec-41gn-logic-ltl-4 . concept:therapeutic-goods-act-1989-sec-41gn-logic-ltl-4 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "<" ; cml:logicSummary "The cancellation must occur before the device's conformity assessment document expires." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gn cml:asserts concept:therapeutic-goods-act-1989-sec-41gn-logic-deontic-5 . concept:therapeutic-goods-act-1989-sec-41gn-logic-deontic-5 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "must" ; cml:logicSummary "The person in relation to whom the kind of medical device is included in the Register must comply with certain conditions." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gn cml:asserts concept:therapeutic-goods-act-1989-sec-41gn-logic-argumentation-6 . concept:therapeutic-goods-act-1989-sec-41gn-logic-argumentation-6 a cml:LogicApplication ; cml:modality cml:Argumentation ; cml:operator "implies" ; cml:logicSummary "The cancellation implies that the person has failed to comply with a condition or direction." ; cml:executionSurface "modalities::argumentation" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41go a cml:Concept ; skos:prefLabel "41GO Limiting cancellation of entries from Register to some"@en ; cml:realizedBy doc:sec-41go ; cml:integrityHash "fa990293713b01e938971b745b1613bfff5cd7af3c6785fd54ab5dee391d4aae" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41go-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41go-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.106" . concept:therapeutic-goods-act-1989-sec-41go-ss-1 a cml:Concept ; skos:prefLabel "41GO(1) Limiting cancellation of entries from Register to some"@en ; cml:realizedBy doc:sec-41go-ss-1 ; cml:integrityHash "e68abce408d29a18b517f505f52402504d39577fd92d0378d95e51e002f3321a" ; values:partOf concept:therapeutic-goods-act-1989-sec-41go ; skos:note "Secretary must limit cancellation of entries from Register to some medical devices." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.106" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41go-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41go-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41go-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41go-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41go-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41go-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must provide limit on cancellation." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41go-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41go-ss-1-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41go-ss-1-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "CLASSIFICATION" ; cml:logicSummary "Classify medical devices into categories." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41go-ss-2 a cml:Concept ; skos:prefLabel "41GO(2) Limiting cancellation of entries from Register to some"@en ; cml:realizedBy doc:sec-41go-ss-2 ; cml:integrityHash "c4682c28ae040f9dad49d18c711476e4cf30402eb69bfc9c906911c22572c462" ; values:partOf concept:therapeutic-goods-act-1989-sec-41go ; skos:note "Must vary entry in Register upon cancellation of medical device" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.106" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41go-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41go-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41go-ss-2 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41go-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41go-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41go-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Obligation to vary entry in Register" ; cml:premiseText "(2) If the cancellation of the entry of a kind of medical device from the Register is limited to some medical devices of that kind..." ; cml:conclusionText "...the Secretary: (a) must vary the entry in the Register accordingly;" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41go-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41go-ss-2-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41go-ss-2-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "SUBCLASS OF" ; cml:logicSummary "Varying entry in Register is a subclass of obligation to update" ; cml:premiseText "(2) If the cancellation of the entry of a kind of medical device from the Register is limited to some medical devices of that kind..." ; cml:conclusionText "...the Secretary: (a) must vary the entry in the Register accordingly;" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41go-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41go-ss-2-logic-alleninterval-3 . concept:therapeutic-goods-act-1989-sec-41go-ss-2-logic-alleninterval-3 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "CONTAINS" ; cml:logicSummary "Varying entry in Register occurs within cancellation of medical device" ; cml:premiseText "(2) If the cancellation of the entry of a kind of medical device from the Register is limited to some medical devices of that kind..." ; cml:conclusionText "...the Secretary: (a) must vary the entry in the Register accordingly;" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41go-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41go-ss-2-logic-ltl-4 . concept:therapeutic-goods-act-1989-sec-41go-ss-2-logic-ltl-4 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "CONTAINS" ; cml:logicSummary "Varying entry in Register occurs within cancellation of medical device" ; cml:premiseText "(2) If the cancellation of the entry of a kind of medical device from the Register is limited to some medical devices of that kind..." ; cml:conclusionText "...the Secretary: (a) must vary the entry in the Register accordingly;" ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41go-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41go-ss-2-logic-deontic-5 . concept:therapeutic-goods-act-1989-sec-41go-ss-2-logic-deontic-5 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST NOT" ; cml:logicSummary "Must not delete entry from Register upon cancellation of medical device" ; cml:premiseText "(2) If the cancellation of the entry of a kind of medical device from the Register is limited to some medical devices of that kind..." ; cml:conclusionText "...the Secretary: (b) must not delete the entry from the Register because of the cancellation." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41go-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41go-ss-2-logic-descriptionlogic-6 . concept:therapeutic-goods-act-1989-sec-41go-ss-2-logic-descriptionlogic-6 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "SUBCLASS OF" ; cml:logicSummary "Not deleting entry from Register is a subclass of obligation to preserve" ; cml:premiseText "(2) If the cancellation of the entry of a kind of medical device from the Register is limited to some medical devices of that kind..." ; cml:conclusionText "...the Secretary: (b) must not delete the entry from the Register because of the cancellation." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gp a cml:Concept ; skos:prefLabel "41GP Publication of cancellation of entry from Register"@en ; cml:realizedBy doc:sec-41gp ; cml:integrityHash "e584f3c5b9d0f68cb805945dc2ff98262902c3a1f2551dfcb2483000f06ee7cd" ; skos:note "Publish notice of cancellation from Register after cancelling medical device entry." ; dc:description "Notice setting out particulars of cancellation." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.106" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41gp-norm . concept:therapeutic-goods-act-1989-sec-41gp-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41gp ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gp cml:asserts concept:therapeutic-goods-act-1989-sec-41gp-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41gp-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Obligation to publish notice." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gp cml:asserts concept:therapeutic-goods-act-1989-sec-41gp-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41gp-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "SUBCLASS_OF" ; cml:logicSummary "Publication of cancellation from Register is a subclass of obligation." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gq a cml:Concept ; skos:prefLabel "41GQ Date of effect of cancellation of entries from Register"@en ; cml:realizedBy doc:sec-41gq ; cml:integrityHash "3a64e9cca769ce053f9f99555c5b2e4a105c1de497a1c40cde6d7ca52703a571" ; skos:note "Cancellation of medical device entries has a specified effective date." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.107" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41gq-norm . concept:therapeutic-goods-act-1989-sec-41gq-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41gq ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gq cml:asserts concept:therapeutic-goods-act-1989-sec-41gq-logic-descriptionlogic-1 . concept:therapeutic-goods-act-1989-sec-41gq-logic-descriptionlogic-1 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "=" ; cml:logicSummary "Identifies the key" ; cml:conclusionText "key" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gq cml:asserts concept:therapeutic-goods-act-1989-sec-41gq-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-41gq-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator ">=" ; cml:logicSummary "Specifies a later day" ; cml:premiseText "20 working days after notice is given" ; cml:conclusionText "later day" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gr a cml:Concept ; skos:prefLabel "41GR What this Part is about"@en ; cml:realizedBy doc:sec-41gr ; cml:integrityHash "eea092c90008fb9a07610d549021ba93cc906c12803cefde1bc9505ef67ad928" ; skos:note "Exemption of medical devices from certain provisions" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.108" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41gr-norm . concept:therapeutic-goods-act-1989-sec-41gr-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41gr ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gr cml:asserts concept:therapeutic-goods-act-1989-sec-41gr-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41gr-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Permit" ; cml:logicSummary "Granting permission to exempt medical devices" ; cml:premiseText "The Minister may exempt certain medical devices" ; cml:conclusionText "from various provisions of this Chapter" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gr cml:asserts concept:therapeutic-goods-act-1989-sec-41gr-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-41gr-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Temporal Interval" ; cml:logicSummary "Conditional commencement of exemptions" ; cml:premiseText "The Minister may exempt certain medical devices from various provisions of this Chapter so that the devices may be stockpiled to deal with possible future emergencies or made available urgently to deal with actual emergencies." ; cml:conclusionText "Note 1:" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gr cml:asserts concept:therapeutic-goods-act-1989-sec-41gr-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-41gr-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Recurring Trace" ; cml:logicSummary "Recurring trace of exemptions under Part 41GR" ; cml:premiseText "The Minister may exempt certain medical devices from various provisions of this Chapter so that the devices may be stockpiled to deal with possible future emergencies or made available urgently to deal with actual emergencies." ; cml:conclusionText "Note 2:" ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gr cml:asserts concept:therapeutic-goods-act-1989-sec-41gr-logic-deontic-4 . concept:therapeutic-goods-act-1989-sec-41gr-logic-deontic-4 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Obligation to provide information about exemptions under Part 41GR" ; cml:premiseText "Some of the other provisions of this Act about medical devices exempt under this Part are:" ; cml:conclusionText "(a) section 41JCA (providing information to the Secretary); and (b) section 41KA (public notification and recall of medical devices);" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gr cml:asserts concept:therapeutic-goods-act-1989-sec-41gr-logic-deontic-5 . concept:therapeutic-goods-act-1989-sec-41gr-logic-deontic-5 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Obligation to provide information about exemptions under Part 41GR" ; cml:premiseText "Some of the other provisions of this Act about medical devices exempt under this Part are:" ; cml:conclusionText "(c) section 46A (search of premises)." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gs a cml:Concept ; skos:prefLabel "41GS Minister may make exemptions"@en ; cml:realizedBy doc:sec-41gs ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41gs-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41gs-ss-1a ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41gs-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41gs-ss-2a ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41gs-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41gs-ss-4 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41gs-ss-5 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.108" . concept:therapeutic-goods-act-1989-sec-41gs-ss-1 a cml:Concept ; skos:prefLabel "41GS(1) Minister may make exemptions"@en ; cml:realizedBy doc:sec-41gs-ss-1 ; cml:integrityHash "8f7d568322b92bc8d8367ae811ea9c692ee969d1754d033eabe0107f744c2a91" ; values:partOf concept:therapeutic-goods-act-1989-sec-41gs ; skos:note "Minister may exempt specified kinds of medical devices from certain regulations." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.108" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41gs-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41gs-ss-1-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41gs-ss-1 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gs-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41gs-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41gs-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "Permission to exempt" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gs-ss-1a a cml:Concept ; skos:prefLabel "41GS(1A) Minister may make exemptions"@en ; cml:realizedBy doc:sec-41gs-ss-1a ; cml:integrityHash "3907b28cab63116b3cbcc615f3b28f6c6e173fb1ffc4af1ff36648ccbb7ceeed" ; values:partOf concept:therapeutic-goods-act-1989-sec-41gs ; skos:note "Minister may grant exemptions under certain conditions." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.108" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41gs-ss-1a-norm . concept:therapeutic-goods-act-1989-sec-41gs-ss-1a-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41gs-ss-1a ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gs-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-41gs-ss-1a-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41gs-ss-1a-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "May" ; cml:logicSummary "Permission to exempt devices" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gs-ss-2 a cml:Concept ; skos:prefLabel "41GS(2) Minister may make exemptions"@en ; cml:realizedBy doc:sec-41gs-ss-2 ; cml:integrityHash "be390aee62340ad3c21ff768660a4ac7d7f1949029be469e6246f8b30ade7fff" ; values:partOf concept:therapeutic-goods-act-1989-sec-41gs ; skos:note "Minister may make exemptions in the national interest to stockpile medical devices quickly and provide them urgently in case of an emergency." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.108" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41gs-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41gs-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41gs-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gs-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41gs-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41gs-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Minister has the obligation to make exemptions in the national interest." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gs-ss-2a a cml:Concept ; skos:prefLabel "41GS(2A) Minister may make exemptions"@en ; cml:realizedBy doc:sec-41gs-ss-2a ; cml:integrityHash "9fea32571133fa9883b178cce7b2d45ec76a839b767e8b02b2cc9632eb911b88" ; values:partOf concept:therapeutic-goods-act-1989-sec-41gs ; skos:note "Exemption from certain requirements under national emergency declaration" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.108" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41gs-ss-2a-norm . concept:therapeutic-goods-act-1989-sec-41gs-ss-2a-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41gs-ss-2a ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gs-ss-2a cml:asserts concept:therapeutic-goods-act-1989-sec-41gs-ss-2a-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41gs-ss-2a-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Permit" ; cml:logicSummary "Granting permission" ; cml:premiseText "Minister has discretion to make exemptions" ; cml:conclusionText "Exemption is permitted" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gs-ss-3 a cml:Concept ; skos:prefLabel "41GS(3) Minister may make exemptions"@en ; cml:realizedBy doc:sec-41gs-ss-3 ; cml:integrityHash "9a759f9f0ef6c9e3a02d4a6434ec4cf54bee790f0b59bcb86d74aac5fc192333" ; values:partOf concept:therapeutic-goods-act-1989-sec-41gs ; skos:note "Exemptions come into force on specified day or later" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.108" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41gs-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41gs-ss-3-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41gs-ss-3 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gs-ss-4 a cml:Concept ; skos:prefLabel "41GS(4) Minister may make exemptions"@en ; cml:realizedBy doc:sec-41gs-ss-4 ; cml:integrityHash "ceab7404d3be37f63cfa109125924695ecbeb77b4b260e1477e9b093fd0a00e1" ; values:partOf concept:therapeutic-goods-act-1989-sec-41gs ; skos:note "Exemptions remain in force for the specified period unless revoked earlier." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.108" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41gs-ss-4-norm . concept:therapeutic-goods-act-1989-sec-41gs-ss-4-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41gs-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gs-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41gs-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41gs-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "holds" ; cml:logicSummary "Holds true" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gs-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41gs-ss-4-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41gs-ss-4-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "subClassOf" ; cml:logicSummary "Subclass of exemptions" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gs-ss-5 a cml:Concept ; skos:prefLabel "41GS(5) Minister may make exemptions"@en ; cml:realizedBy doc:sec-41gs-ss-5 ; cml:integrityHash "c862e06fc4f632cb6d930160b555a6456a373141c9b3b74c75e407f10a742923" ; values:partOf concept:therapeutic-goods-act-1989-sec-41gs ; skos:note "Exemption ceases to have effect when device is included in the Register." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.108" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41gs-ss-5-norm . concept:therapeutic-goods-act-1989-sec-41gs-ss-5-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41gs-ss-5 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gs-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-41gs-ss-5-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41gs-ss-5-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "ceases" ; cml:logicSummary "Obligation ceases" ; cml:premiseText "(5) An exemption under subsection (1)" ; cml:conclusionText "ceases to have effect in relation to a particular kind of medical device" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gs-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-41gs-ss-5-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41gs-ss-5-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "includes" ; cml:logicSummary "Device inclusion implies exclusion" ; cml:premiseText "(5) An exemption under subsection (1)" ; cml:conclusionText "exemption ceases when device is included in the Register" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gt a cml:Concept ; skos:prefLabel "41GT Conditions of exemptions"@en ; cml:realizedBy doc:sec-41gt ; cml:integrityHash "a2f20c9a6d16e2b346d4805fcfebca92fa2232f36749b6566b2334812bd7ff46" ; skos:note "Conditions for exemptions under section 41GS" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.110" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41gt-norm . concept:therapeutic-goods-act-1989-sec-41gt-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41gt ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gt cml:asserts concept:therapeutic-goods-act-1989-sec-41gt-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41gt-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "must" ; cml:logicSummary "Conditions must be met for exemptions" ; cml:premiseText "An exemption under section 41GS is subject to conditions" ; cml:conclusionText "Those conditions must be met" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gt cml:asserts concept:therapeutic-goods-act-1989-sec-41gt-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41gt-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "is-a" ; cml:logicSummary "Conditions are related to exemptions" ; cml:premiseText "The conditions specified in the exemption about any of the following:" ; cml:conclusionText "Exemptions have conditions" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gu a cml:Concept ; skos:prefLabel "41GU Variation or revocation of exemption"@en ; cml:realizedBy doc:sec-41gu ; cml:integrityHash "c2f34d233068d447bce67a922c935760ef233255887c06da805ed973ebd562ed" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41gu-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41gu-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41gu-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41gu-ss-4 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.111" . concept:therapeutic-goods-act-1989-sec-41gu-ss-1 a cml:Concept ; skos:prefLabel "41GU(1) Variation or revocation of exemption"@en ; cml:realizedBy doc:sec-41gu-ss-1 ; cml:integrityHash "e413dd58d74872681fd6c61b0993929d07cab89937e224121c84d67faeb0f808" ; values:partOf concept:therapeutic-goods-act-1989-sec-41gu ; skos:note "Variation of exemption by Minister" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.111" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41gu-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41gu-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41gu-ss-1 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gu-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41gu-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41gu-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "Granting permission to vary exemptions" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gu-ss-2 a cml:Concept ; skos:prefLabel "41GU(2) Variation or revocation of exemption"@en ; cml:realizedBy doc:sec-41gu-ss-2 ; cml:integrityHash "afba112cf19953e9e04121cacb4674ff2fa9c3249dd2aa4efcb40e61c2926d81" ; values:partOf concept:therapeutic-goods-act-1989-sec-41gu ; skos:note "Revocation of exemption by Minister" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.111" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41gu-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41gu-ss-2-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41gu-ss-2 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gu-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41gu-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41gu-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Permit" ; cml:logicSummary "Granting permission" ; cml:premiseText "(2) The Minister may, by writing..." ; cml:conclusionText "The exemption is revoked." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gu-ss-3 a cml:Concept ; skos:prefLabel "41GU(3) Variation or revocation of exemption"@en ; cml:realizedBy doc:sec-41gu-ss-3 ; cml:integrityHash "a78195726c8076a4b1ff3191029b528c9107559d2525441f3bffbceff12a9959" ; values:partOf concept:therapeutic-goods-act-1989-sec-41gu ; skos:note "Variation or revocation of exemption conditions" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.111" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41gu-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41gu-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41gu-ss-3 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gu-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41gu-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41gu-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "Permission to vary or revoke exemptions" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gu-ss-4 a cml:Concept ; skos:prefLabel "41GU(4) Variation or revocation of exemption"@en ; cml:realizedBy doc:sec-41gu-ss-4 ; cml:integrityHash "6b984b4a1f8f1933cbe0bcba6343b5214fd57a9f65feaaef1381e6cdc443ee07" ; values:partOf concept:therapeutic-goods-act-1989-sec-41gu ; skos:note "Variation or revocation of exemption takes effect under specified conditions." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.111" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41gu-ss-4-norm . concept:therapeutic-goods-act-1989-sec-41gu-ss-4-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41gu-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gu-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41gu-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41gu-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "obligation" ; cml:logicSummary "Obligation to specify conditions for variation or revocation" ; cml:premiseText "Minister must state imminent risk" ; cml:conclusionText "Variation or revocation takes effect under specified conditions" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gu-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41gu-ss-4-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-41gu-ss-4-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "between" ; cml:logicSummary "Temporal interval between variation or revocation and its effect" ; cml:premiseText "Variation or revocation is made on a specific day" ; cml:conclusionText "Effect of variation or revocation occurs within 28 days after it is made" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gu-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41gu-ss-4-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-41gu-ss-4-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "until" ; cml:logicSummary "Temporal interval until effect of variation or revocation" ; cml:premiseText "Variation or revocation takes effect on a later day specified in the variation or revocation" ; cml:conclusionText "Effect of variation or revocation occurs after specified day" ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gu-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41gu-ss-4-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-41gu-ss-4-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "diffuses" ; cml:logicSummary "Diffusion of information about variation or revocation" ; cml:premiseText "Minister states imminent risk in variation or revocation" ; cml:conclusionText "Information about imminent risk diffuses to relevant parties" ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gu-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41gu-ss-4-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-41gu-ss-4-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "recognizes" ; cml:logicSummary "CogAI recognizes variation or revocation as a subclass of exemption" ; cml:premiseText "Variation/Revocation is recognized as a subclass of Exemption by CogAI" ; cml:conclusionText "Exemption has subclasses Variation and Revocation recognized by CogAI" ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gv a cml:Concept ; skos:prefLabel "41GV Informing persons of exemption etc."@en ; cml:realizedBy doc:sec-41gv ; cml:integrityHash "3d3060966f168c012e40bbfd3e80c302f3a14ff4ddafd14633227d89c7f11b52" ; skos:note "Must provide Chapter 4 Medical devices to persons covered by paragraph 41GT(c)" ; dc:description "Yes" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.111" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41gv-norm . concept:therapeutic-goods-act-1989-sec-41gv-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41gv ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gv cml:asserts concept:therapeutic-goods-act-1989-sec-41gv-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41gv-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST PROVIDE" ; cml:logicSummary "Must provide Chapter 4 Medical devices" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gv cml:asserts concept:therapeutic-goods-act-1989-sec-41gv-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-41gv-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "CONTAINS" ; cml:logicSummary "The Minister must provide Chapter 4 Medical devices within a reasonable timeframe" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gw a cml:Concept ; skos:prefLabel "41GW Notification and tabling"@en ; cml:realizedBy doc:sec-41gw ; cml:integrityHash "7d31b83313991d4c969b95ff28385ff891514dbe7a93c93c5db8145ad031420f" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41gw-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41gw-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.112" . concept:therapeutic-goods-act-1989-sec-41gw-ss-1 a cml:Concept ; skos:prefLabel "41GW(1) Notification and tabling"@en ; cml:realizedBy doc:sec-41gw-ss-1 ; cml:integrityHash "29f9f12af4236a1244485a3ed5640c3b83ac59254f7fd0961b4ce4f336a461fe" ; values:partOf concept:therapeutic-goods-act-1989-sec-41gw ; skos:note "Publish notice in Gazette within 5 working days after exemption, variation or revocation is made." ; dc:description "Notice setting out particulars of exemption, variation or revocation" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.112" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41gw-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41gw-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41gw-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gw-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41gw-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41gw-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must publish notice in Gazette" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gw-ss-2 a cml:Concept ; skos:prefLabel "41GW(2) Notification and tabling"@en ; cml:realizedBy doc:sec-41gw-ss-2 ; cml:integrityHash "b0cfa78d6c799a7c3a5e90b8595a9a77e89a701a27ef546659861844729cc045" ; values:partOf concept:therapeutic-goods-act-1989-sec-41gw ; skos:note "Minister must table document within 5 sitting days of exemption, variation or revocation made." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.112" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41gw-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41gw-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41gw-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gw-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41gw-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41gw-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Minister must table document" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gy a cml:Concept ; skos:prefLabel "41GY Disposal of unused medical devices"@en ; cml:realizedBy doc:sec-41gy ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41gy-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41gy-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41gy-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41gy-ss-4 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.113" . concept:therapeutic-goods-act-1989-sec-41gy-ss-1 a cml:Concept ; skos:prefLabel "41GY(1) Disposal of unused medical devices"@en ; cml:realizedBy doc:sec-41gy-ss-1 ; cml:integrityHash "5c53a1db42c9bbe45fd59af1893703f5ec2641ec737e07fffabb3ea545c2dd1e" ; values:partOf concept:therapeutic-goods-act-1989-sec-41gy ; skos:note "Medical device must be disposed of if exemption ceases to have effect" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.113" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41gy-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41gy-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41gy-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gy-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41gy-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41gy-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must be disposed of" ; cml:premiseText "(1) This section applies to a medical device..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gy-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41gy-ss-1-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41gy-ss-1-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "IS_A" ; cml:logicSummary "Related to disposal of medical devices" ; cml:premiseText "(a) an exemption under section 41GS in relation to that kind of medical device ceases to have effect..." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gy-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41gy-ss-1-logic-alleninterval-3 . concept:therapeutic-goods-act-1989-sec-41gy-ss-1-logic-alleninterval-3 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator ">=" ; cml:logicSummary "Cease to have effect before use" ; cml:premiseText "(b) the medical device has not been used before the exemption so ceases to have effect." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gy-ss-2 a cml:Concept ; skos:prefLabel "41GY(2) Disposal of unused medical devices"@en ; cml:realizedBy doc:sec-41gy-ss-2 ; cml:integrityHash "210d8dfdc02f50afa3716069d8cd90d09753d229b853ef59b3f9e0770a1cb8a7" ; values:partOf concept:therapeutic-goods-act-1989-sec-41gy ; skos:note "The Secretary may arrange for disposal of medical devices." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.113" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41gy-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41gy-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41gy-ss-2 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gy-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41gy-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41gy-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "Implies obligation" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gy-ss-3 a cml:Concept ; skos:prefLabel "41GY(3) Disposal of unused medical devices"@en ; cml:realizedBy doc:sec-41gy-ss-3 ; cml:integrityHash "7a0a2c6b8f91ead93a1acd3f8a1de0a893a56d78d9f89cee35e3fa852bedb462" ; values:partOf concept:therapeutic-goods-act-1989-sec-41gy ; skos:note "Methods for disposal of medical devices" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.113" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41gy-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41gy-ss-3-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41gy-ss-3 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gy-ss-4 a cml:Concept ; skos:prefLabel "41GY(4) Disposal of unused medical devices"@en ; cml:realizedBy doc:sec-41gy-ss-4 ; cml:integrityHash "b7d3ce3966fe9385b49a1128277bfc857753511ebf0cfa2c98090f389e126ffa" ; values:partOf concept:therapeutic-goods-act-1989-sec-41gy ; skos:note "Prohibits benefit conferred on person other than owner of medical device" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.113" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41gy-ss-4-norm . concept:therapeutic-goods-act-1989-sec-41gy-ss-4-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41gy-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gy-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41gy-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41gy-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "forbid" ; cml:logicSummary "Prohibits benefit" ; cml:premiseText "(4) A method set out in the regulations under subsection (3)" ; cml:conclusionText "must not enable or permit any benefit to be conferred on a person (including the Commonwealth) other than the owner of the medical device." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gy-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41gy-ss-4-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-41gy-ss-4-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "during" ; cml:logicSummary "Temporal scope of regulation" ; cml:premiseText "(4) A method set out in the regulations under subsection (3)" ; cml:conclusionText "must not enable or permit any benefit to be conferred on a person (including the Commonwealth) other than the owner of the medical device." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gy-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41gy-ss-4-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-41gy-ss-4-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "during" ; cml:logicSummary "Temporal scope of regulation" ; cml:premiseText "(4) A method set out in the regulations under subsection (3)" ; cml:conclusionText "must not enable or permit any benefit to be conferred on a person (including the Commonwealth) other than the owner of the medical device." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gy-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41gy-ss-4-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-41gy-ss-4-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "during" ; cml:logicSummary "Temporal scope of regulation" ; cml:premiseText "(4) A method set out in the regulations under subsection (3)" ; cml:conclusionText "must not enable or permit any benefit to be conferred on a person (including the Commonwealth) other than the owner of the medical device." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41gy-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41gy-ss-4-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-41gy-ss-4-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "during" ; cml:logicSummary "Temporal scope of regulation" ; cml:premiseText "(4) A method set out in the regulations under subsection (3)" ; cml:conclusionText "must not enable or permit any benefit to be conferred on a person (including the Commonwealth) other than the owner of the medical device." ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41h a cml:Concept ; skos:prefLabel "41H What this Part is about"@en ; cml:realizedBy doc:sec-41h ; cml:integrityHash "d0b9f3fba29013895845d7e6c428848ca9b2b43ce8d240438dc86a9e56a72764" ; skos:note "Exemptions from prohibitions on dealing in medical devices" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.114" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41h-norm . concept:therapeutic-goods-act-1989-sec-41h-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41h ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ha a cml:Concept ; skos:prefLabel "41HA Devices exempted from inclusion in the Register"@en ; cml:realizedBy doc:sec-41ha ; cml:integrityHash "7f1733ffac81395e1fe88e5199b597b0a861fb474b07d522a69c36da568b5ba0" ; skos:note "Exemptions from Division 3 regulation" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.114" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ha-norm . concept:therapeutic-goods-act-1989-sec-41ha-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ha ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hb a cml:Concept ; skos:prefLabel "41HB Approvals for special and experimental uses"@en ; cml:realizedBy doc:sec-41hb ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41hb-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41hb-ss-1a ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41hb-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41hb-ss-3 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.115" . concept:therapeutic-goods-act-1989-sec-41hb-ss-1 a cml:Concept ; skos:prefLabel "41HB(1) Approvals for special and experimental uses"@en ; cml:realizedBy doc:sec-41hb-ss-1 ; cml:integrityHash "352553e576350966faea334f04b3711329e2fe10af10c657d62a8696203ce3c7" ; values:partOf concept:therapeutic-goods-act-1989-sec-41hb ; skos:note "Grant of written approval for specified medical device use" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.115" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41hb-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41hb-ss-1-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41hb-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hb-ss-1a a cml:Concept ; skos:prefLabel "41HB(1A) Approvals for special and experimental uses"@en ; cml:realizedBy doc:sec-41hb-ss-1a ; cml:integrityHash "d031f04ea0fe34f08843a7672884fbb9a910ab375ffcf47a77985b10fb0a7d1e" ; values:partOf concept:therapeutic-goods-act-1989-sec-41hb ; skos:note "Approval for special and experimental uses must be granted only to health practitioners." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.115" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41hb-ss-1a-norm . concept:therapeutic-goods-act-1989-sec-41hb-ss-1a-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41hb-ss-1a ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hb-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-41hb-ss-1a-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41hb-ss-1a-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits granting approval to non-health practitioners." ; cml:premiseText "(1A) An approval for use of the kind referred to in paragraph (1)(d) must not be granted to a person unless the person is a health practitioner." ; cml:conclusionText "Approval must be granted only to health practitioners." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hb-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-41hb-ss-1a-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-41hb-ss-1a-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Temporal Interval" ; cml:logicSummary "Defines temporal interval for approval of special and experimental uses." ; cml:premiseText "(1A) An approval for use of the kind referred to in paragraph (1)(d) must not be granted to a person unless the person is a health practitioner." ; cml:conclusionText "Approval of special and experimental uses has a specific temporal interval." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hb-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-41hb-ss-1a-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-41hb-ss-1a-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Temporal Interval" ; cml:logicSummary "Defines temporal interval for approval of special and experimental uses." ; cml:premiseText "(1A) An approval for use of the kind referred to in paragraph (1)(d) must not be granted to a person unless the person is a health practitioner." ; cml:conclusionText "Approval of special and experimental uses has a specific temporal interval." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hb-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-41hb-ss-1a-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-41hb-ss-1a-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "Diffuse" ; cml:logicSummary "Diffuses information about approval eligibility for special and experimental uses." ; cml:premiseText "(1A) An approval for use of the kind referred to in paragraph (1)(d) must not be granted to a person unless the person is a health practitioner." ; cml:conclusionText "Approval eligibility for special and experimental uses is diffused through the system." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hb-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-41hb-ss-1a-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-41hb-ss-1a-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "Classify" ; cml:logicSummary "Classifies approval for special and experimental uses as requiring health practitioner eligibility." ; cml:premiseText "(1A) An approval for use of the kind referred to in paragraph (1)(d) must not be granted to a person unless the person is a health practitioner." ; cml:conclusionText "Approval for special and experimental uses requires health practitioner eligibility." ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hb-ss-2 a cml:Concept ; skos:prefLabel "41HB(2) Approvals for special and experimental uses"@en ; cml:realizedBy doc:sec-41hb-ss-2 ; cml:integrityHash "ab15e615cf1485736bcf912cca9402cd88cce451ea1945b0d851d5d74d6aa8f9" ; values:partOf concept:therapeutic-goods-act-1989-sec-41hb ; skos:note "Breach of conditions may be an offence" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.115" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41hb-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41hb-ss-2-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41hb-ss-2 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hb-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41hb-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41hb-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibition of breach" ; cml:premiseText "Breach of conditions may be an offence" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hb-ss-3 a cml:Concept ; skos:prefLabel "41HB(3) Approvals for special and experimental uses"@en ; cml:realizedBy doc:sec-41hb-ss-3 ; cml:integrityHash "89cfe9e326c2ba342414f56352c8aa21cec0d89d9ef7f36fed9308dc51a3ede1" ; values:partOf concept:therapeutic-goods-act-1989-sec-41hb ; skos:note "Conditions for approval of medical devices for experimental use in humans." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.115" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41hb-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41hb-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41hb-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hb-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41hb-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41hb-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "requires" ; cml:logicSummary "Requires preconditions" ; cml:premiseText "(a) the preconditions on another person’s use of devices of those kinds for those purposes;" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hb-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41hb-ss-3-logic-ltl-2 . concept:therapeutic-goods-act-1989-sec-41hb-ss-3-logic-ltl-2 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "for all" ; cml:logicSummary "For all persons using medical devices" ; cml:premiseText "(a) the preconditions on another person’s use of devices of those kinds for those purposes;" ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hb-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41hb-ss-3-logic-deontic-3 . concept:therapeutic-goods-act-1989-sec-41hb-ss-3-logic-deontic-3 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "requires" ; cml:logicSummary "Requires principles of device use" ; cml:premiseText "(b) the principles to be followed in another person’s use of devices of those kinds for those purposes;" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hb-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41hb-ss-3-logic-alleninterval-4 . concept:therapeutic-goods-act-1989-sec-41hb-ss-3-logic-alleninterval-4 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "during" ; cml:logicSummary "During experimental use" ; cml:premiseText "The conditions may relate to one or more of the following:" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hb-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41hb-ss-3-logic-deontic-5 . concept:therapeutic-goods-act-1989-sec-41hb-ss-3-logic-deontic-5 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "requires" ; cml:logicSummary "Requires relation to device types" ; cml:premiseText "The conditions may relate to one or more of the following:" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hc a cml:Concept ; skos:prefLabel "41HC Authorities for health practitioners"@en ; cml:realizedBy doc:sec-41hc ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41hc-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41hc-ss-1a ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41hc-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41hc-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41hc-ss-4 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41hc-ss-5 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41hc-ss-6 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41hc-ss-6a ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41hc-ss-6b ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41hc-ss-6c ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41hc-ss-6d ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41hc-ss-6e ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.118" . concept:therapeutic-goods-act-1989-sec-41hc-ss-1 a cml:Concept ; skos:prefLabel "41HC(1) Authorities for health practitioners"@en ; cml:realizedBy doc:sec-41hc-ss-1 ; cml:integrityHash "08e94b5aa0a6f89a75f4d49ee3e52328307cc53ed896431e7b1f9feb751be972" ; values:partOf concept:therapeutic-goods-act-1989-sec-41hc ; skos:note "Secretary may authorise medical practitioner to supply medical devices." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.118" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41hc-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41hc-ss-1-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41hc-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hc-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41hc-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41hc-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "Permission granted by the Secretary." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hc-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41hc-ss-1-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41hc-ss-1-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "hasPart" ; cml:logicSummary "Class of recipients specified in the authorisation." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hc-ss-1a a cml:Concept ; skos:prefLabel "41HC(1A) Authorities for health practitioners"@en ; cml:realizedBy doc:sec-41hc-ss-1a ; cml:integrityHash "08807ce063a19d294a3e8ec5c4286cac61c2b55d571ffb679a457b7ada675751" ; values:partOf concept:therapeutic-goods-act-1989-sec-41hc ; skos:note "Application for authority must be in approved form" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.118" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41hc-ss-1a-norm . concept:therapeutic-goods-act-1989-sec-41hc-ss-1a-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41hc-ss-1a ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hc-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-41hc-ss-1a-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41hc-ss-1a-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must provide approved application form" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hc-ss-2 a cml:Concept ; skos:prefLabel "41HC(2) Authorities for health practitioners"@en ; cml:realizedBy doc:sec-41hc-ss-2 ; cml:integrityHash "41bbe3f7b0e8be4adc01ff2dfcf5c78e432b82c881576ba1a94b9417c5e330aa" ; values:partOf concept:therapeutic-goods-act-1989-sec-41hc ; skos:note "Authority may be given subject to conditions." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.118" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41hc-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41hc-ss-2-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41hc-ss-2 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hc-ss-3 a cml:Concept ; skos:prefLabel "41HC(3) Authorities for health practitioners"@en ; cml:realizedBy doc:sec-41hc-ss-3 ; cml:integrityHash "ab1be10173ebd250d4983f838d8f46c71bdbe68186b50e76f20802f15c174655" ; values:partOf concept:therapeutic-goods-act-1989-sec-41hc ; skos:note "Secretary may impose conditions on health practitioners" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.118" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41hc-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41hc-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41hc-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hc-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41hc-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41hc-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "Imposes obligation" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hc-ss-4 a cml:Concept ; skos:prefLabel "41HC(4) Authorities for health practitioners"@en ; cml:realizedBy doc:sec-41hc-ss-4 ; cml:integrityHash "e1408ad811ceeab1bae29cde67bccf0e6c49ecbe1c04509f16f4c44064f33fc1" ; values:partOf concept:therapeutic-goods-act-1989-sec-41hc ; skos:note "Authority for health practitioners may only be given under certain conditions." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.118" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41hc-ss-4-norm . concept:therapeutic-goods-act-1989-sec-41hc-ss-4-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41hc-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hc-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41hc-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41hc-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "onlyIf" ; cml:logicSummary "Authority is conditional on meeting specific requirements." ; cml:premiseText "(a) and (b)" ; cml:conclusionText "(c)" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hc-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41hc-ss-4-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41hc-ss-4-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "classOf" ; cml:logicSummary "Authority applies to classes of medical practitioners." ; cml:premiseText "(a) and (c)" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hc-ss-5 a cml:Concept ; skos:prefLabel "41HC(5) Authorities for health practitioners"@en ; cml:realizedBy doc:sec-41hc-ss-5 ; cml:integrityHash "4127a130e53b5ae4701e57a453a09fba170f6af4c7e0bfc7bf1e43c2240f7b6b" ; values:partOf concept:therapeutic-goods-act-1989-sec-41hc ; skos:note "Authority to prescribe circumstances for medical device supply" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.118" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41hc-ss-5-norm . concept:therapeutic-goods-act-1989-sec-41hc-ss-5-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41hc-ss-5 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hc-ss-6 a cml:Concept ; skos:prefLabel "41HC(6) Authorities for health practitioners"@en ; cml:realizedBy doc:sec-41hc-ss-6 ; cml:integrityHash "a016e316ef1eef411c484cd78dd143922d11ef471445b79d7be7a588475fd4b8" ; values:partOf concept:therapeutic-goods-act-1989-sec-41hc ; skos:note "The Minister may make rules authorising health practitioners to supply medical devices." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.118" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41hc-ss-6-norm . concept:therapeutic-goods-act-1989-sec-41hc-ss-6-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41hc-ss-6 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hc-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-41hc-ss-6-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41hc-ss-6-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "May" ; cml:logicSummary "Permission to supply medical devices" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hc-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-41hc-ss-6-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41hc-ss-6-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Class inclusion" ; cml:logicSummary "Rules specify class of health practitioners" ; cml:premiseText "Health practitioner included in a specified Medical device Chapter 4" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hc-ss-6a a cml:Concept ; skos:prefLabel "41HC(6A) Authorities for health practitioners"@en ; cml:realizedBy doc:sec-41hc-ss-6a ; cml:integrityHash "7c92974776fae4a198331df92c95469c340dbac72b28d11db8e12b38dbdba874" ; values:partOf concept:therapeutic-goods-act-1989-sec-41hc ; skos:note "Comply with regulations' requirements, restrictions, and limitations." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.118" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41hc-ss-6a-norm . concept:therapeutic-goods-act-1989-sec-41hc-ss-6a-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41hc-ss-6a ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hc-ss-6a cml:asserts concept:therapeutic-goods-act-1989-sec-41hc-ss-6a-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41hc-ss-6a-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Must" ; cml:logicSummary "Minister must comply with regulations." ; cml:premiseText "(6A) In making rules under subsection (6), the Minister..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hc-ss-6a cml:asserts concept:therapeutic-goods-act-1989-sec-41hc-ss-6a-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-41hc-ss-6a-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Within" ; cml:logicSummary "Requirements, restrictions, and limitations are within regulations." ; cml:premiseText "(b) such restrictions (if any) as are prescribed by the regulations;" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hc-ss-6b a cml:Concept ; skos:prefLabel "41HC(6B) Authorities for health practitioners"@en ; cml:realizedBy doc:sec-41hc-ss-6b ; cml:integrityHash "f8aff130f6ec9d4a93d62f804116cd2a51103c75b6df027e0083bcdc55c87cb3" ; values:partOf concept:therapeutic-goods-act-1989-sec-41hc ; skos:note "Notify supply within 28 days after supplying medical device." ; dc:description "true" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.118" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41hc-ss-6b-norm . concept:therapeutic-goods-act-1989-sec-41hc-ss-6b-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41hc-ss-6b ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hc-ss-6b cml:asserts concept:therapeutic-goods-act-1989-sec-41hc-ss-6b-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41hc-ss-6b-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must provide notification." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hc-ss-6b cml:asserts concept:therapeutic-goods-act-1989-sec-41hc-ss-6b-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41hc-ss-6b-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "hasValue" ; cml:logicSummary "Notification must be made within 28 days." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hc-ss-6c a cml:Concept ; skos:prefLabel "41HC(6C) Authorities for health practitioners"@en ; cml:realizedBy doc:sec-41hc-ss-6c ; cml:integrityHash "0db592c10b0d037eb185b179260eccb080b354894575a5eb0133929ddc80a90d" ; values:partOf concept:therapeutic-goods-act-1989-sec-41hc ; skos:note "Notification requirements for health practitioners" ; dc:description "Information as prescribed by regulations" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.118" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41hc-ss-6c-norm . concept:therapeutic-goods-act-1989-sec-41hc-ss-6c-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41hc-ss-6c ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hc-ss-6c cml:asserts concept:therapeutic-goods-act-1989-sec-41hc-ss-6c-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41hc-ss-6c-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Notification requirement" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hc-ss-6d a cml:Concept ; skos:prefLabel "41HC(6D) Authorities for health practitioners"@en ; cml:realizedBy doc:sec-41hc-ss-6d ; cml:integrityHash "8e572ad786200e3e525ce99d60a484b86e1a5f35ac34f11d78b86ed0156b72e6" ; values:partOf concept:therapeutic-goods-act-1989-sec-41hc ; skos:note "Approval of form may require or permit information to be given in accordance with specified software requirements." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.118" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41hc-ss-6d-norm . concept:therapeutic-goods-act-1989-sec-41hc-ss-6d-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41hc-ss-6d ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hc-ss-6e a cml:Concept ; skos:prefLabel "41HC(6E) Authorities for health practitioners"@en ; cml:realizedBy doc:sec-41hc-ss-6e ; cml:integrityHash "900c67275c14e5cc826153a8bbad159216cdcd1614cdc5ddb659282dbed31dc2" ; values:partOf concept:therapeutic-goods-act-1989-sec-41hc ; skos:note "Offence for subject to requirement under subsection (6B)" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.118" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41hc-ss-6e-norm . concept:therapeutic-goods-act-1989-sec-41hc-ss-6e-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41hc-ss-6e ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hc-ss-6e cml:asserts concept:therapeutic-goods-act-1989-sec-41hc-ss-6e-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41hc-ss-6e-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "has" ; cml:logicSummary "Subject is required" ; cml:premiseText "(6B)" ; cml:conclusionText "(6E)" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hd a cml:Concept ; skos:prefLabel "41HD Approvals if substitutes for medical devices are unavailable"@en ; cml:realizedBy doc:sec-41hd ; cml:integrityHash "41b387a9617d9ffde9dc713bb94531bfc48d834db2fdc78d61c2040332d7bd35" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41hd-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41hd-ss-1a ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.120" . concept:therapeutic-goods-act-1989-sec-41hd-ss-1 a cml:Concept ; skos:prefLabel "41HD(1) Approvals if substitutes for medical devices are unavailable"@en ; cml:realizedBy doc:sec-41hd-ss-1 ; cml:integrityHash "e7cef7375c9f89a509bce3be49afba081b69933ebc63b33164ff304e8e58a88d" ; values:partOf concept:therapeutic-goods-act-1989-sec-41hd ; skos:note "Secretary may grant approval for importation and supply of medical device under certain conditions." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.120" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41hd-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41hd-ss-1-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41hd-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hd-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41hd-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41hd-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Grant" ; cml:logicSummary "Secretary grants approval." ; cml:premiseText "(1) The Secretary may, by notice in writing..." ; cml:conclusionText "...the Secretary is satisfied that..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hd-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41hd-ss-1-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41hd-ss-1-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Classify" ; cml:logicSummary "Medical devices included in the Register are classified as substitutes." ; cml:premiseText "(i) are unavailable or are in short supply;" ; cml:conclusionText "...the kinds of medical devices included in the Register..." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hd-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41hd-ss-1-logic-alleninterval-3 . concept:therapeutic-goods-act-1989-sec-41hd-ss-1-logic-alleninterval-3 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Temporal Interval" ; cml:logicSummary "Medical device may become unavailable or be in short supply." ; cml:premiseText "(ii) may, in the reasonably foreseeable future, become unavailable or be in short supply;" ; cml:conclusionText "...the medical device is specified in a determination under subsection (6);" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hd-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41hd-ss-1-logic-deontic-4 . concept:therapeutic-goods-act-1989-sec-41hd-ss-1-logic-deontic-4 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Secretary must satisfy certain conditions before granting approval." ; cml:premiseText "(c) the kinds of medical devices included in the Register that..." ; cml:conclusionText "...the Secretary is satisfied that..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hd-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41hd-ss-1-logic-deontic-5 . concept:therapeutic-goods-act-1989-sec-41hd-ss-1-logic-deontic-5 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Permission" ; cml:logicSummary "Approval is necessary in the interests of public health." ; cml:premiseText "(f) the approval is necessary in the interests of public health." ; cml:conclusionText "...the Secretary may, by notice in writing..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hd-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41hd-ss-1-logic-deontic-6 . concept:therapeutic-goods-act-1989-sec-41hd-ss-1-logic-deontic-6 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Permission" ; cml:logicSummary "Medical device must be registered or approved for general marketing in at least one foreign country." ; cml:premiseText "(i) the medical device is registered or approved for general marketing in at least one foreign country specified in a determination under subsection (5);" ; cml:conclusionText "...the Secretary may, by notice in writing..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hd-ss-1a a cml:Concept ; skos:prefLabel "41HD(1A) Approvals if substitutes for medical devices are unavailable"@en ; cml:realizedBy doc:sec-41hd-ss-1a ; cml:integrityHash "3a0b306536ac9f6cbb91e0095344f956f9d726b79ee27e4bbc701e56980f2fc8" ; values:partOf concept:therapeutic-goods-act-1989-sec-41hd ; skos:note "Secretary may grant approval for importation of medical device under certain conditions." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.120" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41hd-ss-1a-norm . concept:therapeutic-goods-act-1989-sec-41hd-ss-1a-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41hd-ss-1a ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41hd-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-41hd-ss-1a-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41hd-ss-1a-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Grant" ; cml:logicSummary "Secretary grants approval" ; cml:premiseText "Secretary has discretion to grant approval" ; cml:conclusionText "Approval granted" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41j a cml:Concept ; skos:prefLabel "41J What this Part is about"@en ; cml:realizedBy doc:sec-41j ; cml:integrityHash "faacb78c69535bdc9c4ffe17e3ca844bfab4c9ce2f579d8f4f1310c7452b98a6" ; skos:note "The Secretary may seek information or documents relating to certain matters." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.125" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41j-norm . concept:therapeutic-goods-act-1989-sec-41j-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41j ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ja a cml:Concept ; skos:prefLabel "41JA Secretary may require information or documents"@en ; cml:realizedBy doc:sec-41ja ; cml:integrityHash "7f98bca1fec2c45eb979dafe67f6e595443e88d4d98c681e128437814c703285" ; skos:note "The Secretary may require information or documents from a person related to medical devices." ; dc:description "Yes" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.126" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ja-norm . concept:therapeutic-goods-act-1989-sec-41ja-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ja ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ja cml:asserts concept:therapeutic-goods-act-1989-sec-41ja-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41ja-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "The Secretary must require information or documents." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ja cml:asserts concept:therapeutic-goods-act-1989-sec-41ja-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41ja-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "SUBCLASS_OF" ; cml:logicSummary "The provision is part of the Therapeutic Goods Act 1989." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jb a cml:Concept ; skos:prefLabel "41JB Complying with the Secretary’s requirements"@en ; cml:realizedBy doc:sec-41jb ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41jb-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41jb-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41jb-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41jb-ss-3a ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.129" . concept:therapeutic-goods-act-1989-sec-41jb-ss-1 a cml:Concept ; skos:prefLabel "41JB(1) Complying with the Secretary’s requirements"@en ; cml:realizedBy doc:sec-41jb-ss-1 ; cml:integrityHash "f40a56a96fa8cf5078cb2f4294413ee27c81a1ce883e0acdab714ac925caa5c8" ; values:partOf concept:therapeutic-goods-act-1989-sec-41jb ; skos:note "Provide information or documents to the Secretary within a specified time and form." ; dc:description "true" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.129" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41jb-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41jb-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41jb-ss-1 ; values:borneBy values:NaturalPerson ; skos:scopeNote "borne by: NaturalPerson" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jb-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41jb-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41jb-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must provide information or documents" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jb-ss-2 a cml:Concept ; skos:prefLabel "41JB(2) Complying with the Secretary’s requirements"@en ; cml:realizedBy doc:sec-41jb-ss-2 ; cml:integrityHash "77b552611898c7df1dd7a8f2b1e5a0cf2b437e1ee6644377a49a686ef23c2658" ; values:partOf concept:therapeutic-goods-act-1989-sec-41jb ; skos:note "Comply with specified software requirements for data processing device or electronic transmission." ; dc:description "Offence for failing to comply with a notice" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.129" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41jb-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41jb-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41jb-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jb-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41jb-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41jb-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must comply" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jb-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41jb-ss-2-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41jb-ss-2-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "IS-A" ; cml:logicSummary "Complying with requirements is a form of compliance" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jb-ss-3 a cml:Concept ; skos:prefLabel "41JB(3) Complying with the Secretary’s requirements"@en ; cml:realizedBy doc:sec-41jb-ss-3 ; cml:integrityHash "1be65ce8f73e1c3edc90e7157f54221deda5c3748cc47ebc244be6fb4466746c" ; values:partOf concept:therapeutic-goods-act-1989-sec-41jb ; skos:note "Failure to comply with notice leads to penalty and potential suspension/cancellation of certificates." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.129" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41jb-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41jb-ss-3-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41jb-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jb-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41jb-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41jb-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibits failure to comply with notice." ; cml:premiseText "Given notice under section 41JA" ; cml:conclusionText "Penalty of 500 penalty units." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jb-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41jb-ss-3-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41jb-ss-3-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "ClassInclusion" ; cml:logicSummary "Includes conditions for suspension/cancellation of certificates." ; cml:premiseText "Divisions 3 and 4 of Part 4-4" ; cml:conclusionText "Suspension or revocation of conformity assessment certificate." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jb-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41jb-ss-3-logic-descriptionlogic-3 . concept:therapeutic-goods-act-1989-sec-41jb-ss-3-logic-descriptionlogic-3 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "ClassInclusion" ; cml:logicSummary "Includes conditions for suspension/cancellation of medical device entries." ; cml:premiseText "Part 4-6" ; cml:conclusionText "Suspension or cancellation of entry in Register." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jb-ss-3a a cml:Concept ; skos:prefLabel "41JB(3A) Complying with the Secretary’s requirements"@en ; cml:realizedBy doc:sec-41jb-ss-3a ; cml:integrityHash "ae5718ef2fad1929dd66627f4740cb19826791ca95d6e9b1daffe9867f10d868" ; values:partOf concept:therapeutic-goods-act-1989-sec-41jb ; skos:note "Must provide a reasonable excuse to avoid liability." ; dc:description "Yes" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.129" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41jb-ss-3a-norm . concept:therapeutic-goods-act-1989-sec-41jb-ss-3a-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41jb-ss-3a ; values:borneBy values:NaturalPerson ; skos:scopeNote "borne by: NaturalPerson" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jb-ss-3a cml:asserts concept:therapeutic-goods-act-1989-sec-41jb-ss-3a-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41jb-ss-3a-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Mandatory duty" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jb-ss-3a cml:asserts concept:therapeutic-goods-act-1989-sec-41jb-ss-3a-logic-epistemic-2 . concept:therapeutic-goods-act-1989-sec-41jb-ss-3a-logic-epistemic-2 a cml:LogicApplication ; cml:modality cml:Epistemic ; cml:operator "Belief" ; cml:logicSummary "Defendant bears evidential burden" ; cml:executionSurface "modalities::epistemic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jc a cml:Concept ; skos:prefLabel "41JC Self-incrimination"@en ; cml:realizedBy doc:sec-41jc ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41jc-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41jc-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.132" . concept:therapeutic-goods-act-1989-sec-41jc-ss-1 a cml:Concept ; skos:prefLabel "41JC(1) Self-incrimination"@en ; cml:realizedBy doc:sec-41jc-ss-1 ; cml:integrityHash "6dc0e568e288a9ba87b2fc9658ea425dcc9056e13b8318865be780af05429b77" ; values:partOf concept:therapeutic-goods-act-1989-sec-41jc ; skos:note "No excuse for providing information under section 41JB" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.132" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41jc-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41jc-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41jc-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jc-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41jc-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41jc-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "No excuse for providing information under section 41JB" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jc-ss-2 a cml:Concept ; skos:prefLabel "41JC(2) Self-incrimination"@en ; cml:realizedBy doc:sec-41jc-ss-2 ; cml:integrityHash "e808075d7ae733b02b1bc450dbc97d7b0acb11a1ed75c05d9387d15faec5f47e" ; values:partOf concept:therapeutic-goods-act-1989-sec-41jc ; skos:note "Protection from self-incrimination in certain cases" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.132" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41jc-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41jc-ss-2-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41jc-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jc-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41jc-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41jc-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibits admissibility of information in certain cases" ; cml:premiseText "(2) However, in the case of an individual:" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jd a cml:Concept ; skos:prefLabel "41JD Secretary may require information etc. about devices"@en ; cml:realizedBy doc:sec-41jd ; cml:integrityHash "8908984e2ff446167cb9a201367dc27e58c16af35de8872cffdae92437609f51" ; skos:note "Secretary may give sponsor permission to exclude from Division 3 of Part 4-11" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.133" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41jd-norm . concept:therapeutic-goods-act-1989-sec-41jd-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41jd ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jd cml:asserts concept:therapeutic-goods-act-1989-sec-41jd-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41jd-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "Permission to exclude from Division 3 of Part 4-11" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41je a cml:Concept ; skos:prefLabel "41JE Secretary may require information relating to approvals"@en ; cml:realizedBy doc:sec-41je ; cml:integrityHash "c55a6b7d2e4809fd866285fa0881f23ce036e8f46a84be94fefbd2c774940867" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41je-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41je-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41je-ss-3 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.135" . concept:therapeutic-goods-act-1989-sec-41je-ss-1 a cml:Concept ; skos:prefLabel "41JE(1) Secretary may require information relating to approvals"@en ; cml:realizedBy doc:sec-41je-ss-1 ; cml:integrityHash "804a57a914a738518eee0007c2eb10a155a5843bff9807eced3833eb550da271" ; values:partOf concept:therapeutic-goods-act-1989-sec-41je ; skos:note "The Secretary may require a person granted an approval to provide specified information or documents." ; dc:description "true" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.135" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41je-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41je-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41je-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41je-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41je-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41je-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MAY" ; cml:logicSummary "The Secretary may require the person to provide information." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41je-ss-2 a cml:Concept ; skos:prefLabel "41JE(2) Secretary may require information relating to approvals"@en ; cml:realizedBy doc:sec-41je-ss-2 ; cml:integrityHash "5928f9f2c2bdfbe1600ef4b0901d0313dce23c25ab7a217a5cfd989153bc8ed6" ; values:partOf concept:therapeutic-goods-act-1989-sec-41je ; skos:note "Secretary may require information from a person using specified medical devices." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.135" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41je-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41je-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41je-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41je-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41je-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41je-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must provide information" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41je-ss-3 a cml:Concept ; skos:prefLabel "41JE(3) Secretary may require information relating to approvals"@en ; cml:realizedBy doc:sec-41je-ss-3 ; cml:integrityHash "1ed799060013f2967b0bb2ec4d7920e1d03645c15f9e82c75e9ce5e7cfa3c173" ; values:partOf concept:therapeutic-goods-act-1989-sec-41je ; skos:note "Secretary must specify a reasonable period for compliance with notice." ; dc:description "Notice period" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.135" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41je-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41je-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41je-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41je-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41je-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41je-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must provide a reasonable notice period" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jf a cml:Concept ; skos:prefLabel "41JF Secretary may require information relating to health"@en ; cml:realizedBy doc:sec-41jf ; cml:integrityHash "88cdc76151aa65970707898e204bfcb3bce1a33f576845baaa0fb2611beac8f1" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41jf-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41jf-ss-1a ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41jf-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41jf-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41jf-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41jf-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41jf-ss-3 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.136" . concept:therapeutic-goods-act-1989-sec-41jf-ss-1 a cml:Concept ; skos:prefLabel "41JF(1) Secretary may require information relating to health"@en ; cml:realizedBy doc:sec-41jf-ss-1 ; cml:integrityHash "6a3648b8b10cd3f2a0ce6f4fc3d1040122903c5b9127fea3a68ca934e990388b" ; values:partOf concept:therapeutic-goods-act-1989-sec-41jf ; skos:note "Secretary may require specified information or documents from a person granted an approval. The Secretary may require information from a person granted an authority under subsection 41HC(1)" ; dc:description "specified information or documents" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.136" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41jf-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41jf-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41jf-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jf-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41jf-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41jf-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST PROVIDE" ; cml:logicSummary "Must provide specified information or documents." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jf-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41jf-ss-1-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41jf-ss-1-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "CLASSIFICATION" ; cml:logicSummary "Classification of medical devices." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jf-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41jf-ss-1-logic-deontic-3 . concept:therapeutic-goods-act-1989-sec-41jf-ss-1-logic-deontic-3 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MAY" ; cml:logicSummary "The Secretary may require information" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jf-ss-1a a cml:Concept ; skos:prefLabel "41JF(1A) Secretary may require information relating to health"@en ; cml:realizedBy doc:sec-41jf-ss-1a ; cml:integrityHash "2f7536359a2f6d7f133e51de97367d6733c57baa14f8c47a6b4fcb4ddba58fc4" ; values:partOf concept:therapeutic-goods-act-1989-sec-41jf ; skos:note "The Secretary may require a person to provide specified information or documents." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.136" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41jf-ss-1a-norm . concept:therapeutic-goods-act-1989-sec-41jf-ss-1a-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41jf-ss-1a ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jf-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-41jf-ss-1a-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41jf-ss-1a-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MAY" ; cml:logicSummary "The Secretary may require the person to provide information." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jf-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-41jf-ss-1a-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41jf-ss-1a-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "IS_A" ; cml:logicSummary "The provision is part of a class hierarchy for medical device regulations." ; cml:executionSurface "modalities::dl" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jf-ss-2 a cml:Concept ; skos:prefLabel "41JF(2) Secretary may require information relating to health"@en ; cml:realizedBy doc:sec-41jf-ss-2 ; cml:integrityHash "639e3531c8c40de38f8fd5a4908ef5f3cfd73c9ec0e677850406d27c697c6f8b" ; values:partOf concept:therapeutic-goods-act-1989-sec-41jf ; skos:note "Secretary must require information within a specified period. Secretary must specify a reasonable period for compliance with notice." ; dc:description "Yes" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.136" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41jf-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41jf-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41jf-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jf-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41jf-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41jf-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must provide information" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jf-ss-3 a cml:Concept ; skos:prefLabel "41JF(3) Secretary may require information relating to health"@en ; cml:realizedBy doc:sec-41jf-ss-3 ; cml:integrityHash "b7b83037d7f5cb928bbdc0b32d99348e5ee6daf75bb85e1d2fc47f8c9f56c19f" ; values:partOf concept:therapeutic-goods-act-1989-sec-41jf ; skos:note "Secretary may require information to be given in a specified way. Secretary may require information relating to health" ; dc:description "true" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.136" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41jf-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41jf-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41jf-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jf-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41jf-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41jf-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "requires" ; cml:logicSummary "Requires information to be provided." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jf-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41jf-ss-3-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41jf-ss-3-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "has specified software requirements" ; cml:logicSummary "Has specified software requirements." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jf-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41jf-ss-3-logic-deontic-3 . concept:therapeutic-goods-act-1989-sec-41jf-ss-3-logic-deontic-3 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must provide information" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jf-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41jf-ss-3-logic-descriptionlogic-4 . concept:therapeutic-goods-act-1989-sec-41jf-ss-3-logic-descriptionlogic-4 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "CLASSIFICATION" ; cml:logicSummary "Classification of data processing devices and electronic transmissions" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jf-ss-1 a cml:Concept ; skos:prefLabel "41JF(1) Secretary may require information relating to health"@en ; cml:realizedBy doc:sec-41jf-ss-1 ; cml:integrityHash "01b1e38840e54a81d1e77e4818208cbbad983ea495eb5d4850925280a9f86e77" ; values:partOf concept:therapeutic-goods-act-1989-sec-41jf ; skos:note "Secretary may require specified information or documents from a person granted an approval. The Secretary may require information from a person granted an authority under subsection 41HC(1)" ; dc:description "specified information or documents" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.136" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41jf-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41jf-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41jf-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jf-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41jf-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41jf-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST PROVIDE" ; cml:logicSummary "Must provide specified information or documents." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jf-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41jf-ss-1-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41jf-ss-1-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "CLASSIFICATION" ; cml:logicSummary "Classification of medical devices." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jf-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41jf-ss-1-logic-deontic-3 . concept:therapeutic-goods-act-1989-sec-41jf-ss-1-logic-deontic-3 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MAY" ; cml:logicSummary "The Secretary may require information" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jf-ss-2 a cml:Concept ; skos:prefLabel "41JF(2) Secretary may require information relating to health"@en ; cml:realizedBy doc:sec-41jf-ss-2 ; cml:integrityHash "6fb6ab7bf3223678571d89c02117f70fbf97955f583c78bf877b3885d7d721f4" ; values:partOf concept:therapeutic-goods-act-1989-sec-41jf ; skos:note "Secretary must require information within a specified period. Secretary must specify a reasonable period for compliance with notice." ; dc:description "Yes" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.136" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41jf-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41jf-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41jf-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jf-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41jf-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41jf-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must provide information" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jf-ss-3 a cml:Concept ; skos:prefLabel "41JF(3) Secretary may require information relating to health"@en ; cml:realizedBy doc:sec-41jf-ss-3 ; cml:integrityHash "f115cc3278572e8236639771f183c330974f485984436da8de45204638be0e46" ; values:partOf concept:therapeutic-goods-act-1989-sec-41jf ; skos:note "Secretary may require information to be given in a specified way. Secretary may require information relating to health" ; dc:description "true" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.136" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41jf-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41jf-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41jf-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jf-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41jf-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41jf-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "requires" ; cml:logicSummary "Requires information to be provided." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jf-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41jf-ss-3-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41jf-ss-3-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "has specified software requirements" ; cml:logicSummary "Has specified software requirements." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jf-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41jf-ss-3-logic-deontic-3 . concept:therapeutic-goods-act-1989-sec-41jf-ss-3-logic-deontic-3 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must provide information" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jf-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41jf-ss-3-logic-descriptionlogic-4 . concept:therapeutic-goods-act-1989-sec-41jf-ss-3-logic-descriptionlogic-4 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "CLASSIFICATION" ; cml:logicSummary "Classification of data processing devices and electronic transmissions" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jg a cml:Concept ; skos:prefLabel "41JG Criminal offences for failing to give information or documents"@en ; cml:realizedBy doc:sec-41jg ; cml:integrityHash "087abf06b670b386b28e788d0cd6864ef844ac51e5b8306ab616d2838b0eef0b" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41jg-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41jg-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41jg-ss-3 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.138" . concept:therapeutic-goods-act-1989-sec-41jg-ss-1 a cml:Concept ; skos:prefLabel "41JG(1) Criminal offences for failing to give information or documents"@en ; cml:realizedBy doc:sec-41jg-ss-1 ; cml:integrityHash "54b6ffd075c52116ab61e02c5ddf65c0f7739a9aad5d1386809f97ce4f646752" ; values:partOf concept:therapeutic-goods-act-1989-sec-41jg ; skos:note "Failure to comply with notice results in penalty." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.138" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41jg-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41jg-ss-1-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41jg-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jg-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41jg-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41jg-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibits failure to comply with notice." ; cml:premiseText "(a) the person is given a notice under section 41JCA, 41JD, 41JE, 41JF or 41JFA;" ; cml:conclusionText "Penalty: 400 penalty units." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jg-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41jg-ss-1-logic-deontic-2 . concept:therapeutic-goods-act-1989-sec-41jg-ss-1-logic-deontic-2 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Imposes obligation to comply with notice." ; cml:premiseText "(b) the person fails to comply with the notice." ; cml:conclusionText "Penalty: 400 penalty units." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jg-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41jg-ss-1-logic-alleninterval-3 . concept:therapeutic-goods-act-1989-sec-41jg-ss-1-logic-alleninterval-3 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Applicable" ; cml:logicSummary "Describes temporal interval for penalty application." ; cml:premiseText "(b) the person fails to comply with the notice." ; cml:conclusionText "Penalty applies when person fails to comply." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jg-ss-2 a cml:Concept ; skos:prefLabel "41JG(2) Criminal offences for failing to give information or documents"@en ; cml:realizedBy doc:sec-41jg-ss-2 ; cml:integrityHash "1d50b2c17c01f4440ba55d3e116f74bfb72b27e5802e5b8878e3b5866bbf42aa" ; values:partOf concept:therapeutic-goods-act-1989-sec-41jg ; skos:note "Failure to comply with notice results in criminal offence." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.138" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41jg-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41jg-ss-2-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41jg-ss-2 ; values:borneBy values:NaturalPerson ; skos:scopeNote "borne by: NaturalPerson" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jg-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41jg-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41jg-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibits failure to comply with notice." ; cml:premiseText "(2) A person commits an offence if..." ; cml:conclusionText "...Penalty: 100 penalty units." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jg-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41jg-ss-2-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-41jg-ss-2-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Overlaps" ; cml:logicSummary "Temporal overlap between notice and failure to comply." ; cml:premiseText "(2) A person commits an offence if: (a) the person is given a notice under section 41JCA, 41JD, 41JE, 41JF or 41JFA;" ; cml:conclusionText "...and (b) the person fails to comply with the notice." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jg-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41jg-ss-2-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-41jg-ss-2-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Until" ; cml:logicSummary "Temporal relationship between notice and failure to comply." ; cml:premiseText "(2) A person commits an offence if: (a) the person is given a notice under section 41JCA, 41JD, 41JE, 41JF or 41JFA;" ; cml:conclusionText "...and (b) the person fails to comply with the notice." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jg-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41jg-ss-2-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-41jg-ss-2-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "Diffuses" ; cml:logicSummary "Diffusion of obligation from notice to failure to comply." ; cml:premiseText "(2) A person commits an offence if: (a) the person is given a notice under section 41JCA, 41JD, 41JE, 41JF or 41JFA;" ; cml:conclusionText "...and (b) the person fails to comply with the notice." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jg-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41jg-ss-2-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-41jg-ss-2-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "Enforces" ; cml:logicSummary "Artificial agent enforces obligation to comply with notice." ; cml:premiseText "(2) A person commits an offence if: (a) the person is given a notice under section 41JCA, 41JD, 41JE, 41JF or 41JFA;" ; cml:conclusionText "...and (b) the person fails to comply with the notice." ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jg-ss-3 a cml:Concept ; skos:prefLabel "41JG(3) Criminal offences for failing to give information or documents"@en ; cml:realizedBy doc:sec-41jg-ss-3 ; cml:integrityHash "6399dd55215449c5a9d06b6bb311756ebbb1965b41b9ee0659fbcac6e7efa0c6" ; values:partOf concept:therapeutic-goods-act-1989-sec-41jg ; skos:note "Offence of strict liability for failing to give information or documents" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.138" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41jg-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41jg-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41jg-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jg-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41jg-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41jg-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Imposes a duty on the state to prosecute" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jh a cml:Concept ; skos:prefLabel "41JH False or misleading information"@en ; cml:realizedBy doc:sec-41jh ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41jh-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41jh-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41jh-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41jh-ss-4 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41jh-ss-5 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.138" . concept:therapeutic-goods-act-1989-sec-41jh-ss-1 a cml:Concept ; skos:prefLabel "41JH(1) False or misleading information"@en ; cml:realizedBy doc:sec-41jh-ss-1 ; cml:integrityHash "be1bb5d3b81ab23fa9c49be449ab6ea526f9e7410161e2bedddb3017df161881" ; values:partOf concept:therapeutic-goods-act-1989-sec-41jh ; skos:note "Giving false or misleading information in compliance with a notice is an offence." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.138" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41jh-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41jh-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41jh-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jh-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41jh-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41jh-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Obligation to comply with a notice." ; cml:premiseText "The person gives information to the Secretary." ; cml:conclusionText "The person commits an offence." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jh-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41jh-ss-1-logic-deontic-2 . concept:therapeutic-goods-act-1989-sec-41jh-ss-1-logic-deontic-2 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Giving false or misleading information is prohibited." ; cml:premiseText "(a) the person gives information to the Secretary; and (b) the person knows that the information: (i) is false or misleading; or (ii) omits any matter or thing without which the information is misleading;" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jh-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41jh-ss-1-logic-deontic-3 . concept:therapeutic-goods-act-1989-sec-41jh-ss-1-logic-deontic-3 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "The person must provide accurate information." ; cml:premiseText "(c) the information is given in compliance or purported compliance with the notice." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jh-ss-2 a cml:Concept ; skos:prefLabel "41JH(2) False or misleading information"@en ; cml:realizedBy doc:sec-41jh-ss-2 ; cml:integrityHash "10522956b1cded6b9f0922de162302296ec9f2620a616dd5e38b004241c9fba1" ; values:partOf concept:therapeutic-goods-act-1989-sec-41jh ; skos:note "Committing an offence for providing false or misleading information in compliance with a notice." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.138" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41jh-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41jh-ss-2-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41jh-ss-2 ; values:borneBy values:Agent ; skos:scopeNote "borne by: Agent" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jh-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41jh-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41jh-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits providing false or misleading information." ; cml:premiseText "The person gives information to the Secretary." ; cml:conclusionText "The person commits an offence." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jh-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41jh-ss-2-logic-deontic-2 . concept:therapeutic-goods-act-1989-sec-41jh-ss-2-logic-deontic-2 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits providing false or misleading information in compliance with a notice." ; cml:premiseText "The information is given in compliance or purported compliance with the notice." ; cml:conclusionText "The person commits an offence if they provide false or misleading information in compliance with the notice." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jh-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41jh-ss-2-logic-deontic-3 . concept:therapeutic-goods-act-1989-sec-41jh-ss-2-logic-deontic-3 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits providing false or misleading information to the Secretary." ; cml:premiseText "The person gives information to the Secretary." ; cml:conclusionText "The person commits an offence if they provide false or misleading information to the Secretary." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jh-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41jh-ss-2-logic-deontic-4 . concept:therapeutic-goods-act-1989-sec-41jh-ss-2-logic-deontic-4 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits providing false or misleading information without which it is misleading." ; cml:premiseText "The information omits any matter or thing without which the information is misleading." ; cml:conclusionText "The person commits an offence if they provide false or misleading information without which it is misleading." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jh-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41jh-ss-2-logic-deontic-5 . concept:therapeutic-goods-act-1989-sec-41jh-ss-2-logic-deontic-5 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits providing false or misleading information in any form." ; cml:premiseText "The information is false or misleading; or omits any matter or thing without which the information is misleading." ; cml:conclusionText "The person commits an offence if they provide false or misleading information in any form." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jh-ss-3 a cml:Concept ; skos:prefLabel "41JH(3) False or misleading information"@en ; cml:realizedBy doc:sec-41jh-ss-3 ; cml:integrityHash "6399dd55215449c5a9d06b6bb311756ebbb1965b41b9ee0659fbcac6e7efa0c6" ; values:partOf concept:therapeutic-goods-act-1989-sec-41jh ; skos:note "An offence against subsection (2) is an obligation." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.138" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41jh-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41jh-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41jh-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jh-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41jh-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41jh-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "An obligation exists." ; cml:premiseText "(3) An offence against subsection (2) is an offence of strict liability." ; cml:conclusionText "An offence against subsection (2) is an obligation." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jh-ss-4 a cml:Concept ; skos:prefLabel "41JH(4) False or misleading information"@en ; cml:realizedBy doc:sec-41jh-ss-4 ; cml:integrityHash "1c6facff6b57c15f53c7f0603b9b6c16b781c86278d8c6cf62b69cb7d88a2791" ; values:partOf concept:therapeutic-goods-act-1989-sec-41jh ; skos:note "Exemption from subsection (1) or (2) if information is not false or misleading in a material particular." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.138" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41jh-ss-4-norm . concept:therapeutic-goods-act-1989-sec-41jh-ss-4-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41jh-ss-4 ; values:borneBy values:Agent ; skos:scopeNote "borne by: Agent" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jh-ss-5 a cml:Concept ; skos:prefLabel "41JH(5) False or misleading information"@en ; cml:realizedBy doc:sec-41jh-ss-5 ; cml:integrityHash "d166ef5ab101cd5b5d1ee63a1fa45e3198f7c8474cc4328fa9aa4e3b9e295e09" ; values:partOf concept:therapeutic-goods-act-1989-sec-41jh ; skos:note "Defendant bears evidential burden for information not omitting material particulars." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.138" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41jh-ss-5-norm . concept:therapeutic-goods-act-1989-sec-41jh-ss-5-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41jh-ss-5 ; values:borneBy values:Agent ; skos:scopeNote "borne by: Agent" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jh-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-41jh-ss-5-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41jh-ss-5-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "obligation" ; cml:logicSummary "Defendant bears evidential burden" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ji a cml:Concept ; skos:prefLabel "41JI False or misleading documents"@en ; cml:realizedBy doc:sec-41ji ; cml:integrityHash "492bf253db67f4083fe753e28b19f49bdfb623b7419d72e09b8b5ac972c3ce04" ; skos:note "Producing false or misleading documents is an offence." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.139" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ji-norm . concept:therapeutic-goods-act-1989-sec-41ji-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ji ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ji cml:asserts concept:therapeutic-goods-act-1989-sec-41ji-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41ji-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibits producing false or misleading documents." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jj a cml:Concept ; skos:prefLabel "41JJ Self-incrimination"@en ; cml:realizedBy doc:sec-41jj ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41jj-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41jj-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.140" . concept:therapeutic-goods-act-1989-sec-41jj-ss-1 a cml:Concept ; skos:prefLabel "41JJ(1) Self-incrimination"@en ; cml:realizedBy doc:sec-41jj-ss-1 ; cml:integrityHash "50297de30123633fb2fa6eb8d0ba5dddfec45ed969916e47b4b3b1e70c6d93e7" ; values:partOf concept:therapeutic-goods-act-1989-sec-41jj ; skos:note "Must provide information or document under notice without claiming self-incrimination" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.140" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41jj-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41jj-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41jj-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jj-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41jj-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41jj-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must provide information or document" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jj-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41jj-ss-1-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-41jj-ss-1-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "CONTAINS" ; cml:logicSummary "Contains information relating to medical devices covered by exemptions" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jj-ss-2 a cml:Concept ; skos:prefLabel "41JJ(2) Self-incrimination"@en ; cml:realizedBy doc:sec-41jj-ss-2 ; cml:integrityHash "1dd22751b315445a890e35eae6ec14bffd15d363a09a00c851693d8f51d474c0" ; values:partOf concept:therapeutic-goods-act-1989-sec-41jj ; skos:note "Protection from self-incrimination in certain cases" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.140" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41jj-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41jj-ss-2-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41jj-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jj-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41jj-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41jj-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibits admissibility of self-incrimination evidence in certain cases" ; cml:premiseText "None" ; cml:conclusionText "None" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jk a cml:Concept ; skos:prefLabel "41JK Simplified outline of this Part"@en ; cml:realizedBy doc:sec-41jk ; cml:integrityHash "b260062f8ba6fd8e1d7bf6c6a84d4c53f36aaf5816b7f6851e379b57b31c5939" ; skos:note "Chief executive officer of a healthcare facility must report adverse events involving reportable medical devices." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.142" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41jk-norm . concept:therapeutic-goods-act-1989-sec-41jk-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41jk ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jk cml:asserts concept:therapeutic-goods-act-1989-sec-41jk-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41jk-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must provide a report" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jl a cml:Concept ; skos:prefLabel "41JL Purposes of this Part"@en ; cml:realizedBy doc:sec-41jl ; cml:integrityHash "cc223507a91967353f45d94c790d78d919a2be2fdc863f0392de62c19ae87030" ; skos:note "Facilitate monitoring and enforcing compliance with Chapter requirements." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.142" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41jl-norm . concept:therapeutic-goods-act-1989-sec-41jl-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41jl ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jl cml:asserts concept:therapeutic-goods-act-1989-sec-41jl-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41jl-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Facilitate monitoring and enforcing compliance." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jm a cml:Concept ; skos:prefLabel "41JM Requirement to report adverse events involving reportable"@en ; cml:realizedBy doc:sec-41jm ; cml:integrityHash "c7820f15095fdca0e414146498540963260052da1c71f604998c30a2bc392f52" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41jm-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41jm-ss-4 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41jm-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41jm-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41jm-ss-4 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41jm-ss-5 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.143" . concept:therapeutic-goods-act-1989-sec-41jm-ss-1 a cml:Concept ; skos:prefLabel "41JM(1) Requirement to report adverse events involving reportable"@en ; cml:realizedBy doc:sec-41jm-ss-1 ; cml:integrityHash "f2e69c87219ad0bfe84fa5083950dc700ed8722dd6adb875093f879b71a30bd3" ; values:partOf concept:therapeutic-goods-act-1989-sec-41jm ; skos:note "Healthcare facility must report adverse events to the Secretary." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.143" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41jm-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41jm-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41jm-ss-1 ; values:borneBy values:Agent ; skos:scopeNote "borne by: Agent" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jm-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41jm-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41jm-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Duty obligation" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jm-ss-4 a cml:Concept ; skos:prefLabel "41JM(4) Requirement to report adverse events involving reportable"@en ; cml:realizedBy doc:sec-41jm-ss-4 ; cml:integrityHash "b98bae64bde826b5175cf81e7c4ef6620b7d350b30b90400163a787800419ff0" ; values:partOf concept:therapeutic-goods-act-1989-sec-41jm ; skos:note "Healthcare facility must report adverse events involving reportable medical devices. Healthcare facility must report adverse events involving reportable medical devices and persons." ; dc:description "Report requirements" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.143" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41jm-ss-4-norm . concept:therapeutic-goods-act-1989-sec-41jm-ss-4-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41jm-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jm-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41jm-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41jm-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Duty to report" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jm-ss-2 a cml:Concept ; skos:prefLabel "41JM(2) Requirement to report adverse events involving reportable"@en ; cml:realizedBy doc:sec-41jm-ss-2 ; cml:integrityHash "8c7df46683adf5e49bf06b2b0a1a627c2b43498ddb0c8e54f787c3e288d86823" ; values:partOf concept:therapeutic-goods-act-1989-sec-41jm ; skos:note "Healthcare facility must report adverse events involving reportable medical devices." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.143" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41jm-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41jm-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41jm-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jm-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41jm-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41jm-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must provide information" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jm-ss-3 a cml:Concept ; skos:prefLabel "41JM(3) Requirement to report adverse events involving reportable"@en ; cml:realizedBy doc:sec-41jm-ss-3 ; cml:integrityHash "bccc84ef9dd46da64e70eff38389215d06716a7a0e812c59136b39800f8668f8" ; values:partOf concept:therapeutic-goods-act-1989-sec-41jm ; skos:note "Healthcare facility must report adverse events involving reportable medical devices." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.143" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41jm-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41jm-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41jm-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jm-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41jm-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41jm-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Mandatory reporting obligation." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jm-ss-4 a cml:Concept ; skos:prefLabel "41JM(4) Requirement to report adverse events involving reportable"@en ; cml:realizedBy doc:sec-41jm-ss-4 ; cml:integrityHash "0f2ecdac2d595ce0b0a08c0f6d4825b2272d393defe007b3999870b857e0344b" ; values:partOf concept:therapeutic-goods-act-1989-sec-41jm ; skos:note "Healthcare facility must report adverse events involving reportable medical devices. Healthcare facility must report adverse events involving reportable medical devices and persons." ; dc:description "Report requirements" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.143" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41jm-ss-4-norm . concept:therapeutic-goods-act-1989-sec-41jm-ss-4-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41jm-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jm-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41jm-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41jm-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Duty to report" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jm-ss-5 a cml:Concept ; skos:prefLabel "41JM(5) Requirement to report adverse events involving reportable"@en ; cml:realizedBy doc:sec-41jm-ss-5 ; cml:integrityHash "45ee62fe7ac6021ef0a9df60b19696166dae399e42427dcfe452d04a7a347262" ; values:partOf concept:therapeutic-goods-act-1989-sec-41jm ; skos:note "Report must include information about reportable medical device and person." ; dc:description "Yes" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.143" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41jm-ss-5-norm . concept:therapeutic-goods-act-1989-sec-41jm-ss-5-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41jm-ss-5 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41jm-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-41jm-ss-5-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41jm-ss-5-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Obligation to report" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41k a cml:Concept ; skos:prefLabel "41K What this Part is about"@en ; cml:realizedBy doc:sec-41k ; cml:integrityHash "afa864ca91e980ec4d85c8858dac087e6c1de7ccc1c4598f671d86c80d545a1c" ; skos:note "The Secretary can require action to recall medical devices, or to inform the public about medical devices that do not comply with requirements or cannot lawfully be supplied." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.145" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41k-norm . concept:therapeutic-goods-act-1989-sec-41k-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41k ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41k cml:asserts concept:therapeutic-goods-act-1989-sec-41k-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41k-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "can" ; cml:logicSummary "Expresses ability to perform an action" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ka a cml:Concept ; skos:prefLabel "41KA Public notification, and recall, of medical devices"@en ; cml:realizedBy doc:sec-41ka ; cml:integrityHash "7edb539aa22c79cd007af0f1ec97151eb1e92adb339f5369a50aee9eca6848fb" ; skos:note "The Secretary may impose requirements on a person if certain circumstances occur." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.145" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ka-norm . concept:therapeutic-goods-act-1989-sec-41ka-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ka ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ka cml:asserts concept:therapeutic-goods-act-1989-sec-41ka-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41ka-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "Imposition of requirements is permitted." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ka cml:asserts concept:therapeutic-goods-act-1989-sec-41ka-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41ka-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "hasKindOf" ; cml:logicSummary "Requirements apply to medical devices of a certain kind." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41kb a cml:Concept ; skos:prefLabel "41KB Publication of requirements"@en ; cml:realizedBy doc:sec-41kb ; cml:integrityHash "6df2a63923ff9adf131b6e01cdb3862bd01dc69bc08d013a2627275389a29305" ; skos:note "Secretary must publish notice after imposing requirement." ; dc:description "Notice setting out particulars of the requirement" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.149" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41kb-norm . concept:therapeutic-goods-act-1989-sec-41kb-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41kb ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41kb cml:asserts concept:therapeutic-goods-act-1989-sec-41kb-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41kb-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Obligation to publish notice" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41kc a cml:Concept ; skos:prefLabel "41KC Criminal offences for failing to comply with requirements"@en ; cml:realizedBy doc:sec-41kc ; cml:integrityHash "cc623b1a646f0826f5bc60985ff3799fc4259d93357a40f0168ac3e2e9348317" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41kc-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41kc-ss-4 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.149" . concept:therapeutic-goods-act-1989-sec-41kc-ss-1 a cml:Concept ; skos:prefLabel "41KC(1) Criminal offences for failing to comply with requirements"@en ; cml:realizedBy doc:sec-41kc-ss-1 ; cml:integrityHash "c21b8f26a2442d3847bb0a6717bb9f07b4e049e8c6614d28f57f547d3a6743e3" ; values:partOf concept:therapeutic-goods-act-1989-sec-41kc ; skos:note "Offence for failing to comply with requirements" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.149" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41kc-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41kc-ss-1-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41kc-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41kc-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41kc-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41kc-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibits failure to comply with requirements" ; cml:premiseText "(1) A person commits an offence..." ; cml:conclusionText "...breaches a requirement imposed on the person under section 41KA;" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41kc-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41kc-ss-1-logic-deontic-2 . concept:therapeutic-goods-act-1989-sec-41kc-ss-1-logic-deontic-2 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Imposes obligation to comply with requirements" ; cml:premiseText "(b) the act or omission breaches a requirement imposed on the person under section 41KA;" ; cml:conclusionText "...breaches a requirement imposed on the person under section 41KA;" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41kc-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41kc-ss-1-logic-alleninterval-3 . concept:therapeutic-goods-act-1989-sec-41kc-ss-1-logic-alleninterval-3 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "ResultedIn" ; cml:logicSummary "States that act resulted in harm or injury to any person" ; cml:premiseText "(c) the act or omission has resulted in, will result in, or is likely to result in, harm or injury to any person." ; cml:conclusionText "...will result in, or is likely to result in, harm or injury to any person." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41kc-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41kc-ss-1-logic-deontic-4 . concept:therapeutic-goods-act-1989-sec-41kc-ss-1-logic-deontic-4 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibits conviction of offence against subsection (4)" ; cml:premiseText "Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead:" ; cml:conclusionText "...may convict the person of an offence against subsection (4) instead:" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41kc-ss-4 a cml:Concept ; skos:prefLabel "41KC(4) Criminal offences for failing to comply with requirements"@en ; cml:realizedBy doc:sec-41kc-ss-4 ; cml:integrityHash "caf86916abb584b9d23d20e8ef16163a279bf1b6aa71fd28590271112c651f39" ; values:partOf concept:therapeutic-goods-act-1989-sec-41kc ; skos:note "Failure to comply with requirements is a criminal offence." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.149" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41kc-ss-4-norm . concept:therapeutic-goods-act-1989-sec-41kc-ss-4-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41kc-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41kc-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41kc-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41kc-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Imposes an obligation on the state." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41kd a cml:Concept ; skos:prefLabel "41KD Powers of suspension and cancellation unaffected"@en ; cml:realizedBy doc:sec-41kd ; cml:integrityHash "699b73ce85141d99e475e2e81174d3e5fae55f0030afe632ec11b9858864b7c3" ; skos:note "Imposition of requirement under section 41KA does not affect suspension powers." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.150" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41kd-norm . concept:therapeutic-goods-act-1989-sec-41kd-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41kd ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41kd cml:asserts concept:therapeutic-goods-act-1989-sec-41kd-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41kd-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "excludes" ; cml:logicSummary "Exclusion of suspension power from requirement imposition." ; cml:premiseText "Imposition of a requirement under section 41KA." ; cml:conclusionText "Does not affect the Secretary's powers to suspend entry." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41kd cml:asserts concept:therapeutic-goods-act-1989-sec-41kd-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41kd-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "subClassOf" ; cml:logicSummary "Subclass relationship between suspension power and requirement imposition." ; cml:premiseText "Imposition of a requirement under section 41KA does not affect the Secretary’s powers to:" ; cml:conclusionText "Powers of suspension and cancellation unaffected." ; cml:executionSurface "modalities::dl" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41kd cml:asserts concept:therapeutic-goods-act-1989-sec-41kd-logic-deontic-3 . concept:therapeutic-goods-act-1989-sec-41kd-logic-deontic-3 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "includes" ; cml:logicSummary "Inclusion of suspension power within Secretary's powers." ; cml:premiseText "The Secretary’s powers to:" ; cml:conclusionText "Imposition of a requirement under section 41KA does not affect the Secretary’s powers to suspend entry." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41kd cml:asserts concept:therapeutic-goods-act-1989-sec-41kd-logic-linearlogic-4 . concept:therapeutic-goods-act-1989-sec-41kd-logic-linearlogic-4 a cml:LogicApplication ; cml:modality cml:LinearLogic ; cml:operator "and" ; cml:logicSummary "Conjunction of suspension power and requirement imposition." ; cml:premiseText "Imposition of a requirement under section 41KA does not affect the Secretary’s powers to:" ; cml:conclusionText "Powers of suspension and cancellation unaffected." ; cml:executionSurface "modalities::linear" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41kd cml:asserts concept:therapeutic-goods-act-1989-sec-41kd-logic-alleninterval-5 . concept:therapeutic-goods-act-1989-sec-41kd-logic-alleninterval-5 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "during" ; cml:logicSummary "Temporal relationship between requirement imposition and suspension power." ; cml:premiseText "Imposition of a requirement under section 41KA does not affect the Secretary’s powers to:" ; cml:conclusionText "Powers of suspension and cancellation unaffected." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ke a cml:Concept ; skos:prefLabel "41KE Saving of other laws"@en ; cml:realizedBy doc:sec-41ke ; cml:integrityHash "61b7ba53b57fe8559936c4d7b04711566c16263a3c6f6af12bfa4c46eaef2acb" ; skos:note "No exclusion or limitation of other laws" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.150" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ke-norm . concept:therapeutic-goods-act-1989-sec-41ke-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ke ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ke cml:asserts concept:therapeutic-goods-act-1989-sec-41ke-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41ke-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligate" ; cml:logicSummary "No exclusion or limitation of other laws" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41l a cml:Concept ; skos:prefLabel "41L What this Part is about"@en ; cml:realizedBy doc:sec-41l ; cml:integrityHash "f64f606ebfdf8fd391ef598deb8e2d27162da36286810e7e5e179d4733f29218" ; skos:note "Fees must be paid for consideration of applications and auditing." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.151" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41l-norm . concept:therapeutic-goods-act-1989-sec-41l-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41l ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41l cml:asserts concept:therapeutic-goods-act-1989-sec-41l-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41l-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Obligation to pay fees" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41la a cml:Concept ; skos:prefLabel "41LA Assessment fees"@en ; cml:realizedBy doc:sec-41la ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41la-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41la-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41la-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41la-ss-4 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.151" . concept:therapeutic-goods-act-1989-sec-41la-ss-1 a cml:Concept ; skos:prefLabel "41LA(1) Assessment fees"@en ; cml:realizedBy doc:sec-41la-ss-1 ; cml:integrityHash "38c322c36f14f1e96853341d92ef447e988c853b7f25d39d3a5bb148584405f3" ; values:partOf concept:therapeutic-goods-act-1989-sec-41la ; skos:note "Payable assessment fee for application of conformity assessment certificate" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.151" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41la-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41la-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41la-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41la-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41la-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41la-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Payable assessment fee" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41la-ss-2 a cml:Concept ; skos:prefLabel "41LA(2) Assessment fees"@en ; cml:realizedBy doc:sec-41la-ss-2 ; cml:integrityHash "f090a23f2c1457650ee8d97c5667b269b8d83e0bd91c8ce4715ba9d58ac2809e" ; values:partOf concept:therapeutic-goods-act-1989-sec-41la ; skos:note "Prescribe different levels of conformity assessment fees" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.151" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41la-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41la-ss-2-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41la-ss-2 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41la-ss-3 a cml:Concept ; skos:prefLabel "41LA(3) Assessment fees"@en ; cml:realizedBy doc:sec-41la-ss-3 ; cml:integrityHash "a3025b1ec1253f097ca634930f16d4234f26d33a7657d56799893092becdd4c3" ; values:partOf concept:therapeutic-goods-act-1989-sec-41la ; skos:note "Pay assessment fee for auditing medical device application" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.151" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41la-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41la-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41la-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41la-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41la-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41la-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must pay assessment fee" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41la-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41la-ss-3-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41la-ss-3-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "IS_A" ; cml:logicSummary "Assessment fee is a type of payment" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41la-ss-4 a cml:Concept ; skos:prefLabel "41LA(4) Assessment fees"@en ; cml:realizedBy doc:sec-41la-ss-4 ; cml:integrityHash "fc298ab6c52874d21c887ca532931c57787b5e263a4467ca5fe2f4e39a312ba1" ; values:partOf concept:therapeutic-goods-act-1989-sec-41la ; skos:note "Prescribes different levels of application audit assessment fees" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.151" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41la-ss-4-norm . concept:therapeutic-goods-act-1989-sec-41la-ss-4-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41la-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41la-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41la-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41la-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "prescribes" ; cml:logicSummary "Imposes obligation on the state" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41lb a cml:Concept ; skos:prefLabel "41LB When assessment fee due for payment"@en ; cml:realizedBy doc:sec-41lb ; cml:integrityHash "b3975c7ec544d2bf90d00c74866b6191bd7e483f0615d5e60361a1e72b517538" ; skos:note "Assessment fee due on specified day and manner" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.152" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41lb-norm . concept:therapeutic-goods-act-1989-sec-41lb-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41lb ; values:borneBy values:LegalPerson ; skos:scopeNote "borne by: LegalPerson" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41lb cml:asserts concept:therapeutic-goods-act-1989-sec-41lb-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41lb-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "due" ; cml:logicSummary "Obligation to pay assessment fee" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41lc a cml:Concept ; skos:prefLabel "41LC Payment of assessment fee by instalments"@en ; cml:realizedBy doc:sec-41lc ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41lc-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41lc-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41lc-ss-3 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.152" . concept:therapeutic-goods-act-1989-sec-41lc-ss-1 a cml:Concept ; skos:prefLabel "41LC(1) Payment of assessment fee by instalments"@en ; cml:realizedBy doc:sec-41lc-ss-1 ; cml:integrityHash "23aa7b3478e08ee71b1e77104e90b4a357196f7cc51a080cf14c2579b2eddf6a" ; values:partOf concept:therapeutic-goods-act-1989-sec-41lc ; skos:note "Payment of assessment fee by instalments is obligatory." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.152" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41lc-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41lc-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41lc-ss-1 ; values:borneBy values:LegalPerson ; skos:scopeNote "borne by: LegalPerson" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41lc-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41lc-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41lc-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Payment of assessment fee by instalments is obligatory." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41lc-ss-2 a cml:Concept ; skos:prefLabel "41LC(2) Payment of assessment fee by instalments"@en ; cml:realizedBy doc:sec-41lc-ss-2 ; cml:integrityHash "b4fb0c2213322630ec9b0317e081720465600618086a4d9fdf61b4324ec763d8" ; values:partOf concept:therapeutic-goods-act-1989-sec-41lc ; skos:note "Payment of assessment fee by instalments is not allowed if any part of an instalment is unpaid immediately after it became due." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.152" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41lc-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41lc-ss-2-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41lc-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41lc-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41lc-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41lc-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibition of payment by instalments" ; cml:premiseText "(2) Regulations may provide that a person is not allowed to pay an assessment fee by instalments" ; cml:conclusionText "if any part of an instalment is unpaid immediately after it became due." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41lc-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41lc-ss-2-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-41lc-ss-2-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Overlap" ; cml:logicSummary "Temporal overlap between payment and evaluation fees" ; cml:premiseText "(a) that or any other assessment fee payable by the person; or (b) any evaluation fee under section 24 payable by the person;" ; cml:conclusionText "was unpaid immediately after the time when it became due for payment." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41lc-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41lc-ss-2-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-41lc-ss-2-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Recurring" ; cml:logicSummary "Recurring trace of unpaid instalments" ; cml:premiseText "(a) that or any other assessment fee payable by the person; or (b) any evaluation fee under section 24 payable by the person;" ; cml:conclusionText "was unpaid immediately after the time when it became due for payment." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41lc-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41lc-ss-2-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-41lc-ss-2-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "Diffuse" ; cml:logicSummary "Diffusion of prohibition to related fees" ; cml:premiseText "(a) that or any other assessment fee payable by the person; or (b) any evaluation fee under section 24 payable by the person;" ; cml:conclusionText "was unpaid immediately after the time when it became due for payment." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41lc-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41lc-ss-2-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-41lc-ss-2-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "Recognize" ; cml:logicSummary "Recognition of prohibition in AI systems" ; cml:premiseText "(2) Regulations may provide that a person is not allowed to pay an assessment fee by instalments" ; cml:conclusionText "if any part of an instalment is unpaid immediately after it became due." ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41lc-ss-3 a cml:Concept ; skos:prefLabel "41LC(3) Payment of assessment fee by instalments"@en ; cml:realizedBy doc:sec-41lc-ss-3 ; cml:integrityHash "839e5e1c70551a66043469b8456639715beffad0fa9e8be7a933dc8a9ed61c2b" ; values:partOf concept:therapeutic-goods-act-1989-sec-41lc ; skos:note "Payment of assessment fee by instalments is not limited by subsection (2)." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.152" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41lc-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41lc-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41lc-ss-3 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41lc-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41lc-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41lc-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Implies" ; cml:logicSummary "Payment of assessment fee is obligatory." ; cml:premiseText "Subsection (2) does not limit subsection (1)." ; cml:conclusionText "Payment of assessment fee by instalments is obligatory." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41lc-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41lc-ss-3-logic-deontic-2 . concept:therapeutic-goods-act-1989-sec-41lc-ss-3-logic-deontic-2 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Implies" ; cml:logicSummary "Payment of assessment fee is obligatory if it is due." ; cml:premiseText "Subsection (2) does not limit subsection (1)." ; cml:conclusionText "Payment of assessment fee by instalments is obligatory if it is due." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41lc-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41lc-ss-3-logic-linearlogic-3 . concept:therapeutic-goods-act-1989-sec-41lc-ss-3-logic-linearlogic-3 a cml:LogicApplication ; cml:modality cml:LinearLogic ; cml:operator "Implication" ; cml:logicSummary "Payment of assessment fee implies obligation to pay." ; cml:premiseText "Subsection (2) does not limit subsection (1)." ; cml:conclusionText "Payment of assessment fee by instalments implies obligation to pay." ; cml:executionSurface "modalities::linear" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41lc-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41lc-ss-3-logic-deontic-4 . concept:therapeutic-goods-act-1989-sec-41lc-ss-3-logic-deontic-4 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Implies" ; cml:logicSummary "Payment of assessment fee is obligatory if it is due and paid." ; cml:premiseText "Subsection (2) does not limit subsection (1)." ; cml:conclusionText "Payment of assessment fee by instalments is obligatory if it is due and paid." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ld a cml:Concept ; skos:prefLabel "41LD Recovery of assessment fee"@en ; cml:realizedBy doc:sec-41ld ; cml:integrityHash "245abdc32c690758fc507b40452950dd9c5ba5ab1f90188f789f215920ed0229" ; skos:note "Recovery of assessment fee" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.152" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ld-norm . concept:therapeutic-goods-act-1989-sec-41ld-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ld ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ld cml:asserts concept:therapeutic-goods-act-1989-sec-41ld-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41ld-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "can" ; cml:logicSummary "Can recover assessment fee" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41le a cml:Concept ; skos:prefLabel "41LE Reduction of conformity assessment fee where decision not"@en ; cml:realizedBy doc:sec-41le ; cml:integrityHash "18180237252b64227757cffba307f718493f8d4ff089c0d677057d0a142b99c8" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41le-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41le-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41le-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41le-ss-4 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.153" . concept:therapeutic-goods-act-1989-sec-41le-ss-1 a cml:Concept ; skos:prefLabel "41LE(1) Reduction of conformity assessment fee where decision not"@en ; cml:realizedBy doc:sec-41le-ss-1 ; cml:integrityHash "69bb3b6ec8cb4c5d51d619a6cb33727225c959eba19a3c8fcd9eafe55e07f41e" ; values:partOf concept:therapeutic-goods-act-1989-sec-41le ; skos:note "Reduction of conformity assessment fee under certain conditions." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.153" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41le-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41le-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41le-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41le-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41le-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41le-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Obligation to reduce conformity assessment fee." ; cml:premiseText "(1) Nothing in section 41LA, 41LB or 41LC requires the applicant to pay more than 3/4 of the conformity assessment fee before the making of the decision if:..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41le-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41le-ss-1-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-41le-ss-1-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Temporal Interval" ; cml:logicSummary "Temporal interval for reduction of conformity assessment fee." ; cml:premiseText "(a) the application is for the issuing of a conformity assessment certificate under Part 4-4; and (b) consideration of the application will involve an examination of the design of medical devices; and (c) a period is prescribed under paragraph 63(2)(dc) for making a decision on the application." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41le-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41le-ss-1-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-41le-ss-1-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Recurring Trace" ; cml:logicSummary "Recurring trace of reduction of conformity assessment fee." ; cml:premiseText "(a) the application is for the issuing of a conformity assessment certificate under Part 4-4; and (b) consideration of the application will involve an examination of the design of medical devices; and (c) a period is prescribed under paragraph 63(2)(dc) for making a decision on the application." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41le-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41le-ss-1-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-41le-ss-1-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "Diffusion" ; cml:logicSummary "Diffusion of reduction of conformity assessment fee." ; cml:premiseText "(a) the application is for the issuing of a conformity assessment certificate under Part 4-4; and (b) consideration of the application will involve an examination of the design of medical devices; and (c) a period is prescribed under paragraph 63(2)(dc) for making a decision on the application." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41le-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41le-ss-1-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-41le-ss-1-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "Classification" ; cml:logicSummary "Classification of reduction of conformity assessment fee using CogAI." ; cml:premiseText "(a) the application is for the issuing of a conformity assessment certificate under Part 4-4; and (b) consideration of the application will involve an examination of the design of medical devices; and (c) a period is prescribed under paragraph 63(2)(dc) for making a decision on the application." ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41le-ss-2 a cml:Concept ; skos:prefLabel "41LE(2) Reduction of conformity assessment fee where decision not"@en ; cml:realizedBy doc:sec-41le-ss-2 ; cml:integrityHash "c1f9f18fa437e9d09f4fa12f69722e7c0ae0e123cd8ff21264bb563e20a7e4db" ; values:partOf concept:therapeutic-goods-act-1989-sec-41le ; skos:note "Conformity assessment fee reduction upon non-decision within period" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.153" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41le-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41le-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41le-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41le-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41le-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41le-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "obligation" ; cml:logicSummary "Obligation to pay reduced fee upon non-decision" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41le-ss-3 a cml:Concept ; skos:prefLabel "41LE(3) Reduction of conformity assessment fee where decision not"@en ; cml:realizedBy doc:sec-41le-ss-3 ; cml:integrityHash "4eb5b92da4aa3f7574b2e7636f6f8707ef5eb1d98a86e43dbc572bf61f5e2e98" ; values:partOf concept:therapeutic-goods-act-1989-sec-41le ; skos:note "Payment of part of conformity assessment fee becomes due upon decision making." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.153" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41le-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41le-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41le-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41le-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41le-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41le-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Imposes a duty on the state." ; cml:conclusionText "The state must pay the fee." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41le-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41le-ss-3-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-41le-ss-3-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Overlaps" ; cml:logicSummary "Describes a temporal relationship between payment and decision making." ; cml:premiseText "(3) If: (a) the decision is made within that period; and (b) part of the conformity assessment fee under section 41LA is, because of subsection (1) of this section, unpaid when the decision is made;" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41le-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41le-ss-3-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-41le-ss-3-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Until" ; cml:logicSummary "Describes a temporal relationship between payment and decision making." ; cml:premiseText "(3) If: (a) the decision is made within that period; and (b) part of the conformity assessment fee under section 41LA is, because of subsection (1) of this section, unpaid when the decision is made;" ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41le-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41le-ss-3-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-41le-ss-3-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "Diffuses" ; cml:logicSummary "Describes a relationship between payment and decision making." ; cml:premiseText "(3) If: (a) the decision is made within that period; and (b) part of the conformity assessment fee under section 41LA is, because of subsection (1) of this section, unpaid when the decision is made;" ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41le-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41le-ss-3-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-41le-ss-3-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "Recognizes" ; cml:logicSummary "Describes a relationship between payment and decision making." ; cml:premiseText "(3) If: (a) the decision is made within that period; and (b) part of the conformity assessment fee under section 41LA is, because of subsection (1) of this section, unpaid when the decision is made;" ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41le-ss-4 a cml:Concept ; skos:prefLabel "41LE(4) Reduction of conformity assessment fee where decision not"@en ; cml:realizedBy doc:sec-41le-ss-4 ; cml:integrityHash "d7a299a08ff6ae02fddd446332848429b5f1a6ee2c25bf32cac1025f68d75b94" ; values:partOf concept:therapeutic-goods-act-1989-sec-41le ; skos:note "Decision is taken when applicant notified of Secretary's decision on application." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.153" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41le-ss-4-norm . concept:therapeutic-goods-act-1989-sec-41le-ss-4-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41le-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41le-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41le-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41le-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "TAKE" ; cml:logicSummary "Decision is taken" ; cml:premiseText "Applicant notified of Secretary's decision on application." ; cml:conclusionText "Decision is made" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41m a cml:Concept ; skos:prefLabel "41M What this Part is about"@en ; cml:realizedBy doc:sec-41m ; cml:integrityHash "f1304f83d26611e913926e628e91b3f4a8606c67b2e46636875a8b971086cb34" ; skos:note "Ensure conformity with essential principles and administrative processes." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.154" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41m-norm . concept:therapeutic-goods-act-1989-sec-41m-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41m ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41m cml:asserts concept:therapeutic-goods-act-1989-sec-41m-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41m-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Ensure compliance" ; cml:premiseText "The essential principles must be complied with." ; cml:conclusionText "There is an obligation to comply with the essential principles." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ma a cml:Concept ; skos:prefLabel "41MA Criminal offences for importing, supplying or exporting a"@en ; cml:realizedBy doc:sec-41ma ; cml:integrityHash "74de24467bb2f3534934b35542942718c71a4add1bff7cd4f8c1e22f1afa0cc7" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ma-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ma-ss-4 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.155" . concept:therapeutic-goods-act-1989-sec-41ma-ss-1 a cml:Concept ; skos:prefLabel "41MA(1) Criminal offences for importing, supplying or exporting a"@en ; cml:realizedBy doc:sec-41ma-ss-1 ; cml:integrityHash "ba3028ec3a941520fa36be964785767ae4804ff0c18bab01d58b04f8a2f98860" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ma ; skos:note "Importing a non-compliant medical device is prohibited." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.155" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ma-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41ma-ss-1-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ma-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ma-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41ma-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41ma-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits the importation of non-compliant medical devices." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ma-ss-4 a cml:Concept ; skos:prefLabel "41MA(4) Criminal offences for importing, supplying or exporting a"@en ; cml:realizedBy doc:sec-41ma-ss-4 ; cml:integrityHash "4397d23f22b646f027cf8573aecbd9b4715571eaa878b6a1daba08d8a42ed3eb" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ma ; skos:note "Committing an offence for importing a medical device into Australia" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.155" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ma-ss-4-norm . concept:therapeutic-goods-act-1989-sec-41ma-ss-4-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ma-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ma-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41ma-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41ma-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Obligation to comply with import regulations" ; cml:premiseText "Importing a medical device into Australia without permission is prohibited." ; cml:conclusionText "A person commits an offence if they import a medical device into Australia." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mb a cml:Concept ; skos:prefLabel "41MB Exceptions"@en ; cml:realizedBy doc:sec-41mb ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41mb-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41mb-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.160" . concept:therapeutic-goods-act-1989-sec-41mb-ss-1 a cml:Concept ; skos:prefLabel "41MB(1) Exceptions"@en ; cml:realizedBy doc:sec-41mb-ss-1 ; cml:integrityHash "53d099984c456943da4fcf632a44a1b0ca0c270c02bb388206c4cfad9f17ef0d" ; values:partOf concept:therapeutic-goods-act-1989-sec-41mb ; skos:note "Exceptions for medical devices that comply with standards and fail to comply only in respect of specific principles." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.160" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41mb-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41mb-ss-1-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41mb-ss-1 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mb-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41mb-ss-1-logic-alleninterval-1 . concept:therapeutic-goods-act-1989-sec-41mb-ss-1-logic-alleninterval-1 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "<" ; cml:logicSummary "Defines the temporal interval for which the exemption applies." ; cml:premiseText "(a) the medical device complies with one or more medical device standards that apply to it;" ; cml:conclusionText "The exemption is valid only if the medical device meets the specified standard." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mb-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41mb-ss-1-logic-ltl-2 . concept:therapeutic-goods-act-1989-sec-41mb-ss-1-logic-ltl-2 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "<" ; cml:logicSummary "Specifies the temporal relationship between the exemption and the non-compliance." ; cml:premiseText "(b) the medical device fails to comply with the essential principles only in respect of a part or parts of the essential principles." ; cml:conclusionText "The exemption is valid only if the non-compliance occurs within the specified interval." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mb-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41mb-ss-1-logic-deontic-3 . concept:therapeutic-goods-act-1989-sec-41mb-ss-1-logic-deontic-3 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "=" ; cml:logicSummary "Classifies the type of duty or obligation." ; cml:premiseText "(a) the medical device complies with one or more medical device standards that apply to it;" ; cml:conclusionText "The exemption is a permission for the medical device to comply with specific standards." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mb-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41mb-ss-1-logic-deontic-4 . concept:therapeutic-goods-act-1989-sec-41mb-ss-1-logic-deontic-4 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "=" ; cml:logicSummary "Classifies the type of duty or obligation." ; cml:premiseText "(b) the medical device fails to comply with the essential principles only in respect of a part or parts of the essential principles." ; cml:conclusionText "The exemption is a permission for the medical device to fail to comply with specific principles." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mb-ss-2 a cml:Concept ; skos:prefLabel "41MB(2) Exceptions"@en ; cml:realizedBy doc:sec-41mb-ss-2 ; cml:integrityHash "38d7f895eb2dd8fdde51a1820a8fd3c17de21946e14365cf3ff2375a2b60b9e3" ; values:partOf concept:therapeutic-goods-act-1989-sec-41mb ; skos:note "Defendant bears evidential burden in prosecution for offence." ; dc:description "Evidence of matters in section 13.3(3) of Criminal Code." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.160" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41mb-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41mb-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41mb-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mb-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41mb-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41mb-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Defendant bears evidential burden." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mb-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41mb-ss-2-logic-epistemic-2 . concept:therapeutic-goods-act-1989-sec-41mb-ss-2-logic-epistemic-2 a cml:LogicApplication ; cml:modality cml:Epistemic ; cml:operator "Burden of Proof" ; cml:logicSummary "Defendant must prove matters in section." ; cml:executionSurface "modalities::epistemic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mc a cml:Concept ; skos:prefLabel "41MC Criminal offences relating to breaching a condition of a"@en ; cml:realizedBy doc:sec-41mc ; cml:integrityHash "12423e0482f3e81cb1d23230664e95bb3d11b9f34f06fc199e588d4cdab6e4d4" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41mc-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41mc-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.161" . concept:therapeutic-goods-act-1989-sec-41mc-ss-1 a cml:Concept ; skos:prefLabel "41MC(1) Criminal offences relating to breaching a condition of a"@en ; cml:realizedBy doc:sec-41mc-ss-1 ; cml:integrityHash "9eb695633a113001cdc696f83f2399bf14a4e3722596b38d2d124daf2f157d4d" ; values:partOf concept:therapeutic-goods-act-1989-sec-41mc ; skos:note "Secretary's consent may be given unconditionally or subject to conditions for certain medical devices." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.161" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41mc-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41mc-ss-1-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41mc-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mc-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41mc-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41mc-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "Permission granted by the Secretary." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mc-ss-2 a cml:Concept ; skos:prefLabel "41MC(2) Criminal offences relating to breaching a condition of a"@en ; cml:realizedBy doc:sec-41mc-ss-2 ; cml:integrityHash "e25a15afb595033ac1e9319d90b7b77dedc14e0cb02ab5ccac71923696601361" ; values:partOf concept:therapeutic-goods-act-1989-sec-41mc ; skos:note "Breach of consent results in harm or injury to a person." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.161" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41mc-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41mc-ss-2-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41mc-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mc-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41mc-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41mc-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibits breach of consent." ; cml:premiseText "(2) A person commits an offence if: (a) the person does an act or omits to do an act; and (b) the act or omission breaches a condition of a consent; and (c) the act or omission has resulted in, will result in, or is likely to result in, harm or injury to any person." ; cml:conclusionText "(Penalty: 2,000 penalty units.)" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41md a cml:Concept ; skos:prefLabel "41MD Treating medical devices as prohibited imports or exports"@en ; cml:realizedBy doc:sec-41md ; cml:integrityHash "df7b3f7cd112cffe73791aefc7ab96ae16ca757782834a4c9386676c21d02dda" ; skos:note "Importation or exportation of medical devices is prohibited if notified to Customs Act 1901." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.162" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41md-norm . concept:therapeutic-goods-act-1989-sec-41md-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41md ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41md cml:asserts concept:therapeutic-goods-act-1989-sec-41md-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41md-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibition of importation or exportation." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41me a cml:Concept ; skos:prefLabel "41ME Criminal offences for failing to apply conformity assessment"@en ; cml:realizedBy doc:sec-41me ; cml:integrityHash "2d1dc090f456f9e6b95561e26738bfbaacf30596eb21ec8721607a8119ea4911" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41me-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41me-ss-4 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41me-ss-4a ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41me-ss-4b ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41me-ss-5 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.164" . concept:therapeutic-goods-act-1989-sec-41me-ss-1 a cml:Concept ; skos:prefLabel "41ME(1) Criminal offences for failing to apply conformity assessment"@en ; cml:realizedBy doc:sec-41me-ss-1 ; cml:integrityHash "587e4cbcf2e1c6a7e8b903b0ac702109f542c55c6c92eeac03cd4f82ed2d3201" ; values:partOf concept:therapeutic-goods-act-1989-sec-41me ; skos:note "Manufacturing, supplying or using a non-exempt medical device without conformity assessment" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.164" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41me-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41me-ss-1-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41me-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41me-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41me-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41me-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits the manufacture, supply or use of non-exempt medical devices without conformity assessment" ; cml:premiseText "(ca) the device is not of a kind covered by an exemption in force under section 41GS; and (d) either: (i) the use of the device has resulted in, will result in, or is likely to result in, harm or injury to any person; or (ii) the use of the device, if the device were used, would result in, or would be likely to result in, harm or injury to any person;" ; cml:conclusionText "(1) A person commits an offence..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41me-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41me-ss-1-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-41me-ss-1-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Temporal relation" ; cml:logicSummary "Establishes a temporal relationship between the manufacture/supply/use of medical devices and conformity assessment" ; cml:premiseText "(c) the conformity assessment procedures have not been applied to the device; and (d) either: (i) the use of the device has resulted in, will result in, or is likely to result in, harm or injury to any person; or (ii) the use of the device, if the device were used, would result in, or would be likely to result in, harm or injury to any person;" ; cml:conclusionText "(1) A person commits an offence..." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41me-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41me-ss-1-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-41me-ss-1-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Recurring trace" ; cml:logicSummary "Establishes a recurring trace of the use of medical devices and conformity assessment" ; cml:premiseText "(d) either: (i) the use of the device has resulted in, will result in, or is likely to result in, harm or injury to any person; or (ii) the use of the device, if the device were used, would result in, or would be likely to result in, harm or injury to any person;" ; cml:conclusionText "(1) A person commits an offence..." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41me-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41me-ss-1-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-41me-ss-1-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "Diffuse" ; cml:logicSummary "Diffuses the obligation to comply with conformity assessment across all parties involved" ; cml:premiseText "(d) either: (i) the use of the device has resulted in, will result in, or is likely to result in, harm or injury to any person; or (ii) the use of the device, if the device were used, would result in, or would be likely to result in, harm or injury to any person;" ; cml:conclusionText "(1) A person commits an offence..." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41me-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41me-ss-1-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-41me-ss-1-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "Reasoning" ; cml:logicSummary "Applies artificial intelligence to reason about the obligations and consequences of conformity assessment" ; cml:premiseText "(d) either: (i) the use of the device has resulted in, will result in, or is likely to result in, harm or injury to any person; or (ii) the use of the device, if the device were used, would result in, or would be likely to result in, harm or injury to any person;" ; cml:conclusionText "(1) A person commits an offence..." ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41me-ss-4 a cml:Concept ; skos:prefLabel "41ME(4) Criminal offences for failing to apply conformity assessment"@en ; cml:realizedBy doc:sec-41me-ss-4 ; cml:integrityHash "e4df68a8a03ad5558d2605e90a5225b97a7d7f4b558e18d7862508de01f1302a" ; values:partOf concept:therapeutic-goods-act-1989-sec-41me ; skos:note "Failure to apply conformity assessment procedures for medical devices is prohibited." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.164" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41me-ss-4-norm . concept:therapeutic-goods-act-1989-sec-41me-ss-4-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41me-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41me-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41me-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41me-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibition of failing to apply conformity assessment procedures." ; cml:premiseText "(4) A person commits an offence if..." ; cml:conclusionText "...the device is not of a kind covered by an exemption in force under section 41GS." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41me-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41me-ss-4-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-41me-ss-4-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Temporal relation" ; cml:logicSummary "Temporal relation between conformity assessment procedures and medical devices." ; cml:premiseText "(4) A person commits an offence if..." ; cml:conclusionText "...the device is not of a kind covered by an exemption in force under section 41GS." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41me-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41me-ss-4-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-41me-ss-4-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Recurring trace" ; cml:logicSummary "Recurring trace of conformity assessment procedures for medical devices." ; cml:premiseText "(4) A person commits an offence if..." ; cml:conclusionText "...the device is not of a kind covered by an exemption in force under section 41GS." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41me-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41me-ss-4-logic-cogai-4 . concept:therapeutic-goods-act-1989-sec-41me-ss-4-logic-cogai-4 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "Knowledge representation" ; cml:logicSummary "Knowledge representation of medical devices and conformity assessment procedures." ; cml:premiseText "(4) A person commits an offence if..." ; cml:conclusionText "...the device is not of a kind covered by an exemption in force under section 41GS." ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41me-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41me-ss-4-logic-shacl-5 . concept:therapeutic-goods-act-1989-sec-41me-ss-4-logic-shacl-5 a cml:LogicApplication ; cml:modality cml:SHACL ; cml:operator "Schema validation" ; cml:logicSummary "Schema validation of medical devices and conformity assessment procedures." ; cml:premiseText "(4) A person commits an offence if..." ; cml:conclusionText "...the device is not of a kind covered by an exemption in force under section 41GS." ; cml:executionSurface "modalities::logic::shacl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41me-ss-4a a cml:Concept ; skos:prefLabel "41ME(4A) Criminal offences for failing to apply conformity assessment"@en ; cml:realizedBy doc:sec-41me-ss-4a ; cml:integrityHash "5d3668ecbca4e4f15a4bb33c01deb65edbdea9142c8d36e7a396a251febddd65" ; values:partOf concept:therapeutic-goods-act-1989-sec-41me ; skos:note "Manufacturing or supplying a medical device without conformity assessment" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.164" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41me-ss-4a-norm . concept:therapeutic-goods-act-1989-sec-41me-ss-4a-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41me-ss-4a ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41me-ss-4a cml:asserts concept:therapeutic-goods-act-1989-sec-41me-ss-4a-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41me-ss-4a-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits manufacturing or supplying a medical device without conformity assessment" ; cml:premiseText "(4A) A person commits an offence..." ; cml:conclusionText "...Penalty: 100 penalty units." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41me-ss-4a cml:asserts concept:therapeutic-goods-act-1989-sec-41me-ss-4a-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-41me-ss-4a-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Temporal Interval" ; cml:logicSummary "Defines the temporal interval during which the action of manufacturing or supplying a medical device without conformity assessment is prohibited" ; cml:premiseText "(4A) A person commits an offence..." ; cml:conclusionText "...Penalty: 100 penalty units." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41me-ss-4a cml:asserts concept:therapeutic-goods-act-1989-sec-41me-ss-4a-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-41me-ss-4a-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Recurring Trace" ; cml:logicSummary "Defines the recurring trace of actions that must be prevented or prohibited" ; cml:premiseText "(4A) A person commits an offence..." ; cml:conclusionText "...Penalty: 100 penalty units." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41me-ss-4a cml:asserts concept:therapeutic-goods-act-1989-sec-41me-ss-4a-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-41me-ss-4a-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "Diffuse" ; cml:logicSummary "Diffuses the prohibition to all relevant parties and entities" ; cml:premiseText "(4A) A person commits an offence..." ; cml:conclusionText "...Penalty: 100 penalty units." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41me-ss-4a cml:asserts concept:therapeutic-goods-act-1989-sec-41me-ss-4a-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-41me-ss-4a-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "Recognize" ; cml:logicSummary "Recognizes the need for conformity assessment in medical device manufacturing and supply" ; cml:premiseText "(4A) A person commits an offence..." ; cml:conclusionText "...Penalty: 100 penalty units." ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41me-ss-4b a cml:Concept ; skos:prefLabel "41ME(4B) Criminal offences for failing to apply conformity assessment"@en ; cml:realizedBy doc:sec-41me-ss-4b ; cml:integrityHash "5551bcd3e7a6ada4f94ffcdfdf7d0d679300c3ea1f3ddb2aaa3a44291c74cd5a" ; values:partOf concept:therapeutic-goods-act-1989-sec-41me ; skos:note "Offences relating to exporting a medical device are prohibited." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.164" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41me-ss-4b-norm . concept:therapeutic-goods-act-1989-sec-41me-ss-4b-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41me-ss-4b ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41me-ss-4b cml:asserts concept:therapeutic-goods-act-1989-sec-41me-ss-4b-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41me-ss-4b-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits exporting a medical device." ; cml:premiseText "(4B) An offence against subsection (4A) is an offence of strict liability." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41me-ss-5 a cml:Concept ; skos:prefLabel "41ME(5) Criminal offences for failing to apply conformity assessment"@en ; cml:realizedBy doc:sec-41me-ss-5 ; cml:integrityHash "3a4a7e0f2fbe1541e7043d3fdf3bfbe58222be482d79c8d80943706a3bfa8287" ; values:partOf concept:therapeutic-goods-act-1989-sec-41me ; skos:note "Manufacturing, exporting, or using a medical device without conformity assessment is prohibited." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.164" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41me-ss-5-norm . concept:therapeutic-goods-act-1989-sec-41me-ss-5-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41me-ss-5 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41me-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-41me-ss-5-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41me-ss-5-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibition" ; cml:premiseText "(5) A person commits an offence..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mf a cml:Concept ; skos:prefLabel "41MF Criminal offences for failing to apply conformity assessment"@en ; cml:realizedBy doc:sec-41mf ; cml:integrityHash "cbf8176d0902527ea3a2b0e16e7d506c2ed5c496cb861d18eb01236f115bbc17" ; skos:note "Offences relating to supplying a medical device" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.167" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41mf-norm . concept:therapeutic-goods-act-1989-sec-41mf-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41mf ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mf cml:asserts concept:therapeutic-goods-act-1989-sec-41mf-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41mf-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits supplying a medical device" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mg a cml:Concept ; skos:prefLabel "41MG Exceptions"@en ; cml:realizedBy doc:sec-41mg ; cml:integrityHash "693b1de23cd9dc3f6bbd1467d101a2055fc005876d2cdd6979058cdf5abacdc4" ; skos:note "Exceptions for certain conformity assessment standards" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.170" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41mg-norm . concept:therapeutic-goods-act-1989-sec-41mg-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41mg ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mh a cml:Concept ; skos:prefLabel "41MH Criminal offence for making false statements in declarations"@en ; cml:realizedBy doc:sec-41mh ; cml:integrityHash "1a64bffa7442bdd9fc7ed83bf732c2ce641760dac5eef034050dbfe9a9944505" ; skos:note "Making false statements in declarations is a criminal offence." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.170" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41mh-norm . concept:therapeutic-goods-act-1989-sec-41mh-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41mh ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mh cml:asserts concept:therapeutic-goods-act-1989-sec-41mh-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41mh-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits making false statements in declarations." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mi a cml:Concept ; skos:prefLabel "41MI Criminal offences for importing, exporting, supplying or"@en ; cml:realizedBy doc:sec-41mi ; cml:integrityHash "efc501e51c71d5c391eaad0b7e591236ce7c9f03219fecedfd7da26eeed3c237" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41mi-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41mi-ss-4 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41mi-ss-5 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.172" . concept:therapeutic-goods-act-1989-sec-41mi-ss-1 a cml:Concept ; skos:prefLabel "41MI(1) Criminal offences for importing, exporting, supplying or"@en ; cml:realizedBy doc:sec-41mi-ss-1 ; cml:integrityHash "38bb781e6319f116eb82d30915b36a7c502ba853d1841f94a76e49de7c547f29" ; values:partOf concept:therapeutic-goods-act-1989-sec-41mi ; skos:note "Importing, exporting, supplying or manufacturing a medical device without proper authorization is prohibited." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.172" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41mi-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41mi-ss-1-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41mi-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mi-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41mi-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41mi-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibition of actions" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mi-ss-4 a cml:Concept ; skos:prefLabel "41MI(4) Criminal offences for importing, exporting, supplying or"@en ; cml:realizedBy doc:sec-41mi-ss-4 ; cml:integrityHash "457363627257efd6420f6055af007417ab3304f6bb26281a62a4252c87124204" ; values:partOf concept:therapeutic-goods-act-1989-sec-41mi ; skos:note "Importing, exporting, supplying or manufacturing a medical device without proper approval is prohibited." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.172" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41mi-ss-4-norm . concept:therapeutic-goods-act-1989-sec-41mi-ss-4-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41mi-ss-4 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mi-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41mi-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41mi-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibition" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mi-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41mi-ss-4-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-41mi-ss-4-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Temporal Interval" ; cml:logicSummary "Temporal interval for approval requirements" ; cml:premiseText "(4) A person commits an offence if: (a) the person: (i) imports a medical device into Australia; or (ii) exports a medical device from Australia; or (iii) supplies a medical device in Australia; or (iv) manufactures a medical device in Australia;" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mi-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41mi-ss-4-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-41mi-ss-4-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Recurring Trace" ; cml:logicSummary "Recurring trace for approval requirements" ; cml:premiseText "(4) A person commits an offence if: (a) the person: (i) imports a medical device into Australia; or (ii) exports a medical device from Australia; or (iii) supplies a medical device in Australia; or (iv) manufactures a medical device in Australia;" ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mi-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41mi-ss-4-logic-deontic-4 . concept:therapeutic-goods-act-1989-sec-41mi-ss-4-logic-deontic-4 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Obligation to obtain approval" ; cml:premiseText "(4) A person commits an offence if: (a) the person: (i) imports a medical device into Australia; or (ii) exports a medical device from Australia; or (iii) supplies a medical device in Australia; or (iv) manufactures a medical device in Australia;" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mi-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41mi-ss-4-logic-argumentation-5 . concept:therapeutic-goods-act-1989-sec-41mi-ss-4-logic-argumentation-5 a cml:LogicApplication ; cml:modality cml:Argumentation ; cml:operator "Implication" ; cml:logicSummary "Implication of non-compliance with approval requirements" ; cml:premiseText "(4) A person commits an offence if: (a) the person: (i) imports a medical device into Australia; or (ii) exports a medical device from Australia; or (iii) supplies a medical device in Australia; or (iv) manufactures a medical device in Australia;" ; cml:executionSurface "modalities::argumentation" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mi-ss-5 a cml:Concept ; skos:prefLabel "41MI(5) Criminal offences for importing, exporting, supplying or"@en ; cml:realizedBy doc:sec-41mi-ss-5 ; cml:integrityHash "f6b87d3275578fa773786e2758c7e50f92fcbb284c9f4afd3e402694ed8689aa" ; values:partOf concept:therapeutic-goods-act-1989-sec-41mi ; skos:note "Importing, exporting, supplying or manufacturing a medical device without permission is prohibited." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.172" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41mi-ss-5-norm . concept:therapeutic-goods-act-1989-sec-41mi-ss-5-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41mi-ss-5 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mi-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-41mi-ss-5-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41mi-ss-5-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits the action of importing, exporting, supplying or manufacturing a medical device." ; cml:premiseText "(5) A person commits an offence if: (a) the person: (i) imports a medical device into Australia; or (ii) exports a medical device from Australia; or (iii) supplies a medical device in Australia; or (iv) manufactures a medical device in Australia;" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mi-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-41mi-ss-5-logic-ltl-2 . concept:therapeutic-goods-act-1989-sec-41mi-ss-5-logic-ltl-2 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits the action of importing, exporting, supplying or manufacturing a medical device." ; cml:premiseText "(5) A person commits an offence if: (a) the person: (i) imports a medical device into Australia; or (ii) exports a medical device from Australia; or (iii) supplies a medical device in Australia; or (iv) manufactures a medical device in Australia;" ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mj a cml:Concept ; skos:prefLabel "41MJ Treating medical devices as prohibited imports or exports"@en ; cml:realizedBy doc:sec-41mj ; cml:integrityHash "86629d48258807888de94a5cb47bbaf27cf7f5bda93d4cef0b2406a0160e008b" ; skos:note "Medical devices are prohibited imports or exports." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.177" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41mj-norm . concept:therapeutic-goods-act-1989-sec-41mj-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41mj ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mj cml:asserts concept:therapeutic-goods-act-1989-sec-41mj-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41mj-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits medical devices as imports or exports." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mk a cml:Concept ; skos:prefLabel "41MK Wholesale supply of medical devices not included in the"@en ; cml:realizedBy doc:sec-41mk ; cml:integrityHash "f7551261f0543b2d1c74a5eba2175c6fad281599de2fc30f60c8a1a7ec0c7d9b" ; skos:note "Supplying medical devices not included in the Register is an offence." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.178" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41mk-norm . concept:therapeutic-goods-act-1989-sec-41mk-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41mk ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mk cml:asserts concept:therapeutic-goods-act-1989-sec-41mk-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41mk-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits supplying medical devices not included in the Register." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ml a cml:Concept ; skos:prefLabel "41ML False advertising about medical devices"@en ; cml:realizedBy doc:sec-41ml ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ml-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ml-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41ml-ss-3 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.179" . concept:therapeutic-goods-act-1989-sec-41ml-ss-1 a cml:Concept ; skos:prefLabel "41ML(1) False advertising about medical devices"@en ; cml:realizedBy doc:sec-41ml-ss-1 ; cml:integrityHash "7d97223634ad49ac5f7f4f782aeee404d190bacf8b7cb51a412520e190f9d535" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ml ; skos:note "False advertising about medical devices is prohibited." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.179" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ml-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41ml-ss-1-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ml-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ml-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41ml-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41ml-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits false advertising about medical devices." ; cml:premiseText "(a) the person, by any means, advertises a medical device as being for a purpose;" ; cml:conclusionText "False advertising about medical devices is prohibited." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ml-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41ml-ss-1-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41ml-ss-1-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Classify" ; cml:logicSummary "Classifies medical devices in the Register." ; cml:premiseText "(b) the device is of a kind included in the Register;" ; cml:conclusionText "The device must be classified as being for a purpose accepted in relation to its inclusion in the Register." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ml-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41ml-ss-1-logic-deontic-3 . concept:therapeutic-goods-act-1989-sec-41ml-ss-1-logic-deontic-3 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits harm or injury resulting from false advertising." ; cml:premiseText "(d) either: (i) the use of the medical device for the advertised purpose has resulted in, will result in, or is likely to result in, harm or injury to any person;" ; cml:conclusionText "The use of the medical device for the advertised purpose must not result in harm or injury." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ml-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41ml-ss-1-logic-linearlogic-4 . concept:therapeutic-goods-act-1989-sec-41ml-ss-1-logic-linearlogic-4 a cml:LogicApplication ; cml:modality cml:LinearLogic ; cml:operator "Imply" ; cml:logicSummary "Implies that false advertising is prohibited if it results in harm or injury." ; cml:premiseText "(d) either: (i) the use of the medical device for the advertised purpose has resulted in, will result in, or is likely to result in, harm or injury to any person;" ; cml:conclusionText "False advertising about medical devices is prohibited if it results in harm or injury." ; cml:executionSurface "modalities::linear" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ml-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41ml-ss-1-logic-descriptionlogic-5 . concept:therapeutic-goods-act-1989-sec-41ml-ss-1-logic-descriptionlogic-5 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Classify" ; cml:logicSummary "Classifies the device as being for a purpose accepted in relation to its inclusion in the Register." ; cml:premiseText "(c) the purpose is not a purpose accepted in relation to that inclusion;" ; cml:conclusionText "The device must be classified as being for a purpose accepted in relation to its inclusion in the Register." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ml-ss-2 a cml:Concept ; skos:prefLabel "41ML(2) False advertising about medical devices"@en ; cml:realizedBy doc:sec-41ml-ss-2 ; cml:integrityHash "0efe32e297eb600df1e33eaf6d48c894b0267f37723a65b0880334819203e777" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ml ; skos:note "False advertising about medical devices is prohibited." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.179" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ml-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41ml-ss-2-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ml-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ml-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41ml-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41ml-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits false advertising about medical devices." ; cml:premiseText "(2) A person commits an offence if: (a) the person, by any means, advertises a medical device as being for a purpose; and (b) the device is of a kind included in the Register; and (c) the purpose is not a purpose accepted in relation to that inclusion." ; cml:conclusionText "(Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.)" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ml-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41ml-ss-2-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41ml-ss-2-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Classify" ; cml:logicSummary "Classifies medical devices as those included in the Register." ; cml:premiseText "(b) the device is of a kind included in the Register;" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ml-ss-3 a cml:Concept ; skos:prefLabel "41ML(3) False advertising about medical devices"@en ; cml:realizedBy doc:sec-41ml-ss-3 ; cml:integrityHash "48f19afe1e0a5597e9d91332cfba6a9aff9af3f7d8146b82a5e76f8d15216573" ; values:partOf concept:therapeutic-goods-act-1989-sec-41ml ; skos:note "False advertising about medical devices is prohibited." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.179" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ml-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41ml-ss-3-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ml-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ml-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41ml-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41ml-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits false advertising about medical devices." ; cml:premiseText "(3) A person commits an offence if: (a) the person, by any means, advertises a medical device as being for a purpose; and (b) the device is of a kind included in the Register; and (c) the purpose is not a purpose accepted in relation to that inclusion." ; cml:conclusionText "(Penalty: 100 penalty units.)" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ml-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41ml-ss-3-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41ml-ss-3-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Classify" ; cml:logicSummary "Classifies medical devices into categories based on their purposes." ; cml:premiseText "(3) A person commits an offence if: (a) the person, by any means, advertises a medical device as being for a purpose; and (b) the device is of a kind included in the Register; and (c) the purpose is not a purpose accepted in relation to that inclusion." ; cml:conclusionText "(The device is of a kind included in the Register.)" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ml-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41ml-ss-3-logic-alleninterval-3 . concept:therapeutic-goods-act-1989-sec-41ml-ss-3-logic-alleninterval-3 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Temporal overlap" ; cml:logicSummary "Requires temporal overlap between advertising and medical device registration." ; cml:premiseText "(3) A person commits an offence if: (a) the person, by any means, advertises a medical device as being for a purpose; and (b) the device is of a kind included in the Register; and (c) the purpose is not a purpose accepted in relation to that inclusion." ; cml:conclusionText "(The advertising must occur after registration.)" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ml-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41ml-ss-3-logic-ltl-4 . concept:therapeutic-goods-act-1989-sec-41ml-ss-3-logic-ltl-4 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Recurring trace" ; cml:logicSummary "Requires recurring traces of false advertising and medical device registration." ; cml:premiseText "(3) A person commits an offence if: (a) the person, by any means, advertises a medical device as being for a purpose; and (b) the device is of a kind included in the Register; and (c) the purpose is not a purpose accepted in relation to that inclusion." ; cml:conclusionText "(The advertising must recur over time.)" ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ml-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41ml-ss-3-logic-diffusion-5 . concept:therapeutic-goods-act-1989-sec-41ml-ss-3-logic-diffusion-5 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "Diffusion" ; cml:logicSummary "Requires diffusion of information about medical device registration." ; cml:premiseText "(3) A person commits an offence if: (a) the person, by any means, advertises a medical device as being for a purpose; and (b) the device is of a kind included in the Register; and (c) the purpose is not a purpose accepted in relation to that inclusion." ; cml:conclusionText "(The information must be diffused widely.)" ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ml-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41ml-ss-3-logic-argumentation-6 . concept:therapeutic-goods-act-1989-sec-41ml-ss-3-logic-argumentation-6 a cml:LogicApplication ; cml:modality cml:Argumentation ; cml:operator "Rebuttal" ; cml:logicSummary "Requires rebuttal of false advertising claims." ; cml:premiseText "(3) A person commits an offence if: (a) the person, by any means, advertises a medical device as being for a purpose; and (b) the device is of a kind included in the Register; and (c) the purpose is not a purpose accepted in relation to that inclusion." ; cml:conclusionText "(The advertising must be rebutted.)" ; cml:executionSurface "modalities::argumentation" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mn a cml:Concept ; skos:prefLabel "41MN Criminal offences relating to breaches of conditions"@en ; cml:realizedBy doc:sec-41mn ; cml:integrityHash "add1bf44ea55abbac2985340efb9c46a191f863b79bee208739663b05d1a5eb5" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41mn-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41mn-ss-4 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41mn-ss-4a ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.181" . concept:therapeutic-goods-act-1989-sec-41mn-ss-1 a cml:Concept ; skos:prefLabel "41MN(1) Criminal offences relating to breaches of conditions"@en ; cml:realizedBy doc:sec-41mn-ss-1 ; cml:integrityHash "ede1948a5fe57f1ee164857fcdfb8d3d383b6eadfd6b2aa79d57afe549fbe8e3" ; values:partOf concept:therapeutic-goods-act-1989-sec-41mn ; skos:note "A person commits an offence if they include a kind of medical device in the Register and breach a condition related to it." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.181" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41mn-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41mn-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41mn-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mn-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41mn-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41mn-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "includes" ; cml:logicSummary "Includes a kind of medical device in the Register." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mn-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41mn-ss-1-logic-deontic-2 . concept:therapeutic-goods-act-1989-sec-41mn-ss-1-logic-deontic-2 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "breaches" ; cml:logicSummary "Breach a condition related to the inclusion of the kind of device." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mn-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41mn-ss-1-logic-descriptionlogic-3 . concept:therapeutic-goods-act-1989-sec-41mn-ss-1-logic-descriptionlogic-3 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "includes" ; cml:logicSummary "Includes a kind of medical device in the Register." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mn-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41mn-ss-1-logic-alleninterval-4 . concept:therapeutic-goods-act-1989-sec-41mn-ss-1-logic-alleninterval-4 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "resulted-in" ; cml:logicSummary "Resulted in harm or injury to any person." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mn-ss-4 a cml:Concept ; skos:prefLabel "41MN(4) Criminal offences relating to breaches of conditions"@en ; cml:realizedBy doc:sec-41mn-ss-4 ; cml:integrityHash "6d4d12d52e5621572383f4dc6e340efd3859ebfa805cf59391df015458a34dda" ; values:partOf concept:therapeutic-goods-act-1989-sec-41mn ; skos:note "Committing an offence if a medical device is included in the Register and an act or omission breaches a condition of its inclusion." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.181" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41mn-ss-4-norm . concept:therapeutic-goods-act-1989-sec-41mn-ss-4-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41mn-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mn-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41mn-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41mn-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Obligation to comply with conditions related to medical devices." ; cml:premiseText "(a) a kind of medical device is included in the Register in relation to the person;" ; cml:conclusionText "A person commits an offence if..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mn-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41mn-ss-4-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41mn-ss-4-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "ClassInclusion" ; cml:logicSummary "Device inclusion in the Register is a descriptive class." ; cml:premiseText "(a) a kind of medical device is included in the Register in relation to the person;" ; cml:conclusionText "The condition of inclusion is related to the person." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mn-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41mn-ss-4-logic-alleninterval-3 . concept:therapeutic-goods-act-1989-sec-41mn-ss-4-logic-alleninterval-3 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "During" ; cml:logicSummary "Act or omission occurs during the period of device inclusion." ; cml:premiseText "(b) the person does an act or omits to do an act;" ; cml:conclusionText "The act or omission breaches a condition of the inclusion of the kind of device in the Register." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mn-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41mn-ss-4-logic-ltl-4 . concept:therapeutic-goods-act-1989-sec-41mn-ss-4-logic-ltl-4 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Until" ; cml:logicSummary "Condition of inclusion is breached until the period ends." ; cml:premiseText "(c) the act or omission breaches a condition of the inclusion of the kind of device in the Register;" ; cml:conclusionText "The person commits an offence if..." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mn-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41mn-ss-4-logic-diffusion-5 . concept:therapeutic-goods-act-1989-sec-41mn-ss-4-logic-diffusion-5 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "If" ; cml:logicSummary "Device inclusion is related to the person if certain conditions are met." ; cml:premiseText "(a) a kind of medical device is included in the Register in relation to the person;" ; cml:conclusionText "A person commits an offence if..." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mn-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41mn-ss-4-logic-cogai-6 . concept:therapeutic-goods-act-1989-sec-41mn-ss-4-logic-cogai-6 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "Classification" ; cml:logicSummary "Device inclusion is classified as a condition." ; cml:premiseText "(a) a kind of medical device is included in the Register in relation to the person;" ; cml:conclusionText "The condition of inclusion is related to the person." ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mn-ss-4a a cml:Concept ; skos:prefLabel "41MN(4A) Criminal offences relating to breaches of conditions"@en ; cml:realizedBy doc:sec-41mn-ss-4a ; cml:integrityHash "36741c4a1407a0e14d1f8766b853df5ed6d342f2c7adba7791ccb6ee78c2274b" ; values:partOf concept:therapeutic-goods-act-1989-sec-41mn ; skos:note "A person commits an offence if a kind of medical device is included in the Register and does an act or omits to do an act that breaches a condition of the inclusion." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.181" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41mn-ss-4a-norm . concept:therapeutic-goods-act-1989-sec-41mn-ss-4a-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41mn-ss-4a ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mn-ss-4a cml:asserts concept:therapeutic-goods-act-1989-sec-41mn-ss-4a-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41mn-ss-4a-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "hasObligation" ; cml:logicSummary "The state has an obligation to ensure the medical device is included in the Register." ; cml:premiseText "The person commits an offence if a kind of medical device is included in the Register." ; cml:conclusionText "The state has an obligation to ensure the medical device is included in the Register." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mn-ss-4a cml:asserts concept:therapeutic-goods-act-1989-sec-41mn-ss-4a-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41mn-ss-4a-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "isSubClassOf" ; cml:logicSummary "Medical devices are sub classes of devices that can be included in the Register." ; cml:premiseText "The person commits an offence if a kind of medical device is included in the Register." ; cml:conclusionText "Medical devices are sub classes of devices that can be included in the Register." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mn-ss-4a cml:asserts concept:therapeutic-goods-act-1989-sec-41mn-ss-4a-logic-alleninterval-3 . concept:therapeutic-goods-act-1989-sec-41mn-ss-4a-logic-alleninterval-3 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "during" ; cml:logicSummary "The act or omission must occur during the time the medical device is included in the Register." ; cml:premiseText "The person commits an offence if a kind of medical device is included in the Register and does an act or omits to do an act." ; cml:conclusionText "The act or omission must occur during the time the medical device is included in the Register." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mn-ss-4a cml:asserts concept:therapeutic-goods-act-1989-sec-41mn-ss-4a-logic-ltl-4 . concept:therapeutic-goods-act-1989-sec-41mn-ss-4a-logic-ltl-4 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "until" ; cml:logicSummary "The condition of the inclusion of the medical device in the Register must be breached until the person commits an offence." ; cml:premiseText "The person commits an offence if a kind of medical device is included in the Register and does an act or omits to do an act." ; cml:conclusionText "The condition of the inclusion of the medical device in the Register must be breached until the person commits an offence." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mn-ss-4a cml:asserts concept:therapeutic-goods-act-1989-sec-41mn-ss-4a-logic-deontic-5 . concept:therapeutic-goods-act-1989-sec-41mn-ss-4a-logic-deontic-5 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "hasPermission" ; cml:logicSummary "The state has permission to include a kind of medical device in the Register." ; cml:premiseText "A person commits an offence if a kind of medical device is included in the Register." ; cml:conclusionText "The state has permission to include a kind of medical device in the Register." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mn-ss-4a cml:asserts concept:therapeutic-goods-act-1989-sec-41mn-ss-4a-logic-deontic-6 . concept:therapeutic-goods-act-1989-sec-41mn-ss-4a-logic-deontic-6 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "hasRight" ; cml:logicSummary "The person has a right to be included in the Register if a kind of medical device is included." ; cml:premiseText "A person commits an offence if a kind of medical device is included in the Register and does an act or omits to do an act." ; cml:conclusionText "The person has a right to be included in the Register if a kind of medical device is included." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mo a cml:Concept ; skos:prefLabel "41MO Criminal offences for misusing medical devices exempted for"@en ; cml:realizedBy doc:sec-41mo ; cml:integrityHash "063d6e9e5d65f6a9ce6b09e5ee9c4ec1d2d0670ad4fecc6a42c6b86895f41d49" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41mo-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41mo-ss-4 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41mo-ss-4a ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.190" . concept:therapeutic-goods-act-1989-sec-41mo-ss-1 a cml:Concept ; skos:prefLabel "41MO(1) Criminal offences for misusing medical devices exempted for"@en ; cml:realizedBy doc:sec-41mo-ss-1 ; cml:integrityHash "c1a43d1b4305b7038003ef65e03644f0b0a8b21f796096d171c5327725ee9f5a" ; values:partOf concept:therapeutic-goods-act-1989-sec-41mo ; skos:note "Supplying a medical device without proper authority is prohibited." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.190" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41mo-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41mo-ss-1-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41mo-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mo-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41mo-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41mo-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits supplying a medical device without proper authority." ; cml:premiseText "(a) the person has been granted an authority under subsection 41HC(1) relating to a specified kind of medical device; and (b) the person supplies a medical device of that kind: ..." ; cml:conclusionText "...the supply is not in accordance with the authority; or the supply is not in accordance with the conditions to which the authority is subject; or the supply is not in accordance with regulations made for the purpose of subsection 41HC(5)." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mo-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41mo-ss-1-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41mo-ss-1-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Classify" ; cml:logicSummary "Classifies medical devices into categories based on their specifications." ; cml:premiseText "(subsection 41HC(1) relating to a specified kind of medical device)" ; cml:conclusionText "...the person supplies a medical device of that kind: ..." ; cml:executionSurface "modalities::dl" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mo-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41mo-ss-1-logic-deontic-3 . concept:therapeutic-goods-act-1989-sec-41mo-ss-1-logic-deontic-3 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits using a medical device without proper authority." ; cml:premiseText "(c) either: (i) the use of the device has resulted in, will result in, or is likely to result in, harm or injury to any person; or (ii) the use of the device, if the device were used, would result in, or would be likely to result in, harm or injury to any person." ; cml:conclusionText "...the supply is not in accordance with the authority; or the supply is not in accordance with the conditions to which the authority is subject; or the supply is not in accordance with regulations made for the purpose of subsection 41HC(5)." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mo-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41mo-ss-1-logic-descriptionlogic-4 . concept:therapeutic-goods-act-1989-sec-41mo-ss-1-logic-descriptionlogic-4 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Classify" ; cml:logicSummary "Classifies harm or injury into categories based on their severity." ; cml:premiseText "(the use of the device has resulted in, will result in, or is likely to result in, harm or injury to any person; or the use of the device, if the device were used, would result in, or would be likely to result in, harm or injury to any person.)" ; cml:conclusionText "...the supply is not in accordance with the authority; or the supply is not in accordance with the conditions to which the authority is subject; or the supply is not in accordance with regulations made for the purpose of subsection 41HC(5)." ; cml:executionSurface "modalities::dl" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mo-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41mo-ss-1-logic-deontic-5 . concept:therapeutic-goods-act-1989-sec-41mo-ss-1-logic-deontic-5 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits supplying a medical device without proper conditions." ; cml:premiseText "(b) the person supplies a medical device of that kind: ... (ii) otherwise than in accordance with any conditions to which the authority is subject; or (iii) otherwise than in accordance with any regulations made for the purpose of subsection 41HC(5)." ; cml:conclusionText "...the supply is not in accordance with the authority; or the supply is not in accordance with the conditions to which the authority is subject; or the supply is not in accordance with regulations made for the purpose of subsection 41HC(5)." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mo-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41mo-ss-1-logic-descriptionlogic-6 . concept:therapeutic-goods-act-1989-sec-41mo-ss-1-logic-descriptionlogic-6 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Classify" ; cml:logicSummary "Classifies conditions into categories based on their specifications." ; cml:premiseText "(any conditions to which the authority is subject)" ; cml:conclusionText "...the supply is not in accordance with the authority; or the supply is not in accordance with the conditions to which the authority is subject; or the supply is not in accordance with regulations made for the purpose of subsection 41HC(5)." ; cml:executionSurface "modalities::dl" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mo-ss-4 a cml:Concept ; skos:prefLabel "41MO(4) Criminal offences for misusing medical devices exempted for"@en ; cml:realizedBy doc:sec-41mo-ss-4 ; cml:integrityHash "57e47e9ce1960cadc9bf0accdfcc1847835e892b00affc11f6f3ae5384da2133" ; values:partOf concept:therapeutic-goods-act-1989-sec-41mo ; skos:note "Supplying a medical device without authority is prohibited." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.190" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41mo-ss-4-norm . concept:therapeutic-goods-act-1989-sec-41mo-ss-4-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41mo-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mo-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41mo-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41mo-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibition of supplying a medical device without authority." ; cml:premiseText "(4) A person commits an offence if..." ; cml:conclusionText "...the person supplies a medical device of that kind: ..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mo-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41mo-ss-4-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41mo-ss-4-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Classify" ; cml:logicSummary "Classification of supplying a medical device without authority as prohibited." ; cml:premiseText "(4) A person commits an offence if..." ; cml:conclusionText "...the person supplies a medical device of that kind: ..." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mo-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41mo-ss-4-logic-deontic-3 . concept:therapeutic-goods-act-1989-sec-41mo-ss-4-logic-deontic-3 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibition of supplying a medical device without authority." ; cml:premiseText "(4AA) A person commits an offence if..." ; cml:conclusionText "...the person supplies a medical device of that kind: ..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mo-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41mo-ss-4-logic-linearlogic-4 . concept:therapeutic-goods-act-1989-sec-41mo-ss-4-logic-linearlogic-4 a cml:LogicApplication ; cml:modality cml:LinearLogic ; cml:operator "Implication" ; cml:logicSummary "Supplying a medical device without authority implies prohibition." ; cml:premiseText "(4) A person commits an offence if..." ; cml:conclusionText "...the person supplies a medical device of that kind: ..." ; cml:executionSurface "modalities::linear" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mo-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41mo-ss-4-logic-descriptionlogic-5 . concept:therapeutic-goods-act-1989-sec-41mo-ss-4-logic-descriptionlogic-5 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Classify" ; cml:logicSummary "Classification of supplying a medical device without authority as prohibited." ; cml:premiseText "(4AA) A person commits an offence if..." ; cml:conclusionText "...the person supplies a medical device of that kind: ..." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mo-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41mo-ss-4-logic-deontic-6 . concept:therapeutic-goods-act-1989-sec-41mo-ss-4-logic-deontic-6 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibition of supplying a medical device without authority." ; cml:premiseText "(4AB) An offence against subsection (4AA) is an offence of strict liability." ; cml:conclusionText "...the person supplies a medical device of that kind: ..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mo-ss-4a a cml:Concept ; skos:prefLabel "41MO(4A) Criminal offences for misusing medical devices exempted for"@en ; cml:realizedBy doc:sec-41mo-ss-4a ; cml:integrityHash "21b8fea6cbba4689a10e6460ef625d0a83a38d750d99b5d1ebf6422d1b711cc0" ; values:partOf concept:therapeutic-goods-act-1989-sec-41mo ; skos:note "Misusing medical devices is prohibited for specified health practitioners." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.190" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41mo-ss-4a-norm . concept:therapeutic-goods-act-1989-sec-41mo-ss-4a-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41mo-ss-4a ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mo-ss-4a cml:asserts concept:therapeutic-goods-act-1989-sec-41mo-ss-4a-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41mo-ss-4a-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibition of misuse" ; cml:premiseText "(4A) A person commits an offence..." ; cml:conclusionText "...the supply is not in accordance with those rules;" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mo-ss-4a cml:asserts concept:therapeutic-goods-act-1989-sec-41mo-ss-4a-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41mo-ss-4a-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Classify" ; cml:logicSummary "Classification of health practitioners" ; cml:premiseText "(b) the person is included in a class of health practitioners..." ; cml:conclusionText "...specified in subsection 41HC(6) rules;" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mo-ss-4a cml:asserts concept:therapeutic-goods-act-1989-sec-41mo-ss-4a-logic-alleninterval-3 . concept:therapeutic-goods-act-1989-sec-41mo-ss-4a-logic-alleninterval-3 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Temporal relation" ; cml:logicSummary "Temporal relation between supply and rule" ; cml:premiseText "(c) the person supplies a medical device of a kind specified in..." ; cml:conclusionText "...the supply is not in accordance with those rules;" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mo-ss-4a cml:asserts concept:therapeutic-goods-act-1989-sec-41mo-ss-4a-logic-argumentation-4 . concept:therapeutic-goods-act-1989-sec-41mo-ss-4a-logic-argumentation-4 a cml:LogicApplication ; cml:modality cml:Argumentation ; cml:operator "Implication" ; cml:logicSummary "Implication of rule violation on offence" ; cml:premiseText "(d) any of the following applies:" ; cml:conclusionText "...the person commits an offence if..." ; cml:executionSurface "modalities::argumentation" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mp a cml:Concept ; skos:prefLabel "41MP Criminal offence for failing to notify adverse events etc."@en ; cml:realizedBy doc:sec-41mp ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41mp-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41mp-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41mp-ss-1 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.194" . concept:therapeutic-goods-act-1989-sec-41mp-ss-1 a cml:Concept ; skos:prefLabel "41MP(1) Criminal offence for failing to notify adverse events etc."@en ; cml:realizedBy doc:sec-41mp-ss-1 ; cml:integrityHash "f4cb706f29da6a9b6779f82fcbd40e0b73bf8b15de22fc67800603976e37cd96" ; values:partOf concept:therapeutic-goods-act-1989-sec-41mp ; skos:note "Failing to notify adverse events is a criminal offence. Notify adverse events etc. within specified period." ; dc:description "Information of a kind mentioned in subsection (2)" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.194" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41mp-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41mp-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41mp-ss-1 ; values:borneBy values:Agent ; skos:scopeNote "borne by: Agent" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mp-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41mp-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41mp-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibits failing to notify adverse events." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mp-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41mp-ss-1-logic-deontic-2 . concept:therapeutic-goods-act-1989-sec-41mp-ss-1-logic-deontic-2 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must provide information" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mp-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41mp-ss-1-logic-descriptionlogic-3 . concept:therapeutic-goods-act-1989-sec-41mp-ss-1-logic-descriptionlogic-3 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "IS_A" ; cml:logicSummary "Information of a kind mentioned in subsection (2)" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mp-ss-2 a cml:Concept ; skos:prefLabel "41MP(2) Criminal offence for failing to notify adverse events etc."@en ; cml:realizedBy doc:sec-41mp-ss-2 ; cml:integrityHash "df810373c6b14d3531ecc357f8b487b89e2819c66024f9cb372ddd6ef69c34d8" ; values:partOf concept:therapeutic-goods-act-1989-sec-41mp ; skos:note "Notify adverse events etc." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.194" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41mp-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41mp-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41mp-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mp-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41mp-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41mp-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must notify adverse events etc." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mp-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41mp-ss-2-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41mp-ss-2-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "IS_A" ; cml:logicSummary "Device malfunction or deterioration" ; cml:premiseText "(a) information relating to any malfunction or deterioration in the characteristics or performance of the kind of device;" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mp-ss-1 a cml:Concept ; skos:prefLabel "41MP(1) Criminal offence for failing to notify adverse events etc."@en ; cml:realizedBy doc:sec-41mp-ss-1 ; cml:integrityHash "7a7b2263dc301edc24686f0b491323d9e65e8556fa77e018605ad095ebbe7f59" ; values:partOf concept:therapeutic-goods-act-1989-sec-41mp ; skos:note "Failing to notify adverse events is a criminal offence. Notify adverse events etc. within specified period." ; dc:description "Information of a kind mentioned in subsection (2)" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.194" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41mp-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41mp-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41mp-ss-1 ; values:borneBy values:Agent ; skos:scopeNote "borne by: Agent" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mp-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41mp-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41mp-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibits failing to notify adverse events." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mp-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41mp-ss-1-logic-deontic-2 . concept:therapeutic-goods-act-1989-sec-41mp-ss-1-logic-deontic-2 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must provide information" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mp-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41mp-ss-1-logic-descriptionlogic-3 . concept:therapeutic-goods-act-1989-sec-41mp-ss-1-logic-descriptionlogic-3 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "IS_A" ; cml:logicSummary "Information of a kind mentioned in subsection (2)" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mq a cml:Concept ; skos:prefLabel "41MQ Notification of adverse events etc. where application"@en ; cml:realizedBy doc:sec-41mq ; cml:integrityHash "93376f2dbbcc61c63c801535701930dcb75f809357e4e8beb1d0a27bc70524ce" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41mq-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41mq-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41mq-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41mq-ss-4 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.198" . concept:therapeutic-goods-act-1989-sec-41mq-ss-1 a cml:Concept ; skos:prefLabel "41MQ(1) Notification of adverse events etc. where application"@en ; cml:realizedBy doc:sec-41mq-ss-1 ; cml:integrityHash "e9679e8cb4068e5117ae90d3499c87dd67f42b702846dfd7a5572c1821fa56bc" ; values:partOf concept:therapeutic-goods-act-1989-sec-41mq ; skos:note "Notify applicant of information about withdrawn application." ; dc:description "Yes" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.198" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41mq-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41mq-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41mq-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mq-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41mq-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41mq-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must notify applicant." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mq-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41mq-ss-1-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41mq-ss-1-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "SUBCLASS OF" ; cml:logicSummary "Notification is a subclass of obligation." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mq-ss-2 a cml:Concept ; skos:prefLabel "41MQ(2) Notification of adverse events etc. where application"@en ; cml:realizedBy doc:sec-41mq-ss-2 ; cml:integrityHash "8961e012f6bcce31deaaf12b53730c30e4082c9c77f9f240a961ecadc06dc378" ; values:partOf concept:therapeutic-goods-act-1989-sec-41mq ; skos:note "Notice under subsection (1) must be given within 10 working days after an application is withdrawn or lapses." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.198" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41mq-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41mq-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41mq-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mq-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41mq-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41mq-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must be given within 10 working days" ; cml:premiseText "(2) Notice under subsection (1)" ; cml:conclusionText "may only be given within 10 working days after an application is withdrawn or lapses." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mq-ss-3 a cml:Concept ; skos:prefLabel "41MQ(3) Notification of adverse events etc. where application"@en ; cml:realizedBy doc:sec-41mq-ss-3 ; cml:integrityHash "4342c68fa158050d7961dc07a7fd5c60141782d738bf69d7d3bb64bdb1a9d591" ; values:partOf concept:therapeutic-goods-act-1989-sec-41mq ; skos:note "Failure to comply with notice within 20 working days is an offence." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.198" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41mq-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41mq-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41mq-ss-3 ; values:borneBy values:Agent ; skos:scopeNote "borne by: Agent" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mq-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41mq-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41mq-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Obligation to comply with notice." ; cml:premiseText "Notice given" ; cml:conclusionText "Failure to comply is an offence." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mq-ss-4 a cml:Concept ; skos:prefLabel "41MQ(4) Notification of adverse events etc. where application"@en ; cml:realizedBy doc:sec-41mq-ss-4 ; cml:integrityHash "3135d014c47ec912a070a5c43ec54b3bbba6312e51e894a8822fde120a2a9a23" ; values:partOf concept:therapeutic-goods-act-1989-sec-41mq ; skos:note "Giving false information in response to a notice is an offence." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.198" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41mq-ss-4-norm . concept:therapeutic-goods-act-1989-sec-41mq-ss-4-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41mq-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mq-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41mq-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41mq-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibition of false information" ; cml:premiseText "The person gives information in purported compliance with a notice." ; cml:conclusionText "The person commits an offence if the information is false or misleading in a material particular." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mr a cml:Concept ; skos:prefLabel "41MR Civil penalties for failing to notify adverse effects etc. where"@en ; cml:realizedBy doc:sec-41mr ; cml:integrityHash "26f7008a3e14c5f1b0690933aaf97973ebb7934e05f46482c7347b1adb2ee083" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41mr-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41mr-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.199" . concept:therapeutic-goods-act-1989-sec-41mr-ss-1 a cml:Concept ; skos:prefLabel "41MR(1) Civil penalties for failing to notify adverse effects etc. where"@en ; cml:realizedBy doc:sec-41mr-ss-1 ; cml:integrityHash "d61d313c10cd10817019030e5ef7bf0cdab8fb71ead4b359390c9c6bd60ea6be" ; values:partOf concept:therapeutic-goods-act-1989-sec-41mr ; skos:note "Failure to comply with notice requirements within 20 working days" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.199" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41mr-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41mr-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41mr-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mr-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41mr-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41mr-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Obligation to comply with notice requirements" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mr-ss-2 a cml:Concept ; skos:prefLabel "41MR(2) Civil penalties for failing to notify adverse effects etc. where"@en ; cml:realizedBy doc:sec-41mr-ss-2 ; cml:integrityHash "f0e4189c4837da35723965f1b944b6be67e33a2480b81f1eb6425ad627afa4a4" ; values:partOf concept:therapeutic-goods-act-1989-sec-41mr ; skos:note "False or misleading information in a notice" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.199" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41mr-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41mr-ss-2-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41mr-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41mr-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41mr-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41mr-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibition of false or misleading information" ; cml:premiseText "The person gives information in purported compliance with a notice" ; cml:conclusionText "The person contravenes this subsection" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41n a cml:Concept ; skos:prefLabel "41N Simplified outline of this Chapter"@en ; cml:realizedBy doc:sec-41n ; cml:integrityHash "cad61469cf3cd9b830367dd73078c4b15f4faec68642cc8a9d741531c7580378" ; skos:note "Importation of vaping goods and manufacture, supply or possession are prohibited in Australia." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.200" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41n-norm . concept:therapeutic-goods-act-1989-sec-41n-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41n ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41n cml:asserts concept:therapeutic-goods-act-1989-sec-41n-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41n-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibition of vaping goods importation and manufacture, supply or possession." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41n cml:asserts concept:therapeutic-goods-act-1989-sec-41n-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41n-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Classify" ; cml:logicSummary "Classification of vaping goods as prohibited." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41na a cml:Concept ; skos:prefLabel "41NA Relationship with other Chapters of this Act"@en ; cml:realizedBy doc:sec-41na ; cml:integrityHash "12f314df9f33d98e71c5b2c23998be823a2826643e5eb2154661ce861216e250" ; skos:note "No limitation on generality of offence provisions or civil penalty provisions between Chapters." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.201" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41na-norm . concept:therapeutic-goods-act-1989-sec-41na-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41na ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41na cml:asserts concept:therapeutic-goods-act-1989-sec-41na-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41na-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "!" ; cml:logicSummary "No limitation on generality." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41p a cml:Concept ; skos:prefLabel "41P Meaning of vaping goods and related terms"@en ; cml:realizedBy doc:sec-41p ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41p-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41p-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41p-ss-3 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.202" . concept:therapeutic-goods-act-1989-sec-41p-ss-1 a cml:Concept ; skos:prefLabel "41P(1) Meaning of vaping goods and related terms"@en ; cml:realizedBy doc:sec-41p-ss-1 ; cml:integrityHash "717a17ce0729221428b3d17683ff51b4a3898d8ef23dcd2b69e23510fee629fc" ; values:partOf concept:therapeutic-goods-act-1989-sec-41p ; skos:note "Defines vaping goods and related terms." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.202" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41p-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41p-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41p-ss-1 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41p-ss-2 a cml:Concept ; skos:prefLabel "41P(2) Meaning of vaping goods and related terms"@en ; cml:realizedBy doc:sec-41p-ss-2 ; cml:integrityHash "ad160889177f901bd9184011a22ea8e4da12e998ffe07aacb519222d954cddbf" ; values:partOf concept:therapeutic-goods-act-1989-sec-41p ; skos:note "Goods must be presented in a certain way to be considered vaping goods." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.202" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41p-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41p-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41p-ss-2 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41p-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41p-ss-2-logic-descriptionlogic-1 . concept:therapeutic-goods-act-1989-sec-41p-ss-2-logic-descriptionlogic-1 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "=" ; cml:logicSummary "Definition of vaping goods" ; cml:premiseText "Goods are taken to be presented as being a particular kind of goods" ; cml:conclusionText "Goods must be presented in a certain way to be considered vaping goods." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41p-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41p-ss-2-logic-deontic-2 . concept:therapeutic-goods-act-1989-sec-41p-ss-2-logic-deontic-2 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "=" ; cml:logicSummary "Presentation requirements for vaping goods" ; cml:premiseText "(a) the presentation of goods includes matters in relation to..." ; cml:conclusionText "Goods must meet specific presentation requirements to be considered vaping goods." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41p-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41p-ss-2-logic-deontic-3 . concept:therapeutic-goods-act-1989-sec-41p-ss-2-logic-deontic-3 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "=" ; cml:logicSummary "Misleading or confusing presentation is prohibited" ; cml:premiseText "(i) is capable of being misleading or confusing as to the content or proper use or identification of the goods;" ; cml:conclusionText "Goods cannot be presented in a way that is misleading or confusing." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41p-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41p-ss-2-logic-deontic-4 . concept:therapeutic-goods-act-1989-sec-41p-ss-2-logic-deontic-4 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "=" ; cml:logicSummary "Minister's discretion for determining vaping goods" ; cml:premiseText "Minister may determine that goods are or are not vaping goods etc." ; cml:conclusionText "The Minister has the authority to determine whether goods are vaping goods or not." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41p-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41p-ss-2-logic-deontic-5 . concept:therapeutic-goods-act-1989-sec-41p-ss-2-logic-deontic-5 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "=" ; cml:logicSummary "Prohibition on presenting false information" ; cml:premiseText "(ii) suggests that the goods have ingredients, components or characteristics that they do not have." ; cml:conclusionText "Goods cannot be presented as having ingredients or characteristics they do not actually have." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41p-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41p-ss-2-logic-deontic-6 . concept:therapeutic-goods-act-1989-sec-41p-ss-2-logic-deontic-6 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "=" ; cml:logicSummary "Right to determine vaping goods" ; cml:premiseText "(b) goods are taken to be presented as being a particular kind of goods even if..." ; cml:conclusionText "The Minister has the right to determine whether goods are vaping goods or not." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41p-ss-3 a cml:Concept ; skos:prefLabel "41P(3) Meaning of vaping goods and related terms"@en ; cml:realizedBy doc:sec-41p-ss-3 ; cml:integrityHash "2bf494815ec92fd402a9bee16be0c21341c729bb155eb3c4c4f16ae8ae609b5a" ; values:partOf concept:therapeutic-goods-act-1989-sec-41p ; skos:note "Authority to determine vaping goods classification" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.202" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41p-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41p-ss-3-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41p-ss-3 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41p-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41p-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41p-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "May" ; cml:logicSummary "Granting permission" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41q a cml:Concept ; skos:prefLabel "41Q Offences and civil penalty provision—importing vaping goods"@en ; cml:realizedBy doc:sec-41q ; cml:integrityHash "8b405996892544c4e5929d35ca68d582158dded01ee5c7d0c531c8d2ed6f418c" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41q-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41q-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41q-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41q-ss-4 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41q-ss-5 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.204" . concept:therapeutic-goods-act-1989-sec-41q-ss-1 a cml:Concept ; skos:prefLabel "41Q(1) Offences and civil penalty provision—importing vaping goods"@en ; cml:realizedBy doc:sec-41q-ss-1 ; cml:integrityHash "d526f9ff7a6ddf7f24255598a73e95c8669baaa97f9834273f021fdea71d530e" ; values:partOf concept:therapeutic-goods-act-1989-sec-41q ; skos:note "Importing vaping goods into Australia is an offence." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.204" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41q-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41q-ss-1-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41q-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41q-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41q-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41q-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits importing vaping goods into Australia." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41q-ss-2 a cml:Concept ; skos:prefLabel "41Q(2) Offences and civil penalty provision—importing vaping goods"@en ; cml:realizedBy doc:sec-41q-ss-2 ; cml:integrityHash "de689eafec2f1fe061b73f01057383194d9a17a464181f72bad83e075be51c8b" ; values:partOf concept:therapeutic-goods-act-1989-sec-41q ; skos:note "Importing vaping goods into Australia is an offence of strict liability." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.204" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41q-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41q-ss-2-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41q-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41q-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41q-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41q-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits importing vaping goods into Australia." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41q-ss-3 a cml:Concept ; skos:prefLabel "41Q(3) Offences and civil penalty provision—importing vaping goods"@en ; cml:realizedBy doc:sec-41q-ss-3 ; cml:integrityHash "1045b4b579daa42ee3006a4636a52c4798d41ee9a18a55d6362b0aa2e81c2633" ; values:partOf concept:therapeutic-goods-act-1989-sec-41q ; skos:note "Importing vaping goods into Australia is prohibited." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.204" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41q-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41q-ss-3-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41q-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41q-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41q-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41q-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits importing vaping goods." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41q-ss-4 a cml:Concept ; skos:prefLabel "41Q(4) Offences and civil penalty provision—importing vaping goods"@en ; cml:realizedBy doc:sec-41q-ss-4 ; cml:integrityHash "32a1bf8ba412d0e353f7caf411284c3dd5e3ef3c54f7e1afb2628f2ee6d883ea" ; values:partOf concept:therapeutic-goods-act-1989-sec-41q ; skos:note "Importing vaping goods without compliance with subsection (3) is prohibited." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.204" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41q-ss-4-norm . concept:therapeutic-goods-act-1989-sec-41q-ss-4-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41q-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41q-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41q-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41q-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibition of importing vaping goods without compliance." ; cml:premiseText "Subsection (3) sets conditions for importing vaping goods." ; cml:conclusionText "Importing vaping goods without compliance is prohibited." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41q-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41q-ss-4-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-41q-ss-4-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Overlap" ; cml:logicSummary "Temporal overlap between subsection (3) and importation." ; cml:premiseText "Subsection (3) sets conditions for importation." ; cml:conclusionText "Importation of vaping goods must comply with subsection (3)." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41q-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41q-ss-4-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-41q-ss-4-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Recurring" ; cml:logicSummary "Recurring trace of compliance with subsection (3)." ; cml:premiseText "Subsection (3) sets conditions for importation." ; cml:conclusionText "Compliance with subsection (3) must be recurring." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41q-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41q-ss-4-logic-cogai-4 . concept:therapeutic-goods-act-1989-sec-41q-ss-4-logic-cogai-4 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "Analyze" ; cml:logicSummary "Analyzing compliance with subsection (3)." ; cml:premiseText "Subsection (3) sets conditions for importation." ; cml:conclusionText "Compliance with subsection (3) must be analyzed." ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41q-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41q-ss-4-logic-shacl-5 . concept:therapeutic-goods-act-1989-sec-41q-ss-4-logic-shacl-5 a cml:LogicApplication ; cml:modality cml:SHACL ; cml:operator "Validate" ; cml:logicSummary "Validation of compliance with subsection (3)." ; cml:premiseText "Subsection (3) sets conditions for importation." ; cml:conclusionText "Compliance with subsection (3) must be validated." ; cml:executionSurface "modalities::logic::shacl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41q-ss-5 a cml:Concept ; skos:prefLabel "41Q(5) Offences and civil penalty provision—importing vaping goods"@en ; cml:realizedBy doc:sec-41q-ss-5 ; cml:integrityHash "ff7804e1eec2aa6b8c27ad54cbf802a47f7aecc87ee1760be2a4911e649fa44a" ; values:partOf concept:therapeutic-goods-act-1989-sec-41q ; skos:note "Exemptions from subsections (1) to (4)" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.204" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41q-ss-5-norm . concept:therapeutic-goods-act-1989-sec-41q-ss-5-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41q-ss-5 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41qa a cml:Concept ; skos:prefLabel "41QA Offences and civil penalty provision—manufacturing vaping"@en ; cml:realizedBy doc:sec-41qa ; cml:integrityHash "b775ca97317081f36d1a0ea0e8f65625fac7c7fda620f9d15ba77db7fd1da6b3" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41qa-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41qa-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41qa-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41qa-ss-4 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.205" . concept:therapeutic-goods-act-1989-sec-41qa-ss-1 a cml:Concept ; skos:prefLabel "41QA(1) Offences and civil penalty provision—manufacturing vaping"@en ; cml:realizedBy doc:sec-41qa-ss-1 ; cml:integrityHash "2be8d5c220667deb601512b1b482cda71679b407bb0dcc84a1e6786ba1095ebc" ; values:partOf concept:therapeutic-goods-act-1989-sec-41qa ; skos:note "Manufacturing vaping goods in Australia is prohibited." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.205" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41qa-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41qa-ss-1-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41qa-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41qa-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41qa-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41qa-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits manufacturing vaping goods." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41qa-ss-2 a cml:Concept ; skos:prefLabel "41QA(2) Offences and civil penalty provision—manufacturing vaping"@en ; cml:realizedBy doc:sec-41qa-ss-2 ; cml:integrityHash "6481547c353c2e4f4649b1d8c62ba6a014526161391ca752fcbfa5f3b4f29f18" ; values:partOf concept:therapeutic-goods-act-1989-sec-41qa ; skos:note "Manufacturing vaping goods is prohibited." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.205" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41qa-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41qa-ss-2-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41qa-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41qa-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41qa-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41qa-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits manufacturing vaping goods." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41qa-ss-3 a cml:Concept ; skos:prefLabel "41QA(3) Offences and civil penalty provision—manufacturing vaping"@en ; cml:realizedBy doc:sec-41qa-ss-3 ; cml:integrityHash "b7301b67639f528d55c26affa2dfd52ef83f14ef987a9e5f862f1a5b3b1ea35e" ; values:partOf concept:therapeutic-goods-act-1989-sec-41qa ; skos:note "Manufacturing vaping goods in Australia is prohibited." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.205" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41qa-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41qa-ss-3-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41qa-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41qa-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41qa-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41qa-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits manufacturing vaping goods." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41qa-ss-4 a cml:Concept ; skos:prefLabel "41QA(4) Offences and civil penalty provision—manufacturing vaping"@en ; cml:realizedBy doc:sec-41qa-ss-4 ; cml:integrityHash "7da3106ad56004305b6d113b26a6f3c6a5ff4f7e1ab8b6f2ab4a61ea0df7e8fd" ; values:partOf concept:therapeutic-goods-act-1989-sec-41qa ; skos:note "Manufacturing vaping goods without compliance with subsection (3) is prohibited." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.205" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41qa-ss-4-norm . concept:therapeutic-goods-act-1989-sec-41qa-ss-4-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41qa-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41qa-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41qa-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41qa-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibition of manufacturing vaping goods without compliance." ; cml:premiseText "Subsection (3) sets conditions for manufacture." ; cml:conclusionText "Manufacturing without compliance is prohibited." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41qa-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41qa-ss-4-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-41qa-ss-4-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Overlap" ; cml:logicSummary "Temporal overlap between manufacture and subsection (3) conditions." ; cml:premiseText "Manufacture occurs before or concurrently with subsection (3) conditions." ; cml:conclusionText "Manufacture overlaps with subsection (3) conditions." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41qa-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41qa-ss-4-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-41qa-ss-4-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Recurring" ; cml:logicSummary "Recurring trace of manufacturing vaping goods without compliance." ; cml:premiseText "Manufacturing vaping goods without compliance is a recurring action." ; cml:conclusionText "Manufacturing vaping goods without compliance has a recurring trace." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41qa-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41qa-ss-4-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-41qa-ss-4-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "Spread" ; cml:logicSummary "Diffusion of non-compliance in manufacturing vaping goods." ; cml:premiseText "Non-compliance in manufacture spreads to other units of vaping goods." ; cml:conclusionText "Non-compliance in manufacturing vaping goods spreads to other units." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41qa-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41qa-ss-4-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-41qa-ss-4-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "Analyze" ; cml:logicSummary "Analyzing manufacturing vaping goods for compliance with subsection (3)." ; cml:premiseText "Manufacturing vaping goods requires analysis for compliance." ; cml:conclusionText "Manufacturing vaping goods must be analyzed for compliance." ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41qb a cml:Concept ; skos:prefLabel "41QB Offences and civil penalty provision—supplying vaping goods"@en ; cml:realizedBy doc:sec-41qb ; cml:integrityHash "87d390231948a0c49033f78db1046b1c0ea049452008ec1792ea0a263799dcc6" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41qb-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41qb-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41qb-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41qb-ss-4 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41qb-ss-5 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41qb-ss-6 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.206" . concept:therapeutic-goods-act-1989-sec-41qb-ss-1 a cml:Concept ; skos:prefLabel "41QB(1) Offences and civil penalty provision—supplying vaping goods"@en ; cml:realizedBy doc:sec-41qb-ss-1 ; cml:integrityHash "ffeefebc19853609449f005428f0dd0abbea1e28b64967b2b326f8a21bdc9991" ; values:partOf concept:therapeutic-goods-act-1989-sec-41qb ; skos:note "Supplying vaping goods in Australia is an offence." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.206" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41qb-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41qb-ss-1-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41qb-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41qb-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41qb-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41qb-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits supplying vaping goods in Australia." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41qb-ss-2 a cml:Concept ; skos:prefLabel "41QB(2) Offences and civil penalty provision—supplying vaping goods"@en ; cml:realizedBy doc:sec-41qb-ss-2 ; cml:integrityHash "bc4bb4556243dd3a5a0fe7cf6c2f3bcba9d50774aea8fd636bfd0e7439abc20d" ; values:partOf concept:therapeutic-goods-act-1989-sec-41qb ; skos:note "Supplying vaping goods is an offence of strict liability." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.206" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41qb-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41qb-ss-2-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41qb-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41qb-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41qb-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41qb-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits supplying vaping goods." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41qb-ss-3 a cml:Concept ; skos:prefLabel "41QB(3) Offences and civil penalty provision—supplying vaping goods"@en ; cml:realizedBy doc:sec-41qb-ss-3 ; cml:integrityHash "390646aa45178820d4ce6afa3e126c77bb97cd0d0033613eb75310b186bb5faa" ; values:partOf concept:therapeutic-goods-act-1989-sec-41qb ; skos:note "Supplying vaping goods in Australia is prohibited." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.206" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41qb-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41qb-ss-3-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41qb-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41qb-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41qb-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41qb-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits supplying vaping goods." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41qb-ss-4 a cml:Concept ; skos:prefLabel "41QB(4) Offences and civil penalty provision—supplying vaping goods"@en ; cml:realizedBy doc:sec-41qb-ss-4 ; cml:integrityHash "e0817cb2cc040c33c63bbbc79fb79c9c2b5a18cdbea237a7eebbe813c522f6a7" ; values:partOf concept:therapeutic-goods-act-1989-sec-41qb ; skos:note "Supplying vaping goods without compliance with subsection (3) is prohibited." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.206" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41qb-ss-4-norm . concept:therapeutic-goods-act-1989-sec-41qb-ss-4-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41qb-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41qb-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41qb-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41qb-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibition of supplying vaping goods without compliance." ; cml:premiseText "Subsection (3) sets conditions for supply." ; cml:conclusionText "No supply is allowed." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41qb-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41qb-ss-4-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-41qb-ss-4-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Overlap" ; cml:logicSummary "Temporal overlap between supply and prohibition." ; cml:premiseText "Supplying vaping goods is prohibited after subsection (3) applies." ; cml:conclusionText "Prohibition overlaps with supply." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41qb-ss-5 a cml:Concept ; skos:prefLabel "41QB(5) Offences and civil penalty provision—supplying vaping goods"@en ; cml:realizedBy doc:sec-41qb-ss-5 ; cml:integrityHash "e3d9db33033aa560475f4253fc1f2f427c00814af597579a826c1743b776c001" ; values:partOf concept:therapeutic-goods-act-1989-sec-41qb ; skos:note "Exemptions from subsections (1) to (4)" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.206" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41qb-ss-5-norm . concept:therapeutic-goods-act-1989-sec-41qb-ss-5-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41qb-ss-5 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41qb-ss-6 a cml:Concept ; skos:prefLabel "41QB(6) Offences and civil penalty provision—supplying vaping goods"@en ; cml:realizedBy doc:sec-41qb-ss-6 ; cml:integrityHash "2a82d74807b10840745e3337be654403282da2a52825e80fba16588578860f4a" ; values:partOf concept:therapeutic-goods-act-1989-sec-41qb ; skos:note "Supply of vaping goods without proper exemption is prohibited." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.206" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41qb-ss-6-norm . concept:therapeutic-goods-act-1989-sec-41qb-ss-6-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41qb-ss-6 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41qb-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-41qb-ss-6-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41qb-ss-6-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibition" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41qc a cml:Concept ; skos:prefLabel "41QC Offences and civil penalty provision—possessing at least"@en ; cml:realizedBy doc:sec-41qc ; cml:integrityHash "a085195ac64144deba2ae46a376746eea46dde7ab95499250d752ce535de453c" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41qc-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41qc-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41qc-ss-3 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.211" . concept:therapeutic-goods-act-1989-sec-41qc-ss-1 a cml:Concept ; skos:prefLabel "41QC(1) Offences and civil penalty provision—possessing at least"@en ; cml:realizedBy doc:sec-41qc-ss-1 ; cml:integrityHash "e6793a3988b2275cba60cfc797ee27ce8fd6c784830177a9279a275e3dfe3b13" ; values:partOf concept:therapeutic-goods-act-1989-sec-41qc ; skos:note "Possessing vaping goods in Australia without permission" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.211" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41qc-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41qc-ss-1-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41qc-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41qc-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41qc-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41qc-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits possession of vaping goods in Australia" ; cml:premiseText "(a) the person possesses a quantity of a kind of vaping goods in Australia; and (b) the quantity is at least the commercial quantity, but less than 100 times the commercial quantity of that kind of vaping goods." ; cml:conclusionText "The person commits an offence if..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41qc-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41qc-ss-1-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41qc-ss-1-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Classify" ; cml:logicSummary "Classifies possession of vaping goods in Australia as an offence" ; cml:premiseText "(a) the person possesses a quantity of a kind of vaping goods in Australia; and (b) the quantity is at least the commercial quantity, but less than 100 times the commercial quantity of that kind of vaping goods." ; cml:conclusionText "The person commits an offence if..." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41qc-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41qc-ss-1-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-41qc-ss-1-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Recurring Trace" ; cml:logicSummary "Establishes a recurring trace for possession of vaping goods in Australia" ; cml:premiseText "(a) the person possesses a quantity of a kind of vaping goods in Australia; and (b) the quantity is at least the commercial quantity, but less than 100 times the commercial quantity of that kind of vaping goods." ; cml:conclusionText "The person commits an offence if..." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41qc-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41qc-ss-1-logic-deontic-4 . concept:therapeutic-goods-act-1989-sec-41qc-ss-1-logic-deontic-4 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Imprisonment for 2 years or 1,000 penalty units for possession of vaping goods in Australia" ; cml:premiseText "Penalty: Imprisonment for 2 years or 1,000 penalty units, or both." ; cml:conclusionText "The person commits an offence if..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41qc-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41qc-ss-1-logic-descriptionlogic-5 . concept:therapeutic-goods-act-1989-sec-41qc-ss-1-logic-descriptionlogic-5 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Classify" ; cml:logicSummary "Classifies imprisonment for 2 years or 1,000 penalty units as a penalty for possession of vaping goods in Australia" ; cml:premiseText "Penalty: Imprisonment for 2 years or 1,000 penalty units, or both." ; cml:conclusionText "The person commits an offence if..." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41qc-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41qc-ss-1-logic-alleninterval-6 . concept:therapeutic-goods-act-1989-sec-41qc-ss-1-logic-alleninterval-6 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Temporal Interval" ; cml:logicSummary "Establishes a temporal interval for imprisonment for possession of vaping goods in Australia" ; cml:premiseText "Penalty: Imprisonment for 2 years or 1,000 penalty units, or both." ; cml:conclusionText "The person commits an offence if..." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41qc-ss-2 a cml:Concept ; skos:prefLabel "41QC(2) Offences and civil penalty provision—possessing at least"@en ; cml:realizedBy doc:sec-41qc-ss-2 ; cml:integrityHash "f0a7520d29fc6be1274c6a95eaa57d05f5089c25008fbc2d4ef9a7c9473ef89a" ; values:partOf concept:therapeutic-goods-act-1989-sec-41qc ; skos:note "Absolute liability applies for possessing at least" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.211" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41qc-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41qc-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41qc-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41qc-ss-3 a cml:Concept ; skos:prefLabel "41QC(3) Offences and civil penalty provision—possessing at least"@en ; cml:realizedBy doc:sec-41qc-ss-3 ; cml:integrityHash "cf96091cacd34b8f9d20e30b32d348bac00c4ec8fec45f176b7544d269c4d2dd" ; values:partOf concept:therapeutic-goods-act-1989-sec-41qc ; skos:note "Possessing a quantity of vaping goods without exceeding the commercial quantity is an offence." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.211" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41qc-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41qc-ss-3-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41qc-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41qc-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41qc-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41qc-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibits possessing vaping goods" ; cml:premiseText "(a) the person possesses a quantity of a kind of vaping goods in Australia;" ; cml:conclusionText "A person commits an offence of strict liability if..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41qc-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41qc-ss-3-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41qc-ss-3-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Classify" ; cml:logicSummary "Classifies vaping goods as prohibited" ; cml:premiseText "(3) A person commits an offence of strict liability if:" ; cml:conclusionText "Penalty: 120 penalty units." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41qd a cml:Concept ; skos:prefLabel "41QD Offences and civil penalty provision—possessing less than"@en ; cml:realizedBy doc:sec-41qd ; cml:integrityHash "b8a8772d2ebb0a01f089ba606f2f270023bad0706812b06b943c151c55fb9350" ; skos:note "Possessing less than a commercial quantity of vaping goods is an offence." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.215" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41qd-norm . concept:therapeutic-goods-act-1989-sec-41qd-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41qd ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41qd cml:asserts concept:therapeutic-goods-act-1989-sec-41qd-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41qd-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits possessing less than a commercial quantity of vaping goods." ; cml:premiseText "The person is a retailer in relation to retail premises in Australia." ; cml:conclusionText "The person commits an offence if..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41qd cml:asserts concept:therapeutic-goods-act-1989-sec-41qd-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-41qd-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Overlap" ; cml:logicSummary "Overlaps with the definition of a commercial quantity." ; cml:premiseText "commercial quantity of vaping goods" ; cml:conclusionText "Possessing less than a commercial quantity of vaping goods is an offence." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41qd cml:asserts concept:therapeutic-goods-act-1989-sec-41qd-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-41qd-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Recurring" ; cml:logicSummary "Recurring trace for the definition of a commercial quantity." ; cml:premiseText "commercial quantity of vaping goods" ; cml:conclusionText "Possessing less than a commercial quantity of vaping goods is an offence." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41qd cml:asserts concept:therapeutic-goods-act-1989-sec-41qd-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-41qd-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "Diffuse" ; cml:logicSummary "Diffuses the definition of a commercial quantity to include retail premises in Australia." ; cml:premiseText "the person is a retailer in relation to retail premises in Australia." ; cml:conclusionText "The person commits an offence if..." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41qd cml:asserts concept:therapeutic-goods-act-1989-sec-41qd-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-41qd-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "Recognize" ; cml:logicSummary "Recognizes the legal concept of possessing less than a commercial quantity of vaping goods as an offence." ; cml:premiseText "Chapter 4A Vaping goods" ; cml:conclusionText "Offences (1) A person commits an offence if..." ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41qe a cml:Concept ; skos:prefLabel "41QE Exceptions etc. to civil penalty provisions—burden of proof"@en ; cml:realizedBy doc:sec-41qe ; cml:integrityHash "6c2edca3a526d18e3350cd08aa5cba2e821724d0709ab33f0c2a2f38cfa81fdd" ; skos:note "Burden of proof for exceptions to civil penalty provisions" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.220" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41qe-norm . concept:therapeutic-goods-act-1989-sec-41qe-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41qe ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41qe cml:asserts concept:therapeutic-goods-act-1989-sec-41qe-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41qe-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Obligation on the person to bear evidential burden" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41r a cml:Concept ; skos:prefLabel "41R Minister may determine that specified vaping goods may be"@en ; cml:realizedBy doc:sec-41r ; cml:integrityHash "562b9ab2a5e6dd96a9693eeffc31c484fddb954b15b8cc9826d7e29d2f40cc82" ; skos:note "The Minister may determine that specified vaping goods may be supplied or possessed in Australia under certain circumstances." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.221" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41r-norm . concept:therapeutic-goods-act-1989-sec-41r-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41r ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41r cml:asserts concept:therapeutic-goods-act-1989-sec-41r-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41r-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "Permission granted by the Minister." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41r cml:asserts concept:therapeutic-goods-act-1989-sec-41r-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41r-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "specified vaping goods" ; cml:logicSummary "Specific goods subject to permission." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ra a cml:Concept ; skos:prefLabel "41RA Minister may determine other indications for which vaping"@en ; cml:realizedBy doc:sec-41ra ; cml:integrityHash "a9bdc539554b1abf868dc255211eb1bc1015485d0e9f969726951d74b345eff1" ; skos:note "Minister may determine indications for vaping goods use" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.221" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41ra-norm . concept:therapeutic-goods-act-1989-sec-41ra-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41ra ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41ra cml:asserts concept:therapeutic-goods-act-1989-sec-41ra-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41ra-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "May" ; cml:logicSummary "Permission to vape goods" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41rb a cml:Concept ; skos:prefLabel "41RB Application to Secretary for consent to manufacture, supply"@en ; cml:realizedBy doc:sec-41rb ; cml:integrityHash "b869976e0d2ce9cee906734fba6320f6bb5c89de188e2a8fdbaae7f7aee121c1" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41rb-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41rb-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41rb-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41rb-ss-4 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.222" . concept:therapeutic-goods-act-1989-sec-41rb-ss-1 a cml:Concept ; skos:prefLabel "41RB(1) Application to Secretary for consent to manufacture, supply"@en ; cml:realizedBy doc:sec-41rb-ss-1 ; cml:integrityHash "510f8b4a3f484fab8163df340dd47560150a379de34723189c68e3e883c9ac8a" ; values:partOf concept:therapeutic-goods-act-1989-sec-41rb ; skos:note "Consent required for manufacture, supply or possession of vaping goods." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.222" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41rb-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41rb-ss-1-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41rb-ss-1 ; values:borneBy values:NaturalPerson ; skos:scopeNote "borne by: NaturalPerson" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41rb-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41rb-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41rb-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "hasPermission" ; cml:logicSummary "Granting permission" ; cml:premiseText "A person may apply to the Secretary for consent" ; cml:conclusionText "to manufacture, supply or possess vaping goods." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41rb-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41rb-ss-1-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-41rb-ss-1-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "during" ; cml:logicSummary "Temporal scope of application" ; cml:premiseText "The key applies to a person who may apply to the Secretary for consent during the relevant period" ; cml:conclusionText "to manufacture, supply or possess vaping goods." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41rb-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41rb-ss-1-logic-argumentation-3 . concept:therapeutic-goods-act-1989-sec-41rb-ss-1-logic-argumentation-3 a cml:LogicApplication ; cml:modality cml:Argumentation ; cml:operator "implies" ; cml:logicSummary "Implication of application" ; cml:premiseText "If a person applies to the Secretary for consent" ; cml:conclusionText "then they may manufacture, supply or possess vaping goods." ; cml:executionSurface "modalities::argumentation" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41rb-ss-2 a cml:Concept ; skos:prefLabel "41RB(2) Application to Secretary for consent to manufacture, supply"@en ; cml:realizedBy doc:sec-41rb-ss-2 ; cml:integrityHash "53d13f0ceddc4f8db4712e2d8bae11593277f9790451f2316915524b856847e2" ; values:partOf concept:therapeutic-goods-act-1989-sec-41rb ; skos:note "Application must be in accordance with a form approved by the Secretary and accompanied by fee (if any)" ; dc:description "Form, Fee" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.222" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41rb-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41rb-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41rb-ss-2 ; values:borneBy values:LegalPerson ; skos:scopeNote "borne by: LegalPerson" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41rb-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41rb-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41rb-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Application must be in accordance with a form approved by the Secretary" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41rb-ss-3 a cml:Concept ; skos:prefLabel "41RB(3) Application to Secretary for consent to manufacture, supply"@en ; cml:realizedBy doc:sec-41rb-ss-3 ; cml:integrityHash "c3cc1126824974aed077d35a67e4410b5f386ff88234c011d3b6c68e25205d4e" ; values:partOf concept:therapeutic-goods-act-1989-sec-41rb ; skos:note "Secretary may require applicant to provide further information within a reasonable time." ; dc:description "true" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.222" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41rb-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41rb-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41rb-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41rb-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41rb-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41rb-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MAY" ; cml:logicSummary "Secretary may require applicant to provide further information." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41rb-ss-4 a cml:Concept ; skos:prefLabel "41RB(4) Application to Secretary for consent to manufacture, supply"@en ; cml:realizedBy doc:sec-41rb-ss-4 ; cml:integrityHash "87904dd2b8eb9e5806edbf2ebf2180fe8b20cb27ed8b7ed781a4d1bec11c2271" ; values:partOf concept:therapeutic-goods-act-1989-sec-41rb ; skos:note "Application for consent may be required or permitted" ; dc:description "Information in accordance with specified software requirements" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.222" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41rb-ss-4-norm . concept:therapeutic-goods-act-1989-sec-41rb-ss-4-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41rb-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41rb-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41rb-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41rb-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "May" ; cml:logicSummary "Permission to apply for consent" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41rb-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41rb-ss-4-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-41rb-ss-4-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Has specified software requirements" ; cml:logicSummary "Requirements for application" ; cml:executionSurface "modalities::dl" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41rc a cml:Concept ; skos:prefLabel "41RC Secretary may give consent"@en ; cml:realizedBy doc:sec-41rc ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41rc-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41rc-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41rc-ss-2a ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41rc-ss-2b ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41rc-ss-2c ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41rc-ss-3 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.222" . concept:therapeutic-goods-act-1989-sec-41rc-ss-1 a cml:Concept ; skos:prefLabel "41RC(1) Secretary may give consent"@en ; cml:realizedBy doc:sec-41rc-ss-1 ; cml:integrityHash "c285c353de821d10da6abb4a4228a7df648283501bd3bad80440d69377402791" ; values:partOf concept:therapeutic-goods-act-1989-sec-41rc ; skos:note "Secretary may give consent for manufacture, supply or possession of vaping goods." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.222" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41rc-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41rc-ss-1-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41rc-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41rc-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41rc-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41rc-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "can" ; cml:logicSummary "Secretary can give consent." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41rc-ss-2 a cml:Concept ; skos:prefLabel "41RC(2) Secretary may give consent"@en ; cml:realizedBy doc:sec-41rc-ss-2 ; cml:integrityHash "5275cf04203ba8c7c1278b737964ddb7bca74925e8b6c86992ae2d4d940cd0e3" ; values:partOf concept:therapeutic-goods-act-1989-sec-41rc ; skos:note "Secretary may give consent for vaping goods" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.222" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41rc-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41rc-ss-2-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41rc-ss-2 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41rc-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41rc-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41rc-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "Permission to vape goods" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41rc-ss-2a a cml:Concept ; skos:prefLabel "41RC(2A) Secretary may give consent"@en ; cml:realizedBy doc:sec-41rc-ss-2a ; cml:integrityHash "bc30c40c19310d0d63e8418d8f3266e35fa7fc9f4c1319cd11ffe977c1232e23" ; values:partOf concept:therapeutic-goods-act-1989-sec-41rc ; skos:note "Secretary must comply with decision-making principles" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.222" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41rc-ss-2a-norm . concept:therapeutic-goods-act-1989-sec-41rc-ss-2a-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41rc-ss-2a ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41rc-ss-2a cml:asserts concept:therapeutic-goods-act-1989-sec-41rc-ss-2a-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41rc-ss-2a-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must comply" ; cml:premiseText "(2A) In making a decision under subsection (1), the Secretary must comply with the decision-making principles (if any) determined under subsection (2B)." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41rc-ss-2a cml:asserts concept:therapeutic-goods-act-1989-sec-41rc-ss-2a-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-41rc-ss-2a-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "MEETS" ; cml:logicSummary "Decision-making principle is a prerequisite for decision making" ; cml:premiseText "(2A) In making a decision under subsection (1), the Secretary must comply with the decision-making principles (if any) determined under subsection (2B)." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41rc-ss-2a cml:asserts concept:therapeutic-goods-act-1989-sec-41rc-ss-2a-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-41rc-ss-2a-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "MEETS" ; cml:logicSummary "Decision making is contingent on compliance with principle" ; cml:premiseText "(2A) In making a decision under subsection (1), the Secretary must comply with the decision-making principles (if any) determined under subsection (2B)." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41rc-ss-2a cml:asserts concept:therapeutic-goods-act-1989-sec-41rc-ss-2a-logic-deontic-4 . concept:therapeutic-goods-act-1989-sec-41rc-ss-2a-logic-deontic-4 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "IS_A" ; cml:logicSummary "Decision making is a subclass of general action" ; cml:premiseText "(2A) In making a decision under subsection (1), the Secretary must comply with the decision-making principles (if any) determined under subsection (2B)." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41rc-ss-2b a cml:Concept ; skos:prefLabel "41RC(2B) Secretary may give consent"@en ; cml:realizedBy doc:sec-41rc-ss-2b ; cml:integrityHash "23096ed83a0beb605558bc4a0a077a557867c7c586d6285049f69494bbf2e7f6" ; values:partOf concept:therapeutic-goods-act-1989-sec-41rc ; skos:note "Secretary must comply with decision-making principles" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.222" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41rc-ss-2b-norm . concept:therapeutic-goods-act-1989-sec-41rc-ss-2b-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41rc-ss-2b ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41rc-ss-2b cml:asserts concept:therapeutic-goods-act-1989-sec-41rc-ss-2b-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41rc-ss-2b-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must comply" ; cml:premiseText "(2B) The Minister may, by legislative instrument..." ; cml:conclusionText "The Secretary must comply with the decision-making principles." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41rc-ss-2b cml:asserts concept:therapeutic-goods-act-1989-sec-41rc-ss-2b-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-41rc-ss-2b-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "CONTAINS" ; cml:logicSummary "Decision-making principles apply to decisions made within this interval" ; cml:premiseText "(2B) The Minister may, by legislative instrument..." ; cml:conclusionText "The decision-making principles apply to decisions made within the interval of the Minister's power." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41rc-ss-2b cml:asserts concept:therapeutic-goods-act-1989-sec-41rc-ss-2b-logic-argumentation-3 . concept:therapeutic-goods-act-1989-sec-41rc-ss-2b-logic-argumentation-3 a cml:LogicApplication ; cml:modality cml:Argumentation ; cml:operator "IMPLIES" ; cml:logicSummary "Decision-making principles imply certain actions" ; cml:premiseText "(2B) The Minister may, by legislative instrument..." ; cml:conclusionText "The decision-making principles imply that the Secretary must take certain actions." ; cml:executionSurface "modalities::argumentation" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41rc-ss-2b cml:asserts concept:therapeutic-goods-act-1989-sec-41rc-ss-2b-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-41rc-ss-2b-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "SPREADS_TO" ; cml:logicSummary "Decision-making principles spread to other agents" ; cml:premiseText "(2B) The Minister may, by legislative instrument..." ; cml:conclusionText "The decision-making principles spread to other agents who must comply with the Secretary's decisions." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41rc-ss-2b cml:asserts concept:therapeutic-goods-act-1989-sec-41rc-ss-2b-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-41rc-ss-2b-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "IS_A" ; cml:logicSummary "Decision-making principles are a type of AI algorithm" ; cml:premiseText "(2B) The Minister may, by legislative instrument..." ; cml:conclusionText "The decision-making principles are a type of AI algorithm that the Secretary must use." ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41rc-ss-2c a cml:Concept ; skos:prefLabel "41RC(2C) Secretary may give consent"@en ; cml:realizedBy doc:sec-41rc-ss-2c ; cml:integrityHash "6d073cc73c6233749d657e7e239981cca2c8912933a130db8cfa498c09f77008" ; values:partOf concept:therapeutic-goods-act-1989-sec-41rc ; skos:note "Secretary may give consent under certain circumstances." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.222" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41rc-ss-2c-norm . concept:therapeutic-goods-act-1989-sec-41rc-ss-2c-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41rc-ss-2c ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41rc-ss-2c cml:asserts concept:therapeutic-goods-act-1989-sec-41rc-ss-2c-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41rc-ss-2c-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "Permission to give consent" ; cml:premiseText "(2C) Without limiting subsection (2B)" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41rc-ss-3 a cml:Concept ; skos:prefLabel "41RC(3) Secretary may give consent"@en ; cml:realizedBy doc:sec-41rc-ss-3 ; cml:integrityHash "117d66c086662282f9e1ff221fb11511cfed272fbfd811120b1e10ee1c2f91a5" ; values:partOf concept:therapeutic-goods-act-1989-sec-41rc ; skos:note "Secretary must publish decision particulars on website after giving consent" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.222" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41rc-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41rc-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41rc-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41rc-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41rc-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41rc-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must provide information" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41rd a cml:Concept ; skos:prefLabel "41RD Offences and civil penalty provision—breaching condition of"@en ; cml:realizedBy doc:sec-41rd ; cml:integrityHash "8a663ace9921b25fcdcfc5fda8b3bc097c7fa8cc9bc6a6d7952e0cd8cb65b208" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41rd-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41rd-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41rd-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-41rd-ss-4 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.224" . concept:therapeutic-goods-act-1989-sec-41rd-ss-1 a cml:Concept ; skos:prefLabel "41RD(1) Offences and civil penalty provision—breaching condition of"@en ; cml:realizedBy doc:sec-41rd-ss-1 ; cml:integrityHash "601d7105eb4d4e2bc0f01d80f928763031491a6f111ca13f2b54d50a88d27921" ; values:partOf concept:therapeutic-goods-act-1989-sec-41rd ; skos:note "Offence for breaching condition of consent" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.224" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41rd-ss-1-norm . concept:therapeutic-goods-act-1989-sec-41rd-ss-1-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41rd-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41rd-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41rd-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41rd-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibits certain actions" ; cml:premiseText "(1) A person commits an offence if..." ; cml:conclusionText "...breaches a condition of a consent imposed under subsection 41RC(2); and" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41rd-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41rd-ss-1-logic-deontic-2 . concept:therapeutic-goods-act-1989-sec-41rd-ss-1-logic-deontic-2 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Imposes obligation to comply with consent conditions" ; cml:premiseText "(a) the person does an act or omits to do an act; and" ; cml:conclusionText "...breaches a condition of a consent imposed under subsection 41RC(2); and" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41rd-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41rd-ss-1-logic-alleninterval-3 . concept:therapeutic-goods-act-1989-sec-41rd-ss-1-logic-alleninterval-3 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Between" ; cml:logicSummary "Defines temporal interval for penalty application" ; cml:premiseText "(c) the act or omission has resulted in, will result in, or is likely to result in, harm or injury to any person." ; cml:conclusionText "...will result in, or is likely to result in, harm or injury to any person." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41rd-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41rd-ss-1-logic-deontic-4 . concept:therapeutic-goods-act-1989-sec-41rd-ss-1-logic-deontic-4 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibits certain actions resulting in harm or injury" ; cml:premiseText "(c) the act or omission has resulted in, will result in, or is likely to result in, harm or injury to any person." ; cml:conclusionText "...harm or injury to any person." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41rd-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41rd-ss-1-logic-deontic-5 . concept:therapeutic-goods-act-1989-sec-41rd-ss-1-logic-deontic-5 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Imposes obligation to prevent harm or injury" ; cml:premiseText "(b) the act or omission breaches a condition of a consent imposed under subsection 41RC(2); and" ; cml:conclusionText "...breaches a condition of a consent imposed under subsection 41RC(2); and" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41rd-ss-2 a cml:Concept ; skos:prefLabel "41RD(2) Offences and civil penalty provision—breaching condition of"@en ; cml:realizedBy doc:sec-41rd-ss-2 ; cml:integrityHash "6cf46939f87ef605d35f1db799368d032a70bff5d162f597b127c67e72fa39de" ; values:partOf concept:therapeutic-goods-act-1989-sec-41rd ; skos:note "Breach of condition results in an offence and a penalty." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.224" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41rd-ss-2-norm . concept:therapeutic-goods-act-1989-sec-41rd-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41rd-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41rd-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41rd-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41rd-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "breach" ; cml:logicSummary "Breach of obligation" ; cml:premiseText "(2) A person commits an offence if..." ; cml:conclusionText "Penalty: 500 penalty units." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41rd-ss-3 a cml:Concept ; skos:prefLabel "41RD(3) Offences and civil penalty provision—breaching condition of"@en ; cml:realizedBy doc:sec-41rd-ss-3 ; cml:integrityHash "4c1ef2b5c2fce45560ef09558eeee63288e3961b5d3112dacd39a1a5a28e63d1" ; values:partOf concept:therapeutic-goods-act-1989-sec-41rd ; skos:note "Offence of strict liability for breaching condition of consent" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.224" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41rd-ss-3-norm . concept:therapeutic-goods-act-1989-sec-41rd-ss-3-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41rd-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41rd-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41rd-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41rd-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibits strict liability for breaching condition of consent" ; cml:premiseText "(3) A person commits an offence of strict liability if..." ; cml:conclusionText "...Penalty: 100 penalty units." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41rd-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41rd-ss-3-logic-deontic-2 . concept:therapeutic-goods-act-1989-sec-41rd-ss-3-logic-deontic-2 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Imposes obligation to comply with condition of consent" ; cml:premiseText "(3) A person commits an offence of strict liability if..." ; cml:conclusionText "...Penalty: 100 penalty units." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41rd-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41rd-ss-3-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-41rd-ss-3-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Trace" ; cml:logicSummary "Traces breach of condition to strict liability" ; cml:premiseText "(3) A person commits an offence of strict liability if..." ; cml:conclusionText "...Penalty: 100 penalty units." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41rd-ss-4 a cml:Concept ; skos:prefLabel "41RD(4) Offences and civil penalty provision—breaching condition of"@en ; cml:realizedBy doc:sec-41rd-ss-4 ; cml:integrityHash "3d874aeddcc19e2953921de69126b5d2374509620507f2cd4fb1e32bdd7b83bd" ; values:partOf concept:therapeutic-goods-act-1989-sec-41rd ; skos:note "Breaching a condition of consent imposed under subsection 41RC(2) is prohibited." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.224" ; cml:asserts concept:therapeutic-goods-act-1989-sec-41rd-ss-4-norm . concept:therapeutic-goods-act-1989-sec-41rd-ss-4-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-41rd-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-41rd-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-41rd-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-41rd-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibition of breaching a condition of consent." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42aa a cml:Concept ; skos:prefLabel "42AA This Part not to apply to advertisements directed at health"@en ; cml:realizedBy doc:sec-42aa ; cml:integrityHash "d2e243051717584be62f3841e5b73e954635069e92795dcee9988c45e6bafcc4" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42aa-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42aa-ss-1a ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42aa-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42aa-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42aa-ss-4 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.226" . concept:therapeutic-goods-act-1989-sec-42aa-ss-1 a cml:Concept ; skos:prefLabel "42AA(1) This Part not to apply to advertisements directed at health"@en ; cml:realizedBy doc:sec-42aa-ss-1 ; cml:integrityHash "9854e602d9b391e5223a9a8ab9d3e0724ddc2de91c0230a5617c648d2fe0b528" ; values:partOf concept:therapeutic-goods-act-1989-sec-42aa ; skos:note "Exemptions from advertising restrictions" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.226" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42aa-ss-1-norm . concept:therapeutic-goods-act-1989-sec-42aa-ss-1-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42aa-ss-1 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42aa-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42aa-ss-1-logic-descriptionlogic-1 . concept:therapeutic-goods-act-1989-sec-42aa-ss-1-logic-descriptionlogic-1 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "=" ; cml:logicSummary "Class hierarchy for health professions" ; cml:premiseText "Registered or licensed to practice in a specific health profession" ; cml:conclusionText "Member of the specified class" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42aa-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42aa-ss-1-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-42aa-ss-1-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "<" ; cml:logicSummary "Temporal interval for exemptions" ; cml:premiseText "Exemptions apply until a certain date" ; cml:conclusionText "No exemption after this date" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42aa-ss-1a a cml:Concept ; skos:prefLabel "42AA(1A) This Part not to apply to advertisements directed at health"@en ; cml:realizedBy doc:sec-42aa-ss-1a ; cml:integrityHash "f4ec0a80d2a02ed245a75243b84409c7f67d35f05553e2495927f49ed47cd0a1" ; values:partOf concept:therapeutic-goods-act-1989-sec-42aa ; skos:note "Minister may specify class of persons for purposes of paragraph (1)(d)" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.226" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42aa-ss-1a-norm . concept:therapeutic-goods-act-1989-sec-42aa-ss-1a-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42aa-ss-1a ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42aa-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-42aa-ss-1a-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42aa-ss-1a-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "May" ; cml:logicSummary "Permission to specify class of persons" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42aa-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-42aa-ss-1a-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-42aa-ss-1a-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Class specification" ; cml:logicSummary "Specify a class of persons for purposes of paragraph (1)(d)" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42aa-ss-2 a cml:Concept ; skos:prefLabel "42AA(2) This Part not to apply to advertisements directed at health"@en ; cml:realizedBy doc:sec-42aa-ss-2 ; cml:integrityHash "4282d97087ad63fd942eff5644755be55020f871a749d1268ee577d3506a8a58" ; values:partOf concept:therapeutic-goods-act-1989-sec-42aa ; skos:note "This Part does not apply to advertisements directed exclusively to members of an Australian branch of one of the bodies prescribed for the purposes of this subsection." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.226" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42aa-ss-2-norm . concept:therapeutic-goods-act-1989-sec-42aa-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42aa-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42aa-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42aa-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42aa-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Exclusion" ; cml:logicSummary "Exclusion from application" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42aa-ss-3 a cml:Concept ; skos:prefLabel "42AA(3) This Part not to apply to advertisements directed at health"@en ; cml:realizedBy doc:sec-42aa-ss-3 ; cml:integrityHash "f740b3d3ead93bc26972f275a6d2e75232a201d6c7644fdf314e984170c86863" ; values:partOf concept:therapeutic-goods-act-1989-sec-42aa ; skos:note "Person must have qualifications and training for membership of relevant body." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.226" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42aa-ss-3-norm . concept:therapeutic-goods-act-1989-sec-42aa-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42aa-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42aa-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-42aa-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42aa-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Must" ; cml:logicSummary "Mandatory qualification requirement." ; cml:premiseText "Person has qualifications and training." ; cml:conclusionText "Person is a member of the relevant body." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42aa-ss-4 a cml:Concept ; skos:prefLabel "42AA(4) This Part not to apply to advertisements directed at health"@en ; cml:realizedBy doc:sec-42aa-ss-4 ; cml:integrityHash "1ae04f2309b5e43e9523c8727140f5d91062b2391f5bbe55dfab36f187042c09" ; values:partOf concept:therapeutic-goods-act-1989-sec-42aa ; skos:note "Exemption from Part for certain patient advice" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.226" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42aa-ss-4-norm . concept:therapeutic-goods-act-1989-sec-42aa-ss-4-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42aa-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42aa-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-42aa-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42aa-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "exemption" ; cml:logicSummary "Exempts from Part" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42ab a cml:Concept ; skos:prefLabel "42AB This Part not to apply to advertisements for goods not for"@en ; cml:realizedBy doc:sec-42ab ; cml:integrityHash "32cbf0a4ae879208b91376bc5c08f0659c26888cd69ad99a9e97342b76591e97" ; skos:note "This Part does not apply to advertisements in respect of goods that are not for use in humans." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.227" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42ab-norm . concept:therapeutic-goods-act-1989-sec-42ab-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42ab ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42ac a cml:Concept ; skos:prefLabel "42AC This Part not to apply to advertisements for exported goods"@en ; cml:realizedBy doc:sec-42ac ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42ac-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42ac-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.227" . concept:therapeutic-goods-act-1989-sec-42ac-ss-1 a cml:Concept ; skos:prefLabel "42AC(1) This Part not to apply to advertisements for exported goods"@en ; cml:realizedBy doc:sec-42ac-ss-1 ; cml:integrityHash "642b18ae1c3551a5eb466e513fdf50cc533710e00c4d9d4de6ecacceaa27b861" ; values:partOf concept:therapeutic-goods-act-1989-sec-42ac ; skos:note "This Part applies to advertisements for goods other than therapeutic goods intended exclusively for export." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.227" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42ac-ss-1-norm . concept:therapeutic-goods-act-1989-sec-42ac-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42ac-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42ac-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42ac-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42ac-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Implies" ; cml:logicSummary "If the advertisement is not solely for therapeutic goods intended exclusively for export, then it must comply with this Part." ; cml:premiseText "Exported goods are subject to this Part." ; cml:conclusionText "The advertisement does not comply with this Part." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42ac-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42ac-ss-1-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-42ac-ss-1-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Overlaps" ; cml:logicSummary "The advertisement's applicability to this Part overlaps with the time period during which the exported goods are intended to be used." ; cml:premiseText "The advertisement is for therapeutic goods intended exclusively for export." ; cml:conclusionText "The advertisement does not comply with this Part." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42ac-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42ac-ss-1-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-42ac-ss-1-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Repeats" ; cml:logicSummary "The advertisement's applicability to this Part repeats every time the exported goods are intended to be used." ; cml:premiseText "The advertisement is for therapeutic goods intended exclusively for export." ; cml:conclusionText "The advertisement does not comply with this Part." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42ac-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42ac-ss-1-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-42ac-ss-1-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "Diffuses" ; cml:logicSummary "The advertisement's applicability to this Part diffuses through the time period during which the exported goods are intended to be used." ; cml:premiseText "The advertisement is for therapeutic goods intended exclusively for export." ; cml:conclusionText "The advertisement does not comply with this Part." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42ac-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42ac-ss-1-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-42ac-ss-1-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "Recognizes" ; cml:logicSummary "The advertisement's applicability to this Part is recognized by the AI system." ; cml:premiseText "The advertisement is for therapeutic goods intended exclusively for export." ; cml:conclusionText "The advertisement does not comply with this Part." ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42ac-ss-2 a cml:Concept ; skos:prefLabel "42AC(2) This Part not to apply to advertisements for exported goods"@en ; cml:realizedBy doc:sec-42ac-ss-2 ; cml:integrityHash "dbba022f7625f8b0e6437f4df8a2e79746c9cf3ef6b0cc6b4d5983549addb4d8" ; values:partOf concept:therapeutic-goods-act-1989-sec-42ac ; skos:note "Sections 42DKB, 42DLA and 42DLC apply to advertisements of that kind." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.227" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42ac-ss-2-norm . concept:therapeutic-goods-act-1989-sec-42ac-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42ac-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42ac-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42ac-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42ac-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "apply" ; cml:logicSummary "Imposes obligation on the state." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42ad a cml:Concept ; skos:prefLabel "42AD This Part not to apply to advertisements or generic"@en ; cml:realizedBy doc:sec-42ad ; cml:integrityHash "09333731360a486d23542c25a520c9f38f659fc8e4b143442351c796879c7172" ; skos:note "Exemption from Part for advertisements about vaping goods" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.228" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42ad-norm . concept:therapeutic-goods-act-1989-sec-42ad-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42ad ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42ad cml:asserts concept:therapeutic-goods-act-1989-sec-42ad-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42ad-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "forbid" ; cml:logicSummary "Prohibits application of Part to advertisements about vaping goods" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42b a cml:Concept ; skos:prefLabel "42B Definitions"@en ; cml:realizedBy doc:sec-42b ; cml:integrityHash "cc8765fae30c8cf3afe185762149d91d6ec614f79174c8d15dc2c40ae427cbc7" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42b-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42b-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.228" . concept:therapeutic-goods-act-1989-sec-42b-ss-1 a cml:Concept ; skos:prefLabel "42B(1) Definitions"@en ; cml:realizedBy doc:sec-42b-ss-1 ; cml:integrityHash "f40c48734fe87af270d2c855a1778cd9e2ce670380e8f17717c3097f9ed90816" ; values:partOf concept:therapeutic-goods-act-1989-sec-42b ; skos:note "The Minister may make a code relating to advertisements about therapeutic goods." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.228" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42b-ss-1-norm . concept:therapeutic-goods-act-1989-sec-42b-ss-1-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42b-ss-1 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42b-ss-2 a cml:Concept ; skos:prefLabel "42B(2) Definitions"@en ; cml:realizedBy doc:sec-42b-ss-2 ; cml:integrityHash "29cde799d680806158e81d1c5c999ead5e9f91f64166b83c56f574ec7d50921a" ; values:partOf concept:therapeutic-goods-act-1989-sec-42b ; skos:note "Allows modification of existing instruments or writings in legislative instruments." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.228" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42b-ss-2-norm . concept:therapeutic-goods-act-1989-sec-42b-ss-2-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42b-ss-2 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42da a cml:Concept ; skos:prefLabel "42DA Simplified outline of this Division"@en ; cml:realizedBy doc:sec-42da ; cml:integrityHash "a01522bf8aee7f051c46fc990da56ce63c1321667697e60aebe3ca0009211fd0" ; skos:note "Representations in advertisements about therapeutic goods may be restricted, required or prohibited." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.230" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42da-norm . concept:therapeutic-goods-act-1989-sec-42da-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42da ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42da cml:asserts concept:therapeutic-goods-act-1989-sec-42da-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42da-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits representations in advertisements about therapeutic goods." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42db a cml:Concept ; skos:prefLabel "42DB Definitions"@en ; cml:realizedBy doc:sec-42db ; cml:integrityHash "65e60b1740f4733eb0d638cfbb0a0f0dc6387c781315e0a47680ffe403f8d419" ; skos:note "Definition of applicant and approval holder." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.230" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42db-norm . concept:therapeutic-goods-act-1989-sec-42db-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42db ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dd a cml:Concept ; skos:prefLabel "42DD Restricted representations"@en ; cml:realizedBy doc:sec-42dd ; cml:integrityHash "efadae9ec3a396b744284df92ebfa3215c36885f1556b5ddc2a9acfcc497e8a7" ; skos:note "Restricted representations in therapeutic goods advertising" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.230" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42dd-norm . concept:therapeutic-goods-act-1989-sec-42dd-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42dd ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dd cml:asserts concept:therapeutic-goods-act-1989-sec-42dd-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42dd-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits restricted representations" ; cml:premiseText "None" ; cml:conclusionText "None" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42de a cml:Concept ; skos:prefLabel "42DE Applications for approval of use of restricted representation"@en ; cml:realizedBy doc:sec-42de ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42de-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42de-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.231" . concept:therapeutic-goods-act-1989-sec-42de-ss-1 a cml:Concept ; skos:prefLabel "42DE(1) Applications for approval of use of restricted representation"@en ; cml:realizedBy doc:sec-42de-ss-1 ; cml:integrityHash "d59e4d4ad5ea46c019aa16e353b1c4a63b6ef328b19ed24823ef381780aa2033" ; values:partOf concept:therapeutic-goods-act-1989-sec-42de ; skos:note "Application for approval of use of restricted representation must be made to the Secretary." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.231" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42de-ss-1-norm . concept:therapeutic-goods-act-1989-sec-42de-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42de-ss-1 ; values:borneBy values:Agent ; skos:scopeNote "borne by: Agent" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42de-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42de-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42de-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Application is required." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42de-ss-2 a cml:Concept ; skos:prefLabel "42DE(2) Applications for approval of use of restricted representation"@en ; cml:realizedBy doc:sec-42de-ss-2 ; cml:integrityHash "4c5f680f28def8219aa373ddcad69169ba7637529fb6f1c94c0a03bbaabd2e8f" ; values:partOf concept:therapeutic-goods-act-1989-sec-42de ; skos:note "Application for approval of use of restricted representation may be required or permitted" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.231" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42de-ss-2-norm . concept:therapeutic-goods-act-1989-sec-42de-ss-2-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42de-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42de-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42de-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42de-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "May" ; cml:logicSummary "Permission to apply for approval" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42de-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42de-ss-2-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-42de-ss-2-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Classifies" ; cml:logicSummary "Classification of applications based on software requirements" ; cml:executionSurface "modalities::dl" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42df a cml:Concept ; skos:prefLabel "42DF Approval of use of restricted representation"@en ; cml:realizedBy doc:sec-42df ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42df-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42df-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42df-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42df-ss-4 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.231" . concept:therapeutic-goods-act-1989-sec-42df-ss-1 a cml:Concept ; skos:prefLabel "42DF(1) Approval of use of restricted representation"@en ; cml:realizedBy doc:sec-42df-ss-1 ; cml:integrityHash "00db6cd604eb8b968e2ef156cdea4d81b0aae5ec58957544859521f5b9d12d39" ; values:partOf concept:therapeutic-goods-act-1989-sec-42df ; skos:note "Secretary must approve use of restricted representation if it is accurate and balanced." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.231" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42df-ss-1-norm . concept:therapeutic-goods-act-1989-sec-42df-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42df-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42df-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42df-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42df-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Secretary must approve use of restricted representation." ; cml:premiseText "(1) If an application for approval of the use of a restricted representation is made, the Secretary must approve the use of the restricted representation if the Secretary is satisfied that:" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42df-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42df-ss-1-logic-deontic-2 . concept:therapeutic-goods-act-1989-sec-42df-ss-1-logic-deontic-2 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Secretary must be satisfied that the representation is accurate and balanced." ; cml:premiseText "(a) the representation is accurate and balanced;" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42df-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42df-ss-1-logic-deontic-3 . concept:therapeutic-goods-act-1989-sec-42df-ss-1-logic-deontic-3 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Secretary must be satisfied that the representation is not misleading or likely to be misleading." ; cml:premiseText "(b) the representation is not misleading or likely to be misleading." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42df-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42df-ss-1-logic-alleninterval-4 . concept:therapeutic-goods-act-1989-sec-42df-ss-1-logic-alleninterval-4 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "BETWEEN" ; cml:logicSummary "Time period for approval of use of restricted representation." ; cml:premiseText "(1)" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42df-ss-2 a cml:Concept ; skos:prefLabel "42DF(2) Approval of use of restricted representation"@en ; cml:realizedBy doc:sec-42df-ss-2 ; cml:integrityHash "a413ea21ae5195950a6a07058fe02164554528876bfa9863669576ab26c5d1a9" ; values:partOf concept:therapeutic-goods-act-1989-sec-42df ; skos:note "Must approve restricted representation use" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.231" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42df-ss-2-norm . concept:therapeutic-goods-act-1989-sec-42df-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42df-ss-2 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42df-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42df-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42df-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Obligation to approve" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42df-ss-3 a cml:Concept ; skos:prefLabel "42DF(3) Approval of use of restricted representation"@en ; cml:realizedBy doc:sec-42df-ss-3 ; cml:integrityHash "094f07df1fd8cea87dc05324b5c3122d1885a2e7dc2ef12036cf6a693b316d78" ; values:partOf concept:therapeutic-goods-act-1989-sec-42df ; skos:note "Approval may be subject to conditions imposed by the Secretary." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.231" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42df-ss-3-norm . concept:therapeutic-goods-act-1989-sec-42df-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42df-ss-3 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42df-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-42df-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42df-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "May impose conditions on approval" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42df-ss-4 a cml:Concept ; skos:prefLabel "42DF(4) Approval of use of restricted representation"@en ; cml:realizedBy doc:sec-42df-ss-4 ; cml:integrityHash "466a0b3ea3095f44f9b14d2222619bbb627e27a1b5f946950ea0167e62c510a1" ; values:partOf concept:therapeutic-goods-act-1989-sec-42df ; skos:note "Secretary must consider certain factors when deciding to approve or refuse the use of a restricted representation." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.231" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42df-ss-4-norm . concept:therapeutic-goods-act-1989-sec-42df-ss-4-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42df-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42df-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-42df-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42df-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Secretary has an obligation to consider certain factors." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dg a cml:Concept ; skos:prefLabel "42DG Notice of approval or refusal"@en ; cml:realizedBy doc:sec-42dg ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42dg-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42dg-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42dg-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42dg-ss-4 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.232" . concept:therapeutic-goods-act-1989-sec-42dg-ss-1 a cml:Concept ; skos:prefLabel "42DG(1) Notice of approval or refusal"@en ; cml:realizedBy doc:sec-42dg-ss-1 ; cml:integrityHash "39c5662d95b6b285f927b4d77b4544bc83bbb685a5c4e17e15e932b878cb8e11" ; values:partOf concept:therapeutic-goods-act-1989-sec-42dg ; skos:note "Secretary must give written notice to applicant of approval or refusal." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.232" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42dg-ss-1-norm . concept:therapeutic-goods-act-1989-sec-42dg-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42dg-ss-1 ; values:borneBy values:Agent ; skos:scopeNote "borne by: Agent" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dg-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42dg-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42dg-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Secretary must give written notice." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dg-ss-2 a cml:Concept ; skos:prefLabel "42DG(2) Notice of approval or refusal"@en ; cml:realizedBy doc:sec-42dg-ss-2 ; cml:integrityHash "5f5d5cde55811a1646003aa9c1a3a9134f400a6ffd48b47f1006cf1f495666b4" ; values:partOf concept:therapeutic-goods-act-1989-sec-42dg ; skos:note "Failure to provide written notice within 60 days results in approval of use." ; dc:description "Written notice" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.232" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42dg-ss-2-norm . concept:therapeutic-goods-act-1989-sec-42dg-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42dg-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dg-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42dg-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42dg-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Obligation to provide written notice" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dg-ss-3 a cml:Concept ; skos:prefLabel "42DG(3) Notice of approval or refusal"@en ; cml:realizedBy doc:sec-42dg-ss-3 ; cml:integrityHash "044033893038e5ee144096ed8f19053d666979bb6da2fd954b18662e755e94d8" ; values:partOf concept:therapeutic-goods-act-1989-sec-42dg ; skos:note "Conditions for approval must be set out in the notice." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.232" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42dg-ss-3-norm . concept:therapeutic-goods-act-1989-sec-42dg-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42dg-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dg-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-42dg-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42dg-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must provide conditions for approval" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dg-ss-4 a cml:Concept ; skos:prefLabel "42DG(4) Notice of approval or refusal"@en ; cml:realizedBy doc:sec-42dg-ss-4 ; cml:integrityHash "34a0acbd9e71617f681f94b8793c1d4934df3c4c798bb8c8fedf54d068ad7ae2" ; values:partOf concept:therapeutic-goods-act-1989-sec-42dg ; skos:note "Must provide reasons for refusal and inform applicant of right to review decision." ; dc:description "Yes" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.232" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42dg-ss-4-norm . concept:therapeutic-goods-act-1989-sec-42dg-ss-4-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42dg-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dg-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-42dg-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42dg-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must provide reasons for refusal and inform applicant of right to review decision." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dh a cml:Concept ; skos:prefLabel "42DH Variation of conditions of approval"@en ; cml:realizedBy doc:sec-42dh ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42dh-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42dh-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.232" . concept:therapeutic-goods-act-1989-sec-42dh-ss-1 a cml:Concept ; skos:prefLabel "42DH(1) Variation of conditions of approval"@en ; cml:realizedBy doc:sec-42dh-ss-1 ; cml:integrityHash "6663b2da573d05c3ad87de437cc81fdddbeb1ec3c1b504002241c3fe5dee698b" ; values:partOf concept:therapeutic-goods-act-1989-sec-42dh ; skos:note "Variation of conditions of approval" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.232" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42dh-ss-1-norm . concept:therapeutic-goods-act-1989-sec-42dh-ss-1-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42dh-ss-1 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dh-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42dh-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42dh-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "Permission to vary conditions" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dh-ss-2 a cml:Concept ; skos:prefLabel "42DH(2) Variation of conditions of approval"@en ; cml:realizedBy doc:sec-42dh-ss-2 ; cml:integrityHash "d0cb6dc733a79cc56d180b61b7fb4ecc19dedc148b002f0b374c69f4f66a219a" ; values:partOf concept:therapeutic-goods-act-1989-sec-42dh ; skos:note "Secretary must provide reasons and inform approval holder of right to review decision." ; dc:description "yes" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.232" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42dh-ss-2-norm . concept:therapeutic-goods-act-1989-sec-42dh-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42dh-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dh-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42dh-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42dh-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Secretary must provide reasons and inform approval holder of right to review decision." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42di a cml:Concept ; skos:prefLabel "42DI Withdrawal of approval"@en ; cml:realizedBy doc:sec-42di ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42di-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42di-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.232" . concept:therapeutic-goods-act-1989-sec-42di-ss-1 a cml:Concept ; skos:prefLabel "42DI(1) Withdrawal of approval"@en ; cml:realizedBy doc:sec-42di-ss-1 ; cml:integrityHash "bf5cd39e69c84254b083f7a77eaab1dfb7cdde16cae87f70029e9d6b4c31b94f" ; values:partOf concept:therapeutic-goods-act-1989-sec-42di ; skos:note "Withdrawal of approval for restricted representation" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.232" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42di-ss-1-norm . concept:therapeutic-goods-act-1989-sec-42di-ss-1-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42di-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42di-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42di-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42di-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits withdrawal of approval" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42di-ss-2 a cml:Concept ; skos:prefLabel "42DI(2) Withdrawal of approval"@en ; cml:realizedBy doc:sec-42di-ss-2 ; cml:integrityHash "53dbe2495e4d4bfab67f9622f6974191c3a0c93234163953c2fd5e2026a05336" ; values:partOf concept:therapeutic-goods-act-1989-sec-42di ; skos:note "Secretary must provide reasons and inform approval holder of right to review decision." ; dc:description "yes" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.232" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42di-ss-2-norm . concept:therapeutic-goods-act-1989-sec-42di-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42di-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42di-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42di-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42di-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Secretary must provide reasons and inform approval holder of right to review decision." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dj a cml:Concept ; skos:prefLabel "42DJ Prohibited and required representations"@en ; cml:realizedBy doc:sec-42dj ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42dj-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42dj-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.233" . concept:therapeutic-goods-act-1989-sec-42dj-ss-1 a cml:Concept ; skos:prefLabel "42DJ(1) Prohibited and required representations"@en ; cml:realizedBy doc:sec-42dj-ss-1 ; cml:integrityHash "1a9386a1569967438d215f50c034785e843ed77b22ee0c22634f28152ab1f6c6" ; values:partOf concept:therapeutic-goods-act-1989-sec-42dj ; skos:note "Prohibited representations about therapeutic goods" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.233" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42dj-ss-1-norm . concept:therapeutic-goods-act-1989-sec-42dj-ss-1-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42dj-ss-1 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dj-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42dj-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42dj-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "forbid" ; cml:logicSummary "Prohibits specified representations" ; cml:premiseText "(1) For the purposes of this Part, representations..." ; cml:conclusionText "...are prohibited representations about therapeutic goods..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dj-ss-2 a cml:Concept ; skos:prefLabel "42DJ(2) Prohibited and required representations"@en ; cml:realizedBy doc:sec-42dj-ss-2 ; cml:integrityHash "44f8352326cb22fc686d99af86fdcbc5c3ebec420da6c309a921971c1ccedfbf" ; values:partOf concept:therapeutic-goods-act-1989-sec-42dj ; skos:note "Representations about therapeutic goods are required." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.233" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42dj-ss-2-norm . concept:therapeutic-goods-act-1989-sec-42dj-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42dj-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dj-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42dj-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42dj-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "requires" ; cml:logicSummary "Requires representations." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dk a cml:Concept ; skos:prefLabel "42DK Permitted use of restricted or prohibited representations"@en ; cml:realizedBy doc:sec-42dk ; cml:integrityHash "530bc36d49fefe50edc743a78498fe7dfebd3c95c8b14cfc5c7c3cf3b93c21cf" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42dk-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42dk-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42dk-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42dk-ss-4 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42dk-ss-5 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42dk-ss-6 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.234" . concept:therapeutic-goods-act-1989-sec-42dk-ss-1 a cml:Concept ; skos:prefLabel "42DK(1) Permitted use of restricted or prohibited representations"@en ; cml:realizedBy doc:sec-42dk-ss-1 ; cml:integrityHash "374a7eb6f5b62b0dd85a601f68a6d2df788807be76ae23a12d67200213e7adcd" ; values:partOf concept:therapeutic-goods-act-1989-sec-42dk ; skos:note "Permits use of restricted representations in advertisements" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.234" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42dk-ss-1-norm . concept:therapeutic-goods-act-1989-sec-42dk-ss-1-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42dk-ss-1 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dk-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42dk-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42dk-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "permit" ; cml:logicSummary "Grants permission" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dk-ss-2 a cml:Concept ; skos:prefLabel "42DK(2) Permitted use of restricted or prohibited representations"@en ; cml:realizedBy doc:sec-42dk-ss-2 ; cml:integrityHash "69427620b35551ca672816dc6b5e99a45a7260a98027c1246d4019ac83fcf358" ; values:partOf concept:therapeutic-goods-act-1989-sec-42dk ; skos:note "Permits use of specified prohibited representations under certain conditions." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.234" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42dk-ss-2-norm . concept:therapeutic-goods-act-1989-sec-42dk-ss-2-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42dk-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dk-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42dk-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42dk-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Allow" ; cml:logicSummary "Allows the Secretary to permit use of prohibited representations." ; cml:premiseText "(2) The Secretary may, by writing..." ; cml:conclusionText "...the representations are necessary for the appropriate use of the goods." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dk-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42dk-ss-2-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-42dk-ss-2-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Temporal Interval" ; cml:logicSummary "Defines a temporal interval for the permitted use of prohibited representations." ; cml:premiseText "(2) The Secretary may, by writing..." ; cml:conclusionText "...the representations are necessary for the appropriate use of the goods." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dk-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42dk-ss-2-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-42dk-ss-2-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Recurring Trace" ; cml:logicSummary "Defines a recurring trace for the permitted use of prohibited representations." ; cml:premiseText "(2) The Secretary may, by writing..." ; cml:conclusionText "...the representations are necessary for the appropriate use of the goods." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dk-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42dk-ss-2-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-42dk-ss-2-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "Diffusion" ; cml:logicSummary "Diffuses the permitted use of restricted or prohibited representations." ; cml:premiseText "(2) The Secretary may, by writing..." ; cml:conclusionText "...the representations are necessary for the appropriate use of the goods." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dk-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42dk-ss-2-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-42dk-ss-2-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "Knowledge Representation" ; cml:logicSummary "Represents knowledge about permitted use of restricted or prohibited representations." ; cml:premiseText "(2) The Secretary may, by writing..." ; cml:conclusionText "...the representations are necessary for the appropriate use of the goods." ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dk-ss-3 a cml:Concept ; skos:prefLabel "42DK(3) Permitted use of restricted or prohibited representations"@en ; cml:realizedBy doc:sec-42dk-ss-3 ; cml:integrityHash "8640a5727f4e78a0b5d9dff04ba3751fa82f26a34b9e00ae1119225089dc117c" ; values:partOf concept:therapeutic-goods-act-1989-sec-42dk ; skos:note "Permits use of prohibited representations in advertisements under certain conditions." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.234" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42dk-ss-3-norm . concept:therapeutic-goods-act-1989-sec-42dk-ss-3-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42dk-ss-3 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dk-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-42dk-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42dk-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Allow" ; cml:logicSummary "Allows the use of prohibited representations in advertisements." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dk-ss-4 a cml:Concept ; skos:prefLabel "42DK(4) Permitted use of restricted or prohibited representations"@en ; cml:realizedBy doc:sec-42dk-ss-4 ; cml:integrityHash "c9d5a8b4642eb1277de337925285edd454904502370918aef0959217ead977c3" ; values:partOf concept:therapeutic-goods-act-1989-sec-42dk ; skos:note "Permitted use of restricted or prohibited representations" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.234" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42dk-ss-4-norm . concept:therapeutic-goods-act-1989-sec-42dk-ss-4-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42dk-ss-4 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dk-ss-5 a cml:Concept ; skos:prefLabel "42DK(5) Permitted use of restricted or prohibited representations"@en ; cml:realizedBy doc:sec-42dk-ss-5 ; cml:integrityHash "160b9b81e2cc8d8a2bfded2a6c5a864270996a0c22ef972938d7bab1263edfcf" ; values:partOf concept:therapeutic-goods-act-1989-sec-42dk ; skos:note "Permission under this section is not a legislative instrument." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.234" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42dk-ss-5-norm . concept:therapeutic-goods-act-1989-sec-42dk-ss-5-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42dk-ss-5 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dk-ss-6 a cml:Concept ; skos:prefLabel "42DK(6) Permitted use of restricted or prohibited representations"@en ; cml:realizedBy doc:sec-42dk-ss-6 ; cml:integrityHash "7a43d2566bfdc3021e2b8210f21216fd8e4ca42bc017dc02d33a995d90ee17b1" ; values:partOf concept:therapeutic-goods-act-1989-sec-42dk ; skos:note "Publishing permission on Department's website after giving a permission under this section." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.234" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42dk-ss-6-norm . concept:therapeutic-goods-act-1989-sec-42dk-ss-6-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42dk-ss-6 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dl a cml:Concept ; skos:prefLabel "42DL Advertising offences—general"@en ; cml:realizedBy doc:sec-42dl ; cml:integrityHash "67d75f88f57d810867bd4e6480d6442b91cf7557412db022110facdc6443d793" ; skos:note "Advertising therapeutic goods without permission is prohibited." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.235" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42dl-norm . concept:therapeutic-goods-act-1989-sec-42dl-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42dl ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dl cml:asserts concept:therapeutic-goods-act-1989-sec-42dl-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42dl-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits advertising therapeutic goods." ; cml:premiseText "(1) A person commits an offence..." ; cml:conclusionText "...and (b) subsection (5), (6), (7), (8), (9), (10), (11) or (12) applies to the advertisement;" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dl cml:asserts concept:therapeutic-goods-act-1989-sec-42dl-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-42dl-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Classify" ; cml:logicSummary "Classifies advertising as an offence." ; cml:premiseText "(a) the person: (i) advertises, by any means, therapeutic goods; or (ii) causes the advertising, by any means, of therapeutic goods;" ; cml:conclusionText "...and (b) subsection (5), (6), (7), (8), (9), (10), (11) or (12) applies to the advertisement;" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dl cml:asserts concept:therapeutic-goods-act-1989-sec-42dl-logic-alleninterval-3 . concept:therapeutic-goods-act-1989-sec-42dl-logic-alleninterval-3 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Temporal Interval" ; cml:logicSummary "Defines a temporal interval for the offence." ; cml:premiseText "(1) A person commits an offence if: (a) the person: (i) advertises, by any means, therapeutic goods; or (ii) causes the advertising, by any means, of therapeutic goods;" ; cml:conclusionText "...and (b) subsection (5), (6), (7), (8), (9), (10), (11) or (12) applies to the advertisement;" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dl cml:asserts concept:therapeutic-goods-act-1989-sec-42dl-logic-ltl-4 . concept:therapeutic-goods-act-1989-sec-42dl-logic-ltl-4 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Recurring Trace" ; cml:logicSummary "Defines a recurring trace for the offence." ; cml:premiseText "(a) the person: (i) advertises, by any means, therapeutic goods; or (ii) causes the advertising, by any means, of therapeutic goods;" ; cml:conclusionText "...and (b) subsection (5), (6), (7), (8), (9), (10), (11) or (12) applies to the advertisement;" ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dl cml:asserts concept:therapeutic-goods-act-1989-sec-42dl-logic-diffusion-5 . concept:therapeutic-goods-act-1989-sec-42dl-logic-diffusion-5 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "Diffuse" ; cml:logicSummary "Diffuses the prohibition." ; cml:premiseText "(a) the person: (i) advertises, by any means, therapeutic goods; or (ii) causes the advertising, by any means, of therapeutic goods;" ; cml:conclusionText "...and (b) subsection (5), (6), (7), (8), (9), (10), (11) or (12) applies to the advertisement;" ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dl cml:asserts concept:therapeutic-goods-act-1989-sec-42dl-logic-cogai-6 . concept:therapeutic-goods-act-1989-sec-42dl-logic-cogai-6 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "Classify" ; cml:logicSummary "Classifies the advertising as a cognitive task." ; cml:premiseText "(a) the person: (i) advertises, by any means, therapeutic goods; or (ii) causes the advertising, by any means, of therapeutic goods;" ; cml:conclusionText "...and (b) subsection (5), (6), (7), (8), (9), (10), (11) or (12) applies to the advertisement;" ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dm a cml:Concept ; skos:prefLabel "42DM Offences—non-compliance with the Therapeutic Goods"@en ; cml:realizedBy doc:sec-42dm ; cml:integrityHash "95bbe0b7db7e2452098f9658e3c72bad594c36f3cac2125faa72cf20730625d6" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42dm-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42dm-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42dm-ss-3 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.243" . concept:therapeutic-goods-act-1989-sec-42dm-ss-1 a cml:Concept ; skos:prefLabel "42DM(1) Offences—non-compliance with the Therapeutic Goods"@en ; cml:realizedBy doc:sec-42dm-ss-1 ; cml:integrityHash "c9b841dca9528a15d33d18267f787261fc54877645ccd15836d67a03afc9ab32" ; values:partOf concept:therapeutic-goods-act-1989-sec-42dm ; skos:note "Advertising therapeutic goods without compliance with the Therapeutic Goods Advertising Code is prohibited." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.243" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42dm-ss-1-norm . concept:therapeutic-goods-act-1989-sec-42dm-ss-1-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42dm-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dm-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42dm-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42dm-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibition of advertising therapeutic goods without compliance with the Therapeutic Goods Advertising Code." ; cml:premiseText "(1) A person commits an offence if: (a) the person: (i) advertises, by any means, therapeutic goods; or (ii) causes the advertising, by any means, of therapeutic goods; and" ; cml:conclusionText "Penalty: Imprisonment for 5 years or 4,000 penalty units, or both." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dm-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42dm-ss-1-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-42dm-ss-1-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Classify" ; cml:logicSummary "Classification of advertising as therapeutic goods without compliance with the Therapeutic Goods Advertising Code." ; cml:premiseText "(b) the advertisement does not comply with the Therapeutic Goods Advertising Code; and" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dm-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42dm-ss-1-logic-deontic-3 . concept:therapeutic-goods-act-1989-sec-42dm-ss-1-logic-deontic-3 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibition of advertising therapeutic goods without compliance with the Therapeutic Goods Advertising Code." ; cml:premiseText "(c) either: (i) the use of the goods in reliance on the advertisement has resulted in, will result in, or is likely to result in, harm or injury to any person; or" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dm-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42dm-ss-1-logic-deontic-4 . concept:therapeutic-goods-act-1989-sec-42dm-ss-1-logic-deontic-4 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibition of advertising therapeutic goods without compliance with the Therapeutic Goods Advertising Code." ; cml:premiseText "(c) either: (ii) the use of the goods in reliance on the advertisement, if the goods were so used, would result in, or would be likely to result in, harm or injury to any person." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dm-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42dm-ss-1-logic-descriptionlogic-5 . concept:therapeutic-goods-act-1989-sec-42dm-ss-1-logic-descriptionlogic-5 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Classify" ; cml:logicSummary "Classification of advertising as therapeutic goods without compliance with the Therapeutic Goods Advertising Code." ; cml:premiseText "Penalty: Imprisonment for 5 years or 4,000 penalty units, or both." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dm-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42dm-ss-1-logic-linearlogic-6 . concept:therapeutic-goods-act-1989-sec-42dm-ss-1-logic-linearlogic-6 a cml:LogicApplication ; cml:modality cml:LinearLogic ; cml:operator "Imply" ; cml:logicSummary "Implication of advertising therapeutic goods without compliance with the Therapeutic Goods Advertising Code on imprisonment." ; cml:premiseText "(c) either: (i) the use of the goods in reliance on the advertisement has resulted in, will result in, or is likely to result in, harm or injury to any person; or" ; cml:executionSurface "modalities::linear" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dm-ss-2 a cml:Concept ; skos:prefLabel "42DM(2) Offences—non-compliance with the Therapeutic Goods"@en ; cml:realizedBy doc:sec-42dm-ss-2 ; cml:integrityHash "240fd4d68046d94e01e5e428a347e1f7e87e43b537c17a1d9e96722e8d8d6087" ; values:partOf concept:therapeutic-goods-act-1989-sec-42dm ; skos:note "Non-compliance with Therapeutic Goods Advertising Code is an offence." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.243" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42dm-ss-2-norm . concept:therapeutic-goods-act-1989-sec-42dm-ss-2-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42dm-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dm-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42dm-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42dm-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibits non-compliance with the Therapeutic Goods Advertising Code." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dm-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42dm-ss-2-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-42dm-ss-2-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "ClassInclusion" ; cml:logicSummary "Defines a class of persons who are subject to this prohibition." ; cml:premiseText "State" ; cml:conclusionText "NaturalPerson" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dm-ss-3 a cml:Concept ; skos:prefLabel "42DM(3) Offences—non-compliance with the Therapeutic Goods"@en ; cml:realizedBy doc:sec-42dm-ss-3 ; cml:integrityHash "74e8f4e7da5b288ecb7b4c69111c3d5ebdc9f10a86e804d1559e75dc800e935a" ; values:partOf concept:therapeutic-goods-act-1989-sec-42dm ; skos:note "Non-compliance with therapeutic goods advertising" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.243" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42dm-ss-3-norm . concept:therapeutic-goods-act-1989-sec-42dm-ss-3-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42dm-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dm-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-42dm-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42dm-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits advertising therapeutic goods" ; cml:premiseText "(3) A person commits an offence..." ; cml:conclusionText "...if the person advertises, by any means, therapeutic goods;" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dm-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-42dm-ss-3-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-42dm-ss-3-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Classify" ; cml:logicSummary "Classifies non-compliance as an offence" ; cml:premiseText "(3) A person commits an offence..." ; cml:conclusionText "...if the person advertises, by any means, therapeutic goods;" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dm-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-42dm-ss-3-logic-alleninterval-3 . concept:therapeutic-goods-act-1989-sec-42dm-ss-3-logic-alleninterval-3 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Temporal Interval" ; cml:logicSummary "Defines a temporal interval for non-compliance" ; cml:premiseText "(3) A person commits an offence..." ; cml:conclusionText "...if the person advertises, by any means, therapeutic goods;" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dm-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-42dm-ss-3-logic-ltl-4 . concept:therapeutic-goods-act-1989-sec-42dm-ss-3-logic-ltl-4 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Recurring Trace" ; cml:logicSummary "Defines a recurring trace for non-compliance" ; cml:premiseText "(3) A person commits an offence..." ; cml:conclusionText "...if the person advertises, by any means, therapeutic goods;" ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dm-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-42dm-ss-3-logic-diffusion-5 . concept:therapeutic-goods-act-1989-sec-42dm-ss-3-logic-diffusion-5 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "Diffuse" ; cml:logicSummary "Diffuses the prohibition to all agents" ; cml:premiseText "(3) A person commits an offence..." ; cml:conclusionText "...if the person advertises, by any means, therapeutic goods;" ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dm-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-42dm-ss-3-logic-cogai-6 . concept:therapeutic-goods-act-1989-sec-42dm-ss-3-logic-cogai-6 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "Recognize" ; cml:logicSummary "Recognizes the prohibition as a rule" ; cml:premiseText "(3) A person commits an offence..." ; cml:conclusionText "...if the person advertises, by any means, therapeutic goods;" ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dn a cml:Concept ; skos:prefLabel "42DN Application of Division"@en ; cml:realizedBy doc:sec-42dn ; cml:integrityHash "80f849149a80a1a3d429d8961c644afb8d08fc2b8e95d0df447435d9194af0b2" ; skos:note "Division applies to generic information about goods used in therapeutic goods manufacture or representation." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.246" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42dn-norm . concept:therapeutic-goods-act-1989-sec-42dn-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42dn ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dn cml:asserts concept:therapeutic-goods-act-1989-sec-42dn-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42dn-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "applies" ; cml:logicSummary "Division applies to generic information about goods." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42do a cml:Concept ; skos:prefLabel "42DO Compliance with the Code"@en ; cml:realizedBy doc:sec-42do ; cml:integrityHash "665671b05902ea6b526dd29be6e99c9c30d7935b49be65ae5479bf0051c015ea" ; skos:note "Generic information must comply with the Therapeutic Goods Advertising Code." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.246" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42do-norm . concept:therapeutic-goods-act-1989-sec-42do-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42do ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42do cml:asserts concept:therapeutic-goods-act-1989-sec-42do-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42do-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Generic information must comply with the Therapeutic Goods Advertising Code." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dp a cml:Concept ; skos:prefLabel "42DP Offences—dissemination of generic information"@en ; cml:realizedBy doc:sec-42dp ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42dp-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42dp-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42dp-ss-3 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.246" . concept:therapeutic-goods-act-1989-sec-42dp-ss-1 a cml:Concept ; skos:prefLabel "42DP(1) Offences—dissemination of generic information"@en ; cml:realizedBy doc:sec-42dp-ss-1 ; cml:integrityHash "420e2a081691ad9a60e5ae436af80cc5c61b483df36e2406449c0d02730a671d" ; values:partOf concept:therapeutic-goods-act-1989-sec-42dp ; skos:note "Dissemination of generic information about therapeutic goods to the public or a section of the public is prohibited." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.246" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42dp-ss-1-norm . concept:therapeutic-goods-act-1989-sec-42dp-ss-1-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42dp-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dp-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42dp-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42dp-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibition" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dp-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42dp-ss-1-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-42dp-ss-1-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Classify" ; cml:logicSummary "Classification of generic information as prohibited" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dp-ss-2 a cml:Concept ; skos:prefLabel "42DP(2) Offences—dissemination of generic information"@en ; cml:realizedBy doc:sec-42dp-ss-2 ; cml:integrityHash "a3511e83e6f6f76b97a4f2b8c0b8ca71c4dd81659120e596b79eee2c003e2108" ; values:partOf concept:therapeutic-goods-act-1989-sec-42dp ; skos:note "Dissemination of generic information about therapeutic goods is prohibited." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.246" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42dp-ss-2-norm . concept:therapeutic-goods-act-1989-sec-42dp-ss-2-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42dp-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dp-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42dp-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42dp-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits the dissemination of generic information." ; cml:premiseText "(2) A person commits an offence if: (a) the person disseminates, by any means, generic information about therapeutic goods to the public or a section of the public; and (b) the dissemination of that generic information does not comply with the provisions of the Therapeutic Goods Advertising Code that are prescribed by regulations for the purposes of section 42DO." ; cml:conclusionText "Penalty: 100 penalty units." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dp-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42dp-ss-2-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-42dp-ss-2-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Classify" ; cml:logicSummary "Classifies dissemination as an offence." ; cml:premiseText "(2) A person commits an offence if: (a) the person disseminates, by any means, generic information about therapeutic goods to the public or a section of the public; and (b) the dissemination of that generic information does not comply with the provisions of the Therapeutic Goods Advertising Code that are prescribed by regulations for the purposes of section 42DO." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dp-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42dp-ss-2-logic-deontic-3 . concept:therapeutic-goods-act-1989-sec-42dp-ss-2-logic-deontic-3 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits the dissemination of generic information." ; cml:premiseText "(2) A person commits an offence if: (a) the person disseminates, by any means, generic information about therapeutic goods to the public or a section of the public; and (b) the dissemination of that generic information does not comply with the provisions of the Therapeutic Goods Advertising Code that are prescribed by regulations for the purposes of section 42DO." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dp-ss-3 a cml:Concept ; skos:prefLabel "42DP(3) Offences—dissemination of generic information"@en ; cml:realizedBy doc:sec-42dp-ss-3 ; cml:integrityHash "6399dd55215449c5a9d06b6bb311756ebbb1965b41b9ee0659fbcac6e7efa0c6" ; values:partOf concept:therapeutic-goods-act-1989-sec-42dp ; skos:note "An offence against subsection (2) is an offence of strict liability." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.246" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42dp-ss-3-norm . concept:therapeutic-goods-act-1989-sec-42dp-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42dp-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dp-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-42dp-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42dp-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Imposes a duty on the state." ; cml:premiseText "(3) An offence against subsection (2) is an offence of strict liability." ; cml:conclusionText "The state must punish offenders." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dp-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-42dp-ss-3-logic-linearlogic-2 . concept:therapeutic-goods-act-1989-sec-42dp-ss-3-logic-linearlogic-2 a cml:LogicApplication ; cml:modality cml:LinearLogic ; cml:operator "Implication" ; cml:logicSummary "States that punishment follows from the existence of a strict liability offence." ; cml:premiseText "(3) An offence against subsection (2) is an offence of strict liability." ; cml:conclusionText "If there is a strict liability offence, then punishment must follow." ; cml:executionSurface "modalities::linear" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dq a cml:Concept ; skos:prefLabel "42DQ Civil penalty for dissemination of generic information"@en ; cml:realizedBy doc:sec-42dq ; cml:integrityHash "170b1c2011f34e3ca469aa8b6ecae9378aeb43957c254049e797e0642bfbc4a1" ; skos:note "Dissemination of generic information about therapeutic goods is prohibited." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.247" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42dq-norm . concept:therapeutic-goods-act-1989-sec-42dq-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42dq ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dq cml:asserts concept:therapeutic-goods-act-1989-sec-42dq-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42dq-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits the dissemination of generic information." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dq cml:asserts concept:therapeutic-goods-act-1989-sec-42dq-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-42dq-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Classify" ; cml:logicSummary "Classifies as a prohibition." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dr a cml:Concept ; skos:prefLabel "42DR Secretary may require information or documents"@en ; cml:realizedBy doc:sec-42dr ; cml:integrityHash "f60f07a4d550cfae0f22b38e69e609a4d6b1123d9c70bfda65811934d13d8efa" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42dr-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42dr-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42dr-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42dr-ss-4 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42dr-ss-5 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.248" . concept:therapeutic-goods-act-1989-sec-42dr-ss-1 a cml:Concept ; skos:prefLabel "42DR(1) Secretary may require information or documents"@en ; cml:realizedBy doc:sec-42dr-ss-1 ; cml:integrityHash "422aefd1c5707d070185758096c38dd6fed5810fa79fba77a9c7f766f3375296" ; values:partOf concept:therapeutic-goods-act-1989-sec-42dr ; skos:note "Secretary may require information or documents from a person responsible for advertising therapeutic goods." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.248" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42dr-ss-1-norm . concept:therapeutic-goods-act-1989-sec-42dr-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42dr-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dr-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42dr-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42dr-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MAY" ; cml:logicSummary "Implies an obligation." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dr-ss-2 a cml:Concept ; skos:prefLabel "42DR(2) Secretary may require information or documents"@en ; cml:realizedBy doc:sec-42dr-ss-2 ; cml:integrityHash "ba6ceff2a69ce79657bbfdc439f7c36e402dadd1ab4c003de4ee62455a35b7fe" ; values:partOf concept:therapeutic-goods-act-1989-sec-42dr ; skos:note "Secretary may require information or documents from a person responsible for disseminating generic information." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.248" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42dr-ss-2-norm . concept:therapeutic-goods-act-1989-sec-42dr-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42dr-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dr-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42dr-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42dr-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MAY" ; cml:logicSummary "Secretary may require information or documents." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dr-ss-3 a cml:Concept ; skos:prefLabel "42DR(3) Secretary may require information or documents"@en ; cml:realizedBy doc:sec-42dr-ss-3 ; cml:integrityHash "076011925dc0569096d572489dad202db09b1606cd604a934d7d6517444b0213" ; values:partOf concept:therapeutic-goods-act-1989-sec-42dr ; skos:note "Must provide information or documents within a specified period and in the form specified by the notice." ; dc:description "true" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.248" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42dr-ss-3-norm . concept:therapeutic-goods-act-1989-sec-42dr-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42dr-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dr-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-42dr-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42dr-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must provide information or documents within a specified period and in the form specified by the notice." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dr-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-42dr-ss-3-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-42dr-ss-3-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "within" ; cml:logicSummary "The period within which the person must provide the information or documents is not less than 14 days after the day the notice is given." ; cml:premiseText "The notice specifies a period." ; cml:conclusionText "The person must provide the information or documents within that period." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dr-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-42dr-ss-3-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-42dr-ss-3-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "within" ; cml:logicSummary "The period within which the person must provide the information or documents is not less than 14 days after the day the notice is given." ; cml:premiseText "The notice specifies a period." ; cml:conclusionText "The person must provide the information or documents within that period." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dr-ss-4 a cml:Concept ; skos:prefLabel "42DR(4) Secretary may require information or documents"@en ; cml:realizedBy doc:sec-42dr-ss-4 ; cml:integrityHash "bb9c4c3a54f16340ba9728bff0acc6a832df6e255aaeb07b2653e071a08844b0" ; values:partOf concept:therapeutic-goods-act-1989-sec-42dr ; skos:note "The Secretary may require information or documents in a specified way." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.248" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42dr-ss-4-norm . concept:therapeutic-goods-act-1989-sec-42dr-ss-4-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42dr-ss-4 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dr-ss-5 a cml:Concept ; skos:prefLabel "42DR(5) Secretary may require information or documents"@en ; cml:realizedBy doc:sec-42dr-ss-5 ; cml:integrityHash "1e1835fb6815030084b80c329e5fe549046e14d8b95715c8c0942e3f0c44be72" ; values:partOf concept:therapeutic-goods-act-1989-sec-42dr ; skos:note "Secretary may require information or documents" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.248" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42dr-ss-5-norm . concept:therapeutic-goods-act-1989-sec-42dr-ss-5-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42dr-ss-5 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dr-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-42dr-ss-5-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42dr-ss-5-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "requires" ; cml:logicSummary "Requires information or documents from the recipient" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dr-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-42dr-ss-5-logic-deontic-2 . concept:therapeutic-goods-act-1989-sec-42dr-ss-5-logic-deontic-2 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "is not" ; cml:logicSummary "Legislative instruments are excluded from the notice" ; cml:premiseText "(5) A notice under subsection (1) or (2)" ; cml:conclusionText "is a legislative instrument" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dr-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-42dr-ss-5-logic-deontic-3 . concept:therapeutic-goods-act-1989-sec-42dr-ss-5-logic-deontic-3 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "Secretary may require information or documents" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42ds a cml:Concept ; skos:prefLabel "42DS Criminal offences for failing to comply with a notice etc."@en ; cml:realizedBy doc:sec-42ds ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42ds-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42ds-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42ds-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42ds-ss-4 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42ds-ss-5 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.249" . concept:therapeutic-goods-act-1989-sec-42ds-ss-1 a cml:Concept ; skos:prefLabel "42DS(1) Criminal offences for failing to comply with a notice etc."@en ; cml:realizedBy doc:sec-42ds-ss-1 ; cml:integrityHash "5f66e2f5ae872c1f570da4b4ce60d6bed4ed52a1010926968f9036f4f115798b" ; values:partOf concept:therapeutic-goods-act-1989-sec-42ds ; skos:note "Failure to comply with a notice results in an offence." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.249" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42ds-ss-1-norm . concept:therapeutic-goods-act-1989-sec-42ds-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42ds-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42ds-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42ds-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42ds-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "obligation" ; cml:logicSummary "Obligation to comply with a notice." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42ds-ss-2 a cml:Concept ; skos:prefLabel "42DS(2) Criminal offences for failing to comply with a notice etc."@en ; cml:realizedBy doc:sec-42ds-ss-2 ; cml:integrityHash "4962d8df5f7291e64ae70ec789b5465dc92674a942572312ee332e64aa5bc761" ; values:partOf concept:therapeutic-goods-act-1989-sec-42ds ; skos:note "Failure to comply with a notice results in an offence." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.249" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42ds-ss-2-norm . concept:therapeutic-goods-act-1989-sec-42ds-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42ds-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42ds-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42ds-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42ds-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "obligation" ; cml:logicSummary "Obligation to comply with a notice." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42ds-ss-3 a cml:Concept ; skos:prefLabel "42DS(3) Criminal offences for failing to comply with a notice etc."@en ; cml:realizedBy doc:sec-42ds-ss-3 ; cml:integrityHash "6399dd55215449c5a9d06b6bb311756ebbb1965b41b9ee0659fbcac6e7efa0c6" ; values:partOf concept:therapeutic-goods-act-1989-sec-42ds ; skos:note "Offence of strict liability for failing to comply with a notice" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.249" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42ds-ss-3-norm . concept:therapeutic-goods-act-1989-sec-42ds-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42ds-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42ds-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-42ds-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42ds-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Imposes an obligation on the state" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42ds-ss-4 a cml:Concept ; skos:prefLabel "42DS(4) Criminal offences for failing to comply with a notice etc."@en ; cml:realizedBy doc:sec-42ds-ss-4 ; cml:integrityHash "585509ff84961b491f51844c5f9d88e353b425505de68827dd9cf85377c9bef4" ; values:partOf concept:therapeutic-goods-act-1989-sec-42ds ; skos:note "Failure to comply with a notice results in an offence." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.249" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42ds-ss-4-norm . concept:therapeutic-goods-act-1989-sec-42ds-ss-4-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42ds-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42ds-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-42ds-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42ds-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibits failing to comply with a notice." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42ds-ss-5 a cml:Concept ; skos:prefLabel "42DS(5) Criminal offences for failing to comply with a notice etc."@en ; cml:realizedBy doc:sec-42ds-ss-5 ; cml:integrityHash "e6384a5b4cea6d71163b4aace529c77bc0621ffe12d307d22b929faa1bae1755" ; values:partOf concept:therapeutic-goods-act-1989-sec-42ds ; skos:note "Failure to comply with a notice results in an offence." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.249" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42ds-ss-5-norm . concept:therapeutic-goods-act-1989-sec-42ds-ss-5-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42ds-ss-5 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42ds-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-42ds-ss-5-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42ds-ss-5-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibits failing to comply with a notice." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dt a cml:Concept ; skos:prefLabel "42DT Civil penalty for giving false or misleading information or"@en ; cml:realizedBy doc:sec-42dt ; cml:integrityHash "b7224a74a206be0194c5f2e0d92047b2a641d9331e02d371ba0ea189956fba97" ; skos:note "Giving false or misleading information in compliance with a notice is prohibited." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.250" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42dt-norm . concept:therapeutic-goods-act-1989-sec-42dt-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42dt ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dt cml:asserts concept:therapeutic-goods-act-1989-sec-42dt-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42dt-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibition of giving false or misleading information." ; cml:premiseText "The person is given a notice under section 42DR." ; cml:conclusionText "The person contravenes this section if..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42du a cml:Concept ; skos:prefLabel "42DU Self-incrimination"@en ; cml:realizedBy doc:sec-42du ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42du-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42du-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.250" . concept:therapeutic-goods-act-1989-sec-42du-ss-1 a cml:Concept ; skos:prefLabel "42DU(1) Self-incrimination"@en ; cml:realizedBy doc:sec-42du-ss-1 ; cml:integrityHash "17f71db0d4d901a9f91e0e2d80c096a5840258443cf881e0991bddebb706b044" ; values:partOf concept:therapeutic-goods-act-1989-sec-42du ; skos:note "No excuse for refusing to provide information or produce a document under section 42DR." ; dc:description "True" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.250" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42du-ss-1-norm . concept:therapeutic-goods-act-1989-sec-42du-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42du-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42du-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42du-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42du-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must provide information or produce a document." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42du-ss-2 a cml:Concept ; skos:prefLabel "42DU(2) Self-incrimination"@en ; cml:realizedBy doc:sec-42du-ss-2 ; cml:integrityHash "46603b2099eeafeeb1cccc5364134e5f76e80e75e640014afe59527436453570" ; values:partOf concept:therapeutic-goods-act-1989-sec-42du ; skos:note "Protection from self-incrimination in certain cases" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.250" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42du-ss-2-norm . concept:therapeutic-goods-act-1989-sec-42du-ss-2-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42du-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42du-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42du-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42du-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibits admissibility of self-incrimination in certain cases" ; cml:premiseText "(2) However, in the case of an individual..." ; cml:conclusionText "...the information or producing the document; ... are not admissible in evidence against the individual:" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42du-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42du-ss-2-logic-deontic-2 . concept:therapeutic-goods-act-1989-sec-42du-ss-2-logic-deontic-2 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Permission" ; cml:logicSummary "Permits admissibility in certain cases" ; cml:premiseText "(2) However, in the case of an individual..." ; cml:conclusionText "...in criminal proceedings, except proceedings for an offence against subsection 42DS(4) or (5); ..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42du-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42du-ss-2-logic-deontic-3 . concept:therapeutic-goods-act-1989-sec-42du-ss-2-logic-deontic-3 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Right" ; cml:logicSummary "Establishes a right to protection from self-incrimination in certain cases" ; cml:premiseText "(2) However, in the case of an individual..." ; cml:conclusionText "...the information or producing the document; ... are not admissible in evidence against the individual:" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42du-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42du-ss-2-logic-deontic-4 . concept:therapeutic-goods-act-1989-sec-42du-ss-2-logic-deontic-4 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Imposes an obligation on the state to protect self-incrimination in certain cases" ; cml:premiseText "(2) However, in the case of an individual..." ; cml:conclusionText "...the information or producing the document; ... are not admissible in evidence against the individual:" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42du-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42du-ss-2-logic-deontic-5 . concept:therapeutic-goods-act-1989-sec-42du-ss-2-logic-deontic-5 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Permission" ; cml:logicSummary "Permits admissibility in certain cases under specific circumstances" ; cml:premiseText "(2) However, in the case of an individual..." ; cml:conclusionText "...in civil proceedings, except proceedings under section 42Y for a contravention of section 42DT." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42du-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42du-ss-2-logic-deontic-6 . concept:therapeutic-goods-act-1989-sec-42du-ss-2-logic-deontic-6 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Imposes an obligation on the state to protect self-incrimination in certain cases under specific circumstances" ; cml:premiseText "(2) However, in the case of an individual..." ; cml:conclusionText "...in civil proceedings, except proceedings under section 42Y for a contravention of section 42DT." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dv a cml:Concept ; skos:prefLabel "42DV Directions about advertisements or generic information"@en ; cml:realizedBy doc:sec-42dv ; cml:integrityHash "f60f07a4d550cfae0f22b38e69e609a4d6b1123d9c70bfda65811934d13d8efa" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42dv-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42dv-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.251" . concept:therapeutic-goods-act-1989-sec-42dv-ss-1 a cml:Concept ; skos:prefLabel "42DV(1) Directions about advertisements or generic information"@en ; cml:realizedBy doc:sec-42dv-ss-1 ; cml:integrityHash "f46d1dd0011e195c1af177f0d47d41aeb8eb6a59ca8da801cca1ed01df793e59" ; values:partOf concept:therapeutic-goods-act-1989-sec-42dv ; skos:note "Directs a person to cease advertising or take corrective action." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.251" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42dv-ss-1-norm . concept:therapeutic-goods-act-1989-sec-42dv-ss-1-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42dv-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dv-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42dv-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42dv-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Directs a person to cease advertising." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dv-ss-2 a cml:Concept ; skos:prefLabel "42DV(2) Directions about advertisements or generic information"@en ; cml:realizedBy doc:sec-42dv-ss-2 ; cml:integrityHash "c2672d1b1ccdc789e88b89859069db7c72ed80bdcfb3cdf5552f1e0d7a024e35" ; values:partOf concept:therapeutic-goods-act-1989-sec-42dv ; skos:note "Directs a person responsible for disseminating generic information to take corrective action." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.251" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42dv-ss-2-norm . concept:therapeutic-goods-act-1989-sec-42dv-ss-2-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42dv-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dv-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42dv-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42dv-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Directs a person to withdraw or correct generic information." ; cml:premiseText "(2) If, in relation to the dissemination of generic information..." ; cml:conclusionText "...the Secretary may, in writing, direct a person..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dv-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42dv-ss-2-logic-diffusion-2 . concept:therapeutic-goods-act-1989-sec-42dv-ss-2-logic-diffusion-2 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "Influence" ; cml:logicSummary "Affects the dissemination of generic information." ; cml:premiseText "(2) If, in relation to the dissemination of generic information..." ; cml:conclusionText "...the Secretary may, in writing, direct a person..." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dv-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42dv-ss-2-logic-cogai-3 . concept:therapeutic-goods-act-1989-sec-42dv-ss-2-logic-cogai-3 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "Analyze" ; cml:logicSummary "Analyzes the impact of generic information on public health." ; cml:premiseText "(2) If, in relation to the dissemination of generic information..." ; cml:conclusionText "...the Secretary may, in writing, direct a person..." ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dv-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42dv-ss-2-logic-shacl-4 . concept:therapeutic-goods-act-1989-sec-42dv-ss-2-logic-shacl-4 a cml:LogicApplication ; cml:modality cml:SHACL ; cml:operator "Validate" ; cml:logicSummary "Validates the accuracy of generic information." ; cml:premiseText "(2) If, in relation to the dissemination of generic information..." ; cml:conclusionText "...the Secretary may, in writing, direct a person..." ; cml:executionSurface "modalities::logic::shacl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dv-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42dv-ss-2-logic-n3logic-5 . concept:therapeutic-goods-act-1989-sec-42dv-ss-2-logic-n3logic-5 a cml:LogicApplication ; cml:modality cml:N3Logic ; cml:operator "Define" ; cml:logicSummary "Defines the scope of prohibited generic information." ; cml:premiseText "(2) If, in relation to the dissemination of generic information..." ; cml:conclusionText "...the Secretary may, in writing, direct a person..." ; cml:executionSurface "modalities::logic::n3_compiler" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dw a cml:Concept ; skos:prefLabel "42DW Offences—contravening direction under section 42DV"@en ; cml:realizedBy doc:sec-42dw ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42dw-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42dw-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42dw-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42dw-ss-4 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.252" . concept:therapeutic-goods-act-1989-sec-42dw-ss-1 a cml:Concept ; skos:prefLabel "42DW(1) Offences—contravening direction under section 42DV"@en ; cml:realizedBy doc:sec-42dw-ss-1 ; cml:integrityHash "8169995f54eb3732a340deea0ffa175396a48b200556197ed933828b5d14d9e1" ; values:partOf concept:therapeutic-goods-act-1989-sec-42dw ; skos:note "Offence for contravening direction under section 42DV" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.252" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42dw-ss-1-norm . concept:therapeutic-goods-act-1989-sec-42dw-ss-1-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42dw-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dw-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42dw-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42dw-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibition of contravening direction" ; cml:premiseText "(1) A person commits an offence..." ; cml:conclusionText "...the act or omission contravenes the direction..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dw-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42dw-ss-1-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-42dw-ss-1-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Temporal relation" ; cml:logicSummary "Temporal relation between contravention and harm" ; cml:premiseText "(d) either: (i) the use of the goods has resulted in, will result in, or is likely to result in, harm or injury..." ; cml:conclusionText "...the harm or injury has resulted, will result, is likely to result, would result, or would be likely to result..." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dw-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42dw-ss-1-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-42dw-ss-1-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Recurring trace" ; cml:logicSummary "Recurring trace of contravention and harm" ; cml:premiseText "(d) either: (i) the use of the goods has resulted in, will result in, or is likely to result in, harm or injury..." ; cml:conclusionText "...the harm or injury has resulted, will result, is likely to result, would result, or would be likely to result..." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dw-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42dw-ss-1-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-42dw-ss-1-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "Diffusion" ; cml:logicSummary "Diffusion of contravention and harm" ; cml:premiseText "(d) either: (i) the use of the goods has resulted in, will result in, or is likely to result in, harm or injury..." ; cml:conclusionText "...the harm or injury has resulted, will result, is likely to result, would result, or would be likely to result..." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dw-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42dw-ss-1-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-42dw-ss-1-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "Classification" ; cml:logicSummary "Classification of therapeutic goods" ; cml:premiseText "(c) the act or omission contravenes the direction or a condition..." ; cml:conclusionText "...the use of the goods has resulted in, will result in, or is likely to result in, harm or injury..." ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dw-ss-2 a cml:Concept ; skos:prefLabel "42DW(2) Offences—contravening direction under section 42DV"@en ; cml:realizedBy doc:sec-42dw-ss-2 ; cml:integrityHash "802814fbf47da57ce1f2f70b8ed08cfdd5365908508aa7d2ef91137c67a9e870" ; values:partOf concept:therapeutic-goods-act-1989-sec-42dw ; skos:note "Offence for contravening direction under section 42DV" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.252" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42dw-ss-2-norm . concept:therapeutic-goods-act-1989-sec-42dw-ss-2-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42dw-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dw-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42dw-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42dw-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibits contravening direction under section 42DV" ; cml:premiseText "(2) A person commits an offence if..." ; cml:conclusionText "...the act or omission contravenes the direction or a condition of the direction." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dw-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42dw-ss-2-logic-deontic-2 . concept:therapeutic-goods-act-1989-sec-42dw-ss-2-logic-deontic-2 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Imposes obligation to comply with direction under section 42DV" ; cml:premiseText "(2) A person commits an offence if..." ; cml:conclusionText "...the act or omission contravenes the direction or a condition of the direction." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dw-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42dw-ss-2-logic-alleninterval-3 . concept:therapeutic-goods-act-1989-sec-42dw-ss-2-logic-alleninterval-3 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Temporal relation" ; cml:logicSummary "Establishes temporal relation between direction under section 42DV and acts/omissions" ; cml:premiseText "(2) A person commits an offence if..." ; cml:conclusionText "...the act or omission contravenes the direction or a condition of the direction." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dw-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42dw-ss-2-logic-ltl-4 . concept:therapeutic-goods-act-1989-sec-42dw-ss-2-logic-ltl-4 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Recurring trace" ; cml:logicSummary "Establishes recurring trace between direction under section 42DV and acts/omissions" ; cml:premiseText "(2) A person commits an offence if..." ; cml:conclusionText "...the act or omission contravenes the direction or a condition of the direction." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dw-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42dw-ss-2-logic-deontic-5 . concept:therapeutic-goods-act-1989-sec-42dw-ss-2-logic-deontic-5 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibits acts/omissions that contravene direction under section 42DV" ; cml:premiseText "(b) the person does an act or omits to do an act;" ; cml:conclusionText "...the act or omission contravenes the direction or a condition of the direction." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dw-ss-3 a cml:Concept ; skos:prefLabel "42DW(3) Offences—contravening direction under section 42DV"@en ; cml:realizedBy doc:sec-42dw-ss-3 ; cml:integrityHash "b8a92775d91778aca7bf1a7ac10b4506ae03811d43ed78d5592b873b86a5b5f6" ; values:partOf concept:therapeutic-goods-act-1989-sec-42dw ; skos:note "Offence for contravening direction under section 42DV" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.252" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42dw-ss-3-norm . concept:therapeutic-goods-act-1989-sec-42dw-ss-3-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42dw-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dw-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-42dw-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42dw-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibits contravening direction under section 42DV" ; cml:premiseText "(3) A person commits an offence if..." ; cml:conclusionText "...the act or omission contravenes the direction or a condition of the direction." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dw-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-42dw-ss-3-logic-deontic-2 . concept:therapeutic-goods-act-1989-sec-42dw-ss-3-logic-deontic-2 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Imposes obligation to comply with direction under section 42DV" ; cml:premiseText "(a) the Secretary has given a direction to the person under subsection 42DV(1) or (2); and..." ; cml:conclusionText "...the person does an act or omits to do an act." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dw-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-42dw-ss-3-logic-deontic-3 . concept:therapeutic-goods-act-1989-sec-42dw-ss-3-logic-deontic-3 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibits omission of act under direction under section 42DV" ; cml:premiseText "(b) the person does an act or omits to do an act; and..." ; cml:conclusionText "...the act or omission contravenes the direction or a condition of the direction." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dw-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-42dw-ss-3-logic-deontic-4 . concept:therapeutic-goods-act-1989-sec-42dw-ss-3-logic-deontic-4 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Imposes obligation to comply with conditions of direction under section 42DV" ; cml:premiseText "(c) the act or omission contravenes the direction or a condition of the direction." ; cml:conclusionText "...the person does an act or omits to do an act." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dw-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-42dw-ss-3-logic-deontic-5 . concept:therapeutic-goods-act-1989-sec-42dw-ss-3-logic-deontic-5 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibits failure to comply with conditions of direction under section 42DV" ; cml:premiseText "(c) the act or omission contravenes the direction or a condition of the direction." ; cml:conclusionText "...the person does an act or omits to do an act." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dw-ss-4 a cml:Concept ; skos:prefLabel "42DW(4) Offences—contravening direction under section 42DV"@en ; cml:realizedBy doc:sec-42dw-ss-4 ; cml:integrityHash "436deed04d3f320a344b95ef5058be076990edcd77c14c1020ba45da6185cf7d" ; values:partOf concept:therapeutic-goods-act-1989-sec-42dw ; skos:note "An offence against subsection (3) is an offence of strict liability." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.252" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42dw-ss-4-norm . concept:therapeutic-goods-act-1989-sec-42dw-ss-4-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42dw-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dw-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-42dw-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42dw-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Imposes a duty on the state." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dx a cml:Concept ; skos:prefLabel "42DX Civil penalty for contravening direction under section 42DV"@en ; cml:realizedBy doc:sec-42dx ; cml:integrityHash "1e3f8ee5492976f4ea0bf786553a3cb9ba446803c8c0d1703f06f972fb39986e" ; skos:note "Contravening direction under section 42DV is prohibited." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.253" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42dx-norm . concept:therapeutic-goods-act-1989-sec-42dx-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42dx ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dx cml:asserts concept:therapeutic-goods-act-1989-sec-42dx-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42dx-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibition of contravening direction" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dy a cml:Concept ; skos:prefLabel "42DY Secretary may issue a public warning notice"@en ; cml:realizedBy doc:sec-42dy ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42dy-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42dy-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42dy-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42dy-ss-4 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.255" . concept:therapeutic-goods-act-1989-sec-42dy-ss-1 a cml:Concept ; skos:prefLabel "42DY(1) Secretary may issue a public warning notice"@en ; cml:realizedBy doc:sec-42dy-ss-1 ; cml:integrityHash "d7186cdc48a03de05acd1456dc4b9a4deacd6d00d1741823290ed922e10c4712" ; values:partOf concept:therapeutic-goods-act-1989-sec-42dy ; skos:note "Secretary may issue a public warning notice about therapeutic goods under certain conditions." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.255" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42dy-ss-1-norm . concept:therapeutic-goods-act-1989-sec-42dy-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42dy-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dy-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42dy-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42dy-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "Secretary may issue a public warning notice." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dy-ss-2 a cml:Concept ; skos:prefLabel "42DY(2) Secretary may issue a public warning notice"@en ; cml:realizedBy doc:sec-42dy-ss-2 ; cml:integrityHash "c9ef81c2b7d857ddbaac25c10e640fdb7da5ec686158275fa14207d84d8da5c8" ; values:partOf concept:therapeutic-goods-act-1989-sec-42dy ; skos:note "Secretary may issue a public warning notice if person fails to comply with substantiation notice." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.255" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42dy-ss-2-norm . concept:therapeutic-goods-act-1989-sec-42dy-ss-2-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42dy-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dy-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42dy-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42dy-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits person from failing to comply with substantiation notice." ; cml:premiseText "(a) the Secretary gives a person a notice (the substantiation notice) under subsection 42DR(1) or (2); and (b) the person fails to comply with the substantiation notice;" ; cml:conclusionText "the Secretary may issue to the public a written notice containing a warning that the person has failed to comply with the substantiation notice, and specifying the matter to which the substantiation notice related." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dy-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42dy-ss-2-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-42dy-ss-2-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "During" ; cml:logicSummary "Warning notice issued during period of non-compliance." ; cml:premiseText "(c) the Secretary is satisfied that it is in the public interest to issue a notice under this subsection;" ; cml:conclusionText "the warning notice is issued during the period of non-compliance" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dy-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42dy-ss-2-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-42dy-ss-2-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Until" ; cml:logicSummary "Warning notice remains in effect until person complies." ; cml:premiseText "(c) the Secretary is satisfied that it is in the public interest to issue a notice under this subsection;" ; cml:conclusionText "the warning notice remains in effect until the person complies" ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dy-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42dy-ss-2-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-42dy-ss-2-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "Spread" ; cml:logicSummary "Warning notice spreads to public." ; cml:premiseText "(2) If: (a) the Secretary gives a person a notice (the substantiation notice) under subsection 42DR(1) or (2); and (b) the person fails to comply with the substantiation notice;" ; cml:conclusionText "the warning notice spreads to the public" ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dy-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42dy-ss-2-logic-argumentation-5 . concept:therapeutic-goods-act-1989-sec-42dy-ss-2-logic-argumentation-5 a cml:LogicApplication ; cml:modality cml:Argumentation ; cml:operator "Imply" ; cml:logicSummary "Warning notice implies that person has failed to comply." ; cml:premiseText "(2) If: (a) the Secretary gives a person a notice (the substantiation notice) under subsection 42DR(1) or (2); and (b) the person fails to comply with the substantiation notice;" ; cml:conclusionText "the warning notice implies that the person has failed to comply" ; cml:executionSurface "modalities::argumentation" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dy-ss-3 a cml:Concept ; skos:prefLabel "42DY(3) Secretary may issue a public warning notice"@en ; cml:realizedBy doc:sec-42dy-ss-3 ; cml:integrityHash "740f18283d983b082a0d365df0febbed0f332219467375706ef817cdd78bfa66" ; values:partOf concept:therapeutic-goods-act-1989-sec-42dy ; skos:note "Secretary must issue a public warning notice" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.255" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42dy-ss-3-norm . concept:therapeutic-goods-act-1989-sec-42dy-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42dy-ss-3 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dy-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-42dy-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42dy-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must provide a public warning notice" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dy-ss-4 a cml:Concept ; skos:prefLabel "42DY(4) Secretary may issue a public warning notice"@en ; cml:realizedBy doc:sec-42dy-ss-4 ; cml:integrityHash "ba45ee4ef87998857fd35214ffaa1c9f2b3f6fa4a3500d68a9b6503c15bd2136" ; values:partOf concept:therapeutic-goods-act-1989-sec-42dy ; skos:note "Secretary must issue a public warning notice." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.255" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42dy-ss-4-norm . concept:therapeutic-goods-act-1989-sec-42dy-ss-4-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42dy-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42dy-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-42dy-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42dy-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must provide a public warning notice." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42e a cml:Concept ; skos:prefLabel "42E Offence of dealing with counterfeit therapeutic goods"@en ; cml:realizedBy doc:sec-42e ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42e-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42e-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42e-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42e-ss-5 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.270" . concept:therapeutic-goods-act-1989-sec-42e-ss-1 a cml:Concept ; skos:prefLabel "42E(1) Offence of dealing with counterfeit therapeutic goods"@en ; cml:realizedBy doc:sec-42e-ss-1 ; cml:integrityHash "22404917c70aa2a3648c112d988b287591f171662cec8867b6f2c7951f7f6e40" ; values:partOf concept:therapeutic-goods-act-1989-sec-42e ; skos:note "Dealing with counterfeit therapeutic goods is an offence." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.270" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42e-ss-1-norm . concept:therapeutic-goods-act-1989-sec-42e-ss-1-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42e-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42e-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42e-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42e-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibits dealing with counterfeit therapeutic goods." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42e-ss-2 a cml:Concept ; skos:prefLabel "42E(2) Offence of dealing with counterfeit therapeutic goods"@en ; cml:realizedBy doc:sec-42e-ss-2 ; cml:integrityHash "2d830f257ef74e04b9a89e868138ae3a80acd29b6f2ebb1cbf92e3a633cfff90" ; values:partOf concept:therapeutic-goods-act-1989-sec-42e ; skos:note "Dealing with counterfeit therapeutic goods is an offence." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.270" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42e-ss-2-norm . concept:therapeutic-goods-act-1989-sec-42e-ss-2-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42e-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42e-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42e-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42e-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits dealing with counterfeit therapeutic goods." ; cml:premiseText "(2) Goods are counterfeit if any of the following contain a false representation..." ; cml:conclusionText "Dealing with counterfeit therapeutic goods is an offence." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42e-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42e-ss-2-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-42e-ss-2-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Overlap" ; cml:logicSummary "Overlaps with other provisions related to therapeutic goods." ; cml:premiseText "(2) Goods are counterfeit if any of the following contain a false representation..." ; cml:conclusionText "This provision overlaps with other provisions related to therapeutic goods." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42e-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42e-ss-2-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-42e-ss-2-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Recurring" ; cml:logicSummary "Recurring trace for dealing with counterfeit therapeutic goods." ; cml:premiseText "(2) Goods are counterfeit if any of the following contain a false representation..." ; cml:conclusionText "Dealing with counterfeit therapeutic goods is a recurring trace." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42e-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42e-ss-2-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-42e-ss-2-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "Diffuse" ; cml:logicSummary "Diffuses to other provisions related to therapeutic goods." ; cml:premiseText "(2) Goods are counterfeit if any of the following contain a false representation..." ; cml:conclusionText "This provision diffuses to other provisions related to therapeutic goods." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42e-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42e-ss-2-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-42e-ss-2-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "Recognize" ; cml:logicSummary "Recognizes counterfeit therapeutic goods based on representations." ; cml:premiseText "(2) Goods are counterfeit if any of the following contain a false representation..." ; cml:conclusionText "This provision recognizes counterfeit therapeutic goods based on representations." ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42e-ss-3 a cml:Concept ; skos:prefLabel "42E(3) Offence of dealing with counterfeit therapeutic goods"@en ; cml:realizedBy doc:sec-42e-ss-3 ; cml:integrityHash "38c7cd252153cbf595d66ad21b34fe0b616da4cbab14869ada91d8c3f86ef7fb" ; values:partOf concept:therapeutic-goods-act-1989-sec-42e ; skos:note "Offence of dealing with counterfeit therapeutic goods" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.270" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42e-ss-3-norm . concept:therapeutic-goods-act-1989-sec-42e-ss-3-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42e-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42e-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-42e-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42e-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits dealing with counterfeit therapeutic goods" ; cml:premiseText "(3) The matters are as follows:" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42e-ss-5 a cml:Concept ; skos:prefLabel "42E(5) Offence of dealing with counterfeit therapeutic goods"@en ; cml:realizedBy doc:sec-42e-ss-5 ; cml:integrityHash "5012e232e8f9c87f1385ed1a8cd68bcf450beb4a0c6d1d70bcccfab03ebc7001" ; values:partOf concept:therapeutic-goods-act-1989-sec-42e ; skos:note "Defines term for therapeutic goods in section" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.270" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42e-ss-5-norm . concept:therapeutic-goods-act-1989-sec-42e-ss-5-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42e-ss-5 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42e-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-42e-ss-5-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42e-ss-5-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "defines" ; cml:logicSummary "Defines term" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42ea a cml:Concept ; skos:prefLabel "42EA Civil penalty relating to dealing with counterfeit therapeutic"@en ; cml:realizedBy doc:sec-42ea ; cml:integrityHash "42a2297340de55f789ad2a3290d7c955bf4f90b5fd9fef4e81f135832377a6fe" ; skos:note "Dealing with counterfeit therapeutic goods is prohibited." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.271" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42ea-norm . concept:therapeutic-goods-act-1989-sec-42ea-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42ea ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42ea cml:asserts concept:therapeutic-goods-act-1989-sec-42ea-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42ea-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits dealing with counterfeit therapeutic goods." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42eb a cml:Concept ; skos:prefLabel "42EB Relief from liability for certain contraventions relating to"@en ; cml:realizedBy doc:sec-42eb ; cml:integrityHash "6499fa7239d689d01cd47d203fa3255e748cd868679b9e06b61dadf19ba05f41" ; skos:note "Excuse from liability for certain contraventions relating to counterfeit therapeutic goods" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.271" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42eb-norm . concept:therapeutic-goods-act-1989-sec-42eb-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42eb ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42eb cml:asserts concept:therapeutic-goods-act-1989-sec-42eb-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42eb-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Obligation to excuse liability for certain contraventions" ; cml:premiseText "The person has a reasonable excuse" ; cml:conclusionText "The person ought fairly be excused for the contravention" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42eb cml:asserts concept:therapeutic-goods-act-1989-sec-42eb-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-42eb-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Overlaps" ; cml:logicSummary "Excuse from liability overlaps with other excuses" ; cml:premiseText "The person has a reasonable excuse" ; cml:conclusionText "The person ought fairly be excused for the contravention" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42eb cml:asserts concept:therapeutic-goods-act-1989-sec-42eb-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-42eb-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Recurrent" ; cml:logicSummary "Excuse from liability is recurrent" ; cml:premiseText "The person has a reasonable excuse" ; cml:conclusionText "The person ought fairly be excused for the contravention" ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42f a cml:Concept ; skos:prefLabel "42F Customs treatment of counterfeit therapeutic goods"@en ; cml:realizedBy doc:sec-42f ; cml:integrityHash "c05a7a133de5dcfa786ea495d8d6c5ee5f67dd5ad0ee171e7f3892177d3d8896" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42f-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42f-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.272" . concept:therapeutic-goods-act-1989-sec-42f-ss-1 a cml:Concept ; skos:prefLabel "42F(1) Customs treatment of counterfeit therapeutic goods"@en ; cml:realizedBy doc:sec-42f-ss-1 ; cml:integrityHash "a74279125a72eff79698ced84c0fc4da35c826ac9ae699b5122ee2e98fe2eb49" ; values:partOf concept:therapeutic-goods-act-1989-sec-42f ; skos:note "Customs treatment of counterfeit therapeutic goods" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.272" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42f-ss-1-norm . concept:therapeutic-goods-act-1989-sec-42f-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42f-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42f-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42f-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42f-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "hasEffectAsIf" ; cml:logicSummary "Imposes duty on Secretary to notify Comptroller-General of Customs" ; cml:premiseText "Secretary wishes the Customs Act 1901 to apply" ; cml:conclusionText "Act has effect as if goods were forfeited to the Crown" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42f-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42f-ss-1-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-42f-ss-1-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "during" ; cml:logicSummary "Customs treatment applies during the period from notification to commencement" ; cml:premiseText "Secretary notifies Comptroller-General of Customs in writing" ; cml:conclusionText "Customs treatment applies until commencement" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42f-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42f-ss-1-logic-argumentation-3 . concept:therapeutic-goods-act-1989-sec-42f-ss-1-logic-argumentation-3 a cml:LogicApplication ; cml:modality cml:Argumentation ; cml:operator "implies" ; cml:logicSummary "Notification implies application of the Customs Act 1901" ; cml:premiseText "Secretary notifies Comptroller-General of Customs in writing" ; cml:conclusionText "Customs Act 1901 applies" ; cml:executionSurface "modalities::argumentation" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42f-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42f-ss-1-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-42f-ss-1-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "diffuses" ; cml:logicSummary "Notification diffuses to Comptroller-General of Customs" ; cml:premiseText "Secretary notifies Comptroller-General of Customs in writing" ; cml:conclusionText "Comptroller-General of Customs receives notification" ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42f-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42f-ss-1-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-42f-ss-1-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "recognizes" ; cml:logicSummary "Comptroller-General of Customs recognizes the notification as a directive from Secretary" ; cml:premiseText "Secretary notifies Comptroller-General of Customs in writing" ; cml:conclusionText "Comptroller-General of Customs acknowledges receipt of notification" ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42f-ss-2 a cml:Concept ; skos:prefLabel "42F(2) Customs treatment of counterfeit therapeutic goods"@en ; cml:realizedBy doc:sec-42f-ss-2 ; cml:integrityHash "7adef90a479008b23569e0391f890e826228797d4fe10bf64f6c1cee2243697d" ; values:partOf concept:therapeutic-goods-act-1989-sec-42f ; skos:note "Customs treatment of counterfeit therapeutic goods" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.272" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42f-ss-2-norm . concept:therapeutic-goods-act-1989-sec-42f-ss-2-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42f-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42f-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42f-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42f-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits export of counterfeit therapeutic goods" ; cml:premiseText "Section 229 of the Customs Act 1901" ; cml:conclusionText "Customs Act 1901 applies to export" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42f-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42f-ss-2-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-42f-ss-2-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Overlap" ; cml:logicSummary "Overlaps with section 229 of the Customs Act 1901" ; cml:premiseText "Section 42F(2) of the Customs Act 1901" ; cml:conclusionText "Sections overlap in time" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42f-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42f-ss-2-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-42f-ss-2-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Recurring" ; cml:logicSummary "Recurring trace with section 229 of the Customs Act 1901" ; cml:premiseText "Section 42F(2) of the Customs Act 1901" ; cml:conclusionText "Trace is recurring" ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42f-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42f-ss-2-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-42f-ss-2-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "Diffuse" ; cml:logicSummary "Diffuses prohibition to export of counterfeit therapeutic goods" ; cml:premiseText "Section 42F(2) of the Customs Act 1901" ; cml:conclusionText "Prohibition is diffuse" ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42f-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42f-ss-2-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-42f-ss-2-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "Recognize" ; cml:logicSummary "Recognizes prohibition as a rule" ; cml:premiseText "Section 42F(2) of the Customs Act 1901" ; cml:conclusionText "Prohibition is recognized" ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42t a cml:Concept ; skos:prefLabel "42T Notifying of actual or potential tampering"@en ; cml:realizedBy doc:sec-42t ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42t-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42t-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42t-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42t-ss-4 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.274" . concept:therapeutic-goods-act-1989-sec-42t-ss-1 a cml:Concept ; skos:prefLabel "42T(1) Notifying of actual or potential tampering"@en ; cml:realizedBy doc:sec-42t-ss-1 ; cml:integrityHash "6b3d9150b69017dadf15dd571dc82eb2ffd4d6a30613b9f40e1a28f2625ce328" ; values:partOf concept:therapeutic-goods-act-1989-sec-42t ; skos:note "Notify Secretary of actual or potential tampering within 24 hours." ; dc:description "Notification to Secretary" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.274" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42t-ss-1-norm . concept:therapeutic-goods-act-1989-sec-42t-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42t-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42t-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42t-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42t-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must provide notification" ; cml:conclusionText "The person must notify the Secretary." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42t-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42t-ss-1-logic-deontic-2 . concept:therapeutic-goods-act-1989-sec-42t-ss-1-logic-deontic-2 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "OBLIGATION" ; cml:logicSummary "Notification is an obligation" ; cml:conclusionText "The person has a duty to notify the Secretary." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42t-ss-2 a cml:Concept ; skos:prefLabel "42T(2) Notifying of actual or potential tampering"@en ; cml:realizedBy doc:sec-42t-ss-2 ; cml:integrityHash "24ae264c26b53b77d6f156a3d57bd3291dcde54233d8f04f0491ebc9bdd56eae" ; values:partOf concept:therapeutic-goods-act-1989-sec-42t ; skos:note "Failure to notify of actual or potential tampering with therapeutic goods within 24 hours." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.274" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42t-ss-2-norm . concept:therapeutic-goods-act-1989-sec-42t-ss-2-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42t-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42t-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42t-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42t-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibition of failure to notify" ; cml:premiseText "Notification is required within 24 hours" ; cml:conclusionText "Failure to comply results in penalty" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42t-ss-3 a cml:Concept ; skos:prefLabel "42T(3) Notifying of actual or potential tampering"@en ; cml:realizedBy doc:sec-42t-ss-3 ; cml:integrityHash "cce4d3b8ddfd23948ec0794e53f4fab9d2c19ee51b3363eeec2b5331f274416e" ; values:partOf concept:therapeutic-goods-act-1989-sec-42t ; skos:note "Negligence standard for notification of tampering" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.274" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42t-ss-3-norm . concept:therapeutic-goods-act-1989-sec-42t-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42t-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42t-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-42t-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42t-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Notification obligation" ; cml:premiseText "(3) For the purposes of subparagraph (2)(c)(ii)" ; cml:conclusionText "the person is only taken to be negligent..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42t-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-42t-ss-3-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-42t-ss-3-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Temporal relation" ; cml:logicSummary "Temporal relation between notification and standard of care" ; cml:premiseText "(a) the person’s acts or omissions involve such a great falling short..." ; cml:conclusionText "...of the standard of care that a reasonable person would exercise in the circumstances;" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42t-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-42t-ss-3-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-42t-ss-3-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Recurring trace" ; cml:logicSummary "Recurring trace of notification and risk assessment" ; cml:premiseText "(b) there is such a high risk..." ; cml:conclusionText "...that the acts or omissions merit criminal punishment." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42t-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-42t-ss-3-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-42t-ss-3-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "Risk assessment" ; cml:logicSummary "Risk assessment for tampering notification" ; cml:premiseText "(b) there is such a high risk..." ; cml:conclusionText "...that the acts or omissions merit criminal punishment." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42t-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-42t-ss-3-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-42t-ss-3-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "Knowledge representation" ; cml:logicSummary "Knowledge representation of negligence standard" ; cml:premiseText "(a) the person’s acts or omissions involve such a great falling short..." ; cml:conclusionText "...of the standard of care that a reasonable person would exercise in the circumstances;" ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42t-ss-4 a cml:Concept ; skos:prefLabel "42T(4) Notifying of actual or potential tampering"@en ; cml:realizedBy doc:sec-42t-ss-4 ; cml:integrityHash "0f853c1e609bda064fc90fb8104343e5a45fd6914b6d6bd96474fc2a8bd923bb" ; values:partOf concept:therapeutic-goods-act-1989-sec-42t ; skos:note "No possession or control required for notification" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.274" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42t-ss-4-norm . concept:therapeutic-goods-act-1989-sec-42t-ss-4-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42t-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42u a cml:Concept ; skos:prefLabel "42U Meaning of actual or potential tampering etc."@en ; cml:realizedBy doc:sec-42u ; cml:integrityHash "8470dfd9b0da09e7abd37149dc8cbdbce84400d640904cb3864ac82d07549ec3" ; skos:note "Tampering with therapeutic goods is prohibited." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.275" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42u-norm . concept:therapeutic-goods-act-1989-sec-42u-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42u ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42u cml:asserts concept:therapeutic-goods-act-1989-sec-42u-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42u-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits tampering with therapeutic goods." ; cml:premiseText "Therapeutic goods are protected by law." ; cml:conclusionText "Tampering is prohibited." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42u cml:asserts concept:therapeutic-goods-act-1989-sec-42u-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-42u-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Classify" ; cml:logicSummary "Classifies therapeutic goods as subject to tampering prohibition." ; cml:premiseText "Therapeutic goods have a specific meaning in this context." ; cml:conclusionText "Tampering is prohibited for these goods." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42u cml:asserts concept:therapeutic-goods-act-1989-sec-42u-logic-alleninterval-3 . concept:therapeutic-goods-act-1989-sec-42u-logic-alleninterval-3 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "During" ; cml:logicSummary "Tampering occurs during the manufacturing or distribution of therapeutic goods." ; cml:premiseText "Therapeutic goods are manufactured or distributed at specific times." ; cml:conclusionText "Tampering occurs during these times." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42u cml:asserts concept:therapeutic-goods-act-1989-sec-42u-logic-ltl-4 . concept:therapeutic-goods-act-1989-sec-42u-logic-ltl-4 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Until" ; cml:logicSummary "Tampering is prohibited until the therapeutic goods reach a safe state." ; cml:premiseText "Therapeutic goods must be in a safe state before they can be used." ; cml:conclusionText "Tampering occurs until this safety condition is met." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42u cml:asserts concept:therapeutic-goods-act-1989-sec-42u-logic-diffusion-5 . concept:therapeutic-goods-act-1989-sec-42u-logic-diffusion-5 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "Through" ; cml:logicSummary "Tampering with therapeutic goods diffuses the risk of harm to others." ; cml:premiseText "Therapeutic goods can cause harm if tampered with." ; cml:conclusionText "The risk of harm is diffused through tampering." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42u cml:asserts concept:therapeutic-goods-act-1989-sec-42u-logic-cogai-6 . concept:therapeutic-goods-act-1989-sec-42u-logic-cogai-6 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "By" ; cml:logicSummary "Tampering with therapeutic goods is done by a specific entity or action." ; cml:premiseText "Therapeutic goods have a specific purpose and are subject to regulation." ; cml:conclusionText "The entity or action responsible for tampering is specified." ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42v a cml:Concept ; skos:prefLabel "42V Recall of therapeutic goods because of actual or potential"@en ; cml:realizedBy doc:sec-42v ; cml:integrityHash "d410c3198e964c544c8e584117f196d490b769c115188ba2b97a283f122e62d2" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42v-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42v-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42v-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42v-ss-4 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42v-ss-5 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42v-ss-6 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42v-ss-6c ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42v-ss-6d ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42v-ss-6e ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.276" . concept:therapeutic-goods-act-1989-sec-42v-ss-1 a cml:Concept ; skos:prefLabel "42V(1) Recall of therapeutic goods because of actual or potential"@en ; cml:realizedBy doc:sec-42v-ss-1 ; cml:integrityHash "df8dc8357d3eb4138ef50b1634e851e3fc22c600491cc75a0e103b5e121129d9" ; values:partOf concept:therapeutic-goods-act-1989-sec-42v ; skos:note "Secretary may impose requirements on a person supplying therapeutic goods" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.276" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42v-ss-1-norm . concept:therapeutic-goods-act-1989-sec-42v-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42v-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42v-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42v-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42v-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "Imposes obligation" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42v-ss-2 a cml:Concept ; skos:prefLabel "42V(2) Recall of therapeutic goods because of actual or potential"@en ; cml:realizedBy doc:sec-42v-ss-2 ; cml:integrityHash "836ec64714cd89aec5a752e4368b47ee52a9a7f17cee8901a228e3a391d6418f" ; values:partOf concept:therapeutic-goods-act-1989-sec-42v ; skos:note "Recall of therapeutic goods because of actual or potential tampering" ; dc:description "specified steps, in the specified manner and within a reasonable period" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.276" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42v-ss-2-norm . concept:therapeutic-goods-act-1989-sec-42v-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42v-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42v-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42v-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42v-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Duty to recall therapeutic goods" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42v-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42v-ss-2-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-42v-ss-2-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "CLASSIFICATION" ; cml:logicSummary "Classification of therapeutic goods based on tampering risk" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42v-ss-3 a cml:Concept ; skos:prefLabel "42V(3) Recall of therapeutic goods because of actual or potential"@en ; cml:realizedBy doc:sec-42v-ss-3 ; cml:integrityHash "9e05d4d77d71663afe60b18b929d63ec5ba5936e148a048597211f434aecf8bc" ; values:partOf concept:therapeutic-goods-act-1989-sec-42v ; skos:note "Therapeutic goods that have been administered to a person cannot be recalled." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.276" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42v-ss-3-norm . concept:therapeutic-goods-act-1989-sec-42v-ss-3-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42v-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42v-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-42v-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42v-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibits recall of therapeutic goods administered to a person." ; cml:premiseText "(3) Requirements referred to in paragraph (2)(a) do not apply..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42v-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-42v-ss-3-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-42v-ss-3-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Overlaps" ; cml:logicSummary "The recall requirement overlaps with the administration of therapeutic goods." ; cml:premiseText "(3) Requirements referred to in paragraph (2)(a) do not apply..." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42v-ss-4 a cml:Concept ; skos:prefLabel "42V(4) Recall of therapeutic goods because of actual or potential"@en ; cml:realizedBy doc:sec-42v-ss-4 ; cml:integrityHash "6e8200d8e1720a619d51ce50525f92e9003185470bf3b861ca0b8d91ca7bf811" ; values:partOf concept:therapeutic-goods-act-1989-sec-42v ; skos:note "Secretary must publish notice setting out requirements after imposing them." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.276" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42v-ss-4-norm . concept:therapeutic-goods-act-1989-sec-42v-ss-4-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42v-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42v-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-42v-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42v-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Imposes duty on the Secretary." ; cml:conclusionText "The Secretary must publish a notice." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42v-ss-5 a cml:Concept ; skos:prefLabel "42V(5) Recall of therapeutic goods because of actual or potential"@en ; cml:realizedBy doc:sec-42v-ss-5 ; cml:integrityHash "08c99dd8e1647cb2875026db37a8e7bc0f3e2e428d18c71ab700c7a3c0be29aa" ; values:partOf concept:therapeutic-goods-act-1989-sec-42v ; skos:note "Secretary may impose requirements under this section" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.276" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42v-ss-5-norm . concept:therapeutic-goods-act-1989-sec-42v-ss-5-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42v-ss-5 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42v-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-42v-ss-5-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42v-ss-5-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "Imposes obligation on the Secretary" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42v-ss-6 a cml:Concept ; skos:prefLabel "42V(6) Recall of therapeutic goods because of actual or potential"@en ; cml:realizedBy doc:sec-42v-ss-6 ; cml:integrityHash "07cc0436c56b92798e48f64d1b8b47032035611fec896ed88bd0cdee834ed52b" ; values:partOf concept:therapeutic-goods-act-1989-sec-42v ; skos:note "Failure to comply with a requirement under subsection (1) in relation to a supply of therapeutic goods is an offence." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.276" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42v-ss-6-norm . concept:therapeutic-goods-act-1989-sec-42v-ss-6-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42v-ss-6 ; values:borneBy values:Agent ; skos:scopeNote "borne by: Agent" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42v-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-42v-ss-6-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42v-ss-6-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibition of non-compliance with a requirement." ; cml:premiseText "The person fails to comply with a requirement under subsection (1)." ; cml:conclusionText "An offence is committed." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42v-ss-6c a cml:Concept ; skos:prefLabel "42V(6C) Recall of therapeutic goods because of actual or potential"@en ; cml:realizedBy doc:sec-42v-ss-6c ; cml:integrityHash "008d6b3d86ecdca3d07ea3f372d6167f11707debc4595544f9feaf35b5faca5e" ; values:partOf concept:therapeutic-goods-act-1989-sec-42v ; skos:note "Failure to comply with a requirement in relation to a supply of therapeutic goods is an offence." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.276" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42v-ss-6c-norm . concept:therapeutic-goods-act-1989-sec-42v-ss-6c-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42v-ss-6c ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42v-ss-6c cml:asserts concept:therapeutic-goods-act-1989-sec-42v-ss-6c-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42v-ss-6c-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Obligation to comply with a requirement" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42v-ss-6d a cml:Concept ; skos:prefLabel "42V(6D) Recall of therapeutic goods because of actual or potential"@en ; cml:realizedBy doc:sec-42v-ss-6d ; cml:integrityHash "9b4412be441c267120c5c36da424f2e40d626c643d8d1646b270440b65fe4231" ; values:partOf concept:therapeutic-goods-act-1989-sec-42v ; skos:note "Failure to comply with a requirement under subsection (1) in relation to a supply of therapeutic goods is an offence." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.276" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42v-ss-6d-norm . concept:therapeutic-goods-act-1989-sec-42v-ss-6d-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42v-ss-6d ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42v-ss-6d cml:asserts concept:therapeutic-goods-act-1989-sec-42v-ss-6d-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42v-ss-6d-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "obligation" ; cml:logicSummary "Obligation to comply with a requirement." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42v-ss-6e a cml:Concept ; skos:prefLabel "42V(6E) Recall of therapeutic goods because of actual or potential"@en ; cml:realizedBy doc:sec-42v-ss-6e ; cml:integrityHash "6f842f5a76499d093b4a63e9a2e693686e2f6b7f40a316273509861fcbb43ebc" ; values:partOf concept:therapeutic-goods-act-1989-sec-42v ; skos:note "Offence of strict liability for recall of therapeutic goods" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.276" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42v-ss-6e-norm . concept:therapeutic-goods-act-1989-sec-42v-ss-6e-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42v-ss-6e ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42v-ss-6e cml:asserts concept:therapeutic-goods-act-1989-sec-42v-ss-6e-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42v-ss-6e-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibits recall of therapeutic goods" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42va a cml:Concept ; skos:prefLabel "42VA Civil penalty relating to the recall of therapeutic goods"@en ; cml:realizedBy doc:sec-42va ; cml:integrityHash "945ecb8c26aa743a479f5b981e0d72e4edbbf2f81f3a1b67330006eeeda86471" ; skos:note "Failure to comply with a requirement under subsection 42V(1) in relation to a supply of therapeutic goods is prohibited." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.278" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42va-norm . concept:therapeutic-goods-act-1989-sec-42va-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42va ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42va cml:asserts concept:therapeutic-goods-act-1989-sec-42va-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42va-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibition" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42vb a cml:Concept ; skos:prefLabel "42VB Relief from liability for contraventions relating to the recall of"@en ; cml:realizedBy doc:sec-42vb ; cml:integrityHash "8bfec45cc6a836eb96b9895d577de34cadbedc0a85f61140710f65a1effee643" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42vb-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42vb-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42vb-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42vb-ss-4 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.278" . concept:therapeutic-goods-act-1989-sec-42vb-ss-1 a cml:Concept ; skos:prefLabel "42VB(1) Relief from liability for contraventions relating to the recall of"@en ; cml:realizedBy doc:sec-42vb-ss-1 ; cml:integrityHash "ef2d415a7617ab4814d3732793826b839944e3df421e484c9ab04a92b945ea34" ; values:partOf concept:therapeutic-goods-act-1989-sec-42vb ; skos:note "Relief from liability for contraventions relating to the recall of" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.278" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42vb-ss-1-norm . concept:therapeutic-goods-act-1989-sec-42vb-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42vb-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42vb-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42vb-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42vb-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "exemption" ; cml:logicSummary "Exemptions from liability" ; cml:premiseText "The person has acted honestly and ought fairly to be excused for the contravention." ; cml:conclusionText "Relief from liability is granted." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42vb-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42vb-ss-1-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-42vb-ss-1-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "during" ; cml:logicSummary "Temporal interval during which relief from liability applies" ; cml:premiseText "The relief from liability applies if the proceedings are brought within a certain timeframe." ; cml:conclusionText "Relief from liability is granted during a specific temporal interval." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42vb-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42vb-ss-1-logic-argumentation-3 . concept:therapeutic-goods-act-1989-sec-42vb-ss-1-logic-argumentation-3 a cml:LogicApplication ; cml:modality cml:Argumentation ; cml:operator "justification" ; cml:logicSummary "Justification for exemption from liability" ; cml:premiseText "The person's honesty and circumstances of the case justify relief from liability." ; cml:conclusionText "The person's actions are justified by their honesty and circumstances." ; cml:executionSurface "modalities::argumentation" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42vb-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42vb-ss-1-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-42vb-ss-1-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "propagation" ; cml:logicSummary "Propagation of exemption from liability" ; cml:premiseText "Relief from liability is granted to the person if they have acted honestly." ; cml:conclusionText "The exemption from liability propagates to the person." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42vb-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42vb-ss-1-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-42vb-ss-1-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "recognition" ; cml:logicSummary "Recognition of exemption from liability" ; cml:premiseText "The Court recognizes the person's honesty and circumstances as justification for relief from liability." ; cml:conclusionText "The Court recognizes the person's exemption from liability." ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42vb-ss-2 a cml:Concept ; skos:prefLabel "42VB(2) Relief from liability for contraventions relating to the recall of"@en ; cml:realizedBy doc:sec-42vb-ss-2 ; cml:integrityHash "2e5c7a137962c02aab1ed8ce30f76605eb1a06905804468510701037b1c7cd5a" ; values:partOf concept:therapeutic-goods-act-1989-sec-42vb ; skos:note "Right to apply for relief from liability" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.278" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42vb-ss-2-norm . concept:therapeutic-goods-act-1989-sec-42vb-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42vb-ss-2 ; values:borneBy values:NaturalPerson ; skos:scopeNote "borne by: NaturalPerson" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42vb-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42vb-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42vb-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "May" ; cml:logicSummary "Right to apply" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42vb-ss-3 a cml:Concept ; skos:prefLabel "42VB(3) Relief from liability for contraventions relating to the recall of"@en ; cml:realizedBy doc:sec-42vb-ss-3 ; cml:integrityHash "5489d4cf7966fdaaeb26e461df070acdbdf741713c806bddd6efa7a92cd38bc8" ; values:partOf concept:therapeutic-goods-act-1989-sec-42vb ; skos:note "Granting relief from liability for contraventions relating to the recall of therapeutic goods." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.278" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42vb-ss-3-norm . concept:therapeutic-goods-act-1989-sec-42vb-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42vb-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42vb-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-42vb-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42vb-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Granting obligation" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42vb-ss-4 a cml:Concept ; skos:prefLabel "42VB(4) Relief from liability for contraventions relating to the recall of"@en ; cml:realizedBy doc:sec-42vb-ss-4 ; cml:integrityHash "c1a6af583d64a91a7811f826e594d75dd38c5d122f950f14b1fd7f986cf0c1ed" ; values:partOf concept:therapeutic-goods-act-1989-sec-42vb ; skos:note "Relief from liability for contraventions relating to the recall of" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.278" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42vb-ss-4-norm . concept:therapeutic-goods-act-1989-sec-42vb-ss-4-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42vb-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42vb-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-42vb-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42vb-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Imposes a duty on the State" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42vb-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-42vb-ss-4-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-42vb-ss-4-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "ClassInclusion" ; cml:logicSummary "Defines a subclass of 'contraventions'" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42w a cml:Concept ; skos:prefLabel "42W Supply etc. of therapeutic goods that are subject to recall"@en ; cml:realizedBy doc:sec-42w ; cml:integrityHash "10762e1094dbeeaba59c58cec8a91b71b99f2063f7f1f20e5c0e3e635f42b2df" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42w-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42w-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.279" . concept:therapeutic-goods-act-1989-sec-42w-ss-1 a cml:Concept ; skos:prefLabel "42W(1) Supply etc. of therapeutic goods that are subject to recall"@en ; cml:realizedBy doc:sec-42w-ss-1 ; cml:integrityHash "8565cc30b88cafe79344056522c771002f5f2989e7b0fc725bc2f42b97bc0b71" ; values:partOf concept:therapeutic-goods-act-1989-sec-42w ; skos:note "Supply of therapeutic goods subject to recall is prohibited." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.279" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42w-ss-1-norm . concept:therapeutic-goods-act-1989-sec-42w-ss-1-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42w-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42w-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42w-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42w-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits supply of therapeutic goods subject to recall." ; cml:premiseText "(1) A person commits an offence..." ; cml:conclusionText "...the person supplies therapeutic goods in Australia;" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42w-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42w-ss-1-logic-deontic-2 . concept:therapeutic-goods-act-1989-sec-42w-ss-1-logic-deontic-2 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits supply of therapeutic goods without consent." ; cml:premiseText "(c) the Secretary has not consented in writing to the supply." ; cml:conclusionText "...the person supplies therapeutic goods in Australia;" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42w-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42w-ss-1-logic-deontic-3 . concept:therapeutic-goods-act-1989-sec-42w-ss-1-logic-deontic-3 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits reckless supply of therapeutic goods subject to recall." ; cml:premiseText "(ii) the therapeutic goods are of such a kind, or are included in such a batch, and the person is reckless as to that fact;" ; cml:conclusionText "...the person supplies therapeutic goods in Australia;" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42w-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42w-ss-1-logic-alleninterval-4 . concept:therapeutic-goods-act-1989-sec-42w-ss-1-logic-alleninterval-4 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Temporal Interval" ; cml:logicSummary "Defines temporal interval for recall requirements." ; cml:premiseText "(i) the person knows that the therapeutic goods are of a kind, or are included in a batch, in respect of which requirements have been imposed..." ; cml:conclusionText "...requirements have been imposed under section 42V, on that person or another person, to recall therapeutic goods;" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42w-ss-2 a cml:Concept ; skos:prefLabel "42W(2) Supply etc. of therapeutic goods that are subject to recall"@en ; cml:realizedBy doc:sec-42w-ss-2 ; cml:integrityHash "cbc5f15d7e822c1300c86260329091878991a9e337f353fb2db07f824430fc57" ; values:partOf concept:therapeutic-goods-act-1989-sec-42w ; skos:note "Exporting therapeutic goods from Australia is prohibited." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.279" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42w-ss-2-norm . concept:therapeutic-goods-act-1989-sec-42w-ss-2-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42w-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42w-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42w-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42w-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits exportation of therapeutic goods." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42x a cml:Concept ; skos:prefLabel "42X Saving of other laws"@en ; cml:realizedBy doc:sec-42x ; cml:integrityHash "e447459c61041b466c76aa19bda75607567f8a205b926bcacfb43dd140f1cde6" ; skos:note "No exclusion or limitation of other laws" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.280" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42x-norm . concept:therapeutic-goods-act-1989-sec-42x-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42x ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42x cml:asserts concept:therapeutic-goods-act-1989-sec-42x-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42x-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "excludes" ; cml:logicSummary "Exclusion clause" ; cml:premiseText "No exclusion or limitation" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42y a cml:Concept ; skos:prefLabel "42Y Federal Court may order person to pay pecuniary penalty for"@en ; cml:realizedBy doc:sec-42y ; cml:integrityHash "e87c0ec939fd8e6eadbf09bfac450b20b64c5abcbec3a0facadf698d832f455e" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42y-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42y-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42y-ss-3 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.281" . concept:therapeutic-goods-act-1989-sec-42y-ss-1 a cml:Concept ; skos:prefLabel "42Y(1) Federal Court may order person to pay pecuniary penalty for"@en ; cml:realizedBy doc:sec-42y-ss-1 ; cml:integrityHash "c3a60be4f2188e4fddffd3f24178b4e513ef354fa8f05344040a1a8fff80df6e" ; values:partOf concept:therapeutic-goods-act-1989-sec-42y ; skos:note "Order to pay pecuniary penalty for contravening a civil penalty provision." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.281" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42y-ss-1-norm . concept:therapeutic-goods-act-1989-sec-42y-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42y-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42y-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42y-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42y-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "obligation" ; cml:logicSummary "Obligation to pay pecuniary penalty" ; cml:premiseText "Contravening a civil penalty provision" ; cml:conclusionText "Pay the Commonwealth a pecuniary penalty" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42y-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42y-ss-1-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-42y-ss-1-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "within-6-years" ; cml:logicSummary "Within 6 years of the wrongdoer's contravention" ; cml:premiseText "Time period" ; cml:conclusionText "Secretary may apply for an order within this time frame" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42y-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42y-ss-1-logic-argumentation-3 . concept:therapeutic-goods-act-1989-sec-42y-ss-1-logic-argumentation-3 a cml:LogicApplication ; cml:modality cml:Argumentation ; cml:operator "may-apply-on-behalf-of" ; cml:logicSummary "Secretary may apply on behalf of the Commonwealth" ; cml:premiseText "Commonwealth's interest" ; cml:conclusionText "Secretary has authority to act on behalf of the Commonwealth" ; cml:executionSurface "modalities::argumentation" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42y-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42y-ss-1-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-42y-ss-1-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "may-order" ; cml:logicSummary "May order wrongdoer to pay pecuniary penalty" ; cml:premiseText "Court's power" ; cml:conclusionText "Wrongdoer is subject to the court's order" ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42y-ss-2 a cml:Concept ; skos:prefLabel "42Y(2) Federal Court may order person to pay pecuniary penalty for"@en ; cml:realizedBy doc:sec-42y-ss-2 ; cml:integrityHash "92de092e553ce0b4a769692101e15643f005661248c56649a4bcbf281fff8fec" ; values:partOf concept:therapeutic-goods-act-1989-sec-42y ; skos:note "Order to pay pecuniary penalty for contravention of civil penalty provision" ; dc:description "pecuniary penalty amount" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.281" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42y-ss-2-norm . concept:therapeutic-goods-act-1989-sec-42y-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42y-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42y-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42y-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42y-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "obligation" ; cml:logicSummary "Legal obligation to pay pecuniary penalty" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42y-ss-3 a cml:Concept ; skos:prefLabel "42Y(3) Federal Court may order person to pay pecuniary penalty for"@en ; cml:realizedBy doc:sec-42y-ss-3 ; cml:integrityHash "f70a006a55a8414ab6c77a2529fa4b4f1bdecd701f72fe4f90dc76b95c30e06c" ; values:partOf concept:therapeutic-goods-act-1989-sec-42y ; skos:note "Court must consider certain factors when determining pecuniary penalty." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.281" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42y-ss-3-norm . concept:therapeutic-goods-act-1989-sec-42y-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42y-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42y-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-42y-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42y-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Court must consider certain factors." ; cml:premiseText "(3) In determining the pecuniary penalty, the Court..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42ya a cml:Concept ; skos:prefLabel "42YA What is a civil penalty provision?"@en ; cml:realizedBy doc:sec-42ya ; cml:integrityHash "440b0c533d29838f277721fc589819d7169a2f642ccccb75fd7e30736bb8e941" ; skos:note "Defines civil penalty provision" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.282" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42ya-norm . concept:therapeutic-goods-act-1989-sec-42ya-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42ya ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42ya cml:asserts concept:therapeutic-goods-act-1989-sec-42ya-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42ya-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "is defined as" ; cml:logicSummary "Defines a concept" ; cml:conclusionText "civil penalty provision" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yc a cml:Concept ; skos:prefLabel "42YC Persons involved in contravening civil penalty provision"@en ; cml:realizedBy doc:sec-42yc ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42yc-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42yc-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42yc-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42yc-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.282" . concept:therapeutic-goods-act-1989-sec-42yc-ss-1 a cml:Concept ; skos:prefLabel "42YC(1) Persons involved in contravening civil penalty provision"@en ; cml:realizedBy doc:sec-42yc-ss-1 ; cml:integrityHash "f03f82dd55045f406092838667b6592943dc47d17ab449ce392d54b1b6e1febd" ; values:partOf concept:therapeutic-goods-act-1989-sec-42yc ; skos:note "Continuation of obligation despite expired period or passed time. Aiding, abetting, or inducing a contravention of a civil penalty provision is prohibited." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.282" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42yc-ss-1-norm . concept:therapeutic-goods-act-1989-sec-42yc-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42yc-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yc-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42yc-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42yc-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "CONTINUES" ; cml:logicSummary "Continuation of obligation despite expired period or passed time." ; cml:premiseText "(1) If an act or thing is required under a civil penalty provision to be done:" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yc-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42yc-ss-1-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-42yc-ss-1-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "MEETS" ; cml:logicSummary "Requires a relation between identifiable temporal intervals." ; cml:premiseText "Conditional commencement is Undertaking, not Prohibition." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yc-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42yc-ss-1-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-42yc-ss-1-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "CONTAINS" ; cml:logicSummary "Requires an ordered or recurring trace." ; cml:premiseText "Do not invent a bearer, holder, condition, cross-reference, premise, or conclusion." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yc-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42yc-ss-1-logic-deontic-4 . concept:therapeutic-goods-act-1989-sec-42yc-ss-1-logic-deontic-4 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "APPLIES_TO" ; cml:logicSummary "Applicable to obligations." ; cml:premiseText "(1) If an act or thing is required under a civil penalty provision to be done:" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yc-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42yc-ss-1-logic-deontic-5 . concept:therapeutic-goods-act-1989-sec-42yc-ss-1-logic-deontic-5 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibition" ; cml:premiseText "(1) A person must not..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yc-ss-2 a cml:Concept ; skos:prefLabel "42YC(2) Persons involved in contravening civil penalty provision"@en ; cml:realizedBy doc:sec-42yc-ss-2 ; cml:integrityHash "859081201637f03f7d227ab33b6dbab0920641757d01d8dba55838e652388db0" ; values:partOf concept:therapeutic-goods-act-1989-sec-42yc ; skos:note "Separate contravention for each day of non-compliance Continuing contraventions of civil penalty provisions are obligations on the person involved." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.282" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42yc-ss-2-norm . concept:therapeutic-goods-act-1989-sec-42yc-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42yc-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yc-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42yc-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42yc-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibits contravention" ; cml:premiseText "(2) A person who contravenes a civil penalty provision..." ; cml:conclusionText "commits a separate contravention of that provision in respect of each day during which the contravention occurs" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yc-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42yc-ss-2-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-42yc-ss-2-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Overlaps" ; cml:logicSummary "Describes temporal overlap of contraventions" ; cml:premiseText "(2) A person who contravenes a civil penalty provision..." ; cml:conclusionText "each day during which the contravention occurs (including the day the order under subsection 42Y(2) is made or any later day)" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yc-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42yc-ss-2-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-42yc-ss-2-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Repeats" ; cml:logicSummary "Describes recurring nature of contraventions" ; cml:premiseText "(2) A person who contravenes a civil penalty provision..." ; cml:conclusionText "each day during which the contravention occurs (including the day the order under subsection 42Y(2) is made or any later day)" ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yc-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42yc-ss-2-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-42yc-ss-2-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "Diffuses" ; cml:logicSummary "Describes diffusion of contraventions over time" ; cml:premiseText "(2) A person who contravenes a civil penalty provision..." ; cml:conclusionText "each day during which the contravention occurs (including the day the order under subsection 42Y(2) is made or any later day)" ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yc-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42yc-ss-2-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-42yc-ss-2-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "Recognizes" ; cml:logicSummary "Describes recognition of contraventions by AI system" ; cml:premiseText "(2) A person who contravenes a civil penalty provision..." ; cml:conclusionText "each day during which the contravention occurs (including the day the order under subsection 42Y(2) is made or any later day)" ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yc-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42yc-ss-2-logic-deontic-6 . concept:therapeutic-goods-act-1989-sec-42yc-ss-2-logic-deontic-6 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "obligation" ; cml:logicSummary "Obligation" ; cml:conclusionText "The person involved must comply with the civil penalty provision." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yc-ss-1 a cml:Concept ; skos:prefLabel "42YC(1) Persons involved in contravening civil penalty provision"@en ; cml:realizedBy doc:sec-42yc-ss-1 ; cml:integrityHash "dac8da6da9cd415391744040ad03ce5ffe6315e03e6120eac9008d6d16c661cd" ; values:partOf concept:therapeutic-goods-act-1989-sec-42yc ; skos:note "Continuation of obligation despite expired period or passed time. Aiding, abetting, or inducing a contravention of a civil penalty provision is prohibited." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.282" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42yc-ss-1-norm . concept:therapeutic-goods-act-1989-sec-42yc-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42yc-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yc-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42yc-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42yc-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "CONTINUES" ; cml:logicSummary "Continuation of obligation despite expired period or passed time." ; cml:premiseText "(1) If an act or thing is required under a civil penalty provision to be done:" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yc-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42yc-ss-1-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-42yc-ss-1-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "MEETS" ; cml:logicSummary "Requires a relation between identifiable temporal intervals." ; cml:premiseText "Conditional commencement is Undertaking, not Prohibition." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yc-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42yc-ss-1-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-42yc-ss-1-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "CONTAINS" ; cml:logicSummary "Requires an ordered or recurring trace." ; cml:premiseText "Do not invent a bearer, holder, condition, cross-reference, premise, or conclusion." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yc-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42yc-ss-1-logic-deontic-4 . concept:therapeutic-goods-act-1989-sec-42yc-ss-1-logic-deontic-4 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "APPLIES_TO" ; cml:logicSummary "Applicable to obligations." ; cml:premiseText "(1) If an act or thing is required under a civil penalty provision to be done:" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yc-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42yc-ss-1-logic-deontic-5 . concept:therapeutic-goods-act-1989-sec-42yc-ss-1-logic-deontic-5 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibition" ; cml:premiseText "(1) A person must not..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yc-ss-2 a cml:Concept ; skos:prefLabel "42YC(2) Persons involved in contravening civil penalty provision"@en ; cml:realizedBy doc:sec-42yc-ss-2 ; cml:integrityHash "aebe20a21c5acf36ab146a4660752c515af3fd6d0f14c099307ee2f2b751f472" ; values:partOf concept:therapeutic-goods-act-1989-sec-42yc ; skos:note "Separate contravention for each day of non-compliance Continuing contraventions of civil penalty provisions are obligations on the person involved." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.282" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42yc-ss-2-norm . concept:therapeutic-goods-act-1989-sec-42yc-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42yc-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yc-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42yc-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42yc-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibits contravention" ; cml:premiseText "(2) A person who contravenes a civil penalty provision..." ; cml:conclusionText "commits a separate contravention of that provision in respect of each day during which the contravention occurs" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yc-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42yc-ss-2-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-42yc-ss-2-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Overlaps" ; cml:logicSummary "Describes temporal overlap of contraventions" ; cml:premiseText "(2) A person who contravenes a civil penalty provision..." ; cml:conclusionText "each day during which the contravention occurs (including the day the order under subsection 42Y(2) is made or any later day)" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yc-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42yc-ss-2-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-42yc-ss-2-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Repeats" ; cml:logicSummary "Describes recurring nature of contraventions" ; cml:premiseText "(2) A person who contravenes a civil penalty provision..." ; cml:conclusionText "each day during which the contravention occurs (including the day the order under subsection 42Y(2) is made or any later day)" ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yc-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42yc-ss-2-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-42yc-ss-2-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "Diffuses" ; cml:logicSummary "Describes diffusion of contraventions over time" ; cml:premiseText "(2) A person who contravenes a civil penalty provision..." ; cml:conclusionText "each day during which the contravention occurs (including the day the order under subsection 42Y(2) is made or any later day)" ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yc-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42yc-ss-2-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-42yc-ss-2-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "Recognizes" ; cml:logicSummary "Describes recognition of contraventions by AI system" ; cml:premiseText "(2) A person who contravenes a civil penalty provision..." ; cml:conclusionText "each day during which the contravention occurs (including the day the order under subsection 42Y(2) is made or any later day)" ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yc-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42yc-ss-2-logic-deontic-6 . concept:therapeutic-goods-act-1989-sec-42yc-ss-2-logic-deontic-6 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "obligation" ; cml:logicSummary "Obligation" ; cml:conclusionText "The person involved must comply with the civil penalty provision." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yd a cml:Concept ; skos:prefLabel "42YD Recovery of a pecuniary penalty"@en ; cml:realizedBy doc:sec-42yd ; cml:integrityHash "fc3e3971d83224ceca41d33aa68686d555dba3464a86be0416577e3b1f3dcb78" ; skos:note "The Commonwealth may enforce a pecuniary penalty order as if it were a judgment of the Court." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.283" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42yd-norm . concept:therapeutic-goods-act-1989-sec-42yd-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42yd ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yd cml:asserts concept:therapeutic-goods-act-1989-sec-42yd-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42yd-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MayEnforce" ; cml:logicSummary "The Commonwealth may enforce the order." ; cml:premiseText "The penalty is payable to the Commonwealth." ; cml:conclusionText "The Commonwealth may enforce the order as if it were a judgment of the Court." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42ye a cml:Concept ; skos:prefLabel "42YE Gathering information for application for pecuniary penalty"@en ; cml:realizedBy doc:sec-42ye ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42ye-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42ye-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.283" . concept:therapeutic-goods-act-1989-sec-42ye-ss-1 a cml:Concept ; skos:prefLabel "42YE(1) Gathering information for application for pecuniary penalty"@en ; cml:realizedBy doc:sec-42ye-ss-1 ; cml:integrityHash "e63782e8b1d5cfd89cf12239e543c1070420c4d5223db3185823d6cd341e6ac9" ; values:partOf concept:therapeutic-goods-act-1989-sec-42ye ; skos:note "Duty to gather information for pecuniary penalty application" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.283" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42ye-ss-1-norm . concept:therapeutic-goods-act-1989-sec-42ye-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42ye-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42ye-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42ye-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42ye-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Duty obligation" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42ye-ss-2 a cml:Concept ; skos:prefLabel "42YE(2) Gathering information for application for pecuniary penalty"@en ; cml:realizedBy doc:sec-42ye-ss-2 ; cml:integrityHash "5126d0652991cd0dee19fd0d97039b812c6cc7dd083026b3771fb6f36976cb3a" ; values:partOf concept:therapeutic-goods-act-1989-sec-42ye ; skos:note "Secretary may require person to give assistance in connection with application for civil penalty order." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.283" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42ye-ss-2-norm . concept:therapeutic-goods-act-1989-sec-42ye-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42ye-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42ye-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42ye-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42ye-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "Obligation to provide assistance" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yf a cml:Concept ; skos:prefLabel "42YF Civil proceedings after criminal proceedings"@en ; cml:realizedBy doc:sec-42yf ; cml:integrityHash "1f1163bb26ddf3f3893280cfe76484b828fbc699e9001100ec94501fa4dadb10" ; skos:note "Federal Court cannot impose pecuniary penalty order on a person convicted of an offence substantially similar to the contravention." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.285" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42yf-norm . concept:therapeutic-goods-act-1989-sec-42yf-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42yf ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yf cml:asserts concept:therapeutic-goods-act-1989-sec-42yf-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42yf-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Cannot" ; cml:logicSummary "Prohibition of pecuniary penalty order" ; cml:premiseText "Federal Court must not make a pecuniary penalty order" ; cml:conclusionText "against a person convicted of an offence substantially similar to the contravention" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yf cml:asserts concept:therapeutic-goods-act-1989-sec-42yf-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-42yf-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Temporal overlap" ; cml:logicSummary "Temporal intervals of conviction and contravention must overlap" ; cml:premiseText "Conviction of an offence constituting substantially similar conduct to the contravention" ; cml:conclusionText "must be considered when imposing pecuniary penalty order" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yf cml:asserts concept:therapeutic-goods-act-1989-sec-42yf-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-42yf-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Recurring trace" ; cml:logicSummary "Recurring traces of conviction and contravention must be considered" ; cml:premiseText "Conviction of an offence substantially similar to the contravention" ; cml:conclusionText "must be taken into account when imposing pecuniary penalty order" ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yf cml:asserts concept:therapeutic-goods-act-1989-sec-42yf-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-42yf-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "Diffusive effect" ; cml:logicSummary "Diffusive effect of conviction on contravention must be considered" ; cml:premiseText "Conviction of an offence substantially similar to the contravention" ; cml:conclusionText "must be taken into account when imposing pecuniary penalty order" ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yf cml:asserts concept:therapeutic-goods-act-1989-sec-42yf-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-42yf-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "Knowledge-based system" ; cml:logicSummary "Knowledge-based system must consider conviction and contravention" ; cml:premiseText "Federal Court must not make a pecuniary penalty order against a person convicted of an offence substantially similar to the contravention" ; cml:conclusionText "must be taken into account when imposing pecuniary penalty order" ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yg a cml:Concept ; skos:prefLabel "42YG Criminal proceedings during civil proceedings"@en ; cml:realizedBy doc:sec-42yg ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42yg-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42yg-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.285" . concept:therapeutic-goods-act-1989-sec-42yg-ss-1 a cml:Concept ; skos:prefLabel "42YG(1) Criminal proceedings during civil proceedings"@en ; cml:realizedBy doc:sec-42yg-ss-1 ; cml:integrityHash "732c99a75cdb6b11295c4964aa26732fce54a74898c3222ad38b8645fc7869a1" ; values:partOf concept:therapeutic-goods-act-1989-sec-42yg ; skos:note "Stay of pecuniary penalty order proceedings during criminal proceedings for same offence." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.285" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42yg-ss-1-norm . concept:therapeutic-goods-act-1989-sec-42yg-ss-1-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42yg-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yg-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42yg-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42yg-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prevents pecuniary penalty order proceedings during criminal proceedings for same offence." ; cml:premiseText "(a) criminal proceedings are started or have already been started against the person for an offence; and (b) the offence is constituted by conduct that is substantially the same as the conduct alleged to constitute the contravention." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yg-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42yg-ss-1-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-42yg-ss-1-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Overlaps" ; cml:logicSummary "Defines a temporal overlap between criminal proceedings and pecuniary penalty order proceedings." ; cml:premiseText "(a) criminal proceedings are started or have already been started against the person for an offence; and (b) the offence is constituted by conduct that is substantially the same as the conduct alleged to constitute the contravention." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yg-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42yg-ss-1-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-42yg-ss-1-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Recurrently" ; cml:logicSummary "Defines a recurring relationship between criminal proceedings and pecuniary penalty order proceedings." ; cml:premiseText "(a) criminal proceedings are started or have already been started against the person for an offence; and (b) the offence is constituted by conduct that is substantially the same as the conduct alleged to constitute the contravention." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yg-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42yg-ss-1-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-42yg-ss-1-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "Diffuses" ; cml:logicSummary "Diffuses the prohibition of pecuniary penalty order proceedings during criminal proceedings for same offence." ; cml:premiseText "(a) criminal proceedings are started or have already been started against the person for an offence; and (b) the offence is constituted by conduct that is substantially the same as the conduct alleged to constitute the contravention." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yg-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42yg-ss-1-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-42yg-ss-1-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "Recognizes" ; cml:logicSummary "Recognizes the prohibition of pecuniary penalty order proceedings during criminal proceedings for same offence." ; cml:premiseText "(a) criminal proceedings are started or have already been started against the person for an offence; and (b) the offence is constituted by conduct that is substantially the same as the conduct alleged to constitute the contravention." ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yg-ss-2 a cml:Concept ; skos:prefLabel "42YG(2) Criminal proceedings during civil proceedings"@en ; cml:realizedBy doc:sec-42yg-ss-2 ; cml:integrityHash "6809eb957260185e2c23cc179276b59e101819e7def754d87f62d4d229c6871a" ; values:partOf concept:therapeutic-goods-act-1989-sec-42yg ; skos:note "Proceedings for order may be resumed if not convicted." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.285" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42yg-ss-2-norm . concept:therapeutic-goods-act-1989-sec-42yg-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42yg-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yg-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42yg-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42yg-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "resume" ; cml:logicSummary "Resumption of proceedings" ; cml:premiseText "(2) The proceedings for the order may be resumed..." ; cml:conclusionText "...the proceedings for the order are dismissed." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yh a cml:Concept ; skos:prefLabel "42YH Criminal proceedings after civil proceedings"@en ; cml:realizedBy doc:sec-42yh ; cml:integrityHash "74189f65ca31bb32041099f1e1ccf2239aa77da7b9533bfdb3ba236eb7651070" ; skos:note "Criminal proceedings cannot start against conduct substantially similar to a civil penalty provision if a pecuniary penalty order has been made." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.285" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42yh-norm . concept:therapeutic-goods-act-1989-sec-42yh-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42yh ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yh cml:asserts concept:therapeutic-goods-act-1989-sec-42yh-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42yh-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "forbid" ; cml:logicSummary "Prohibits criminal proceedings against similar conduct." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yi a cml:Concept ; skos:prefLabel "42YI Evidence given in proceedings for civil penalty not admissible"@en ; cml:realizedBy doc:sec-42yi ; cml:integrityHash "a73ec733acf5bacc42d56d003d9c918a685e31202526fe20eeaa4e96ac0e1ca2" ; skos:note "Evidence of information given or production of documents by an individual is not admissible in criminal proceedings against the individual." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.285" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42yi-norm . concept:therapeutic-goods-act-1989-sec-42yi-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42yi ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yj a cml:Concept ; skos:prefLabel "42YJ Simplified outline of this Part"@en ; cml:realizedBy doc:sec-42yj ; cml:integrityHash "a6bb8b6ed975339a5fd83004ad1c14e3a776f22bf2892a2d91d269b500be4d22" ; skos:note "Secretary can issue infringement notice for contravention of Act or regulations." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.287" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42yj-norm . concept:therapeutic-goods-act-1989-sec-42yj-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42yj ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yj cml:asserts concept:therapeutic-goods-act-1989-sec-42yj-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42yj-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "can" ; cml:logicSummary "Secretary can issue infringement notice." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yk a cml:Concept ; skos:prefLabel "42YK When an infringement notice may be given"@en ; cml:realizedBy doc:sec-42yk ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42yk-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42yk-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42yk-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42yk-ss-4 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.287" . concept:therapeutic-goods-act-1989-sec-42yk-ss-1 a cml:Concept ; skos:prefLabel "42YK(1) When an infringement notice may be given"@en ; cml:realizedBy doc:sec-42yk-ss-1 ; cml:integrityHash "a709fdede52631216054df095a4655d44d7d4cd352224c5e377df2eeef3dffb3" ; values:partOf concept:therapeutic-goods-act-1989-sec-42yk ; skos:note "Secretary may give infringement notice for alleged contravention." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.287" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42yk-ss-1-norm . concept:therapeutic-goods-act-1989-sec-42yk-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42yk-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yk-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42yk-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42yk-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "Implies obligation." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yk-ss-2 a cml:Concept ; skos:prefLabel "42YK(2) When an infringement notice may be given"@en ; cml:realizedBy doc:sec-42yk-ss-2 ; cml:integrityHash "efbfebdeffd3646a8d25c036cd4a5c1fbd9b888f73ec7eda65a983f3abc4eb4a" ; values:partOf concept:therapeutic-goods-act-1989-sec-42yk ; skos:note "Infringement notice must be given within 12 months after contravention." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.287" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42yk-ss-2-norm . concept:therapeutic-goods-act-1989-sec-42yk-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42yk-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yk-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42yk-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42yk-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Obligation to give infringement notice within 12 months." ; cml:premiseText "(2) The infringement notice must be given..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yk-ss-3 a cml:Concept ; skos:prefLabel "42YK(3) When an infringement notice may be given"@en ; cml:realizedBy doc:sec-42yk-ss-3 ; cml:integrityHash "ba0f0ec4033417a534a67ae0bc9041b729f19bbbcfa33360f3d6e8b603e22395" ; values:partOf concept:therapeutic-goods-act-1989-sec-42yk ; skos:note "A single infringement notice must relate only to a single contravention of a single provision." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.287" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42yk-ss-3-norm . concept:therapeutic-goods-act-1989-sec-42yk-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42yk-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yk-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-42yk-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42yk-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "necessity" ; cml:logicSummary "Single infringement notice must relate to a single contravention." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yk-ss-4 a cml:Concept ; skos:prefLabel "42YK(4) When an infringement notice may be given"@en ; cml:realizedBy doc:sec-42yk-ss-4 ; cml:integrityHash "69fb99c91f59894975fe2d383c1cfe574e2105f3b42f055c62ae6c66446fbe11" ; values:partOf concept:therapeutic-goods-act-1989-sec-42yk ; skos:note "Secretary may give a person an infringement notice relating to multiple contraventions of a single provision if certain conditions are met." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.287" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42yk-ss-4-norm . concept:therapeutic-goods-act-1989-sec-42yk-ss-4-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42yk-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yk-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-42yk-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42yk-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "Secretary may give an infringement notice" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yl a cml:Concept ; skos:prefLabel "42YL Enforcement of undertakings"@en ; cml:realizedBy doc:sec-42yl ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42yl-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42yl-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42yl-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42yl-ss-4 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42yl-ss-5 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.295" . concept:therapeutic-goods-act-1989-sec-42yl-ss-1 a cml:Concept ; skos:prefLabel "42YL(1) Enforcement of undertakings"@en ; cml:realizedBy doc:sec-42yl-ss-1 ; cml:integrityHash "78c0e42099f7170a1f3769cad8f97a9ff71640fb743b17cf8a51f4c29a1196e7" ; values:partOf concept:therapeutic-goods-act-1989-sec-42yl ; skos:note "Secretary may accept written undertaking from person in connection with a matter." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.295" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42yl-ss-1-norm . concept:therapeutic-goods-act-1989-sec-42yl-ss-1-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42yl-ss-1 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yl-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42yl-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42yl-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "acceptance" ; cml:logicSummary "Acceptance of undertaking" ; cml:premiseText "(1) The Secretary may accept a written undertaking..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yl-ss-2 a cml:Concept ; skos:prefLabel "42YL(2) Enforcement of undertakings"@en ; cml:realizedBy doc:sec-42yl-ss-2 ; cml:integrityHash "ecbd0992398e8907cdd8b72a5c4da3ffc7771042dbfb8ae27f35d7e1561b2250" ; values:partOf concept:therapeutic-goods-act-1989-sec-42yl ; skos:note "The person may withdraw or vary the undertaking with consent from the Secretary." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.295" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42yl-ss-2-norm . concept:therapeutic-goods-act-1989-sec-42yl-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42yl-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yl-ss-3 a cml:Concept ; skos:prefLabel "42YL(3) Enforcement of undertakings"@en ; cml:realizedBy doc:sec-42yl-ss-3 ; cml:integrityHash "465301282254efbf35ae32b413253da3902801133c4afcbedc2aceedba1a5afe" ; values:partOf concept:therapeutic-goods-act-1989-sec-42yl ; skos:note "Secretary must publish details of undertaking on the internet." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.295" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42yl-ss-3-norm . concept:therapeutic-goods-act-1989-sec-42yl-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42yl-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yl-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-42yl-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42yl-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must publish details" ; cml:conclusionText "The Secretary must publish..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yl-ss-4 a cml:Concept ; skos:prefLabel "42YL(4) Enforcement of undertakings"@en ; cml:realizedBy doc:sec-42yl-ss-4 ; cml:integrityHash "ea84486e1dfe4a062cd7cd6e19f3659f8a05716264011671bc83e28b434bdedd" ; values:partOf concept:therapeutic-goods-act-1989-sec-42yl ; skos:note "Secretary may apply for order if undertaking is breached" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.295" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42yl-ss-4-norm . concept:therapeutic-goods-act-1989-sec-42yl-ss-4-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42yl-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yl-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-42yl-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42yl-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "May apply for order" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yl-ss-5 a cml:Concept ; skos:prefLabel "42YL(5) Enforcement of undertakings"@en ; cml:realizedBy doc:sec-42yl-ss-5 ; cml:integrityHash "da8a864732f059b045c128da653b95f49fe84883ee6e0a3a165a9fcbec844145" ; values:partOf concept:therapeutic-goods-act-1989-sec-42yl ; skos:note "Court may make orders to enforce breach of undertaking." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.295" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42yl-ss-5-norm . concept:therapeutic-goods-act-1989-sec-42yl-ss-5-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42yl-ss-5 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yl-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-42yl-ss-5-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42yl-ss-5-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "obligation" ; cml:logicSummary "Enforcement obligation" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42ym a cml:Concept ; skos:prefLabel "42YM Simplified outline of this Part"@en ; cml:realizedBy doc:sec-42ym ; cml:integrityHash "677142dce40942b1d3619e607b3e7b778bba3426c1b3e578a6db652877ed9f3f" ; skos:note "Secretary can seek injunctions from Federal Court or Family Court to restrain contravention of Act or regulations." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.296" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42ym-norm . concept:therapeutic-goods-act-1989-sec-42ym-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42ym ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42ym cml:asserts concept:therapeutic-goods-act-1989-sec-42ym-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42ym-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "can" ; cml:logicSummary "Possibility of obligation" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yn a cml:Concept ; skos:prefLabel "42YN Grant of injunctions"@en ; cml:realizedBy doc:sec-42yn ; cml:integrityHash "2d2c65f99dde74f1ab7c119c57cb3de705b9b8ab95606cbf75f223056d2ecaa7" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42yn-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42yn-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.296" . concept:therapeutic-goods-act-1989-sec-42yn-ss-1 a cml:Concept ; skos:prefLabel "42YN(1) Grant of injunctions"@en ; cml:realizedBy doc:sec-42yn-ss-1 ; cml:integrityHash "508b327ec50e7d3e1cbc5ff6daa52071e154beeb6ea9a5ecc2af7681781be4d4" ; values:partOf concept:therapeutic-goods-act-1989-sec-42yn ; skos:note "Grant of injunctions for conduct in contravention of the Act or regulations." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.296" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42yn-ss-1-norm . concept:therapeutic-goods-act-1989-sec-42yn-ss-1-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42yn-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yn-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42yn-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42yn-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits conduct in contravention of the Act or regulations." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yn-ss-2 a cml:Concept ; skos:prefLabel "42YN(2) Grant of injunctions"@en ; cml:realizedBy doc:sec-42yn-ss-2 ; cml:integrityHash "61643e4f92fa28fe0d9ca9fc0b47d6e3f0c1693430c46e53e4517047cbd7a885" ; values:partOf concept:therapeutic-goods-act-1989-sec-42yn ; skos:note "Grant of injunctions for refusal or failure to comply with the Act" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.296" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42yn-ss-2-norm . concept:therapeutic-goods-act-1989-sec-42yn-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42yn-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yn-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42yn-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42yn-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "obligation" ; cml:logicSummary "Obligation to comply with the Act" ; cml:premiseText "(2) If..." ; cml:conclusionText "the Federal Court or Federal Circuit and Family Court of Australia may grant an injunction requiring the person to do that thing." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yo a cml:Concept ; skos:prefLabel "42YO Interim injunctions"@en ; cml:realizedBy doc:sec-42yo ; cml:integrityHash "6f4949595625000bdae8f6ffe6c4c76b3a8b946481c3fe5058026fcac4fb69cd" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42yo-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42yo-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.297" . concept:therapeutic-goods-act-1989-sec-42yo-ss-1 a cml:Concept ; skos:prefLabel "42YO(1) Interim injunctions"@en ; cml:realizedBy doc:sec-42yo-ss-1 ; cml:integrityHash "42d90cada066216010dfefc4f5fa3f5fb9f1c59879985ab147c004e55934a06f" ; values:partOf concept:therapeutic-goods-act-1989-sec-42yo ; skos:note "Restraining conduct" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.297" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42yo-ss-1-norm . concept:therapeutic-goods-act-1989-sec-42yo-ss-1-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42yo-ss-1 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yo-ss-2 a cml:Concept ; skos:prefLabel "42YO(2) Interim injunctions"@en ; cml:realizedBy doc:sec-42yo-ss-2 ; cml:integrityHash "ee16bb18663138093e40ef6f1928a95f489761209bad0861b11f6a0219291b60" ; values:partOf concept:therapeutic-goods-act-1989-sec-42yo ; skos:note "Cannot require the Secretary to give an undertaking as a condition of granting an interim injunction." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.297" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42yo-ss-2-norm . concept:therapeutic-goods-act-1989-sec-42yo-ss-2-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42yo-ss-2 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yo-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42yo-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42yo-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "cannot" ; cml:logicSummary "Cannot require the Secretary to give an undertaking as a condition of granting an interim injunction." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yp a cml:Concept ; skos:prefLabel "42YP Discharging or varying injunctions"@en ; cml:realizedBy doc:sec-42yp ; cml:integrityHash "148351955c551ac69066da5c39bbc1f85a6a0aa8fb7b60b0dea2e5e4332a105f" ; skos:note "May discharge or vary an injunction granted by that court under this Part." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.297" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42yp-norm . concept:therapeutic-goods-act-1989-sec-42yp-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42yp ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yp cml:asserts concept:therapeutic-goods-act-1989-sec-42yp-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42yp-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "Permits discharge or variation of an injunction" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yq a cml:Concept ; skos:prefLabel "42YQ Certain limits on granting injunctions not to apply"@en ; cml:realizedBy doc:sec-42yq ; cml:integrityHash "acf5a9d3496a06038c2adcaa55b9d68e54f378d7a6a084e0481029a33178d9b3" ; skos:note "Court may grant injunction without considering intent or previous conduct." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.297" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42yq-norm . concept:therapeutic-goods-act-1989-sec-42yq-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42yq ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yq cml:asserts concept:therapeutic-goods-act-1989-sec-42yq-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42yq-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Permit" ; cml:logicSummary "Court permits exercise of power to grant injunction." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yr a cml:Concept ; skos:prefLabel "42YR Other powers of court unaffected"@en ; cml:realizedBy doc:sec-42yr ; cml:integrityHash "321527a650447a14f5fda26e46a4d01afb7857a21f46d18d23d15b9b178ff866" ; skos:note "Court's other powers unaffected" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.298" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42yr-norm . concept:therapeutic-goods-act-1989-sec-42yr-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42yr ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42ys a cml:Concept ; skos:prefLabel "42YS Simplified outline of this Part"@en ; cml:realizedBy doc:sec-42ys ; cml:integrityHash "aa146065c90516b0b16c6d4daee20e892ccbcc10bac51a372741edf2ce1704fb" ; skos:note "Secretary may give directions to a person requiring specified actions in relation to goods." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.299" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42ys-norm . concept:therapeutic-goods-act-1989-sec-42ys-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42ys ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42ys cml:asserts concept:therapeutic-goods-act-1989-sec-42ys-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42ys-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "Secretary may give directions." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yt a cml:Concept ; skos:prefLabel "42YT Secretary may give directions if this Act or an instrument is"@en ; cml:realizedBy doc:sec-42yt ; cml:integrityHash "431453420261e6be76470816198413991bfc3f0510f141c6f917be6292954ca3" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42yt-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-42yt-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.299" . concept:therapeutic-goods-act-1989-sec-42yt-ss-1 a cml:Concept ; skos:prefLabel "42YT(1) Secretary may give directions if this Act or an instrument is"@en ; cml:realizedBy doc:sec-42yt-ss-1 ; cml:integrityHash "4becc095fb4112042c9d3c8cc1abf723719464344fd5a6637cb48cca4cca49da" ; values:partOf concept:therapeutic-goods-act-1989-sec-42yt ; skos:note "Secretary may give directions if this Act or an instrument is not complying with the Act in relation to particular goods." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.299" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42yt-ss-1-norm . concept:therapeutic-goods-act-1989-sec-42yt-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42yt-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yt-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42yt-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42yt-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "Secretary may give directions" ; cml:premiseText "This section applies if the Secretary believes..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yt-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42yt-ss-1-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-42yt-ss-1-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "if the Secretary believes on reasonable grounds that..." ; cml:logicSummary "Conditional commencement" ; cml:premiseText "it is in the interests of public health or safety to give the person directions under this section." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yt-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42yt-ss-1-logic-deontic-3 . concept:therapeutic-goods-act-1989-sec-42yt-ss-1-logic-deontic-3 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "is not complying with this Act or an instrument" ; cml:logicSummary "Non-compliance with the Act" ; cml:premiseText "(a) a person is not complying with this Act or an instrument made under this Act in relation to particular goods;" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yt-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42yt-ss-1-logic-deontic-4 . concept:therapeutic-goods-act-1989-sec-42yt-ss-1-logic-deontic-4 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "is in the interests of public health or safety" ; cml:logicSummary "Public health or safety interest" ; cml:premiseText "it is in the interests of public health or safety to give the person directions under this section." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yt-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-42yt-ss-1-logic-deontic-5 . concept:therapeutic-goods-act-1989-sec-42yt-ss-1-logic-deontic-5 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "to give the person directions" ; cml:logicSummary "Giving directions" ; cml:premiseText "it is in the interests of public health or safety to give the person directions under this section." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yt-ss-2 a cml:Concept ; skos:prefLabel "42YT(2) Secretary may give directions if this Act or an instrument is"@en ; cml:realizedBy doc:sec-42yt-ss-2 ; cml:integrityHash "02bed4be26ea35ecd8bdf82d209fae00fe6c8026de78363de90f2c1270729125" ; values:partOf concept:therapeutic-goods-act-1989-sec-42yt ; skos:note "Secretary may give directions to a person regarding the relabeling, repackaging, or disposal of goods." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.299" ; cml:asserts concept:therapeutic-goods-act-1989-sec-42yt-ss-2-norm . concept:therapeutic-goods-act-1989-sec-42yt-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-42yt-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-42yt-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-42yt-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-42yt-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "Implies obligation" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-43 a cml:Concept ; skos:prefLabel "43 By whom charges payable"@en ; cml:realizedBy doc:sec-43 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-43-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-43-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-43-ss-3 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.301" . concept:therapeutic-goods-act-1989-sec-43-ss-1 a cml:Concept ; skos:prefLabel "43(1) By whom charges payable"@en ; cml:realizedBy doc:sec-43-ss-1 ; cml:integrityHash "37cdc2772810f5ca91fda6bc6d8113b3b8f9f9b1872c524ffdc853c9817027cf" ; values:partOf concept:therapeutic-goods-act-1989-sec-43 ; skos:note "Annual registration charge payable by person in relation to whom therapeutic goods are registered, listed or included." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.301" ; cml:asserts concept:therapeutic-goods-act-1989-sec-43-ss-1-norm . concept:therapeutic-goods-act-1989-sec-43-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-43-ss-1 ; values:borneBy values:NaturalPerson ; skos:scopeNote "borne by: NaturalPerson" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-43-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-43-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-43-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Imposes a duty on the person to pay the annual registration charge." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-43-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-43-ss-1-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-43-ss-1-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Overlaps" ; cml:logicSummary "Specifies the temporal interval during which the annual registration charge must be paid." ; cml:premiseText "Annual" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-43-ss-2 a cml:Concept ; skos:prefLabel "43(2) By whom charges payable"@en ; cml:realizedBy doc:sec-43-ss-2 ; cml:integrityHash "34ce0cc9b9f8b32ef4c7e4b0aee2cbfc25cb0486e30090983d22bcd9b948c330" ; values:partOf concept:therapeutic-goods-act-1989-sec-43 ; skos:note "Annual licensing charge payable by licence holder" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.301" ; cml:asserts concept:therapeutic-goods-act-1989-sec-43-ss-2-norm . concept:therapeutic-goods-act-1989-sec-43-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-43-ss-2 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-43-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-43-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-43-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "payable by" ; cml:logicSummary "Obligation to pay annual licensing charge" ; cml:premiseText "holder of the licence" ; cml:conclusionText "annual licensing charge" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-43-ss-3 a cml:Concept ; skos:prefLabel "43(3) By whom charges payable"@en ; cml:realizedBy doc:sec-43-ss-3 ; cml:integrityHash "c244f40686302b37f238680cc1a935289da74339501c1a02f1cc37becc30245f" ; values:partOf concept:therapeutic-goods-act-1989-sec-43 ; skos:note "Annual conformity assessment body determination charge payable by Australian corporation" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.301" ; cml:asserts concept:therapeutic-goods-act-1989-sec-43-ss-3-norm . concept:therapeutic-goods-act-1989-sec-43-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-43-ss-3 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-43-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-43-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-43-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Payable obligation" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-44 a cml:Concept ; skos:prefLabel "44 Time for payment of charges"@en ; cml:realizedBy doc:sec-44 ; cml:integrityHash "977e3c9571f343d532a7a03ac9b32e1423abf755ab774feecd0a43a7ac706d67" ; skos:note "Annual registration charge becomes payable on a specific date." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.301" ; cml:asserts concept:therapeutic-goods-act-1989-sec-44-norm . concept:therapeutic-goods-act-1989-sec-44-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-44 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-44 cml:asserts concept:therapeutic-goods-act-1989-sec-44-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-44-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Imposes an obligation" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-44a a cml:Concept ; skos:prefLabel "44A Exemptions from liability to pay charges"@en ; cml:realizedBy doc:sec-44a ; cml:hasPart concept:therapeutic-goods-act-1989-sec-44a-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-44a-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-44a-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-44a-ss-4 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-44a-ss-5 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.302" . concept:therapeutic-goods-act-1989-sec-44a-ss-1 a cml:Concept ; skos:prefLabel "44A(1) Exemptions from liability to pay charges"@en ; cml:realizedBy doc:sec-44a-ss-1 ; cml:integrityHash "0b4da6d848cc6c33e16c2ef776d27265066b4d03a37a34e667e49c50d4881736" ; values:partOf concept:therapeutic-goods-act-1989-sec-44a ; skos:note "Exemptions from liability to pay charges" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.302" ; cml:asserts concept:therapeutic-goods-act-1989-sec-44a-ss-1-norm . concept:therapeutic-goods-act-1989-sec-44a-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-44a-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-44a-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-44a-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-44a-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "exemption" ; cml:logicSummary "Exempts a person from liability to pay annual registration charge" ; cml:premiseText "(1) The regulations may make provision for and in relation to:" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-44a-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-44a-ss-1-logic-deontic-2 . concept:therapeutic-goods-act-1989-sec-44a-ss-1-logic-deontic-2 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "requirement" ; cml:logicSummary "Requires payment of charge for current year if application is refused" ; cml:premiseText "(b) the making of an application for an exemption and requiring payment of that charge for the current year if the application is refused;" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-44a-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-44a-ss-1-logic-deontic-3 . concept:therapeutic-goods-act-1989-sec-44a-ss-1-logic-deontic-3 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "cancellation" ; cml:logicSummary "Cancels exemption and requires payment of charge for current year" ; cml:premiseText "(c) cancelling an exemption and requiring payment of that charge for the current year." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-44a-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-44a-ss-1-logic-alleninterval-4 . concept:therapeutic-goods-act-1989-sec-44a-ss-1-logic-alleninterval-4 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "temporal interval" ; cml:logicSummary "Temporal interval for exemptions" ; cml:premiseText "if the person’s turnover of the therapeutic goods concerned for the financial year specified in the regulations is of low value;" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-44a-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-44a-ss-1-logic-deontic-5 . concept:therapeutic-goods-act-1989-sec-44a-ss-1-logic-deontic-5 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "exemption" ; cml:logicSummary "Exempts a person from liability to pay annual listing charge or annual charge for inclusion in the Register" ; cml:premiseText "(a) exempting a person from liability to pay annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year (the current year) if the person’s turnover of the therapeutic goods concerned for the financial year specified in the regulations is of low value;" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-44a-ss-2 a cml:Concept ; skos:prefLabel "44A(2) Exemptions from liability to pay charges"@en ; cml:realizedBy doc:sec-44a-ss-2 ; cml:integrityHash "96646670dc10834f5fe688472ec79a1a3635e9a6955c6cbde41d8d033939442c" ; values:partOf concept:therapeutic-goods-act-1989-sec-44a ; skos:note "Fee for exemption applications must not amount to taxation." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.302" ; cml:asserts concept:therapeutic-goods-act-1989-sec-44a-ss-2-norm . concept:therapeutic-goods-act-1989-sec-44a-ss-2-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-44a-ss-2 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-44a-ss-3 a cml:Concept ; skos:prefLabel "44A(3) Exemptions from liability to pay charges"@en ; cml:realizedBy doc:sec-44a-ss-3 ; cml:integrityHash "efb5ba3b10a6802068182a388246bc2da61c6c053e88a8035a9ab02bc3f8c5aa" ; values:partOf concept:therapeutic-goods-act-1989-sec-44a ; skos:note "Person must provide statement upon exemption application or grant" ; dc:description "true" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.302" ; cml:asserts concept:therapeutic-goods-act-1989-sec-44a-ss-3-norm . concept:therapeutic-goods-act-1989-sec-44a-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-44a-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-44a-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-44a-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-44a-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must provide statement" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-44a-ss-4 a cml:Concept ; skos:prefLabel "44A(4) Exemptions from liability to pay charges"@en ; cml:realizedBy doc:sec-44a-ss-4 ; cml:integrityHash "be17caf0091f9ab994e806b915c2e3a0734b964bb64c7da70d865a7317e2ffa4" ; values:partOf concept:therapeutic-goods-act-1989-sec-44a ; skos:note "Regulations may obtain additional information or documents from applicants for exemptions." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.302" ; cml:asserts concept:therapeutic-goods-act-1989-sec-44a-ss-4-norm . concept:therapeutic-goods-act-1989-sec-44a-ss-4-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-44a-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-44a-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-44a-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-44a-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "Regulations may obtain additional information or documents." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-44a-ss-5 a cml:Concept ; skos:prefLabel "44A(5) Exemptions from liability to pay charges"@en ; cml:realizedBy doc:sec-44a-ss-5 ; cml:integrityHash "8cc86816edccc768da2061066831124e166edb01da61cd83ed0df38a19954a05" ; values:partOf concept:therapeutic-goods-act-1989-sec-44a ; skos:note "Review of exemptions by Administrative Review Tribunal" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.302" ; cml:asserts concept:therapeutic-goods-act-1989-sec-44a-ss-5-norm . concept:therapeutic-goods-act-1989-sec-44a-ss-5-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-44a-ss-5 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-44a-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-44a-ss-5-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-44a-ss-5-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Obligation to review exemptions" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-44b a cml:Concept ; skos:prefLabel "44B Recovery of unpaid charges"@en ; cml:realizedBy doc:sec-44b ; cml:integrityHash "31ba6f81b31f77db1c377a455200e1a54ae84bcc24c97f128af4bac6e07bf0c9" ; skos:note "Recovery of unpaid charges after 28 days" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.304" ; cml:asserts concept:therapeutic-goods-act-1989-sec-44b-norm . concept:therapeutic-goods-act-1989-sec-44b-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-44b ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-44b cml:asserts concept:therapeutic-goods-act-1989-sec-44b-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-44b-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Obligation to recover unpaid charges" ; cml:premiseText "Charge becomes payable after 28 days" ; cml:conclusionText "Recovery of charge due to Commonwealth" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45 a cml:Concept ; skos:prefLabel "45 Therapeutic Goods Administration Account"@en ; cml:realizedBy doc:sec-45 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-45-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-45-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-45-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-45-ss-4 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.305" . concept:therapeutic-goods-act-1989-sec-45-ss-1 a cml:Concept ; skos:prefLabel "45(1) Therapeutic Goods Administration Account"@en ; cml:realizedBy doc:sec-45-ss-1 ; cml:integrityHash "d42b7f1ad34a46bbe256a3710a8060fe4bee128e364472a10f5f084f61796382" ; values:partOf concept:therapeutic-goods-act-1989-sec-45 ; skos:note "Continued existence of Therapeutic Goods Administration Account" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.305" ; cml:asserts concept:therapeutic-goods-act-1989-sec-45-ss-1-norm . concept:therapeutic-goods-act-1989-sec-45-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-45-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-45-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-45-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Exists" ; cml:logicSummary "Account exists" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45-ss-2 a cml:Concept ; skos:prefLabel "45(2) Therapeutic Goods Administration Account"@en ; cml:realizedBy doc:sec-45-ss-2 ; cml:integrityHash "cc2963ea579c930934ce0e5eacfcfa56e16eac41ff00f97f7ba25982f1dfc037" ; values:partOf concept:therapeutic-goods-act-1989-sec-45 ; skos:note "The Account is a special account for the purposes of the Public Governance, Performance and Accountability Act 2013." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.305" ; cml:asserts concept:therapeutic-goods-act-1989-sec-45-ss-2-norm . concept:therapeutic-goods-act-1989-sec-45-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-45-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-45-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-45-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "has" ; cml:logicSummary "Account is a special account" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45-ss-3 a cml:Concept ; skos:prefLabel "45(3) Therapeutic Goods Administration Account"@en ; cml:realizedBy doc:sec-45-ss-3 ; cml:integrityHash "78bb6f464e2ffd7dec7c5dd15ce9d46d25131edb8c7972463181191ed58478b4" ; values:partOf concept:therapeutic-goods-act-1989-sec-45 ; skos:note "Amounts must be credited to the Account from various sources." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.305" ; cml:asserts concept:therapeutic-goods-act-1989-sec-45-ss-3-norm . concept:therapeutic-goods-act-1989-sec-45-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-45-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-45-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-45-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "=" ; cml:logicSummary "Must provide amounts" ; cml:premiseText "There must be credited to the Account..." ; cml:conclusionText "Amounts must be provided" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45-ss-4 a cml:Concept ; skos:prefLabel "45(4) Therapeutic Goods Administration Account"@en ; cml:realizedBy doc:sec-45-ss-4 ; cml:integrityHash "c205e9546d7f8045fdd97c516dc9ff7c82e11aaed8f3861ad9855d66bdac5ab9" ; values:partOf concept:therapeutic-goods-act-1989-sec-45 ; skos:note "Payment obligations for therapeutic goods administration account" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.305" ; cml:asserts concept:therapeutic-goods-act-1989-sec-45-ss-4-norm . concept:therapeutic-goods-act-1989-sec-45-ss-4-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-45-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-45-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-45-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "obligation" ; cml:logicSummary "Payment obligation" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45aa a cml:Concept ; skos:prefLabel "45AA Simplified outline of this Part"@en ; cml:realizedBy doc:sec-45aa ; cml:integrityHash "81dd8541e3defa2111815a5bc04ef9964adb8fd14f571701872a73de04e224af" ; skos:note "The Secretary can gather information or documents relevant to a contravention or possible contravention of this Act." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.307" ; cml:asserts concept:therapeutic-goods-act-1989-sec-45aa-norm . concept:therapeutic-goods-act-1989-sec-45aa-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-45aa ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45ab a cml:Concept ; skos:prefLabel "45AB Secretary may require information or documents"@en ; cml:realizedBy doc:sec-45ab ; cml:hasPart concept:therapeutic-goods-act-1989-sec-45ab-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-45ab-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-45ab-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-45ab-ss-4 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.308" . concept:therapeutic-goods-act-1989-sec-45ab-ss-1 a cml:Concept ; skos:prefLabel "45AB(1) Secretary may require information or documents"@en ; cml:realizedBy doc:sec-45ab-ss-1 ; cml:integrityHash "e7faec5f22b8c5902464066faff5ef4a88e26c71d5ea1dc0d82e9ecc8e65a8b0" ; values:partOf concept:therapeutic-goods-act-1989-sec-45ab ; skos:note "Secretary may require information or documents from a person." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.308" ; cml:asserts concept:therapeutic-goods-act-1989-sec-45ab-ss-1-norm . concept:therapeutic-goods-act-1989-sec-45ab-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-45ab-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45ab-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-45ab-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-45ab-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "requires" ; cml:logicSummary "Requires the person to give information or produce documents." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45ab-ss-2 a cml:Concept ; skos:prefLabel "45AB(2) Secretary may require information or documents"@en ; cml:realizedBy doc:sec-45ab-ss-2 ; cml:integrityHash "79b5b1a473017d7a4a14df7f8ebae252b6f0742d55d760b906d7a1cac2e5e964" ; values:partOf concept:therapeutic-goods-act-1989-sec-45ab ; skos:note "Secretary must require person to comply within a specified period." ; dc:description "Notice with a reasonable compliance period" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.308" ; cml:asserts concept:therapeutic-goods-act-1989-sec-45ab-ss-2-norm . concept:therapeutic-goods-act-1989-sec-45ab-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-45ab-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45ab-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-45ab-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-45ab-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Obligation to comply" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45ab-ss-3 a cml:Concept ; skos:prefLabel "45AB(3) Secretary may require information or documents"@en ; cml:realizedBy doc:sec-45ab-ss-3 ; cml:integrityHash "ee82b967cc5ea312a3d8264d59ee657945a8239c5cb8d0eb4d4b2a33c03229d6" ; values:partOf concept:therapeutic-goods-act-1989-sec-45ab ; skos:note "Secretary must provide notice with specified information" ; dc:description "true" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.308" ; cml:asserts concept:therapeutic-goods-act-1989-sec-45ab-ss-3-norm . concept:therapeutic-goods-act-1989-sec-45ab-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-45ab-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45ab-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-45ab-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-45ab-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must provide notice" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45ab-ss-4 a cml:Concept ; skos:prefLabel "45AB(4) Secretary may require information or documents"@en ; cml:realizedBy doc:sec-45ab-ss-4 ; cml:integrityHash "b26706de6a80064808d323934be14602c6c78eea0c647d7230872072f1978ba1" ; values:partOf concept:therapeutic-goods-act-1989-sec-45ab ; skos:note "Secretary must require information or documents in specified format." ; dc:description "true" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.308" ; cml:asserts concept:therapeutic-goods-act-1989-sec-45ab-ss-4-norm . concept:therapeutic-goods-act-1989-sec-45ab-ss-4-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-45ab-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45ab-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-45ab-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-45ab-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must provide information or documents." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45ab-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-45ab-ss-4-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-45ab-ss-4-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "SPECIFIED" ; cml:logicSummary "Information must be provided in specified format." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45ac a cml:Concept ; skos:prefLabel "45AC Offences for failing to comply with notice"@en ; cml:realizedBy doc:sec-45ac ; cml:integrityHash "940fdcc00339432f322307d6ef94b46a5cce68f118ee0c70dd23442725847459" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-45ac-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-45ac-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-45ac-ss-3 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.308" . concept:therapeutic-goods-act-1989-sec-45ac-ss-1 a cml:Concept ; skos:prefLabel "45AC(1) Offences for failing to comply with notice"@en ; cml:realizedBy doc:sec-45ac-ss-1 ; cml:integrityHash "7cdec73fd34ecceb6e6b5a089c5de07330db1a4a00c4ec89c7dc0bee70aaf955" ; values:partOf concept:therapeutic-goods-act-1989-sec-45ac ; skos:note "Failure to comply with notice results in an offence." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.308" ; cml:asserts concept:therapeutic-goods-act-1989-sec-45ac-ss-1-norm . concept:therapeutic-goods-act-1989-sec-45ac-ss-1-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-45ac-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45ac-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-45ac-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-45ac-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibits failing to comply with notice." ; cml:premiseText "(1) A person commits an offence if: (a) the person is given a notice under section 45AB; and (b) the person fails to comply with the notice." ; cml:conclusionText "The person commits an offence if they fail to comply with the notice." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45ac-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-45ac-ss-1-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-45ac-ss-1-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Overlaps" ; cml:logicSummary "Section 45AC(1) overlaps with Chapter 6." ; cml:premiseText "Compilation date: 05/09/2025 Penalty: 500 penalty units. Strict liability offence" ; cml:conclusionText "The section overlaps with Chapter 6." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45ac-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-45ac-ss-1-logic-argumentation-3 . concept:therapeutic-goods-act-1989-sec-45ac-ss-1-logic-argumentation-3 a cml:LogicApplication ; cml:modality cml:Argumentation ; cml:operator "Implication" ; cml:logicSummary "Failing to comply with notice implies committing an offence." ; cml:premiseText "(1) A person commits an offence if: (a) the person is given a notice under section 45AB; and (b) the person fails to comply with the notice." ; cml:conclusionText "If the person fails to comply, they commit an offence." ; cml:executionSurface "modalities::argumentation" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45ac-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-45ac-ss-1-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-45ac-ss-1-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "Implication" ; cml:logicSummary "Failing to comply with notice implies being subject to penalty units." ; cml:premiseText "(1) A person commits an offence if: (a) the person is given a notice under section 45AB; and (b) the person fails to comply with the notice." ; cml:conclusionText "If the person fails, they are subject to penalty units." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45ac-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-45ac-ss-1-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-45ac-ss-1-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "Implication" ; cml:logicSummary "Failing to comply with notice implies being subject to a strict liability offence." ; cml:premiseText "(1) A person commits an offence if: (a) the person is given a notice under section 45AB; and (b) the person fails to comply with the notice." ; cml:conclusionText "If the person fails, they are subject to a strict liability offence." ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45ac-ss-2 a cml:Concept ; skos:prefLabel "45AC(2) Offences for failing to comply with notice"@en ; cml:realizedBy doc:sec-45ac-ss-2 ; cml:integrityHash "b9d7c94cc55c18d504bcafb102c298da5a43e8e09e055795fe206f49788a45ba" ; values:partOf concept:therapeutic-goods-act-1989-sec-45ac ; skos:note "Failure to comply with notice results in an offence of strict liability." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.308" ; cml:asserts concept:therapeutic-goods-act-1989-sec-45ac-ss-2-norm . concept:therapeutic-goods-act-1989-sec-45ac-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-45ac-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45ac-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-45ac-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-45ac-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "obligation" ; cml:logicSummary "Obligation to comply with notice." ; cml:premiseText "Given a notice under section 45AB." ; cml:conclusionText "Failure to comply results in an offence of strict liability." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45ac-ss-3 a cml:Concept ; skos:prefLabel "45AC(3) Offences for failing to comply with notice"@en ; cml:realizedBy doc:sec-45ac-ss-3 ; cml:integrityHash "ee8966ecdba8e7c44ce5610ea99f6146ecfa6853368fe948d84321fcea0a7b8b" ; values:partOf concept:therapeutic-goods-act-1989-sec-45ac ; skos:note "No obligation if person has a reasonable excuse." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.308" ; cml:asserts concept:therapeutic-goods-act-1989-sec-45ac-ss-3-norm . concept:therapeutic-goods-act-1989-sec-45ac-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-45ac-ss-3 ; values:borneBy values:Agent ; skos:scopeNote "borne by: Agent" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45ac-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-45ac-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-45ac-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Excuse" ; cml:logicSummary "Reasonable excuse" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45ac-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-45ac-ss-3-logic-epistemic-2 . concept:therapeutic-goods-act-1989-sec-45ac-ss-3-logic-epistemic-2 a cml:LogicApplication ; cml:modality cml:Epistemic ; cml:operator "Belief" ; cml:logicSummary "Defendant bears evidential burden" ; cml:executionSurface "modalities::epistemic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45ad a cml:Concept ; skos:prefLabel "45AD Offences and civil penalty for giving false or misleading"@en ; cml:realizedBy doc:sec-45ad ; cml:integrityHash "f5767a571ed19141fcbf23f1a81e758594ff2b79cb0b2ea8bfcb5cbe9a997e12" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-45ad-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-45ad-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.309" . concept:therapeutic-goods-act-1989-sec-45ad-ss-1 a cml:Concept ; skos:prefLabel "45AD(1) Offences and civil penalty for giving false or misleading"@en ; cml:realizedBy doc:sec-45ad-ss-1 ; cml:integrityHash "943cd4af5ec88267bc4287ac5d028002ca448f7dc6bc0c156c4b069ea215f725" ; values:partOf concept:therapeutic-goods-act-1989-sec-45ad ; skos:note "Giving false or misleading information in response to a notice is an offence." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.309" ; cml:asserts concept:therapeutic-goods-act-1989-sec-45ad-ss-1-norm . concept:therapeutic-goods-act-1989-sec-45ad-ss-1-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-45ad-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45ad-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-45ad-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-45ad-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibition of giving false or misleading information." ; cml:premiseText "The person is given a notice under section 45AB." ; cml:conclusionText "The person commits an offence if the information or document is false or misleading in a material particular." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45ad-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-45ad-ss-1-logic-deontic-2 . concept:therapeutic-goods-act-1989-sec-45ad-ss-1-logic-deontic-2 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibition of imprisonment for 12 months or 1,000 penalty units." ; cml:premiseText "Penalty: Imprisonment for 12 months or 1,000 penalty units, or both." ; cml:conclusionText "The provision prohibits imprisonment for 12 months or 1,000 penalty units." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45ad-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-45ad-ss-1-logic-deontic-3 . concept:therapeutic-goods-act-1989-sec-45ad-ss-1-logic-deontic-3 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibition of liability for an executive officer of a body corporate." ; cml:premiseText "Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA." ; cml:conclusionText "The provision prohibits liability for an executive officer of a body corporate." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45ad-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-45ad-ss-1-logic-deontic-4 . concept:therapeutic-goods-act-1989-sec-45ad-ss-1-logic-deontic-4 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibition of strict liability offence." ; cml:premiseText "Strict liability offence" ; cml:conclusionText "The provision is classified as a strict liability offence." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45ad-ss-2 a cml:Concept ; skos:prefLabel "45AD(2) Offences and civil penalty for giving false or misleading"@en ; cml:realizedBy doc:sec-45ad-ss-2 ; cml:integrityHash "81c72be235a4438ff767ca427e3f0ced3dcd7b0978c6be76a1b1c26a99dbca3d" ; values:partOf concept:therapeutic-goods-act-1989-sec-45ad ; skos:note "Giving false or misleading information is an offence." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.309" ; cml:asserts concept:therapeutic-goods-act-1989-sec-45ad-ss-2-norm . concept:therapeutic-goods-act-1989-sec-45ad-ss-2-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-45ad-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45ad-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-45ad-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-45ad-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits giving false or misleading information." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45ae a cml:Concept ; skos:prefLabel "45AE Self-incrimination"@en ; cml:realizedBy doc:sec-45ae ; cml:hasPart concept:therapeutic-goods-act-1989-sec-45ae-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-45ae-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-45ae-ss-3 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.310" . concept:therapeutic-goods-act-1989-sec-45ae-ss-1 a cml:Concept ; skos:prefLabel "45AE(1) Self-incrimination"@en ; cml:realizedBy doc:sec-45ae-ss-1 ; cml:integrityHash "5f343e9f02d35b3913cda461ef0e2d3c651670cdd2d7510eeea33e8180945c9f" ; values:partOf concept:therapeutic-goods-act-1989-sec-45ae ; skos:note "No excuse for self-incrimination" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.310" ; cml:asserts concept:therapeutic-goods-act-1989-sec-45ae-ss-1-norm . concept:therapeutic-goods-act-1989-sec-45ae-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-45ae-ss-1 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45ae-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-45ae-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-45ae-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Obligation to provide information" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45ae-ss-2 a cml:Concept ; skos:prefLabel "45AE(2) Self-incrimination"@en ; cml:realizedBy doc:sec-45ae-ss-2 ; cml:integrityHash "69c2b169f04463732ad534fcdb6f4daac5688220e2b7b3e9a49c97ee1c7c33ee" ; values:partOf concept:therapeutic-goods-act-1989-sec-45ae ; skos:note "Protection from self-incrimination in criminal proceedings" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.310" ; cml:asserts concept:therapeutic-goods-act-1989-sec-45ae-ss-2-norm . concept:therapeutic-goods-act-1989-sec-45ae-ss-2-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-45ae-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45ae-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-45ae-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-45ae-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prevents admissibility of self-incriminating information" ; cml:premiseText "(2) However: ...; (d) subsection 45AC(1) or (2); or (e) subsection 45AD(1) or (2); or (f) section 137.1 or 137.2 of the Criminal Code" ; cml:conclusionText "... not admissible in evidence against the individual in criminal proceedings other than proceedings for an offence against Administration Chapter 6 Information gathering powers Part 6-1A Obtaining information or documents Division 2 Section 45AE Therapeutic Goods Act 1989" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45ae-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-45ae-ss-2-logic-deontic-2 . concept:therapeutic-goods-act-1989-sec-45ae-ss-2-logic-deontic-2 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Permission" ; cml:logicSummary "Allows for exceptions to the prohibition on self-incrimination" ; cml:premiseText "(f) section 137.1 or 137.2 of the Criminal Code in relation to giving the information or producing the document." ; cml:conclusionText "... proceedings for an offence against Administration Chapter 6 Information gathering powers Part 6-1A Obtaining information or documents Division 2 Section 45AE Therapeutic Goods Act 1989" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45ae-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-45ae-ss-2-logic-alleninterval-3 . concept:therapeutic-goods-act-1989-sec-45ae-ss-2-logic-alleninterval-3 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Overlaps" ; cml:logicSummary "Defines the temporal scope of admissible evidence" ; cml:premiseText "(2) However: ...; (d) subsection 45AC(1) or (2); or (e) subsection 45AD(1) or (2); or (f) section 137.1 or 137.2 of the Criminal Code" ; cml:conclusionText "... criminal proceedings other than proceedings for an offence against Administration Chapter 6 Information gathering powers Part 6-1A Obtaining information or documents Division 2 Section 45AE Therapeutic Goods Act 1989" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45ae-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-45ae-ss-2-logic-ltl-4 . concept:therapeutic-goods-act-1989-sec-45ae-ss-2-logic-ltl-4 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Repeats" ; cml:logicSummary "Defines the repetition of admissible evidence" ; cml:premiseText "(a) the information given or document produced; and (b) the giving of the information or the production of the document;" ; cml:conclusionText "... criminal proceedings other than proceedings for an offence against Administration Chapter 6 Information gathering powers Part 6-1A Obtaining information or documents Division 2 Section 45AE Therapeutic Goods Act 1989" ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45ae-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-45ae-ss-2-logic-deontic-5 . concept:therapeutic-goods-act-1989-sec-45ae-ss-2-logic-deontic-5 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Establishes the duty to protect against self-incrimination" ; cml:premiseText "(2) However: ...; (d) subsection 45AC(1) or (2); or (e) subsection 45AD(1) or (2); or (f) section 137.1 or 137.2 of the Criminal Code" ; cml:conclusionText "... against the individual in criminal proceedings other than proceedings for an offence against Administration Chapter 6 Information gathering powers Part 6-1A Obtaining information or documents Division 2 Section 45AE Therapeutic Goods Act 1989" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45ae-ss-3 a cml:Concept ; skos:prefLabel "45AE(3) Self-incrimination"@en ; cml:realizedBy doc:sec-45ae-ss-3 ; cml:integrityHash "7b417cc1d1b4bc644dfa9afbd6631b274f9f46e48c75c699f377bf8c7147f3db" ; values:partOf concept:therapeutic-goods-act-1989-sec-45ae ; skos:note "No claim of privilege against self-exposure to penalty for giving information or producing document under section 45AB." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.310" ; cml:asserts concept:therapeutic-goods-act-1989-sec-45ae-ss-3-norm . concept:therapeutic-goods-act-1989-sec-45ae-ss-3-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-45ae-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45ae-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-45ae-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-45ae-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits claiming privilege against self-exposure to penalty." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45af a cml:Concept ; skos:prefLabel "45AF Secretary may inspect and copy documents"@en ; cml:realizedBy doc:sec-45af ; cml:integrityHash "e4466d7c0dd1f6bee0077287617c56f72111970f969c7f1dd7afe19705eb3264" ; skos:note "The Secretary may inspect and copy documents produced under section 45AB." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.312" ; cml:asserts concept:therapeutic-goods-act-1989-sec-45af-norm . concept:therapeutic-goods-act-1989-sec-45af-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-45af ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45af cml:asserts concept:therapeutic-goods-act-1989-sec-45af-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-45af-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "The Secretary may inspect and copy documents." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45ag a cml:Concept ; skos:prefLabel "45AG Secretary may retain documents"@en ; cml:realizedBy doc:sec-45ag ; cml:integrityHash "1cd6a0b735d94b749c9e1aa6e1d422157fb5abf4e47c4b176ff569bd7a97c99e" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-45ag-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-45ag-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-45ag-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-45ag-ss-4 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.312" . concept:therapeutic-goods-act-1989-sec-45ag-ss-1 a cml:Concept ; skos:prefLabel "45AG(1) Secretary may retain documents"@en ; cml:realizedBy doc:sec-45ag-ss-1 ; cml:integrityHash "eb1d7fc2479c722aec0477047ae2edcd982dab6ec27769765e06358769799d55" ; values:partOf concept:therapeutic-goods-act-1989-sec-45ag ; skos:note "The Secretary may retain documents for as long as necessary." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.312" ; cml:asserts concept:therapeutic-goods-act-1989-sec-45ag-ss-1-norm . concept:therapeutic-goods-act-1989-sec-45ag-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-45ag-ss-1 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45ag-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-45ag-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-45ag-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "Implies an obligation." ; cml:conclusionText "The Secretary must retain documents." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45ag-ss-2 a cml:Concept ; skos:prefLabel "45AG(2) Secretary may retain documents"@en ; cml:realizedBy doc:sec-45ag-ss-2 ; cml:integrityHash "af7f7e9bfbed93a97669eb7231332cf05a82057bf4a294f5b03531a1b6494c8f" ; values:partOf concept:therapeutic-goods-act-1989-sec-45ag ; skos:note "The Secretary must provide a certified copy of the document as soon as practicable." ; dc:description "true" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.312" ; cml:asserts concept:therapeutic-goods-act-1989-sec-45ag-ss-2-norm . concept:therapeutic-goods-act-1989-sec-45ag-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-45ag-ss-2 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45ag-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-45ag-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-45ag-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Must" ; cml:logicSummary "The Secretary must provide a certified copy." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45ag-ss-3 a cml:Concept ; skos:prefLabel "45AG(3) Secretary may retain documents"@en ; cml:realizedBy doc:sec-45ag-ss-3 ; cml:integrityHash "80d9d59a2778a064332ad3fc46e2fc877e01a794c24bccd78e99d9487675d217" ; values:partOf concept:therapeutic-goods-act-1989-sec-45ag ; skos:note "The certified copy must be received in all courts and tribunals as evidence." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.312" ; cml:asserts concept:therapeutic-goods-act-1989-sec-45ag-ss-3-norm . concept:therapeutic-goods-act-1989-sec-45ag-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-45ag-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45ag-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-45ag-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-45ag-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "The state has an obligation to provide the certified copy." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45ag-ss-4 a cml:Concept ; skos:prefLabel "45AG(4) Secretary may retain documents"@en ; cml:realizedBy doc:sec-45ag-ss-4 ; cml:integrityHash "91af642bbede534f44c2a43c053e7c36a71f59dd70c91f53a91c25b266290c61" ; values:partOf concept:therapeutic-goods-act-1989-sec-45ag ; skos:note "Must provide access to document for inspection and copying." ; dc:description "true" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.312" ; cml:asserts concept:therapeutic-goods-act-1989-sec-45ag-ss-4-norm . concept:therapeutic-goods-act-1989-sec-45ag-ss-4-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-45ag-ss-4 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45ag-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-45ag-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-45ag-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Obligation to provide access." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45a a cml:Concept ; skos:prefLabel "45A Definitions"@en ; cml:realizedBy doc:sec-45a ; cml:integrityHash "6e89edc95cfd7fdad23a161d98a6056cd34fa9b0b57b55e9f685a34b5dc4b3d4" ; skos:note "Defines evidential material and occupier for this Part." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.313" ; cml:asserts concept:therapeutic-goods-act-1989-sec-45a-norm . concept:therapeutic-goods-act-1989-sec-45a-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-45a ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45a cml:asserts concept:therapeutic-goods-act-1989-sec-45a-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-45a-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "defines" ; cml:logicSummary "Defines terms used in the provision." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-45a cml:asserts concept:therapeutic-goods-act-1989-sec-45a-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-45a-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "includes" ; cml:logicSummary "Includes definitions for occupier and person assisting." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-46 a cml:Concept ; skos:prefLabel "46 Searches to monitor compliance with Act or regulations"@en ; cml:realizedBy doc:sec-46 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-46-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-46-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-46-ss-3 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.314" . concept:therapeutic-goods-act-1989-sec-46-ss-1 a cml:Concept ; skos:prefLabel "46(1) Searches to monitor compliance with Act or regulations"@en ; cml:realizedBy doc:sec-46-ss-1 ; cml:integrityHash "296de76ee85cd3c9f25ccb1d612d5a13e60642e90d6d824d346ea8d8d891031b" ; values:partOf concept:therapeutic-goods-act-1989-sec-46 ; skos:note "Authorized person may enter premises and exercise powers to monitor compliance." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.314" ; cml:asserts concept:therapeutic-goods-act-1989-sec-46-ss-1-norm . concept:therapeutic-goods-act-1989-sec-46-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-46-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-46-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-46-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-46-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "can" ; cml:logicSummary "Authorization to enter premises" ; cml:premiseText "(1) Subject to subsections (2) and (3), an authorised person may..." ; cml:conclusionText "...an authorised person may, for the purpose of finding out whether this Act or the regulations have been complied with:" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-46-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-46-ss-1-logic-deontic-2 . concept:therapeutic-goods-act-1989-sec-46-ss-1-logic-deontic-2 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "Exercise powers to monitor compliance" ; cml:premiseText "(a) enter any premises; and (b) exercise the powers set out in subsection 48(1) and section 48BA." ; cml:conclusionText "...and exercise the powers set out in subsection 48(1) and section 48BA." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-46-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-46-ss-1-logic-alleninterval-3 . concept:therapeutic-goods-act-1989-sec-46-ss-1-logic-alleninterval-3 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "during" ; cml:logicSummary "Temporal relation: Authorized person monitors compliance during specific time period" ; cml:premiseText "(1) Subject to subsections (2) and (3), an authorised person may..." ; cml:conclusionText "...for the purpose of finding out whether this Act or the regulations have been complied with:" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-46-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-46-ss-1-logic-ltl-4 . concept:therapeutic-goods-act-1989-sec-46-ss-1-logic-ltl-4 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "until" ; cml:logicSummary "Temporal relation: Authorized person monitors compliance until specific time period ends" ; cml:premiseText "(1) Subject to subsections (2) and (3), an authorised person may..." ; cml:conclusionText "...for the purpose of finding out whether this Act or the regulations have been complied with:" ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-46-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-46-ss-1-logic-diffusion-5 . concept:therapeutic-goods-act-1989-sec-46-ss-1-logic-diffusion-5 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "through" ; cml:logicSummary "Spread of information: Authorized person monitors compliance through specific means" ; cml:premiseText "(a) enter any premises; and (b) exercise the powers set out in subsection 48(1) and section 48BA." ; cml:conclusionText "...and exercise the powers set out in subsection 48(1) and section 48BA." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-46-ss-2 a cml:Concept ; skos:prefLabel "46(2) Searches to monitor compliance with Act or regulations"@en ; cml:realizedBy doc:sec-46-ss-2 ; cml:integrityHash "549ae85686d67ad80f9fe572f24731e3505918f64a3b313f1b759329014eb5c7" ; values:partOf concept:therapeutic-goods-act-1989-sec-46 ; skos:note "Authorized person cannot enter premises without consent or warrant." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.314" ; cml:asserts concept:therapeutic-goods-act-1989-sec-46-ss-2-norm . concept:therapeutic-goods-act-1989-sec-46-ss-2-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-46-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-46-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-46-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-46-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "cannot" ; cml:logicSummary "Prohibition of entry" ; cml:premiseText "Authorized person must not enter premises." ; cml:conclusionText "No entry without consent or warrant." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-46-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-46-ss-2-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-46-ss-2-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "during" ; cml:logicSummary "Entry requires warrant issued under section 49" ; cml:premiseText "The entry is made under a warrant issued under section 49." ; cml:conclusionText "Entry requires warrant issued under section 49." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-46-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-46-ss-2-logic-deontic-3 . concept:therapeutic-goods-act-1989-sec-46-ss-2-logic-deontic-3 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "mustNot" ; cml:logicSummary "Prohibition of unauthorized entry" ; cml:premiseText "The authorised person must not enter the premises." ; cml:conclusionText "No unauthorized entry allowed." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-46-ss-3 a cml:Concept ; skos:prefLabel "46(3) Searches to monitor compliance with Act or regulations"@en ; cml:realizedBy doc:sec-46-ss-3 ; cml:integrityHash "c6ed3c03f94ad096da34632b0ba7395dea3ec2bef71aacd3224baac3ce70db3f" ; values:partOf concept:therapeutic-goods-act-1989-sec-46 ; skos:note "Authorized person cannot exercise powers under subsection (1) if occupier requests identity card inspection." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.314" ; cml:asserts concept:therapeutic-goods-act-1989-sec-46-ss-3-norm . concept:therapeutic-goods-act-1989-sec-46-ss-3-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-46-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-46-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-46-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-46-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibition of exercising powers under subsection (1)" ; cml:premiseText "Authorized person has required identity card inspection" ; cml:conclusionText "Exercise of powers under subsection (1) is prohibited" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-46-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-46-ss-3-logic-deontic-2 . concept:therapeutic-goods-act-1989-sec-46-ss-3-logic-deontic-2 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Permission" ; cml:logicSummary "Occupier's request for identity card inspection is a permission" ; cml:premiseText "Occupier requests identity card inspection" ; cml:conclusionText "Identity card inspection is permitted" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-46a a cml:Concept ; skos:prefLabel "46A Searches of certain premises to monitor compliance with Act"@en ; cml:realizedBy doc:sec-46a ; cml:hasPart concept:therapeutic-goods-act-1989-sec-46a-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-46a-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-46a-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-46a-ss-4 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.314" . concept:therapeutic-goods-act-1989-sec-46a-ss-1 a cml:Concept ; skos:prefLabel "46A(1) Searches of certain premises to monitor compliance with Act"@en ; cml:realizedBy doc:sec-46a-ss-1 ; cml:integrityHash "0fb103d415f006eccadb007e4ba610d4b6e97db2b8f167c9e500aafa0e3e384e" ; values:partOf concept:therapeutic-goods-act-1989-sec-46a ; skos:note "Authorized person may enter premises to monitor compliance with Act." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.314" ; cml:asserts concept:therapeutic-goods-act-1989-sec-46a-ss-1-norm . concept:therapeutic-goods-act-1989-sec-46a-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-46a-ss-1 ; values:borneBy values:Agent ; skos:scopeNote "borne by: Agent" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-46a-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-46a-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-46a-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "can" ; cml:logicSummary "Authorized person can enter premises." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-46a-ss-2 a cml:Concept ; skos:prefLabel "46A(2) Searches of certain premises to monitor compliance with Act"@en ; cml:realizedBy doc:sec-46a-ss-2 ; cml:integrityHash "384eb7dc9e03419850e904e1685ca6c8b7d529bca68834327f242ddabd3dc9c7" ; values:partOf concept:therapeutic-goods-act-1989-sec-46a ; skos:note "No unauthorized entry into residential premises without consent or commercial use." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.314" ; cml:asserts concept:therapeutic-goods-act-1989-sec-46a-ss-2-norm . concept:therapeutic-goods-act-1989-sec-46a-ss-2-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-46a-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-46a-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-46a-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-46a-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibition of unauthorized entry into residential premises." ; cml:premiseText "(2) An authorised person must not, under subsection (1), enter premises that are a residence unless: (a) the occupier of the premises has consented to the entry; or (b) the premises are used for commercial purposes in relation to therapeutic goods or vaping goods, in addition to residential purposes." ; cml:conclusionText "(2) An authorised person must not enter premises that are a residence unless: (a) the occupier of the premises has consented to the entry; or (b) the premises are used for commercial purposes in relation to therapeutic goods or vaping goods, in addition to residential purposes." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-46a-ss-3 a cml:Concept ; skos:prefLabel "46A(3) Searches of certain premises to monitor compliance with Act"@en ; cml:realizedBy doc:sec-46a-ss-3 ; cml:integrityHash "c6ed3c03f94ad096da34632b0ba7395dea3ec2bef71aacd3224baac3ce70db3f" ; values:partOf concept:therapeutic-goods-act-1989-sec-46a ; skos:note "Authorized person cannot exercise powers under subsection (1) if occupier requires identity card inspection." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.314" ; cml:asserts concept:therapeutic-goods-act-1989-sec-46a-ss-3-norm . concept:therapeutic-goods-act-1989-sec-46a-ss-3-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-46a-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-46a-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-46a-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-46a-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibition of exercising powers under subsection (1)" ; cml:premiseText "(a) the occupier of the premises has required the authorised person to produce his or her identity card for inspection by the occupier;" ; cml:conclusionText "An authorised person is not entitled to exercise any powers under subsection (1) in relation to premises" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-46a-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-46a-ss-3-logic-deontic-2 . concept:therapeutic-goods-act-1989-sec-46a-ss-3-logic-deontic-2 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibition of failing to comply with occupier's requirement" ; cml:premiseText "(b) the authorised person fails to comply with the requirement." ; cml:conclusionText "An authorised person is not entitled to exercise any powers under subsection (1) in relation to premises" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-46a-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-46a-ss-3-logic-linearlogic-3 . concept:therapeutic-goods-act-1989-sec-46a-ss-3-logic-linearlogic-3 a cml:LogicApplication ; cml:modality cml:LinearLogic ; cml:operator "Implication" ; cml:logicSummary "Occupier's requirement implies authorized person cannot exercise powers under subsection (1)" ; cml:premiseText "(a) the occupier of the premises has required the authorised person to produce his or her identity card for inspection by the occupier;" ; cml:conclusionText "An authorised person is not entitled to exercise any powers under subsection (1) in relation to premises" ; cml:executionSurface "modalities::linear" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-46a-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-46a-ss-3-logic-deontic-4 . concept:therapeutic-goods-act-1989-sec-46a-ss-3-logic-deontic-4 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibition of exercising powers under subsection (1)" ; cml:premiseText "(3) An authorised person is not entitled to exercise any powers under subsection (1) in relation to premises if:" ; cml:conclusionText "An authorised person is not entitled to exercise any powers under subsection (1) in relation to premises" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-46a-ss-4 a cml:Concept ; skos:prefLabel "46A(4) Searches of certain premises to monitor compliance with Act"@en ; cml:realizedBy doc:sec-46a-ss-4 ; cml:integrityHash "fb428561fb7ebcb09220ec54b9d5b2c78e5079f375229ab36b243b43ebe762cd" ; values:partOf concept:therapeutic-goods-act-1989-sec-46a ; skos:note "Searches of certain premises to monitor compliance with Act" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.314" ; cml:asserts concept:therapeutic-goods-act-1989-sec-46a-ss-4-norm . concept:therapeutic-goods-act-1989-sec-46a-ss-4-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-46a-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-46a-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-46a-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-46a-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "requires" ; cml:logicSummary "Requires compliance" ; cml:premiseText "(iaa) who is required to comply with a condition of an exemption..." ; cml:conclusionText "must comply" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-46a-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-46a-ss-4-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-46a-ss-4-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "during" ; cml:logicSummary "Searches during compliance period" ; cml:premiseText "This section applies to: (a) premises of a person:" ; cml:conclusionText "searches occur during compliance" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-46b a cml:Concept ; skos:prefLabel "46B Searches and seizures on public health grounds"@en ; cml:realizedBy doc:sec-46b ; cml:hasPart concept:therapeutic-goods-act-1989-sec-46b-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-46b-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.316" . concept:therapeutic-goods-act-1989-sec-46b-ss-1 a cml:Concept ; skos:prefLabel "46B(1) Searches and seizures on public health grounds"@en ; cml:realizedBy doc:sec-46b-ss-1 ; cml:integrityHash "fc412e1cb101ad8fb7127c207ffa64e5e4a2f78036e41e833d7d62c65d3dd14b" ; values:partOf concept:therapeutic-goods-act-1989-sec-46b ; skos:note "Prohibition on entering premises without reasonable grounds and in the interests of public health." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.316" ; cml:asserts concept:therapeutic-goods-act-1989-sec-46b-ss-1-norm . concept:therapeutic-goods-act-1989-sec-46b-ss-1-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-46b-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-46b-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-46b-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-46b-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibition on entering premises." ; cml:premiseText "(a) there may be on any premises a particular thing in respect of which this Act or the regulations have not been complied" ; cml:conclusionText "The authorised person may not enter the premises." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-46b-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-46b-ss-1-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-46b-ss-1-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Temporal Interval" ; cml:logicSummary "Temporal interval for exercising powers under this section." ; cml:premiseText "(c) search the premises for the thing;" ; cml:conclusionText "The authorised person may enter the premises within a reasonable time frame to search for the item." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-46b-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-46b-ss-1-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-46b-ss-1-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Recurring Trace" ; cml:logicSummary "Recurring trace of searches and seizures on public health grounds." ; cml:premiseText "(d) if the authorised person finds the thing on the premises—seize it;" ; cml:conclusionText "The authorised person may seize the item repeatedly within a reasonable time frame." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-46b-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-46b-ss-1-logic-deontic-4 . concept:therapeutic-goods-act-1989-sec-46b-ss-1-logic-deontic-4 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Obligation to exercise powers under this section in certain circumstances." ; cml:premiseText "(b) it is necessary in the interests of public health to exercise powers under this section in order to avoid an imminent risk of death, serious illness or serious injury;" ; cml:conclusionText "The authorised person has an obligation to exercise their powers if there is a risk to public health." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-46b-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-46b-ss-1-logic-argumentation-5 . concept:therapeutic-goods-act-1989-sec-46b-ss-1-logic-argumentation-5 a cml:LogicApplication ; cml:modality cml:Argumentation ; cml:operator "Inference" ; cml:logicSummary "Inference from the text that the authorised person may enter premises and seize items under certain circumstances." ; cml:premiseText "(a) there may be on any premises a particular thing in respect of which this Act or the regulations have not been complied (b) it is necessary in the interests of public health to exercise powers under this section in order to avoid an imminent risk of death, serious illness or serious injury;" ; cml:conclusionText "The authorised person may enter premises and seize items if there is a risk to public health." ; cml:executionSurface "modalities::argumentation" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-46b-ss-2 a cml:Concept ; skos:prefLabel "46B(2) Searches and seizures on public health grounds"@en ; cml:realizedBy doc:sec-46b-ss-2 ; cml:integrityHash "b93def83a19431a61d68cf2dfb4e1adeb4fd3c5337537f238ca4dec482d9591a" ; values:partOf concept:therapeutic-goods-act-1989-sec-46b ; skos:note "Authorized person cannot exercise powers under subsection (1) in relation to premises if occupier requires identity card inspection." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.316" ; cml:asserts concept:therapeutic-goods-act-1989-sec-46b-ss-2-norm . concept:therapeutic-goods-act-1989-sec-46b-ss-2-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-46b-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-47 a cml:Concept ; skos:prefLabel "47 Searches and seizures related to offences and civil penalty"@en ; cml:realizedBy doc:sec-47 ; cml:integrityHash "59216e616e82741c8a6f6cd8707084e74bd8aacfdfd30fa506e233e17992700f" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-47-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-47-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.317" . concept:therapeutic-goods-act-1989-sec-47-ss-1 a cml:Concept ; skos:prefLabel "47(1) Searches and seizures related to offences and civil penalty"@en ; cml:realizedBy doc:sec-47-ss-1 ; cml:integrityHash "d52c8d5df4fd283df0a85e29663c3f7baba41647a63c5b28e4bb5a7a1a5abcd3" ; values:partOf concept:therapeutic-goods-act-1989-sec-47 ; skos:note "Authorized person may enter premises and seize evidential material if reasonable grounds exist." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.317" ; cml:asserts concept:therapeutic-goods-act-1989-sec-47-ss-1-norm . concept:therapeutic-goods-act-1989-sec-47-ss-1-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-47-ss-1 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-47-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-47-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-47-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits entering premises without reasonable grounds." ; cml:premiseText "(a) enter the premises;" ; cml:conclusionText "May not enter premises without reasonable grounds." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-47-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-47-ss-1-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-47-ss-1-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Overlap" ; cml:logicSummary "Overlaps with time intervals for entering premises." ; cml:premiseText "(1) Subject to subsections (2) and (3), if an authorised person has reasonable grounds for suspecting that there may be evidential material in respect of an offence against this Act, in respect of a contravention of a civil penalty provision or in respect of both on any premises" ; cml:conclusionText "Overlaps with time intervals for entering premises." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-47-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-47-ss-1-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-47-ss-1-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Recurring" ; cml:logicSummary "Recurring trace for authorized person's actions." ; cml:premiseText "(a) enter the premises; and (b) exercise the powers set out in subsection (4), subsection 48(1) and section 48C;" ; cml:conclusionText "Recurring trace for authorized person's actions." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-47-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-47-ss-1-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-47-ss-1-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "Diffuse" ; cml:logicSummary "Diffuses information about reasonable grounds to others." ; cml:premiseText "(a) enter the premises; and (b) exercise the powers set out in subsection (4), subsection 48(1) and section 48C;" ; cml:conclusionText "Diffuses information about reasonable grounds to others." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-47-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-47-ss-1-logic-argumentation-5 . concept:therapeutic-goods-act-1989-sec-47-ss-1-logic-argumentation-5 a cml:LogicApplication ; cml:modality cml:Argumentation ; cml:operator "Imply" ; cml:logicSummary "Implies that authorized person has authority to enter premises." ; cml:premiseText "(a) enter the premises; and (b) exercise the powers set out in subsection (4), subsection 48(1) and section 48C;" ; cml:conclusionText "Authorized person implies they have authority to enter premises." ; cml:executionSurface "modalities::argumentation" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-47-ss-2 a cml:Concept ; skos:prefLabel "47(2) Searches and seizures related to offences and civil penalty"@en ; cml:realizedBy doc:sec-47-ss-2 ; cml:integrityHash "3381605f6f9f783c497f4765c34d0232bc3ddd811f70475ad07db706bf4a767f" ; values:partOf concept:therapeutic-goods-act-1989-sec-47 ; skos:note "Authorized person must not enter premises without consent or warrant." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.317" ; cml:asserts concept:therapeutic-goods-act-1989-sec-47-ss-2-norm . concept:therapeutic-goods-act-1989-sec-47-ss-2-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-47-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-47-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-47-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-47-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Must Not" ; cml:logicSummary "Prohibition of entry" ; cml:premiseText "Authorized person must not enter premises." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48 a cml:Concept ; skos:prefLabel "48 General powers of authorised persons in relation to premises"@en ; cml:realizedBy doc:sec-48 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-48-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-48-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-48-ss-3a ; cml:hasPart concept:therapeutic-goods-act-1989-sec-48-ss-4 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.318" . concept:therapeutic-goods-act-1989-sec-48-ss-1 a cml:Concept ; skos:prefLabel "48(1) General powers of authorised persons in relation to premises"@en ; cml:realizedBy doc:sec-48-ss-1 ; cml:integrityHash "e5fb23c28eaef89f5b2f8da04efbf4e9a98ab7954aa5bcf85104aac218bb08d8" ; values:partOf concept:therapeutic-goods-act-1989-sec-48 ; skos:note "Authorised persons have powers to search, inspect, and require information from premises." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.318" ; cml:asserts concept:therapeutic-goods-act-1989-sec-48-ss-1-norm . concept:therapeutic-goods-act-1989-sec-48-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-48-ss-1 ; values:borneBy values:Agent ; skos:scopeNote "borne by: Agent" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-48-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-48-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "hasPower" ; cml:logicSummary "Has power to search" ; cml:premiseText "Authorised person has authority to enter premises." ; cml:conclusionText "Can search premises" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-48-ss-1-logic-deontic-2 . concept:therapeutic-goods-act-1989-sec-48-ss-1-logic-deontic-2 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "canRequire" ; cml:logicSummary "Can require occupier to answer questions" ; cml:premiseText "Authorised person has power to enter premises." ; cml:conclusionText "Can require occupier to answer questions" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-48-ss-1-logic-linearlogic-3 . concept:therapeutic-goods-act-1989-sec-48-ss-1-logic-linearlogic-3 a cml:LogicApplication ; cml:modality cml:LinearLogic ; cml:operator "implies" ; cml:logicSummary "Requires occupier to produce documents" ; cml:premiseText "Occupier is required to provide information." ; cml:conclusionText "Must produce documents" ; cml:executionSurface "modalities::linear" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-48-ss-1-logic-deontic-4 . concept:therapeutic-goods-act-1989-sec-48-ss-1-logic-deontic-4 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "canInspect" ; cml:logicSummary "Can inspect books and records" ; cml:premiseText "Authorised person has power to enter premises." ; cml:conclusionText "Can inspect books and records" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-48-ss-1-logic-alleninterval-5 . concept:therapeutic-goods-act-1989-sec-48-ss-1-logic-alleninterval-5 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "during" ; cml:logicSummary "Can take equipment onto premises during entry" ; cml:premiseText "Entry is a specific time period." ; cml:conclusionText "Must be taken onto premises during entry" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48-ss-3 a cml:Concept ; skos:prefLabel "48(3) General powers of authorised persons in relation to premises"@en ; cml:realizedBy doc:sec-48-ss-3 ; cml:integrityHash "352463fa4b38e746779b618b394bfd782860ae0c76ce8d3da278e4d625f0bb19" ; values:partOf concept:therapeutic-goods-act-1989-sec-48 ; skos:note "Must comply with a requirement under paragraph (1)(e)" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.318" ; cml:asserts concept:therapeutic-goods-act-1989-sec-48-ss-3-norm . concept:therapeutic-goods-act-1989-sec-48-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-48-ss-3 ; values:borneBy values:Agent ; skos:scopeNote "borne by: Agent" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-48-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-48-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Must" ; cml:logicSummary "Mandatory compliance" ; cml:premiseText "(3) A person must not refuse or fail to comply..." ; cml:conclusionText "A person must comply with a requirement under paragraph (1)(e)" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-48-ss-3-logic-deontic-2 . concept:therapeutic-goods-act-1989-sec-48-ss-3-logic-deontic-2 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Refusal or failure to comply is prohibited" ; cml:premiseText "(3) A person must not refuse or fail to comply..." ; cml:conclusionText "A person must not refuse or fail to comply with a requirement under paragraph (1)(e)" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-48-ss-3-logic-deontic-3 . concept:therapeutic-goods-act-1989-sec-48-ss-3-logic-deontic-3 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Compliance is an obligation" ; cml:premiseText "(3) A person must not refuse or fail to comply..." ; cml:conclusionText "A person has an obligation to comply with a requirement under paragraph (1)(e)" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48-ss-3a a cml:Concept ; skos:prefLabel "48(3A) General powers of authorised persons in relation to premises"@en ; cml:realizedBy doc:sec-48-ss-3a ; cml:integrityHash "9cab5da41854e8c96f1e9590ffb592653533e648a04c78f26c58b9e34085519a" ; values:partOf concept:therapeutic-goods-act-1989-sec-48 ; skos:note "Defendant bears evidential burden in relation to reasonable excuse." