Home > institutions / au-fed-legislation > C2025C00525VOL01
Therapeutic Goods Act 1989
Register ID:
Compilation date: 5 September 2025
Canonical URI:
Promulgating Institution / Scope: institutions, au-fed-legislation, C2025C00525VOL01
Triples Extracted: 26029
C2025C00525VOL01Compilation date: 5 September 2025
Canonical URI:
https://ns.webcivics.net/institutions/au-fed-legislation/C2025C00525VOL01/Promulgating Institution / Scope: institutions, au-fed-legislation, C2025C00525VOL01
Triples Extracted: 26029
Normative Modalities
This instrument defines specific modalities of human agency and fundamental freedoms. The RDF properties and SHACL shapes parsed below codify these rights as affirmable undertakings binding upon actors.
Note: We strictly map these rights to the natural person, prioritizing self-determination and autonomy. Institutional constructs (such as corporate personhood) are explicitly disjoint from these human-centric dignity classifications within the SHACL constraints.
Contextual Data Structures (CML & nquins)
The underlying structure of this schema utilizes nquins and Context Markup Language (CML) to provide deep, context-aware semantic mapping.
This architecture ensures that whenever multiple cryptography-supported identifiers are utilized to manage state or attribute assertions, they remain entirely enumerated and compartmentalized. This prevents the blending of distinct agent presence modalities and secures the structural integrity of the Human-Centric system against opaque institutional tracking.
Triples / Shapes Viewer
@prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix skos: <http://www.w3.org/2004/02/skos/core#> .
@prefix dc: <http://purl.org/dc/terms/> .
@prefix prov: <http://www.w3.org/ns/prov#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .
@prefix oa: <http://www.w3.org/ns/oa#> .
@prefix cml: <https://ns.webcivics.net/cml/> .
@prefix values: <https://ns.webcivics.net/values/> .
@prefix concept: <https://ns.webcivics.net/concept/> .
@prefix cof: <https://ns.webcivics.net/cof/> .
@prefix doc: <https://ns.webcivics.net/values/therapeutic-goods-act-1989#> .
# 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.
<https://ns.webcivics.net/values/au/c2025c00525vol01> a cof:Document ;
dc:identifier "C2025C00525VOL01" ;
prov:wasDerivedFrom <https://www.legislation.gov.au/C2025C00525> ;
dc:title "Therapeutic Goods Act 1989"@en ;
values:category "AU" ;
dc:identifier "No. 21 of 1990" ;
dc:date "5 September 2025" ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
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 "ac58f4b00e4a79b9c0f4fb8614645f192b3df3b7a2965fd86f5422dd18071ee5" ;
skos:note "Compilation information and notes on amendments." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
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 "=" ;
cml:logicSummary "Identifies the compilation date." ;
cml:premiseText "Compilation date: 05/09/2025" ;
cml:conclusionText "The compilation date is 05/09/2025." ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-1 a cml:Concept ;
skos:prefLabel "1 Short title"@en ;
cml:realizedBy doc:sec-1 ;
cml:integrityHash "7be442b62851adeef219c9d693b9584a142701966b7dcd45b8b6cd46e5168d41" ;
skos:note "Citation of the Act" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.17" ;
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-2 a cml:Concept ;
skos:prefLabel "2 Commencement"@en ;
cml:realizedBy doc:sec-2 ;
cml:integrityHash "16b31689a5796009e0114137dc64e2f5d5ac545196ee77f04ceb4306cc95c3b1" ;
skos:note "Commencement conditions" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.17" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-2-norm .
concept:therapeutic-goods-act-1989-sec-2-norm a values:Undertaking ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-2 ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3 a cml:Concept ;
skos:prefLabel "3 Interpretation"@en ;
cml:realizedBy doc:sec-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-3-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-3-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-3-ss-2a ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-3-ss-2b ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-3-ss-4 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-3-ss-5 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-3-ss-5a ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-3-ss-5b ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-3-ss-6 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-3-ss-7 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-3-ss-7a ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-3-ss-8 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.17" .
concept:therapeutic-goods-act-1989-sec-3-ss-1 a cml:Concept ;
skos:prefLabel "3(1) Interpretation"@en ;
cml:realizedBy doc:sec-3-ss-1 ;
cml:integrityHash "f01827ecb9c8f5dd9f3b64d1ff91d36608bc3aecd70e7a90dfa5fb89f7bf2701" ;
values:partOf concept:therapeutic-goods-act-1989-sec-3 ;
skos:note "Accessory means a thing specifically intended to be used with the device. Defines terms used in the Act State or Territory must issue search warrants. Definition of 'private hospital' Goods that have a tradition of use as foods for humans in the form in which they are presented, or goods covered by a determination under subsection 7AA(1) or (2), must be used, advertised, or presented for supply in the way specified in the determination." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.17" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-3-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-3-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-3-ss-1 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-3-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-3-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligate" ;
cml:logicSummary "Accessory means a thing specifically intended to be used with the device." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-2 .
concept:therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-2 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "=" ;
cml:logicSummary "Classifies 'accessory'" ;
cml:premiseText "Accessory means a thing that the manufacturer of the thing specifically intended to be used together with the device." ;
cml:conclusionText "Accessory is an obligation." ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-3 .
concept:therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-3 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "=" ;
cml:logicSummary "Classifies terms into categories" ;
cml:premiseText "The term 'customs officer' is defined as an officer of Customs within the meaning of the Customs Act 1901." ;
cml:conclusionText "Customs officer means an officer of Customs within the meaning of the Customs Act 1901." ;
cml:executionSurface "modalities::dl" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-4 .
concept:therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-4 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "=" ;
cml:logicSummary "Classifies terms into categories" ;
cml:premiseText "The term 'data processing device' is defined as any article or material from which information is capable of being reproduced with or without the aid of any other article or device." ;
cml:conclusionText "Data processing device means any article or material (for example, a disc) from which information is capable of being reproduced with or without the aid of any other article or device." ;
cml:executionSurface "modalities::dl" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-5 .
concept:therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-5 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "=" ;
cml:logicSummary "Classifies terms into categories" ;
cml:premiseText "The term 'default standard' is defined as any of the following: (a) a standard referred to in paragraph (b) of the definition of standard in this subsection; (b) a standard referred to in paragraph (c) of that definition; (c) a standard referred to in paragraph (d) of that definition." ;
cml:conclusionText "Default standard means any of the following: (a) a standard referred to in paragraph (b) of the definition of standard in this subsection; (b) a standard referred to in paragraph (c) of that definition; (c) a standard referred to in paragraph (d) of that definition." ;
cml:executionSurface "modalities::dl" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-6 .
concept:therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-6 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "=" ;
cml:logicSummary "Classifies terms into categories" ;
cml:premiseText "The term 'directions for use' is defined as information on: (a) appropriate doses of the goods; and (b) the method of administration or use of the goods; and (c) the frequency and duration of treatment for each indication of the goods; and (d) the use of the goods by persons of particular ages or by persons having particular medical conditions." ;
cml:conclusionText "Directions for use, in relation to therapeutic goods, includes information on: (a) appropriate doses of the goods; and (b) the method of administration or use of the goods; and (c) the frequency and duration of treatment for each indication of the goods; and (d) the use of the goods by persons of particular ages or by persons having particular medical conditions." ;
cml:executionSurface "modalities::dl" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-7 .
concept:therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-7 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "=" ;
cml:logicSummary "Classifies terms into categories" ;
cml:premiseText "The term 'export only biological' is defined as a biological that is: (a) manufactured in Australia for export only; or (b) imported into Australia for export only." ;
cml:conclusionText "Export only biological means a biological that is: (a) manufactured in Australia for export only; or (b) imported into Australia for export only." ;
cml:executionSurface "modalities::dl" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-8 .
concept:therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-8 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "=" ;
cml:logicSummary "Classifies terms into categories" ;
cml:premiseText "The term 'export only medicine' is defined as a medicine that: (a) is manufactured in Australia for export only, or imported into Australia for export only; and (b) is listable goods only because it is so manufactured or imported (and not for any other reason)." ;
cml:conclusionText "Export only medicine means a medicine that: (a) is manufactured in Australia for export only, or imported into Australia for export only; and (b) is listable goods only because it is so manufactured or imported (and not for any other reason)." ;
cml:executionSurface "modalities::dl" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-3-ss-1-logic-deontic-9 .
concept:therapeutic-goods-act-1989-sec-3-ss-1-logic-deontic-9 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Must provide" ;
cml:premiseText "State or Territory must issue search warrants." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-10 .
concept:therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-10 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "label" ;
cml:logicSummary "Labeling requirements" ;
cml:premiseText "label, in relation to therapeutic goods, means a display of printed information:" ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-11 .
concept:therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-11 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "=" ;
cml:logicSummary "Class hierarchy for therapeutic goods" ;
cml:premiseText "therapeutic goods are goods that are represented in any way to be, or that are, whether because of the way in which the goods are presented or for any other reason, likely to be taken to be..." ;
cml:conclusionText "product information, in relation to therapeutic goods, means information relating to the safe and effective use of the goods" ;
cml:executionSurface "modalities::dl" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-12 .
concept:therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-12 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "=" ;
cml:logicSummary "Class hierarchy for reportable medical device" ;
cml:premiseText "reportable medical device means a medical device of a kind prescribed by regulations made for the purposes of this definition" ;
cml:conclusionText "reportable medicine has the meaning given by section 30EH" ;
cml:executionSurface "modalities::dl" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-13 .
concept:therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-13 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "=" ;
cml:logicSummary "Class hierarchy for reportable medicine" ;
cml:premiseText "restricted medicine means: (a) a medicine specified in an instrument under subsection (2A); or (b) a medicine included in a class of medicine specified in an instrument under subsection (2B)" ;
cml:conclusionText "reportable medicine has the meaning given by section 30EH" ;
cml:executionSurface "modalities::dl" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-14 .
concept:therapeutic-goods-act-1989-sec-3-ss-1-logic-descriptionlogic-14 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "=" ;
cml:logicSummary "Class hierarchy for therapeutic goods" ;
cml:premiseText "therapeutic goods means goods: (a) that are represented in any way to be, or that are, whether because of the way in which the goods are presented or for any other reason, likely to be taken to be..." ;
cml:conclusionText "biologicals, medical devices and goods declared to be therapeutic goods under an order in force under section 7 but do not include..." ;
cml:executionSurface "modalities::dl" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3-ss-2 a cml:Concept ;
skos:prefLabel "3(2) Interpretation"@en ;
cml:realizedBy doc:sec-3-ss-2 ;
cml:integrityHash "1850d309205a511e2bd290a222ad83aa8a24359a60007e63d6b21e1a31d32eda" ;
values:partOf concept:therapeutic-goods-act-1989-sec-3 ;
skos:note "Therapeutic goods are taken to be for use in humans if they are not solely for use in animals." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.17" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-3-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-3-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-3-ss-2 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-3-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-3-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "if" ;
cml:logicSummary "Conditional obligation" ;
cml:premiseText "(2) For the purposes of this Act, therapeutic goods are taken to be for use in humans if they are not solely for use in animals." ;
cml:conclusionText "Therapeutic goods are taken to be for use in humans if they are not solely for use in animals." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-3-ss-2-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-3-ss-2-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "during" ;
cml:logicSummary "Temporal relation between definitions" ;
cml:premiseText "(2) For the purposes of this Act, therapeutic goods are taken to be for use in humans if they are not solely for use in animals." ;
cml:conclusionText "Therapeutic goods are taken to be for use in humans during the period when they are not solely for use in animals." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-3-ss-2-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-3-ss-2-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "during" ;
cml:logicSummary "Temporal relation between definitions" ;
cml:premiseText "(2) For the purposes of this Act, therapeutic goods are taken to be for use in humans if they are not solely for use in animals." ;
cml:conclusionText "Therapeutic goods are taken to be for use in humans during the period when they are not solely for use in animals." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-3-ss-2-logic-diffusion-4 .
concept:therapeutic-goods-act-1989-sec-3-ss-2-logic-diffusion-4 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "if" ;
cml:logicSummary "Conditional obligation with diffusion" ;
cml:premiseText "(2) For the purposes of this Act, therapeutic goods are taken to be for use in humans if they are not solely for use in animals." ;
cml:conclusionText "Therapeutic goods are taken to be for use in humans if they are not solely for use in animals." ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-3-ss-2-logic-cogai-5 .
concept:therapeutic-goods-act-1989-sec-3-ss-2-logic-cogai-5 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "if" ;
cml:logicSummary "Conditional obligation with CogAI" ;
cml:premiseText "(2) For the purposes of this Act, therapeutic goods are taken to be for use in humans if they are not solely for use in animals." ;
cml:conclusionText "Therapeutic goods are taken to be for use in humans if they are not solely for use in animals." ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3-ss-2a a cml:Concept ;
skos:prefLabel "3(2A) Interpretation"@en ;
cml:realizedBy doc:sec-3-ss-2a ;
cml:integrityHash "dcef1eaca35798482c2f3a3ff76c4e144e2f43b41c45292a45b84c5567e074b3" ;
values:partOf concept:therapeutic-goods-act-1989-sec-3 ;
skos:note "Specify medicines for restricted medicine purposes" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.17" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-3-ss-2a-norm .
concept:therapeutic-goods-act-1989-sec-3-ss-2a-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-3-ss-2a ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3-ss-2a cml:asserts concept:therapeutic-goods-act-1989-sec-3-ss-2a-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-3-ss-2a-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "May" ;
cml:logicSummary "Permission to specify medicines" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3-ss-2b a cml:Concept ;
skos:prefLabel "3(2B) Interpretation"@en ;
cml:realizedBy doc:sec-3-ss-2b ;
cml:integrityHash "750ebaff9559b0e7eb87f8ba0926c251b35d450a108d02f212658c9bc814b0e3" ;
values:partOf concept:therapeutic-goods-act-1989-sec-3 ;
skos:note "Specify classes of medicine for restricted medicine purposes" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.17" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-3-ss-2b-norm .
concept:therapeutic-goods-act-1989-sec-3-ss-2b-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-3-ss-2b ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3-ss-2b cml:asserts concept:therapeutic-goods-act-1989-sec-3-ss-2b-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-3-ss-2b-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "May" ;
cml:logicSummary "Permission to specify classes of medicine" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3-ss-4 a cml:Concept ;
skos:prefLabel "3(4) Interpretation"@en ;
cml:realizedBy doc:sec-3-ss-4 ;
cml:integrityHash "da2ac2a15c03fc9eaf595c69d7f54ad3af1ee3395823541aa3183582a6f00d39" ;
values:partOf concept:therapeutic-goods-act-1989-sec-3 ;
skos:note "Provisions of this Act are in addition to, and not in substitution for, the provisions of any other Act that relate to therapeutic goods." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.17" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-3-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-3-ss-4-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-3-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-3-ss-5 a cml:Concept ;
skos:prefLabel "3(5) Interpretation"@en ;
cml:realizedBy doc:sec-3-ss-5 ;
cml:integrityHash "8f5ef4ffcf78372c7ffab9926afb5106f4af2072d9972353c2b2d2dfc6236662" ;
values:partOf concept:therapeutic-goods-act-1989-sec-3 ;
skos:note "Presentation of therapeutic goods is unacceptable if it is capable of being misleading or confusing." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.17" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-3-ss-5-norm .
concept:therapeutic-goods-act-1989-sec-3-ss-5-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-3-ss-5 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-3-ss-5-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-3-ss-5-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits the presentation of therapeutic goods that is misleading or confusing." ;
cml:premiseText "(5) For the purposes of this Act, the presentation of therapeutic goods is unacceptable if it is capable of being misleading or confusing as to the content or proper use or identification of the goods and" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-3-ss-5-logic-descriptionlogic-2 .
concept:therapeutic-goods-act-1989-sec-3-ss-5-logic-descriptionlogic-2 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "Classify" ;
cml:logicSummary "Classifies presentation of therapeutic goods as unacceptable if it is misleading or confusing." ;
cml:premiseText "(5) For the purposes of this Act, the presentation of therapeutic goods is unacceptable if it is capable of being misleading or confusing as to the content or proper use or identification of the goods and" ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-3-ss-5-logic-alleninterval-3 .
concept:therapeutic-goods-act-1989-sec-3-ss-5-logic-alleninterval-3 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Temporal Interval" ;
cml:logicSummary "Defines a temporal interval for when presentation of therapeutic goods is unacceptable." ;
cml:premiseText "(5) For the purposes of this Act, the presentation of therapeutic goods is unacceptable if it is capable of being misleading or confusing as to the content or proper use or identification of the goods and" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-3-ss-5-logic-ltl-4 .
concept:therapeutic-goods-act-1989-sec-3-ss-5-logic-ltl-4 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "Recurring Trace" ;
cml:logicSummary "Defines a recurring trace for when presentation of therapeutic goods is unacceptable." ;
cml:premiseText "(5) For the purposes of this Act, the presentation of therapeutic goods is unacceptable if it is capable of being misleading or confusing as to the content or proper use or identification of the goods and" ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-3-ss-5-logic-diffusion-5 .
concept:therapeutic-goods-act-1989-sec-3-ss-5-logic-diffusion-5 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "Diffuse" ;
cml:logicSummary "Diffuses the prohibition on presentation of therapeutic goods that is misleading or confusing." ;
cml:premiseText "(5) For the purposes of this Act, the presentation of therapeutic goods is unacceptable if it is capable of being misleading or confusing as to the content or proper use or identification of the goods and" ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-3-ss-5-logic-cogai-6 .
concept:therapeutic-goods-act-1989-sec-3-ss-5-logic-cogai-6 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "Recognize" ;
cml:logicSummary "Recognizes the presentation of therapeutic goods that is misleading or confusing." ;
cml:premiseText "(5) For the purposes of this Act, the presentation of therapeutic goods is unacceptable if it is capable of being misleading or confusing as to the content or proper use or identification of the goods and" ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3-ss-5a a cml:Concept ;
skos:prefLabel "3(5A) Interpretation"@en ;
cml:realizedBy doc:sec-3-ss-5a ;
cml:integrityHash "94d9ab255ae5ce528a847689c0708d021c095ad5722cdd66b18ad95b4c86ad4d" ;
values:partOf concept:therapeutic-goods-act-1989-sec-3 ;
skos:note "Specify advisory statements in relation to medicine" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.17" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-3-ss-5a-norm .
concept:therapeutic-goods-act-1989-sec-3-ss-5a-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-3-ss-5a ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3-ss-5a cml:asserts concept:therapeutic-goods-act-1989-sec-3-ss-5a-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-3-ss-5a-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "May" ;
cml:logicSummary "Permission to specify advisory statements" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3-ss-5b a cml:Concept ;
skos:prefLabel "3(5B) Interpretation"@en ;
cml:realizedBy doc:sec-3-ss-5b ;
cml:integrityHash "a9f4871cbd50c0881fef88a837e22cffac63589fe9d1ef318487ff150c7e6fc9" ;
values:partOf concept:therapeutic-goods-act-1989-sec-3 ;
skos:note "Specify different advisory statements for medicines or classes of medicine." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.17" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-3-ss-5b-norm .
concept:therapeutic-goods-act-1989-sec-3-ss-5b-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-3-ss-5b ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3-ss-5b cml:asserts concept:therapeutic-goods-act-1989-sec-3-ss-5b-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-3-ss-5b-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "May" ;
cml:logicSummary "Permission to specify advisory statements" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3-ss-6 a cml:Concept ;
skos:prefLabel "3(6) Interpretation"@en ;
cml:realizedBy doc:sec-3-ss-6 ;
cml:integrityHash "945be2371ee49e84657d83b2b4d293f510054509f82023466561e2a3d00f9e12" ;
values:partOf concept:therapeutic-goods-act-1989-sec-3 ;
skos:note "References charges under Therapeutic Goods (Charges) Act 1989." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.17" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-3-ss-6-norm .
concept:therapeutic-goods-act-1989-sec-3-ss-6-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-3-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-3-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-3-ss-6-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-3-ss-6-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "=" ;
cml:logicSummary "Definition of charge reference" ;
cml:premiseText "Annual charges under Therapeutic Goods (Charges) Act 1989" ;
cml:conclusionText "Charge reference defined as such a charge imposed under the Act" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3-ss-7 a cml:Concept ;
skos:prefLabel "3(7) Interpretation"@en ;
cml:realizedBy doc:sec-3-ss-7 ;
cml:integrityHash "1506cb92deedf30c0a5143deb9bf5143c6496ae4898956b843354da7dea6d5ba" ;
values:partOf concept:therapeutic-goods-act-1989-sec-3 ;
skos:note "References an offence against this Act to related offences under other laws." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.17" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-3-ss-7-norm .
concept:therapeutic-goods-act-1989-sec-3-ss-7-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-3-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-3-ss-7 cml:asserts concept:therapeutic-goods-act-1989-sec-3-ss-7-logic-descriptionlogic-1 .
concept:therapeutic-goods-act-1989-sec-3-ss-7-logic-descriptionlogic-1 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "=" ;
cml:logicSummary "Classifies the subject of the reference" ;
cml:premiseText "A reference to an offence against this Act includes a reference to..." ;
cml:conclusionText "an offence against section 6 of the Crimes Act 1914, or section 11.1, 11.4 or 11.5 of the Criminal Code" ;
cml:executionSurface "modalities::dl" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3-ss-7 cml:asserts concept:therapeutic-goods-act-1989-sec-3-ss-7-logic-descriptionlogic-2 .
concept:therapeutic-goods-act-1989-sec-3-ss-7-logic-descriptionlogic-2 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "=" ;
cml:logicSummary "Classifies the subject of the reference" ;
cml:premiseText "A reference to an offence against this Act includes a reference to..." ;
cml:conclusionText "an offence against section 136.1, 137.1 or 137.2 of the Criminal Code" ;
cml:executionSurface "modalities::dl" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3-ss-7 cml:asserts concept:therapeutic-goods-act-1989-sec-3-ss-7-logic-descriptionlogic-3 .
concept:therapeutic-goods-act-1989-sec-3-ss-7-logic-descriptionlogic-3 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "=" ;
cml:logicSummary "Classifies the subject of the reference" ;
cml:premiseText "A reference to an offence against this Act includes a reference to..." ;
cml:conclusionText "an offence against the regulations" ;
cml:executionSurface "modalities::dl" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3-ss-7a a cml:Concept ;
skos:prefLabel "3(7A) Interpretation"@en ;
cml:realizedBy doc:sec-3-ss-7a ;
cml:integrityHash "dad2a826af5c8026e8470e53d5e0e2cb7b4091c84d99773f2cffbe884f04f139" ;
values:partOf concept:therapeutic-goods-act-1989-sec-3 ;
skos:note "Imposes a duty on Commonwealth authorities if corresponding State law confers function or power and gives rise to obligation." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.17" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-3-ss-7a-norm .
concept:therapeutic-goods-act-1989-sec-3-ss-7a-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-3-ss-7a ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3-ss-7a cml:asserts concept:therapeutic-goods-act-1989-sec-3-ss-7a-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-3-ss-7a-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Imposes" ;
cml:logicSummary "States a duty" ;
cml:premiseText "(7A) For the purposes of this Act, a corresponding State law imposes a duty..." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3-ss-8 a cml:Concept ;
skos:prefLabel "3(8) Interpretation"@en ;
cml:realizedBy doc:sec-3-ss-8 ;
cml:integrityHash "98247abf26c246b884444c5b0e286260062ae4cc252a403f190c49d8b71a0650" ;
values:partOf concept:therapeutic-goods-act-1989-sec-3 ;
skos:note "Clarifies interpretation of registered therapeutic goods and provisional registration." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.17" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-3-ss-8-norm .
concept:therapeutic-goods-act-1989-sec-3-ss-8-norm a values:Undertaking ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-3-ss-8 ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3aa a cml:Concept ;
skos:prefLabel "3AA Homoeopathic preparations and homoeopathic standards"@en ;
cml:realizedBy doc:sec-3aa ;
cml:integrityHash "3383fc12fd184a212b036669080fed02cfce6c85a65900defc3d341e2543595c" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-3aa-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-3aa-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-3aa-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-3aa-ss-4 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-3aa-ss-5 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.39" .
concept:therapeutic-goods-act-1989-sec-3aa-ss-1 a cml:Concept ;
skos:prefLabel "3AA(1) Homoeopathic preparations and homoeopathic standards"@en ;
cml:realizedBy doc:sec-3aa-ss-1 ;
cml:integrityHash "2468155ff462464456cf287e87a529abadb4b74097581bf842d27bf0784aea27" ;
values:partOf concept:therapeutic-goods-act-1989-sec-3aa ;
skos:note "Definition of homoeopathic preparation and standard." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.39" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-3aa-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-3aa-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-3aa-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-3aa-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-3aa-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-3aa-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "=" ;
cml:logicSummary "Defines a term with a clear obligation." ;
cml:premiseText "(1) For the purposes of this Act, a homoeopathic preparation is a..." ;
cml:conclusionText "a homoeopathic standard" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3aa-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-3aa-ss-1-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-3aa-ss-1-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "=" ;
cml:logicSummary "Defines a temporal interval." ;
cml:premiseText "(1) For the purposes of this Act, a homoeopathic preparation is a..." ;
cml:conclusionText "a preparation manufactured from a mother substance and in accordance with a manufacturing procedure described in a homoeopathic pharmacopoeia" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3aa-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-3aa-ss-1-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-3aa-ss-1-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "=" ;
cml:logicSummary "Defines a temporal interval." ;
cml:premiseText "(1) For the purposes of this Act, a homoeopathic preparation is a..." ;
cml:conclusionText "a preparation manufactured from a mother substance and in accordance with a manufacturing procedure described in a homoeopathic pharmacopoeia" ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3aa-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-3aa-ss-1-logic-diffusion-4 .
concept:therapeutic-goods-act-1989-sec-3aa-ss-1-logic-diffusion-4 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "=" ;
cml:logicSummary "Defines a concept that can be shared." ;
cml:premiseText "(1) For the purposes of this Act, a homoeopathic preparation is a..." ;
cml:conclusionText "a preparation manufactured from a mother substance and in accordance with a manufacturing procedure described in a homoeopathic pharmacopoeia" ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3aa-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-3aa-ss-1-logic-cogai-5 .
concept:therapeutic-goods-act-1989-sec-3aa-ss-1-logic-cogai-5 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "=" ;
cml:logicSummary "Defines a concept that can be processed by AI." ;
cml:premiseText "(1) For the purposes of this Act, a homoeopathic preparation is a..." ;
cml:conclusionText "a preparation manufactured from a mother substance and in accordance with a manufacturing procedure described in a homoeopathic pharmacopoeia" ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3aa-ss-2 a cml:Concept ;
skos:prefLabel "3AA(2) Homoeopathic preparations and homoeopathic standards"@en ;
cml:realizedBy doc:sec-3aa-ss-2 ;
cml:integrityHash "2b9d0e85e9795e3f27d8f63accc0a2bae97cf91e0b9f1ab249e0afc5e8406a5f" ;
values:partOf concept:therapeutic-goods-act-1989-sec-3aa ;
skos:note "A homoeopathic standard is constituted by the statements in monographs describing manufacturing procedures." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.39" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-3aa-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-3aa-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-3aa-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-3aa-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-3aa-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-3aa-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "constitutes" ;
cml:logicSummary "Establishes a homoeopathic standard" ;
cml:premiseText "(a) and (b)" ;
cml:conclusionText "then there is a homoeopathic standard" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3aa-ss-3 a cml:Concept ;
skos:prefLabel "3AA(3) Homoeopathic preparations and homoeopathic standards"@en ;
cml:realizedBy doc:sec-3aa-ss-3 ;
cml:integrityHash "45cdd88808aaf87e773c2b61bbf8606d68baa57a49ccd04d75705b06b5f9cfbd" ;
values:partOf concept:therapeutic-goods-act-1989-sec-3aa ;
skos:note "Specify publications and/or parts of publications for homoeopathic pharmacopoeia definition" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.39" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-3aa-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-3aa-ss-3-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-3aa-ss-3 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3aa-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-3aa-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-3aa-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "May" ;
cml:logicSummary "Specify" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3aa-ss-4 a cml:Concept ;
skos:prefLabel "3AA(4) Homoeopathic preparations and homoeopathic standards"@en ;
cml:realizedBy doc:sec-3aa-ss-4 ;
cml:integrityHash "2014ec9a7bfcb2462e110b40564dbfb491c94ec915f766889e78dde19832e831" ;
values:partOf concept:therapeutic-goods-act-1989-sec-3aa ;
skos:note "Minister may exempt specified monographs from certain requirements." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.39" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-3aa-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-3aa-ss-4-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-3aa-ss-4 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3aa-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-3aa-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-3aa-ss-4-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-3aa-ss-5 a cml:Concept ;
skos:prefLabel "3AA(5) Homoeopathic preparations and homoeopathic standards"@en ;
cml:realizedBy doc:sec-3aa-ss-5 ;
cml:integrityHash "761a8e6221f0c333ce2ca7b34fe57eeb0581a8c6b8624b4cf596a6301cc70da0" ;
values:partOf concept:therapeutic-goods-act-1989-sec-3aa ;
skos:note "The Minister may determine exemptions for specified statements in monographs." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.39" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-3aa-ss-5-norm .
concept:therapeutic-goods-act-1989-sec-3aa-ss-5-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-3aa-ss-5 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3aa-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-3aa-ss-5-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-3aa-ss-5-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-3ab a cml:Concept ;
skos:prefLabel "3AB Anthroposophic preparations and anthroposophic standards"@en ;
cml:realizedBy doc:sec-3ab ;
cml:integrityHash "616a5e4d58a92a1643addf2008857abdb58306c5f1b564f2a341b39416332003" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-3ab-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-3ab-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-3ab-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-3ab-ss-4 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-3ab-ss-5 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.41" .
concept:therapeutic-goods-act-1989-sec-3ab-ss-1 a cml:Concept ;
skos:prefLabel "3AB(1) Anthroposophic preparations and anthroposophic standards"@en ;
cml:realizedBy doc:sec-3ab-ss-1 ;
cml:integrityHash "7b6040a6c5dba2bb1c82b3197f924094eb594a49c653e6caf75d6aae8c10873a" ;
values:partOf concept:therapeutic-goods-act-1989-sec-3ab ;
skos:note "Definition of anthroposophic preparation" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.41" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-3ab-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-3ab-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-3ab-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-3ab-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-3ab-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-3ab-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "=" ;
cml:logicSummary "Definition of term" ;
cml:premiseText "(1) For the purposes of this Act, an anthroposophic preparation is a..." ;
cml:conclusionText "anthroposophic standard" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3ab-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-3ab-ss-1-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-3ab-ss-1-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "=" ;
cml:logicSummary "Temporal relation definition" ;
cml:premiseText "(1) For the purposes of this Act, an anthroposophic preparation is a..." ;
cml:conclusionText "anthroposophic standard" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3ab-ss-2 a cml:Concept ;
skos:prefLabel "3AB(2) Anthroposophic preparations and anthroposophic standards"@en ;
cml:realizedBy doc:sec-3ab-ss-2 ;
cml:integrityHash "5a9112d0b2f7a6654668609dc0008051402f6ddf8efd41215c859b20db44b341" ;
values:partOf concept:therapeutic-goods-act-1989-sec-3ab ;
skos:note "An anthroposophic standard is constituted by the statements in monographs describing manufacturing procedures." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.41" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-3ab-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-3ab-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-3ab-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-3ab-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-3ab-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-3ab-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "constitutes" ;
cml:logicSummary "Anthroposophic standard is constituted by statements in monographs" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3ab-ss-3 a cml:Concept ;
skos:prefLabel "3AB(3) Anthroposophic preparations and anthroposophic standards"@en ;
cml:realizedBy doc:sec-3ab-ss-3 ;
cml:integrityHash "c8f55ce7f31562fadef757bede35d126cee48cdecb9144d3820112f7583b2c8a" ;
values:partOf concept:therapeutic-goods-act-1989-sec-3ab ;
skos:note "Specify publications and/or parts of publications for the definition of anthroposophic pharmacopoeia." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.41" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-3ab-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-3ab-ss-3-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-3ab-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-3ab-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-3ab-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-3ab-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Specify" ;
cml:logicSummary "Specify publications and/or parts of publications." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3ab-ss-4 a cml:Concept ;
skos:prefLabel "3AB(4) Anthroposophic preparations and anthroposophic standards"@en ;
cml:realizedBy doc:sec-3ab-ss-4 ;
cml:integrityHash "0c1c8c1104378d5af8dd0a6af68a57438157bca869326cc6a4400e1033ce064e" ;
values:partOf concept:therapeutic-goods-act-1989-sec-3ab ;
skos:note "Minister may exempt specified monographs from paragraph (2)(b) purposes." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.41" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-3ab-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-3ab-ss-4-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-3ab-ss-4 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3ab-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-3ab-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-3ab-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "may" ;
cml:logicSummary "Permission to exempt monographs" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3ab-ss-5 a cml:Concept ;
skos:prefLabel "3AB(5) Anthroposophic preparations and anthroposophic standards"@en ;
cml:realizedBy doc:sec-3ab-ss-5 ;
cml:integrityHash "6052f101770fb2722a70f542e40a860bff0ccafef0f96b61719e2084c2bbb84f" ;
values:partOf concept:therapeutic-goods-act-1989-sec-3ab ;
skos:note "Minister may exempt specified statements from subsection (2)" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.41" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-3ab-ss-5-norm .
concept:therapeutic-goods-act-1989-sec-3ab-ss-5-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-3ab-ss-5 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3ab-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-3ab-ss-5-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-3ab-ss-5-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 "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3a a cml:Concept ;
skos:prefLabel "3A Declaration—member of European Community"@en ;
cml:realizedBy doc:sec-3a ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-3a-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-3a-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.42" .
concept:therapeutic-goods-act-1989-sec-3a-ss-1 a cml:Concept ;
skos:prefLabel "3A(1) Declaration—member of European Community"@en ;
cml:realizedBy doc:sec-3a-ss-1 ;
cml:integrityHash "47395a8dc65c38789bd40e2037d2a2a0e436311ad6f889fac323aed227e049b1" ;
values:partOf concept:therapeutic-goods-act-1989-sec-3a ;
skos:note "Declaration of membership in European Community or EFTA" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.42" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-3a-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-3a-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-3a-ss-1 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3a-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-3a-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-3a-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "may" ;
cml:logicSummary "Declaration obligation" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3a-ss-2 a cml:Concept ;
skos:prefLabel "3A(2) Declaration—member of European Community"@en ;
cml:realizedBy doc:sec-3a-ss-2 ;
cml:integrityHash "ce8a07762001e7922592074630c962071f4bd9e1a5a1eef85c826579ffda2e73" ;
values:partOf concept:therapeutic-goods-act-1989-sec-3a ;
skos:note "Declaration must be published in Gazette or on Department's website." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.42" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-3a-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-3a-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-3a-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-3a-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-3a-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-3a-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Must publish declaration" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3b a cml:Concept ;
skos:prefLabel "3B Declaration—country covered by non-EC/EFTA MRA"@en ;
cml:realizedBy doc:sec-3b ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-3b-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-3b-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.42" .
concept:therapeutic-goods-act-1989-sec-3b-ss-1 a cml:Concept ;
skos:prefLabel "3B(1) Declaration—country covered by non-EC/EFTA MRA"@en ;
cml:realizedBy doc:sec-3b-ss-1 ;
cml:integrityHash "f8c2ec7d62fa2e3ce83fdd9b65d8538fce65f5b85ff17cb2123aabbe543dd042" ;
values:partOf concept:therapeutic-goods-act-1989-sec-3b ;
skos:note "Minister may declare a country covered by non-EC/EFTA MRA." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.42" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-3b-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-3b-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-3b-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-3b-ss-2 a cml:Concept ;
skos:prefLabel "3B(2) Declaration—country covered by non-EC/EFTA MRA"@en ;
cml:realizedBy doc:sec-3b-ss-2 ;
cml:integrityHash "7d1abd80b36fc2a7f20ac273a9aa6cdbcf45f178c822e80bc1081e7f18cee3bd" ;
values:partOf concept:therapeutic-goods-act-1989-sec-3b ;
skos:note "Declaration must be published in Gazette or on Department's website." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.42" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-3b-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-3b-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-3b-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-3b-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-3b-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-3b-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Declaration is mandatory." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3c a cml:Concept ;
skos:prefLabel "3C Exempting monographs in pharmacopoeias"@en ;
cml:realizedBy doc:sec-3c ;
cml:integrityHash "76e928dcfd1bf39452eac3f6689a84a5d9ec084d04dde922c23dc544cc24e1a2" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-3c-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-3c-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-3c-ss-3 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.43" .