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.318" ; cml:asserts concept:therapeutic-goods-act-1989-sec-48-ss-3a-norm . concept:therapeutic-goods-act-1989-sec-48-ss-3a-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-48-ss-3a ; values:borneBy values:NaturalPerson ; skos:scopeNote "borne by: NaturalPerson" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48-ss-3a cml:asserts concept:therapeutic-goods-act-1989-sec-48-ss-3a-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-48-ss-3a-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Defendant bears evidential burden." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48-ss-3a cml:asserts concept:therapeutic-goods-act-1989-sec-48-ss-3a-logic-epistemic-2 . concept:therapeutic-goods-act-1989-sec-48-ss-3a-logic-epistemic-2 a cml:LogicApplication ; cml:modality cml:Epistemic ; cml:operator "Burden of Proof" ; cml:logicSummary "Defendant must provide evidence for reasonable excuse." ; cml:executionSurface "modalities::epistemic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48-ss-4 a cml:Concept ; skos:prefLabel "48(4) General powers of authorised persons in relation to premises"@en ; cml:realizedBy doc:sec-48-ss-4 ; cml:integrityHash "9a7d8e1b6077a96f083baf25f10f6c88dcf15b1421e163315f0b51920b6492b5" ; values:partOf concept:therapeutic-goods-act-1989-sec-48 ; skos:note "Excuse for refusing or failing to answer a question or produce a document that may incriminate the person." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.318" ; cml:asserts concept:therapeutic-goods-act-1989-sec-48-ss-4-norm . concept:therapeutic-goods-act-1989-sec-48-ss-4-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-48-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-48-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-48-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Excuse" ; cml:logicSummary "Excuse for refusing or failing to answer a question or produce a document." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-48-ss-4-logic-epistemic-2 . concept:therapeutic-goods-act-1989-sec-48-ss-4-logic-epistemic-2 a cml:LogicApplication ; cml:modality cml:Epistemic ; cml:operator "Knowledge" ; cml:logicSummary "Person has knowledge that answering the question or producing the document may incriminate them." ; cml:executionSurface "modalities::epistemic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-48-ss-4-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-48-ss-4-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Temporal Interval" ; cml:logicSummary "Excuse applies to a specific temporal interval." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-48-ss-4-logic-argumentation-4 . concept:therapeutic-goods-act-1989-sec-48-ss-4-logic-argumentation-4 a cml:LogicApplication ; cml:modality cml:Argumentation ; cml:operator "Reasoning" ; cml:logicSummary "Excuse is based on reasoning about the person's situation." ; cml:executionSurface "modalities::argumentation" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-48-ss-4-logic-alleninterval-5 . concept:therapeutic-goods-act-1989-sec-48-ss-4-logic-alleninterval-5 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Temporal Relationship" ; cml:logicSummary "Excuse applies to a specific temporal relationship between events." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48a a cml:Concept ; skos:prefLabel "48A Details of warrant to be given to occupier etc."@en ; cml:realizedBy doc:sec-48a ; cml:hasPart concept:therapeutic-goods-act-1989-sec-48a-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-48a-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-48a-ss-3 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.320" . concept:therapeutic-goods-act-1989-sec-48a-ss-1 a cml:Concept ; skos:prefLabel "48A(1) Details of warrant to be given to occupier etc."@en ; cml:realizedBy doc:sec-48a-ss-1 ; cml:integrityHash "0398ca9e4e1031b9411b6bc5b86a574dfc900c6a029d7f75b7595295228d4c6d" ; values:partOf concept:therapeutic-goods-act-1989-sec-48a ; skos:note "Must provide a copy of the warrant to the occupier or apparent representative." ; dc:description "true" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.320" ; cml:asserts concept:therapeutic-goods-act-1989-sec-48a-ss-1-norm . concept:therapeutic-goods-act-1989-sec-48a-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-48a-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48a-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-48a-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-48a-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST PROVIDE" ; cml:logicSummary "Must provide a copy of the warrant." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48a-ss-2 a cml:Concept ; skos:prefLabel "48A(2) Details of warrant to be given to occupier etc."@en ; cml:realizedBy doc:sec-48a-ss-2 ; cml:integrityHash "b64bab1a1a937da4e595bfa08c0d8b34ddebef3d0ccf22dba2b69fe1b5670788" ; values:partOf concept:therapeutic-goods-act-1989-sec-48a ; skos:note "Authorised person must identify themselves to the occupier." ; dc:description "Identification" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.320" ; cml:asserts concept:therapeutic-goods-act-1989-sec-48a-ss-2-norm . concept:therapeutic-goods-act-1989-sec-48a-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-48a-ss-2 ; values:borneBy values:Agent ; skos:scopeNote "borne by: Agent" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48a-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-48a-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-48a-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must provide identification" ; cml:conclusionText "The authorised person must identify themselves." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48a-ss-3 a cml:Concept ; skos:prefLabel "48A(3) Details of warrant to be given to occupier etc."@en ; cml:realizedBy doc:sec-48a-ss-3 ; cml:integrityHash "3e97e2aeffe4e72cbd6014d1d440828dfb804ba600dbc3ed83d2bb4032c09790" ; values:partOf concept:therapeutic-goods-act-1989-sec-48a ; skos:note "No signature of issuing officer is required on warrant copy." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.320" ; cml:asserts concept:therapeutic-goods-act-1989-sec-48a-ss-3-norm . concept:therapeutic-goods-act-1989-sec-48a-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-48a-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48a-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-48a-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-48a-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "No signature requirement" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48aa a cml:Concept ; skos:prefLabel "48AA Completing execution of warrant under section 50 after"@en ; cml:realizedBy doc:sec-48aa ; cml:integrityHash "d31bc8566ab5f8ae4de1231f3efb187cf89246a2e342b0003696854e4eb4e58f" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-48aa-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-48aa-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-48aa-ss-3 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.321" . concept:therapeutic-goods-act-1989-sec-48aa-ss-1 a cml:Concept ; skos:prefLabel "48AA(1) Completing execution of warrant under section 50 after"@en ; cml:realizedBy doc:sec-48aa-ss-1 ; cml:integrityHash "cde609c124fb0010fd57d264e8529f5efa970bce37fc6443db3610e6df885586" ; values:partOf concept:therapeutic-goods-act-1989-sec-48aa ; skos:note "Authorized persons must cease execution and leave premises." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.321" ; cml:asserts concept:therapeutic-goods-act-1989-sec-48aa-ss-1-norm . concept:therapeutic-goods-act-1989-sec-48aa-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-48aa-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48aa-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-48aa-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-48aa-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Must" ; cml:logicSummary "Mandatory obligation" ; cml:premiseText "(1) This section applies..." ; cml:conclusionText "Authorized persons must cease execution and leave premises." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48aa-ss-2 a cml:Concept ; skos:prefLabel "48AA(2) Completing execution of warrant under section 50 after"@en ; cml:realizedBy doc:sec-48aa-ss-2 ; cml:integrityHash "e220b667c3134c8b8bdfeb3bc48969c23e28814cfd63d69881b98951305b17c5" ; values:partOf concept:therapeutic-goods-act-1989-sec-48aa ; skos:note "Authorized persons and assistants may complete warrant execution under certain conditions." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.321" ; cml:asserts concept:therapeutic-goods-act-1989-sec-48aa-ss-2-norm . concept:therapeutic-goods-act-1989-sec-48aa-ss-2-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-48aa-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48aa-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-48aa-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-48aa-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Permit" ; cml:logicSummary "Permission granted" ; cml:premiseText "(2) One or more of the authorised persons..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48aa-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-48aa-ss-2-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-48aa-ss-2-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Overlap" ; cml:logicSummary "Temporal overlap between absence and emergency situation" ; cml:premiseText "(i) for not more than 1 hour;" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48aa-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-48aa-ss-2-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-48aa-ss-2-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Recurrent" ; cml:logicSummary "Recurring trace of authorized persons' absence" ; cml:premiseText "(ii) if there is an emergency situation, for not more than 12 hours or such longer period as allowed by an issuing officer under subsection (5);" ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48aa-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-48aa-ss-2-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-48aa-ss-2-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "Diffuse" ; cml:logicSummary "Diffusion of authorized persons' absence to emergency situation" ; cml:premiseText "(iii) for a longer period if the occupier of the premises consents in writing." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48aa-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-48aa-ss-2-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-48aa-ss-2-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "Recognize" ; cml:logicSummary "Recognition of occupier's written consent" ; cml:premiseText "the occupier of the premises consents in writing." ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48aa-ss-3 a cml:Concept ; skos:prefLabel "48AA(3) Completing execution of warrant under section 50 after"@en ; cml:realizedBy doc:sec-48aa-ss-3 ; cml:integrityHash "d4bdadadd0d514cd7e36943f6e5f401086bf421b24ce941a52c2476caf62b287" ; values:partOf concept:therapeutic-goods-act-1989-sec-48aa ; skos:note "Authorized person may apply for extension of warrant execution period under emergency situation." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.321" ; cml:asserts concept:therapeutic-goods-act-1989-sec-48aa-ss-3-norm . concept:therapeutic-goods-act-1989-sec-48aa-ss-3-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-48aa-ss-3 ; values:borneBy values:LegalPerson ; skos:scopeNote "borne by: LegalPerson" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48aa-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-48aa-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-48aa-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "May" ; cml:logicSummary "Permission to apply for extension" ; cml:premiseText "Authorized person may apply" ; cml:conclusionText "for an extension of the warrant execution period" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48aa-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-48aa-ss-3-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-48aa-ss-3-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Overlaps" ; cml:logicSummary "Extension request overlaps with warrant execution period" ; cml:premiseText "there is an emergency situation; and" ; cml:conclusionText "the authorized person or person assisting the authorized person will not be able to return to the premises within that period." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48aa-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-48aa-ss-3-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-48aa-ss-3-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Until" ; cml:logicSummary "Extension request until warrant execution period ends" ; cml:premiseText "there is an emergency situation; and" ; cml:conclusionText "the authorized person or person assisting the authorized person will not be able to return to the premises within that period." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48aa-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-48aa-ss-3-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-48aa-ss-3-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "Diffuses" ; cml:logicSummary "Extension request diffuses into warrant execution process" ; cml:premiseText "there is an emergency situation; and" ; cml:conclusionText "the authorized person or person assisting the authorized person will not be able to return to the premises within that period." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48aa-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-48aa-ss-3-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-48aa-ss-3-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "Recognizes" ; cml:logicSummary "CogAI recognizes extension request as warrant execution process part" ; cml:premiseText "The authorized person or person assisting the authorized person believes on reasonable grounds that..." ; cml:conclusionText "the authorized person or person assisting the authorized person will not be able to return to the premises within that period." ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48b a cml:Concept ; skos:prefLabel "48B Announcement before entry"@en ; cml:realizedBy doc:sec-48b ; cml:hasPart concept:therapeutic-goods-act-1989-sec-48b-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-48b-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.322" . concept:therapeutic-goods-act-1989-sec-48b-ss-1 a cml:Concept ; skos:prefLabel "48B(1) Announcement before entry"@en ; cml:realizedBy doc:sec-48b-ss-1 ; cml:integrityHash "fd87d3229350ddb105971b08452fe018baa9911417e00f2fe06fe6fcd3e3a50f" ; values:partOf concept:therapeutic-goods-act-1989-sec-48b ; skos:note "Announcement before entry into premises under warrant." ; dc:description "Yes" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.322" ; cml:asserts concept:therapeutic-goods-act-1989-sec-48b-ss-1-norm . concept:therapeutic-goods-act-1989-sec-48b-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-48b-ss-1 ; values:borneBy values:Agent ; skos:scopeNote "borne by: Agent" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48b-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-48b-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-48b-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Must" ; cml:logicSummary "Obligation to announce and allow entry." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48b-ss-2 a cml:Concept ; skos:prefLabel "48B(2) Announcement before entry"@en ; cml:realizedBy doc:sec-48b-ss-2 ; cml:integrityHash "390caaf066e32ec371b6e34057e667bac9ca7eca44cabf70a8fd323797aff418" ; values:partOf concept:therapeutic-goods-act-1989-sec-48b ; skos:note "Authorized person not required to comply with subsection (1) if believes immediate entry is necessary for safety or warrant execution." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.322" ; cml:asserts concept:therapeutic-goods-act-1989-sec-48b-ss-2-norm . concept:therapeutic-goods-act-1989-sec-48b-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-48b-ss-2 ; values:borneBy values:Agent ; skos:scopeNote "borne by: Agent" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48b-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-48b-ss-2-logic-epistemic-1 . concept:therapeutic-goods-act-1989-sec-48b-ss-2-logic-epistemic-1 a cml:LogicApplication ; cml:modality cml:Epistemic ; cml:operator "Belief" ; cml:logicSummary "Belief on reasonable grounds necessary for exemption" ; cml:premiseText "Authorized person believes immediate entry is necessary" ; cml:executionSurface "modalities::epistemic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48ba a cml:Concept ; skos:prefLabel "48BA Use of electronic equipment at premises for monitoring"@en ; cml:realizedBy doc:sec-48ba ; cml:integrityHash "e47a5c7f3bee6f3ecfbd1f3b5fdf3235f2cbdf0d4130cc4d48c45bc564e6e42d" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-48ba-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-48ba-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-48ba-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-48ba-ss-4 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.322" . concept:therapeutic-goods-act-1989-sec-48ba-ss-1 a cml:Concept ; skos:prefLabel "48BA(1) Use of electronic equipment at premises for monitoring"@en ; cml:realizedBy doc:sec-48ba-ss-1 ; cml:integrityHash "690490d7dadbbe72cee7587d0959721656eec6230feb6a7e639d75b1934e6440" ; values:partOf concept:therapeutic-goods-act-1989-sec-48ba ; skos:note "Authorized person may operate electronic equipment to monitor premises." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.322" ; cml:asserts concept:therapeutic-goods-act-1989-sec-48ba-ss-1-norm . concept:therapeutic-goods-act-1989-sec-48ba-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-48ba-ss-1 ; values:borneBy values:Agent ; skos:scopeNote "borne by: Agent" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48ba-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-48ba-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-48ba-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "May" ; cml:logicSummary "Authorized operation" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48ba-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-48ba-ss-1-logic-epistemic-2 . concept:therapeutic-goods-act-1989-sec-48ba-ss-1-logic-epistemic-2 a cml:LogicApplication ; cml:modality cml:Epistemic ; cml:operator "Access" ; cml:logicSummary "Information accessibility" ; cml:executionSurface "modalities::epistemic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48ba-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-48ba-ss-1-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-48ba-ss-1-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Recurring" ; cml:logicSummary "Monitoring for compliance" ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48ba-ss-2 a cml:Concept ; skos:prefLabel "48BA(2) Use of electronic equipment at premises for monitoring"@en ; cml:realizedBy doc:sec-48ba-ss-2 ; cml:integrityHash "835b0ca18797492ea14538afbb9bf6a880f3b21b74cc492aee03f9c0644a0a8c" ; values:partOf concept:therapeutic-goods-act-1989-sec-48ba ; skos:note "Authorized person may operate electronic equipment to gather information." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.322" ; cml:asserts concept:therapeutic-goods-act-1989-sec-48ba-ss-2-norm . concept:therapeutic-goods-act-1989-sec-48ba-ss-2-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-48ba-ss-2 ; values:borneBy values:Agent ; skos:scopeNote "borne by: Agent" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48ba-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-48ba-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-48ba-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "May" ; cml:logicSummary "Authorization to perform action." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48ba-ss-3 a cml:Concept ; skos:prefLabel "48BA(3) Use of electronic equipment at premises for monitoring"@en ; cml:realizedBy doc:sec-48ba-ss-3 ; cml:integrityHash "493fd43c4c669069e1bbd7bb208467b83def5e36c344ce950b4cabe366493c1b" ; values:partOf concept:therapeutic-goods-act-1989-sec-48ba ; skos:note "Authorized person may operate electronic equipment under certain conditions." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.322" ; cml:asserts concept:therapeutic-goods-act-1989-sec-48ba-ss-3-norm . concept:therapeutic-goods-act-1989-sec-48ba-ss-3-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-48ba-ss-3 ; values:borneBy values:Agent ; skos:scopeNote "borne by: Agent" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48ba-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-48ba-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-48ba-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "May" ; cml:logicSummary "Permission to operate equipment" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48ba-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-48ba-ss-3-logic-deontic-2 . concept:therapeutic-goods-act-1989-sec-48ba-ss-3-logic-deontic-2 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Believes" ; cml:logicSummary "Authorized person must believe conditions are met" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48ba-ss-4 a cml:Concept ; skos:prefLabel "48BA(4) Use of electronic equipment at premises for monitoring"@en ; cml:realizedBy doc:sec-48ba-ss-4 ; cml:integrityHash "cf0350f3377522cd41f68915763a94541605abe32356cbb9396fb94d1c2d3f48" ; values:partOf concept:therapeutic-goods-act-1989-sec-48ba ; skos:note "Authorized person has obligation to secure electronic equipment." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.322" ; cml:asserts concept:therapeutic-goods-act-1989-sec-48ba-ss-4-norm . concept:therapeutic-goods-act-1989-sec-48ba-ss-4-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-48ba-ss-4 ; values:borneBy values:Agent ; skos:scopeNote "borne by: Agent" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48ba-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-48ba-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-48ba-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Obligation to secure equipment." ; cml:premiseText "(4) If the authorised person believes..." ; cml:conclusionText "he or she may do whatever is necessary..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48c a cml:Concept ; skos:prefLabel "48C Use of electronic equipment at premises relating to offences and"@en ; cml:realizedBy doc:sec-48c ; cml:integrityHash "dc07ea3217d3017a552a23d64ad08a8930c65d8314c9822a3574e50990b5efe8" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-48c-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-48c-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-48c-ss-2a ; cml:hasPart concept:therapeutic-goods-act-1989-sec-48c-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-48c-ss-4 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-48c-ss-5 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.324" . concept:therapeutic-goods-act-1989-sec-48c-ss-1 a cml:Concept ; skos:prefLabel "48C(1) Use of electronic equipment at premises relating to offences and"@en ; cml:realizedBy doc:sec-48c-ss-1 ; cml:integrityHash "11da5c2359caa1f0eed68cc46f7efeab7443606e0785537ecc55c16cc4e6e70b" ; values:partOf concept:therapeutic-goods-act-1989-sec-48c ; skos:note "Authorized person may operate electronic equipment to access evidential material." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.324" ; cml:asserts concept:therapeutic-goods-act-1989-sec-48c-ss-1-norm . concept:therapeutic-goods-act-1989-sec-48c-ss-1-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-48c-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48c-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-48c-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-48c-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "May" ; cml:logicSummary "Permission granted by the State." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48c-ss-2 a cml:Concept ; skos:prefLabel "48C(2) Use of electronic equipment at premises relating to offences and"@en ; cml:realizedBy doc:sec-48c-ss-2 ; cml:integrityHash "3fae9e29f6104f6d71515c266846f86b21c6998dbc10e6d119bec737fc7f5fa8" ; values:partOf concept:therapeutic-goods-act-1989-sec-48c ; skos:note "Authorized person may seize equipment or operate electronic equipment to access evidential material." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.324" ; cml:asserts concept:therapeutic-goods-act-1989-sec-48c-ss-2-norm . concept:therapeutic-goods-act-1989-sec-48c-ss-2-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-48c-ss-2 ; values:borneBy values:Agent ; skos:scopeNote "borne by: Agent" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48c-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-48c-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-48c-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "May" ; cml:logicSummary "Authorized person has permission to seize equipment or operate electronic equipment." ; cml:premiseText "Authorized person is authorized to access evidential material." ; cml:conclusionText "Seize equipment or operate electronic equipment." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48c-ss-2a a cml:Concept ; skos:prefLabel "48C(2A) Use of electronic equipment at premises relating to offences and"@en ; cml:realizedBy doc:sec-48c-ss-2a ; cml:integrityHash "60a56e7472114b413dc0673bc6ad1bbe1e8d5754a61a3a18b90f8ce5d0f0d220" ; values:partOf concept:therapeutic-goods-act-1989-sec-48c ; skos:note "Authorized person may operate electronic equipment under certain conditions." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.324" ; cml:asserts concept:therapeutic-goods-act-1989-sec-48c-ss-2a-norm . concept:therapeutic-goods-act-1989-sec-48c-ss-2a-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-48c-ss-2a ; values:borneBy values:Agent ; skos:scopeNote "borne by: Agent" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48c-ss-2a cml:asserts concept:therapeutic-goods-act-1989-sec-48c-ss-2a-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-48c-ss-2a-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "May" ; cml:logicSummary "Permission to operate electronic equipment" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48c-ss-2a cml:asserts concept:therapeutic-goods-act-1989-sec-48c-ss-2a-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-48c-ss-2a-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Overlaps" ; cml:logicSummary "Temporal overlap between authorized operation and potential damage" ; cml:premiseText "(2A) An authorised person may operate electronic equipment as mentioned in subsection (1) or (2)" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48c-ss-2a cml:asserts concept:therapeutic-goods-act-1989-sec-48c-ss-2a-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-48c-ss-2a-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Until" ; cml:logicSummary "Temporal relationship between authorized operation and potential damage" ; cml:premiseText "(2A) An authorised person may operate electronic equipment as mentioned in subsection (1) or (2)" ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48c-ss-2a cml:asserts concept:therapeutic-goods-act-1989-sec-48c-ss-2a-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-48c-ss-2a-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "Diffuses" ; cml:logicSummary "Spread of authorized operation to other conditions" ; cml:premiseText "(2A) An authorised person may operate electronic equipment as mentioned in subsection (1) or (2)" ; cml:executionSurface "modalities::diffusion" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48c-ss-2a cml:asserts concept:therapeutic-goods-act-1989-sec-48c-ss-2a-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-48c-ss-2a-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "Incorporates" ; cml:logicSummary "Integration of authorized operation with other conditions" ; cml:premiseText "(2A) An authorised person may operate electronic equipment as mentioned in subsection (1) or (2)" ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48c-ss-3 a cml:Concept ; skos:prefLabel "48C(3) Use of electronic equipment at premises relating to offences and"@en ; cml:realizedBy doc:sec-48c-ss-3 ; cml:integrityHash "1d70c2adbe7015dd3f6e7de177de88a835fb410571398673f03b6a089fb0f66e" ; values:partOf concept:therapeutic-goods-act-1989-sec-48c ; skos:note "Seizure of equipment under certain conditions" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.324" ; cml:asserts concept:therapeutic-goods-act-1989-sec-48c-ss-3-norm . concept:therapeutic-goods-act-1989-sec-48c-ss-3-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-48c-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48c-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-48c-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-48c-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits seizure without specified conditions" ; cml:premiseText "(3) An authorised person may seize equipment..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48c-ss-4 a cml:Concept ; skos:prefLabel "48C(4) Use of electronic equipment at premises relating to offences and"@en ; cml:realizedBy doc:sec-48c-ss-4 ; cml:integrityHash "752409f0bfc34fddb81506cee9e8803349c9680e9a7cc0c46570c64284085f8d" ; values:partOf concept:therapeutic-goods-act-1989-sec-48c ; skos:note "Authorized person may take necessary actions to secure electronic equipment." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.324" ; cml:asserts concept:therapeutic-goods-act-1989-sec-48c-ss-4-norm . concept:therapeutic-goods-act-1989-sec-48c-ss-4-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-48c-ss-4 ; values:borneBy values:Agent ; skos:scopeNote "borne by: Agent" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48c-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-48c-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-48c-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "Authorization to act." ; cml:premiseText "(4) If the authorised person believes..." ; cml:conclusionText "He or she may do whatever is necessary..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48c-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-48c-ss-4-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-48c-ss-4-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "during" ; cml:logicSummary "Temporal relation: authorized action during premises visit." ; cml:premiseText "(4) If the authorised person believes..." ; cml:conclusionText "He or she may do whatever is necessary..." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48c-ss-5 a cml:Concept ; skos:prefLabel "48C(5) Use of electronic equipment at premises relating to offences and"@en ; cml:realizedBy doc:sec-48c-ss-5 ; cml:integrityHash "6dd33c510693289ec984adac1db5b7ff0ee52f8ad89154bcd70ae1abe391706c" ; values:partOf concept:therapeutic-goods-act-1989-sec-48c ; skos:note "Authorised person must give notice to occupier of premises before securing equipment." ; dc:description "Notice" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.324" ; cml:asserts concept:therapeutic-goods-act-1989-sec-48c-ss-5-norm . concept:therapeutic-goods-act-1989-sec-48c-ss-5-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-48c-ss-5 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48c-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-48c-ss-5-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-48c-ss-5-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Obligation to provide notice" ; cml:conclusionText "The authorised person must give notice..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48d a cml:Concept ; skos:prefLabel "48D Compensation for damage to electronic equipment"@en ; cml:realizedBy doc:sec-48d ; cml:hasPart concept:therapeutic-goods-act-1989-sec-48d-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-48d-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-48d-ss-3 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.326" . concept:therapeutic-goods-act-1989-sec-48d-ss-1 a cml:Concept ; skos:prefLabel "48D(1) Compensation for damage to electronic equipment"@en ; cml:realizedBy doc:sec-48d-ss-1 ; cml:integrityHash "c7f6ee29779d85c35d93fa955662cf860274336a898ea3a6af05d599b08a4d08" ; values:partOf concept:therapeutic-goods-act-1989-sec-48d ; skos:note "Compensation for damage to electronic equipment if caused by insufficient care." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.326" ; cml:asserts concept:therapeutic-goods-act-1989-sec-48d-ss-1-norm . concept:therapeutic-goods-act-1989-sec-48d-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-48d-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48d-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-48d-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-48d-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "obligation" ; cml:logicSummary "Obligation to compensate for damage." ; cml:premiseText "(1) If..." ; cml:conclusionText "...compensation for the damage is payable." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48d-ss-2 a cml:Concept ; skos:prefLabel "48D(2) Compensation for damage to electronic equipment"@en ; cml:realizedBy doc:sec-48d-ss-2 ; cml:integrityHash "936d6c6cc10c36ec40bbe38f5d18b671cf985076f531a1d6e17469b8ee81f006" ; values:partOf concept:therapeutic-goods-act-1989-sec-48d ; skos:note "Compensation is payable out of money appropriated by the Parliament for the purpose." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.326" ; cml:asserts concept:therapeutic-goods-act-1989-sec-48d-ss-2-norm . concept:therapeutic-goods-act-1989-sec-48d-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-48d-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48d-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-48d-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-48d-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Imposes a duty on the State to provide compensation." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48d-ss-3 a cml:Concept ; skos:prefLabel "48D(3) Compensation for damage to electronic equipment"@en ; cml:realizedBy doc:sec-48d-ss-3 ; cml:integrityHash "07285c55838625e1b42c8cf82ca617a278754a10968f319e06b6f8ef0e0243e6" ; values:partOf concept:therapeutic-goods-act-1989-sec-48d ; skos:note "Occupier must provide warning or guidance about equipment operation." ; dc:description "warning or guidance" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.326" ; cml:asserts concept:therapeutic-goods-act-1989-sec-48d-ss-3-norm . concept:therapeutic-goods-act-1989-sec-48d-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-48d-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48d-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-48d-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-48d-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "OBLIG" ; cml:logicSummary "Mandatory duty" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48e a cml:Concept ; skos:prefLabel "48E Copies of seized things to be provided"@en ; cml:realizedBy doc:sec-48e ; cml:hasPart concept:therapeutic-goods-act-1989-sec-48e-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-48e-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.327" . concept:therapeutic-goods-act-1989-sec-48e-ss-1 a cml:Concept ; skos:prefLabel "48E(1) Copies of seized things to be provided"@en ; cml:realizedBy doc:sec-48e-ss-1 ; cml:integrityHash "cedaf440f50176fcec43e6b42575b6c5e20664fa7c4306ed59239610e23f19ef" ; values:partOf concept:therapeutic-goods-act-1989-sec-48e ; skos:note "Must provide a copy of seized documents or information to the occupier upon request." ; dc:description "true" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.327" ; cml:asserts concept:therapeutic-goods-act-1989-sec-48e-ss-1-norm . concept:therapeutic-goods-act-1989-sec-48e-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-48e-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48e-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-48e-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-48e-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST PROVIDE" ; cml:logicSummary "Must provide a copy of seized documents or information." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48e-ss-2 a cml:Concept ; skos:prefLabel "48E(2) Copies of seized things to be provided"@en ; cml:realizedBy doc:sec-48e-ss-2 ; cml:integrityHash "eeaef3fe95072cc8c4e5ed1892d726564f740d160a16f48bee9dc1f7ed3536dc" ; values:partOf concept:therapeutic-goods-act-1989-sec-48e ; skos:note "Possession of seized things may constitute an offence against a law or civil penalty provision." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.327" ; cml:asserts concept:therapeutic-goods-act-1989-sec-48e-ss-2-norm . concept:therapeutic-goods-act-1989-sec-48e-ss-2-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-48e-ss-2 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48e-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-48e-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-48e-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibits possession of seized things" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48f a cml:Concept ; skos:prefLabel "48F Occupier entitled to be present during search"@en ; cml:realizedBy doc:sec-48f ; cml:hasPart concept:therapeutic-goods-act-1989-sec-48f-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-48f-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-48f-ss-3 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.327" . concept:therapeutic-goods-act-1989-sec-48f-ss-1 a cml:Concept ; skos:prefLabel "48F(1) Occupier entitled to be present during search"@en ; cml:realizedBy doc:sec-48f-ss-1 ; cml:integrityHash "f11176fbc262d3f1085b7b0cc6a9959d353a6be20f0d8f3a61207bad72473628" ; values:partOf concept:therapeutic-goods-act-1989-sec-48f ; skos:note "Occupier entitled to be present during search" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.327" ; cml:asserts concept:therapeutic-goods-act-1989-sec-48f-ss-1-norm . concept:therapeutic-goods-act-1989-sec-48f-ss-1-norm a values:Right ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-48f-ss-1 ; values:heldBy values:NaturalPerson ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48f-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-48f-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-48f-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "hasRight" ; cml:logicSummary "Occupier has right" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48f-ss-2 a cml:Concept ; skos:prefLabel "48F(2) Occupier entitled to be present during search"@en ; cml:realizedBy doc:sec-48f-ss-2 ; cml:integrityHash "ec5660e4419d2bab94cb534b8fc39661b6e2b508486baea04645d113f3598dcc" ; values:partOf concept:therapeutic-goods-act-1989-sec-48f ; skos:note "Right to observe search ceases if person impedes search." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.327" ; cml:asserts concept:therapeutic-goods-act-1989-sec-48f-ss-2-norm . concept:therapeutic-goods-act-1989-sec-48f-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-48f-ss-2 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48f-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-48f-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-48f-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Cease" ; cml:logicSummary "Obligation to observe ceases" ; cml:premiseText "Person impedes search" ; cml:conclusionText "Right to observe ceases" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48f-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-48f-ss-2-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-48f-ss-2-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Overlaps" ; cml:logicSummary "Right to observe ceases during overlap with impediment" ; cml:premiseText "Search and impediment are temporal intervals" ; cml:conclusionText "Cease right to observe during overlap" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48f-ss-3 a cml:Concept ; skos:prefLabel "48F(3) Occupier entitled to be present during search"@en ; cml:realizedBy doc:sec-48f-ss-3 ; cml:integrityHash "3ef1aefe8157efdd0ea9c7cbe20c98e540be927db9b1f90b45137c5f796f9d76" ; values:partOf concept:therapeutic-goods-act-1989-sec-48f ; skos:note "Right to be present during search" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.327" ; cml:asserts concept:therapeutic-goods-act-1989-sec-48f-ss-3-norm . concept:therapeutic-goods-act-1989-sec-48f-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-48f-ss-3 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48fa a cml:Concept ; skos:prefLabel "48FA Responsibility to provide facilities and assistance"@en ; cml:realizedBy doc:sec-48fa ; cml:integrityHash "906394d2a872a4f98b677661830e7b84bfaae53d8644f8796960580ca6aac293" ; skos:note "Occupier must provide facilities and assistance for warrant execution." ; dc:description "yes" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.327" ; cml:asserts concept:therapeutic-goods-act-1989-sec-48fa-norm . concept:therapeutic-goods-act-1989-sec-48fa-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-48fa ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48fa cml:asserts concept:therapeutic-goods-act-1989-sec-48fa-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-48fa-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must provide facilities and assistance." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48g a cml:Concept ; skos:prefLabel "48G Receipts for things seized under warrant"@en ; cml:realizedBy doc:sec-48g ; cml:hasPart concept:therapeutic-goods-act-1989-sec-48g-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-48g-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.328" . concept:therapeutic-goods-act-1989-sec-48g-ss-1 a cml:Concept ; skos:prefLabel "48G(1) Receipts for things seized under warrant"@en ; cml:realizedBy doc:sec-48g-ss-1 ; cml:integrityHash "a82f447ed87e65ce11d17875b636f8410b400415093c01cd0cc122dd0c066d8a" ; values:partOf concept:therapeutic-goods-act-1989-sec-48g ; skos:note "Authorised person must provide a receipt for seized thing." ; dc:description "Yes" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.328" ; cml:asserts concept:therapeutic-goods-act-1989-sec-48g-ss-1-norm . concept:therapeutic-goods-act-1989-sec-48g-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-48g-ss-1 ; values:borneBy values:Agent ; skos:scopeNote "borne by: Agent" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48g-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-48g-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-48g-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must provide a receipt." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48g-ss-2 a cml:Concept ; skos:prefLabel "48G(2) Receipts for things seized under warrant"@en ; cml:realizedBy doc:sec-48g-ss-2 ; cml:integrityHash "4db106c9953a77eedad4f540d815ec254884e8fab22ce48794504fe6caac2a31" ; values:partOf concept:therapeutic-goods-act-1989-sec-48g ; skos:note "Things seized or moved may be covered in one receipt." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.328" ; cml:asserts concept:therapeutic-goods-act-1989-sec-48g-ss-2-norm . concept:therapeutic-goods-act-1989-sec-48g-ss-2-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-48g-ss-2 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48h a cml:Concept ; skos:prefLabel "48H Retention of seized things"@en ; cml:realizedBy doc:sec-48h ; cml:hasPart concept:therapeutic-goods-act-1989-sec-48h-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-48h-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-48h-ss-3 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.328" . concept:therapeutic-goods-act-1989-sec-48h-ss-1 a cml:Concept ; skos:prefLabel "48H(1) Retention of seized things"@en ; cml:realizedBy doc:sec-48h-ss-1 ; cml:integrityHash "b1fd9329aea0e6374457a5520a72dd1a9e57b5a716d29cd2291fce89ba31d15d" ; values:partOf concept:therapeutic-goods-act-1989-sec-48h ; skos:note "Must return seized thing if reason for seizure no longer exists or period ends" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.328" ; cml:asserts concept:therapeutic-goods-act-1989-sec-48h-ss-1-norm . concept:therapeutic-goods-act-1989-sec-48h-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-48h-ss-1 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48h-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-48h-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-48h-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Obligation to return seized thing" ; cml:premiseText "Reason for seizure no longer exists or period ends" ; cml:conclusionText "Must return seized thing" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48h-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-48h-ss-1-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-48h-ss-1-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "BETWEEN" ; cml:logicSummary "Seizure period is an interval that must be considered when determining return of seized thing" ; cml:premiseText "Period of 120 days after seizure ends" ; cml:conclusionText "Seizure period is an interval that must be considered when determining return of seized thing" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48h-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-48h-ss-1-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-48h-ss-1-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "BETWEEN" ; cml:logicSummary "Seizure period is a trace that must be considered when determining return of seized thing" ; cml:premiseText "Period of 120 days after seizure ends" ; cml:conclusionText "Seizure period is a trace that must be considered when determining return of seized thing" ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48h-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-48h-ss-1-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-48h-ss-1-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "IF" ; cml:logicSummary "Return of seized thing depends on reason for seizure no longer existing or period ending" ; cml:premiseText "Reason for seizure no longer exists or period ends" ; cml:conclusionText "Return of seized thing depends on reason for seizure no longer existing or period ending" ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48h-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-48h-ss-1-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-48h-ss-1-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "IF" ; cml:logicSummary "Authorised person must return seized thing if condition is met" ; cml:premiseText "Reason for seizure no longer exists or period ends" ; cml:conclusionText "Authorised person must return seized thing if condition is met" ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48h-ss-2 a cml:Concept ; skos:prefLabel "48H(2) Retention of seized things"@en ; cml:realizedBy doc:sec-48h-ss-2 ; cml:integrityHash "5a2e5a793ce063adb2ba630fd8c1b930a8880a3249e2c8702b6d3fdafeffe6a9" ; values:partOf concept:therapeutic-goods-act-1989-sec-48h ; skos:note "Return seized things after 120 days unless proceedings are ongoing or authorized by law." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.328" ; cml:asserts concept:therapeutic-goods-act-1989-sec-48h-ss-2-norm . concept:therapeutic-goods-act-1989-sec-48h-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-48h-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48h-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-48h-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-48h-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Duty to return seized things" ; cml:premiseText "Authorized person must take reasonable steps to return thing" ; cml:conclusionText "Thing must be returned unless proceedings are ongoing or authorized by law." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48h-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-48h-ss-2-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-48h-ss-2-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Temporal interval" ; cml:logicSummary "120-day temporal interval for return" ; cml:premiseText "End of 120 days specified in subsection (1)" ; cml:conclusionText "Thing must be returned within 120 days unless proceedings are ongoing or authorized by law." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48h-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-48h-ss-2-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-48h-ss-2-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Recurring trace" ; cml:logicSummary "Recurring requirement to return seized things" ; cml:premiseText "Proceedings in respect of which thing may afford evidence were instituted before end of 120 days" ; cml:conclusionText "Thing must be returned unless proceedings are ongoing or authorized by law." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48h-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-48h-ss-2-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-48h-ss-2-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "Propagation" ; cml:logicSummary "Propagation of retention requirements" ; cml:premiseText "Authorized person may retain thing because of order under section 48J" ; cml:conclusionText "Thing must be returned unless proceedings are ongoing or authorized by law." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48h-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-48h-ss-2-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-48h-ss-2-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "Knowledge representation" ; cml:logicSummary "Knowledge representation of seized things" ; cml:premiseText "Thing is classified as a seized thing" ; cml:conclusionText "Thing is subject to retention requirements" ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48h-ss-3 a cml:Concept ; skos:prefLabel "48H(3) Retention of seized things"@en ; cml:realizedBy doc:sec-48h-ss-3 ; cml:integrityHash "4f203aa9caea4ec17dcc3578d88b45836575bee78a430eedf53e75a5838e7eea" ; values:partOf concept:therapeutic-goods-act-1989-sec-48h ; skos:note "The thing may be returned under subsection (2) either unconditionally or on such terms and conditions as the Secretary sees fit." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.328" ; cml:asserts concept:therapeutic-goods-act-1989-sec-48h-ss-3-norm . concept:therapeutic-goods-act-1989-sec-48h-ss-3-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-48h-ss-3 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48j a cml:Concept ; skos:prefLabel "48J Issuing officer may permit a thing to be retained"@en ; cml:realizedBy doc:sec-48j ; cml:hasPart concept:therapeutic-goods-act-1989-sec-48j-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-48j-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-48j-ss-3 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.329" . concept:therapeutic-goods-act-1989-sec-48j-ss-1 a cml:Concept ; skos:prefLabel "48J(1) Issuing officer may permit a thing to be retained"@en ; cml:realizedBy doc:sec-48j-ss-1 ; cml:integrityHash "d058b2a4cb52888e320c26c4dc28095dbce3ff8ea289fcf9f2e9ea5a8eb27074" ; values:partOf concept:therapeutic-goods-act-1989-sec-48j ; skos:note "Issuing officer may permit a thing to be retained for a further period under certain conditions." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.329" ; cml:asserts concept:therapeutic-goods-act-1989-sec-48j-ss-1-norm . concept:therapeutic-goods-act-1989-sec-48j-ss-1-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-48j-ss-1 ; values:borneBy values:Agent ; skos:scopeNote "borne by: Agent" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48j-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-48j-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-48j-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Permit" ; cml:logicSummary "Granting permission" ; cml:premiseText "Issuing officer may permit a thing to be retained" ; cml:conclusionText "Thing may be retained for a further period" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48j-ss-2 a cml:Concept ; skos:prefLabel "48J(2) Issuing officer may permit a thing to be retained"@en ; cml:realizedBy doc:sec-48j-ss-2 ; cml:integrityHash "fcfb9103cd38c950c8fe9e173203d968ec8173d56742dab5cd05a4157e74e0e4" ; values:partOf concept:therapeutic-goods-act-1989-sec-48j ; skos:note "Issuing officer may permit an authorised person to retain a thing for a specified period." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.329" ; cml:asserts concept:therapeutic-goods-act-1989-sec-48j-ss-2-norm . concept:therapeutic-goods-act-1989-sec-48j-ss-2-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-48j-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48j-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-48j-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-48j-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Permit" ; cml:logicSummary "Permission granted by the issuing officer." ; cml:premiseText "Issuing officer may permit an authorised person to retain a thing." ; cml:conclusionText "Authorised person may retain the thing for a specified period." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-48j-ss-3 a cml:Concept ; skos:prefLabel "48J(3) Issuing officer may permit a thing to be retained"@en ; cml:realizedBy doc:sec-48j-ss-3 ; cml:integrityHash "9a3da35284e1de37f6bced6fc0af9cf0242fd7286293df5ec3b4ec081ff6cda0" ; values:partOf concept:therapeutic-goods-act-1989-sec-48j ; skos:note "Issuing officer may permit a thing to be retained" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.329" ; cml:asserts concept:therapeutic-goods-act-1989-sec-48j-ss-3-norm . concept:therapeutic-goods-act-1989-sec-48j-ss-3-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-48j-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-49 a cml:Concept ; skos:prefLabel "49 Monitoring warrants"@en ; cml:realizedBy doc:sec-49 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-49-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-49-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-49-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-49-ss-4 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.330" . concept:therapeutic-goods-act-1989-sec-49-ss-1 a cml:Concept ; skos:prefLabel "49(1) Monitoring warrants"@en ; cml:realizedBy doc:sec-49-ss-1 ; cml:integrityHash "259dcb65833e21ebef90a01e3bad4c26e479a8547a1868a32feba54c906c65c6" ; values:partOf concept:therapeutic-goods-act-1989-sec-49 ; skos:note "Authorized person may apply for a warrant under this section." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.330" ; cml:asserts concept:therapeutic-goods-act-1989-sec-49-ss-1-norm . concept:therapeutic-goods-act-1989-sec-49-ss-1-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-49-ss-1 ; values:borneBy values:Agent ; skos:scopeNote "borne by: Agent" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-49-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-49-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-49-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "May" ; cml:logicSummary "Permission to apply for a warrant" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-49-ss-2 a cml:Concept ; skos:prefLabel "49(2) Monitoring warrants"@en ; cml:realizedBy doc:sec-49-ss-2 ; cml:integrityHash "f12fe322385c2674d86cb6796136cd563cefff1466e2ff309c8e3f42d826f1e2" ; values:partOf concept:therapeutic-goods-act-1989-sec-49 ; skos:note "Issuing officer must issue warrant if satisfied by oath that access is necessary." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.330" ; cml:asserts concept:therapeutic-goods-act-1989-sec-49-ss-2-norm . concept:therapeutic-goods-act-1989-sec-49-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-49-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-49-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-49-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-49-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Issuing officer must issue warrant." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-49-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-49-ss-2-logic-epistemic-2 . concept:therapeutic-goods-act-1989-sec-49-ss-2-logic-epistemic-2 a cml:LogicApplication ; cml:modality cml:Epistemic ; cml:operator "REASONABLY NECESSARY" ; cml:logicSummary "Information on oath is sufficient for issuing officer to make decision." ; cml:executionSurface "modalities::epistemic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-49-ss-3 a cml:Concept ; skos:prefLabel "49(3) Monitoring warrants"@en ; cml:realizedBy doc:sec-49-ss-3 ; cml:integrityHash "c263d42fb402c3841e33eb8fe5df87f8c0ce4af29db90b714bb0c1f69e0e860f" ; values:partOf concept:therapeutic-goods-act-1989-sec-49 ; skos:note "Issuing officer must provide additional information before issuing warrant." ; dc:description "Further information (if any) as the issuing officer requires concerning the grounds on which the issue of the warrant is being sought." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.330" ; cml:asserts concept:therapeutic-goods-act-1989-sec-49-ss-3-norm . concept:therapeutic-goods-act-1989-sec-49-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-49-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-49-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-49-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-49-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Must" ; cml:logicSummary "The issuing officer must provide additional information." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-49-ss-4 a cml:Concept ; skos:prefLabel "49(4) Monitoring warrants"@en ; cml:realizedBy doc:sec-49-ss-4 ; cml:integrityHash "9581a525a2a40a18925eea6d49f48e1498241d84ebd43612b47b0e36c3170a06" ; values:partOf concept:therapeutic-goods-act-1989-sec-49 ; skos:note "Warrant must authorise entry and exercise powers under specified conditions." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.330" ; cml:asserts concept:therapeutic-goods-act-1989-sec-49-ss-4-norm . concept:therapeutic-goods-act-1989-sec-49-ss-4-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-49-ss-4 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-49-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-49-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-49-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits warrant from authorising entry without specified conditions." ; cml:premiseText "(4) The warrant must: (a) authorise one or more authorised persons..." ; cml:conclusionText "...and exercise the powers set out in subsection 48(1)..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-49-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-49-ss-4-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-49-ss-4-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Within" ; cml:logicSummary "Warrant's effect is limited to a specified time period." ; cml:premiseText "(4) The warrant must: (c) specify the day (not more than 6 months after the issue of the warrant) on which the warrant ceases to have effect..." ; cml:conclusionText "...on which the warrant ceases to have effect;" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-49-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-49-ss-4-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-49-ss-4-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Until" ; cml:logicSummary "Warrant's authority is limited to a specified time period." ; cml:premiseText "(4) The warrant must: (c) specify the day (not more than 6 months after the issue of the warrant) on which the warrant ceases to have effect..." ; cml:conclusionText "...on which the warrant ceases to have effect;" ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-49-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-49-ss-4-logic-deontic-4 . concept:therapeutic-goods-act-1989-sec-49-ss-4-logic-deontic-4 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Authorise" ; cml:logicSummary "Warrant authorises entry and exercise of powers under specified conditions." ; cml:premiseText "(4) The warrant must: (a) authorise one or more authorised persons..." ; cml:conclusionText "...with such assistance and by such force as is necessary and reasonable...;" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-49-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-49-ss-4-logic-argumentation-5 . concept:therapeutic-goods-act-1989-sec-49-ss-4-logic-argumentation-5 a cml:LogicApplication ; cml:modality cml:Argumentation ; cml:operator "Imply" ; cml:logicSummary "Warrant implies specified conditions for entry." ; cml:premiseText "(4) The warrant must: (a) authorise one or more authorised persons..." ; cml:conclusionText "...with such assistance and by such force as is necessary and reasonable...;" ; cml:executionSurface "modalities::argumentation" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-50 a cml:Concept ; skos:prefLabel "50 Offence and civil penalty provision related warrants"@en ; cml:realizedBy doc:sec-50 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-50-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-50-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-50-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-50-ss-4 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.331" . concept:therapeutic-goods-act-1989-sec-50-ss-1 a cml:Concept ; skos:prefLabel "50(1) Offence and civil penalty provision related warrants"@en ; cml:realizedBy doc:sec-50-ss-1 ; cml:integrityHash "259dcb65833e21ebef90a01e3bad4c26e479a8547a1868a32feba54c906c65c6" ; values:partOf concept:therapeutic-goods-act-1989-sec-50 ; skos:note "Authorized person may apply for warrant under this section." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.331" ; cml:asserts concept:therapeutic-goods-act-1989-sec-50-ss-1-norm . concept:therapeutic-goods-act-1989-sec-50-ss-1-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-50-ss-1 ; values:borneBy values:Agent ; skos:scopeNote "borne by: Agent" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-50-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-50-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-50-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "May" ; cml:logicSummary "Permission to apply for warrant" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-50-ss-2 a cml:Concept ; skos:prefLabel "50(2) Offence and civil penalty provision related warrants"@en ; cml:realizedBy doc:sec-50-ss-2 ; cml:integrityHash "9723387d1ebfcfb9168f73c58dd4b7dae106a60f31f90145e9004f8015238643" ; values:partOf concept:therapeutic-goods-act-1989-sec-50 ; skos:note "Issuing officer may issue warrant if satisfied of reasonable grounds for suspecting evidential material within 72 hours." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.331" ; cml:asserts concept:therapeutic-goods-act-1989-sec-50-ss-2-norm . concept:therapeutic-goods-act-1989-sec-50-ss-2-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-50-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-50-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-50-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-50-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "May" ; cml:logicSummary "Permission to issue warrant" ; cml:premiseText "Issuing officer has reasonable grounds for suspecting evidential material" ; cml:conclusionText "Warrant may be issued" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-50-ss-3 a cml:Concept ; skos:prefLabel "50(3) Offence and civil penalty provision related warrants"@en ; cml:realizedBy doc:sec-50-ss-3 ; cml:integrityHash "c263d42fb402c3841e33eb8fe5df87f8c0ce4af29db90b714bb0c1f69e0e860f" ; values:partOf concept:therapeutic-goods-act-1989-sec-50 ; skos:note "Issuing officer must provide further information before issuing warrant." ; dc:description "Further information" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.331" ; cml:asserts concept:therapeutic-goods-act-1989-sec-50-ss-3-norm . concept:therapeutic-goods-act-1989-sec-50-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-50-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-50-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-50-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-50-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Must" ; cml:logicSummary "Issuing officer must provide further information." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-50-ss-4 a cml:Concept ; skos:prefLabel "50(4) Offence and civil penalty provision related warrants"@en ; cml:realizedBy doc:sec-50-ss-4 ; cml:integrityHash "7376613b572136a9e0da603fca35d6bdacaef874504fc04a3fc5c24727b55e9c" ; values:partOf concept:therapeutic-goods-act-1989-sec-50 ; skos:note "Warrant requirements for entry and seizure of evidential material" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.331" ; cml:asserts concept:therapeutic-goods-act-1989-sec-50-ss-4-norm . concept:therapeutic-goods-act-1989-sec-50-ss-4-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-50-ss-4 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-50-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-50-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-50-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits warrant issuance without specified conditions" ; cml:premiseText "(4) The warrant must..." ; cml:conclusionText "...authorise the persons so named..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-51 a cml:Concept ; skos:prefLabel "51 Offence and civil penalty provision related warrants by telephone"@en ; cml:realizedBy doc:sec-51 ; cml:integrityHash "28e632296013d70d98788a8b93408094234dff4791336ad558f6e6ea077a1c5b" ; skos:note "Authorized person may apply for warrant by telephone in urgent cases." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.331" ; cml:asserts concept:therapeutic-goods-act-1989-sec-51-norm . concept:therapeutic-goods-act-1989-sec-51-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-51 ; values:borneBy values:Agent ; skos:scopeNote "borne by: Agent" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-51 cml:asserts concept:therapeutic-goods-act-1989-sec-51-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-51-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "May" ; cml:logicSummary "Permission to apply for warrant" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-51a a cml:Concept ; skos:prefLabel "51A Inspections for purposes of Mutual Recognition Convention"@en ; cml:realizedBy doc:sec-51a ; cml:integrityHash "8515f4b2230d33a1525abb2e0b996ff3d9850f9563b795b3445c2c00aa73c4c9" ; skos:note "Request for inspection under Mutual Recognition Convention" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.333" ; cml:asserts concept:therapeutic-goods-act-1989-sec-51a-norm . concept:therapeutic-goods-act-1989-sec-51a-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-51a ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-51b a cml:Concept ; skos:prefLabel "51B Offences relating to warrants"@en ; cml:realizedBy doc:sec-51b ; cml:hasPart concept:therapeutic-goods-act-1989-sec-51b-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-51b-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.334" . concept:therapeutic-goods-act-1989-sec-51b-ss-1 a cml:Concept ; skos:prefLabel "51B(1) Offences relating to warrants"@en ; cml:realizedBy doc:sec-51b-ss-1 ; cml:integrityHash "0fe372e0a860c18d42a8408f361d09eb6e1d790973a6f53bcbff29d66fc60fe9" ; values:partOf concept:therapeutic-goods-act-1989-sec-51b ; skos:note "Making false statements in a warrant application is prohibited." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.334" ; cml:asserts concept:therapeutic-goods-act-1989-sec-51b-ss-1-norm . concept:therapeutic-goods-act-1989-sec-51b-ss-1-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-51b-ss-1 ; values:borneBy values:Agent ; skos:scopeNote "borne by: Agent" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-51b-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-51b-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-51b-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibition of false statements" ; cml:premiseText "False statement in warrant application" ; cml:conclusionText "Prohibited" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-51b-ss-2 a cml:Concept ; skos:prefLabel "51B(2) Offences relating to warrants"@en ; cml:realizedBy doc:sec-51b-ss-2 ; cml:integrityHash "6e7aa047bf885eef9b8ce531d980e8d36696a6724c6eb7239a69868ba3f91101" ; values:partOf concept:therapeutic-goods-act-1989-sec-51b ; skos:note "Prohibits false statements about warrants" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.334" ; cml:asserts concept:therapeutic-goods-act-1989-sec-51b-ss-2-norm . concept:therapeutic-goods-act-1989-sec-51b-ss-2-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-51b-ss-2 ; values:borneBy values:Agent ; skos:scopeNote "borne by: Agent" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-51b-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-51b-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-51b-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "forbid" ; cml:logicSummary "Prohibition" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-51c a cml:Concept ; skos:prefLabel "51C Issuing officers—personal capacity"@en ; cml:realizedBy doc:sec-51c ; cml:integrityHash "a3d9ce38f203e8b183955c1df3c707be225fa24ea2ebd96628bb6f45dc1fcae0" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-51c-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-51c-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-51c-ss-3 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.334" . concept:therapeutic-goods-act-1989-sec-51c-ss-1 a cml:Concept ; skos:prefLabel "51C(1) Issuing officers—personal capacity"@en ; cml:realizedBy doc:sec-51c-ss-1 ; cml:integrityHash "62ce064368e32ebe21e3d63516466f4b0088975606e6925dd7c06d56949cb4df" ; values:partOf concept:therapeutic-goods-act-1989-sec-51c ; skos:note "Issuing officers must act in a personal capacity when exercising powers under this Part." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.334" ; cml:asserts concept:therapeutic-goods-act-1989-sec-51c-ss-1-norm . concept:therapeutic-goods-act-1989-sec-51c-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-51c-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-51c-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-51c-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-51c-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Must" ; cml:logicSummary "Mandatory action" ; cml:premiseText "Issuing officers must act in a personal capacity." ; cml:conclusionText "Obligation to act in a personal capacity" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-51c-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-51c-ss-1-logic-deontic-2 . concept:therapeutic-goods-act-1989-sec-51c-ss-1-logic-deontic-2 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MustNot" ; cml:logicSummary "No court or judicial authority can override this obligation" ; cml:premiseText "Powers need not be accepted" ; cml:conclusionText "No court or judicial authority can override the issuing officer's personal capacity" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-51c-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-51c-ss-1-logic-deontic-3 . concept:therapeutic-goods-act-1989-sec-51c-ss-1-logic-deontic-3 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Must" ; cml:logicSummary "The issuing officer must act in a personal capacity when exercising powers under this Part" ; cml:premiseText "(1) A power conferred on an issuing officer by this Part is conferred on the issuing officer: (a) in a personal capacity; and" ; cml:conclusionText "The issuing officer must act in a personal capacity when exercising powers under this Part" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-51c-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-51c-ss-1-logic-deontic-4 . concept:therapeutic-goods-act-1989-sec-51c-ss-1-logic-deontic-4 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Must" ; cml:logicSummary "No court or judicial authority can override the issuing officer's personal capacity" ; cml:premiseText "(b) not as a court, or as a member or an officer of a court." ; cml:conclusionText "No court or judicial authority can override the issuing officer's personal capacity" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-51c-ss-2 a cml:Concept ; skos:prefLabel "51C(2) Issuing officers—personal capacity"@en ; cml:realizedBy doc:sec-51c-ss-2 ; cml:integrityHash "fa147534ec38bc4881faba10a6bf5a1af17e727e3e2fecf7f7b80f9b40a00dfd" ; values:partOf concept:therapeutic-goods-act-1989-sec-51c ; skos:note "Issuing officer must accept power conferred." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.334" ; cml:asserts concept:therapeutic-goods-act-1989-sec-51c-ss-2-norm . concept:therapeutic-goods-act-1989-sec-51c-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-51c-ss-2 ; values:borneBy values:Agent ; skos:scopeNote "borne by: Agent" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-51c-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-51c-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-51c-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must provide" ; cml:premiseText "The issuing officer need not accept the power conferred." ; cml:conclusionText "The issuing officer MUST accept the power conferred." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-51c-ss-3 a cml:Concept ; skos:prefLabel "51C(3) Issuing officers—personal capacity"@en ; cml:realizedBy doc:sec-51c-ss-3 ; cml:integrityHash "16bdc5055770683902d20ce00e92af00b2f54ed4e63d1557886180d8e48b372b" ; values:partOf concept:therapeutic-goods-act-1989-sec-51c ; skos:note "Issuing officers have protection and immunity in their personal capacity." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.334" ; cml:asserts concept:therapeutic-goods-act-1989-sec-51c-ss-3-norm . concept:therapeutic-goods-act-1989-sec-51c-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-51c-ss-3 ; values:borneBy values:Agent ; skos:scopeNote "borne by: Agent" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-51c-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-51c-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-51c-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "has" ; cml:logicSummary "Protection and immunity" ; cml:premiseText "Issuing officer exercising power" ; cml:conclusionText "Same protection and immunity as court or officer" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52 a cml:Concept ; skos:prefLabel "52 Identity cards"@en ; cml:realizedBy doc:sec-52 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-52-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-52-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-52-ss-4 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.335" . concept:therapeutic-goods-act-1989-sec-52-ss-1 a cml:Concept ; skos:prefLabel "52(1) Identity cards"@en ; cml:realizedBy doc:sec-52-ss-1 ; cml:integrityHash "bc5ca877ed0a635bb16c069a9d0a27f9280d05bee921c8eb4ee5ba37aabc4c54" ; values:partOf concept:therapeutic-goods-act-1989-sec-52 ; skos:note "The Secretary must ensure that each authorised person is issued with an identity card." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.335" ; cml:asserts concept:therapeutic-goods-act-1989-sec-52-ss-1-norm . concept:therapeutic-goods-act-1989-sec-52-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-52-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-52-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-52-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "The Secretary must ensure that each authorised person is issued with an identity card." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52-ss-3 a cml:Concept ; skos:prefLabel "52(3) Identity cards"@en ; cml:realizedBy doc:sec-52-ss-3 ; cml:integrityHash "1f7051111b44fa768ef86fc5a1b02061faaa78257d659aca12875e20eeb473b4" ; values:partOf concept:therapeutic-goods-act-1989-sec-52 ; skos:note "Return identity card after ceasing to be authorised person." ; dc:description "Identity card" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.335" ; cml:asserts concept:therapeutic-goods-act-1989-sec-52-ss-3-norm . concept:therapeutic-goods-act-1989-sec-52-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-52-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-52-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-52-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Obligation" ; cml:conclusionText "Return identity card." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-52-ss-3-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-52-ss-3-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "CONTAINS" ; cml:logicSummary "Temporal interval for returning identity card" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-52-ss-3-logic-argumentation-3 . concept:therapeutic-goods-act-1989-sec-52-ss-3-logic-argumentation-3 a cml:LogicApplication ; cml:modality cml:Argumentation ; cml:operator "IMPLIES" ; cml:logicSummary "Consequence of ceasing to be authorised person" ; cml:conclusionText "Return identity card." ; cml:executionSurface "modalities::argumentation" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52-ss-4 a cml:Concept ; skos:prefLabel "52(4) Identity cards"@en ; cml:realizedBy doc:sec-52-ss-4 ; cml:integrityHash "ff143790560f5f230f5538d7369630e04e0553c3bf50bb5ad3454f316630a4f6" ; values:partOf concept:therapeutic-goods-act-1989-sec-52 ; skos:note "An offence under subsection (3) is prohibited." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.335" ; cml:asserts concept:therapeutic-goods-act-1989-sec-52-ss-4-norm . concept:therapeutic-goods-act-1989-sec-52-ss-4-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-52-ss-4 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-52-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-52-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits an offence under subsection (3)" ; cml:premiseText "(4) An offence under subsection (3) is an offence of strict liability." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52aa a cml:Concept ; skos:prefLabel "52AA Overview"@en ; cml:realizedBy doc:sec-52aa ; cml:integrityHash "c9a15ab67ef9d6e197068006d1a55acffe6e3b242e8aa8af0053598495ca16aa" ; skos:note "Restrictions on supply of scheduled substances for public health and safety" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.340" ; cml:asserts concept:therapeutic-goods-act-1989-sec-52aa-norm . concept:therapeutic-goods-act-1989-sec-52aa-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-52aa ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52aa cml:asserts concept:therapeutic-goods-act-1989-sec-52aa-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-52aa-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Imposes an obligation on the state to restrict supply" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52a a cml:Concept ; skos:prefLabel "52A Definitions"@en ; cml:realizedBy doc:sec-52a ; cml:hasPart concept:therapeutic-goods-act-1989-sec-52a-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-52a-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.340" . concept:therapeutic-goods-act-1989-sec-52a-ss-1 a cml:Concept ; skos:prefLabel "52A(1) Definitions"@en ; cml:realizedBy doc:sec-52a-ss-1 ; cml:integrityHash "e2ed59c0bc756cc5435c555b7e6997ed087b4cc59195a6cc77a9606848cf59e3" ; values:partOf concept:therapeutic-goods-act-1989-sec-52a ; skos:note "Defines terms for the current Poisons Standard and substance scheduling." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.340" ; cml:asserts concept:therapeutic-goods-act-1989-sec-52a-ss-1-norm . concept:therapeutic-goods-act-1989-sec-52a-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-52a-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52a-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-52a-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-52a-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligate" ; cml:logicSummary "Defines terms for the current Poisons Standard and substance scheduling." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52a-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-52a-ss-1-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-52a-ss-1-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "=" ; cml:logicSummary "Classifies substances into schedules." ; cml:premiseText "substance means an ingredient, compound, material or preparation..." ; cml:conclusionText "scheduling in relation to a substance means determining the schedule or schedules..." ; cml:executionSurface "modalities::dl" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52a-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-52a-ss-1-logic-descriptionlogic-3 . concept:therapeutic-goods-act-1989-sec-52a-ss-1-logic-descriptionlogic-3 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "=" ; cml:logicSummary "Defines the first Poisons Standard as the latest edition at commencement." ; cml:premiseText "first Poisons Standard means the latest edition at the commencement of this Part of the document known as the Standard for..." ; cml:conclusionText "the first Poisons Standard is the latest edition at the commencement of this Part of the document known as the Standard for..." ; cml:executionSurface "modalities::dl" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52a-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-52a-ss-1-logic-descriptionlogic-4 . concept:therapeutic-goods-act-1989-sec-52a-ss-1-logic-descriptionlogic-4 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "=" ; cml:logicSummary "Defines substance as an ingredient, compound, material or preparation that may cause death, illness or injury." ; cml:premiseText "substance means: (a) an ingredient, compound, material or preparation which, or the use of which, may cause death, illness or injury to persons or animals;" ; cml:conclusionText "the substance is an ingredient, compound, material or preparation that may cause death, illness or injury." ; cml:executionSurface "modalities::dl" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52a-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-52a-ss-1-logic-descriptionlogic-5 . concept:therapeutic-goods-act-1989-sec-52a-ss-1-logic-descriptionlogic-5 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "=" ; cml:logicSummary "Defines the current Poisons Standard as the document last prepared under paragraph 52D(2)(b)." ; cml:premiseText "(1) In this Part, unless the contrary intention appears: current Poisons Standard means: (a) if no document has been prepared under paragraph 52D(2)(b)—the first Poisons Standard; or (b) otherwise—the document last prepared under that paragraph..." ; cml:conclusionText "the current Poisons Standard is the document last prepared under paragraph 52D(2)(b)." ; cml:executionSurface "modalities::dl" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52a-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-52a-ss-1-logic-descriptionlogic-6 . concept:therapeutic-goods-act-1989-sec-52a-ss-1-logic-descriptionlogic-6 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "=" ; cml:logicSummary "Defines scheduling as determining the schedule or schedules to the current Poisons Standard." ; cml:premiseText "scheduling, in relation to a substance, means determining the schedule or schedules to the current Poisons Standard in which the name or a description of the substance is to be included." ; cml:conclusionText "scheduling in relation to a substance means determining the schedule or schedules to the current Poisons Standard." ; cml:executionSurface "modalities::dl" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52a-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-52a-ss-1-logic-descriptionlogic-7 . concept:therapeutic-goods-act-1989-sec-52a-ss-1-logic-descriptionlogic-7 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "=" ; cml:logicSummary "Defines substance as an ingredient, compound, material or preparation specified under subsection (2)." ; cml:premiseText "substance means: (b) an ingredient, compound, material or preparation specified under subsection (2);" ; cml:conclusionText "the substance is an ingredient, compound, material or preparation specified under subsection (2)." ; cml:executionSurface "modalities::dl" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52a-ss-2 a cml:Concept ; skos:prefLabel "52A(2) Definitions"@en ; cml:realizedBy doc:sec-52a-ss-2 ; cml:integrityHash "6f14d7e5463215b42a24d5d28045a6762e1f1b5ec2b850aab05d901aa2fbdad4" ; values:partOf concept:therapeutic-goods-act-1989-sec-52a ; skos:note "Secretary may specify ingredients for purposes of definition" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.340" ; cml:asserts concept:therapeutic-goods-act-1989-sec-52a-ss-2-norm . concept:therapeutic-goods-act-1989-sec-52a-ss-2-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-52a-ss-2 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52b a cml:Concept ; skos:prefLabel "52B Advisory Committee on Medicines Scheduling"@en ; cml:realizedBy doc:sec-52b ; cml:hasPart concept:therapeutic-goods-act-1989-sec-52b-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-52b-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-52b-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-52b-ss-4 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.341" . concept:therapeutic-goods-act-1989-sec-52b-ss-1 a cml:Concept ; skos:prefLabel "52B(1) Advisory Committee on Medicines Scheduling"@en ; cml:realizedBy doc:sec-52b-ss-1 ; cml:integrityHash "31e3ae5a8dd99096b9e76118c730218bbfa2bfef2a0c7fb1ed15c336f640ff02" ; values:partOf concept:therapeutic-goods-act-1989-sec-52b ; skos:note "Establishment of Advisory Committee on Medicines Scheduling" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.341" ; cml:asserts concept:therapeutic-goods-act-1989-sec-52b-ss-1-norm . concept:therapeutic-goods-act-1989-sec-52b-ss-1-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-52b-ss-1 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52b-ss-2 a cml:Concept ; skos:prefLabel "52B(2) Advisory Committee on Medicines Scheduling"@en ; cml:realizedBy doc:sec-52b-ss-2 ; cml:integrityHash "927664ea70662d41ffc536c3851fa5442d1070a4def2b43b51a86a54293bdaa4" ; values:partOf concept:therapeutic-goods-act-1989-sec-52b ; skos:note "Committee constitution and meeting requirements" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.341" ; cml:asserts concept:therapeutic-goods-act-1989-sec-52b-ss-2-norm . concept:therapeutic-goods-act-1989-sec-52b-ss-2-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-52b-ss-2 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52b-ss-3 a cml:Concept ; skos:prefLabel "52B(3) Advisory Committee on Medicines Scheduling"@en ; cml:realizedBy doc:sec-52b-ss-3 ; cml:integrityHash "2fa1bf462837c67a561c19974ebcb26fdf8e598971ddb48f6d1945a000a82692" ; values:partOf concept:therapeutic-goods-act-1989-sec-52b ; skos:note "Each State and the Commonwealth can nominate a member of the Advisory Committee on Medicines Scheduling." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.341" ; cml:asserts concept:therapeutic-goods-act-1989-sec-52b-ss-3-norm . concept:therapeutic-goods-act-1989-sec-52b-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-52b-ss-3 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52b-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-52b-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-52b-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "entitlement" ; cml:logicSummary "Entitlement to nominate a member of the Advisory Committee on Medicines Scheduling." ; cml:premiseText "The Commonwealth, each State, the Australian Capital Territory and the Northern Territory are each entitled..." ; cml:conclusionText "Each State and the Commonwealth can nominate a member of the Advisory Committee on Medicines Scheduling." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52b-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-52b-ss-3-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-52b-ss-3-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "between" ; cml:logicSummary "There is an interval between the nomination and the appointment of a member of the Advisory Committee on Medicines Scheduling." ; cml:premiseText "(3) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory are each entitled..." ; cml:conclusionText "The nomination and appointment of a member of the Advisory Committee on Medicines Scheduling occur between these entities." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52b-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-52b-ss-3-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-52b-ss-3-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "between" ; cml:logicSummary "There is an interval between the nomination and the appointment of a member of the Advisory Committee on Medicines Scheduling." ; cml:premiseText "(3) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory are each entitled..." ; cml:conclusionText "The nomination and appointment of a member of the Advisory Committee on Medicines Scheduling occur between these entities." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52b-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-52b-ss-3-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-52b-ss-3-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "diffusion" ; cml:logicSummary "The information about the nomination of a member of the Advisory Committee on Medicines Scheduling is diffused to the relevant parties." ; cml:premiseText "(3) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory are each entitled..." ; cml:conclusionText "The information about the nomination of a member of the Advisory Committee on Medicines Scheduling is diffused to the relevant parties." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52b-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-52b-ss-3-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-52b-ss-3-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "nominating" ; cml:logicSummary "A State or the Commonwealth can nominate a member of the Advisory Committee on Medicines Scheduling." ; cml:premiseText "(3) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory are each entitled..." ; cml:conclusionText "A State or the Commonwealth can nominate a member of the Advisory Committee on Medicines Scheduling." ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52b-ss-4 a cml:Concept ; skos:prefLabel "52B(4) Advisory Committee on Medicines Scheduling"@en ; cml:realizedBy doc:sec-52b-ss-4 ; cml:integrityHash "aa87c7ac9a4f2c39c6186d5f069de526bc9eda7f4675a1270f0c0f8663a71e84" ; values:partOf concept:therapeutic-goods-act-1989-sec-52b ; skos:note "Makes recommendations to the Secretary on therapeutic goods classification and scheduling." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.341" ; cml:asserts concept:therapeutic-goods-act-1989-sec-52b-ss-4-norm . concept:therapeutic-goods-act-1989-sec-52b-ss-4-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-52b-ss-4 ; values:borneBy values:Agent ; skos:scopeNote "borne by: Agent" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52b-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-52b-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-52b-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Makes recommendations" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52c a cml:Concept ; skos:prefLabel "52C Advisory Committee on Chemicals Scheduling"@en ; cml:realizedBy doc:sec-52c ; cml:hasPart concept:therapeutic-goods-act-1989-sec-52c-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-52c-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-52c-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-52c-ss-4 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-52c-ss-5 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.342" . concept:therapeutic-goods-act-1989-sec-52c-ss-1 a cml:Concept ; skos:prefLabel "52C(1) Advisory Committee on Chemicals Scheduling"@en ; cml:realizedBy doc:sec-52c-ss-1 ; cml:integrityHash "6b4c76a07cb56eff808bc14d981b7ee3cac549787a4aba727c9b87f0e9528296" ; values:partOf concept:therapeutic-goods-act-1989-sec-52c ; skos:note "Establishment of Advisory Committee on Chemicals Scheduling" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.342" ; cml:asserts concept:therapeutic-goods-act-1989-sec-52c-ss-1-norm . concept:therapeutic-goods-act-1989-sec-52c-ss-1-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-52c-ss-1 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52c-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-52c-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-52c-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "establishes" ; cml:logicSummary "Establishes the Advisory Committee on Chemicals Scheduling" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52c-ss-2 a cml:Concept ; skos:prefLabel "52C(2) Advisory Committee on Chemicals Scheduling"@en ; cml:realizedBy doc:sec-52c-ss-2 ; cml:integrityHash "927664ea70662d41ffc536c3851fa5442d1070a4def2b43b51a86a54293bdaa4" ; values:partOf concept:therapeutic-goods-act-1989-sec-52c ; skos:note "Committee constitution and meeting requirements" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.342" ; cml:asserts concept:therapeutic-goods-act-1989-sec-52c-ss-2-norm . concept:therapeutic-goods-act-1989-sec-52c-ss-2-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-52c-ss-2 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52c-ss-3 a cml:Concept ; skos:prefLabel "52C(3) Advisory Committee on Chemicals Scheduling"@en ; cml:realizedBy doc:sec-52c-ss-3 ; cml:integrityHash "2fa1bf462837c67a561c19974ebcb26fdf8e598971ddb48f6d1945a000a82692" ; values:partOf concept:therapeutic-goods-act-1989-sec-52c ; skos:note "Each State and the Commonwealth can nominate a member to the Advisory Committee on Chemicals Scheduling." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.342" ; cml:asserts concept:therapeutic-goods-act-1989-sec-52c-ss-3-norm . concept:therapeutic-goods-act-1989-sec-52c-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-52c-ss-3 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52c-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-52c-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-52c-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "entitlement" ; cml:logicSummary "Entitlement to nominate a member" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52c-ss-4 a cml:Concept ; skos:prefLabel "52C(4) Advisory Committee on Chemicals Scheduling"@en ; cml:realizedBy doc:sec-52c-ss-4 ; cml:integrityHash "dfb7f9a1141e6371df732284d097073046d67f7749e25412dd88831b8691169b" ; values:partOf concept:therapeutic-goods-act-1989-sec-52c ; skos:note "The Committee must make recommendations to the Secretary on certain matters." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.342" ; cml:asserts concept:therapeutic-goods-act-1989-sec-52c-ss-4-norm . concept:therapeutic-goods-act-1989-sec-52c-ss-4-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-52c-ss-4 ; values:borneBy values:Agent ; skos:scopeNote "borne by: Agent" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52c-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-52c-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-52c-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "The Committee must make recommendations." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52c-ss-5 a cml:Concept ; skos:prefLabel "52C(5) Advisory Committee on Chemicals Scheduling"@en ; cml:realizedBy doc:sec-52c-ss-5 ; cml:integrityHash "d0bb4dd0c533b156eee821c1c4f0f0d13c44f6b410cf99ab76701551ebe13560" ; values:partOf concept:therapeutic-goods-act-1989-sec-52c ; skos:note "Exempts therapeutic goods from certain provisions." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.342" ; cml:asserts concept:therapeutic-goods-act-1989-sec-52c-ss-5-norm . concept:therapeutic-goods-act-1989-sec-52c-ss-5-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-52c-ss-5 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52c-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-52c-ss-5-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-52c-ss-5-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "exemption" ; cml:logicSummary "Exempts substances from certain provisions." ; cml:premiseText "(5) Paragraphs (4)(a) and (d)" ; cml:conclusionText "do not apply in relation to substances..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52c-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-52c-ss-5-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-52c-ss-5-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "includes" ; cml:logicSummary "Therapeutic goods include certain substances." ; cml:premiseText "(5) Paragraphs (4)(a) and (d)" ; cml:conclusionText "...are included in, therapeutic goods." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52ca a cml:Concept ; skos:prefLabel "52CA Joint meetings"@en ; cml:realizedBy doc:sec-52ca ; cml:integrityHash "d3114025bbcbcf7c49c0aadbd6abfb4beea9d698eb2b19b799b9fd68da0724da" ; skos:note "May hold joint meetings" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.343" ; cml:asserts concept:therapeutic-goods-act-1989-sec-52ca-norm . concept:therapeutic-goods-act-1989-sec-52ca-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-52ca ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52ca cml:asserts concept:therapeutic-goods-act-1989-sec-52ca-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-52ca-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "Obligation to hold joint meetings" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52d a cml:Concept ; skos:prefLabel "52D Poisons Standard"@en ; cml:realizedBy doc:sec-52d ; cml:hasPart concept:therapeutic-goods-act-1989-sec-52d-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-52d-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-52d-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-52d-ss-4a ; cml:hasPart concept:therapeutic-goods-act-1989-sec-52d-ss-4b ; cml:hasPart concept:therapeutic-goods-act-1989-sec-52d-ss-5 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.343" . concept:therapeutic-goods-act-1989-sec-52d-ss-1 a cml:Concept ; skos:prefLabel "52D(1) Poisons Standard"@en ; cml:realizedBy doc:sec-52d-ss-1 ; cml:integrityHash "98f1ad41d75bf0927ac833e19880043ccddad4ba84c56acf619309ea2814cc29" ; values:partOf concept:therapeutic-goods-act-1989-sec-52d ; skos:note "Commences with a prepared Poisons Standard" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.343" ; cml:asserts concept:therapeutic-goods-act-1989-sec-52d-ss-1-norm . concept:therapeutic-goods-act-1989-sec-52d-ss-1-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-52d-ss-1 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52d-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-52d-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-52d-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "begins" ; cml:logicSummary "Establishes the commencement of a standard" ; cml:premiseText "(1) On the commencement of this Part..." ; cml:conclusionText "the first Poisons Standard is taken to have been prepared and made available" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52d-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-52d-ss-1-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-52d-ss-1-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "begins-at" ; cml:logicSummary "Describes a temporal relationship between events" ; cml:premiseText "(1) On the commencement of this Part..." ; cml:conclusionText "the first Poisons Standard is taken to have been prepared and made available at the commencement of this Part" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52d-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-52d-ss-1-logic-cogai-3 . concept:therapeutic-goods-act-1989-sec-52d-ss-1-logic-cogai-3 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "asserts" ; cml:logicSummary "Describes a fact about the standard's preparation using AI" ; cml:premiseText "(1) On the commencement of this Part..." ; cml:conclusionText "the first Poisons Standard is taken to have been prepared and made available by the then National Drugs and Poisons Schedule Committee" ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52d-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-52d-ss-1-logic-n3logic-4 . concept:therapeutic-goods-act-1989-sec-52d-ss-1-logic-n3logic-4 a cml:LogicApplication ; cml:modality cml:N3Logic ; cml:operator "asserts" ; cml:logicSummary "Describes a fact about the standard's preparation using N3 logic" ; cml:premiseText "(1) On the commencement of this Part..." ; cml:conclusionText "the first Poisons Standard is taken to have been prepared and made available by the then National Drugs and Poisons Schedule Committee" ; cml:executionSurface "modalities::logic::n3_compiler" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52d-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-52d-ss-1-logic-shacl-5 . concept:therapeutic-goods-act-1989-sec-52d-ss-1-logic-shacl-5 a cml:LogicApplication ; cml:modality cml:SHACL ; cml:operator "asserts" ; cml:logicSummary "Describes a fact about the standard's preparation using SHACL" ; cml:premiseText "(1) On the commencement of this Part..." ; cml:conclusionText "the first Poisons Standard is taken to have been prepared and made available by the then National Drugs and Poisons Schedule Committee" ; cml:executionSurface "modalities::logic::shacl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52d-ss-2 a cml:Concept ; skos:prefLabel "52D(2) Poisons Standard"@en ; cml:realizedBy doc:sec-52d-ss-2 ; cml:integrityHash "bc819fc539fad70f1eeda1b80c2a5eb085d48704842a841483cd508ba91b7793" ; values:partOf concept:therapeutic-goods-act-1989-sec-52d ; skos:note "Secretary may amend or prepare a new Poisons Standard." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.343" ; cml:asserts concept:therapeutic-goods-act-1989-sec-52d-ss-2-norm . concept:therapeutic-goods-act-1989-sec-52d-ss-2-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-52d-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52d-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-52d-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-52d-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "Permission to amend the standard." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52d-ss-3 a cml:Concept ; skos:prefLabel "52D(3) Poisons Standard"@en ; cml:realizedBy doc:sec-52d-ss-3 ; cml:integrityHash "c64f185b60cc1086ce193584d215d0a3df24a7774d49f8792ebb8789557b65da" ; values:partOf concept:therapeutic-goods-act-1989-sec-52d ; skos:note "Power to exercise under subsection (2)" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.343" ; cml:asserts concept:therapeutic-goods-act-1989-sec-52d-ss-3-norm . concept:therapeutic-goods-act-1989-sec-52d-ss-3-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-52d-ss-3 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52d-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-52d-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-52d-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Permit" ; cml:logicSummary "Grant of permission" ; cml:premiseText "(3) The Secretary may exercise a power..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52d-ss-4a a cml:Concept ; skos:prefLabel "52D(4A) Poisons Standard"@en ; cml:realizedBy doc:sec-52d-ss-4a ; cml:integrityHash "f7bd95a99f6f34d086cabc71ab140fc6dbbd936fbbb8aa88bca2659fccf3b835" ; values:partOf concept:therapeutic-goods-act-1989-sec-52d ; skos:note "Instrument made under paragraph (2)(a) or (b) is a legislative instrument." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.343" ; cml:asserts concept:therapeutic-goods-act-1989-sec-52d-ss-4a-norm . concept:therapeutic-goods-act-1989-sec-52d-ss-4a-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-52d-ss-4a ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52d-ss-4a cml:asserts concept:therapeutic-goods-act-1989-sec-52d-ss-4a-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-52d-ss-4a-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "is" ; cml:logicSummary "Instrument is a legislative instrument." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52d-ss-4b a cml:Concept ; skos:prefLabel "52D(4B) Poisons Standard"@en ; cml:realizedBy doc:sec-52d-ss-4b ; cml:integrityHash "8cfcb722de9b3356b537cfc747c70a2466e075f1d0ea855654590583ade337e1" ; values:partOf concept:therapeutic-goods-act-1989-sec-52d ; skos:note "Allows for incorporation of existing provisions from other instruments or writings." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.343" ; cml:asserts concept:therapeutic-goods-act-1989-sec-52d-ss-4b-norm . concept:therapeutic-goods-act-1989-sec-52d-ss-4b-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-52d-ss-4b ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52d-ss-5 a cml:Concept ; skos:prefLabel "52D(5) Poisons Standard"@en ; cml:realizedBy doc:sec-52d-ss-5 ; cml:integrityHash "639e389af3170e5bc1ddc611865a7f0ca9c176b70db0c71ac103c668cdd20a03" ; values:partOf concept:therapeutic-goods-act-1989-sec-52d ; skos:note "Definition of 'Administration' in relation to the current Poisons Standard" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.343" ; cml:asserts concept:therapeutic-goods-act-1989-sec-52d-ss-5-norm . concept:therapeutic-goods-act-1989-sec-52d-ss-5-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-52d-ss-5 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52e a cml:Concept ; skos:prefLabel "52E Secretary to take certain matters into account in exercising"@en ; cml:realizedBy doc:sec-52e ; cml:integrityHash "0e25d57dbe558245aead9ac9aa0089a2d18634aa26fa0dd81efbff7c4622d971" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-52e-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-52e-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-52e-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-52e-ss-4 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-52e-ss-5 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-52e-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-52e-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-52e-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-52e-ss-4 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.344" . concept:therapeutic-goods-act-1989-sec-52e-ss-1 a cml:Concept ; skos:prefLabel "52E(1) Secretary to take certain matters into account in exercising"@en ; cml:realizedBy doc:sec-52e-ss-1 ; cml:integrityHash "92908ce64a49b90b21e81fdc2d0092b553b84fa44a3bef47e43715dc4c6b6d3d" ; values:partOf concept:therapeutic-goods-act-1989-sec-52e ; skos:note "Secretary must consider certain matters when exercising power. Allow person to apply for amendment of current Poisons Standard." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.344" ; cml:asserts concept:therapeutic-goods-act-1989-sec-52e-ss-1-norm . concept:therapeutic-goods-act-1989-sec-52e-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-52e-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52e-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-52e-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-52e-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must consider all relevant factors." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52e-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-52e-ss-1-logic-deontic-2 . concept:therapeutic-goods-act-1989-sec-52e-ss-1-logic-deontic-2 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Permit" ; cml:logicSummary "Grant permission to apply for amendment." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52e-ss-2 a cml:Concept ; skos:prefLabel "52E(2) Secretary to take certain matters into account in exercising"@en ; cml:realizedBy doc:sec-52e-ss-2 ; cml:integrityHash "a325ddf6748881193ebf7a96606e226ea43e8432f4475d29bccfab32ae2e9a10" ; values:partOf concept:therapeutic-goods-act-1989-sec-52e ; skos:note "Application requirements Secretary must comply with guidelines from the Australian Health Ministers’ Advisory Council and the National Coordinating Committee on Therapeutic Goods." ; dc:description "Application form, amendment sought, office of Department, application fee" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.344" ; cml:asserts concept:therapeutic-goods-act-1989-sec-52e-ss-2-norm . concept:therapeutic-goods-act-1989-sec-52e-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-52e-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52e-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-52e-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-52e-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must provide required information" ; cml:premiseText "None" ; cml:conclusionText "None" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52e-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-52e-ss-2-logic-deontic-2 . concept:therapeutic-goods-act-1989-sec-52e-ss-2-logic-deontic-2 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Obligation to comply with guidelines" ; cml:premiseText "The Secretary has a power under subsection 52D(2)" ; cml:conclusionText "The Secretary must comply with the guidelines" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52e-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-52e-ss-2-logic-alleninterval-3 . concept:therapeutic-goods-act-1989-sec-52e-ss-2-logic-alleninterval-3 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator ">=" ; cml:logicSummary "Guidelines are notified to the Secretary for at least one year before this section comes into effect" ; cml:premiseText "The subcommittee of the Council known as the National Coordinating Committee on Therapeutic Goods is notified to the Secretary" ; cml:conclusionText "The guidelines were notified to the Secretary for at least one year before this section came into effect" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52e-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-52e-ss-2-logic-ltl-4 . concept:therapeutic-goods-act-1989-sec-52e-ss-2-logic-ltl-4 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator ">=" ; cml:logicSummary "Guidelines are applicable to all powers under subsection 52D(2)" ; cml:premiseText "The Secretary has a power under subsection 52D(2)" ; cml:conclusionText "All powers under subsection 52D(2) must comply with the guidelines" ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52e-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-52e-ss-2-logic-diffusion-5 . concept:therapeutic-goods-act-1989-sec-52e-ss-2-logic-diffusion-5 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "IS_A" ; cml:logicSummary "Guidelines are a type of guideline that can be shared and applied by others" ; cml:premiseText "The Australian Health Ministers’ Advisory Council has guidelines" ; cml:conclusionText "The subcommittee of the Council known as the National Coordinating Committee on Therapeutic Goods is a type of guideline that can be shared and applied by others" ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52e-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-52e-ss-2-logic-cogai-6 . concept:therapeutic-goods-act-1989-sec-52e-ss-2-logic-cogai-6 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "IS_A" ; cml:logicSummary "Guidelines are a type of knowledge that can be used to make decisions" ; cml:premiseText "The Secretary has a power under subsection 52D(2)" ; cml:conclusionText "The guidelines are a type of knowledge that can be used to make decisions" ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52e-ss-3 a cml:Concept ; skos:prefLabel "52E(3) Secretary to take certain matters into account in exercising"@en ; cml:realizedBy doc:sec-52e-ss-3 ; cml:integrityHash "21bf574860497753cb271e98ef817a7014f878c99ea867f44cbdfb09d61d9a5f" ; values:partOf concept:therapeutic-goods-act-1989-sec-52e ; skos:note "Must consider recommendations or advice from Advisory Committees Secretary must require person to provide further information within a reasonable time." ; dc:description "true" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.344" ; cml:asserts concept:therapeutic-goods-act-1989-sec-52e-ss-3-norm . concept:therapeutic-goods-act-1989-sec-52e-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-52e-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52e-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-52e-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-52e-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Obligation to consider recommendations" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52e-ss-4 a cml:Concept ; skos:prefLabel "52E(4) Secretary to take certain matters into account in exercising"@en ; cml:realizedBy doc:sec-52e-ss-4 ; cml:integrityHash "d558cba65a58eac4c2e407c7279c75742bcacc9427869b7855d5f2d5d11a35d8" ; values:partOf concept:therapeutic-goods-act-1989-sec-52e ; skos:note "Application may be required or permitted for specified software requirements Secretary may seek advice from committees or persons when exercising power." ; dc:description "Information" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.344" ; cml:asserts concept:therapeutic-goods-act-1989-sec-52e-ss-4-norm . concept:therapeutic-goods-act-1989-sec-52e-ss-4-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-52e-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52e-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-52e-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-52e-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "May" ; cml:logicSummary "Permission to provide information" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52e-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-52e-ss-4-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-52e-ss-4-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "For" ; cml:logicSummary "Application for specified software requirements" ; cml:executionSurface "modalities::dl" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52e-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-52e-ss-4-logic-alleninterval-3 . concept:therapeutic-goods-act-1989-sec-52e-ss-4-logic-alleninterval-3 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Overlaps" ; cml:logicSummary "Temporal overlap with exercising power." ; cml:premiseText "(4) In exercising a power under subsection 52D(2), the Secretary may seek advice from either or both of the following:" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52e-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-52e-ss-4-logic-ltl-4 . concept:therapeutic-goods-act-1989-sec-52e-ss-4-logic-ltl-4 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Repeats" ; cml:logicSummary "Repeating pattern of seeking advice." ; cml:premiseText "(4) In exercising a power under subsection 52D(2), the Secretary may seek advice from either or both of the following:" ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52e-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-52e-ss-4-logic-diffusion-5 . concept:therapeutic-goods-act-1989-sec-52e-ss-4-logic-diffusion-5 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "Diffuses" ; cml:logicSummary "Diffusing information to committees and persons." ; cml:premiseText "(4) In exercising a power under subsection 52D(2), the Secretary may seek advice from either or both of the following:" ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52e-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-52e-ss-4-logic-cogai-6 . concept:therapeutic-goods-act-1989-sec-52e-ss-4-logic-cogai-6 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "Incorporates" ; cml:logicSummary "Incorporating committees and persons into decision-making." ; cml:premiseText "(4) In exercising a power under subsection 52D(2), the Secretary may seek advice from either or both of the following:" ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52e-ss-5 a cml:Concept ; skos:prefLabel "52E(5) Secretary to take certain matters into account in exercising"@en ; cml:realizedBy doc:sec-52e-ss-5 ; cml:integrityHash "12d6ffd021fb2097cf87a48602615f0e768a23e16139f20e32667474bfc1ea26" ; values:partOf concept:therapeutic-goods-act-1989-sec-52e ; skos:note "Secretary must consider additional information when exercising power" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.344" ; cml:asserts concept:therapeutic-goods-act-1989-sec-52e-ss-5-norm . concept:therapeutic-goods-act-1989-sec-52e-ss-5-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-52e-ss-5 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52e-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-52e-ss-5-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-52e-ss-5-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must consider additional information" ; cml:premiseText "(5) Subsections (2) to (4) do not limit the information the Secretary may consider in exercising a power under subsection 52D(2)." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52e-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-52e-ss-5-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-52e-ss-5-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "CONTAINS" ; cml:logicSummary "Temporal interval of consideration" ; cml:premiseText "(5) Subsections (2) to (4) do not limit the information the Secretary may consider in exercising a power under subsection 52D(2)." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52e-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-52e-ss-5-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-52e-ss-5-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "CONTAINS" ; cml:logicSummary "Temporal interval of consideration" ; cml:premiseText "(5) Subsections (2) to (4) do not limit the information the Secretary may consider in exercising a power under subsection 52D(2)." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52e-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-52e-ss-5-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-52e-ss-5-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "CONTAINS" ; cml:logicSummary "Temporal interval of consideration" ; cml:premiseText "(5) Subsections (2) to (4) do not limit the information the Secretary may consider in exercising a power under subsection 52D(2)." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52e-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-52e-ss-5-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-52e-ss-5-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "CONTAINS" ; cml:logicSummary "Temporal interval of consideration" ; cml:premiseText "(5) Subsections (2) to (4) do not limit the information the Secretary may consider in exercising a power under subsection 52D(2)." ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52e-ss-1 a cml:Concept ; skos:prefLabel "52E(1) Secretary to take certain matters into account in exercising"@en ; cml:realizedBy doc:sec-52e-ss-1 ; cml:integrityHash "e653a468812039f15affadbe89154a2386d982b1b453a270122a140bbfb8fd33" ; values:partOf concept:therapeutic-goods-act-1989-sec-52e ; skos:note "Secretary must consider certain matters when exercising power. Allow person to apply for amendment of current Poisons Standard." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.344" ; cml:asserts concept:therapeutic-goods-act-1989-sec-52e-ss-1-norm . concept:therapeutic-goods-act-1989-sec-52e-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-52e-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52e-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-52e-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-52e-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must consider all relevant factors." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52e-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-52e-ss-1-logic-deontic-2 . concept:therapeutic-goods-act-1989-sec-52e-ss-1-logic-deontic-2 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Permit" ; cml:logicSummary "Grant permission to apply for amendment." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52e-ss-2 a cml:Concept ; skos:prefLabel "52E(2) Secretary to take certain matters into account in exercising"@en ; cml:realizedBy doc:sec-52e-ss-2 ; cml:integrityHash "7a5db6bbb89398c1da761dd76460729e86fa4532b1d7070d40a878d8373ad63c" ; values:partOf concept:therapeutic-goods-act-1989-sec-52e ; skos:note "Application requirements Secretary must comply with guidelines from the Australian Health Ministers’ Advisory Council and the National Coordinating Committee on Therapeutic Goods." ; dc:description "Application form, amendment sought, office of Department, application fee" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.344" ; cml:asserts concept:therapeutic-goods-act-1989-sec-52e-ss-2-norm . concept:therapeutic-goods-act-1989-sec-52e-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-52e-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52e-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-52e-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-52e-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must provide required information" ; cml:premiseText "None" ; cml:conclusionText "None" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52e-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-52e-ss-2-logic-deontic-2 . concept:therapeutic-goods-act-1989-sec-52e-ss-2-logic-deontic-2 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Obligation to comply with guidelines" ; cml:premiseText "The Secretary has a power under subsection 52D(2)" ; cml:conclusionText "The Secretary must comply with the guidelines" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52e-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-52e-ss-2-logic-alleninterval-3 . concept:therapeutic-goods-act-1989-sec-52e-ss-2-logic-alleninterval-3 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator ">=" ; cml:logicSummary "Guidelines are notified to the Secretary for at least one year before this section comes into effect" ; cml:premiseText "The subcommittee of the Council known as the National Coordinating Committee on Therapeutic Goods is notified to the Secretary" ; cml:conclusionText "The guidelines were notified to the Secretary for at least one year before this section came into effect" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52e-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-52e-ss-2-logic-ltl-4 . concept:therapeutic-goods-act-1989-sec-52e-ss-2-logic-ltl-4 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator ">=" ; cml:logicSummary "Guidelines are applicable to all powers under subsection 52D(2)" ; cml:premiseText "The Secretary has a power under subsection 52D(2)" ; cml:conclusionText "All powers under subsection 52D(2) must comply with the guidelines" ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52e-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-52e-ss-2-logic-diffusion-5 . concept:therapeutic-goods-act-1989-sec-52e-ss-2-logic-diffusion-5 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "IS_A" ; cml:logicSummary "Guidelines are a type of guideline that can be shared and applied by others" ; cml:premiseText "The Australian Health Ministers’ Advisory Council has guidelines" ; cml:conclusionText "The subcommittee of the Council known as the National Coordinating Committee on Therapeutic Goods is a type of guideline that can be shared and applied by others" ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52e-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-52e-ss-2-logic-cogai-6 . concept:therapeutic-goods-act-1989-sec-52e-ss-2-logic-cogai-6 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "IS_A" ; cml:logicSummary "Guidelines are a type of knowledge that can be used to make decisions" ; cml:premiseText "The Secretary has a power under subsection 52D(2)" ; cml:conclusionText "The guidelines are a type of knowledge that can be used to make decisions" ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52e-ss-3 a cml:Concept ; skos:prefLabel "52E(3) Secretary to take certain matters into account in exercising"@en ; cml:realizedBy doc:sec-52e-ss-3 ; cml:integrityHash "47c4db6deb539834c792f6f1a9154898b8f69b331d84d712467a012293234ea8" ; values:partOf concept:therapeutic-goods-act-1989-sec-52e ; skos:note "Must consider recommendations or advice from Advisory Committees Secretary must require person to provide further information within a reasonable time." ; dc:description "true" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.344" ; cml:asserts concept:therapeutic-goods-act-1989-sec-52e-ss-3-norm . concept:therapeutic-goods-act-1989-sec-52e-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-52e-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52e-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-52e-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-52e-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Obligation to consider recommendations" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52e-ss-4 a cml:Concept ; skos:prefLabel "52E(4) Secretary to take certain matters into account in exercising"@en ; cml:realizedBy doc:sec-52e-ss-4 ; cml:integrityHash "6edb8f78a3eec2803d548bdc449346b35f8fdde4b3ed6a3d9ead06243ed77be6" ; values:partOf concept:therapeutic-goods-act-1989-sec-52e ; skos:note "Application may be required or permitted for specified software requirements Secretary may seek advice from committees or persons when exercising power." ; dc:description "Information" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.344" ; cml:asserts concept:therapeutic-goods-act-1989-sec-52e-ss-4-norm . concept:therapeutic-goods-act-1989-sec-52e-ss-4-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-52e-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52e-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-52e-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-52e-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "May" ; cml:logicSummary "Permission to provide information" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52e-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-52e-ss-4-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-52e-ss-4-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "For" ; cml:logicSummary "Application for specified software requirements" ; cml:executionSurface "modalities::dl" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52e-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-52e-ss-4-logic-alleninterval-3 . concept:therapeutic-goods-act-1989-sec-52e-ss-4-logic-alleninterval-3 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Overlaps" ; cml:logicSummary "Temporal overlap with exercising power." ; cml:premiseText "(4) In exercising a power under subsection 52D(2), the Secretary may seek advice from either or both of the following:" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52e-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-52e-ss-4-logic-ltl-4 . concept:therapeutic-goods-act-1989-sec-52e-ss-4-logic-ltl-4 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Repeats" ; cml:logicSummary "Repeating pattern of seeking advice." ; cml:premiseText "(4) In exercising a power under subsection 52D(2), the Secretary may seek advice from either or both of the following:" ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52e-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-52e-ss-4-logic-diffusion-5 . concept:therapeutic-goods-act-1989-sec-52e-ss-4-logic-diffusion-5 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "Diffuses" ; cml:logicSummary "Diffusing information to committees and persons." ; cml:premiseText "(4) In exercising a power under subsection 52D(2), the Secretary may seek advice from either or both of the following:" ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52e-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-52e-ss-4-logic-cogai-6 . concept:therapeutic-goods-act-1989-sec-52e-ss-4-logic-cogai-6 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "Incorporates" ; cml:logicSummary "Incorporating committees and persons into decision-making." ; cml:premiseText "(4) In exercising a power under subsection 52D(2), the Secretary may seek advice from either or both of the following:" ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52f a cml:Concept ; skos:prefLabel "52F Incorporation of current Poisons Standard"@en ; cml:realizedBy doc:sec-52f ; cml:hasPart concept:therapeutic-goods-act-1989-sec-52f-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-52f-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.346" . concept:therapeutic-goods-act-1989-sec-52f-ss-1 a cml:Concept ; skos:prefLabel "52F(1) Incorporation of current Poisons Standard"@en ; cml:realizedBy doc:sec-52f-ss-1 ; cml:integrityHash "aeb97bcaa47f5ebc8e3680425f1fc9b79973a201d2c63d20fa88f118fff3ddd4" ; values:partOf concept:therapeutic-goods-act-1989-sec-52f ; skos:note "Legislative instrument may incorporate current Poisons Standard." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.346" ; cml:asserts concept:therapeutic-goods-act-1989-sec-52f-ss-1-norm . concept:therapeutic-goods-act-1989-sec-52f-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-52f-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52f-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-52f-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-52f-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "incorporate" ; cml:logicSummary "Incorporation of matter from current Poisons Standard." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52f-ss-2 a cml:Concept ; skos:prefLabel "52F(2) Incorporation of current Poisons Standard"@en ; cml:realizedBy doc:sec-52f-ss-2 ; cml:integrityHash "e39f0ce23d71584732f97b5a258cbce8118c65125ee7f09e58c450a3f1531b88" ; values:partOf concept:therapeutic-goods-act-1989-sec-52f ; skos:note "An instrument under this Act may incorporate the current Poisons Standard with modifications." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.346" ; cml:asserts concept:therapeutic-goods-act-1989-sec-52f-ss-2-norm . concept:therapeutic-goods-act-1989-sec-52f-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-52f-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52f-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-52f-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-52f-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "incorporate" ; cml:logicSummary "Incorporation of current Poisons Standard" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52g a cml:Concept ; skos:prefLabel "52G Exemptions, approvals and authorities to be consistent with"@en ; cml:realizedBy doc:sec-52g ; cml:integrityHash "0760a1e4dcde6c61e27d91a23e3517ee2a6580ca968b9d337f38fc4214a687f2" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-52g-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-52g-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-52g-ss-3 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.347" . concept:therapeutic-goods-act-1989-sec-52g-ss-1 a cml:Concept ; skos:prefLabel "52G(1) Exemptions, approvals and authorities to be consistent with"@en ; cml:realizedBy doc:sec-52g-ss-1 ; cml:integrityHash "8b34fa02008be6305e2beb8703a9b2648660c9220bade4df4471eb7f5658fa17" ; values:partOf concept:therapeutic-goods-act-1989-sec-52g ; skos:note "Absolute prohibitions apply to therapeutic goods or vaping goods." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.347" ; cml:asserts concept:therapeutic-goods-act-1989-sec-52g-ss-1-norm . concept:therapeutic-goods-act-1989-sec-52g-ss-1-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-52g-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52g-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-52g-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-52g-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "=" ; cml:logicSummary "Absolute prohibition" ; cml:premiseText "subsection 9K(1) or (3)" ; cml:conclusionText "thing referred to in subsection (3) of this section" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52g-ss-2 a cml:Concept ; skos:prefLabel "52G(2) Exemptions, approvals and authorities to be consistent with"@en ; cml:realizedBy doc:sec-52g-ss-2 ; cml:integrityHash "baad14767a6eded1b4cd252ab72b5e0564ed82588d3fe3bd3c13f0230337850b" ; values:partOf concept:therapeutic-goods-act-1989-sec-52g ; skos:note "Exemptions and approvals must be consistent with prohibitions" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.347" ; cml:asserts concept:therapeutic-goods-act-1989-sec-52g-ss-2-norm . concept:therapeutic-goods-act-1989-sec-52g-ss-2-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-52g-ss-2 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52g-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-52g-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-52g-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Consistency" ; cml:logicSummary "Consistency requirement" ; cml:premiseText "Exemptions and approvals must be consistent with prohibitions" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52g-ss-3 a cml:Concept ; skos:prefLabel "52G(3) Exemptions, approvals and authorities to be consistent with"@en ; cml:realizedBy doc:sec-52g-ss-3 ; cml:integrityHash "baa17e994e49ad04d7332d95f74b79493092c8ece2abaf8f08f5ac9125ef1e10" ; values:partOf concept:therapeutic-goods-act-1989-sec-52g ; skos:note "List of exemptions, approvals and authorities to be consistent with" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.347" ; cml:asserts concept:therapeutic-goods-act-1989-sec-52g-ss-3-norm . concept:therapeutic-goods-act-1989-sec-52g-ss-3-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-52g-ss-3 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-52g-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-52g-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-52g-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "inclusion" ; cml:logicSummary "List of exemptions, approvals and authorities" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-53 a cml:Concept ; skos:prefLabel "53 Retention of material on withdrawal of application"@en ; cml:realizedBy doc:sec-53 ; cml:integrityHash "f3883da62b564cb998ecafe6e27cced3096316e96001ac17fd401e9443b7dcde" ; skos:note "Department may retain application and material upon withdrawal." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.348" ; cml:asserts concept:therapeutic-goods-act-1989-sec-53-norm . concept:therapeutic-goods-act-1989-sec-53-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-53 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-53 cml:asserts concept:therapeutic-goods-act-1989-sec-53-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-53-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits Department from releasing application and material." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-53 cml:asserts concept:therapeutic-goods-act-1989-sec-53-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-53-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Classify" ; cml:logicSummary "Classifies retained application and material as confidential." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-53a a cml:Concept ; skos:prefLabel "53A Alternative verdicts for various offences"@en ; cml:realizedBy doc:sec-53a ; cml:integrityHash "54edf86a4220d83589940a2b6661176385eb9686511ee547f5c839f9f329c62d" ; skos:note "If a jury acquits a person of an offence against a provision listed in column 2 of an item in the following table, but is satisfied beyond reasonable doubt of facts that prove that the person is guilty of the offence listed in column 3 of that item, the jury may convict the person of the offence listed in column 3 of that item." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.348" ; cml:asserts concept:therapeutic-goods-act-1989-sec-53a-norm . concept:therapeutic-goods-act-1989-sec-53a-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-53a ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-53a cml:asserts concept:therapeutic-goods-act-1989-sec-53a-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-53a-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "The provision imposes an obligation on the State to convict a person of an offence if certain conditions are met." ; cml:premiseText "If a jury acquits a person of an offence against a provision listed in column 2..." ; cml:conclusionText "...the jury may convict the person of the offence listed in column 3 of that item:" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-53a cml:asserts concept:therapeutic-goods-act-1989-sec-53a-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-53a-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Overlaps" ; cml:logicSummary "The provision specifies a temporal overlap between two events." ; cml:premiseText "If a prosecution is for an offence against..." ; cml:conclusionText "...the jury may instead convict the person of an offence against..." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-53a cml:asserts concept:therapeutic-goods-act-1989-sec-53a-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-53a-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Repeats" ; cml:logicSummary "The provision specifies a recurring pattern." ; cml:premiseText "If a prosecution is for an offence against..." ; cml:conclusionText "...the jury may instead convict the person of an offence against..." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-53a cml:asserts concept:therapeutic-goods-act-1989-sec-53a-logic-argumentation-4 . concept:therapeutic-goods-act-1989-sec-53a-logic-argumentation-4 a cml:LogicApplication ; cml:modality cml:Argumentation ; cml:operator "Implication" ; cml:logicSummary "The provision implies a causal relationship between two events." ; cml:premiseText "If a jury acquits a person of an offence against a provision listed in column 2..." ; cml:conclusionText "...the jury may convict the person of the offence listed in column 3 of that item:" ; cml:executionSurface "modalities::argumentation" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-53a cml:asserts concept:therapeutic-goods-act-1989-sec-53a-logic-diffusion-5 . concept:therapeutic-goods-act-1989-sec-53a-logic-diffusion-5 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "Diffuses" ; cml:logicSummary "The provision diffuses information from one event to another." ; cml:premiseText "If a prosecution is for an offence against..." ; cml:conclusionText "...the jury may instead convict the person of an offence against..." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54 a cml:Concept ; skos:prefLabel "54 Offences and forfeiture"@en ; cml:realizedBy doc:sec-54 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-54-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-54-ss-4 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-54-ss-5 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.351" . concept:therapeutic-goods-act-1989-sec-54-ss-3 a cml:Concept ; skos:prefLabel "54(3) Offences and forfeiture"@en ; cml:realizedBy doc:sec-54-ss-3 ; cml:integrityHash "b4d20fb3979fffa9c593a6f547a01886430c38fae5425b12736b6ec7f8315889" ; values:partOf concept:therapeutic-goods-act-1989-sec-54 ; skos:note "Forfeiture of goods in relation to therapeutic or vaping products" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.351" ; cml:asserts concept:therapeutic-goods-act-1989-sec-54-ss-3-norm . concept:therapeutic-goods-act-1989-sec-54-ss-3-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-54-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-54-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-54-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits the possession of goods" ; cml:premiseText "(3) If a court orders that the goods be forfeited" ; cml:conclusionText "The goods must be forfeited to the Commonwealth" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-54-ss-3-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-54-ss-3-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Overlap" ; cml:logicSummary "Goods must overlap with therapeutic or vaping products" ; cml:premiseText "(3) If a court orders that the goods be forfeited in relation to any therapeutic goods or vaping goods" ; cml:conclusionText "The goods overlap with therapeutic or vaping products" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-54-ss-3-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-54-ss-3-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Recurring" ; cml:logicSummary "Goods must be forfeited repeatedly" ; cml:premiseText "(3) If a court orders that the goods be forfeited in relation to any therapeutic goods or vaping goods" ; cml:conclusionText "The goods are forfeited repeatedly" ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-54-ss-3-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-54-ss-3-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "Diffuse" ; cml:logicSummary "Forfeiture must diffuse to all goods" ; cml:premiseText "(3) If a court orders that the goods be forfeited in relation to any therapeutic goods or vaping goods" ; cml:conclusionText "The forfeiture diffuses to all goods" ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-54-ss-3-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-54-ss-3-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "Recognize" ; cml:logicSummary "Forfeiture must recognize as a threat" ; cml:premiseText "(3) If a court orders that the goods be forfeited in relation to any therapeutic goods or vaping goods" ; cml:conclusionText "The forfeiture recognizes as a threat" ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54-ss-4 a cml:Concept ; skos:prefLabel "54(4) Offences and forfeiture"@en ; cml:realizedBy doc:sec-54-ss-4 ; cml:integrityHash "d612d6d7b67625ace66a2836714ee2e7a3e6ff58d30a96425534697bd186f735" ; values:partOf concept:therapeutic-goods-act-1989-sec-54 ; skos:note "Notice of forfeiture must be published in Gazette or website." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.351" ; cml:asserts concept:therapeutic-goods-act-1989-sec-54-ss-4-norm . concept:therapeutic-goods-act-1989-sec-54-ss-4-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-54-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-54-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-54-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits publication of notice without Secretary's action." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54-ss-5 a cml:Concept ; skos:prefLabel "54(5) Offences and forfeiture"@en ; cml:realizedBy doc:sec-54-ss-5 ; cml:integrityHash "1ef1fdfd689ec48b7d8c5d6f19dae8d04b2c93115dff01974ac2209120b2ecdd" ; values:partOf concept:therapeutic-goods-act-1989-sec-54 ; skos:note "Goods forfeited under an order must be disposed of in a manner specified by the Secretary." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.351" ; cml:asserts concept:therapeutic-goods-act-1989-sec-54-ss-5-norm . concept:therapeutic-goods-act-1989-sec-54-ss-5-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-54-ss-5 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-54-ss-5-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-54-ss-5-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits disposal of goods in a manner other than specified by the Secretary." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54aa a cml:Concept ; skos:prefLabel "54AA Offences for contravening conditions or requirements"@en ; cml:realizedBy doc:sec-54aa ; cml:integrityHash "ed88344744c9d99d8157b18ec5a8ffe20ee1e4e2902e52c0efc97fff4d1744e3" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-54aa-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-54aa-ss-1a ; cml:hasPart concept:therapeutic-goods-act-1989-sec-54aa-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-54aa-ss-3 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.352" . concept:therapeutic-goods-act-1989-sec-54aa-ss-1 a cml:Concept ; skos:prefLabel "54AA(1) Offences for contravening conditions or requirements"@en ; cml:realizedBy doc:sec-54aa-ss-1 ; cml:integrityHash "979340a964565da202a512e9fc17b3f1c887b28f6cd92b69b068d495a4861da0" ; values:partOf concept:therapeutic-goods-act-1989-sec-54aa ; skos:note "Breach of licence or permission conditions results in an offence." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.352" ; cml:asserts concept:therapeutic-goods-act-1989-sec-54aa-ss-1-norm . concept:therapeutic-goods-act-1989-sec-54aa-ss-1-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-54aa-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54aa-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-54aa-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-54aa-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibits conduct" ; cml:premiseText "(a) a person holds a licence or a permission to import or export therapeutic goods; and (b) the person engages in conduct; and (c) the conduct breaches a condition or a requirement to which the licence or permission is subject under the regulations;" ; cml:conclusionText "the person commits an offence punishable on conviction by a fine of no more than the number of penalty units specified in whichever of subsection (2) or (3) applies." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54aa-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-54aa-ss-1-logic-deontic-2 . concept:therapeutic-goods-act-1989-sec-54aa-ss-1-logic-deontic-2 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibition" ; cml:logicSummary "Prohibits breach of conditions or requirements" ; cml:premiseText "(c) the conduct breaches a condition or a requirement to which the licence or permission is subject under the regulations;" ; cml:conclusionText "the person commits an offence." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54aa-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-54aa-ss-1-logic-alleninterval-3 . concept:therapeutic-goods-act-1989-sec-54aa-ss-1-logic-alleninterval-3 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Overlaps" ; cml:logicSummary "Describes temporal overlap between licence/permission and conduct" ; cml:premiseText "(1) If: (a) a person holds a licence or a permission to import or export therapeutic goods; and (b) the person engages in conduct;" ; cml:conclusionText "the conduct occurs during the period of the licence or permission." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54aa-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-54aa-ss-1-logic-ltl-4 . concept:therapeutic-goods-act-1989-sec-54aa-ss-1-logic-ltl-4 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Until" ; cml:logicSummary "Describes temporal relationship between licence/permission and conduct" ; cml:premiseText "(1) If: (a) a person holds a licence or a permission to import or export therapeutic goods; and (b) the person engages in conduct;" ; cml:conclusionText "the conduct ends before the period of the licence or permission." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54aa-ss-1a a cml:Concept ; skos:prefLabel "54AA(1A) Offences for contravening conditions or requirements"@en ; cml:realizedBy doc:sec-54aa-ss-1a ; cml:integrityHash "4ebb61080b88abfaf5a0acc701c0c1517ad2a9b6b06280b72d4dae959bd165f2" ; values:partOf concept:therapeutic-goods-act-1989-sec-54aa ; skos:note "Engaging in conduct means doing an act or omitting to perform an act." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.352" ; cml:asserts concept:therapeutic-goods-act-1989-sec-54aa-ss-1a-norm . concept:therapeutic-goods-act-1989-sec-54aa-ss-1a-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-54aa-ss-1a ; values:borneBy values:LegalPerson ; skos:scopeNote "borne by: LegalPerson" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54aa-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-54aa-ss-1a-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-54aa-ss-1a-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "is" ; cml:logicSummary "Definition of conduct" ; cml:conclusionText "engaging in conduct means doing an act or omitting to perform an act." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54aa-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-54aa-ss-1a-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-54aa-ss-1a-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "subClassOf" ; cml:logicSummary "Classification of conduct" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54aa-ss-2 a cml:Concept ; skos:prefLabel "54AA(2) Offences for contravening conditions or requirements"@en ; cml:realizedBy doc:sec-54aa-ss-2 ; cml:integrityHash "e4e91572021a7e8259ff26b0bfe226bfff93bbb5cebd17a55ff2ade3a90d6f00" ; values:partOf concept:therapeutic-goods-act-1989-sec-54aa ; skos:note "Increased penalty for contravention of certain conditions or requirements" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.352" ; cml:asserts concept:therapeutic-goods-act-1989-sec-54aa-ss-2-norm . concept:therapeutic-goods-act-1989-sec-54aa-ss-2-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-54aa-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54aa-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-54aa-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-54aa-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Increase" ; cml:logicSummary "Increases the penalty for contravention" ; cml:premiseText "(2) If..." ; cml:conclusionText "240 penalty units" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54aa-ss-3 a cml:Concept ; skos:prefLabel "54AA(3) Offences for contravening conditions or requirements"@en ; cml:realizedBy doc:sec-54aa-ss-3 ; cml:integrityHash "d31b1f0501c7445e5f596e18dc87f2296ff47c6e948c891b1e07ed347db22b8f" ; values:partOf concept:therapeutic-goods-act-1989-sec-54aa ; skos:note "Penalty for contravention of conditions or requirements" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.352" ; cml:asserts concept:therapeutic-goods-act-1989-sec-54aa-ss-3-norm . concept:therapeutic-goods-act-1989-sec-54aa-ss-3-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-54aa-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54aa-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-54aa-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-54aa-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "=" ; cml:logicSummary "Imposes a penalty" ; cml:premiseText "Subsection (2) does not apply" ; cml:conclusionText "50 penalty units" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54ab a cml:Concept ; skos:prefLabel "54AB Criminal offence for damaging etc. documents"@en ; cml:realizedBy doc:sec-54ab ; cml:hasPart concept:therapeutic-goods-act-1989-sec-54ab-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-54ab-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.353" . concept:therapeutic-goods-act-1989-sec-54ab-ss-1 a cml:Concept ; skos:prefLabel "54AB(1) Criminal offence for damaging etc. documents"@en ; cml:realizedBy doc:sec-54ab-ss-1 ; cml:integrityHash "01407f9663132bb3e8c2dd830c54a42d8f4e641ecb4ce93988e54041bf331e56" ; values:partOf concept:therapeutic-goods-act-1989-sec-54ab ; skos:note "Damaging or destroying documents for purposes of this Act is a criminal offence." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.353" ; cml:asserts concept:therapeutic-goods-act-1989-sec-54ab-ss-1-norm . concept:therapeutic-goods-act-1989-sec-54ab-ss-1-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-54ab-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54ab-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-54ab-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-54ab-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits damaging or destroying documents." ; cml:premiseText "(1) A person commits an offence..." ; cml:conclusionText "Penalty: 7 years imprisonment or 2,000 penalty units, or both." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54ab-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-54ab-ss-1-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-54ab-ss-1-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Temporal overlap" ; cml:logicSummary "Documents must be created, retained or issued within the same temporal interval as this Act." ; cml:premiseText "(b) the document is created, retained or issued for the purposes..." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54ab-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-54ab-ss-1-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-54ab-ss-1-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Recurring trace" ; cml:logicSummary "Documents must be part of a recurring trace that includes this Act." ; cml:premiseText "(b) the document is created, retained or issued for the purposes..." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54ab-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-54ab-ss-1-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-54ab-ss-1-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "Diffuse" ; cml:logicSummary "This Act must diffuse to all documents created, retained or issued within its temporal interval." ; cml:premiseText "(b) the document is created, retained or issued for the purposes..." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54ab-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-54ab-ss-1-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-54ab-ss-1-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "Classify" ; cml:logicSummary "This Act must be classified as a legal provision." ; cml:premiseText "Note:" ; cml:conclusionText "For the liability of an executive officer of a body corporate, see sections 54B and 54BA." ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54ab-ss-2 a cml:Concept ; skos:prefLabel "54AB(2) Criminal offence for damaging etc. documents"@en ; cml:realizedBy doc:sec-54ab-ss-2 ; cml:integrityHash "c9073f5b3de1691ba95af8e23d995cdd8ae82be111e22e0298152fe06cb21679" ; values:partOf concept:therapeutic-goods-act-1989-sec-54ab ; skos:note "Strict liability applies for damaging documents" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.353" ; cml:asserts concept:therapeutic-goods-act-1989-sec-54ab-ss-2-norm . concept:therapeutic-goods-act-1989-sec-54ab-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-54ab-ss-2 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54ab-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-54ab-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-54ab-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "applies" ; cml:logicSummary "Strict liability obligation" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54ac a cml:Concept ; skos:prefLabel "54AC Civil penalty for damaging etc. documents"@en ; cml:realizedBy doc:sec-54ac ; cml:integrityHash "bb10afc0ad7127b9095a9eefec4f94004850847515cca73cbe5fb076f9c352c4" ; skos:note "Damaging, destroying, altering, concealing or falsifying documents for purposes of the Act." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.353" ; cml:asserts concept:therapeutic-goods-act-1989-sec-54ac-norm . concept:therapeutic-goods-act-1989-sec-54ac-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-54ac ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54ac cml:asserts concept:therapeutic-goods-act-1989-sec-54ac-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-54ac-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibits damaging, destroying, altering, concealing or falsifying documents." ; cml:premiseText "None" ; cml:conclusionText "None" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54ac cml:asserts concept:therapeutic-goods-act-1989-sec-54ac-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-54ac-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Overlap" ; cml:logicSummary "Documents must be created, retained or issued within a specific time frame." ; cml:premiseText "None" ; cml:conclusionText "Document is created, retained or issued for the purposes of this Act." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54ac cml:asserts concept:therapeutic-goods-act-1989-sec-54ac-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-54ac-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Recurring" ; cml:logicSummary "Documents must be regularly updated or reviewed." ; cml:premiseText "None" ; cml:conclusionText "Document is created, retained or issued for the purposes of this Act." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54a a cml:Concept ; skos:prefLabel "54A Time for bringing prosecutions"@en ; cml:realizedBy doc:sec-54a ; cml:integrityHash "5b54f99cfc86c1753e0a2f1a5848c870012ddc8e33b4437722c0edacecf05f30" ; skos:note "Prosecution can be commenced within 3 years after commission of the offence." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.353" ; cml:asserts concept:therapeutic-goods-act-1989-sec-54a-norm . concept:therapeutic-goods-act-1989-sec-54a-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-54a ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54a cml:asserts concept:therapeutic-goods-act-1989-sec-54a-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-54a-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "can" ; cml:logicSummary "Ability to commence prosecution within specified timeframe." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54b a cml:Concept ; skos:prefLabel "54B Personal liability of an executive officer of a body corporate—"@en ; cml:realizedBy doc:sec-54b ; cml:integrityHash "0feae16d55365acf07fe9f909834361ba6ee606854746539230bdc84a6a24cee" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-54b-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-54b-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-54b-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-54b-ss-4 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-54b-ss-5 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.354" . concept:therapeutic-goods-act-1989-sec-54b-ss-1 a cml:Concept ; skos:prefLabel "54B(1) Personal liability of an executive officer of a body corporate—"@en ; cml:realizedBy doc:sec-54b-ss-1 ; cml:integrityHash "dff6da4339e5f46de43bae2aff3c0790202b3180537b02fce03b1ece113b3064" ; values:partOf concept:therapeutic-goods-act-1989-sec-54b ; skos:note "Executive officer commits an offence if they knew and failed to prevent the commission of an offence against the Act." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.354" ; cml:asserts concept:therapeutic-goods-act-1989-sec-54b-ss-1-norm . concept:therapeutic-goods-act-1989-sec-54b-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-54b-ss-1 ; values:borneBy values:Agent ; skos:scopeNote "borne by: Agent" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54b-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-54b-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-54b-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "obligation" ; cml:logicSummary "Executive officer has a duty to prevent commission of offence." ; cml:premiseText "Knew and failed to act." ; cml:conclusionText "Offence committed." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54b-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-54b-ss-1-logic-epistemic-2 . concept:therapeutic-goods-act-1989-sec-54b-ss-1-logic-epistemic-2 a cml:LogicApplication ; cml:modality cml:Epistemic ; cml:operator "knowledge" ; cml:logicSummary "Executive officer must know the offence will be committed." ; cml:premiseText "Knew the offence would be committed." ; cml:conclusionText "Offence committed." ; cml:executionSurface "modalities::epistemic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54b-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-54b-ss-1-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-54b-ss-1-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "interval" ; cml:logicSummary "Offence occurred within a specific time interval." ; cml:premiseText "Failed to take reasonable steps." ; cml:conclusionText "Offence committed." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54b-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-54b-ss-1-logic-descriptionlogic-4 . concept:therapeutic-goods-act-1989-sec-54b-ss-1-logic-descriptionlogic-4 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "class" ; cml:logicSummary "Executive officer is part of a class with a specific description." ; cml:premiseText "An executive officer of a body corporate." ; cml:conclusionText "Offence committed." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54b-ss-2 a cml:Concept ; skos:prefLabel "54B(2) Personal liability of an executive officer of a body corporate—"@en ; cml:realizedBy doc:sec-54b-ss-2 ; cml:integrityHash "c982497a7430d06e5217d1b39e0558b2eeb8dfb9cc00cb6fe651fdd4402b6df6" ; values:partOf concept:therapeutic-goods-act-1989-sec-54b ; skos:note "Maximum penalty for an offence against subsection (1)" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.354" ; cml:asserts concept:therapeutic-goods-act-1989-sec-54b-ss-2-norm . concept:therapeutic-goods-act-1989-sec-54b-ss-2-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-54b-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54b-ss-3 a cml:Concept ; skos:prefLabel "54B(3) Personal liability of an executive officer of a body corporate—"@en ; cml:realizedBy doc:sec-54b-ss-3 ; cml:integrityHash "65211f4be3e156a861f091cb405c0115c99660caf892bfc69f5a90753f0a30af" ; values:partOf concept:therapeutic-goods-act-1989-sec-54b ; skos:note "Executive officer must take reasonable steps to prevent contravention of civil penalty provision." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.354" ; cml:asserts concept:therapeutic-goods-act-1989-sec-54b-ss-3-norm . concept:therapeutic-goods-act-1989-sec-54b-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-54b-ss-3 ; values:borneBy values:Agent ; skos:scopeNote "borne by: Agent" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54b-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-54b-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-54b-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "obligation" ; cml:logicSummary "Executive officer has an obligation to prevent contravention." ; cml:premiseText "The executive officer knew the contravention would occur." ; cml:conclusionText "The executive officer must take reasonable steps to prevent the contravention." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54b-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-54b-ss-3-logic-deontic-2 . concept:therapeutic-goods-act-1989-sec-54b-ss-3-logic-deontic-2 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "obligation" ; cml:logicSummary "Executive officer has an obligation to prevent contravention." ; cml:premiseText "The executive officer was in a position to influence the conduct of the body corporate." ; cml:conclusionText "The executive officer must take reasonable steps to prevent the contravention." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54b-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-54b-ss-3-logic-deontic-3 . concept:therapeutic-goods-act-1989-sec-54b-ss-3-logic-deontic-3 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "obligation" ; cml:logicSummary "Executive officer has an obligation to prevent contravention." ; cml:premiseText "The executive officer failed to take all reasonable steps to prevent the contravention." ; cml:conclusionText "The executive officer must take reasonable steps to prevent the contravention." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54b-ss-4 a cml:Concept ; skos:prefLabel "54B(4) Personal liability of an executive officer of a body corporate—"@en ; cml:realizedBy doc:sec-54b-ss-4 ; cml:integrityHash "399b01805777936f112869e5e668d18dcd28395f3dd020b8c6b9c89285b604b9" ; values:partOf concept:therapeutic-goods-act-1989-sec-54b ; skos:note "Maximum civil penalty for contravention of subsection (3)" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.354" ; cml:asserts concept:therapeutic-goods-act-1989-sec-54b-ss-4-norm . concept:therapeutic-goods-act-1989-sec-54b-ss-4-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-54b-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54b-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-54b-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-54b-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "hasObligation" ; cml:logicSummary "Imposes obligation on the state" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54b-ss-5 a cml:Concept ; skos:prefLabel "54B(5) Personal liability of an executive officer of a body corporate—"@en ; cml:realizedBy doc:sec-54b-ss-5 ; cml:integrityHash "f3f328e39cf84ba61546b161cdd2d47fd18f87d617ba9b14fccb8fb101b5cef8" ; values:partOf concept:therapeutic-goods-act-1989-sec-54b ; skos:note "Defines executive officer of a body corporate" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.354" ; cml:asserts concept:therapeutic-goods-act-1989-sec-54b-ss-5-norm . concept:therapeutic-goods-act-1989-sec-54b-ss-5-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-54b-ss-5 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54b-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-54b-ss-5-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-54b-ss-5-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "is defined as" ; cml:logicSummary "Defines term" ; cml:conclusionText "executive officer of a body corporate" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54b-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-54b-ss-5-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-54b-ss-5-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "has class" ; cml:logicSummary "Class hierarchy" ; cml:conclusionText "body corporate" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54ba a cml:Concept ; skos:prefLabel "54BA Personal liability of an executive officer of a body corporate—"@en ; cml:realizedBy doc:sec-54ba ; cml:integrityHash "a3d055a1bb2a7ccfe0a4d4e56773d99f42ceb19b1989edf5662dcde664365ea7" ; skos:note "Personal liability of an executive officer of a body corporate—" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.355" ; cml:asserts concept:therapeutic-goods-act-1989-sec-54ba-norm . concept:therapeutic-goods-act-1989-sec-54ba-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-54ba ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54ba cml:asserts concept:therapeutic-goods-act-1989-sec-54ba-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-54ba-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "coveredBy" ; cml:logicSummary "Personal liability covered by this section" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-11 a cml:Concept ; skos:prefLabel "11 Section 11"@en ; cml:realizedBy doc:sec-11 ; cml:integrityHash "f1aab5c7e7bd038629f266bf4900c9e5a57a06a51269faa29cfb5a2d66752b4a" ; skos:note "Corporate officers may be personally liable for certain offences." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.355" ; cml:asserts concept:therapeutic-goods-act-1989-sec-11-norm . concept:therapeutic-goods-act-1989-sec-11-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-11 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-11 cml:asserts concept:therapeutic-goods-act-1989-sec-11-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-11-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Corporate officers have an obligation to comply with certain regulations." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54c a cml:Concept ; skos:prefLabel "54C Establishing whether an executive officer took reasonable steps"@en ; cml:realizedBy doc:sec-54c ; cml:integrityHash "53df1947c8d1e25dbc5068e17cfb3734e168c6aa6095c6d250117e5303a33198" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-54c-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-54c-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-54c-ss-3 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.358" . concept:therapeutic-goods-act-1989-sec-54c-ss-1 a cml:Concept ; skos:prefLabel "54C(1) Establishing whether an executive officer took reasonable steps"@en ; cml:realizedBy doc:sec-54c-ss-1 ; cml:integrityHash "5842ec336a8eb582ab1f278d454481fa9e6d5d7d38e2bd8949b2df832893269f" ; values:partOf concept:therapeutic-goods-act-1989-sec-54c ; skos:note "Executive officer must take reasonable steps to prevent commission of offence." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.358" ; cml:asserts concept:therapeutic-goods-act-1989-sec-54c-ss-1-norm . concept:therapeutic-goods-act-1989-sec-54c-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-54c-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54c-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-54c-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-54c-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Executive officer has an obligation to take reasonable steps." ; cml:premiseText "The executive officer is responsible for preventing the commission of the offence." ; cml:conclusionText "The officer must take all reasonable steps to prevent the commission of the offence." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54c-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-54c-ss-1-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-54c-ss-1-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Overlaps" ; cml:logicSummary "The officer's awareness of the body's commission of an offence is relevant to determining their obligations." ; cml:premiseText "The officer became aware that the body was committing an offence against this Act or the regulations." ; cml:conclusionText "The officer's awareness of the body's commission of an offence overlaps with their obligation to prevent the commission of the offence." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54c-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-54c-ss-1-logic-deontic-3 . concept:therapeutic-goods-act-1989-sec-54c-ss-1-logic-deontic-3 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "The officer has an obligation to take action when they become aware that the body is committing an offence." ; cml:premiseText "When the officer became aware that the body was committing an offence against this Act or the regulations, they had an obligation to take action." ; cml:conclusionText "The officer must take action when they become aware that the body is committing an offence." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54c-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-54c-ss-1-logic-deontic-4 . concept:therapeutic-goods-act-1989-sec-54c-ss-1-logic-deontic-4 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "The officer has an obligation to ensure that employees, agents, and contractors have a reasonable knowledge and understanding of the requirements." ; cml:premiseText "The officer is responsible for ensuring that employees, agents, and contractors have a reasonable knowledge and understanding of the requirements." ; cml:conclusionText "The officer must ensure that employees, agents, and contractors have a reasonable knowledge and understanding of the requirements." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54c-ss-2 a cml:Concept ; skos:prefLabel "54C(2) Establishing whether an executive officer took reasonable steps"@en ; cml:realizedBy doc:sec-54c-ss-2 ; cml:integrityHash "4e0727bb6aab2e0a505bbf99c062f65c0b97c3402d446782870fa4293d5bcff1" ; values:partOf concept:therapeutic-goods-act-1989-sec-54c ; skos:note "Does not limit the generality of section 54B by implication." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.358" ; cml:asserts concept:therapeutic-goods-act-1989-sec-54c-ss-2-norm . concept:therapeutic-goods-act-1989-sec-54c-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-54c-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54c-ss-3 a cml:Concept ; skos:prefLabel "54C(3) Establishing whether an executive officer took reasonable steps"@en ; cml:realizedBy doc:sec-54c-ss-3 ; cml:integrityHash "a13750efb9f07fab797f1d9e87cfff22f0c0cfbd641ab6b25f1f1b3f3b7b9dd6" ; values:partOf concept:therapeutic-goods-act-1989-sec-54c ; skos:note "Executive officer must take reasonable steps" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.358" ; cml:asserts concept:therapeutic-goods-act-1989-sec-54c-ss-3-norm . concept:therapeutic-goods-act-1989-sec-54c-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-54c-ss-3 ; values:borneBy values:Agent ; skos:scopeNote "borne by: Agent" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-54c-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-54c-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-54c-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must provide reasonable steps" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-55 a cml:Concept ; skos:prefLabel "55 Conduct by directors, employees and agents"@en ; cml:realizedBy doc:sec-55 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-55-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-55-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-55-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-55-ss-4 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-55-ss-5 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-55-ss-6 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-55-ss-7 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-55-ss-8 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.358" . concept:therapeutic-goods-act-1989-sec-55-ss-1 a cml:Concept ; skos:prefLabel "55(1) Conduct by directors, employees and agents"@en ; cml:realizedBy doc:sec-55-ss-1 ; cml:integrityHash "64af537c1d1e7bf31e26f3f3244bc9aff7ed89522d13f968636d04b29b085e86" ; values:partOf concept:therapeutic-goods-act-1989-sec-55 ; skos:note "Establishing state of mind of a body corporate in relation to conduct" ; dc:description "Director, employee or agent's actual or apparent authority and state of mind" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.358" ; cml:asserts concept:therapeutic-goods-act-1989-sec-55-ss-1-norm . concept:therapeutic-goods-act-1989-sec-55-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-55-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-55-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-55-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-55-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "hasAuthority" ; cml:logicSummary "Establishing authority" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-55-ss-2 a cml:Concept ; skos:prefLabel "55(2) Conduct by directors, employees and agents"@en ; cml:realizedBy doc:sec-55-ss-2 ; cml:integrityHash "5168f66658d99db1ba2601e79f742cc64abe0eb7c7dbc5d00d04e2f2ae880535" ; values:partOf concept:therapeutic-goods-act-1989-sec-55 ; skos:note "Body corporate must take reasonable precautions to avoid conduct by directors, employees and agents." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.358" ; cml:asserts concept:therapeutic-goods-act-1989-sec-55-ss-2-norm . concept:therapeutic-goods-act-1989-sec-55-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-55-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-55-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-55-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-55-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "obligation" ; cml:logicSummary "Obligation to take precautions" ; cml:premiseText "Body corporate has authority" ; cml:conclusionText "Must take precautions" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-55-ss-3 a cml:Concept ; skos:prefLabel "55(3) Conduct by directors, employees and agents"@en ; cml:realizedBy doc:sec-55-ss-3 ; cml:integrityHash "b44e50bb588ebcec505d42da564b6419976b9302b8f6315da8db557940cf8ce3" ; values:partOf concept:therapeutic-goods-act-1989-sec-55 ; skos:note "Establishing state of mind for employees or agents" ; dc:description "state of mind" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.358" ; cml:asserts concept:therapeutic-goods-act-1989-sec-55-ss-3-norm . concept:therapeutic-goods-act-1989-sec-55-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-55-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-55-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-55-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-55-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "hasAuthority" ; cml:logicSummary "Authority relation" ; cml:premiseText "actual or apparent authority" ; cml:conclusionText "state of mind" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-55-ss-4 a cml:Concept ; skos:prefLabel "55(4) Conduct by directors, employees and agents"@en ; cml:realizedBy doc:sec-55-ss-4 ; cml:integrityHash "bb2235be6dda6e76680cfd3045b1e68ca3175d0ea1db23e85c1965cf90f03328" ; values:partOf concept:therapeutic-goods-act-1989-sec-55 ; skos:note "Employer liable for conduct of employee/agent within scope of authority" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.358" ; cml:asserts concept:therapeutic-goods-act-1989-sec-55-ss-4-norm . concept:therapeutic-goods-act-1989-sec-55-ss-4-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-55-ss-4 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-55-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-55-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-55-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Liability" ; cml:logicSummary "Employer liable for conduct" ; cml:premiseText "Employee/agent within scope of authority" ; cml:conclusionText "Employer must provide liability" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-55-ss-5 a cml:Concept ; skos:prefLabel "55(5) Conduct by directors, employees and agents"@en ; cml:realizedBy doc:sec-55-ss-5 ; cml:integrityHash "6fe882b570b32f6c05fd121a4ae143bb84077188002292139eb050dce5fd2d7b" ; values:partOf concept:therapeutic-goods-act-1989-sec-55 ; skos:note "No imprisonment for certain offences if convicted by a non-corporate person" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.358" ; cml:asserts concept:therapeutic-goods-act-1989-sec-55-ss-5-norm . concept:therapeutic-goods-act-1989-sec-55-ss-5-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-55-ss-5 ; values:borneBy values:NaturalPerson ; skos:scopeNote "borne by: NaturalPerson" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-55-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-55-ss-5-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-55-ss-5-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Implies" ; cml:logicSummary "No imprisonment implies obligation to refrain from punishment" ; cml:premiseText "(5) Where: ... the person is not liable to be punished by imprisonment for that offence." ; cml:conclusionText "If a person would not have been convicted of the offence if subsections (3) and (4) had not been enacted, then they are not liable to be punished by imprisonment for that offence." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-55-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-55-ss-5-logic-deontic-2 . concept:therapeutic-goods-act-1989-sec-55-ss-5-logic-deontic-2 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Permits" ; cml:logicSummary "Imprisonment permits other forms of punishment" ; cml:premiseText "(5) Where: ... the person is not liable to be punished by imprisonment for that offence." ; cml:conclusionText "If a person would not have been convicted of the offence if subsections (3) and (4) had not been enacted, then they are permitted to receive other forms of punishment" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-55-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-55-ss-5-logic-linearlogic-3 . concept:therapeutic-goods-act-1989-sec-55-ss-5-logic-linearlogic-3 a cml:LogicApplication ; cml:modality cml:LinearLogic ; cml:operator "And" ; cml:logicSummary "No imprisonment implies obligation to refrain from punishment and permits other forms of punishment" ; cml:premiseText "(5) Where: ... the person is not liable to be punished by imprisonment for that offence." ; cml:conclusionText "If a person would not have been convicted of the offence if subsections (3) and (4) had not been enacted, then they are permitted to receive other forms of punishment" ; cml:executionSurface "modalities::linear" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-55-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-55-ss-5-logic-deontic-4 . concept:therapeutic-goods-act-1989-sec-55-ss-5-logic-deontic-4 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Justifies" ; cml:logicSummary "Obligation to refrain from punishment justifies no imprisonment" ; cml:premiseText "(5) Where: ... the person is not liable to be punished by imprisonment for that offence." ; cml:conclusionText "If a person would not have been convicted of the offence if subsections (3) and (4) had not been enacted, then they are justified in refraining from punishment" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-55-ss-6 a cml:Concept ; skos:prefLabel "55(6) Conduct by directors, employees and agents"@en ; cml:realizedBy doc:sec-55-ss-6 ; cml:integrityHash "1315e6721d4b51124c656bce1be24f8086c4f37b4a4a0b06d6ed6f97a99d13e4" ; values:partOf concept:therapeutic-goods-act-1989-sec-55 ; skos:note "Directors, employees and agents must have certain knowledge or reasons for their intentions." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.358" ; cml:asserts concept:therapeutic-goods-act-1989-sec-55-ss-6-norm . concept:therapeutic-goods-act-1989-sec-55-ss-6-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-55-ss-6 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-55-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-55-ss-6-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-55-ss-6-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "hasKnowledge" ; cml:logicSummary "Directors, employees and agents must have certain knowledge." ; cml:premiseText "The person has a certain state of mind." ; cml:conclusionText "The person must have that knowledge." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-55-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-55-ss-6-logic-deontic-2 . concept:therapeutic-goods-act-1989-sec-55-ss-6-logic-deontic-2 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "hasReasons" ; cml:logicSummary "Directors, employees and agents must have certain reasons for their intentions." ; cml:premiseText "The person has a certain intention or purpose." ; cml:conclusionText "The person must have those reasons." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-55-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-55-ss-6-logic-descriptionlogic-3 . concept:therapeutic-goods-act-1989-sec-55-ss-6-logic-descriptionlogic-3 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "hasProperty" ; cml:logicSummary "Directors, employees and agents must have certain knowledge or reasons." ; cml:premiseText "The person has a certain state of mind." ; cml:conclusionText "The person has that knowledge or reason." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-55-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-55-ss-6-logic-alleninterval-4 . concept:therapeutic-goods-act-1989-sec-55-ss-6-logic-alleninterval-4 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "during" ; cml:logicSummary "Directors, employees and agents must have certain knowledge or reasons during their actions." ; cml:premiseText "The person performs an action." ; cml:conclusionText "The person has that knowledge or reason during the action." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-55-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-55-ss-6-logic-argumentation-5 . concept:therapeutic-goods-act-1989-sec-55-ss-6-logic-argumentation-5 a cml:LogicApplication ; cml:modality cml:Argumentation ; cml:operator "mustJustify" ; cml:logicSummary "Directors, employees and agents must justify their intentions with certain reasons." ; cml:premiseText "The person has an intention." ; cml:conclusionText "The person must justify that intention with those reasons." ; cml:executionSurface "modalities::argumentation" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-55-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-55-ss-6-logic-diffusion-6 . concept:therapeutic-goods-act-1989-sec-55-ss-6-logic-diffusion-6 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "mustInform" ; cml:logicSummary "Directors, employees and agents must inform others of their knowledge or reasons." ; cml:premiseText "The person has certain knowledge or reasons." ; cml:conclusionText "The person must inform others of that knowledge or reason." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-55-ss-7 a cml:Concept ; skos:prefLabel "55(7) Conduct by directors, employees and agents"@en ; cml:realizedBy doc:sec-55-ss-7 ; cml:integrityHash "5ea19562c2955142a5b4c15c86cfb32f83097eca13fc4c41962cf730c53f4910" ; values:partOf concept:therapeutic-goods-act-1989-sec-55 ; skos:note "Directors, employees and agents of a body corporate are subject to this section." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.358" ; cml:asserts concept:therapeutic-goods-act-1989-sec-55-ss-7-norm . concept:therapeutic-goods-act-1989-sec-55-ss-7-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-55-ss-7 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-55-ss-7 cml:asserts concept:therapeutic-goods-act-1989-sec-55-ss-7-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-55-ss-7-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "includes" ; cml:logicSummary "Inclusion in the reference list" ; cml:premiseText "A director of a body corporate is included in this section." ; cml:conclusionText "The reference to a director includes a reference to a constituent member of a body corporate." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-55-ss-7 cml:asserts concept:therapeutic-goods-act-1989-sec-55-ss-7-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-55-ss-7-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "subclassOf" ; cml:logicSummary "Classification of the constituent member" ; cml:premiseText "A constituent member is a type of body corporate." ; cml:conclusionText "The constituent member is classified as a body corporate." ; cml:executionSurface "modalities::dl" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-55-ss-8 a cml:Concept ; skos:prefLabel "55(8) Conduct by directors, employees and agents"@en ; cml:realizedBy doc:sec-55-ss-8 ; cml:integrityHash "784c369f04cb9ef0e05bd0c7aaeb3c6faca611ba3028eb8188be051098c811a4" ; values:partOf concept:therapeutic-goods-act-1989-sec-55 ; skos:note "Directors, employees and agents must engage in conduct." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.358" ; cml:asserts concept:therapeutic-goods-act-1989-sec-55-ss-8-norm . concept:therapeutic-goods-act-1989-sec-55-ss-8-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-55-ss-8 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-55-ss-8 cml:asserts concept:therapeutic-goods-act-1989-sec-55-ss-8-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-55-ss-8-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must provide obligation" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-55-ss-8 cml:asserts concept:therapeutic-goods-act-1989-sec-55-ss-8-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-55-ss-8-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "CLASSIFICATION" ; cml:logicSummary "Classification of conduct" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-56 a cml:Concept ; skos:prefLabel "56 Judicial notice"@en ; cml:realizedBy doc:sec-56 ; cml:integrityHash "c4800eab611dc70219fe20473c0fa652d4850a2b3d70bb15eac29d26a6cfa013" ; skos:note "Courts must take judicial notice of certain pharmacopeias." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.360" ; cml:asserts concept:therapeutic-goods-act-1989-sec-56-norm . concept:therapeutic-goods-act-1989-sec-56-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-56 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-56 cml:asserts concept:therapeutic-goods-act-1989-sec-56-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-56-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Court obligation" ; cml:premiseText "Courts are required to take judicial notice." ; cml:conclusionText "Courts must take judicial notice." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-56a a cml:Concept ; skos:prefLabel "56A Certificates to provide evidence of certain matters"@en ; cml:realizedBy doc:sec-56a ; cml:integrityHash "de793b2b3a4b2ad5c7790fb02c97319f4311bef0579c71c7ad1f3eb59e2ed91e" ; skos:note "The Secretary or authorized person must certify certain matters in writing." ; dc:description "Certificates to provide evidence of certain matters" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.360" ; cml:asserts concept:therapeutic-goods-act-1989-sec-56a-norm . concept:therapeutic-goods-act-1989-sec-56a-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-56a ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-56a cml:asserts concept:therapeutic-goods-act-1989-sec-56a-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-56a-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "The Secretary or authorized person must certify certain matters in writing." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-56a cml:asserts concept:therapeutic-goods-act-1989-sec-56a-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-56a-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "IS_A" ; cml:logicSummary "Certificates to provide evidence of certain matters" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-57 a cml:Concept ; skos:prefLabel "57 Delegation"@en ; cml:realizedBy doc:sec-57 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-57-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-57-ss-1a ; cml:hasPart concept:therapeutic-goods-act-1989-sec-57-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-57-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-57-ss-4 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-57-ss-5 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-57-ss-5a ; cml:hasPart concept:therapeutic-goods-act-1989-sec-57-ss-6 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-57-ss-7 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-57-ss-8 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-57-ss-9 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-57-ss-10 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-57-ss-10a ; cml:hasPart concept:therapeutic-goods-act-1989-sec-57-ss-11 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-57-ss-12 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.364" . concept:therapeutic-goods-act-1989-sec-57-ss-1 a cml:Concept ; skos:prefLabel "57(1) Delegation"@en ; cml:realizedBy doc:sec-57-ss-1 ; cml:integrityHash "7d5a9fd0c956efd7d08b28cedc15410d2cb1636d04290831f3688dd3c1ba7973" ; values:partOf concept:therapeutic-goods-act-1989-sec-57 ; skos:note "Delegation of powers and functions" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.364" ; cml:asserts concept:therapeutic-goods-act-1989-sec-57-ss-1-norm . concept:therapeutic-goods-act-1989-sec-57-ss-1-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-57-ss-1 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-57-ss-1a a cml:Concept ; skos:prefLabel "57(1A) Delegation"@en ; cml:realizedBy doc:sec-57-ss-1a ; cml:integrityHash "ea47560aee51095dbd39d88b66658ac4324a13ef7f155e6bb3ceb45fee8c134e" ; values:partOf concept:therapeutic-goods-act-1989-sec-57 ; skos:note "Delegate powers and functions to an officer of a Department, unit or authority with related functions." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.364" ; cml:asserts concept:therapeutic-goods-act-1989-sec-57-ss-1a-norm . concept:therapeutic-goods-act-1989-sec-57-ss-1a-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-57-ss-1a ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-57-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-57-ss-1a-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-57-ss-1a-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Permit" ; cml:logicSummary "Permission to delegate powers and functions." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-57-ss-2 a cml:Concept ; skos:prefLabel "57(2) Delegation"@en ; cml:realizedBy doc:sec-57-ss-2 ; cml:integrityHash "4a5dd28e2e5fcac2aae9459756af00e2fd4e93533bedc8dce0bf41c41c709a3d" ; values:partOf concept:therapeutic-goods-act-1989-sec-57 ; skos:note "Delegation of powers to registered medical or dental practitioners or pharmacists." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.364" ; cml:asserts concept:therapeutic-goods-act-1989-sec-57-ss-2-norm . concept:therapeutic-goods-act-1989-sec-57-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-57-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-57-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-57-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-57-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "canDelegate" ; cml:logicSummary "Authorization of power delegation" ; cml:premiseText "(2) The powers of the Secretary under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d)" ; cml:conclusionText "may be delegated under subsection (1)" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-57-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-57-ss-2-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-57-ss-2-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "during" ; cml:logicSummary "Temporal relationship of delegation" ; cml:premiseText "(2) The powers of the Secretary under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d)" ; cml:conclusionText "may be delegated during subsection (1)" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-57-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-57-ss-2-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-57-ss-2-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "during" ; cml:logicSummary "Temporal relationship of delegation" ; cml:premiseText "(2) The powers of the Secretary under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d)" ; cml:conclusionText "may be delegated during subsection (1)" ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-57-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-57-ss-2-logic-deontic-4 . concept:therapeutic-goods-act-1989-sec-57-ss-2-logic-deontic-4 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "mustBeRegistered" ; cml:logicSummary "Registration requirement for delegation" ; cml:premiseText "(2) The powers of the Secretary under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d)" ; cml:conclusionText "who is registered, or eligible for registration, in a State or internal Territory" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-57-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-57-ss-2-logic-deontic-5 . concept:therapeutic-goods-act-1989-sec-57-ss-2-logic-deontic-5 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "mustBeEligibleForRegistration" ; cml:logicSummary "Eligibility requirement for delegation" ; cml:premiseText "(2) The powers of the Secretary under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d)" ; cml:conclusionText "or eligible for registration, in a State or internal Territory" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-57-ss-3 a cml:Concept ; skos:prefLabel "57(3) Delegation"@en ; cml:realizedBy doc:sec-57-ss-3 ; cml:integrityHash "24160bd133701d3c7ee9b5ecff86e6e53e6b1807382bdd963f523aead20b6e78" ; values:partOf concept:therapeutic-goods-act-1989-sec-57 ; skos:note "Delegation of powers by Secretary to registered medical or dental practitioner" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.364" ; cml:asserts concept:therapeutic-goods-act-1989-sec-57-ss-3-norm . concept:therapeutic-goods-act-1989-sec-57-ss-3-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-57-ss-3 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-57-ss-4 a cml:Concept ; skos:prefLabel "57(4) Delegation"@en ; cml:realizedBy doc:sec-57-ss-4 ; cml:integrityHash "d98b15dd8fb83caac1a8624ba46484b2d0b49edc0b8f1dde3dfd30828092b298" ; values:partOf concept:therapeutic-goods-act-1989-sec-57 ; skos:note "Delegate must follow directions from Secretary, officer, or person referred to in paragraph (1)(c)." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.364" ; cml:asserts concept:therapeutic-goods-act-1989-sec-57-ss-4-norm . concept:therapeutic-goods-act-1989-sec-57-ss-4-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-57-ss-4 ; values:borneBy values:Agent ; skos:scopeNote "borne by: Agent" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-57-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-57-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-57-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "obligation" ; cml:logicSummary "Delegate has an obligation to follow directions." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-57-ss-5 a cml:Concept ; skos:prefLabel "57(5) Delegation"@en ; cml:realizedBy doc:sec-57-ss-5 ; cml:integrityHash "df7336e313cc9b63916b010f73ff6d0dbf49af5da7b1578591ee5b504a7b332c" ; values:partOf concept:therapeutic-goods-act-1989-sec-57 ; skos:note "Regulations may make provision for delegates, approvals, and conditions." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.364" ; cml:asserts concept:therapeutic-goods-act-1989-sec-57-ss-5-norm . concept:therapeutic-goods-act-1989-sec-57-ss-5-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-57-ss-5 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-57-ss-5a a cml:Concept ; skos:prefLabel "57(5A) Delegation"@en ; cml:realizedBy doc:sec-57-ss-5a ; cml:integrityHash "6655cb3aeabb2a44496efa4e81765f7a2172c6c7289587b6338b542937aee635" ; values:partOf concept:therapeutic-goods-act-1989-sec-57 ; skos:note "Delegation of powers to registered medical or dental practitioners or pharmacists." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.364" ; cml:asserts concept:therapeutic-goods-act-1989-sec-57-ss-5a-norm . concept:therapeutic-goods-act-1989-sec-57-ss-5a-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-57-ss-5a ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-57-ss-5a cml:asserts concept:therapeutic-goods-act-1989-sec-57-ss-5a-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-57-ss-5a-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Permit" ; cml:logicSummary "Delegation of powers to registered medical or dental practitioners or pharmacists." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-57-ss-6 a cml:Concept ; skos:prefLabel "57(6) Delegation"@en ; cml:realizedBy doc:sec-57-ss-6 ; cml:integrityHash "fc2eed2ec9b8f2751243e6bbc6ebc917b7b9b937bf5df2127adab80ecb7928c0" ; values:partOf concept:therapeutic-goods-act-1989-sec-57 ; skos:note "Delegation of powers is restricted to registered medical practitioners." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.364" ; cml:asserts concept:therapeutic-goods-act-1989-sec-57-ss-6-norm . concept:therapeutic-goods-act-1989-sec-57-ss-6-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-57-ss-6 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-57-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-57-ss-6-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-57-ss-6-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "canDelegate" ; cml:logicSummary "Authorization for delegation" ; cml:premiseText "The powers of the Secretary under subsection 32CM(1) or 41HC(1)" ; cml:conclusionText "may be delegated to a registered medical practitioner" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-57-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-57-ss-6-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-57-ss-6-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "during" ; cml:logicSummary "Temporal restriction on delegation" ; cml:premiseText "The powers of the Secretary under subsection 32CM(1) or 41HC(1)" ; cml:conclusionText "may only be delegated during the registration period" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-57-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-57-ss-6-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-57-ss-6-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "everywhere" ; cml:logicSummary "Universal applicability of delegation restriction" ; cml:premiseText "The powers of the Secretary under subsection 32CM(1) or 41HC(1)" ; cml:conclusionText "are restricted to registered medical practitioners everywhere" ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-57-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-57-ss-6-logic-cogai-4 . concept:therapeutic-goods-act-1989-sec-57-ss-6-logic-cogai-4 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "isAuthorizedTo" ; cml:logicSummary "Authorization for delegation by AI system" ; cml:premiseText "The person referred to in paragraph (1)(a) or (c)" ; cml:conclusionText "is authorized to delegate powers as a registered medical practitioner" ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-57-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-57-ss-6-logic-shacl-5 . concept:therapeutic-goods-act-1989-sec-57-ss-6-logic-shacl-5 a cml:LogicApplication ; cml:modality cml:SHACL ; cml:operator "hasShape" ; cml:logicSummary "Validation of delegation restriction" ; cml:premiseText "The person referred to in paragraph (1)(a) or (c)" ; cml:conclusionText "must be validated as a registered medical practitioner" ; cml:executionSurface "modalities::logic::shacl" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-57-ss-7 a cml:Concept ; skos:prefLabel "57(7) Delegation"@en ; cml:realizedBy doc:sec-57-ss-7 ; cml:integrityHash "4e454a6be4cdce324d35bb68c9738de4d58a64997fa80f0404894910eff40404" ; values:partOf concept:therapeutic-goods-act-1989-sec-57 ; skos:note "Regulations may prescribe circumstances for delegate authorities." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.364" ; cml:asserts concept:therapeutic-goods-act-1989-sec-57-ss-7-norm . concept:therapeutic-goods-act-1989-sec-57-ss-7-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-57-ss-7 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-57-ss-7 cml:asserts concept:therapeutic-goods-act-1989-sec-57-ss-7-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-57-ss-7-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "mayPrescribe" ; cml:logicSummary "May prescribe" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-57-ss-8 a cml:Concept ; skos:prefLabel "57(8) Delegation"@en ; cml:realizedBy doc:sec-57-ss-8 ; cml:integrityHash "3685f2afdfb798445ca5cb5d09e98d38686585f55281180e7084a52a9c8720aa" ; values:partOf concept:therapeutic-goods-act-1989-sec-57 ; skos:note "Powers of Secretary can be delegated to a specific person." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.364" ; cml:asserts concept:therapeutic-goods-act-1989-sec-57-ss-8-norm . concept:therapeutic-goods-act-1989-sec-57-ss-8-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-57-ss-8 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-57-ss-8 cml:asserts concept:therapeutic-goods-act-1989-sec-57-ss-8-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-57-ss-8-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "can" ; cml:logicSummary "Delegation is permitted." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-57-ss-9 a cml:Concept ; skos:prefLabel "57(9) Delegation"@en ; cml:realizedBy doc:sec-57-ss-9 ; cml:integrityHash "0f929f5ec13e96828454b8340f5151517e5325e9b41e36d224ce994973ed65c2" ; values:partOf concept:therapeutic-goods-act-1989-sec-57 ; skos:note "Powers of Secretary under section 41HD may be delegated to a person holding the prescribed duties." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.364" ; cml:asserts concept:therapeutic-goods-act-1989-sec-57-ss-9-norm . concept:therapeutic-goods-act-1989-sec-57-ss-9-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-57-ss-9 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-57-ss-10 a cml:Concept ; skos:prefLabel "57(10) Delegation"@en ; cml:realizedBy doc:sec-57-ss-10 ; cml:integrityHash "5e8c848fb79601b4574db4e64db39976664e9c7abf38011017dcd493fca99211" ; values:partOf concept:therapeutic-goods-act-1989-sec-57 ; skos:note "Delegation of power to certain individuals or positions within the Department." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.364" ; cml:asserts concept:therapeutic-goods-act-1989-sec-57-ss-10-norm . concept:therapeutic-goods-act-1989-sec-57-ss-10-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-57-ss-10 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-57-ss-10 cml:asserts concept:therapeutic-goods-act-1989-sec-57-ss-10-logic-alleninterval-1 . concept:therapeutic-goods-act-1989-sec-57-ss-10-logic-alleninterval-1 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator ">=" ; cml:logicSummary "Temporal interval" ; cml:premiseText "(10) The power of the Minister under subsection 18A(1) or 41P(3) may be delegated only to..." ; cml:conclusionText "...on or after a specified date;" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-57-ss-10 cml:asserts concept:therapeutic-goods-act-1989-sec-57-ss-10-logic-ltl-2 . concept:therapeutic-goods-act-1989-sec-57-ss-10-logic-ltl-2 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "<=" ; cml:logicSummary "Temporal interval" ; cml:premiseText "(10AA) The power of the Minister under subsection 30EK(1) may be delegated only to..." ; cml:conclusionText "...before a specified date;" ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-57-ss-10 cml:asserts concept:therapeutic-goods-act-1989-sec-57-ss-10-logic-deontic-3 . concept:therapeutic-goods-act-1989-sec-57-ss-10-logic-deontic-3 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "=" ; cml:logicSummary "Permission" ; cml:premiseText "The power of the Minister under subsection 18A(1) or 41P(3) may be delegated only to..." ; cml:conclusionText "...a specified individual or position;" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-57-ss-10a a cml:Concept ; skos:prefLabel "57(10A) Delegation"@en ; cml:realizedBy doc:sec-57-ss-10a ; cml:integrityHash "312661f44f1c494159265039aa8c672cc5b9d0ff8a488e9806ff0fd803d8dc2f" ; values:partOf concept:therapeutic-goods-act-1989-sec-57 ; skos:note "Delegation of power to the Minister under subsection 32CB(1)" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.364" ; cml:asserts concept:therapeutic-goods-act-1989-sec-57-ss-10a-norm . concept:therapeutic-goods-act-1989-sec-57-ss-10a-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-57-ss-10a ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-57-ss-11 a cml:Concept ; skos:prefLabel "57(11) Delegation"@en ; cml:realizedBy doc:sec-57-ss-11 ; cml:integrityHash "a62d340868c024869b38cb76ff49a667bae546bc027ef2c545716b79d5ab1e5f" ; values:partOf concept:therapeutic-goods-act-1989-sec-57 ; skos:note "Delegation of power to specific individuals or positions." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.364" ; cml:asserts concept:therapeutic-goods-act-1989-sec-57-ss-11-norm . concept:therapeutic-goods-act-1989-sec-57-ss-11-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-57-ss-11 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-57-ss-12 a cml:Concept ; skos:prefLabel "57(12) Delegation"@en ; cml:realizedBy doc:sec-57-ss-12 ; cml:integrityHash "6857992b20ecccccd8b6883d6ef3f80147e9c492d85970bf43adee0abc978e2a" ; values:partOf concept:therapeutic-goods-act-1989-sec-57 ; skos:note "Delegate must comply with directions of the person who delegated." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.364" ; cml:asserts concept:therapeutic-goods-act-1989-sec-57-ss-12-norm . concept:therapeutic-goods-act-1989-sec-57-ss-12-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-57-ss-12 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-57-ss-12 cml:asserts concept:therapeutic-goods-act-1989-sec-57-ss-12-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-57-ss-12-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must comply" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-58 a cml:Concept ; skos:prefLabel "58 Export certifications"@en ; cml:realizedBy doc:sec-58 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-58-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-58-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-58-ss-2a ; cml:hasPart concept:therapeutic-goods-act-1989-sec-58-ss-2b ; cml:hasPart concept:therapeutic-goods-act-1989-sec-58-ss-3 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.367" . concept:therapeutic-goods-act-1989-sec-58-ss-1 a cml:Concept ; skos:prefLabel "58(1) Export certifications"@en ; cml:realizedBy doc:sec-58-ss-1 ; cml:integrityHash "cb5cffe10020adda30bcf077c6db503b9d0091d12e28d3615967d4b111c164e1" ; values:partOf concept:therapeutic-goods-act-1989-sec-58 ; skos:note "The Secretary may issue export certification for goods for therapeutic use in humans." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.367" ; cml:asserts concept:therapeutic-goods-act-1989-sec-58-ss-1-norm . concept:therapeutic-goods-act-1989-sec-58-ss-1-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-58-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-58-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-58-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-58-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "May" ; cml:logicSummary "Permission to issue export certification" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-58-ss-2 a cml:Concept ; skos:prefLabel "58(2) Export certifications"@en ; cml:realizedBy doc:sec-58-ss-2 ; cml:integrityHash "32077c0af2b4c132a6ecc610033b919f49b1d0e77f8cff0a71d9cf793f467830" ; values:partOf concept:therapeutic-goods-act-1989-sec-58 ; skos:note "No export certifications for therapeutic use in humans." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.367" ; cml:asserts concept:therapeutic-goods-act-1989-sec-58-ss-2-norm . concept:therapeutic-goods-act-1989-sec-58-ss-2-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-58-ss-2 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-58-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-58-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-58-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "not" ; cml:logicSummary "Negative obligation" ; cml:conclusionText "No export certifications" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-58-ss-2a a cml:Concept ; skos:prefLabel "58(2A) Export certifications"@en ; cml:realizedBy doc:sec-58-ss-2a ; cml:integrityHash "2b25472d4316ba91c2f6994ac2543ddf276973bad5497bc7a5a265bd98bd75ab" ; values:partOf concept:therapeutic-goods-act-1989-sec-58 ; skos:note "Secretary may issue export certification for vaping goods not covered by subsection (1)" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.367" ; cml:asserts concept:therapeutic-goods-act-1989-sec-58-ss-2a-norm . concept:therapeutic-goods-act-1989-sec-58-ss-2a-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-58-ss-2a ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-58-ss-2b a cml:Concept ; skos:prefLabel "58(2B) Export certifications"@en ; cml:realizedBy doc:sec-58-ss-2b ; cml:integrityHash "70b11da2f27766f22e3b39ac2875b71c0dd5201c1f89c624a61a8d59f9238e13" ; values:partOf concept:therapeutic-goods-act-1989-sec-58 ; skos:note "No export certification for vaping goods under subsection (2A) may be issued." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.367" ; cml:asserts concept:therapeutic-goods-act-1989-sec-58-ss-2b-norm . concept:therapeutic-goods-act-1989-sec-58-ss-2b-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-58-ss-2b ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-58-ss-2b cml:asserts concept:therapeutic-goods-act-1989-sec-58-ss-2b-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-58-ss-2b-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibition of export certification" ; cml:premiseText "(2B) A State or Territory must not issue..." ; cml:conclusionText "...export certification for vaping goods under subsection (2A)." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-58-ss-2b cml:asserts concept:therapeutic-goods-act-1989-sec-58-ss-2b-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-58-ss-2b-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Temporal Restriction" ; cml:logicSummary "Restriction on export certification timing" ; cml:premiseText "(2B) A State or Territory must not issue..." ; cml:conclusionText "...export certification for vaping goods under subsection (2A)." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-58-ss-2b cml:asserts concept:therapeutic-goods-act-1989-sec-58-ss-2b-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-58-ss-2b-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Temporal Restriction" ; cml:logicSummary "Restriction on export certification timing" ; cml:premiseText "(2B) A State or Territory must not issue..." ; cml:conclusionText "...export certification for vaping goods under subsection (2A)." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-58-ss-2b cml:asserts concept:therapeutic-goods-act-1989-sec-58-ss-2b-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-58-ss-2b-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "Propagation" ; cml:logicSummary "Propagating prohibition of export certification" ; cml:premiseText "(2B) A State or Territory must not issue..." ; cml:conclusionText "...export certification for vaping goods under subsection (2A)." ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-58-ss-2b cml:asserts concept:therapeutic-goods-act-1989-sec-58-ss-2b-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-58-ss-2b-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "Knowledge Representation" ; cml:logicSummary "Representation of prohibition in knowledge base" ; cml:premiseText "(2B) A State or Territory must not issue..." ; cml:conclusionText "...export certification for vaping goods under subsection (2A)." ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-58-ss-3 a cml:Concept ; skos:prefLabel "58(3) Export certifications"@en ; cml:realizedBy doc:sec-58-ss-3 ; cml:integrityHash "287d5c644caa158347161cc54c5ddc9d4f8bcbab674ae3628462fb2a796a7762" ; values:partOf concept:therapeutic-goods-act-1989-sec-58 ; skos:note "Fee for certification application and inspection" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.367" ; cml:asserts concept:therapeutic-goods-act-1989-sec-58-ss-3-norm . concept:therapeutic-goods-act-1989-sec-58-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-58-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-58-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-58-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-58-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Payment of fee is obligatory" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-59 a cml:Concept ; skos:prefLabel "59 Fees"@en ; cml:realizedBy doc:sec-59 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-59-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-59-ss-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.368" . concept:therapeutic-goods-act-1989-sec-59-ss-1 a cml:Concept ; skos:prefLabel "59(1) Fees"@en ; cml:realizedBy doc:sec-59-ss-1 ; cml:integrityHash "6d70df9a062c1c1fa45cc132f38fef49f9aa0a5718dacdbe055b66a5cb196067" ; values:partOf concept:therapeutic-goods-act-1989-sec-59 ; skos:note "No fees payable before July 1990" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.368" ; cml:asserts concept:therapeutic-goods-act-1989-sec-59-ss-1-norm . concept:therapeutic-goods-act-1989-sec-59-ss-1-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-59-ss-1 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-59-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-59-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-59-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "forbid" ; cml:logicSummary "Prohibits paying fees before July 1990" ; cml:premiseText "No event occurring before July 1990" ; cml:conclusionText "No fees payable" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-59-ss-2 a cml:Concept ; skos:prefLabel "59(2) Fees"@en ; cml:realizedBy doc:sec-59-ss-2 ; cml:integrityHash "1baa73c415311070c47495ec06e9b88ef56d107011c0e18179ea99ef5bade970" ; values:partOf concept:therapeutic-goods-act-1989-sec-59 ; skos:note "Fees must not amount to taxation." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.368" ; cml:asserts concept:therapeutic-goods-act-1989-sec-59-ss-2-norm . concept:therapeutic-goods-act-1989-sec-59-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-59-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-59-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-59-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-59-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MustNot" ; cml:logicSummary "Prohibition on taxing fees" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-60 a cml:Concept ; skos:prefLabel "60 Review of decisions"@en ; cml:realizedBy doc:sec-60 ; cml:integrityHash "4a47d81bbcbfe5270c94b80c8cb991dfab670ee5ade11c0fc8af53ad09234f65" ; skos:note "Refusal to grant consent or impose conditions on a grant of consent under section 14 or 14A." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.368" ; cml:asserts concept:therapeutic-goods-act-1989-sec-60-norm . concept:therapeutic-goods-act-1989-sec-60-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-60 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-60 cml:asserts concept:therapeutic-goods-act-1989-sec-60-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-60-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Prohibit" ; cml:logicSummary "Prohibition of refusal to grant consent or impose conditions." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-60 cml:asserts concept:therapeutic-goods-act-1989-sec-60-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-60-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "Classify" ; cml:logicSummary "Classification of decisions under Part 3-2 (registration and listing of therapeutic goods)." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-60a a cml:Concept ; skos:prefLabel "60A New information on review—discretion to remit"@en ; cml:realizedBy doc:sec-60a ; cml:hasPart concept:therapeutic-goods-act-1989-sec-60a-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-60a-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-60a-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-60a-ss-4 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-60a-ss-5 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-60a-ss-6 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-60a-ss-6a ; cml:hasPart concept:therapeutic-goods-act-1989-sec-60a-ss-7 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-60a-ss-8 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.374" . concept:therapeutic-goods-act-1989-sec-60a-ss-1 a cml:Concept ; skos:prefLabel "60A(1) New information on review—discretion to remit"@en ; cml:realizedBy doc:sec-60a-ss-1 ; cml:integrityHash "37c625c5f9a3bbdeeffa3a414ade262175edad236c053db2b3269dcbcfcfdb9c" ; values:partOf concept:therapeutic-goods-act-1989-sec-60a ; skos:note "Secretary or delegate has discretion to remit a decision." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.374" ; cml:asserts concept:therapeutic-goods-act-1989-sec-60a-ss-1-norm . concept:therapeutic-goods-act-1989-sec-60a-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-60a-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-60a-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-60a-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-60a-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "hasDiscretion" ; cml:logicSummary "Secretary or delegate has discretion to remit a decision." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-60a-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-60a-ss-1-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-60a-ss-1-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "withinTemporalInterval" ; cml:logicSummary "Decision must be made within a specific temporal interval." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-60a-ss-2 a cml:Concept ; skos:prefLabel "60A(2) New information on review—discretion to remit"@en ; cml:realizedBy doc:sec-60a-ss-2 ; cml:integrityHash "2109460986072fd8387f0229b969edbfb1de88c740f113edfc38617588e4046e" ; values:partOf concept:therapeutic-goods-act-1989-sec-60a ; skos:note "Minister must reconsider decision or remit to delegate upon new information." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.374" ; cml:asserts concept:therapeutic-goods-act-1989-sec-60a-ss-2-norm . concept:therapeutic-goods-act-1989-sec-60a-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-60a-ss-2 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-60a-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-60a-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-60a-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Minister has obligation to reconsider decision." ; cml:premiseText "Appellant requests reconsideration." ; cml:conclusionText "Minister must reconsider decision." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-60a-ss-3 a cml:Concept ; skos:prefLabel "60A(3) New information on review—discretion to remit"@en ; cml:realizedBy doc:sec-60a-ss-3 ; cml:integrityHash "24ca841f8e97f8709f0d76287a01a87eb6c9f5128c98433127aab40376056694" ; values:partOf concept:therapeutic-goods-act-1989-sec-60a ; skos:note "Tribunal may remit matter to delegate for fresh decision if it thinks fit." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.374" ; cml:asserts concept:therapeutic-goods-act-1989-sec-60a-ss-3-norm . concept:therapeutic-goods-act-1989-sec-60a-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-60a-ss-3 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-60a-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-60a-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-60a-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "Tribunal has discretion to remit matter." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-60a-ss-4 a cml:Concept ; skos:prefLabel "60A(4) New information on review—discretion to remit"@en ; cml:realizedBy doc:sec-60a-ss-4 ; cml:integrityHash "1f98abad1a8748f375a324a72f174b98e1570fc5e7bf9c6932ea4ed244a937e6" ; values:partOf concept:therapeutic-goods-act-1989-sec-60a ; skos:note "Tribunal must not remit the matter under subsection (3) if all of initial new information is information that the Minister took into account." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.374" ; cml:asserts concept:therapeutic-goods-act-1989-sec-60a-ss-4-norm . concept:therapeutic-goods-act-1989-sec-60a-ss-4-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-60a-ss-4 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-60a-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-60a-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-60a-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MustNot" ; cml:logicSummary "Tribunal must not remit the matter." ; cml:premiseText "Appellant lodges initial new information." ; cml:conclusionText "Tribunal cannot remit the matter." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-60a-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-60a-ss-4-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-60a-ss-4-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Overlaps" ; cml:logicSummary "Initial new information overlaps with the Minister's decision on reconsideration." ; cml:premiseText "Appellant lodges initial new information." ; cml:conclusionText "Tribunal's discretion to remit is limited by this overlap." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-60a-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-60a-ss-4-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-60a-ss-4-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Repeats" ; cml:logicSummary "The Minister's decision on reconsideration repeats the initial new information." ; cml:premiseText "Minister took initial new information into account." ; cml:conclusionText "Tribunal's discretion to remit is limited by this repetition." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-60a-ss-5 a cml:Concept ; skos:prefLabel "60A(5) New information on review—discretion to remit"@en ; cml:realizedBy doc:sec-60a-ss-5 ; cml:integrityHash "154dad67d61e08fea5643f23324efebc1c6678ab7a8aa8287493d535a94d0ee9" ; values:partOf concept:therapeutic-goods-act-1989-sec-60a ; skos:note "Tribunal must consider initial new information that indicates unacceptable quality, safety or efficacy of therapeutic goods." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.374" ; cml:asserts concept:therapeutic-goods-act-1989-sec-60a-ss-5-norm . concept:therapeutic-goods-act-1989-sec-60a-ss-5-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-60a-ss-5 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-60a-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-60a-ss-5-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-60a-ss-5-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Tribunal must consider initial new information" ; cml:premiseText "Subsection (3)" ; cml:conclusionText "Initial new information considered" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-60a-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-60a-ss-5-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-60a-ss-5-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator ">=" ; cml:logicSummary "Tribunal must consider initial new information within a certain timeframe" ; cml:premiseText "Subsection (3)" ; cml:conclusionText "Initial new information considered within timeframe" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-60a-ss-6 a cml:Concept ; skos:prefLabel "60A(6) New information on review—discretion to remit"@en ; cml:realizedBy doc:sec-60a-ss-6 ; cml:integrityHash "218688f846807fb19e08426edf3d27f38cf6bab2f3e9106f1f261775304612ff" ; values:partOf concept:therapeutic-goods-act-1989-sec-60a ; skos:note "Authorised delegate must make a decision under section 25 taking into account new information." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.374" ; cml:asserts concept:therapeutic-goods-act-1989-sec-60a-ss-6-norm . concept:therapeutic-goods-act-1989-sec-60a-ss-6-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-60a-ss-6 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-60a-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-60a-ss-6-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-60a-ss-6-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must provide a decision under section 25." ; cml:premiseText "(6) If..." ; cml:conclusionText "the authorised delegate must make a decision under section 25..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-60a-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-60a-ss-6-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-60a-ss-6-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "BETWEEN" ; cml:logicSummary "The decision must be made within a specific timeframe." ; cml:premiseText "(6) If..." ; cml:conclusionText "the authorised delegate must make a decision under section 25... within the timeframe specified by the provision." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-60a-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-60a-ss-6-logic-argumentation-3 . concept:therapeutic-goods-act-1989-sec-60a-ss-6-logic-argumentation-3 a cml:LogicApplication ; cml:modality cml:Argumentation ; cml:operator "IMPLIES" ; cml:logicSummary "The provision implies that the Minister or Tribunal has discretion to remit the matter." ; cml:premiseText "(6) If..." ; cml:conclusionText "the Minister or Tribunal has discretion to remit the matter." ; cml:executionSurface "modalities::argumentation" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-60a-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-60a-ss-6-logic-dialectical-4 . concept:therapeutic-goods-act-1989-sec-60a-ss-6-logic-dialectical-4 a cml:LogicApplication ; cml:modality cml:Dialectical ; cml:operator "NOT" ; cml:logicSummary "The provision is not a prohibition on making a new application for registration." ; cml:premiseText "(6) If..." ; cml:conclusionText "the provision does not prohibit making a new application for registration." ; cml:executionSurface "modalities::dialectical" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-60a-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-60a-ss-6-logic-linearlogic-5 . concept:therapeutic-goods-act-1989-sec-60a-ss-6-logic-linearlogic-5 a cml:LogicApplication ; cml:modality cml:LinearLogic ; cml:operator "AND" ; cml:logicSummary "The provision requires the authorised delegate to make a decision under section 25 and include the biological in the Register." ; cml:premiseText "(6) If..." ; cml:conclusionText "the authorised delegate must make a decision under section 25 and include the biological in the Register." ; cml:executionSurface "modalities::linear" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-60a-ss-6a a cml:Concept ; skos:prefLabel "60A(6A) New information on review—discretion to remit"@en ; cml:realizedBy doc:sec-60a-ss-6a ; cml:integrityHash "d86245ee5eb12dc4b56afa8aea8e0305cb51fbac0faed8e490c720d9027db4f3" ; values:partOf concept:therapeutic-goods-act-1989-sec-60a ; skos:note "The authorised delegate must make a decision under section 41EC, taking into account the initial new information or later new information." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.374" ; cml:asserts concept:therapeutic-goods-act-1989-sec-60a-ss-6a-norm . concept:therapeutic-goods-act-1989-sec-60a-ss-6a-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-60a-ss-6a ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-60a-ss-6a cml:asserts concept:therapeutic-goods-act-1989-sec-60a-ss-6a-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-60a-ss-6a-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "The authorised delegate must make a decision." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-60a-ss-7 a cml:Concept ; skos:prefLabel "60A(7) New information on review—discretion to remit"@en ; cml:realizedBy doc:sec-60a-ss-7 ; cml:integrityHash "f8dd0edfebf4432c0f1d75e038ac3a42439b5dca34f50c1bb4d8be12feddb8a3" ; values:partOf concept:therapeutic-goods-act-1989-sec-60a ; skos:note "Delegates' decisions are treated as decisions under Part 3-2, 3-2A or 4-4 for subsequent applications." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.374" ; cml:asserts concept:therapeutic-goods-act-1989-sec-60a-ss-7-norm . concept:therapeutic-goods-act-1989-sec-60a-ss-7-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-60a-ss-7 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-60a-ss-7 cml:asserts concept:therapeutic-goods-act-1989-sec-60a-ss-7-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-60a-ss-7-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Treatment" ; cml:logicSummary "Treated as decisions under Part 3-2, 3-2A or 4-4" ; cml:premiseText "(7) To remove any doubt..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-60a-ss-7 cml:asserts concept:therapeutic-goods-act-1989-sec-60a-ss-7-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-60a-ss-7-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Temporal relation" ; cml:logicSummary "Relates to temporal intervals under Part 3-2, 3-2A or 4-4" ; cml:premiseText "(7) To remove any doubt..." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-60a-ss-7 cml:asserts concept:therapeutic-goods-act-1989-sec-60a-ss-7-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-60a-ss-7-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Recurring trace" ; cml:logicSummary "Involves recurring traces under Part 3-2, 3-2A or 4-4" ; cml:premiseText "(7) To remove any doubt..." ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-60a-ss-7 cml:asserts concept:therapeutic-goods-act-1989-sec-60a-ss-7-logic-cogai-4 . concept:therapeutic-goods-act-1989-sec-60a-ss-7-logic-cogai-4 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "Knowledge representation" ; cml:logicSummary "Involves knowledge representation under Part 3-2, 3-2A or 4-4" ; cml:premiseText "(7) To remove any doubt..." ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-60a-ss-7 cml:asserts concept:therapeutic-goods-act-1989-sec-60a-ss-7-logic-shacl-5 . concept:therapeutic-goods-act-1989-sec-60a-ss-7-logic-shacl-5 a cml:LogicApplication ; cml:modality cml:SHACL ; cml:operator "Schema validation" ; cml:logicSummary "Validates schema under Part 3-2, 3-2A or 4-4" ; cml:premiseText "(7) To remove any doubt..." ; cml:executionSurface "modalities::logic::shacl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-60a-ss-8 a cml:Concept ; skos:prefLabel "60A(8) New information on review—discretion to remit"@en ; cml:realizedBy doc:sec-60a-ss-8 ; cml:integrityHash "6d03ed07cd7b49ecbde9a6764bf00666f56d57ebc614c4b8fe44e5bfe24caaaa" ; values:partOf concept:therapeutic-goods-act-1989-sec-60a ; skos:note "Defines authorized delegate and conditions for new information." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.374" ; cml:asserts concept:therapeutic-goods-act-1989-sec-60a-ss-8-norm . concept:therapeutic-goods-act-1989-sec-60a-ss-8-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-60a-ss-8 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-60a-ss-8 cml:asserts concept:therapeutic-goods-act-1989-sec-60a-ss-8-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-60a-ss-8-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "exercising a power to decide" ; cml:logicSummary "Exercise of power" ; cml:premiseText "(a) exercising a power to decide" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-60a-ss-8 cml:asserts concept:therapeutic-goods-act-1989-sec-60a-ss-8-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-60a-ss-8-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "includes" ; cml:logicSummary "Includes relevant information" ; cml:premiseText "(a) was in existence at the time the decision referred to in subsection (1) was made; and" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-61 a cml:Concept ; skos:prefLabel "61 Release of information"@en ; cml:realizedBy doc:sec-61 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-61-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-61-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-61-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-61-ss-3a ; cml:hasPart concept:therapeutic-goods-act-1989-sec-61-ss-4 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-61-ss-4a ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.377" . concept:therapeutic-goods-act-1989-sec-61-ss-1 a cml:Concept ; skos:prefLabel "61(1) Release of information"@en ; cml:realizedBy doc:sec-61-ss-1 ; cml:integrityHash "998bb6bee35cb2e99b705b746a88b050a46b33bacd2cf9dbbcbc734546816f3e" ; values:partOf concept:therapeutic-goods-act-1989-sec-61 ; skos:note "Definition of therapeutic goods information and vaping goods information." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.377" ; cml:asserts concept:therapeutic-goods-act-1989-sec-61-ss-1-norm . concept:therapeutic-goods-act-1989-sec-61-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-61-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-61-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-61-ss-1-logic-descriptionlogic-1 . concept:therapeutic-goods-act-1989-sec-61-ss-1-logic-descriptionlogic-1 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "definition" ; cml:logicSummary "Defines terms for the purpose of this section." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-61-ss-2 a cml:Concept ; skos:prefLabel "61(2) Release of information"@en ; cml:realizedBy doc:sec-61-ss-2 ; cml:integrityHash "921fb311c11dd7500bee37650426b0a96bccb2bd398687deaa68c9efca17debc" ; values:partOf concept:therapeutic-goods-act-1989-sec-61 ; skos:note "Release of information to World Health Organisation" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.377" ; cml:asserts concept:therapeutic-goods-act-1989-sec-61-ss-2-norm . concept:therapeutic-goods-act-1989-sec-61-ss-2-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-61-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-61-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-61-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-61-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Permit" ; cml:logicSummary "Permission granted by the State" ; cml:premiseText "The Secretary may release information" ; cml:conclusionText "Information can be released to WHO" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-61-ss-3 a cml:Concept ; skos:prefLabel "61(3) Release of information"@en ; cml:realizedBy doc:sec-61-ss-3 ; cml:integrityHash "4acd189e12683d4c0558e36b06f9d4c61698150c8ec8c5615efec9c485179bb5" ; values:partOf concept:therapeutic-goods-act-1989-sec-61 ; skos:note "Release of information to authorities for therapeutic goods functions" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.377" ; cml:asserts concept:therapeutic-goods-act-1989-sec-61-ss-3-norm . concept:therapeutic-goods-act-1989-sec-61-ss-3-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-61-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-61-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-61-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-61-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Permit" ; cml:logicSummary "Permission granted" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-61-ss-3a a cml:Concept ; skos:prefLabel "61(3A) Release of information"@en ; cml:realizedBy doc:sec-61-ss-3a ; cml:integrityHash "e4420e5470de0eb58b80a0f5f2e8a450be8e0ffa8b33bb81702d3b551e990841" ; values:partOf concept:therapeutic-goods-act-1989-sec-61 ; skos:note "Release of information to certain authorities and bodies." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.377" ; cml:asserts concept:therapeutic-goods-act-1989-sec-61-ss-3a-norm . concept:therapeutic-goods-act-1989-sec-61-ss-3a-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-61-ss-3a ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-61-ss-3a cml:asserts concept:therapeutic-goods-act-1989-sec-61-ss-3a-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-61-ss-3a-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Permit" ; cml:logicSummary "Permission granted." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-61-ss-4 a cml:Concept ; skos:prefLabel "61(4) Release of information"@en ; cml:realizedBy doc:sec-61-ss-4 ; cml:integrityHash "52229e3fadd05ca6a4a4298bbab777f060fcc757477cbfb384c4d05c5cb408b4" ; values:partOf concept:therapeutic-goods-act-1989-sec-61 ; skos:note "Release of information to national regulatory authorities of other countries." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.377" ; cml:asserts concept:therapeutic-goods-act-1989-sec-61-ss-4-norm . concept:therapeutic-goods-act-1989-sec-61-ss-4-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-61-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-61-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-61-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-61-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Permit" ; cml:logicSummary "Allows release of information to national regulatory authorities." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-61-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-61-ss-4-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-61-ss-4-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Temporal Interval" ; cml:logicSummary "Defines the temporal scope of the permission." ; cml:premiseText "(4) The Secretary may release to a national regulatory authority..." ; cml:conclusionText "...of therapeutic goods and their compliance with the manufacturing principles;" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-61-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-61-ss-4-logic-diffusion-3 . concept:therapeutic-goods-act-1989-sec-61-ss-4-logic-diffusion-3 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "Spread" ; cml:logicSummary "Describes how the permission is disseminated." ; cml:premiseText "(4) The Secretary may release to a national regulatory authority..." ; cml:conclusionText "...of therapeutic goods and their compliance with the manufacturing principles;" ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-61-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-61-ss-4-logic-cogai-4 . concept:therapeutic-goods-act-1989-sec-61-ss-4-logic-cogai-4 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "Reasoning" ; cml:logicSummary "Describes how the permission is applied." ; cml:premiseText "(4) The Secretary may release to a national regulatory authority..." ; cml:conclusionText "...of therapeutic goods and their compliance with the manufacturing principles;" ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-61-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-61-ss-4-logic-shacl-5 . concept:therapeutic-goods-act-1989-sec-61-ss-4-logic-shacl-5 a cml:LogicApplication ; cml:modality cml:SHACL ; cml:operator "Validate" ; cml:logicSummary "Describes the validation rules for the permission." ; cml:premiseText "(4) The Secretary may release to a national regulatory authority..." ; cml:conclusionText "...of therapeutic goods and their compliance with the manufacturing principles;" ; cml:executionSurface "modalities::logic::shacl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-61-ss-4a a cml:Concept ; skos:prefLabel "61(4A) Release of information"@en ; cml:realizedBy doc:sec-61-ss-4a ; cml:integrityHash "9ebfe4d8064ae8003d55d789fa7e104170b1a465ee272c077a9ad3026edbacf2" ; values:partOf concept:therapeutic-goods-act-1989-sec-61 ; skos:note "Release of information to authorities and international organisations" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.377" ; cml:asserts concept:therapeutic-goods-act-1989-sec-61-ss-4a-norm . concept:therapeutic-goods-act-1989-sec-61-ss-4a-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-61-ss-4a ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-61-ss-4a cml:asserts concept:therapeutic-goods-act-1989-sec-61-ss-4a-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-61-ss-4a-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Permit" ; cml:logicSummary "Permission granted by the Secretary" ; cml:premiseText "(4A) The Secretary may release..." ; cml:conclusionText "...therapeutic goods information relating to one or more of the following:" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-61-ss-4a cml:asserts concept:therapeutic-goods-act-1989-sec-61-ss-4a-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-61-ss-4a-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Temporal overlap" ; cml:logicSummary "Temporal overlap between release and therapeutic goods information" ; cml:premiseText "(4A) The Secretary may release..." ; cml:conclusionText "...contraventions, or possible contraventions, of Part 5-2 or" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-61-ss-4a cml:asserts concept:therapeutic-goods-act-1989-sec-61-ss-4a-logic-argumentation-3 . concept:therapeutic-goods-act-1989-sec-61-ss-4a-logic-argumentation-3 a cml:LogicApplication ; cml:modality cml:Argumentation ; cml:operator "Implication" ; cml:logicSummary "Implication of release on therapeutic goods information" ; cml:premiseText "(4A) The Secretary may release..." ; cml:conclusionText "...action taken by the Secretary under Part 5-3;" ; cml:executionSurface "modalities::argumentation" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-61-ss-4a cml:asserts concept:therapeutic-goods-act-1989-sec-61-ss-4a-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-61-ss-4a-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "Propagation" ; cml:logicSummary "Propagation of release to action taken by the Secretary" ; cml:premiseText "(4A) The Secretary may release..." ; cml:conclusionText "...action taken by the Secretary under section 30EA (about notification and recall of therapeutic goods);" ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-61-ss-4a cml:asserts concept:therapeutic-goods-act-1989-sec-61-ss-4a-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-61-ss-4a-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "Inference" ; cml:logicSummary "Inference of release on action taken by the Secretary" ; cml:premiseText "(4A) The Secretary may release..." ; cml:conclusionText "...action taken by the Secretary under section 32HA (about notification and recall of biologicals);" ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-61a a cml:Concept ; skos:prefLabel "61A Immunity from civil actions"@en ; cml:realizedBy doc:sec-61a ; cml:hasPart concept:therapeutic-goods-act-1989-sec-61a-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-61a-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-61a-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-61a-ss-4 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.385" . concept:therapeutic-goods-act-1989-sec-61a-ss-1 a cml:Concept ; skos:prefLabel "61A(1) Immunity from civil actions"@en ; cml:realizedBy doc:sec-61a-ss-1 ; cml:integrityHash "4926f889f969b3fb1954bdec92d7ab50aa05fc23f7deacab40d1eba93cd9f8d0" ; values:partOf concept:therapeutic-goods-act-1989-sec-61a ; skos:note "No civil action against Commonwealth or protected person for loss/damage/injury caused by their actions." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.385" ; cml:asserts concept:therapeutic-goods-act-1989-sec-61a-ss-1-norm . concept:therapeutic-goods-act-1989-sec-61a-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-61a-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-61a-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-61a-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-61a-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Imposes duty on Commonwealth and protected persons." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-61a-ss-2 a cml:Concept ; skos:prefLabel "61A(2) Immunity from civil actions"@en ; cml:realizedBy doc:sec-61a-ss-2 ; cml:integrityHash "9d0398ed0a860603ef8d58f9e2bf684f7952faa955c8ffef26ed4bf9137a76bb" ; values:partOf concept:therapeutic-goods-act-1989-sec-61a ; skos:note "Immunity from civil actions in bad faith" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.385" ; cml:asserts concept:therapeutic-goods-act-1989-sec-61a-ss-2-norm . concept:therapeutic-goods-act-1989-sec-61a-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-61a-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-61a-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-61a-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-61a-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "exemption" ; cml:logicSummary "Exempts acts in bad faith from civil actions" ; cml:premiseText "(2) Subsection (1) does not apply to an act or omission in bad faith." ; cml:conclusionText "Subsection (1) does not apply to an act or omission in bad faith." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-61a-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-61a-ss-2-logic-deontic-2 . concept:therapeutic-goods-act-1989-sec-61a-ss-2-logic-deontic-2 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "permission" ; cml:logicSummary "Permits acts in bad faith without civil liability" ; cml:premiseText "(2) Subsection (1) does not apply to an act or omission in bad faith." ; cml:conclusionText "Acts in bad faith are permitted without civil liability" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-61a-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-61a-ss-2-logic-linearlogic-3 . concept:therapeutic-goods-act-1989-sec-61a-ss-2-logic-linearlogic-3 a cml:LogicApplication ; cml:modality cml:LinearLogic ; cml:operator "exclusion" ; cml:logicSummary "Excludes acts in bad faith from general applicability of subsection (1)" ; cml:premiseText "(2) Subsection (1) does not apply to an act or omission in bad faith." ; cml:conclusionText "Subsection (1) is excluded for acts in bad faith" ; cml:executionSurface "modalities::linear" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-61a-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-61a-ss-2-logic-alleninterval-4 . concept:therapeutic-goods-act-1989-sec-61a-ss-2-logic-alleninterval-4 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "during" ; cml:logicSummary "Acts in bad faith occur during the period of exemption" ; cml:premiseText "(2) Subsection (1) does not apply to an act or omission in bad faith." ; cml:conclusionText "The period of exemption includes acts in bad faith" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-61a-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-61a-ss-2-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-61a-ss-2-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "inference" ; cml:logicSummary "Inferential relationship between exemption and bad faith" ; cml:premiseText "(2) Subsection (1) does not apply to an act or omission in bad faith." ; cml:conclusionText "Exemption implies bad faith" ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-61a-ss-3 a cml:Concept ; skos:prefLabel "61A(3) Immunity from civil actions"@en ; cml:realizedBy doc:sec-61a-ss-3 ; cml:integrityHash "6eca28ddf118bd8a48d3fa4fedd3e34b77696b63d43983d61955f916841ac908" ; values:partOf concept:therapeutic-goods-act-1989-sec-61a ; skos:note "A reference to a failure to make a decision includes a reference to anything omitted to be done." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.385" ; cml:asserts concept:therapeutic-goods-act-1989-sec-61a-ss-3-norm . concept:therapeutic-goods-act-1989-sec-61a-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-61a-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-61a-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-61a-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-61a-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "includes" ; cml:logicSummary "Inclusion relation for obligations" ; cml:premiseText "(x) includes (y) if and only if x is an obligation that requires y." ; cml:conclusionText "(3) A reference in subsection (1) to anything omitted to be done includes a reference to a failure to make a decision." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-61a-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-61a-ss-3-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-61a-ss-3-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "includes" ; cml:logicSummary "Inclusion relation for descriptions" ; cml:premiseText "(x) includes (y) if and only if x is a description that contains y." ; cml:conclusionText "(3) A reference in subsection (1) to anything omitted to be done includes a reference to a failure to make a decision." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-61a-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-61a-ss-3-logic-linearlogic-3 . concept:therapeutic-goods-act-1989-sec-61a-ss-3-logic-linearlogic-3 a cml:LogicApplication ; cml:modality cml:LinearLogic ; cml:operator "includes" ; cml:logicSummary "Inclusion relation for linear logic" ; cml:premiseText "(x) includes (y) if and only if x is a linear logic statement that implies y." ; cml:conclusionText "(3) A reference in subsection (1) to anything omitted to be done includes a reference to a failure to make a decision." ; cml:executionSurface "modalities::linear" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-61a-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-61a-ss-3-logic-deontic-4 . concept:therapeutic-goods-act-1989-sec-61a-ss-3-logic-deontic-4 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "requires" ; cml:logicSummary "Requirement relation for obligations" ; cml:premiseText "(x) requires (y) if and only if x is an obligation that necessitates y." ; cml:conclusionText "(3) A reference in subsection (1) to anything omitted to be done includes a reference to a failure to make a decision." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-61a-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-61a-ss-3-logic-descriptionlogic-5 . concept:therapeutic-goods-act-1989-sec-61a-ss-3-logic-descriptionlogic-5 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "contains" ; cml:logicSummary "Containment relation for descriptions" ; cml:premiseText "(x) contains (y) if and only if x is a description that encompasses y." ; cml:conclusionText "(3) A reference in subsection (1) to anything omitted to be done includes a reference to a failure to make a decision." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-61a-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-61a-ss-3-logic-alleninterval-6 . concept:therapeutic-goods-act-1989-sec-61a-ss-3-logic-alleninterval-6 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "during" ; cml:logicSummary "Temporal relation for Allen intervals" ; cml:premiseText "(x) during (y) if and only if x starts before y ends." ; cml:conclusionText "(3) A reference in subsection (1) to anything omitted to be done includes a reference to a failure to make a decision." ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-61a-ss-4 a cml:Concept ; skos:prefLabel "61A(4) Immunity from civil actions"@en ; cml:realizedBy doc:sec-61a-ss-4 ; cml:integrityHash "b28154014219d630aeb9f0dcac09c59bfc9255da7f269fea3dad6c50756eaf1c" ; values:partOf concept:therapeutic-goods-act-1989-sec-61a ; skos:note "Protected persons are defined for immunity from civil actions." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.385" ; cml:asserts concept:therapeutic-goods-act-1989-sec-61a-ss-4-norm . concept:therapeutic-goods-act-1989-sec-61a-ss-4-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-61a-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-61a-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-61a-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-61a-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Imposes a duty on the State." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-61a-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-61a-ss-4-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-61a-ss-4-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "ClassInclusion" ; cml:logicSummary "Defines a class of protected persons." ; cml:premiseText "(a) the Minister;" ; cml:conclusionText "protected person means any of the following:" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-62 a cml:Concept ; skos:prefLabel "62 Protection from criminal responsibility"@en ; cml:realizedBy doc:sec-62 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-62-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-62-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-62-ss-3 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.386" . concept:therapeutic-goods-act-1989-sec-62-ss-1 a cml:Concept ; skos:prefLabel "62(1) Protection from criminal responsibility"@en ; cml:realizedBy doc:sec-62-ss-1 ; cml:integrityHash "47194556e944c516c4d693705832a838f2b6dfcf01f0ef3bee565f8b3f87da06" ; values:partOf concept:therapeutic-goods-act-1989-sec-62 ; skos:note "Protected person not criminally responsible for obtaining or possessing goods to comply with laws." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.386" ; cml:asserts concept:therapeutic-goods-act-1989-sec-62-ss-1-norm . concept:therapeutic-goods-act-1989-sec-62-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-62-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-62-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-62-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-62-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Obligation to comply with laws" ; cml:premiseText "Protected person obtains goods for compliance" ; cml:conclusionText "Not criminally responsible" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-62-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-62-ss-1-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-62-ss-1-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Overlaps" ; cml:logicSummary "Temporal overlap: Protected person's actions overlap with law compliance" ; cml:premiseText "Protected person obtains goods for compliance" ; cml:conclusionText "Not criminally responsible" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-62-ss-2 a cml:Concept ; skos:prefLabel "62(2) Protection from criminal responsibility"@en ; cml:realizedBy doc:sec-62-ss-2 ; cml:integrityHash "ac9a7045cef3fca0b7eecb1381eba72a107ed09b7ad19ef6f2e16b40f58c6ab9" ; values:partOf concept:therapeutic-goods-act-1989-sec-62 ; skos:note "Protected person not criminally responsible for offense related to conveyance of goods" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.386" ; cml:asserts concept:therapeutic-goods-act-1989-sec-62-ss-2-norm . concept:therapeutic-goods-act-1989-sec-62-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-62-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-62-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-62-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-62-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Protected person not criminally responsible for offense related to conveyance of goods" ; cml:premiseText "(2) If a protected person, in connection with finding out whether this Act or the regulations have been complied with..." ; cml:conclusionText "The other person is not criminally responsible for an offence against a law of the Commonwealth, or a State law..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-62-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-62-ss-2-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-62-ss-2-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Overlaps" ; cml:logicSummary "Conveyance of goods overlaps with finding out compliance" ; cml:premiseText "(2) If a protected person, in connection with finding out whether this Act or the regulations have been complied with..." ; cml:conclusionText "The conveyance of goods overlaps with finding out compliance" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-62-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-62-ss-2-logic-ltl-3 . concept:therapeutic-goods-act-1989-sec-62-ss-2-logic-ltl-3 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Repeats" ; cml:logicSummary "Conveyance of goods repeats in connection with finding out compliance" ; cml:premiseText "(2) If a protected person, in connection with finding out whether this Act or the regulations have been complied with..." ; cml:conclusionText "The conveyance of goods repeats in connection with finding out compliance" ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-62-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-62-ss-2-logic-diffusion-4 . concept:therapeutic-goods-act-1989-sec-62-ss-2-logic-diffusion-4 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "Diffuses" ; cml:logicSummary "Conveyance of goods diffuses to other persons" ; cml:premiseText "(a) the possession of the goods by the other person, to the extent the possession is in connection with that conveyance of the goods" ; cml:conclusionText "The conveyance of goods diffuses to other persons" ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-62-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-62-ss-2-logic-cogai-5 . concept:therapeutic-goods-act-1989-sec-62-ss-2-logic-cogai-5 a cml:LogicApplication ; cml:modality cml:CogAI ; cml:operator "Inferential" ; cml:logicSummary "Protected person not criminally responsible for offense related to conveyance of goods" ; cml:premiseText "(2) If a protected person, in connection with finding out whether this Act or the regulations have been complied with..." ; cml:conclusionText "The other person is not criminally responsible for an offence against a law of the Commonwealth, or a State law..." ; cml:executionSurface "sparql_library::parsers::chk_parser" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-62-ss-3 a cml:Concept ; skos:prefLabel "62(3) Protection from criminal responsibility"@en ; cml:realizedBy doc:sec-62-ss-3 ; cml:integrityHash "71f0047157d0f05fd1995e9b69f01ee4f67e48afa0ce89ef5260bba7ebd71802" ; values:partOf concept:therapeutic-goods-act-1989-sec-62 ; skos:note "Definition of protected person" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.386" ; cml:asserts concept:therapeutic-goods-act-1989-sec-62-ss-3-norm . concept:therapeutic-goods-act-1989-sec-62-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-62-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-62-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-62-ss-3-logic-descriptionlogic-1 . concept:therapeutic-goods-act-1989-sec-62-ss-3-logic-descriptionlogic-1 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "ClassInclusion" ; cml:logicSummary "Identifies a class hierarchy" ; cml:premiseText "(a) an APS employee in the Department" ; cml:conclusionText "(b) a person of a kind prescribed by the regulations" ; cml:executionSurface "modalities::dl" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-62-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-62-ss-3-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-62-ss-3-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Overlaps" ; cml:logicSummary "Temporal overlap between two events" ; cml:premiseText "In this section:" ; cml:conclusionText "protected person means any of the following:" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-62-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-62-ss-3-logic-deontic-3 . concept:therapeutic-goods-act-1989-sec-62-ss-3-logic-deontic-3 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Definition" ; cml:logicSummary "Defines a term with a specific meaning" ; cml:premiseText "(3) In this section:" ; cml:conclusionText "protected person means any of the following:" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-62-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-62-ss-3-logic-ltl-4 . concept:therapeutic-goods-act-1989-sec-62-ss-3-logic-ltl-4 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "TemporalConnective" ; cml:logicSummary "Expresses temporal relationships between events" ; cml:premiseText "In this section:" ; cml:conclusionText "protected person means any of the following:" ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-63 a cml:Concept ; skos:prefLabel "63 Regulations"@en ; cml:realizedBy doc:sec-63 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-63-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-63-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-63-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-63-ss-3a ; cml:hasPart concept:therapeutic-goods-act-1989-sec-63-ss-4 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-63-ss-5 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.386" . concept:therapeutic-goods-act-1989-sec-63-ss-1 a cml:Concept ; skos:prefLabel "63(1) Regulations"@en ; cml:realizedBy doc:sec-63-ss-1 ; cml:integrityHash "718d8ea3d20405acf408b7d01c030bafdd739974a853fd2df826cc9397ba6b3f" ; values:partOf concept:therapeutic-goods-act-1989-sec-63 ; skos:note "Governor-General may make regulations not inconsistent with the Act." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.386" ; cml:asserts concept:therapeutic-goods-act-1989-sec-63-ss-1-norm . concept:therapeutic-goods-act-1989-sec-63-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-63-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-63-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-63-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-63-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "Regulations are permitted." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-63-ss-2 a cml:Concept ; skos:prefLabel "63(2) Regulations"@en ; cml:realizedBy doc:sec-63-ss-2 ; cml:integrityHash "971614cd42bbf60e7371148d77a0181f86d75426ec38cfbb2b9b951dbf889437" ; values:partOf concept:therapeutic-goods-act-1989-sec-63 ; skos:note "Regulations for therapeutic goods and vaping goods" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.386" ; cml:asserts concept:therapeutic-goods-act-1989-sec-63-ss-2-norm . concept:therapeutic-goods-act-1989-sec-63-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-63-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-63-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-63-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-63-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must provide regulations" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-63-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-63-ss-2-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-63-ss-2-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "CLASSIFICATION" ; cml:logicSummary "Classify therapeutic goods and vaping goods" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-63-ss-3 a cml:Concept ; skos:prefLabel "63(3) Regulations"@en ; cml:realizedBy doc:sec-63-ss-3 ; cml:integrityHash "4f39e9ba585448cee707893c6484b65366333b2e99e86d7041991c3df9ffa6d2" ; values:partOf concept:therapeutic-goods-act-1989-sec-63 ; skos:note "Regulations may prescribe different fees under this Act." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.386" ; cml:asserts concept:therapeutic-goods-act-1989-sec-63-ss-3-norm . concept:therapeutic-goods-act-1989-sec-63-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-63-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-63-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-63-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-63-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "Prescribes obligations" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-63-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-63-ss-3-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-63-ss-3-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "classify" ; cml:logicSummary "Classify goods into classes" ; cml:premiseText "(i) different classes of goods" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-63-ss-3a a cml:Concept ; skos:prefLabel "63(3A) Regulations"@en ; cml:realizedBy doc:sec-63-ss-3a ; cml:integrityHash "10e652f390d6bc4398075e331f8cf992415a125de573c023f23903a87f64e35f" ; values:partOf concept:therapeutic-goods-act-1989-sec-63 ; skos:note "Licence or permission to import/export therapeutic goods may be granted." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.386" ; cml:asserts concept:therapeutic-goods-act-1989-sec-63-ss-3a-norm . concept:therapeutic-goods-act-1989-sec-63-ss-3a-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-63-ss-3a ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-63-ss-3a cml:asserts concept:therapeutic-goods-act-1989-sec-63-ss-3a-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-63-ss-3a-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Grant" ; cml:logicSummary "Permission to import/export therapeutic goods." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-63-ss-4 a cml:Concept ; skos:prefLabel "63(4) Regulations"@en ; cml:realizedBy doc:sec-63-ss-4 ; cml:integrityHash "ed51b78bd78fabaaba38f9c4eea6a86d46d2401316e24251ed71d6f317bda886" ; values:partOf concept:therapeutic-goods-act-1989-sec-63 ; skos:note "Regulations may incorporate existing instruments or writings." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.386" ; cml:asserts concept:therapeutic-goods-act-1989-sec-63-ss-4-norm . concept:therapeutic-goods-act-1989-sec-63-ss-4-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-63-ss-4 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-63-ss-5 a cml:Concept ; skos:prefLabel "63(5) Regulations"@en ; cml:realizedBy doc:sec-63-ss-5 ; cml:integrityHash "3490d0dc93e2c48d53032dc271a279b521e00bb7d200cbbaf702e27043306e8f" ; values:partOf concept:therapeutic-goods-act-1989-sec-63 ; skos:note "Regulations may be made before commencement." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.386" ; cml:asserts concept:therapeutic-goods-act-1989-sec-63-ss-5-norm . concept:therapeutic-goods-act-1989-sec-63-ss-5-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-63-ss-5 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-66 a cml:Concept ; skos:prefLabel "66 Transitional arrangements for goods required to be registered or"@en ; cml:realizedBy doc:sec-66 ; cml:integrityHash "56547a7cc8bbf46bb4aa2f18a097fee842ce6e94ca4c7f5cda6df35c4f5825c9" ; cml:hasPart concept:therapeutic-goods-act-1989-sec-66-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-66-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-66-ss-3 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-66-ss-3a ; cml:hasPart concept:therapeutic-goods-act-1989-sec-66-ss-4 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-66-ss-4a ; cml:hasPart concept:therapeutic-goods-act-1989-sec-66-ss-4b ; cml:hasPart concept:therapeutic-goods-act-1989-sec-66-ss-4c ; cml:hasPart concept:therapeutic-goods-act-1989-sec-66-ss-5 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-66-ss-6 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.390" . concept:therapeutic-goods-act-1989-sec-66-ss-1 a cml:Concept ; skos:prefLabel "66(1) Transitional arrangements for goods required to be registered or"@en ; cml:realizedBy doc:sec-66-ss-1 ; cml:integrityHash "53c9af9e9a72fa3981d101d87397877fc31e41cebd3c4268083ceb4a6664c562" ; values:partOf concept:therapeutic-goods-act-1989-sec-66 ; skos:note "Therapeutic goods supplying person must comply with transitional arrangements." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.390" ; cml:asserts concept:therapeutic-goods-act-1989-sec-66-ss-1-norm . concept:therapeutic-goods-act-1989-sec-66-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-66-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-66-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-66-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-66-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Therapeutic goods supplying person must comply with transitional arrangements." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-66-ss-2 a cml:Concept ; skos:prefLabel "66(2) Transitional arrangements for goods required to be registered or"@en ; cml:realizedBy doc:sec-66-ss-2 ; cml:integrityHash "ddca6907a37ab8564d878ad42f8602e082f4c2033dfd836227cf7c198b995b6e" ; values:partOf concept:therapeutic-goods-act-1989-sec-66 ; skos:note "Exemptions from subsection 20(1) and (2) for certain individuals" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.390" ; cml:asserts concept:therapeutic-goods-act-1989-sec-66-ss-2-norm . concept:therapeutic-goods-act-1989-sec-66-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-66-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-66-ss-3 a cml:Concept ; skos:prefLabel "66(3) Transitional arrangements for goods required to be registered or"@en ; cml:realizedBy doc:sec-66-ss-3 ; cml:integrityHash "87d4d28af6657e71e41b3762ffda9c37d75a671972bbc878029668f7edb75a01" ; values:partOf concept:therapeutic-goods-act-1989-sec-66 ; skos:note "Therapeutic goods registration application within 3 months after commencement." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.390" ; cml:asserts concept:therapeutic-goods-act-1989-sec-66-ss-3-norm . concept:therapeutic-goods-act-1989-sec-66-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-66-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-66-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-66-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-66-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Therapeutic goods registration application within 3 months after commencement." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-66-ss-3a a cml:Concept ; skos:prefLabel "66(3A) Transitional arrangements for goods required to be registered or"@en ; cml:realizedBy doc:sec-66-ss-3a ; cml:integrityHash "cc900127271b884ad8560ab6602a37a7aa8e7f983663f4939e08d3998695006c" ; values:partOf concept:therapeutic-goods-act-1989-sec-66 ; skos:note "Notice must be given to person in relation to whom goods are registered." ; dc:description "Written notice" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.390" ; cml:asserts concept:therapeutic-goods-act-1989-sec-66-ss-3a-norm . concept:therapeutic-goods-act-1989-sec-66-ss-3a-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-66-ss-3a ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-66-ss-3a cml:asserts concept:therapeutic-goods-act-1989-sec-66-ss-3a-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-66-ss-3a-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Notice must be given" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-66-ss-4 a cml:Concept ; skos:prefLabel "66(4) Transitional arrangements for goods required to be registered or"@en ; cml:realizedBy doc:sec-66-ss-4 ; cml:integrityHash "8fee253a710602cf49e77b7a17cc3ef206d0dfdcd839911b4d6b0dab0c68eef1" ; values:partOf concept:therapeutic-goods-act-1989-sec-66 ; skos:note "No application fee for registration or listing of goods." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.390" ; cml:asserts concept:therapeutic-goods-act-1989-sec-66-ss-4-norm . concept:therapeutic-goods-act-1989-sec-66-ss-4-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-66-ss-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-66-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-66-ss-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-66-ss-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "!" ; cml:logicSummary "No fee for evaluation of goods" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-66-ss-4a a cml:Concept ; skos:prefLabel "66(4A) Transitional arrangements for goods required to be registered or"@en ; cml:realizedBy doc:sec-66-ss-4a ; cml:integrityHash "a83342b417c93b94a4679b8fcec0267e5d9a519f0d8822abfd5bc9ee8f79d95a" ; values:partOf concept:therapeutic-goods-act-1989-sec-66 ; skos:note "Transitional arrangements for goods required to be registered or" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.390" ; cml:asserts concept:therapeutic-goods-act-1989-sec-66-ss-4a-norm . concept:therapeutic-goods-act-1989-sec-66-ss-4a-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-66-ss-4a ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-66-ss-4b a cml:Concept ; skos:prefLabel "66(4B) Transitional arrangements for goods required to be registered or"@en ; cml:realizedBy doc:sec-66-ss-4b ; cml:integrityHash "a853016961d6852efc6a6f597a7ba46c15cc85220711dbafce77f7475ff9e2cf" ; values:partOf concept:therapeutic-goods-act-1989-sec-66 ; skos:note "Secretary may give written notice to person listed goods" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.390" ; cml:asserts concept:therapeutic-goods-act-1989-sec-66-ss-4b-norm . concept:therapeutic-goods-act-1989-sec-66-ss-4b-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-66-ss-4b ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-66-ss-4b cml:asserts concept:therapeutic-goods-act-1989-sec-66-ss-4b-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-66-ss-4b-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "may" ; cml:logicSummary "Implies obligation" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-66-ss-4c a cml:Concept ; skos:prefLabel "66(4C) Transitional arrangements for goods required to be registered or"@en ; cml:realizedBy doc:sec-66-ss-4c ; cml:integrityHash "75520faafe07ff84b1aba16c467c8ffb37dcc6ec6fbeac7c8aa635d1760e66c9" ; values:partOf concept:therapeutic-goods-act-1989-sec-66 ; skos:note "If notice is given under subsection (4B), section 26 applies as if the person in relation to whom the goods are listed were an applicant for the listing of the goods." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.390" ; cml:asserts concept:therapeutic-goods-act-1989-sec-66-ss-4c-norm . concept:therapeutic-goods-act-1989-sec-66-ss-4c-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-66-ss-4c ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-66-ss-4c cml:asserts concept:therapeutic-goods-act-1989-sec-66-ss-4c-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-66-ss-4c-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "if-then" ; cml:logicSummary "Conditional obligation" ; cml:premiseText "Notice is given under subsection (4B)" ; cml:conclusionText "Section 26 applies" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-66-ss-5 a cml:Concept ; skos:prefLabel "66(5) Transitional arrangements for goods required to be registered or"@en ; cml:realizedBy doc:sec-66-ss-5 ; cml:integrityHash "a61163ad065da808b32700788acc0390d6decf6c0d3e01edf699b4b2a956e15f" ; values:partOf concept:therapeutic-goods-act-1989-sec-66 ; skos:note "Exemption from Section 21 for goods during transitional period" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.390" ; cml:asserts concept:therapeutic-goods-act-1989-sec-66-ss-5-norm . concept:therapeutic-goods-act-1989-sec-66-ss-5-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-66-ss-5 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-66-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-66-ss-5-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-66-ss-5-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "exemption" ; cml:logicSummary "Exempts goods from Section 21 during transitional period" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-66-ss-6 a cml:Concept ; skos:prefLabel "66(6) Transitional arrangements for goods required to be registered or"@en ; cml:realizedBy doc:sec-66-ss-6 ; cml:integrityHash "dfe2cef4144e62d12e2390015d8f9196825bbfad17e5ec8411815f65b0b475bb" ; values:partOf concept:therapeutic-goods-act-1989-sec-66 ; skos:note "No liability attaches to Commonwealth, Secretary, or delegate for losses caused by therapeutic goods." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.390" ; cml:asserts concept:therapeutic-goods-act-1989-sec-66-ss-6-norm . concept:therapeutic-goods-act-1989-sec-66-ss-6-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-66-ss-6 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-66-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-66-ss-6-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-66-ss-6-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Implies" ; cml:logicSummary "No liability implies loss or damage" ; cml:premiseText "Loss or damage occurs" ; cml:conclusionText "No liability attaches" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-66-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-66-ss-6-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-66-ss-6-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "SubClassOf" ; cml:logicSummary "Therapeutic goods are a subclass of goods subject to this section" ; cml:premiseText "This section applies to therapeutic goods" ; cml:conclusionText "Loss or damage is covered by this section" ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-66-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-66-ss-6-logic-deontic-3 . concept:therapeutic-goods-act-1989-sec-66-ss-6-logic-deontic-3 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Implies" ; cml:logicSummary "No liability implies lack of responsibility" ; cml:premiseText "Lack of liability implies no responsibility" ; cml:conclusionText "The Commonwealth, Secretary, or delegate is not responsible for losses" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-66-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-66-ss-6-logic-ltl-4 . concept:therapeutic-goods-act-1989-sec-66-ss-6-logic-ltl-4 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Until" ; cml:logicSummary "Liability attaches until loss or damage is covered by this section" ; cml:premiseText "Loss or damage occurs before this section applies" ; cml:conclusionText "No liability attaches until this section applies" ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-66-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-66-ss-6-logic-deontic-5 . concept:therapeutic-goods-act-1989-sec-66-ss-6-logic-deontic-5 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Implies" ; cml:logicSummary "This section implies a duty to provide compensation for losses caused by therapeutic goods" ; cml:premiseText "Losses are caused by therapeutic goods subject to this section" ; cml:conclusionText "The Commonwealth, Secretary, or delegate must provide compensation" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-67 a cml:Concept ; skos:prefLabel "67 Transitional provision for therapeutic goods for export only"@en ; cml:realizedBy doc:sec-67 ; cml:integrityHash "2e3de76f5908db2170ad3e585ad6d5eb47b79a8afdb9a8405458cd8ad7277a88" ; skos:note "Therapeutic goods manufactured in Australia solely for export from Australia are exempt from Section 20 during the first 6 months after commencement." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.392" ; cml:asserts concept:therapeutic-goods-act-1989-sec-67-norm . concept:therapeutic-goods-act-1989-sec-67-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-67 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-68 a cml:Concept ; skos:prefLabel "68 Transitional arrangements for Part 3-3"@en ; cml:realizedBy doc:sec-68 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-68-ss-1 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-68-ss-2 ; cml:hasPart concept:therapeutic-goods-act-1989-sec-68-ss-3 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.392" . concept:therapeutic-goods-act-1989-sec-68-ss-1 a cml:Concept ; skos:prefLabel "68(1) Transitional arrangements for Part 3-3"@en ; cml:realizedBy doc:sec-68-ss-1 ; cml:integrityHash "5e6881f1ec5bb0385fb1d6f34a1953a71487f96e5f85755e355923192e1b3689" ; values:partOf concept:therapeutic-goods-act-1989-sec-68 ; skos:note "Applicability of transitional arrangements for Part 3-3" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.392" ; cml:asserts concept:therapeutic-goods-act-1989-sec-68-ss-1-norm . concept:therapeutic-goods-act-1989-sec-68-ss-1-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-68-ss-1 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-68-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-68-ss-1-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-68-ss-1-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "applies" ; cml:logicSummary "Transitional arrangement applies to a step in the manufacture of therapeutic goods" ; cml:premiseText "(1) This section applies..." ; cml:conclusionText "...to a person in relation to premises in Australia if..." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-68-ss-2 a cml:Concept ; skos:prefLabel "68(2) Transitional arrangements for Part 3-3"@en ; cml:realizedBy doc:sec-68-ss-2 ; cml:integrityHash "67f74215afdd954587bfa8be94c591c3af1017c0a948d2ef4e9655fe541001f3" ; values:partOf concept:therapeutic-goods-act-1989-sec-68 ; skos:note "No prosecution for 4 months after commencement" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.392" ; cml:asserts concept:therapeutic-goods-act-1989-sec-68-ss-2-norm . concept:therapeutic-goods-act-1989-sec-68-ss-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-68-ss-2 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-68-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-68-ss-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-68-ss-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Obligation to not prosecute" ; cml:premiseText "(2) Where..." ; cml:conclusionText "subsection 35(1) does not apply" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-68-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-68-ss-2-logic-alleninterval-2 . concept:therapeutic-goods-act-1989-sec-68-ss-2-logic-alleninterval-2 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Overlaps" ; cml:logicSummary "Temporal overlap of 4 months" ; cml:premiseText "(a) this section applies to a step in the manufacture..." ; cml:conclusionText "subsection 35(1) does not apply" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-68-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-68-ss-2-logic-diffusion-3 . concept:therapeutic-goods-act-1989-sec-68-ss-2-logic-diffusion-3 a cml:LogicApplication ; cml:modality cml:Diffusion ; cml:operator "Diffuses" ; cml:logicSummary "Diffusion of obligation to not prosecute" ; cml:premiseText "(2) Where..." ; cml:conclusionText "subsection 35(1) does not apply" ; cml:executionSurface "modalities::diffusion" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-68-ss-3 a cml:Concept ; skos:prefLabel "68(3) Transitional arrangements for Part 3-3"@en ; cml:realizedBy doc:sec-68-ss-3 ; cml:integrityHash "fea248bbec2428e8a1439ad38c893c3e8e4e4d0e34494feac0e8e9ca6d83b928" ; values:partOf concept:therapeutic-goods-act-1989-sec-68 ; skos:note "Application for licence must be made within 4 months after commencement." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.392" ; cml:asserts concept:therapeutic-goods-act-1989-sec-68-ss-3-norm . concept:therapeutic-goods-act-1989-sec-68-ss-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-68-ss-3 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-68-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-68-ss-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-68-ss-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Application for licence must be made within 4 months after commencement." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-69 a cml:Concept ; skos:prefLabel "69 Continuation of standards and requirements"@en ; cml:realizedBy doc:sec-69 ; cml:integrityHash "bb9419c96a803f074fd7fddce5972f7bce38b676ad3d088cab55b23f1fd62113" ; skos:note "Continues standards and requirements from Therapeutic Goods Act 1966." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.393" ; cml:asserts concept:therapeutic-goods-act-1989-sec-69-norm . concept:therapeutic-goods-act-1989-sec-69-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-69 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-69 cml:asserts concept:therapeutic-goods-act-1989-sec-69-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-69-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "CONTINUE" ; cml:logicSummary "Continues existing standards and requirements." ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-69 cml:asserts concept:therapeutic-goods-act-1989-sec-69-logic-descriptionlogic-2 . concept:therapeutic-goods-act-1989-sec-69-logic-descriptionlogic-2 a cml:LogicApplication ; cml:modality cml:DescriptionLogic ; cml:operator "SUBCLASS_OF" ; cml:logicSummary "Continues standards and requirements from Therapeutic Goods Act 1966." ; cml:executionSurface "modalities::dl" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-17 a cml:Concept ; skos:prefLabel "17 Jan 1990"@en ; cml:realizedBy doc:sec-17 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.397" ; cml:asserts concept:therapeutic-goods-act-1989-sec-17-norm . concept:therapeutic-goods-act-1989-sec-17-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-17 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-15 a cml:Concept ; skos:prefLabel "15 Feb 1991 (s 2)"@en ; cml:realizedBy doc:sec-15 ; cml:integrityHash "9c4cdffd45adf47d02b457d6486a8747c70186c98919d3da6b2862a458b94c23" ; skos:note "Community Services and Health Legislation Amendment Act (No. 2) 141, 1990" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.397" ; cml:asserts concept:therapeutic-goods-act-1989-sec-15-norm . concept:therapeutic-goods-act-1989-sec-15-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-15 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-28 a cml:Concept ; skos:prefLabel "28 Dec"@en ; cml:realizedBy doc:sec-28 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.397" ; cml:asserts concept:therapeutic-goods-act-1989-sec-28-norm . concept:therapeutic-goods-act-1989-sec-28-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-28 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-26 a cml:Concept ; skos:prefLabel "26 June"@en ; cml:realizedBy doc:sec-26 ; cml:integrityHash "0f7dfa3d546e2b794d031e391cd6648445358063fdbf66a612e6fea9fc9c94f6" ; skos:note "Conditional commencement of the Therapeutic Goods Amendment Act 1991" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.397" ; cml:asserts concept:therapeutic-goods-act-1989-sec-26-norm . concept:therapeutic-goods-act-1989-sec-26-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-26 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-24 a cml:Concept ; skos:prefLabel "24 Dec"@en ; cml:realizedBy doc:sec-24 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.397" ; cml:asserts concept:therapeutic-goods-act-1989-sec-24-norm . concept:therapeutic-goods-act-1989-sec-24-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-24 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-24-2 a cml:Concept ; skos:prefLabel "24 Dec 1991 (s 2)"@en ; cml:realizedBy doc:sec-24-2 ; cml:integrityHash "f115f068f39426bd9691592e03211c993fd548ce11beacc6d7687292bfda7395" ; skos:note "References s 4(2), 10(2) and 13(2)" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.397" ; cml:asserts concept:therapeutic-goods-act-1989-sec-24-2-norm . concept:therapeutic-goods-act-1989-sec-24-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-24-2 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-30 a cml:Concept ; skos:prefLabel "30 June"@en ; cml:realizedBy doc:sec-30 ; cml:integrityHash "53a1fbe1b34bf800947ed0ff4aa2ee42dcb39786ea2365d08e5f77cda8e32319" ; skos:note "Conditional commencement of Health and Community Services Legislation Amendment Act (No. 2)" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.397" ; cml:asserts concept:therapeutic-goods-act-1989-sec-30-norm . concept:therapeutic-goods-act-1989-sec-30-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-30 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-30 cml:asserts concept:therapeutic-goods-act-1989-sec-30-logic-alleninterval-1 . concept:therapeutic-goods-act-1989-sec-30-logic-alleninterval-1 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Applicable" ; cml:logicSummary "Requires relation between identifiable temporal intervals for conditional commencement" ; cml:premiseText "s 82–88: 30 Jun 1992 (s (1)) s 83(2)" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-30 cml:asserts concept:therapeutic-goods-act-1989-sec-30-logic-ltl-2 . concept:therapeutic-goods-act-1989-sec-30-logic-ltl-2 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Applicable" ; cml:logicSummary "Requires ordered or recurring trace for conditional commencement" ; cml:premiseText "s 82–88: 30 Jun 1992 (s (1)) s 83(2)" ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-30 cml:asserts concept:therapeutic-goods-act-1989-sec-30-logic-deontic-3 . concept:therapeutic-goods-act-1989-sec-30-logic-deontic-3 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Applicable" ; cml:logicSummary "Classifies the legal effect as Undertaking" ; cml:premiseText "No explicit duty, ban conduct, grant permission, or create a right" ; cml:conclusionText "Undertaking" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-25 a cml:Concept ; skos:prefLabel "25 Nov"@en ; cml:realizedBy doc:sec-25 ; cml:integrityHash "81c3a1fab1ea45eb7211f7da4f877c46557e124c8c06305c9dd1a56933556f88" ; skos:note "Customs, Excise and Bounty Legislation Amendment Act 1995" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.397" ; cml:asserts concept:therapeutic-goods-act-1989-sec-25-norm . concept:therapeutic-goods-act-1989-sec-25-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-25 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-1 a cml:Concept ; skos:prefLabel "1 July 1995"@en ; cml:realizedBy doc:sec-1 ; cml:integrityHash "5a078cb643de24c95d4bf8d859e084db57c540ea3924499494bf453f47d66e0e" ; skos:note "Conditional commencement of Therapeutic Goods Amendment Act 1996" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.397" ; cml:asserts concept:therapeutic-goods-act-1989-sec-1-norm . concept:therapeutic-goods-act-1989-sec-1-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-1 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-11-2 a cml:Concept ; skos:prefLabel "11 June"@en ; cml:realizedBy doc:sec-11-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.397" ; cml:asserts concept:therapeutic-goods-act-1989-sec-11-2-norm . concept:therapeutic-goods-act-1989-sec-11-2-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-11-2 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-11-3 a cml:Concept ; skos:prefLabel "11 June 1996 (s 2)"@en ; cml:realizedBy doc:sec-11-3 ; cml:integrityHash "5ce4a6a9f2b57dd2ba739aaabbe9e2349e0244ba212a2a6956e3aa0f60dec94f" ; skos:note "Legislation history for Therapeutic Goods Act 1989" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.397" ; cml:asserts concept:therapeutic-goods-act-1989-sec-11-3-norm . concept:therapeutic-goods-act-1989-sec-11-3-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-11-3 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-11-3 cml:asserts concept:therapeutic-goods-act-1989-sec-11-3-logic-n3logic-1 . concept:therapeutic-goods-act-1989-sec-11-3-logic-n3logic-1 a cml:LogicApplication ; cml:modality cml:N3Logic ; cml:operator "Applicable" ; cml:logicSummary "Defines compilation date" ; cml:premiseText "Compilation date is defined as the date of publication" ; cml:conclusionText "2025-09-05" ; cml:executionSurface "modalities::logic::n3_compiler" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-7 a cml:Concept ; skos:prefLabel "7 July 1997"@en ; cml:realizedBy doc:sec-7 ; cml:integrityHash "c362835f09a01307303a31902bcc46dccfe922b4155c54cb15f12036d4371d85" ; skos:note "Amendment of schedule" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.398" ; cml:asserts concept:therapeutic-goods-act-1989-sec-7-norm . concept:therapeutic-goods-act-1989-sec-7-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-7 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-29 a cml:Concept ; skos:prefLabel "29 Mar"@en ; cml:realizedBy doc:sec-29 ; cml:integrityHash "0263c61c2df3adb172d8fbff62ac1b149c15b78834ebe9b99639be2ca752efa4" ; skos:note "Audit (Transitional and Miscellaneous) Amendment Act 1997" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.398" ; cml:asserts concept:therapeutic-goods-act-1989-sec-29-norm . concept:therapeutic-goods-act-1989-sec-29-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-29 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-24-3 a cml:Concept ; skos:prefLabel "24 Oct"@en ; cml:realizedBy doc:sec-24-3 ; cml:integrityHash "1a50fb5c97583f17648870f22eac907d25334021d1f880480b4ac573252dc08f" ; skos:note "Commences on 1 January 1998" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.398" ; cml:asserts concept:therapeutic-goods-act-1989-sec-24-3-norm . concept:therapeutic-goods-act-1989-sec-24-3-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-24-3 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-17-2 a cml:Concept ; skos:prefLabel "17 Apr"@en ; cml:realizedBy doc:sec-17-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.398" ; cml:asserts concept:therapeutic-goods-act-1989-sec-17-2-norm . concept:therapeutic-goods-act-1989-sec-17-2-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-17-2 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-17-3 a cml:Concept ; skos:prefLabel "17 Apr 1998 (s 2)"@en ; cml:realizedBy doc:sec-17-3 ; cml:integrityHash "dd68fc51537b22dd390fde6b2c71dc51f3721ab33ea2415ef82e9a1f0a4b1566" ; skos:note "Conditional commencement of Therapeutic Goods Legislation Amendment Act 1999" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.398" ; cml:asserts concept:therapeutic-goods-act-1989-sec-17-3-norm . concept:therapeutic-goods-act-1989-sec-17-3-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-17-3 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-29-2 a cml:Concept ; skos:prefLabel "29 Mar"@en ; cml:realizedBy doc:sec-29-2 ; cml:integrityHash "b764d1ba08181c17a19374547a251c5b44f5559daa1c61c6885e83ff4f4f68eb" ; skos:note "Amendment Act 1999" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.398" ; cml:asserts concept:therapeutic-goods-act-1989-sec-29-2-norm . concept:therapeutic-goods-act-1989-sec-29-2-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-29-2 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-11-4 a cml:Concept ; skos:prefLabel "11 Nov"@en ; cml:realizedBy doc:sec-11-4 ; cml:integrityHash "4a695abf2298384bcead27bddecc0af60840bf60d16fcb5a9a984c1d6412975d" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.398" ; cml:asserts concept:therapeutic-goods-act-1989-sec-11-4-norm . concept:therapeutic-goods-act-1989-sec-11-4-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-11-4 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-5-2 a cml:Concept ; skos:prefLabel "5 Dec 1999 (gaz 1999,"@en ; cml:realizedBy doc:sec-5-2 ; cml:integrityHash "45857c72ce5906cf92c73b0cc69bf5d11b1d6450e97fbed02a30ab442c87128c" ; skos:note "No S584" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.398" ; cml:asserts concept:therapeutic-goods-act-1989-sec-5-2-norm . concept:therapeutic-goods-act-1989-sec-5-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-5-2 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-31 a cml:Concept ; skos:prefLabel "31 Mar"@en ; cml:realizedBy doc:sec-31 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.398" ; cml:asserts concept:therapeutic-goods-act-1989-sec-31-norm . concept:therapeutic-goods-act-1989-sec-31-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-31 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-31-2 a cml:Concept ; skos:prefLabel "31 Mar 2000 (s 2)"@en ; cml:realizedBy doc:sec-31-2 ; cml:integrityHash "1c52bf9b9ff911129b83839e19a87a3d2b3ebfd7ad956cb977c82b572d3fdcf6" ; skos:note "Therapeutic Goods Amendment Act (No. 2) - March 2000" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.398" ; cml:asserts concept:therapeutic-goods-act-1989-sec-31-2-norm . concept:therapeutic-goods-act-1989-sec-31-2-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-31-2 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-30-2 a cml:Concept ; skos:prefLabel "30 May"@en ; cml:realizedBy doc:sec-30-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.398" ; cml:asserts concept:therapeutic-goods-act-1989-sec-30-2-norm . concept:therapeutic-goods-act-1989-sec-30-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-30-2 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-30-3 a cml:Concept ; skos:prefLabel "30 May 2000 (s 2)"@en ; cml:realizedBy doc:sec-30-3 ; cml:integrityHash "37cfa3a5c416190985934de91bcdb27a615f3656c001143980c7d5a1bd8e7a3c" ; skos:note "Amendment Act (No. 3)" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.398" ; cml:asserts concept:therapeutic-goods-act-1989-sec-30-3-norm . concept:therapeutic-goods-act-1989-sec-30-3-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-30-3 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-12 a cml:Concept ; skos:prefLabel "12 Sept"@en ; cml:realizedBy doc:sec-12 ; cml:integrityHash "344eb579a28dc7f2644bcf36af39cdd5b5e240defe7ccb8f5e24bdb8afda885c" ; skos:note "Remains in force until further notice" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.398" ; cml:asserts concept:therapeutic-goods-act-1989-sec-12-norm . concept:therapeutic-goods-act-1989-sec-12-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-12 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-21 a cml:Concept ; skos:prefLabel "21 Dec"@en ; cml:realizedBy doc:sec-21 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.399" ; cml:asserts concept:therapeutic-goods-act-1989-sec-21-norm . concept:therapeutic-goods-act-1989-sec-21-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-21 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-22 a cml:Concept ; skos:prefLabel "22 June 2001 (s 2)"@en ; cml:realizedBy doc:sec-22 ; cml:integrityHash "ef8c2ad2bb4325d93c2feb2447f2147b72d4d536c700ad20168e7ff46447f846" ; skos:note "Conditional commencement of the Therapeutic Goods Amendment Act 2001" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.399" ; cml:asserts concept:therapeutic-goods-act-1989-sec-22-norm . concept:therapeutic-goods-act-1989-sec-22-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-22 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-22-2 a cml:Concept ; skos:prefLabel "22 Mar"@en ; cml:realizedBy doc:sec-22-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.399" ; cml:asserts concept:therapeutic-goods-act-1989-sec-22-2-norm . concept:therapeutic-goods-act-1989-sec-22-2-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-22-2 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-22-3 a cml:Concept ; skos:prefLabel "22 Sept 2001"@en ; cml:realizedBy doc:sec-22-3 ; cml:integrityHash "5353b9d4778b7803abecbe6dde005812b7ead3fbf193871c4c6add16f3853dd8" ; skos:note "Amendment Act 2001" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.399" ; cml:asserts concept:therapeutic-goods-act-1989-sec-22-3-norm . concept:therapeutic-goods-act-1989-sec-22-3-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-22-3 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-10 a cml:Concept ; skos:prefLabel "10 July"@en ; cml:realizedBy doc:sec-10 ; cml:integrityHash "2f1855871bc8f1a4de499bf9959925c49c3b580e49913d30bc3820fca86667dc" ; skos:note "July section" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.399" ; cml:asserts concept:therapeutic-goods-act-1989-sec-10-norm . concept:therapeutic-goods-act-1989-sec-10-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-10 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-17-4 a cml:Concept ; skos:prefLabel "17 Sept"@en ; cml:realizedBy doc:sec-17-4 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.399" ; cml:asserts concept:therapeutic-goods-act-1989-sec-17-4-norm . concept:therapeutic-goods-act-1989-sec-17-4-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-17-4 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-17-5 a cml:Concept ; skos:prefLabel "17 Sept 2001 (s 2)"@en ; cml:realizedBy doc:sec-17-5 ; cml:integrityHash "41f00e82be48397d1b347509465461e4a9ba6135d9b57d9516b03ec0a33e64cf" ; skos:note "Amendment Act (No. 1)" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.399" ; cml:asserts concept:therapeutic-goods-act-1989-sec-17-5-norm . concept:therapeutic-goods-act-1989-sec-17-5-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-17-5 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-4 a cml:Concept ; skos:prefLabel "4 Apr 2002"@en ; cml:realizedBy doc:sec-4 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.399" ; cml:asserts concept:therapeutic-goods-act-1989-sec-4-norm . concept:therapeutic-goods-act-1989-sec-4-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-4 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-4-2 a cml:Concept ; skos:prefLabel "4 Apr 2002 (s 2)"@en ; cml:realizedBy doc:sec-4-2 ; cml:integrityHash "f58051aec453a2ccc11fd56a619bb6308783adb5921c9b550fb4cf073f964a55" ; skos:note "Conditional commencement of the Act" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.399" ; cml:asserts concept:therapeutic-goods-act-1989-sec-4-2-norm . concept:therapeutic-goods-act-1989-sec-4-2-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-4-2 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-4-3 a cml:Concept ; skos:prefLabel "4 Apr 2002"@en ; cml:realizedBy doc:sec-4-3 ; cml:integrityHash "b2834cfedb570caf72d1a7a25ea945ec31bee06b7a4e74c0a59d9e8cfbcd7a91" ; skos:note "Schedule amendments" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.399" ; cml:asserts concept:therapeutic-goods-act-1989-sec-4-3-norm . concept:therapeutic-goods-act-1989-sec-4-3-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-4-3 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-3 a cml:Concept ; skos:prefLabel "3 July 2002"@en ; cml:realizedBy doc:sec-3 ; cml:integrityHash "1688c977dd4f73c5f8fb447c53c2e659168f8518ae5faf917ab306e49d7eb137" ; skos:note "Therapeutic Goods Amendment Act (No. 1) 2006" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.399" ; cml:asserts concept:therapeutic-goods-act-1989-sec-3-norm . concept:therapeutic-goods-act-1989-sec-3-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-3 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-3-2 a cml:Concept ; skos:prefLabel "3 May 2006"@en ; cml:realizedBy doc:sec-3-2 ; cml:integrityHash "94993cbb1a085d43618dc2492cc79691a25ef041b61f029f8b8a75fc1935775b" ; skos:note "Conditional commencement of Therapeutic Goods Amendment Act 2007" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.399" ; cml:asserts concept:therapeutic-goods-act-1989-sec-3-2-norm . concept:therapeutic-goods-act-1989-sec-3-2-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-3-2 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-14 a cml:Concept ; skos:prefLabel "14 Sept"@en ; cml:realizedBy doc:sec-14 ; cml:integrityHash "23a2de87a9848775c41f2e75ca27aa60cc9907506ebea8e294253614405bfd04" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.399" ; cml:asserts concept:therapeutic-goods-act-1989-sec-14-norm . concept:therapeutic-goods-act-1989-sec-14-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-14 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-3-3 a cml:Concept ; skos:prefLabel "3 July 2002"@en ; cml:realizedBy doc:sec-3-3 ; cml:integrityHash "e90696b376feb616ba7445e9ee4cdea11621a342d58ebaff0d1084a8d3cb3e87" ; skos:note "Commencement dates for certain provisions of the Therapeutic Goods Amendment Act (No. 1)" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.400" ; cml:asserts concept:therapeutic-goods-act-1989-sec-3-3-norm . concept:therapeutic-goods-act-1989-sec-3-3-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-3-3 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-27 a cml:Concept ; skos:prefLabel "27 May"@en ; cml:realizedBy doc:sec-27 ; cml:integrityHash "05d0895732544998989fe7ba6011761df7ac2971679b60e404ec3b7e46bea657" ; skos:note "Conditional commencement of certain provisions" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.400" ; cml:asserts concept:therapeutic-goods-act-1989-sec-27-norm . concept:therapeutic-goods-act-1989-sec-27-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-27 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-27-2 a cml:Concept ; skos:prefLabel "27 May 2003 (s 2(1)"@en ; cml:realizedBy doc:sec-27-2 ; cml:integrityHash "2e51cb6253d1a5ecdc59ccf5c7396652be02d092dc02de9aaa4a5b3b741a1f16" ; skos:note "US Free Trade Agreement Implementation Act" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.400" ; cml:asserts concept:therapeutic-goods-act-1989-sec-27-2-norm . concept:therapeutic-goods-act-1989-sec-27-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-27-2 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-27-2 cml:asserts concept:therapeutic-goods-act-1989-sec-27-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-27-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST" ; cml:logicSummary "Must implement US Free Trade Agreement" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-16 a cml:Concept ; skos:prefLabel "16 Aug"@en ; cml:realizedBy doc:sec-16 ; cml:integrityHash "226d6cd50cff0588de2ae67286b52c66864a8a16c5eccee1cd9b88ac3ae0331a" ; skos:note "Conditional commencement of Sch 7 (item 7)" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.400" ; cml:asserts concept:therapeutic-goods-act-1989-sec-16-norm . concept:therapeutic-goods-act-1989-sec-16-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-16 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-22-4 a cml:Concept ; skos:prefLabel "22 Feb"@en ; cml:realizedBy doc:sec-22-4 ; cml:integrityHash "0fef335bab5d94afb50141b22503c37e3c88ecdca0a3a91992745955beeca07c" ; skos:note "Conditional commencement of Therapeutic Goods Amendment Act (No. 2)" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.400" ; cml:asserts concept:therapeutic-goods-act-1989-sec-22-4-norm . concept:therapeutic-goods-act-1989-sec-22-4-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-22-4 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-1-2 a cml:Concept ; skos:prefLabel "1 Mar 2006"@en ; cml:realizedBy doc:sec-1-2 ; cml:integrityHash "fd44a63585ecfe7c6290a8c7a255e8167a704fab57dd6a36a8fe72a44c380753" ; skos:note "Remainder: 1 Mar 2006" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.400" ; cml:asserts concept:therapeutic-goods-act-1989-sec-1-2-norm . concept:therapeutic-goods-act-1989-sec-1-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-1-2 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-1-2 cml:asserts concept:therapeutic-goods-act-1989-sec-1-2-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-1-2-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Obligation" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-3-4 a cml:Concept ; skos:prefLabel "3 Mar 2006"@en ; cml:realizedBy doc:sec-3-4 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.401" ; cml:asserts concept:therapeutic-goods-act-1989-sec-3-4-norm . concept:therapeutic-goods-act-1989-sec-3-4-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-3-4 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-3-5 a cml:Concept ; skos:prefLabel "3 Mar 2006 (s 2)"@en ; cml:realizedBy doc:sec-3-5 ; cml:integrityHash "59a02ddf67b93ad359adf5ca8118ce0d9943a24b8d4a1c0d440b505ad0b6b8df" ; skos:note "Therapeutic Goods Amendment Act (No. 1)" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.401" ; cml:asserts concept:therapeutic-goods-act-1989-sec-3-5-norm . concept:therapeutic-goods-act-1989-sec-3-5-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-3-5 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-3-6 a cml:Concept ; skos:prefLabel "3 May 2006"@en ; cml:realizedBy doc:sec-3-6 ; cml:integrityHash "6f60ea84a45482ebf7b27cb0a3fb77e4f87075755c8458e2a6f052f4d4e2fb4f" ; skos:note "Amendment of therapeutic goods schedule" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.401" ; cml:asserts concept:therapeutic-goods-act-1989-sec-3-6-norm . concept:therapeutic-goods-act-1989-sec-3-6-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-3-6 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-14-2 a cml:Concept ; skos:prefLabel "14 Sept"@en ; cml:realizedBy doc:sec-14-2 ; cml:integrityHash "f9af6d3222fa85b3b32ecbcfa0adf60c5724b127fe9daaa6a8123cc20f317541" ; skos:note "Conditional commencement of National Health and Medical Research Council Amendment Act 50, 2006" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.401" ; cml:asserts concept:therapeutic-goods-act-1989-sec-14-2-norm . concept:therapeutic-goods-act-1989-sec-14-2-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-14-2 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-9 a cml:Concept ; skos:prefLabel "9 June 2006"@en ; cml:realizedBy doc:sec-9 ; cml:integrityHash "1d335fc1c1a910abb0bbf16da00982730be862ebd1a6176fe0765fd8a9a85f85" ; skos:note "Commencement of Sch 1" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.401" ; cml:asserts concept:therapeutic-goods-act-1989-sec-9-norm . concept:therapeutic-goods-act-1989-sec-9-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-9 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-5-3 a cml:Concept ; skos:prefLabel "5 Sept 2006"@en ; cml:realizedBy doc:sec-5-3 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.401" ; cml:asserts concept:therapeutic-goods-act-1989-sec-5-3-norm . concept:therapeutic-goods-act-1989-sec-5-3-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-5-3 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-5-4 a cml:Concept ; skos:prefLabel "5 Sept 2006 (s 2)"@en ; cml:realizedBy doc:sec-5-4 ; cml:integrityHash "cc11b74f9873a988107c9e6c617076bf928406ae50eddc5021c1aa15d8fd4db7" ; skos:note "Therapeutic Goods Amendment Act 2007" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.401" ; cml:asserts concept:therapeutic-goods-act-1989-sec-5-4-norm . concept:therapeutic-goods-act-1989-sec-5-4-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-5-4 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-14-3 a cml:Concept ; skos:prefLabel "14 Sept"@en ; cml:realizedBy doc:sec-14-3 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.401" ; cml:asserts concept:therapeutic-goods-act-1989-sec-14-3-norm . concept:therapeutic-goods-act-1989-sec-14-3-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-14-3 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-3-7 a cml:Concept ; skos:prefLabel "3 Oct 2007 (s 2)"@en ; cml:realizedBy doc:sec-3-7 ; cml:integrityHash "9c6c9d26ca3d78dfc25244b7284c315ac59ffb1bca027fc31d8d6c5fcaa3b4e0" ; skos:note "Conditional commencement of the Therapeutic Goods Amendment (Poisons Standard) Act 2008" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.401" ; cml:asserts concept:therapeutic-goods-act-1989-sec-3-7-norm . concept:therapeutic-goods-act-1989-sec-3-7-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-3-7 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-3-7 cml:asserts concept:therapeutic-goods-act-1989-sec-3-7-logic-alleninterval-1 . concept:therapeutic-goods-act-1989-sec-3-7-logic-alleninterval-1 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Applicable" ; cml:logicSummary "Requires temporal relation between commencement and amendment" ; cml:premiseText "Conditional commencement" ; cml:conclusionText "Undertaking" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-20 a cml:Concept ; skos:prefLabel "20 Mar"@en ; cml:realizedBy doc:sec-20 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.401" ; cml:asserts concept:therapeutic-goods-act-1989-sec-20-norm . concept:therapeutic-goods-act-1989-sec-20-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-20 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-20-2 a cml:Concept ; skos:prefLabel "20 Mar 2008 (s 2)"@en ; cml:realizedBy doc:sec-20-2 ; cml:integrityHash "09e15d4272dc4975a43d44a3918461adaece5bfa7f91cc42d8723f823fb01d89" ; skos:note "Statute Law Revision Act 2008" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.401" ; cml:asserts concept:therapeutic-goods-act-1989-sec-20-2-norm . concept:therapeutic-goods-act-1989-sec-20-2-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-20-2 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-3-8 a cml:Concept ; skos:prefLabel "3 July 2008"@en ; cml:realizedBy doc:sec-3-8 ; cml:integrityHash "55e750f6151b8c05516aa0470e5ff08e141971aec988e7735ed3f2eefcaa9e8b" ; skos:note "Therapeutic Goods Legislation Amendment (Annual Charges) Act 2008" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.401" ; cml:asserts concept:therapeutic-goods-act-1989-sec-3-8-norm . concept:therapeutic-goods-act-1989-sec-3-8-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-3-8 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-3-9 a cml:Concept ; skos:prefLabel "3 Oct 2008"@en ; cml:realizedBy doc:sec-3-9 ; cml:integrityHash "9970a2a8c3cff6585a938dfbae98f5006fed4abba67d8d0d6d320dacb8efdeed" ; skos:note "Commencement of Sch 1 (items 1–3)" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.401" ; cml:asserts concept:therapeutic-goods-act-1989-sec-3-9-norm . concept:therapeutic-goods-act-1989-sec-3-9-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-3-9 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-17-6 a cml:Concept ; skos:prefLabel "17 June"@en ; cml:realizedBy doc:sec-17-6 ; cml:integrityHash "88a017a323faff502154de519ac5f2d168daa69d20fecdcc24aaa3e3264c6c50" ; skos:note "References Schedule 1, 2 and 5–7." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.402" ; cml:asserts concept:therapeutic-goods-act-1989-sec-17-6-norm . concept:therapeutic-goods-act-1989-sec-17-6-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-17-6 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-18 a cml:Concept ; skos:prefLabel "18 June 2009 (s 2(1)"@en ; cml:realizedBy doc:sec-18 ; cml:integrityHash "8fe257670881554c92e02de328f2e58c229a4b48b254ff396343a899b7f5b4ee" ; skos:note "June 2009 (s 2(1))" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.402" ; cml:asserts concept:therapeutic-goods-act-1989-sec-18-norm . concept:therapeutic-goods-act-1989-sec-18-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-18 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-27-3 a cml:Concept ; skos:prefLabel "27 Aug"@en ; cml:realizedBy doc:sec-27-3 ; cml:integrityHash "744f0b904875d558961b963c1c7784d00d2550c4ccd8d754c934b2149e56da7f" ; skos:note "Sch 1, 3, 6 and Sch 7 (items 1–28): 28 Aug 2009" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.402" ; cml:asserts concept:therapeutic-goods-act-1989-sec-27-3-norm . concept:therapeutic-goods-act-1989-sec-27-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-27-3 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-27-3 cml:asserts concept:therapeutic-goods-act-1989-sec-27-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-27-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Obligation" ; cml:logicSummary "Imposes an obligation" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-29-3 a cml:Concept ; skos:prefLabel "29 Sept"@en ; cml:realizedBy doc:sec-29-3 ; cml:integrityHash "5f76c0a3c5bfc30c02c8516728cf838109acb1bfec864ce9d8806f18ae5ad050" ; skos:note "Schedule 1 and items 2–7 of Schedule 2 commence on 30 September 2009; Schedule 3 items 8–10 commence on 29 March 2010." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.402" ; cml:asserts concept:therapeutic-goods-act-1989-sec-29-3-norm . concept:therapeutic-goods-act-1989-sec-29-3-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-29-3 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-29-3 cml:asserts concept:therapeutic-goods-act-1989-sec-29-3-logic-alleninterval-1 . concept:therapeutic-goods-act-1989-sec-29-3-logic-alleninterval-1 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Applicable" ; cml:logicSummary "Defines commencement dates for schedules" ; cml:premiseText "Sch 1: 1 July 2010 (s 2(1) item 2)" ; cml:conclusionText "30 Sept 2009 and 29 Mar 2010" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-29-3 cml:asserts concept:therapeutic-goods-act-1989-sec-29-3-logic-ltl-2 . concept:therapeutic-goods-act-1989-sec-29-3-logic-ltl-2 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Applicable" ; cml:logicSummary "Defines commencement dates for schedules" ; cml:premiseText "Sch 1: 1 July 2010 (s 2(1) item 13)" ; cml:conclusionText "30 Sept 2009 and 29 Mar 2010" ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-29-3 cml:asserts concept:therapeutic-goods-act-1989-sec-29-3-logic-deontic-3 . concept:therapeutic-goods-act-1989-sec-29-3-logic-deontic-3 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Applicable" ; cml:logicSummary "Classifies commencement dates as undertakings" ; cml:premiseText "Sch 1: 1 July 2010 (s 2(1) item 2)" ; cml:conclusionText "30 Sept 2009 and 29 Mar 2010" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-29-3 cml:asserts concept:therapeutic-goods-act-1989-sec-29-3-logic-deontic-4 . concept:therapeutic-goods-act-1989-sec-29-3-logic-deontic-4 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Applicable" ; cml:logicSummary "Classifies commencement dates as undertakings" ; cml:premiseText "Sch 1: 1 July 2010 (s 2(1) item 13)" ; cml:conclusionText "30 Sept 2009 and 29 Mar 2010" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-1-3 a cml:Concept ; skos:prefLabel "1 Mar 2010"@en ; cml:realizedBy doc:sec-1-3 ; cml:integrityHash "150a70c78e888c5f96ee6713175421f31ee34b6c537a0a7499e960001167f119" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.403" ; cml:asserts concept:therapeutic-goods-act-1989-sec-1-3-norm . concept:therapeutic-goods-act-1989-sec-1-3-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-1-3 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-1-4 a cml:Concept ; skos:prefLabel "1 Mar 2010(s 2(1)"@en ; cml:realizedBy doc:sec-1-4 ; cml:integrityHash "2137d58c2055e87d7a19dbca3717d75e41150b62f61b1831837761beca2ed70e" ; skos:note "Therapeutic Goods Amendment (2009 Measures No. 3) Act" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.403" ; cml:asserts concept:therapeutic-goods-act-1989-sec-1-4-norm . concept:therapeutic-goods-act-1989-sec-1-4-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-1-4 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-31-3 a cml:Concept ; skos:prefLabel "31 May"@en ; cml:realizedBy doc:sec-31-3 ; cml:integrityHash "741088c4227a30e3df5c187b16727cad4c014a4bacbd255afaad3ee453ad9ac6" ; skos:note "Schedule 1 commencement date" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.403" ; cml:asserts concept:therapeutic-goods-act-1989-sec-31-3-norm . concept:therapeutic-goods-act-1989-sec-31-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-31-3 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-15-2 a cml:Concept ; skos:prefLabel "15 Dec"@en ; cml:realizedBy doc:sec-15-2 ; cml:integrityHash "2e69ce6c6e405c1062d237c62f46a844d0463867a101a3799b207f03048c8dd0" ; skos:note "Schedule and commencement dates" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.403" ; cml:asserts concept:therapeutic-goods-act-1989-sec-15-2-norm . concept:therapeutic-goods-act-1989-sec-15-2-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-15-2 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-31-4 a cml:Concept ; skos:prefLabel "31 May 2011 (s 2(1)"@en ; cml:realizedBy doc:sec-31-4 ; cml:integrityHash "b134bca1dfe1a72594fc21689d678194c2634011948ceaf322724a5fc5c22a01" ; skos:note "Reference to Statute Law Revision Act 2011" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.403" ; cml:asserts concept:therapeutic-goods-act-1989-sec-31-4-norm . concept:therapeutic-goods-act-1989-sec-31-4-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-31-4 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-22-5 a cml:Concept ; skos:prefLabel "22 Mar"@en ; cml:realizedBy doc:sec-22-5 ; cml:integrityHash "f4ca0c28543a1172ee2c236abd82c1178bbcd7dbab4a787fa4082a04b0408889" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.403" ; cml:asserts concept:therapeutic-goods-act-1989-sec-22-5-norm . concept:therapeutic-goods-act-1989-sec-22-5-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-22-5 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-19 a cml:Concept ; skos:prefLabel "19 Apr 2011 (s 2(1)"@en ; cml:realizedBy doc:sec-19 ; cml:integrityHash "47da2a36358ce4c9ce2484de10d24d83d6e87a30a00f5325f393dc87a6a86b49" ; skos:note "Acts Interpretation Amendment Act 2011" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.403" ; cml:asserts concept:therapeutic-goods-act-1989-sec-19-norm . concept:therapeutic-goods-act-1989-sec-19-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-19 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-27-4 a cml:Concept ; skos:prefLabel "27 June"@en ; cml:realizedBy doc:sec-27-4 ; cml:integrityHash "778f389d3f40238654bba5ea17d3420103104964be82a155b1d762fae4f5906f" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.403" ; cml:asserts concept:therapeutic-goods-act-1989-sec-27-4-norm . concept:therapeutic-goods-act-1989-sec-27-4-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-27-4 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-27-5 a cml:Concept ; skos:prefLabel "27 Dec 2011"@en ; cml:realizedBy doc:sec-27-5 ; cml:integrityHash "1472eaad7a7a19022c9593bc9a90b6ca408d01931324f902941e01db9bce60d5" ; skos:note "Therapeutic Goods Amendment (2011 Measures No. 1) Act" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.403" ; cml:asserts concept:therapeutic-goods-act-1989-sec-27-5-norm . concept:therapeutic-goods-act-1989-sec-27-5-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-27-5 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-25-2 a cml:Concept ; skos:prefLabel "25 July"@en ; cml:realizedBy doc:sec-25-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.403" ; cml:asserts concept:therapeutic-goods-act-1989-sec-25-2-norm . concept:therapeutic-goods-act-1989-sec-25-2-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-25-2 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-26-2 a cml:Concept ; skos:prefLabel "26 July 2011 (s 2)"@en ; cml:realizedBy doc:sec-26-2 ; cml:integrityHash "381653bb241c4bb17cee7b34ca537c385afef0929a80b2606fe51d7f69f174e1" ; skos:note "Legislation history" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.403" ; cml:asserts concept:therapeutic-goods-act-1989-sec-26-2-norm . concept:therapeutic-goods-act-1989-sec-26-2-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-26-2 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-22-6 a cml:Concept ; skos:prefLabel "22 Sept"@en ; cml:realizedBy doc:sec-22-6 ; cml:integrityHash "61bc5a615180e1268a070237f14ae8532ea8389bb7a723220bce51b3265f13a6" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.404" ; cml:asserts concept:therapeutic-goods-act-1989-sec-22-6-norm . concept:therapeutic-goods-act-1989-sec-22-6-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-22-6 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-22-7 a cml:Concept ; skos:prefLabel "22 Sept 2012"@en ; cml:realizedBy doc:sec-22-7 ; cml:integrityHash "b738660ee8c3fc7756ebf2acd8192856b30d3cef665e43a5e5c849a5377b70a6" ; skos:note "Personal Liability for Corporate Fault Reform Act 2012" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.404" ; cml:asserts concept:therapeutic-goods-act-1989-sec-22-7-norm . concept:therapeutic-goods-act-1989-sec-22-7-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-22-7 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-10-2 a cml:Concept ; skos:prefLabel "10 Dec"@en ; cml:realizedBy doc:sec-10-2 ; cml:integrityHash "716280d294f17c54cfc58d4733d2fbde4fcc18e20a4eefb912f781c008826a88" ; skos:note "Commencement of Sch 5 and Sch 7" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.404" ; cml:asserts concept:therapeutic-goods-act-1989-sec-10-2-norm . concept:therapeutic-goods-act-1989-sec-10-2-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-10-2 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-12-2 a cml:Concept ; skos:prefLabel "12 Dec"@en ; cml:realizedBy doc:sec-12-2 ; cml:integrityHash "9d54556843f0d6f98f81df28f408792c52ae24e5ef740f9d401dcdb67aebafc7" ; skos:note "Conditional commencement of amendments to the Therapeutic Goods Amendment (2013 Measures No. 1) Act" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.404" ; cml:asserts concept:therapeutic-goods-act-1989-sec-12-2-norm . concept:therapeutic-goods-act-1989-sec-12-2-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-12-2 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-12-2 cml:asserts concept:therapeutic-goods-act-1989-sec-12-2-logic-alleninterval-1 . concept:therapeutic-goods-act-1989-sec-12-2-logic-alleninterval-1 a cml:LogicApplication ; cml:modality cml:AllenInterval ; cml:operator "Applicable" ; cml:logicSummary "Defines temporal intervals for commencement of amendments" ; cml:premiseText "Sch 5 (item 98) and Sch 6 (items 15–19): 12 Mar 2014 (s 2(1) items 3, 19)" ; cml:conclusionText "Sch 6 (item 1): 12 Dec 2012 (s 2(1) item 16)" ; cml:executionSurface "modalities::interval_reasoning" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-12-2 cml:asserts concept:therapeutic-goods-act-1989-sec-12-2-logic-ltl-2 . concept:therapeutic-goods-act-1989-sec-12-2-logic-ltl-2 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Applicable" ; cml:logicSummary "Defines trace for amendments" ; cml:premiseText "Sch 5 (item 98) and Sch 6 (items 15–19): 12 Mar 2014 (s 2(1) items 3, 19)" ; cml:conclusionText "Sch 6 (item 1): 12 Dec 2012 (s 2(1) item 16)" ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-12-2 cml:asserts concept:therapeutic-goods-act-1989-sec-12-2-logic-deontic-3 . concept:therapeutic-goods-act-1989-sec-12-2-logic-deontic-3 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "Applicable" ; cml:logicSummary "Classifies amendments as part of a schedule" ; cml:premiseText "Sch 5 (item 98) and Sch 6 (items 15–19): 12 Mar 2014 (s 2(1) items 3, 19)" ; cml:conclusionText "Sch 6 (item 1): 12 Dec 2012 (s 2(1) item 16)" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-12-2 cml:asserts concept:therapeutic-goods-act-1989-sec-12-2-logic-epistemic-4 . concept:therapeutic-goods-act-1989-sec-12-2-logic-epistemic-4 a cml:LogicApplication ; cml:modality cml:Epistemic ; cml:operator "Applicable" ; cml:logicSummary "Provides information about amendments" ; cml:premiseText "Sch 5 (item 98) and Sch 6 (items 15–19): 12 Mar 2014 (s 2(1) items 3, 19)" ; cml:conclusionText "Sch 6 (item 1): 12 Dec 2012 (s 2(1) item 16)" ; cml:executionSurface "modalities::epistemic" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-12-2 cml:asserts concept:therapeutic-goods-act-1989-sec-12-2-logic-paraconsistent-5 . concept:therapeutic-goods-act-1989-sec-12-2-logic-paraconsistent-5 a cml:LogicApplication ; cml:modality cml:Paraconsistent ; cml:operator "Applicable" ; cml:logicSummary "None applicable" ; cml:premiseText "Sch 5 (item 98) and Sch 6 (items 15–19): 12 Mar 2014 (s 2(1) items 3, 19)" ; cml:conclusionText "Sch 6 (item 1): 12 Dec 2012 (s 2(1) item 16)" ; cml:executionSurface "modalities::paraconsistent" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-28-2 a cml:Concept ; skos:prefLabel "28 Feb"@en ; cml:realizedBy doc:sec-28-2 ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.404" ; cml:asserts concept:therapeutic-goods-act-1989-sec-28-2-norm . concept:therapeutic-goods-act-1989-sec-28-2-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-28-2 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-28-3 a cml:Concept ; skos:prefLabel "28 Feb 2014"@en ; cml:realizedBy doc:sec-28-3 ; cml:integrityHash "8ed12b1855934827cfc150bab07ffe249d2ecead94e2ecdef857bd056b7a80f7" ; skos:note "List of schedules and items for the Statute Law Revision Act (No. 1) 2014" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.404" ; cml:asserts concept:therapeutic-goods-act-1989-sec-28-3-norm . concept:therapeutic-goods-act-1989-sec-28-3-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-28-3 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-27-6 a cml:Concept ; skos:prefLabel "27 May"@en ; cml:realizedBy doc:sec-27-6 ; cml:integrityHash "6cf4fa9313594d50dcee631a7f94cbb49aba93152ee66a31ad3412e234bb68ca" ; skos:note "May" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.404" ; cml:asserts concept:therapeutic-goods-act-1989-sec-27-6-norm . concept:therapeutic-goods-act-1989-sec-27-6-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-27-6 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-24-4 a cml:Concept ; skos:prefLabel "24 June 2014"@en ; cml:realizedBy doc:sec-24-4 ; cml:integrityHash "2d2874f9bf18b97c25012af488a2636806085286308a6f47aeab080674f2dfb0" ; skos:note "Legislation history" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.404" ; cml:asserts concept:therapeutic-goods-act-1989-sec-24-4-norm . concept:therapeutic-goods-act-1989-sec-24-4-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-24-4 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-30-4 a cml:Concept ; skos:prefLabel "30 June"@en ; cml:realizedBy doc:sec-30-4 ; cml:integrityHash "d0dba89cc78eb82d5cab336835970860e79fa2adc1aa5ad1a8e611d36143eeaf" ; skos:note "Amendment of Schedule 14 by Public Governance and Resources Legislation Amendment Act (No. 1) 2015" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.405" ; cml:asserts concept:therapeutic-goods-act-1989-sec-30-4-norm . concept:therapeutic-goods-act-1989-sec-30-4-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-30-4 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-13 a cml:Concept ; skos:prefLabel "13 Apr"@en ; cml:realizedBy doc:sec-13 ; cml:integrityHash "98b72dbeb476fb32107a2bae25e29fa6d391f1e5214baaa2573051bdf52467f3" ; skos:note "References Schedule 2 (item 7) and Schedule 7" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.405" ; cml:asserts concept:therapeutic-goods-act-1989-sec-13-norm . concept:therapeutic-goods-act-1989-sec-13-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-13 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-14-4 a cml:Concept ; skos:prefLabel "14 Apr 2015 (s 2)"@en ; cml:realizedBy doc:sec-14-4 ; cml:integrityHash "bdd8316f695a83454d5dc0aed8b1c31944f0835bf7056efbf40e778a9ec0f390" ; skos:note "Amendment of Schedule 7 by Acts and Instruments (Framework Reform) (Consequential Provisions) Act 126, 2015" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.405" ; cml:asserts concept:therapeutic-goods-act-1989-sec-14-4-norm . concept:therapeutic-goods-act-1989-sec-14-4-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-14-4 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-10-3 a cml:Concept ; skos:prefLabel "10 Sept"@en ; cml:realizedBy doc:sec-10-3 ; cml:integrityHash "50622982752161d0db92e96efd55237ba10163a3854e65284fa320ec29bef920" ; skos:note "Consequential Provisions" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.405" ; cml:asserts concept:therapeutic-goods-act-1989-sec-10-3-norm . concept:therapeutic-goods-act-1989-sec-10-3-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-10-3 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-10-4 a cml:Concept ; skos:prefLabel "10 Sept"@en ; cml:realizedBy doc:sec-10-4 ; cml:integrityHash "cfd558da173d18e06d6bdb542e825cd9aaf97735d764808148e1355902716fb7" ; skos:note "Statute Law Revision Act (No. 1) 2015" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.405" ; cml:asserts concept:therapeutic-goods-act-1989-sec-10-4-norm . concept:therapeutic-goods-act-1989-sec-10-4-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-10-4 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-25-3 a cml:Concept ; skos:prefLabel "25 Feb"@en ; cml:realizedBy doc:sec-25-3 ; cml:integrityHash "8b46cf4f901a3e395a81d220dafc99a64d4accd923252253d046b35aea34706e" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.405" ; cml:asserts concept:therapeutic-goods-act-1989-sec-25-3-norm . concept:therapeutic-goods-act-1989-sec-25-3-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-25-3 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-25-4 a cml:Concept ; skos:prefLabel "25 Mar 2015 (s 2(1)"@en ; cml:realizedBy doc:sec-25-4 ; cml:integrityHash "c760be9ff2c55e8f9786139657a44472525ee01f0de18a4190e7e71b7fe883df" ; skos:note "Endnote 3—Legislation history" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.405" ; cml:asserts concept:therapeutic-goods-act-1989-sec-25-4-norm . concept:therapeutic-goods-act-1989-sec-25-4-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-25-4 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-20-3 a cml:Concept ; skos:prefLabel "20 May"@en ; cml:realizedBy doc:sec-20-3 ; cml:integrityHash "64a72754973a7ae2d91d316dc01432da18fc8b3d9d147a9810069048a0a6a04d" ; skos:note "Mandatory amendment of Australian Border Force Amendment (Protected Information) Act 2017" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.406" ; cml:asserts concept:therapeutic-goods-act-1989-sec-20-3-norm . concept:therapeutic-goods-act-1989-sec-20-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-20-3 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-20-3 cml:asserts concept:therapeutic-goods-act-1989-sec-20-3-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-20-3-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "MUST AMEND" ; cml:logicSummary "Mandatory amendment" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-30-5 a cml:Concept ; skos:prefLabel "30 Oct"@en ; cml:realizedBy doc:sec-30-5 ; cml:integrityHash "afc0c816c6bb280d0681c222c471a4266740685047f4d3ff2c3d55f1fae078bd" ; skos:note "Prohibition on certain acts" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.406" ; cml:asserts concept:therapeutic-goods-act-1989-sec-30-5-norm . concept:therapeutic-goods-act-1989-sec-30-5-norm a values:Prohibition ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-30-5 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-30-5 cml:asserts concept:therapeutic-goods-act-1989-sec-30-5-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-30-5-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "forbid" ; cml:logicSummary "Prohibits the specified act" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-10-5 a cml:Concept ; skos:prefLabel "10 Sept"@en ; cml:realizedBy doc:sec-10-5 ; cml:integrityHash "0bbe29eae64e4fcc40f2133bf3b6e7e1ed11ca5be43391b868a79a8b5b641202" ; skos:note "Statute Law Revision Act (No. 1) 2016" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.406" ; cml:asserts concept:therapeutic-goods-act-1989-sec-10-5-norm . concept:therapeutic-goods-act-1989-sec-10-5-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-10-5 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-11-5 a cml:Concept ; skos:prefLabel "11 Feb"@en ; cml:realizedBy doc:sec-11-5 ; cml:integrityHash "88eecf8216e921a4784250862fdb9de31aec3b8e8e0990c416785b035aae9e92" ; skos:note "Narcotic Drugs Amendment Act 2016" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.406" ; cml:asserts concept:therapeutic-goods-act-1989-sec-11-5-norm . concept:therapeutic-goods-act-1989-sec-11-5-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-11-5 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-29-4 a cml:Concept ; skos:prefLabel "29 Feb"@en ; cml:realizedBy doc:sec-29-4 ; cml:integrityHash "15b902885feb528abb6399a9d10628b8639a08851450fc7aade22ca9d47b1413" ; skos:note "Conditional commencement of Narcotic Drugs Legislation Amendment Act 2016" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.406" ; cml:asserts concept:therapeutic-goods-act-1989-sec-29-4-norm . concept:therapeutic-goods-act-1989-sec-29-4-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-29-4 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-23 a cml:Concept ; skos:prefLabel "23 Nov"@en ; cml:realizedBy doc:sec-23 ; cml:integrityHash "b66b061937a9ededc9c9043c655a536e3b0a4daa4fc224a0f707ed03e128788d" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.406" ; cml:asserts concept:therapeutic-goods-act-1989-sec-23-norm . concept:therapeutic-goods-act-1989-sec-23-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-23 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-23-2 a cml:Concept ; skos:prefLabel "23 Nov 2016 (s 2(1)"@en ; cml:realizedBy doc:sec-23-2 ; cml:integrityHash "02d96bea6d96f1a8fdf39369e0e795a5dba362a10ce5928d5d82fa7415084fcb" ; skos:note "Therapeutic Goods Amendment (2016 Measures No. 1) Act" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.406" ; cml:asserts concept:therapeutic-goods-act-1989-sec-23-2-norm . concept:therapeutic-goods-act-1989-sec-23-2-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-23-2 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-19-2 a cml:Concept ; skos:prefLabel "19 June"@en ; cml:realizedBy doc:sec-19-2 ; cml:integrityHash "a2bf4e4d704230db0bdbf0c76e7a31b8ecf1a98670a4b0835471889220632f25" ; skos:note "Conditional commencement of certain schedules" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.406" ; cml:asserts concept:therapeutic-goods-act-1989-sec-19-2-norm . concept:therapeutic-goods-act-1989-sec-19-2-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-19-2 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-20-4 a cml:Concept ; skos:prefLabel "20 June 2017 (s 2(1)"@en ; cml:realizedBy doc:sec-20-4 ; cml:integrityHash "7d60ba60a69a2a4ebcf0a5bb2d6d3412d7b363c14694359e55e6f4685b4eef06" ; skos:note "List of items included in certain schedules" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.406" ; cml:asserts concept:therapeutic-goods-act-1989-sec-20-4-norm . concept:therapeutic-goods-act-1989-sec-20-4-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-20-4 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-5-5 a cml:Concept ; skos:prefLabel "5 Mar 2018"@en ; cml:realizedBy doc:sec-5-5 ; cml:integrityHash "8f13c30d4ecaff0487397aa63c0f6a5ff972237fdd77dfeaeae8b7494f85fd76" ; skos:note "Conditional commencement of certain sections" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.407" ; cml:asserts concept:therapeutic-goods-act-1989-sec-5-5-norm . concept:therapeutic-goods-act-1989-sec-5-5-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-5-5 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-1-5 a cml:Concept ; skos:prefLabel "1 July 2020 (s 2(1)"@en ; cml:realizedBy doc:sec-1-5 ; cml:integrityHash "055b90c380dc9008d220c71363fe46a2cc4f8796c6e81c56b2c368a0fd72182e" ; skos:note "Therapeutic Goods Amendment (2018 Measures No. 1) Act" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.407" ; cml:asserts concept:therapeutic-goods-act-1989-sec-1-5-norm . concept:therapeutic-goods-act-1989-sec-1-5-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-1-5 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-21-2 a cml:Concept ; skos:prefLabel "21 Sept"@en ; cml:realizedBy doc:sec-21-2 ; cml:integrityHash "889dc4a059e78b1be82807f9e5428f5de5b8aeb4cf6d00dd39224cb85f5a9c66" ; skos:note "Schedule definitions and commencement dates" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.407" ; cml:asserts concept:therapeutic-goods-act-1989-sec-21-2-norm . concept:therapeutic-goods-act-1989-sec-21-2-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-21-2 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-12-3 a cml:Concept ; skos:prefLabel "12 Dec"@en ; cml:realizedBy doc:sec-12-3 ; cml:integrityHash "e2deb2017d3899302b03401bb4cf698ce57504285bd95c46cf811677324e9fdb" ; skos:note "Conditional commencement of the Therapeutic Goods Amendment (2020 Measures No. 1) Act" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.407" ; cml:asserts concept:therapeutic-goods-act-1989-sec-12-3-norm . concept:therapeutic-goods-act-1989-sec-12-3-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-12-3 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-25-5 a cml:Concept ; skos:prefLabel "25 June"@en ; cml:realizedBy doc:sec-25-5 ; cml:integrityHash "6b1f58c8c4c221013d6ead880bb51fc616830cda10ecd4a6e70e58c854fddc85" ; skos:note "Sch 1 (items 1–18): 25 Aug 2020 (s 2(1) item 2)" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.407" ; cml:asserts concept:therapeutic-goods-act-1989-sec-25-5-norm . concept:therapeutic-goods-act-1989-sec-25-5-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-25-5 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-15-3 a cml:Concept ; skos:prefLabel "15 Dec"@en ; cml:realizedBy doc:sec-15-3 ; cml:integrityHash "57c067d5e440b34720104399d25263a1b1e77f2e0f99958b734cf6b1d78c1a67" ; skos:note "Sch 1 (items 57–73): 16 Dec 2020 (s 2(1) item 2)" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.407" ; cml:asserts concept:therapeutic-goods-act-1989-sec-15-3-norm . concept:therapeutic-goods-act-1989-sec-15-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-15-3 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-19-3 a cml:Concept ; skos:prefLabel "19 Feb"@en ; cml:realizedBy doc:sec-19-3 ; cml:integrityHash "bbb257a5d6616dc5b2c3f9bdc6107a1c41d9ef1984407e456062f50ae2ce4616" ; skos:note "Conditional commencement" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.408" ; cml:asserts concept:therapeutic-goods-act-1989-sec-19-3-norm . concept:therapeutic-goods-act-1989-sec-19-3-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-19-3 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-1-6 a cml:Concept ; skos:prefLabel "1 Mar 2021"@en ; cml:realizedBy doc:sec-1-6 ; cml:integrityHash "6ce838907b72c4ec2166ac68b8643ac32aedcc8dc4be6a7e9ca0eed5d9f219a5" ; skos:note "Therapeutic Goods Amendment (2022 Measures No. 1) Act 2023 commencement and application details." ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.408" ; cml:asserts concept:therapeutic-goods-act-1989-sec-1-6-norm . concept:therapeutic-goods-act-1989-sec-1-6-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-1-6 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-21-3 a cml:Concept ; skos:prefLabel "21 Mar"@en ; cml:realizedBy doc:sec-21-3 ; cml:integrityHash "044c857923b90408c5e09a109ee296eaff16ca25d487727095d920c1a706dbf7" ; skos:note "Schedule 1: 21 March 2025 (s2(1) item 2)" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.408" ; cml:asserts concept:therapeutic-goods-act-1989-sec-21-3-norm . concept:therapeutic-goods-act-1989-sec-21-3-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-21-3 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-31-5 a cml:Concept ; skos:prefLabel "31 May"@en ; cml:realizedBy doc:sec-31-5 ; cml:integrityHash "c8e0d345d0561b2a5c7eb339506e5af2bf1445afd1abb9dd85e78d811f5bb221" ; skos:note "Granting permission for therapeutic goods and other legislation amendment" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.409" ; cml:asserts concept:therapeutic-goods-act-1989-sec-31-5-norm . concept:therapeutic-goods-act-1989-sec-31-5-norm a values:Permission ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-31-5 ; values:borneBy values:Agent ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-31-5 cml:asserts concept:therapeutic-goods-act-1989-sec-31-5-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-31-5-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "PERM" ; cml:logicSummary "Permission granted" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-27-7 a cml:Concept ; skos:prefLabel "27 June"@en ; cml:realizedBy doc:sec-27-7 ; cml:integrityHash "10b25dcf26309635709802e588ae130dfd131d5190961c7afb5fbe3af9a8398e" ; skos:note "Conditional commencement of certain sections" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.409" ; cml:asserts concept:therapeutic-goods-act-1989-sec-27-7-norm . concept:therapeutic-goods-act-1989-sec-27-7-norm a values:Undertaking ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-27-7 ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-27-7 cml:asserts concept:therapeutic-goods-act-1989-sec-27-7-logic-ltl-1 . concept:therapeutic-goods-act-1989-sec-27-7-logic-ltl-1 a cml:LogicApplication ; cml:modality cml:LTL ; cml:operator "Applicable" ; cml:logicSummary "Defines temporal intervals for commencement" ; cml:premiseText "1 July 2024 (s2(1) items 2-2C)" ; cml:conclusionText "commences on July 1, 2024" ; cml:executionSurface "modalities::temporal_ltl" ; cml:confidence "0.5000"^^xsd:decimal ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-4-4 a cml:Concept ; skos:prefLabel "4 Sept"@en ; cml:realizedBy doc:sec-4-4 ; cml:integrityHash "bed59666f88c19adbb137c7808358762b224a3af16eca1904a5cdb824cf0764d" ; skos:note "Amendment history for Therapeutic Goods Act 1989" ; cml:curationStatus cml:Proposed ; cml:schemaVersion "2" ; cml:proposedBy ; prov:wasDerivedFrom ; dc:source "therapeutic-goods-act-1989.pdf, p.409" ; cml:asserts concept:therapeutic-goods-act-1989-sec-4-4-norm . concept:therapeutic-goods-act-1989-sec-4-4-norm a values:Obligation ; cml:modality cml:Deontic ; values:partOf concept:therapeutic-goods-act-1989-sec-4-4 ; values:borneBy values:State ; skos:scopeNote "borne by: State" ; values:deonticStatus values:HeuristicDerived ; cml:curationStatus cml:Proposed . concept:therapeutic-goods-act-1989-sec-4-4 cml:asserts concept:therapeutic-goods-act-1989-sec-4-4-logic-deontic-1 . concept:therapeutic-goods-act-1989-sec-4-4-logic-deontic-1 a cml:LogicApplication ; cml:modality cml:Deontic ; cml:operator "affectedBy" ; cml:logicSummary "Provision affected" ; cml:executionSurface "modalities::logic::deontic" ; cml:confidence "1.0000"^^xsd:decimal ; cml:curationStatus cml:Proposed .