concept:therapeutic-goods-act-1989-sec-3c-ss-1 a cml:Concept ;
skos:prefLabel "3C(1) Exempting monographs in pharmacopoeias"@en ;
cml:realizedBy doc:sec-3c-ss-1 ;
cml:integrityHash "b9ae919e1a3a4af94b7e6ee771f5d22d3b5bc57e2701f5beedc7cc7283e47b01" ;
values:partOf concept:therapeutic-goods-act-1989-sec-3c ;
skos:note "The Minister may determine exemptions for specified monographs in relation to therapeutic goods." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.43" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-3c-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-3c-ss-1-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-3c-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-3c-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-3c-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-3c-ss-1-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-3c-ss-2 a cml:Concept ;
skos:prefLabel "3C(2) Exempting monographs in pharmacopoeias"@en ;
cml:realizedBy doc:sec-3c-ss-2 ;
cml:integrityHash "36fd97ef13fb0d3e9067ce8b7e1794fc4339503eee8b5ce3db359249b345e987" ;
values:partOf concept:therapeutic-goods-act-1989-sec-3c ;
skos:note "Determination of exemptions for therapeutic goods" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.43" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-3c-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-3c-ss-2-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-3c-ss-2 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3c-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-3c-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-3c-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "may" ;
cml:logicSummary "Permission to determine exemptions" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3c-ss-3 a cml:Concept ;
skos:prefLabel "3C(3) Exempting monographs in pharmacopoeias"@en ;
cml:realizedBy doc:sec-3c-ss-3 ;
cml:integrityHash "702308b78f8723eecf04dca3e87d1cff57823311df60208c27656e04ecff70b6" ;
values:partOf concept:therapeutic-goods-act-1989-sec-3c ;
skos:note "Exempts monographs in pharmacopoeias from certain legislation" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.43" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-3c-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-3c-ss-3-norm a values:Undertaking ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-3c-ss-3 ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-3c-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-3c-ss-3-logic-alleninterval-1 .
concept:therapeutic-goods-act-1989-sec-3c-ss-3-logic-alleninterval-1 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Applicable" ;
cml:logicSummary "Requires temporal relation between instrument and writing" ;
cml:premiseText "Temporal intervals mentioned" ;
cml:conclusionText "Undertaking" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-4 a cml:Concept ;
skos:prefLabel "4 Objects of Act"@en ;
cml:realizedBy doc:sec-4 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-4-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-4-ss-1a ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-4-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.43" .
concept:therapeutic-goods-act-1989-sec-4-ss-1 a cml:Concept ;
skos:prefLabel "4(1) Objects of Act"@en ;
cml:realizedBy doc:sec-4-ss-1 ;
cml:integrityHash "8fb5346a1b3cd40e4e1d64f4f29348d2d7cd955b442b6df21d1529f6da805aec" ;
values:partOf concept:therapeutic-goods-act-1989-sec-4 ;
skos:note "List therapeutic goods for national system of controls" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.43" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-4-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-4-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-4-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-4-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-4-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-4-ss-1-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-4-ss-1a a cml:Concept ;
skos:prefLabel "4(1A) Objects of Act"@en ;
cml:realizedBy doc:sec-4-ss-1a ;
cml:integrityHash "cc38919b75adb824f18af495257f7e66af429c0879d7343a08577a4f5bdf56be" ;
values:partOf concept:therapeutic-goods-act-1989-sec-4 ;
skos:note "Manufacturer's intent for medical devices" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.43" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-4-ss-1a-norm .
concept:therapeutic-goods-act-1989-sec-4-ss-1a-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-4-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-4-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-4-ss-1a-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-4-ss-1a-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "performance" ;
cml:logicSummary "Performance of devices as intended" ;
cml:premiseText "(1A) The reference in paragraph (1)(a)" ;
cml:conclusionText "The efficacy of therapeutic goods is a reference to the performance of devices as the manufacturer intended." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-4-ss-2 a cml:Concept ;
skos:prefLabel "4(2) Objects of Act"@en ;
cml:realizedBy doc:sec-4-ss-2 ;
cml:integrityHash "a50835daff620962963f1f4d961a7587b753102a3288bedcb988f54cc079cf30" ;
values:partOf concept:therapeutic-goods-act-1989-sec-4 ;
skos:note "Act does not exclude concurrent operation with other laws." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.43" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-4-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-4-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-4-ss-2 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-4-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-4-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-4-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "exclusion" ;
cml:logicSummary "Exclusion of concurrent operation" ;
cml:premiseText "(2) This Act is therefore not intended to apply..." ;
cml:conclusionText "to the extent that the law is capable of operating concurrently with this Act." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-4-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-4-ss-2-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-4-ss-2-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "simultaneity" ;
cml:logicSummary "Simultaneous operation allowed" ;
cml:premiseText "(2) This Act is therefore not intended to apply..." ;
cml:conclusionText "to the extent that the law is capable of operating concurrently with this Act." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-4-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-4-ss-2-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-4-ss-2-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "trace" ;
cml:logicSummary "Tracing concurrent operation" ;
cml:premiseText "(2) This Act is therefore not intended to apply..." ;
cml:conclusionText "to the exclusion of a law of a State, of the Australian Capital Territory or of the Northern Territory." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-4-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-4-ss-2-logic-diffusion-4 .
concept:therapeutic-goods-act-1989-sec-4-ss-2-logic-diffusion-4 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "diffusion" ;
cml:logicSummary "Diffusing concurrent operation" ;
cml:premiseText "(2) This Act is therefore not intended to apply..." ;
cml:conclusionText "to the extent that the law is capable of operating concurrently with this Act." ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-4-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-4-ss-2-logic-cogai-5 .
concept:therapeutic-goods-act-1989-sec-4-ss-2-logic-cogai-5 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "cognitive framework" ;
cml:logicSummary "Cognitive framework for concurrent operation" ;
cml:premiseText "(2) This Act is therefore not intended to apply..." ;
cml:conclusionText "to the exclusion of a law of a State, of the Australian Capital Territory or of the Northern Territory." ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-5-2 a cml:Concept ;
skos:prefLabel "5 Act to bind Crown"@en ;
cml:realizedBy doc:sec-5-2 ;
cml:integrityHash "8468cb9f88c3ac4e007082b53259900c7146fff27b7ba4143822c6f7b069a4a0" ;
skos:note "The Crown is bound by this Act." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.44" ;
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:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-5-2 cml:asserts concept:therapeutic-goods-act-1989-sec-5-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-5-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Binding" ;
cml:logicSummary "The Crown is obligated to comply with the Act." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-5a a cml:Concept ;
skos:prefLabel "5A Application of the Criminal Code—extended geographical"@en ;
cml:realizedBy doc:sec-5a ;
cml:integrityHash "c04b54bc7dade6d16eea6a2d4ae8a04f4c86922cb5b9386d2f9674c96b96e24e" ;
skos:note "Jurisdiction applies to specific offences" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.45" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-5a-norm .
concept:therapeutic-goods-act-1989-sec-5a-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-5a ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-5a cml:asserts concept:therapeutic-goods-act-1989-sec-5a-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-5a-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "applies" ;
cml:logicSummary "Jurisdiction is applied" ;
cml:premiseText "Section 15.2 of the Criminal Code" ;
cml:conclusionText "to offences against specified subsections" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-6 a cml:Concept ;
skos:prefLabel "6 Operation of Act"@en ;
cml:realizedBy doc:sec-6 ;
cml:integrityHash "952e8645f555289bf5258c873872be3a8c92384012e309f79c40542ee5d3de15" ;
skos:note "Applicable to corporations and natural persons/corporations in certain trade/commerce contexts." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.45" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-6-norm .
concept:therapeutic-goods-act-1989-sec-6-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-6 ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-6 cml:asserts concept:therapeutic-goods-act-1989-sec-6-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-6-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "appliesTo" ;
cml:logicSummary "Applicable to corporations and natural persons/corporations." ;
cml:premiseText "(1) This Act (other than Part 4-8A or Part 6-1A)" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-6 cml:asserts concept:therapeutic-goods-act-1989-sec-6-logic-deontic-2 .
concept:therapeutic-goods-act-1989-sec-6-logic-deontic-2 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "appliesTo" ;
cml:logicSummary "Applicable to corporations and natural persons/corporations." ;
cml:premiseText "(a) things done by corporations; (b) things done by natural persons or corporations in so far as those things are done:" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-6 cml:asserts concept:therapeutic-goods-act-1989-sec-6-logic-deontic-3 .
concept:therapeutic-goods-act-1989-sec-6-logic-deontic-3 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "appliesTo" ;
cml:logicSummary "Applicable to trade/commerce between Australia and a place outside Australia, among the States, between a State and a Territory or between 2 Territories." ;
cml:premiseText "(i) in the course of, or in preparation for, trade or commerce between Australia and a place outside Australia, among the States, between a State and a Territory or between 2 Territories;" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-6b a cml:Concept ;
skos:prefLabel "6B Review of certain decisions under State laws"@en ;
cml:realizedBy doc:sec-6b ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-6b-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-6b-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-6b-ss-3 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.50" .
concept:therapeutic-goods-act-1989-sec-6b-ss-1 a cml:Concept ;
skos:prefLabel "6B(1) Review of certain decisions under State laws"@en ;
cml:realizedBy doc:sec-6b-ss-1 ;
cml:integrityHash "718bc1f991af17014aaf3fc89bb49ab2b139d5c057fdb1c85b5ef5a58ddf5ba4" ;
values:partOf concept:therapeutic-goods-act-1989-sec-6b ;
skos:note "Application for review of a State decision may be made." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.50" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-6b-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-6b-ss-1-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-6b-ss-1 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-6b-ss-2 a cml:Concept ;
skos:prefLabel "6B(2) Review of certain decisions under State laws"@en ;
cml:realizedBy doc:sec-6b-ss-2 ;
cml:integrityHash "860d4eb148e8b26fe9b92c965f9bb1d645a769e6e3f1924b6262c6ef54df285e" ;
values:partOf concept:therapeutic-goods-act-1989-sec-6b ;
skos:note "A decision made by the Secretary is reviewable if it meets certain conditions." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.50" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-6b-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-6b-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-6b-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-6b-ss-3 a cml:Concept ;
skos:prefLabel "6B(3) Review of certain decisions under State laws"@en ;
cml:realizedBy doc:sec-6b-ss-3 ;
cml:integrityHash "309f536be3a43d55e5a766e013e8ed4fe252116d00a67b42ca1e75ec777f63bf" ;
values:partOf concept:therapeutic-goods-act-1989-sec-6b ;
skos:note "Administrative Review Tribunal Act 2024 has effect as if a corresponding State law were an Act." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.50" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-6b-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-6b-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-6b-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-6b-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-6b-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-6b-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "hasEffectAsIf" ;
cml:logicSummary "Legal effect of the Administrative Review Tribunal Act 2024 on State laws." ;
cml:premiseText "State law" ;
cml:conclusionText "Administrative Review Tribunal Act 2024 has effect as if a corresponding State law were an Act." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-6b-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-6b-ss-3-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-6b-ss-3-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "during" ;
cml:logicSummary "The Administrative Review Tribunal Act 2024 has effect during the period of a corresponding State law." ;
cml:premiseText "State law" ;
cml:conclusionText "Administrative Review Tribunal Act 2024" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-6b-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-6b-ss-3-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-6b-ss-3-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "during" ;
cml:logicSummary "The Administrative Review Tribunal Act 2024 has effect during the period of a corresponding State law." ;
cml:premiseText "State law" ;
cml:conclusionText "Administrative Review Tribunal Act 2024" ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-6b-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-6b-ss-3-logic-cogai-4 .
concept:therapeutic-goods-act-1989-sec-6b-ss-3-logic-cogai-4 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "hasEffectAsIf" ;
cml:logicSummary "The Administrative Review Tribunal Act 2024 has effect as if a corresponding State law were an Act." ;
cml:premiseText "State law" ;
cml:conclusionText "Administrative Review Tribunal Act 2024" ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-6b-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-6b-ss-3-logic-shacl-5 .
concept:therapeutic-goods-act-1989-sec-6b-ss-3-logic-shacl-5 a cml:LogicApplication ;
cml:modality cml:SHACL ;
cml:operator "hasEffectAsIf" ;
cml:logicSummary "The Administrative Review Tribunal Act 2024 has effect as if a corresponding State law were an Act." ;
cml:premiseText "State law" ;
cml:conclusionText "Administrative Review Tribunal Act 2024" ;
cml:executionSurface "modalities::logic::shacl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-6c a cml:Concept ;
skos:prefLabel "6C Fees payable to Commonwealth under State laws"@en ;
cml:realizedBy doc:sec-6c ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-6c-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-6c-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.51" .
concept:therapeutic-goods-act-1989-sec-6c-ss-1 a cml:Concept ;
skos:prefLabel "6C(1) Fees payable to Commonwealth under State laws"@en ;
cml:realizedBy doc:sec-6c-ss-1 ;
cml:integrityHash "3f6c303772fb336c3c8ce85f73889c8132af069820bd5c6b8317af583fe1aee0" ;
values:partOf concept:therapeutic-goods-act-1989-sec-6c ;
skos:note "Fees payable to Commonwealth under State laws" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.51" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-6c-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-6c-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-6c-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-6c-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-6c-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-6c-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Imposes an obligation on States to pay fees to the Commonwealth" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-6c-ss-2 a cml:Concept ;
skos:prefLabel "6C(2) Fees payable to Commonwealth under State laws"@en ;
cml:realizedBy doc:sec-6c-ss-2 ;
cml:integrityHash "423a26e76b991ef6deddf868d261030592fb1649e92b8db414a6449db8a0e1b7" ;
values:partOf concept:therapeutic-goods-act-1989-sec-6c ;
skos:note "Arrangements for Commonwealth fees under State laws" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.51" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-6c-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-6c-ss-2-norm a values:Undertaking ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-6c-ss-2 ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7 a cml:Concept ;
skos:prefLabel "7 Declaration that goods are/are not therapeutic goods"@en ;
cml:realizedBy doc:sec-7 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-7-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-7-ss-1a ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-7-ss-4 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-7-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-7-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-7-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.51" .
concept:therapeutic-goods-act-1989-sec-7-ss-1 a cml:Concept ;
skos:prefLabel "7(1) Declaration that goods are/are not therapeutic goods"@en ;
cml:realizedBy doc:sec-7-ss-1 ;
cml:integrityHash "4324705dc4e7c5a718d167072d3d60adbb7ef8ee95d157c2f31ac28bf4d6713d" ;
values:partOf concept:therapeutic-goods-act-1989-sec-7 ;
skos:note "The Secretary may make an order declaring classes of goods are or are not therapeutic goods. Minister may determine goods are therapeutic for Act purposes" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.51" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-7-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-7-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-7-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-7-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-7-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-7-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "May" ;
cml:logicSummary "The Secretary may make an order" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-7-ss-1-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-7-ss-1-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Temporal interval" ;
cml:logicSummary "The Secretary may make an order at any time" ;
cml:premiseText "(1) Where the Secretary is satisfied that classes of goods:" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-7-ss-1-logic-deontic-3 .
concept:therapeutic-goods-act-1989-sec-7-ss-1-logic-deontic-3 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "may" ;
cml:logicSummary "Obligation to determine goods" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7-ss-1a a cml:Concept ;
skos:prefLabel "7(1A) Declaration that goods are/are not therapeutic goods"@en ;
cml:realizedBy doc:sec-7-ss-1a ;
cml:integrityHash "cdb9890940f4dc43b544369957516ad17c9920ec90a4914b3e81d6e4f57f750a" ;
values:partOf concept:therapeutic-goods-act-1989-sec-7 ;
skos:note "Secretary must disregard certain paragraphs when deciding if goods are therapeutic." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.51" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-7-ss-1a-norm .
concept:therapeutic-goods-act-1989-sec-7-ss-1a-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-7-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-7-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-7-ss-1a-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-7-ss-1a-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Must Disregard" ;
cml:logicSummary "Secretary must disregard certain paragraphs." ;
cml:premiseText "(1A) In deciding..." ;
cml:conclusionText "...must disregard paragraphs (e) and (f)" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7-ss-4 a cml:Concept ;
skos:prefLabel "7(4) Declaration that goods are/are not therapeutic goods"@en ;
cml:realizedBy doc:sec-7-ss-4 ;
cml:integrityHash "7730eebf64333862e58a47abbe913dedb4d18fa268e00cd1de9fc5c47f70238b" ;
values:partOf concept:therapeutic-goods-act-1989-sec-7 ;
skos:note "Goods are not therapeutic goods if declaration applies wholly or partly to goods that would be medical devices." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.51" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-7-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-7-ss-4-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-7-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-7-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-7-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-7-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Implies" ;
cml:logicSummary "Declaration applies implies goods are not therapeutic goods." ;
cml:premiseText "Declaration applies wholly or partly to goods that would be medical devices." ;
cml:conclusionText "Goods are not therapeutic goods." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-7-ss-4-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-7-ss-4-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "During" ;
cml:logicSummary "Declaration applies during use, advertisement, or presentation for supply." ;
cml:premiseText "Declaration applies wholly or partly to goods that would be medical devices." ;
cml:conclusionText "Goods are not therapeutic goods during use, advertisement, or presentation for supply." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-7-ss-4-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-7-ss-4-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "Recurring" ;
cml:logicSummary "Declaration is recurring in its application to goods." ;
cml:premiseText "Declaration applies wholly or partly to goods that would be medical devices." ;
cml:conclusionText "Goods are not therapeutic goods due to recurring declaration." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-7-ss-4-logic-diffusion-4 .
concept:therapeutic-goods-act-1989-sec-7-ss-4-logic-diffusion-4 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "Implication" ;
cml:logicSummary "Declaration implies diffusion of goods being non-therapeutic goods." ;
cml:premiseText "Declaration applies wholly or partly to goods that would be medical devices." ;
cml:conclusionText "Goods are diffused as non-therapeutic goods." ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-7-ss-4-logic-cogai-5 .
concept:therapeutic-goods-act-1989-sec-7-ss-4-logic-cogai-5 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "Classification" ;
cml:logicSummary "Declaration classifies goods using AI." ;
cml:premiseText "Declaration is a declaration that classes of goods are not therapeutic goods." ;
cml:conclusionText "Goods are classified as non-therapeutic goods by AI." ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7-ss-1 a cml:Concept ;
skos:prefLabel "7(1) Declaration that goods are/are not therapeutic goods"@en ;
cml:realizedBy doc:sec-7-ss-1 ;
cml:integrityHash "fd4a32a34ab6f321a245aa001a105c48c97ea0e716254fc1cdeb5f406d8ebff1" ;
values:partOf concept:therapeutic-goods-act-1989-sec-7 ;
skos:note "The Secretary may make an order declaring classes of goods are or are not therapeutic goods. Minister may determine goods are therapeutic for Act purposes" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.51" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-7-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-7-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-7-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-7-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-7-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-7-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "May" ;
cml:logicSummary "The Secretary may make an order" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-7-ss-1-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-7-ss-1-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Temporal interval" ;
cml:logicSummary "The Secretary may make an order at any time" ;
cml:premiseText "(1) Where the Secretary is satisfied that classes of goods:" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-7-ss-1-logic-deontic-3 .
concept:therapeutic-goods-act-1989-sec-7-ss-1-logic-deontic-3 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "may" ;
cml:logicSummary "Obligation to determine goods" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7-ss-2 a cml:Concept ;
skos:prefLabel "7(2) Declaration that goods are/are not therapeutic goods"@en ;
cml:realizedBy doc:sec-7-ss-2 ;
cml:integrityHash "d55875c47c7dfb66a280e6f67a99f8c270f3ea486b7af25b42ef854c74e8bfc0" ;
values:partOf concept:therapeutic-goods-act-1989-sec-7 ;
skos:note "Goods are not therapeutic goods under certain conditions. Minister must consider certain matters before making a determination about regulating goods." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.51" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-7-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-7-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-7-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-7-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-7-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-7-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "not" ;
cml:logicSummary "Negative assertion of a property" ;
cml:premiseText "(2) (excluded goods)" ;
cml:conclusionText "(a) are not therapeutic goods; or (b) when used, advertised, or presented for supply in a particular way, are not therapeutic goods." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-7-ss-2-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-7-ss-2-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "before" ;
cml:logicSummary "Temporal relationship between conditions" ;
cml:premiseText "(2)" ;
cml:conclusionText "when used, advertised, or presented for supply in a particular way" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-7-ss-2-logic-deontic-3 .
concept:therapeutic-goods-act-1989-sec-7-ss-2-logic-deontic-3 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Minister must consider certain matters." ;
cml:premiseText "(2) Before making a determination under subsection (1), the Minister:" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7-ss-2 a cml:Concept ;
skos:prefLabel "7(2) Declaration that goods are/are not therapeutic goods"@en ;
cml:realizedBy doc:sec-7-ss-2 ;
cml:integrityHash "2fc439d34c27e4c639531f6ed6e4489d5cb149aae973396bb8f7ef9d2e563fb3" ;
values:partOf concept:therapeutic-goods-act-1989-sec-7 ;
skos:note "Goods are not therapeutic goods under certain conditions. Minister must consider certain matters before making a determination about regulating goods." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.51" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-7-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-7-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-7-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-7-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-7-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-7-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "not" ;
cml:logicSummary "Negative assertion of a property" ;
cml:premiseText "(2) (excluded goods)" ;
cml:conclusionText "(a) are not therapeutic goods; or (b) when used, advertised, or presented for supply in a particular way, are not therapeutic goods." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-7-ss-2-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-7-ss-2-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "before" ;
cml:logicSummary "Temporal relationship between conditions" ;
cml:premiseText "(2)" ;
cml:conclusionText "when used, advertised, or presented for supply in a particular way" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-7-ss-2-logic-deontic-3 .
concept:therapeutic-goods-act-1989-sec-7-ss-2-logic-deontic-3 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Minister must consider certain matters." ;
cml:premiseText "(2) Before making a determination under subsection (1), the Minister:" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7aa a cml:Concept ;
skos:prefLabel "7AA Excluded goods"@en ;
cml:realizedBy doc:sec-7aa ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-7aa-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-7aa-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-7aa-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-7aa-ss-4 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.52" .
concept:therapeutic-goods-act-1989-sec-7aa-ss-1 a cml:Concept ;
skos:prefLabel "7AA(1) Excluded goods"@en ;
cml:realizedBy doc:sec-7aa-ss-1 ;
cml:integrityHash "14873a5a6633e32a373575110392d748f1d7eb7f7f55b3953574c6123d640d4a" ;
values:partOf concept:therapeutic-goods-act-1989-sec-7aa ;
skos:note "The Minister may determine that specified goods are excluded goods." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.52" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-7aa-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-7aa-ss-1-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-7aa-ss-1 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7aa-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-7aa-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-7aa-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "may" ;
cml:logicSummary "Permission to exclude goods" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7aa-ss-2 a cml:Concept ;
skos:prefLabel "7AA(2) Excluded goods"@en ;
cml:realizedBy doc:sec-7aa-ss-2 ;
cml:integrityHash "7a7c846511c26385796b7c1e46494d7fdb45d5d2a5273181012f29bf1fc3f25e" ;
values:partOf concept:therapeutic-goods-act-1989-sec-7aa ;
skos:note "Determination of excluded goods" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.52" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-7aa-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-7aa-ss-2-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-7aa-ss-2 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7aa-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-7aa-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-7aa-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "may" ;
cml:logicSummary "Permission to determine excluded goods" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7aa-ss-3 a cml:Concept ;
skos:prefLabel "7AA(3) Excluded goods"@en ;
cml:realizedBy doc:sec-7aa-ss-3 ;
cml:integrityHash "1e2a3f1ee50aff9948ee58e7b766037eced0ab1f2d821d9928ab897b70098d47" ;
values:partOf concept:therapeutic-goods-act-1989-sec-7aa ;
skos:note "Minister must consider certain matters before making a determination under this section." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.52" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-7aa-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-7aa-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-7aa-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-7aa-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-7aa-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-7aa-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Minister must consider certain matters." ;
cml:premiseText "(3) Before making a determination under this section, the Minister..." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7aa-ss-4 a cml:Concept ;
skos:prefLabel "7AA(4) Excluded goods"@en ;
cml:realizedBy doc:sec-7aa-ss-4 ;
cml:integrityHash "b5dcc2727e2b5c9e50188db4654abbd32feeb22b3b25b933e1d0774b24fba80e" ;
values:partOf concept:therapeutic-goods-act-1989-sec-7aa ;
skos:note "Consideration of relevant matters by the Minister" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.52" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-7aa-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-7aa-ss-4-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-7aa-ss-4 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7aa-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-7aa-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-7aa-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "may" ;
cml:logicSummary "Permission to consider other matters" ;
cml:premiseText "The Minister may have regard to..." ;
cml:conclusionText "Consideration of relevant matters by the Minister" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7aa-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-7aa-ss-4-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-7aa-ss-4-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "during" ;
cml:logicSummary "Temporal relation between consideration and action" ;
cml:premiseText "The Minister may have regard to any other matter he or she considers relevant." ;
cml:conclusionText "Consideration of relevant matters by the Minister" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7aa-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-7aa-ss-4-logic-argumentation-3 .
concept:therapeutic-goods-act-1989-sec-7aa-ss-4-logic-argumentation-3 a cml:LogicApplication ;
cml:modality cml:Argumentation ;
cml:operator "may" ;
cml:logicSummary "Relevance consideration in decision-making" ;
cml:premiseText "The Minister may have regard to any other matter he or she considers relevant." ;
cml:conclusionText "Consideration of relevant matters by the Minister" ;
cml:executionSurface "modalities::argumentation" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7aa-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-7aa-ss-4-logic-diffusion-4 .
concept:therapeutic-goods-act-1989-sec-7aa-ss-4-logic-diffusion-4 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "may" ;
cml:logicSummary "Relevance consideration in decision-making" ;
cml:premiseText "The Minister may have regard to any other matter he or she considers relevant." ;
cml:conclusionText "Consideration of relevant matters by the Minister" ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7aa-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-7aa-ss-4-logic-cogai-5 .
concept:therapeutic-goods-act-1989-sec-7aa-ss-4-logic-cogai-5 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "may" ;
cml:logicSummary "Relevance consideration in decision-making" ;
cml:premiseText "The Minister may have regard to any other matter he or she considers relevant." ;
cml:conclusionText "Consideration of relevant matters by the Minister" ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7a a cml:Concept ;
skos:prefLabel "7A Authorised persons"@en ;
cml:realizedBy doc:sec-7a ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-7a-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-7a-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.53" .
concept:therapeutic-goods-act-1989-sec-7a-ss-1 a cml:Concept ;
skos:prefLabel "7A(1) Authorised persons"@en ;
cml:realizedBy doc:sec-7a-ss-1 ;
cml:integrityHash "ab3004bad75e7760ecd72f8356f324b455d3bf2f42508b259ea7ba9d2b53025d" ;
values:partOf concept:therapeutic-goods-act-1989-sec-7a ;
skos:note "Authorises Secretary to authorise persons to exercise powers under specified provisions of the Act." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.53" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-7a-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-7a-ss-1-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-7a-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-7a-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-7a-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-7a-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "authorise" ;
cml:logicSummary "Authorisation is granted." ;
cml:premiseText "Secretary may authorise persons to exercise powers under specified provisions of the Act." ;
cml:conclusionText "Persons are authorised to exercise powers." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7a-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-7a-ss-1-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-7a-ss-1-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "during" ;
cml:logicSummary "The authority is granted during the term of the Secretary's office." ;
cml:premiseText "Authority is granted by the Secretary." ;
cml:conclusionText "Authority is granted during the term of the Secretary's office." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7a-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-7a-ss-1-logic-argumentation-3 .
concept:therapeutic-goods-act-1989-sec-7a-ss-1-logic-argumentation-3 a cml:LogicApplication ;
cml:modality cml:Argumentation ;
cml:operator "entails" ;
cml:logicSummary "The authority implies that the person exercising powers has a specified role." ;
cml:premiseText "Person exercising powers has a specified role." ;
cml:conclusionText "Authority implies that the person exercising powers has a specified role." ;
cml:executionSurface "modalities::argumentation" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7a-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-7a-ss-1-logic-diffusion-4 .
concept:therapeutic-goods-act-1989-sec-7a-ss-1-logic-diffusion-4 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "implies" ;
cml:logicSummary "The authority implies that the Secretary's office is responsible for enforcing health matters or law enforcement matters." ;
cml:premiseText "Secretary's office is responsible for enforcing health matters or law enforcement matters." ;
cml:conclusionText "Authority implies that the Secretary's office is responsible for enforcing health matters or law enforcement matters." ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7a-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-7a-ss-1-logic-cogai-5 .
concept:therapeutic-goods-act-1989-sec-7a-ss-1-logic-cogai-5 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "implies" ;
cml:logicSummary "The authority implies that the person exercising powers has a specified function." ;
cml:premiseText "Person exercising powers has a specified function." ;
cml:conclusionText "Authority implies that the person exercising powers has a specified function." ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7a-ss-2 a cml:Concept ;
skos:prefLabel "7A(2) Authorised persons"@en ;
cml:realizedBy doc:sec-7a-ss-2 ;
cml:integrityHash "cc0b5b63c93670398039fcce9d1e5a093611d00cc5c93c393a43a8d866290828" ;
values:partOf concept:therapeutic-goods-act-1989-sec-7a ;
skos:note "Authorised person must comply with directions of the Secretary." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.53" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-7a-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-7a-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-7a-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-7a-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-7a-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-7a-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Must comply" ;
cml:premiseText "Authorised person has power under a provision of this Act." ;
cml:conclusionText "Comply with directions of the Secretary." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7a-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-7a-ss-2-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-7a-ss-2-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "CONTAINS" ;
cml:logicSummary "Temporal relation between directions and actions" ;
cml:premiseText "Directions are given at some point in time." ;
cml:conclusionText "Action must occur after directions are given." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7b a cml:Concept ;
skos:prefLabel "7B Kits"@en ;
cml:realizedBy doc:sec-7b ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-7b-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-7b-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-7b-ss-3 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.54" .
concept:therapeutic-goods-act-1989-sec-7b-ss-1 a cml:Concept ;
skos:prefLabel "7B(1) Kits"@en ;
cml:realizedBy doc:sec-7b-ss-1 ;
cml:integrityHash "12e211e70bf98de0afac83d5d9a89708dfc4d62a1f861c4d92d74cd641d050ae" ;
values:partOf concept:therapeutic-goods-act-1989-sec-7b ;
skos:note "A package and its goods constitute a kit if they meet certain conditions." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.54" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-7b-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-7b-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-7b-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-7b-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-7b-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-7b-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "must-be" ;
cml:logicSummary "Kit definition" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7b-ss-2 a cml:Concept ;
skos:prefLabel "7B(2) Kits"@en ;
cml:realizedBy doc:sec-7b-ss-2 ;
cml:integrityHash "49b98032f4e01978b1c65670c243c3c8d85d5114d13553f0dd0927102755f18a" ;
values:partOf concept:therapeutic-goods-act-1989-sec-7b ;
skos:note "Therapeutic goods must be combined before administration or in a particular sequence." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.54" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-7b-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-7b-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-7b-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-7b-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-7b-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-7b-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Must" ;
cml:logicSummary "Therapeutic goods must be combined before administration or in a particular sequence." ;
cml:premiseText "(2) A package and therapeutic goods in the package together constitute a composite pack if:..." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7b-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-7b-ss-2-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-7b-ss-2-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Requires" ;
cml:logicSummary "Combining therapeutic goods is necessary before administration." ;
cml:premiseText "it is necessary that the therapeutic goods be combined before administration or that they be administered in a particular sequence." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7b-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-7b-ss-2-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-7b-ss-2-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "Requires" ;
cml:logicSummary "Combining therapeutic goods must happen before administration." ;
cml:premiseText "it is necessary that the therapeutic goods be combined before administration or that they be administered in a particular sequence." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7b-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-7b-ss-2-logic-diffusion-4 .
concept:therapeutic-goods-act-1989-sec-7b-ss-2-logic-diffusion-4 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "Requires" ;
cml:logicSummary "Combining therapeutic goods must happen in a particular order." ;
cml:premiseText "the package does not contain any medical devices; and" ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7b-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-7b-ss-2-logic-cogai-5 .
concept:therapeutic-goods-act-1989-sec-7b-ss-2-logic-cogai-5 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "Classifies" ;
cml:logicSummary "Therapeutic goods are for administration as a single treatment or course of treatment." ;
cml:premiseText "(c) the therapeutic goods are for administration as a single treatment or as a single course of treatment; and" ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7b-ss-3 a cml:Concept ;
skos:prefLabel "7B(3) Kits"@en ;
cml:realizedBy doc:sec-7b-ss-3 ;
cml:integrityHash "d3df2603ce7c7087f5afd84633445dd30b84efc7756d22a1a34b4cd5650f038e" ;
values:partOf concept:therapeutic-goods-act-1989-sec-7b ;
skos:note "A kit constitutes therapeutic goods." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.54" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-7b-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-7b-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-7b-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-7b-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-7b-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-7b-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "is" ;
cml:logicSummary "Definition of a kit" ;
cml:premiseText "A kit is defined as..." ;
cml:conclusionText "It is declared that..." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7c a cml:Concept ;
skos:prefLabel "7C Secretary may arrange for use of computer programs to make"@en ;
cml:realizedBy doc:sec-7c ;
cml:integrityHash "3183d37be5060278b0f0b2ea1095fea98e027d276f661719821018f5511f4927" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-7c-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-7c-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-7c-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-7c-ss-4 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.55" .
concept:therapeutic-goods-act-1989-sec-7c-ss-1 a cml:Concept ;
skos:prefLabel "7C(1) Secretary may arrange for use of computer programs to make"@en ;
cml:realizedBy doc:sec-7c-ss-1 ;
cml:integrityHash "fba878466a007c7c06cefd3d6dbb98456c09f2a902ea5f994b47a52f8ff7ee0d" ;
values:partOf concept:therapeutic-goods-act-1989-sec-7c ;
skos:note "The Secretary may arrange for the use of computer programs under their control." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.55" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-7c-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-7c-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-7c-ss-1 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7c-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-7c-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-7c-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "may" ;
cml:logicSummary "Implies permission or obligation" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7c-ss-2 a cml:Concept ;
skos:prefLabel "7C(2) Secretary may arrange for use of computer programs to make"@en ;
cml:realizedBy doc:sec-7c-ss-2 ;
cml:integrityHash "0ca54776f55e6b8faaf5a3d48958a920e1dbdab3bf103ffe3375e7446571db43" ;
values:partOf concept:therapeutic-goods-act-1989-sec-7c ;
skos:note "Decision made by computer program is taken to be Secretary's decision." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.55" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-7c-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-7c-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-7c-ss-2 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7c-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-7c-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-7c-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "=" ;
cml:logicSummary "Decision making" ;
cml:premiseText "Computer program makes a decision" ;
cml:conclusionText "Secretary's decision" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7c-ss-3 a cml:Concept ;
skos:prefLabel "7C(3) Secretary may arrange for use of computer programs to make"@en ;
cml:realizedBy doc:sec-7c-ss-3 ;
cml:integrityHash "c2c6eab04637835a93c75f1463eb8a0ec0c3a4bc16bb19ffabe64a9e9637a22a" ;
values:partOf concept:therapeutic-goods-act-1989-sec-7c ;
skos:note "Secretary may correct initial decision made by computer program." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.55" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-7c-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-7c-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-7c-ss-3 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7c-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-7c-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-7c-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MAY" ;
cml:logicSummary "May correct initial decision" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7c-ss-4 a cml:Concept ;
skos:prefLabel "7C(4) Secretary may arrange for use of computer programs to make"@en ;
cml:realizedBy doc:sec-7c-ss-4 ;
cml:integrityHash "03659ac93cc30e71042f6c5f2a486b2a35e9520e1882855f0eb6713292133e6c" ;
values:partOf concept:therapeutic-goods-act-1989-sec-7c ;
skos:note "Secretary must make substituted decision within 60 days of initial decision." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.55" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-7c-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-7c-ss-4-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-7c-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-7c-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-7c-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-7c-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Must provide a substituted decision within the specified timeframe." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7d a cml:Concept ;
skos:prefLabel "7D Form for product information for medicine"@en ;
cml:realizedBy doc:sec-7d ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-7d-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-7d-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.55" .
concept:therapeutic-goods-act-1989-sec-7d-ss-1 a cml:Concept ;
skos:prefLabel "7D(1) Form for product information for medicine"@en ;
cml:realizedBy doc:sec-7d-ss-1 ;
cml:integrityHash "91edc8f13740e3c030223041c0d2518d6a1c4e83ffd694516531dbd52476e2cc" ;
values:partOf concept:therapeutic-goods-act-1989-sec-7d ;
skos:note "The Secretary may approve a form for product information in relation to medicine." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.55" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-7d-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-7d-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-7d-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-7d-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-7d-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-7d-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "May" ;
cml:logicSummary "The Secretary may approve a form." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-7d-ss-2 a cml:Concept ;
skos:prefLabel "7D(2) Form for product information for medicine"@en ;
cml:realizedBy doc:sec-7d-ss-2 ;
cml:integrityHash "56878a263264a37a448d5da4457d78716e9f2e36cf9851978b0e2f8c4aefcb0d" ;
values:partOf concept:therapeutic-goods-act-1989-sec-7d ;
skos:note "Secretary may approve different forms for different medicines or classes of medicine." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.55" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-7d-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-7d-ss-2-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-7d-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-8 a cml:Concept ;
skos:prefLabel "8 Power to obtain information with respect to therapeutic goods"@en ;
cml:realizedBy doc:sec-8 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-8-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-8-ss-1a ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-8-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-8-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-8-ss-4 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.55" .
concept:therapeutic-goods-act-1989-sec-8-ss-1 a cml:Concept ;
skos:prefLabel "8(1) Power to obtain information with respect to therapeutic goods"@en ;
cml:realizedBy doc:sec-8-ss-1 ;
cml:integrityHash "6d17cd04cdd8f5e892f8c022bd67333cb2301544946adbde7178ab2c3cdf4342" ;
values:partOf concept:therapeutic-goods-act-1989-sec-8 ;
skos:note "Request for information about therapeutic goods" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.55" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-8-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-8-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-8-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-8-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-8-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-8-ss-1-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-8-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-8-ss-1-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-8-ss-1-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "WITHIN" ;
cml:logicSummary "Within a reasonable period" ;
cml:premiseText "within such reasonable period as is specified in the notice" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-8-ss-1a a cml:Concept ;
skos:prefLabel "8(1A) Power to obtain information with respect to therapeutic goods"@en ;
cml:realizedBy doc:sec-8-ss-1a ;
cml:integrityHash "fd3dfc60a96eb831e510f0988bd70096e358016338e16a18d91461c28f6b096c" ;
values:partOf concept:therapeutic-goods-act-1989-sec-8 ;
skos:note "Notice may require information to be given in writing or according to specified software requirements." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.55" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-8-ss-1a-norm .
concept:therapeutic-goods-act-1989-sec-8-ss-1a-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-8-ss-1a ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-8-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-8-ss-1a-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-8-ss-1a-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-8-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-8-ss-1a-logic-descriptionlogic-2 .
concept:therapeutic-goods-act-1989-sec-8-ss-1a-logic-descriptionlogic-2 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "Classifies" ;
cml:logicSummary "Classification of software requirements" ;
cml:premiseText "(a) in writing; or (b) in accordance with specified software requirements:" ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-8-ss-2 a cml:Concept ;
skos:prefLabel "8(2) Power to obtain information with respect to therapeutic goods"@en ;
cml:realizedBy doc:sec-8-ss-2 ;
cml:integrityHash "0dd37f0585aad5323a250bdff55a5202158523b73b0753889d735af5843407ac" ;
values:partOf concept:therapeutic-goods-act-1989-sec-8 ;
skos:note "Must comply with notice given under section." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.55" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-8-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-8-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-8-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-8-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-8-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-8-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Obligation to comply" ;
cml:premiseText "Notice given under section." ;
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-8-ss-3 a cml:Concept ;
skos:prefLabel "8(3) Power to obtain information with respect to therapeutic goods"@en ;
cml:realizedBy doc:sec-8-ss-3 ;
cml:integrityHash "89de1c90ed386be3887be1b7edefd187d3717d77b51b45f2d3026b5fc3758291" ;
values:partOf concept:therapeutic-goods-act-1989-sec-8 ;
skos:note "A reasonable excuse is a valid reason for not applying subsection (2)." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.55" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-8-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-8-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-8-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-8-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-8-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-8-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Obligation to provide a reasonable excuse." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-8-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-8-ss-3-logic-epistemic-2 .
concept:therapeutic-goods-act-1989-sec-8-ss-3-logic-epistemic-2 a cml:LogicApplication ;
cml:modality cml:Epistemic ;
cml:operator "Belief" ;
cml:logicSummary "The defendant believes they have a reasonable excuse." ;
cml:executionSurface "modalities::epistemic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-8-ss-4 a cml:Concept ;
skos:prefLabel "8(4) Power to obtain information with respect to therapeutic goods"@en ;
cml:realizedBy doc:sec-8-ss-4 ;
cml:integrityHash "2f4c062b4d9fcbf735959fc2360ecd2f7f01ab3c9ccdd23ad5ec0dada4a827c6" ;
values:partOf concept:therapeutic-goods-act-1989-sec-8 ;
skos:note "An offence under subsection (2) is an obligation." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.55" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-8-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-8-ss-4-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-8-ss-4 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-8-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-8-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-8-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "An obligation" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9 a cml:Concept ;
skos:prefLabel "9 Arrangements with States etc."@en ;
cml:realizedBy doc:sec-9 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.56" .
concept:therapeutic-goods-act-1989-sec-9-ss-1 a cml:Concept ;
skos:prefLabel "9(1) Arrangements with States etc."@en ;
cml:realizedBy doc:sec-9-ss-1 ;
cml:integrityHash "c2624c7bfaa86617f9b2a2a5c3be9f4b7947d4962b2c67c829affa1f5c2c1356" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9 ;
skos:note "The Minister may make arrangements with a State for the carrying out of certain functions on behalf of the Commonwealth." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.56" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-9-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9-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-9-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-9-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-9-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "may" ;
cml:logicSummary "Permission to make arrangements" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-9-ss-1-logic-deontic-2 .
concept:therapeutic-goods-act-1989-sec-9-ss-1-logic-deontic-2 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "must" ;
cml:logicSummary "Obligation to make arrangements" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9-ss-2 a cml:Concept ;
skos:prefLabel "9(2) Arrangements with States etc."@en ;
cml:realizedBy doc:sec-9-ss-2 ;
cml:integrityHash "d43d8f7eec65d1874f5957c66c6f95522f56cf7268490c61737f6e1dfdb36f86" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9 ;
skos:note "Payment of amounts to a State or Territory for performance of functions under an arrangement." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.56" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-9-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9-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-9-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-9-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-9-ss-2-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-9a a cml:Concept ;
skos:prefLabel "9A Australian Register of Therapeutic Goods"@en ;
cml:realizedBy doc:sec-9a ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9a-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9a-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9a-ss-3 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.58" .
concept:therapeutic-goods-act-1989-sec-9a-ss-1 a cml:Concept ;
skos:prefLabel "9A(1) Australian Register of Therapeutic Goods"@en ;
cml:realizedBy doc:sec-9a-ss-1 ;
cml:integrityHash "3611fe3d0b7ae6a491c1d4f8fcca69eec0fe05aaa929c045a0b1882fb613694a" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9a ;
skos:note "Maintain a register of therapeutic goods." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.58" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9a-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-9a-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9a-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-9a-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-9a-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-9a-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Obligation to maintain a register." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9a-ss-2 a cml:Concept ;
skos:prefLabel "9A(2) Australian Register of Therapeutic Goods"@en ;
cml:realizedBy doc:sec-9a-ss-2 ;
cml:integrityHash "c8217ea34a1eee31e0baadbd6fed53e2e347268d7cc5e8465e6eb7b7fb225ab9" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9a ;
skos:note "The Register is to be kept in such form as the Secretary determines." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.58" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9a-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-9a-ss-2-norm a values:Undertaking ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9a-ss-2 ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9a-ss-3 a cml:Concept ;
skos:prefLabel "9A(3) Australian Register of Therapeutic Goods"@en ;
cml:realizedBy doc:sec-9a-ss-3 ;
cml:integrityHash "5b71051ed32004df1a11d6a089c0cd34461efbfa16116f8a988de21e81398973" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9a ;
skos:note "Classification of goods in the Australian Register of Therapeutic Goods" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.58" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9a-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-9a-ss-3-norm a values:Undertaking ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9a-ss-3 ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9c a cml:Concept ;
skos:prefLabel "9C Inspection of entries in Register"@en ;
cml:realizedBy doc:sec-9c ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9c-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9c-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9c-ss-3 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.59" .
concept:therapeutic-goods-act-1989-sec-9c-ss-1 a cml:Concept ;
skos:prefLabel "9C(1) Inspection of entries in Register"@en ;
cml:realizedBy doc:sec-9c-ss-1 ;
cml:integrityHash "5cd00a9ac302b318dde73812828a4943b7d5ec1cfd05112a4dfdd39cebfdc4a2" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9c ;
skos:note "Request for copy of entry in Register" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.59" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9c-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-9c-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9c-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-9c-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-9c-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-9c-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "hasObligation" ;
cml:logicSummary "Therapeutic goods entry request" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9c-ss-2 a cml:Concept ;
skos:prefLabel "9C(2) Inspection of entries in Register"@en ;
cml:realizedBy doc:sec-9c-ss-2 ;
cml:integrityHash "55247de2a616851acdd5f20403b362896de4859ef557c9b936cb6d55659ec690" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9c ;
skos:note "Must provide a copy of requested entry from computer database" ;
dc:description "Yes" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.59" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9c-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-9c-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9c-ss-2 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9c-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-9c-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-9c-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-9c-ss-3 a cml:Concept ;
skos:prefLabel "9C(3) Inspection of entries in Register"@en ;
cml:realizedBy doc:sec-9c-ss-3 ;
cml:integrityHash "39ee6041ad21ed00a14d761a141fbe6528c12324252764a431c93b6f726b58c4" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9c ;
skos:note "Secretary may provide information in electronic format upon request." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.59" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9c-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-9c-ss-3-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9c-ss-3 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d a cml:Concept ;
skos:prefLabel "9D Variation of entries in Register"@en ;
cml:realizedBy doc:sec-9d ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9d-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9d-ss-1a ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9d-ss-1b ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9d-ss-1c ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9d-ss-1d ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9d-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9d-ss-2a ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9d-ss-2c ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9d-ss-2d ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9d-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9d-ss-3a ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9d-ss-3b ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9d-ss-3c ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9d-ss-3d ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9d-ss-4 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9d-ss-6 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9d-ss-7 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9d-ss-8 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.59" .
concept:therapeutic-goods-act-1989-sec-9d-ss-1 a cml:Concept ;
skos:prefLabel "9D(1) Variation of entries in Register"@en ;
cml:realizedBy doc:sec-9d-ss-1 ;
cml:integrityHash "35cfff09f8a83f4cff7ba134984e7614f9175bc1ef15da6b302d04ccb682c309" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9d ;
skos:note "Secretary may vary entry in Register under certain conditions." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.59" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-9d-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9d-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-9d-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-9d-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "may" ;
cml:logicSummary "Permissive obligation" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-1a a cml:Concept ;
skos:prefLabel "9D(1A) Variation of entries in Register"@en ;
cml:realizedBy doc:sec-9d-ss-1a ;
cml:integrityHash "983caa18fe2a18004dd611b254056785e7ba943ca6d13b5d8b625c953587c331" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9d ;
skos:note "Secretary may vary entry in Register under certain conditions." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.59" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-1a-norm .
concept:therapeutic-goods-act-1989-sec-9d-ss-1a-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9d-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-9d-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-1a-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-9d-ss-1a-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "May" ;
cml:logicSummary "Permits Secretary to take action." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-1a-logic-descriptionlogic-2 .
concept:therapeutic-goods-act-1989-sec-9d-ss-1a-logic-descriptionlogic-2 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "ClassInclusion" ;
cml:logicSummary "Variation of entries in Register is a class inclusion." ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-1b a cml:Concept ;
skos:prefLabel "9D(1B) Variation of entries in Register"@en ;
cml:realizedBy doc:sec-9d-ss-1b ;
cml:integrityHash "6ec60157496fbc8835c6aa5612657dcdac7f6830f9f52dcae0b61fb21bf28f48" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9d ;
skos:note "The Secretary may vary the entry in the Register on their own initiative." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.59" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-1b-norm .
concept:therapeutic-goods-act-1989-sec-9d-ss-1b-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9d-ss-1b ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-1b cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-1b-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-9d-ss-1b-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "May" ;
cml:logicSummary "Permission to vary the entry in the Register." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-1b cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-1b-logic-descriptionlogic-2 .
concept:therapeutic-goods-act-1989-sec-9d-ss-1b-logic-descriptionlogic-2 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "Variation of entries" ;
cml:logicSummary "Varying the entry in the Register." ;
cml:premiseText "(1B) If..." ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-1c a cml:Concept ;
skos:prefLabel "9D(1C) Variation of entries in Register"@en ;
cml:realizedBy doc:sec-9d-ss-1c ;
cml:integrityHash "85142cccf63885ba5352f3f582139f32a1a19c4606a818191d4c8252a6a97801" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9d ;
skos:note "Secretary must give notice and opportunity to submit before making variation." ;
dc:description "written notice, submission" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.59" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-1c-norm .
concept:therapeutic-goods-act-1989-sec-9d-ss-1c-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9d-ss-1c ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-1c cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-1c-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-9d-ss-1c-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Secretary must take submission into account" ;
cml:premiseText "Submission made in accordance with paragraph (b)" ;
cml:conclusionText "Decision to make variation" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-1c cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-1c-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-9d-ss-1c-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator ">=" ;
cml:logicSummary "Secretary must give notice before making variation" ;
cml:premiseText "Date of proposed variation" ;
cml:conclusionText "Notice given at least this far in advance" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-1d a cml:Concept ;
skos:prefLabel "9D(1D) Variation of entries in Register"@en ;
cml:realizedBy doc:sec-9d-ss-1d ;
cml:integrityHash "6032000971de34ad6c8405086321be1ac4a4f5f4552c4b6da0d62f9d01d7fa4f" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9d ;
skos:note "Subsections (1A) and (1B) apply despite subsection 16(1)." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.59" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-1d-norm .
concept:therapeutic-goods-act-1989-sec-9d-ss-1d-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9d-ss-1d ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-1d cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-1d-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-9d-ss-1d-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Continuation" ;
cml:logicSummary "Continues the obligation despite a condition." ;
cml:premiseText "(1D) Subsections (1A) and (1B)" ;
cml:conclusionText "Subsections (1A) and (1B) apply despite subsection 16(1)." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-1d cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-1d-logic-deontic-2 .
concept:therapeutic-goods-act-1989-sec-9d-ss-1d-logic-deontic-2 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Overriding Condition" ;
cml:logicSummary "Overrides the condition." ;
cml:premiseText "(1D)" ;
cml:conclusionText "Subsections (1A) and (1B) apply despite subsection 16(1)." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-1d cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-1d-logic-linearlogic-3 .
concept:therapeutic-goods-act-1989-sec-9d-ss-1d-logic-linearlogic-3 a cml:LogicApplication ;
cml:modality cml:LinearLogic ;
cml:operator "Continuation" ;
cml:logicSummary "Continues the linear logic application." ;
cml:premiseText "(1D)" ;
cml:conclusionText "Subsections (1A) and (1B) apply despite subsection 16(1)." ;
cml:executionSurface "modalities::linear" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-1d cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-1d-logic-deontic-4 .
concept:therapeutic-goods-act-1989-sec-9d-ss-1d-logic-deontic-4 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Negation" ;
cml:logicSummary "Negates the condition." ;
cml:premiseText "(1D)" ;
cml:conclusionText "Subsections (1A) and (1B) do not apply despite subsection 16(1)." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-2 a cml:Concept ;
skos:prefLabel "9D(2) Variation of entries in Register"@en ;
cml:realizedBy doc:sec-9d-ss-2 ;
cml:integrityHash "a3d17269b40dbe63e3bd653cecdaf2709639d6423e1c74626c440b3e9add4fbd" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9d ;
skos:note "Variation of entries in Register upon request" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.59" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-9d-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9d-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-9d-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-9d-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Must provide variation upon request" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-2-logic-descriptionlogic-2 .
concept:therapeutic-goods-act-1989-sec-9d-ss-2-logic-descriptionlogic-2 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "CLASSIFICATION" ;
cml:logicSummary "Classification of therapeutic goods" ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-2a a cml:Concept ;
skos:prefLabel "9D(2A) Variation of entries in Register"@en ;
cml:realizedBy doc:sec-9d-ss-2a ;
cml:integrityHash "7e75cdfda3733a253b29509e4289bd40d7ab54229143edd22f2212d511777919" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9d ;
skos:note "Subsection (2) of section 16(1) applies despite subsection (2A)" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.59" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-2a-norm .
concept:therapeutic-goods-act-1989-sec-9d-ss-2a-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9d-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-9d-ss-2a cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-2a-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-9d-ss-2a-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "applies" ;
cml:logicSummary "Subsection (2) applies despite subsection (2A)" ;
cml:premiseText "(2A)" ;
cml:conclusionText "(2)" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-2c a cml:Concept ;
skos:prefLabel "9D(2C) Variation of entries in Register"@en ;
cml:realizedBy doc:sec-9d-ss-2c ;
cml:integrityHash "57cad66c5a121bdd6d17126d128b102867b3fda0335e6482d08e76b62fb6089b" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9d ;
skos:note "Secretary must vary entry in Register upon request." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.59" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-2c-norm .
concept:therapeutic-goods-act-1989-sec-9d-ss-2c-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9d-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-9d-ss-2c cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-2c-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-9d-ss-2c-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Must provide variation upon request." ;
cml:premiseText "(a) the person in relation to whom therapeutic goods are registered or listed has requested the Secretary to vary the entry in the Register that relates to the goods;" ;
cml:conclusionText "the Secretary must vary the entry in accordance with the request." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-2c cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-2c-logic-deontic-2 .
concept:therapeutic-goods-act-1989-sec-9d-ss-2c-logic-deontic-2 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Must satisfy conditions specified in regulations." ;
cml:premiseText "(b) the variation is of a kind specified in the regulations;" ;
cml:conclusionText "the conditions (if any) specified in the regulations are satisfied;" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-2c cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-2c-logic-alleninterval-3 .
concept:therapeutic-goods-act-1989-sec-9d-ss-2c-logic-alleninterval-3 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "BETWEEN" ;
cml:logicSummary "Request must be made within unspecified time frame." ;
cml:premiseText "(a) the person in relation to whom therapeutic goods are registered or listed has requested the Secretary to vary the entry in the Register that relates to the goods;" ;
cml:conclusionText "the request was made at some point in time." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-2c cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-2c-logic-ltl-4 .
concept:therapeutic-goods-act-1989-sec-9d-ss-2c-logic-ltl-4 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "BETWEEN" ;
cml:logicSummary "Request must be made within unspecified time frame." ;
cml:premiseText "(a) the person in relation to whom therapeutic goods are registered or listed has requested the Secretary to vary the entry in the Register that relates to the goods;" ;
cml:conclusionText "the request was made at some point in time." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-2c cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-2c-logic-deontic-5 .
concept:therapeutic-goods-act-1989-sec-9d-ss-2c-logic-deontic-5 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Request must be made by person with registered or listed therapeutic goods." ;
cml:premiseText "(a) the person in relation to whom therapeutic goods are registered or listed has requested the Secretary to vary the entry in the Register that relates to the goods;" ;
cml:conclusionText "the request was made by a person who has registered or listed therapeutic goods." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-2d a cml:Concept ;
skos:prefLabel "9D(2D) Variation of entries in Register"@en ;
cml:realizedBy doc:sec-9d-ss-2d ;
cml:integrityHash "be85a7a28ac6f6ee5a4d3e7e090bad0f78a939e2a1882e5a8e022338ce29d5e4" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9d ;
skos:note "Subsection (2C) applies despite subsection 16(1)." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.59" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-2d-norm .
concept:therapeutic-goods-act-1989-sec-9d-ss-2d-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9d-ss-2d ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-2d cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-2d-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-9d-ss-2d-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Implies" ;
cml:logicSummary "Subsection (2C) implies subsection 16(1)." ;
cml:premiseText "(2D)" ;
cml:conclusionText "(2C)" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-3 a cml:Concept ;
skos:prefLabel "9D(3) Variation of entries in Register"@en ;
cml:realizedBy doc:sec-9d-ss-3 ;
cml:integrityHash "b32b31452e17103c8ea14d4dfa410bf0bd23e58c8a1dc2ba799d6a91b98c5c52" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9d ;
skos:note "Secretary may vary entry in Register upon request." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.59" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-9d-ss-3-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9d-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-9d-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-9d-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "May" ;
cml:logicSummary "Permits variation of entries in Register." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-3-logic-descriptionlogic-2 .
concept:therapeutic-goods-act-1989-sec-9d-ss-3-logic-descriptionlogic-2 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "Variation" ;
cml:logicSummary "Specifies conditions for variation of entries in Register." ;
cml:premiseText "(3) If: ...; (3AA) If: ...; (3AC) If: ...;" ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-3-logic-deontic-3 .
concept:therapeutic-goods-act-1989-sec-9d-ss-3-logic-deontic-3 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Must" ;
cml:logicSummary "Secretary must vary entry in Register upon request." ;
cml:premiseText "(3AA) If: ...; (3AC) If: ...;" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-3-logic-linearlogic-4 .
concept:therapeutic-goods-act-1989-sec-9d-ss-3-logic-linearlogic-4 a cml:LogicApplication ;
cml:modality cml:LinearLogic ;
cml:operator "And" ;
cml:logicSummary "Combines conditions for variation of entries in Register." ;
cml:premiseText "(3) If: ... And (3AA) If: ... And (3AC) If: ...;" ;
cml:executionSurface "modalities::linear" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-3-logic-descriptionlogic-5 .
concept:therapeutic-goods-act-1989-sec-9d-ss-3-logic-descriptionlogic-5 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "Satisfies" ;
cml:logicSummary "Specifies conditions for variation of entries in Register." ;
cml:premiseText "(c) the Secretary is satisfied that the variation requested does not indicate any reduction in the quality, safety or efficacy of the goods for the purposes for which they are to be used;" ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-3-logic-deontic-6 .
concept:therapeutic-goods-act-1989-sec-9d-ss-3-logic-deontic-6 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Must" ;
cml:logicSummary "Secretary must vary entry in Register upon request." ;
cml:premiseText "(3) If: ...; (3AA) If: ...; (3AC) If: ...;" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-3a a cml:Concept ;
skos:prefLabel "9D(3A) Variation of entries in Register"@en ;
cml:realizedBy doc:sec-9d-ss-3a ;
cml:integrityHash "2ebc7b3de21f93c195cabfd58b42db0773a777e91c1534d4f59df0d2147cf6b6" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9d ;
skos:note "Secretary may vary entry in Register upon request." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.59" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-3a-norm .
concept:therapeutic-goods-act-1989-sec-9d-ss-3a-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9d-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-9d-ss-3a cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-3a-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-9d-ss-3a-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "May" ;
cml:logicSummary "Permits variation of entries in Register." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-3b a cml:Concept ;
skos:prefLabel "9D(3B) Variation of entries in Register"@en ;
cml:realizedBy doc:sec-9d-ss-3b ;
cml:integrityHash "b21e1e9da45f15a88d019c656873026c68501ede9c65b35b3758112ea02ddff0" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9d ;
skos:note "Secretary must move entry from part of Register for biologicals to applicable part." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.59" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-3b-norm .
concept:therapeutic-goods-act-1989-sec-9d-ss-3b-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9d-ss-3b ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-3b cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-3b-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-9d-ss-3b-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Obligation to move entry" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-3c a cml:Concept ;
skos:prefLabel "9D(3C) Variation of entries in Register"@en ;
cml:realizedBy doc:sec-9d-ss-3c ;
cml:integrityHash "0200ff3c57bdf9899fdff339cf2574e201d8017db0935fda2cb585532d4ad480" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9d ;
skos:note "Variation of entries in Register upon request" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.59" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-3c-norm .
concept:therapeutic-goods-act-1989-sec-9d-ss-3c-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9d-ss-3c ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-3c cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-3c-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-9d-ss-3c-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Must vary entry" ;
cml:premiseText "(a) the person in relation to whom a kind of medical device is included in the Register has requested..." ;
cml:conclusionText "...the Secretary must vary the entry in accordance with the request." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-3c cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-3c-logic-deontic-2 .
concept:therapeutic-goods-act-1989-sec-9d-ss-3c-logic-deontic-2 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Must satisfy conditions" ;
cml:premiseText "(c) the conditions (if any) specified in the regulations are satisfied;" ;
cml:conclusionText "...the Secretary must vary the entry in accordance with the request." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-3c cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-3c-logic-descriptionlogic-3 .
concept:therapeutic-goods-act-1989-sec-9d-ss-3c-logic-descriptionlogic-3 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "SUBCLASS_OF" ;
cml:logicSummary "Variation of entries is a subclass of variation upon request" ;
cml:premiseText "(3C) If..." ;
cml:conclusionText "...the Secretary must vary the entry in accordance with the request." ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-3c cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-3c-logic-alleninterval-4 .
concept:therapeutic-goods-act-1989-sec-9d-ss-3c-logic-alleninterval-4 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "CONTAINS" ;
cml:logicSummary "Variation of entries is contained within variation upon request" ;
cml:premiseText "(3C) If..." ;
cml:conclusionText "...the Secretary must vary the entry in accordance with the request." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-3c cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-3c-logic-deontic-5 .
concept:therapeutic-goods-act-1989-sec-9d-ss-3c-logic-deontic-5 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MAY" ;
cml:logicSummary "May vary entry without conditions" ;
cml:premiseText "(3CB) If...(a) the person in relation to whom a kind of medical device is included in the Register has requested..." ;
cml:conclusionText "...the Secretary must vary the entry in accordance with the request." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-3c cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-3c-logic-deontic-6 .
concept:therapeutic-goods-act-1989-sec-9d-ss-3c-logic-deontic-6 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Must add warning, restriction or precaution" ;
cml:premiseText "(b) the only effect of the variation would be...(ii) to add a warning, restriction or precaution..." ;
cml:conclusionText "...the Secretary must vary the entry in accordance with the request." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-3d a cml:Concept ;
skos:prefLabel "9D(3D) Variation of entries in Register"@en ;
cml:realizedBy doc:sec-9d-ss-3d ;
cml:integrityHash "c7eda553a0b10dd8f9c80280822007e1c4e2addd1451c921c6265b5a81d68d95" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9d ;
skos:note "Secretary may vary entry in Register upon request." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.59" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-3d-norm .
concept:therapeutic-goods-act-1989-sec-9d-ss-3d-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9d-ss-3d ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-3d cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-3d-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-9d-ss-3d-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "May" ;
cml:logicSummary "Permits variation of entries in Register." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-3d cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-3d-logic-descriptionlogic-2 .
concept:therapeutic-goods-act-1989-sec-9d-ss-3d-logic-descriptionlogic-2 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "Variation" ;
cml:logicSummary "Allows for variation of entries in Register." ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-4 a cml:Concept ;
skos:prefLabel "9D(4) Variation of entries in Register"@en ;
cml:realizedBy doc:sec-9d-ss-4 ;
cml:integrityHash "c7777b0612bfe49962582486faf9e48f06dfc78b2d893d7b86a58d11aa114da8" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9d ;
skos:note "Must move entry from medical devices part to applicable part of Register" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.59" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-9d-ss-4-norm a values:Undertaking ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9d-ss-4 ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-6 a cml:Concept ;
skos:prefLabel "9D(6) Variation of entries in Register"@en ;
cml:realizedBy doc:sec-9d-ss-6 ;
cml:integrityHash "a8b3f09d9518d7e2889f52f740f6174283ee915d8f98d2e82cb87b5358755563" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9d ;
skos:note "Secretary may approve forms and manners for requests under this section." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.59" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-6-norm .
concept:therapeutic-goods-act-1989-sec-9d-ss-6-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9d-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-9d-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-6-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-9d-ss-6-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "May" ;
cml:logicSummary "Permits the Secretary to approve forms and manners." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-6-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-9d-ss-6-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Within" ;
cml:logicSummary "Limits the scope to specific temporal intervals." ;
cml:premiseText "(6) The Secretary may, by writing:" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-7 a cml:Concept ;
skos:prefLabel "9D(7) Variation of entries in Register"@en ;
cml:realizedBy doc:sec-9d-ss-7 ;
cml:integrityHash "78820e3d3a70dc5784d0360e97d151428bf9c084ae08c0fbe6bfe1790a946453" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9d ;
skos:note "Request for variation of entries in Register must comply with approved form and contain required information." ;
dc:description "Form, information, application fee, and prescribed documentation" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.59" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-7-norm .
concept:therapeutic-goods-act-1989-sec-9d-ss-7-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9d-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-9d-ss-7 cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-7-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-9d-ss-7-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Request must comply with approved form" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-7 cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-7-logic-descriptionlogic-2 .
concept:therapeutic-goods-act-1989-sec-9d-ss-7-logic-descriptionlogic-2 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "IS_A" ;
cml:logicSummary "Form and information are of a kind determined under subsection (8)" ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9d-ss-8 a cml:Concept ;
skos:prefLabel "9D(8) Variation of entries in Register"@en ;
cml:realizedBy doc:sec-9d-ss-8 ;
cml:integrityHash "c8acdfa9eebc15a9477630719dd06bd48300858ef11776cca53a6109aa38b695" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9d ;
skos:note "The Secretary may determine a kind of information for the purposes of subparagraph (7)(g)(i)." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.59" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9d-ss-8-norm .
concept:therapeutic-goods-act-1989-sec-9d-ss-8-norm a values:Undertaking ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9d-ss-8 ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9e a cml:Concept ;
skos:prefLabel "9E Publication of list of goods on Register"@en ;
cml:realizedBy doc:sec-9e ;
cml:integrityHash "7f470528acde4bcf8c8e752d1f079acbe43971bd2702ad338c807440f7149bf8" ;
skos:note "The Secretary must publish a list of therapeutic goods on the Register at least once every 12 months." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.65" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9e-norm .
concept:therapeutic-goods-act-1989-sec-9e-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9e ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9e cml:asserts concept:therapeutic-goods-act-1989-sec-9e-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-9e-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "The Secretary must publish a list of therapeutic goods on the Register." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9f a cml:Concept ;
skos:prefLabel "9F Removal of entries from Register"@en ;
cml:realizedBy doc:sec-9f ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9f-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9f-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9f-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9f-ss-4 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9f-ss-5 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9f-ss-6 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9f-ss-7 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.65" .
concept:therapeutic-goods-act-1989-sec-9f-ss-1 a cml:Concept ;
skos:prefLabel "9F(1) Removal of entries from Register"@en ;
cml:realizedBy doc:sec-9f-ss-1 ;
cml:integrityHash "f20ec0ad3465730dea3a9c906e3c6b86d92e3b76ec72c9b7c3454297c6ac9854" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9f ;
skos:note "Prohibition on removal of entries from Register if goods are therapeutic" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.65" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9f-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-9f-ss-1-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9f-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-9f-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-9f-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-9f-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "forbid" ;
cml:logicSummary "Prohibits removal of entries from Register" ;
cml:premiseText "(1) This section applies if: (a) there is an entry on the Register in relation to goods; and (b) the Secretary is satisfied that the goods are not therapeutic goods." ;
cml:conclusionText "The removal of entries from the Register is prohibited." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9f-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-9f-ss-1-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-9f-ss-1-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "during" ;
cml:logicSummary "Describes the temporal relationship between the provision and its application" ;
cml:premiseText "(1) This section applies if: (a) there is an entry on the Register in relation to goods; and (b) the Secretary is satisfied that the goods are not therapeutic goods." ;
cml:conclusionText "The provision applies during the existence of an entry on the Register related to goods that are not therapeutic goods." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9f-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-9f-ss-1-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-9f-ss-1-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "everywhere" ;
cml:logicSummary "Describes the spatial relationship between the provision and its application" ;
cml:premiseText "(a) there is an entry on the Register in relation to goods; and (b) the Secretary is satisfied that the goods are not therapeutic goods." ;
cml:conclusionText "The provision applies everywhere where there is an entry on the Register related to goods that are not therapeutic goods." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9f-ss-2 a cml:Concept ;
skos:prefLabel "9F(2) Removal of entries from Register"@en ;
cml:realizedBy doc:sec-9f-ss-2 ;
cml:integrityHash "e160d9c518b13a788c45335c0363d09a5008c282417fbe88b29050f4bb5a5fe2" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9f ;
skos:note "Secretary may remove entry from Register" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.65" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9f-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-9f-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9f-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-9f-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-9f-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-9f-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "may" ;
cml:logicSummary "Obligation to remove entry" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9f-ss-3 a cml:Concept ;
skos:prefLabel "9F(3) Removal of entries from Register"@en ;
cml:realizedBy doc:sec-9f-ss-3 ;
cml:integrityHash "327e09ec79bb25bf63354e9999ee0289b257d84869477fc38d7a62fcf9c8a3e1" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9f ;
skos:note "Secretary must inform person of proposed removal and invite written submissions." ;
dc:description "written submissions" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.65" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9f-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-9f-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9f-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-9f-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-9f-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-9f-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Secretary must inform person of proposed removal." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9f-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-9f-ss-3-logic-deontic-2 .
concept:therapeutic-goods-act-1989-sec-9f-ss-3-logic-deontic-2 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MAY" ;
cml:logicSummary "Person may make written submissions to Secretary." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9f-ss-4 a cml:Concept ;
skos:prefLabel "9F(4) Removal of entries from Register"@en ;
cml:realizedBy doc:sec-9f-ss-4 ;
cml:integrityHash "5293dad18aef60ccfcf180a425ea7b6c3f45f3e6b0f3c50aaa7d6fea34b56e6f" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9f ;
skos:note "Secretary must consider submissions before giving notice." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.65" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9f-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-9f-ss-4-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9f-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-9f-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-9f-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-9f-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Must" ;
cml:logicSummary "Mandatory action" ;
cml:premiseText "The Secretary must not..." ;
cml:conclusionText "...until the Secretary has had regard to..." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9f-ss-5 a cml:Concept ;
skos:prefLabel "9F(5) Removal of entries from Register"@en ;
cml:realizedBy doc:sec-9f-ss-5 ;
cml:integrityHash "d42ef7be6d86528b8640db4091ff3474c857b5d86c78c8578d5e92cd81b913ea" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9f ;
skos:note "Notice under subsection (2) is not a legislative instrument." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.65" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9f-ss-5-norm .
concept:therapeutic-goods-act-1989-sec-9f-ss-5-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9f-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-9f-ss-6 a cml:Concept ;
skos:prefLabel "9F(6) Removal of entries from Register"@en ;
cml:realizedBy doc:sec-9f-ss-6 ;
cml:integrityHash "4da4b55b769d42e8d6eb9387bd6510fa1d0ac5e7fbeead75d0f3baaa02b18580" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9f ;
skos:note "Removal of entries from Register has effect on specified day" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.65" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9f-ss-6-norm .
concept:therapeutic-goods-act-1989-sec-9f-ss-6-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9f-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-9f-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-9f-ss-6-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-9f-ss-6-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "hasEffect" ;
cml:logicSummary "Imposes obligation" ;
cml:conclusionText "The removal has effect..." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9f-ss-7 a cml:Concept ;
skos:prefLabel "9F(7) Removal of entries from Register"@en ;
cml:realizedBy doc:sec-9f-ss-7 ;
cml:integrityHash "8161738457e3877d2d02251f316a0d1fcc828b9104b3de2d39ffcd6f8f5eefec" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9f ;
skos:note "Secretary must publish notice after removing entry from Register." ;
dc:description "Notice setting out particulars of removal" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.65" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9f-ss-7-norm .
concept:therapeutic-goods-act-1989-sec-9f-ss-7-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9f-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-9f-ss-7 cml:asserts concept:therapeutic-goods-act-1989-sec-9f-ss-7-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-9f-ss-7-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-9g a cml:Concept ;
skos:prefLabel "9G Criminal offences for false statements in requests for variation of"@en ;
cml:realizedBy doc:sec-9g ;
cml:integrityHash "8a2cf7facb7b9373af2789f3f8774361565cd5291d5e460ff55ff32a7154e1b3" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9g-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9g-ss-4 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9g-ss-5 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9g-ss-6 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.66" .
concept:therapeutic-goods-act-1989-sec-9g-ss-1 a cml:Concept ;
skos:prefLabel "9G(1) Criminal offences for false statements in requests for variation of"@en ;
cml:realizedBy doc:sec-9g-ss-1 ;
cml:integrityHash "0f78a194971f9ac7e7a922966282ff3020eeb613ea0b4db3afa40b517adb35e7" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9g ;
skos:note "Making false statements in requests for variation of therapeutic goods entries is prohibited." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.66" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9g-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-9g-ss-1-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9g-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-9g-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-9g-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-9g-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-9g-ss-4 a cml:Concept ;
skos:prefLabel "9G(4) Criminal offences for false statements in requests for variation of"@en ;
cml:realizedBy doc:sec-9g-ss-4 ;
cml:integrityHash "2bf760abeb38f2ce7c2a2c987836836979c1848d0fabfbbbfb81f5cee93694d2" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9g ;
skos:note "Making false statements in requests for variation of therapeutic goods entries is prohibited." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.66" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9g-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-9g-ss-4-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9g-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-9g-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-9g-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-9g-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits making false statements in requests for variation of therapeutic goods entries." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9g-ss-5 a cml:Concept ;
skos:prefLabel "9G(5) Criminal offences for false statements in requests for variation of"@en ;
cml:realizedBy doc:sec-9g-ss-5 ;
cml:integrityHash "6302431c0645a2b6a6f111cc023a9da8e26f4d70003dea417bd25f695f6a8592" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9g ;
skos:note "Making false statements in requests for variation of therapeutic goods entries is an offence." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.66" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9g-ss-5-norm .
concept:therapeutic-goods-act-1989-sec-9g-ss-5-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9g-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-9g-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-9g-ss-5-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-9g-ss-5-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibition" ;
cml:logicSummary "Prohibits making false statements in requests for variation of therapeutic goods entries." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9g-ss-6 a cml:Concept ;
skos:prefLabel "9G(6) Criminal offences for false statements in requests for variation of"@en ;
cml:realizedBy doc:sec-9g-ss-6 ;
cml:integrityHash "aa2c5c6c78224eb2b4b4ccc76ad45c9abbf2cf07d58268540d047ab8b3703b0d" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9g ;
skos:note "An offence against subsection (5) is an offence of strict liability." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.66" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9g-ss-6-norm .
concept:therapeutic-goods-act-1989-sec-9g-ss-6-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9g-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-9g-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-9g-ss-6-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-9g-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-9h a cml:Concept ;
skos:prefLabel "9H Civil penalty for false statements in requests for variation of"@en ;
cml:realizedBy doc:sec-9h ;
cml:integrityHash "342a544e86298c11472ae3580dd65426662dc1027f0dadf461c1c468bda20af9" ;
skos:note "False statements in requests for variation of entries in Register" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.68" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9h-norm .
concept:therapeutic-goods-act-1989-sec-9h-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9h ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9h cml:asserts concept:therapeutic-goods-act-1989-sec-9h-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-9h-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibition" ;
cml:logicSummary "Prohibits making false statements" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9j a cml:Concept ;
skos:prefLabel "9J Simplified outline of this Chapter"@en ;
cml:realizedBy doc:sec-9j ;
cml:integrityHash "f5d6023a0da9969ac44554361e9d3c51868f29fffc9f43a94565cfb7ecf7f812" ;
skos:note "Regulations may prohibit imports, exports, manufacture, and supplies of certain goods." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.69" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9j-norm .
concept:therapeutic-goods-act-1989-sec-9j-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9j ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9j cml:asserts concept:therapeutic-goods-act-1989-sec-9j-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-9j-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Regulations prohibit imports, exports, manufacture, and supplies of certain goods." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9j cml:asserts concept:therapeutic-goods-act-1989-sec-9j-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-9j-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Temporal Interval" ;
cml:logicSummary "Regulations apply to imports, exports, manufacture, and supplies within 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-9k a cml:Concept ;
skos:prefLabel "9K Prohibition on import, export, manufacture or supply of"@en ;
cml:realizedBy doc:sec-9k ;
cml:integrityHash "7655ae8d2dfd3a36d7eb99e26bd08b44dd2f31133138e14a9e06673f0467e173" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9k-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9k-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9k-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9k-ss-4 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9k-ss-5 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9k-ss-6 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9k-ss-7 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9k-ss-8 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.69" .
concept:therapeutic-goods-act-1989-sec-9k-ss-1 a cml:Concept ;
skos:prefLabel "9K(1) Prohibition on import, export, manufacture or supply of"@en ;
cml:realizedBy doc:sec-9k-ss-1 ;
cml:integrityHash "a7acaba5ee705c954d1cc176766e4324c721bf536ebd49372206c691b4e358d9" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9k ;
skos:note "Prohibition on import, export, manufacture or supply of therapeutic goods or vaping goods" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.69" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9k-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-9k-ss-1-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9k-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-9k-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-9k-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-9k-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits the specified actions" ;
cml:premiseText "(1) If therapeutic goods or vaping goods are the subject of an international agreement prescribed for the purposes of this subsection, the regulations may prohibit 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-9k-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-9k-ss-1-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-9k-ss-1-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "During" ;
cml:logicSummary "Prohibition applies during international agreements" ;
cml:premiseText "If therapeutic goods or vaping goods are the subject of an international agreement prescribed for the purposes of this subsection, the regulations may prohibit 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-9k-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-9k-ss-1-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-9k-ss-1-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "Until" ;
cml:logicSummary "Prohibition ends when international agreements expire" ;
cml:premiseText "(1) If therapeutic goods or vaping goods are the subject of an international agreement prescribed for the purposes of this subsection, the regulations may prohibit one or more of the following:" ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9k-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-9k-ss-1-logic-deontic-4 .
concept:therapeutic-goods-act-1989-sec-9k-ss-1-logic-deontic-4 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits the specified actions" ;
cml:premiseText "(b) the export from Australia of the therapeutic goods or vaping goods;" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9k-ss-2 a cml:Concept ;
skos:prefLabel "9K(2) Prohibition on import, export, manufacture or supply of"@en ;
cml:realizedBy doc:sec-9k-ss-2 ;
cml:integrityHash "b07b1180e4d38f1087f4560876d54ba356e1a7804dd2f47985063ac6f6c37140" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9k ;
skos:note "Regulations must prohibit or restrict import, export, manufacture and supply of certain goods before an international agreement is made." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.69" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9k-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-9k-ss-2-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9k-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-9k-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-9k-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-9k-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Regulations must prohibit or restrict certain goods." ;
cml:premiseText "International agreement requires parties to take steps to prohibit or restrict import, export, manufacture and supply of certain goods." ;
cml:conclusionText "Regulations must prohibit or restrict import, export, manufacture and supply of certain goods." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9k-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-9k-ss-2-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-9k-ss-2-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Temporal Interval" ;
cml:logicSummary "Regulations must be made before an international agreement is made." ;
cml:premiseText "Before regulations are made prescribing an international agreement for the purposes of subsection (1), the Minister must be satisfied that the agreement requires parties to the agreement to take steps to prohibit or restrict one or more of the import, export, manufacture and supply of certain goods." ;
cml:conclusionText "Regulations must be made before an international agreement is made." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9k-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-9k-ss-2-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-9k-ss-2-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "Recurring Trace" ;
cml:logicSummary "International agreements require parties to take steps to prohibit or restrict import, export, manufacture and supply of certain goods." ;
cml:premiseText "The Minister must be satisfied that the agreement requires parties to the agreement to take steps to prohibit or restrict one or more of the import, export, manufacture and supply of certain goods." ;
cml:conclusionText "International agreements require parties to take steps to prohibit or restrict import, export, manufacture and supply of certain goods." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9k-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-9k-ss-2-logic-diffusion-4 .
concept:therapeutic-goods-act-1989-sec-9k-ss-2-logic-diffusion-4 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "Diffuse" ;
cml:logicSummary "Regulations must diffuse to all parties to the agreement." ;
cml:premiseText "The Minister must be satisfied that the agreement requires parties to the agreement to take steps to prohibit or restrict one or more of the import, export, manufacture and supply of certain goods." ;
cml:conclusionText "Regulations must diffuse to all parties to the agreement." ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9k-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-9k-ss-2-logic-argumentation-5 .
concept:therapeutic-goods-act-1989-sec-9k-ss-2-logic-argumentation-5 a cml:LogicApplication ;
cml:modality cml:Argumentation ;
cml:operator "Implication" ;
cml:logicSummary "International agreements imply regulations that prohibit or restrict import, export, manufacture and supply of certain goods." ;
cml:premiseText "The Minister must be satisfied that the agreement requires parties to the agreement to take steps to prohibit or restrict one or more of the import, export, manufacture and supply of certain goods." ;
cml:conclusionText "International agreements imply regulations that prohibit or restrict import, export, manufacture and supply of certain goods." ;
cml:executionSurface "modalities::argumentation" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9k-ss-3 a cml:Concept ;
skos:prefLabel "9K(3) Prohibition on import, export, manufacture or supply of"@en ;
cml:realizedBy doc:sec-9k-ss-3 ;
cml:integrityHash "dd769768394d63c02443553e2558e312353996753c3e9bdae52290112acec0f3" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9k ;
skos:note "Regulations may prohibit import, export, manufacture or supply of therapeutic goods or vaping goods containing a specified ingredient or component." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.69" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9k-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-9k-ss-3-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9k-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-9k-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-9k-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-9k-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Regulations prohibit certain actions." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9k-ss-4 a cml:Concept ;
skos:prefLabel "9K(4) Prohibition on import, export, manufacture or supply of"@en ;
cml:realizedBy doc:sec-9k-ss-4 ;
cml:integrityHash "2e86778b334a804e0b9a34226c0aa9b1cee156a55133b857b1811703a4e08956" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9k ;
skos:note "Regulations must prohibit or restrict import, export, manufacture and supply of goods containing a specific ingredient or component." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.69" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9k-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-9k-ss-4-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9k-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-9k-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-9k-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-9k-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Regulations must prohibit the specified activity." ;
cml:premiseText "(4) Before regulations are made..." ;
cml:conclusionText "...the Minister must be satisfied..." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9k-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-9k-ss-4-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-9k-ss-4-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Temporal Interval" ;
cml:logicSummary "The regulation must be made before a specific temporal interval." ;
cml:premiseText "(4) Before regulations are made..." ;
cml:conclusionText "...the Minister must be satisfied..." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9k-ss-5 a cml:Concept ;
skos:prefLabel "9K(5) Prohibition on import, export, manufacture or supply of"@en ;
cml:realizedBy doc:sec-9k-ss-5 ;
cml:integrityHash "64d23a5e753ccd7afa4f10349f138612ae966580f0df93dce99197322d0a7a3f" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9k ;
skos:note "Absolute or conditionally prescribed prohibition on import, export, manufacture or supply of therapeutic goods or vaping goods." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.69" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9k-ss-5-norm .
concept:therapeutic-goods-act-1989-sec-9k-ss-5-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9k-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-9k-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-9k-ss-5-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-9k-ss-5-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Absolute prohibition" ;
cml:premiseText "(5) A prohibition referred to in subsection (1) or (3) may be absolute" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9k-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-9k-ss-5-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-9k-ss-5-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Temporal Interval" ;
cml:logicSummary "Temporal interval for prohibition" ;
cml:premiseText "(5) A prohibition referred to in subsection (1) or (3) may be absolute" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9k-ss-6 a cml:Concept ;
skos:prefLabel "9K(6) Prohibition on import, export, manufacture or supply of"@en ;
cml:realizedBy doc:sec-9k-ss-6 ;
cml:integrityHash "90748b5f61c3cea7534e2e8c8d75ee7240390991609fc7ab3ddd2fcc363596f4" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9k ;
skos:note "Regulations containing a prohibition must be published and wait 30 days before implementation." ;
dc:description "(i) the international agreement; (ii) the Minister’s satisfaction; (iii) the proposed prohibition" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.69" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9k-ss-6-norm .
concept:therapeutic-goods-act-1989-sec-9k-ss-6-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9k-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-9k-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-9k-ss-6-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-9k-ss-6-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibition" ;
cml:logicSummary "Regulations containing a prohibition" ;
cml:premiseText "(6) Regulations containing a prohibition referred to in subsection (1) or (3)" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9k-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-9k-ss-6-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-9k-ss-6-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Temporal Interval" ;
cml:logicSummary "Notice must be published for at least 30 days before implementation" ;
cml:premiseText "(b) a period of 30 days has passed since the notice was published" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9k-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-9k-ss-6-logic-deontic-3 .
concept:therapeutic-goods-act-1989-sec-9k-ss-6-logic-deontic-3 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Permission" ;
cml:logicSummary "Regulations must be published for public review" ;
cml:premiseText "(a) the Minister causes to be published on the Department’s website a notice setting out details of: (i) the international agreement; and (ii) the Minister’s satisfaction" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9k-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-9k-ss-6-logic-deontic-4 .
concept:therapeutic-goods-act-1989-sec-9k-ss-6-logic-deontic-4 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Minister must cause publication of notice" ;
cml:premiseText "(a) the Minister causes to be published on the Department’s website a notice setting out details of: (i) the international agreement; and (ii) the Minister’s satisfaction" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9k-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-9k-ss-6-logic-deontic-5 .
concept:therapeutic-goods-act-1989-sec-9k-ss-6-logic-deontic-5 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibition" ;
cml:logicSummary "Regulations containing prohibition must be implemented after publication" ;
cml:premiseText "(b) a period of 30 days has passed since the notice was published" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9k-ss-7 a cml:Concept ;
skos:prefLabel "9K(7) Prohibition on import, export, manufacture or supply of"@en ;
cml:realizedBy doc:sec-9k-ss-7 ;
cml:integrityHash "b2841988c0a3f35a1f6741d1a37750933cc8a45282ea541e4f981447030e2dc9" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9k ;
skos:note "Regulations with prohibition must not start before the international agreement enters into force." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.69" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9k-ss-7-norm .
concept:therapeutic-goods-act-1989-sec-9k-ss-7-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9k-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-9k-ss-7 cml:asserts concept:therapeutic-goods-act-1989-sec-9k-ss-7-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-9k-ss-7-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Cannot" ;
cml:logicSummary "Regulations with prohibition cannot start before the international agreement enters into force." ;
cml:premiseText "(7) Regulations containing a prohibition referred to in subsection (1) or (3)" ;
cml:conclusionText "must not be expressed to commence on a day earlier than the day the international agreement enters into force for Australia." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9k-ss-7 cml:asserts concept:therapeutic-goods-act-1989-sec-9k-ss-7-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-9k-ss-7-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Overlaps" ;
cml:logicSummary "Regulations with prohibition overlap with the international agreement." ;
cml:premiseText "(7) Regulations containing a prohibition referred to in subsection (1) or (3)" ;
cml:conclusionText "the day the international agreement enters into force for Australia." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9k-ss-7 cml:asserts concept:therapeutic-goods-act-1989-sec-9k-ss-7-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-9k-ss-7-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "Until" ;
cml:logicSummary "Regulations with prohibition are until the international agreement enters into force." ;
cml:premiseText "(7) Regulations containing a prohibition referred to in subsection (1) or (3)" ;
cml:conclusionText "must not be expressed to commence on a day earlier than the day the international agreement enters into force for Australia." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9k-ss-7 cml:asserts concept:therapeutic-goods-act-1989-sec-9k-ss-7-logic-diffusion-4 .
concept:therapeutic-goods-act-1989-sec-9k-ss-7-logic-diffusion-4 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "Diffuses" ;
cml:logicSummary "Regulations with prohibition diffuse to the international agreement." ;
cml:premiseText "(7) Regulations containing a prohibition referred to in subsection (1) or (3)" ;
cml:conclusionText "the day the international agreement enters into force for Australia." ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9k-ss-7 cml:asserts concept:therapeutic-goods-act-1989-sec-9k-ss-7-logic-cogai-5 .
concept:therapeutic-goods-act-1989-sec-9k-ss-7-logic-cogai-5 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "Infer" ;
cml:logicSummary "Regulations with prohibition infer the international agreement." ;
cml:premiseText "(7) Regulations containing a prohibition referred to in subsection (1) or (3)" ;
cml:conclusionText "must not be expressed to commence on a day earlier than the day the international agreement enters into force for Australia." ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9k-ss-8 a cml:Concept ;
skos:prefLabel "9K(8) Prohibition on import, export, manufacture or supply of"@en ;
cml:realizedBy doc:sec-9k-ss-8 ;
cml:integrityHash "db29f6246b2ea2103822fbb9d3b5941d6a90f6bd69503813aa7342e156cb5ab8" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9k ;
skos:note "Regulations may confer power on Minister or Secretary to make administrative decisions." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.69" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9k-ss-8-norm .
concept:therapeutic-goods-act-1989-sec-9k-ss-8-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9k-ss-8 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9l a cml:Concept ;
skos:prefLabel "9L Offence and civil penalty"@en ;
cml:realizedBy doc:sec-9l ;
cml:integrityHash "cd25b8565d4b57e8f856cf50c696d80d49eb0c79087d2888c0de2bddefadce7e" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9l-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9l-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.71" .
concept:therapeutic-goods-act-1989-sec-9l-ss-1 a cml:Concept ;
skos:prefLabel "9L(1) Offence and civil penalty"@en ;
cml:realizedBy doc:sec-9l-ss-1 ;
cml:integrityHash "06d52d20d16713928efe4b0944d7486a22ea7c286b6663056a821fa850751a66" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9l ;
skos:note "Import, export, manufacture or supply of therapeutic goods or vaping goods is prohibited." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.71" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9l-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-9l-ss-1-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9l-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-9l-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-9l-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-9l-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits the import, export, manufacture or supply of therapeutic goods or vaping goods." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9l-ss-2 a cml:Concept ;
skos:prefLabel "9L(2) Offence and civil penalty"@en ;
cml:realizedBy doc:sec-9l-ss-2 ;
cml:integrityHash "40867a6982a686e5b8a004ceae81e4a8f9c683856c649f5f7d242fe05da35478" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9l ;
skos:note "Prohibition on import, export, manufacture or supply of therapeutic goods or vaping goods—international agreements" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.71" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9l-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-9l-ss-2-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9l-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-9l-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-9l-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-9l-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "=" ;
cml:logicSummary "Absolute prohibition" ;
cml:premiseText "(i) an absolute prohibition in force for the purposes of subsection 9K(1) or (3);" ;
cml:conclusionText "Prohibition on import, export, manufacture or supply of therapeutic goods or vaping goods—international agreements" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9l-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-9l-ss-2-logic-deontic-2 .
concept:therapeutic-goods-act-1989-sec-9l-ss-2-logic-deontic-2 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "=" ;
cml:logicSummary "Prohibition on import, export, manufacture or supply of therapeutic goods or vaping goods—international agreements" ;
cml:premiseText "(ii) one or more conditions of a prohibition in force for the purposes of subsection 9K(1) or (3)." ;
cml:conclusionText "Prohibition on import, export, manufacture or supply of therapeutic goods or vaping goods—international agreements" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9l-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-9l-ss-2-logic-deontic-3 .
concept:therapeutic-goods-act-1989-sec-9l-ss-2-logic-deontic-3 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "=" ;
cml:logicSummary "Maximum civil penalty: Prohibition on import, export, manufacture or supply of therapeutic goods or vaping goods—international agreements" ;
cml:premiseText "(a) for an individual—300 penalty units; and (b) for a body corporate—3,000 penalty units." ;
cml:conclusionText "Prohibition on import, export, manufacture or supply of therapeutic goods or vaping goods—international agreements" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9l-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-9l-ss-2-logic-alleninterval-4 .
concept:therapeutic-goods-act-1989-sec-9l-ss-2-logic-alleninterval-4 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "=" ;
cml:logicSummary "Temporal interval: Maximum civil penalty" ;
cml:premiseText "(a) for an individual—300 penalty units; and (b) for a body corporate—3,000 penalty units." ;
cml:conclusionText "Maximum civil penalty: Prohibition on import, export, manufacture or supply of therapeutic goods or vaping goods—international agreements" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9m a cml:Concept ;
skos:prefLabel "9M Application of Customs Act 1901"@en ;
cml:realizedBy doc:sec-9m ;
cml:integrityHash "973b96a65206bf65b02d38f9d6ac5cb0952713650c14bc704280eb1391e3b022" ;
skos:note "Customs Act 1901 applies to prohibited imports or exports if notified by Secretary." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.73" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9m-norm .
concept:therapeutic-goods-act-1989-sec-9m-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9m ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9n a cml:Concept ;
skos:prefLabel "9N Constitutional basis"@en ;
cml:realizedBy doc:sec-9n ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9n-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-9n-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.73" .
concept:therapeutic-goods-act-1989-sec-9n-ss-1 a cml:Concept ;
skos:prefLabel "9N(1) Constitutional basis"@en ;
cml:realizedBy doc:sec-9n-ss-1 ;
cml:integrityHash "0a2dfcf17877926e8ad7f65735ed3f9f2b9cc151bb39625dcba3aa487802b5b6" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9n ;
skos:note "Relies on Commonwealth's legislative power under paragraph 51(xxix) of the Constitution." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.73" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9n-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-9n-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9n-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-9n-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-9n-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-9n-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "ReliesOn" ;
cml:logicSummary "Relies on Commonwealth's legislative power" ;
cml:premiseText "(1) This Chapter, and any other provision of this Act to the extent it relates to this Chapter, relies..." ;
cml:conclusionText "...to give effect to an international agreement prescribed for the purposes of subsection 9K(1) or (3)." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9n-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-9n-ss-1-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-9n-ss-1-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "PrescribedFor" ;
cml:logicSummary "Prescribed for the purposes of subsection 9K(1) or (3)" ;
cml:premiseText "...prescribed for the purposes of subsection 9K(1) or (3)." ;
cml:conclusionText "...to give effect to an international agreement prescribed for the purposes of subsection 9K(1) or (3)." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9n-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-9n-ss-1-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-9n-ss-1-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "RecurringTrace" ;
cml:logicSummary "Recurring trace of subsection 9K(1) or (3)" ;
cml:premiseText "...prescribed for the purposes of subsection 9K(1) or (3)." ;
cml:conclusionText "...to give effect to an international agreement prescribed for the purposes of subsection 9K(1) or (3)." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9n-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-9n-ss-1-logic-diffusion-4 .
concept:therapeutic-goods-act-1989-sec-9n-ss-1-logic-diffusion-4 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "InternationalAgreement" ;
cml:logicSummary "International agreement" ;
cml:premiseText "...prescribed for the purposes of subsection 9K(1) or (3)." ;
cml:conclusionText "...to give effect to an international agreement prescribed for the purposes of subsection 9K(1) or (3)." ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9n-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-9n-ss-1-logic-cogai-5 .
concept:therapeutic-goods-act-1989-sec-9n-ss-1-logic-cogai-5 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "SHACL" ;
cml:logicSummary "SHACL validation" ;
cml:premiseText "...prescribed for the purposes of subsection 9K(1) or (3)." ;
cml:conclusionText "...to give effect to an international agreement prescribed for the purposes of subsection 9K(1) or (3)." ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9n-ss-2 a cml:Concept ;
skos:prefLabel "9N(2) Constitutional basis"@en ;
cml:realizedBy doc:sec-9n-ss-2 ;
cml:integrityHash "3cf8cd3288d97c3a07989386e89750e4a30998e7a96f14fca24819573468a027" ;
values:partOf concept:therapeutic-goods-act-1989-sec-9n ;
skos:note "Does not limit section 6" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.73" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-9n-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-9n-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-9n-ss-2 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9n-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-9n-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-9n-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "does not imply" ;
cml:logicSummary "Limits the scope of section 6" ;
cml:premiseText "Section 9N(2)" ;
cml:conclusionText "Section 6 is unaffected" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9n-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-9n-ss-2-logic-deontic-2 .
concept:therapeutic-goods-act-1989-sec-9n-ss-2-logic-deontic-2 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "does not prohibit" ;
cml:logicSummary "Does not ban conduct related to section 6" ;
cml:premiseText "Section 9N(2) does not limit section 6" ;
cml:conclusionText "Conduct related to section 6 is permitted" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-9n-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-9n-ss-2-logic-deontic-3 .
concept:therapeutic-goods-act-1989-sec-9n-ss-2-logic-deontic-3 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "does not create right" ;
cml:logicSummary "Does not grant a right to conduct related to section 6" ;
cml:premiseText "Section 9N(2) does not limit section 6" ;
cml:conclusionText "Conduct related to section 6 is permitted but not a right" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-10 a cml:Concept ;
skos:prefLabel "10 Determination of standards"@en ;
cml:realizedBy doc:sec-10 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-10-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-10-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-10-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-10-ss-3a ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-10-ss-4 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.74" .
concept:therapeutic-goods-act-1989-sec-10-ss-1 a cml:Concept ;
skos:prefLabel "10(1) Determination of standards"@en ;
cml:realizedBy doc:sec-10-ss-1 ;
cml:integrityHash "54824efcd24bfef605ef38a5a09b605cd3c03bf8115e972fb20fbe9e4f9696c0" ;
values:partOf concept:therapeutic-goods-act-1989-sec-10 ;
skos:note "The Minister may make an order determining standards for therapeutic goods." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.74" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-10-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-10-ss-1-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-10-ss-1 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-10-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-10-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-10-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "May" ;
cml:logicSummary "Permission to determine standards" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-10-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-10-ss-1-logic-descriptionlogic-2 .
concept:therapeutic-goods-act-1989-sec-10-ss-1-logic-descriptionlogic-2 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "Classifies" ;
cml:logicSummary "Therapeutic goods or class of therapeutic goods" ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-10-ss-2 a cml:Concept ;
skos:prefLabel "10(2) Determination of standards"@en ;
cml:realizedBy doc:sec-10-ss-2 ;
cml:integrityHash "692802e7963ba0c0b726b7f67cff30ee85270dd557407d9e973ddcfc2b99dbcb" ;
values:partOf concept:therapeutic-goods-act-1989-sec-10 ;
skos:note "Establishing standards for therapeutic goods may be specified by reference to various factors." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.74" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-10-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-10-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-10-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-10-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-10-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-10-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "requires" ;
cml:logicSummary "Requires the specification of standards for therapeutic goods." ;
cml:premiseText "(2) Without limiting the generality of subsection (1), an order establishing a standard for therapeutic goods may..." ;
cml:conclusionText "...or (vii) a standard published by Standards Australia; or ..." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-10-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-10-ss-2-logic-descriptionlogic-2 .
concept:therapeutic-goods-act-1989-sec-10-ss-2-logic-descriptionlogic-2 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "is specified by reference to" ;
cml:logicSummary "Specifies standards for therapeutic goods by reference to various factors." ;
cml:premiseText "(a) be specified by reference to:..." ;
cml:conclusionText "...or (v)" ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-10-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-10-ss-2-logic-deontic-3 .
concept:therapeutic-goods-act-1989-sec-10-ss-2-logic-deontic-3 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "requires" ;
cml:logicSummary "Requires the determination of matters relating to standards for therapeutic goods." ;
cml:premiseText "(b) require that a matter relating to the standard be determined in accordance with a particular test;..." ;
cml:conclusionText "...or (c)" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-10-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-10-ss-2-logic-deontic-4 .
concept:therapeutic-goods-act-1989-sec-10-ss-2-logic-deontic-4 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "requires" ;
cml:logicSummary "Requires therapeutic goods or a class of therapeutic goods to be labelled or packaged in a manner specified in the order." ;
cml:premiseText "(c) require that therapeutic goods or a class of therapeutic goods identified in the order be labelled or packaged in a manner, or kept in containers that comply with requirements, specified in the order." ;
cml:conclusionText "...or (d)" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-10-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-10-ss-2-logic-alleninterval-5 .
concept:therapeutic-goods-act-1989-sec-10-ss-2-logic-alleninterval-5 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "within a specified time frame" ;
cml:logicSummary "Establishing standards for therapeutic goods may be done within a specified time frame." ;
cml:premiseText "(2) Without limiting the generality of subsection (1), an order establishing a standard for therapeutic goods may..." ;
cml:conclusionText "...or (vii)" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-10-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-10-ss-2-logic-ltl-6 .
concept:therapeutic-goods-act-1989-sec-10-ss-2-logic-ltl-6 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "recurring trace" ;
cml:logicSummary "Establishing standards for therapeutic goods may be done in a recurring manner." ;
cml:premiseText "(2) Without limiting the generality of subsection (1), an order establishing a standard for therapeutic goods may..." ;
cml:conclusionText "...or (viii)" ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-10-ss-3 a cml:Concept ;
skos:prefLabel "10(3) Determination of standards"@en ;
cml:realizedBy doc:sec-10-ss-3 ;
cml:integrityHash "a7dc813a2e895cf6270489faf0777f5852b49c3e9a8436745c5c0554366a3ed3" ;
values:partOf concept:therapeutic-goods-act-1989-sec-10 ;
skos:note "Directs particulars to be set out on a label or package of therapeutic goods" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.74" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-10-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-10-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-10-ss-3 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-10-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-10-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-10-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "requires" ;
cml:logicSummary "Requires particulars to be set out" ;
cml:premiseText "(3) Without limiting the generality of paragraph (2)(c), the Minister may, in an order establishing a standard..." ;
cml:conclusionText "such particulars as are required by the order." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-10-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-10-ss-3-logic-descriptionlogic-2 .
concept:therapeutic-goods-act-1989-sec-10-ss-3-logic-descriptionlogic-2 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "identifies" ;
cml:logicSummary "Identifies particulars to be set out" ;
cml:premiseText "(a) therapeutic goods or a class of therapeutic goods identified in the order;" ;
cml:conclusionText "or (b) a container or package containing therapeutic goods or a class of therapeutic goods identified in the order;" ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-10-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-10-ss-3-logic-alleninterval-3 .
concept:therapeutic-goods-act-1989-sec-10-ss-3-logic-alleninterval-3 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "between" ;
cml:logicSummary "Establishes relation between particulars and order" ;
cml:premiseText "(3) Without limiting the generality of paragraph (2)(c), the Minister may, in an order establishing a standard..." ;
cml:conclusionText "such particulars as are required by the order." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-10-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-10-ss-3-logic-argumentation-4 .
concept:therapeutic-goods-act-1989-sec-10-ss-3-logic-argumentation-4 a cml:LogicApplication ;
cml:modality cml:Argumentation ;
cml:operator "implies" ;
cml:logicSummary "Implies that particulars must be set out if order is established" ;
cml:premiseText "(3) Without limiting the generality of paragraph (2)(c), the Minister may, in an order establishing a standard..." ;
cml:conclusionText "such particulars as are required by the order." ;
cml:executionSurface "modalities::argumentation" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-10-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-10-ss-3-logic-diffusion-5 .
concept:therapeutic-goods-act-1989-sec-10-ss-3-logic-diffusion-5 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "diffuses" ;
cml:logicSummary "Diffuses requirement to set out particulars" ;
cml:premiseText "(3) Without limiting the generality of paragraph (2)(c), the Minister may, in an order establishing a standard..." ;
cml:conclusionText "such particulars as are required by the order." ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-10-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-10-ss-3-logic-cogai-6 .
concept:therapeutic-goods-act-1989-sec-10-ss-3-logic-cogai-6 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "recognizes" ;
cml:logicSummary "Recognizes requirement to set out particulars" ;
cml:premiseText "(3) Without limiting the generality of paragraph (2)(c), the Minister may, in an order establishing a standard..." ;
cml:conclusionText "such particulars as are required by the order." ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-10-ss-3a a cml:Concept ;
skos:prefLabel "10(3A) Determination of standards"@en ;
cml:realizedBy doc:sec-10-ss-3a ;
cml:integrityHash "4a4a57b2be7548a1f29f2fecb9e90f6dd3559b0230804b0da353b757e0f425e5" ;
values:partOf concept:therapeutic-goods-act-1989-sec-10 ;
skos:note "Variation or revocation of orders made under subsection (1)" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.74" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-10-ss-3a-norm .
concept:therapeutic-goods-act-1989-sec-10-ss-3a-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-10-ss-3a ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-10-ss-3a cml:asserts concept:therapeutic-goods-act-1989-sec-10-ss-3a-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-10-ss-3a-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "may" ;
cml:logicSummary "Permission to vary or revoke orders" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-10-ss-4 a cml:Concept ;
skos:prefLabel "10(4) Determination of standards"@en ;
cml:realizedBy doc:sec-10-ss-4 ;
cml:integrityHash "52046a47fc4bce7b893fb6f69f731205e0c09189c24efaea579396237c5ac80b" ;
values:partOf concept:therapeutic-goods-act-1989-sec-10 ;
skos:note "May incorporate existing provisions from instruments or writings." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.74" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-10-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-10-ss-4-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-10-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-10-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-10-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-10-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "may" ;
cml:logicSummary "Obligation to incorporate existing provisions" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-13 a cml:Concept ;
skos:prefLabel "13 Special provisions relating to Ministerial standards and default"@en ;
cml:realizedBy doc:sec-13 ;
cml:integrityHash "0b21aaddae93d0233f598f4d15c6bdc695206094e89cba27044e721a83c79219" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-13-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-13-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-13-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-13-ss-4 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-13-ss-5 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-13-ss-6 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-13-ss-7 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.76" .
concept:therapeutic-goods-act-1989-sec-13-ss-1 a cml:Concept ;
skos:prefLabel "13(1) Special provisions relating to Ministerial standards and default"@en ;
cml:realizedBy doc:sec-13-ss-1 ;
cml:integrityHash "7082ecac8a155184ba6c9db24920b057b063a33c75887cd3e1a794cd55dc3e60" ;
values:partOf concept:therapeutic-goods-act-1989-sec-13 ;
skos:note "Statement in one publication is taken to include another statement." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.76" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-13-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-13-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-13-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-13-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-13-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-13-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "=" ;
cml:logicSummary "Equivalence of statements" ;
cml:premiseText "Statement in one publication is taken to include another statement." ;
cml:conclusionText "Main statement includes other statement." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-13-ss-2 a cml:Concept ;
skos:prefLabel "13(2) Special provisions relating to Ministerial standards and default"@en ;
cml:realizedBy doc:sec-13-ss-2 ;
cml:integrityHash "3d50d9a0a877b56f848e0c0d0ce5be477bb6d71f44a5f053e0f847f2e041af3a" ;
values:partOf concept:therapeutic-goods-act-1989-sec-13 ;
skos:note "Disregard inconsistent requirements for therapeutic goods" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.76" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-13-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-13-ss-2-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-13-ss-2 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-13-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-13-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-13-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits inconsistent requirements" ;
cml:premiseText "(2) If..." ;
cml:conclusionText "...the requirements referred to in paragraph (b) are, so far as they are inconsistent, to be disregarded for the purposes of this Act." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-13-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-13-ss-2-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-13-ss-2-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Overlap" ;
cml:logicSummary "Overlaps with inconsistent requirements" ;
cml:premiseText "(2) If..." ;
cml:conclusionText "...the requirements referred to in paragraph (b) are, so far as they are inconsistent, to be disregarded 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-13-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-13-ss-2-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-13-ss-2-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "Overlap" ;
cml:logicSummary "Overlaps with inconsistent requirements" ;
cml:premiseText "(2) If..." ;
cml:conclusionText "...the requirements referred to in paragraph (b) are, so far as they are inconsistent, to be disregarded 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-13-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-13-ss-2-logic-diffusion-4 .
concept:therapeutic-goods-act-1989-sec-13-ss-2-logic-diffusion-4 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "Overlap" ;
cml:logicSummary "Overlaps with inconsistent requirements" ;
cml:premiseText "(2) If..." ;
cml:conclusionText "...the requirements referred to in paragraph (b) are, so far as they are inconsistent, to be disregarded for the purposes of this Act." ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-13-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-13-ss-2-logic-cogai-5 .
concept:therapeutic-goods-act-1989-sec-13-ss-2-logic-cogai-5 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "Overlap" ;
cml:logicSummary "Overlaps with inconsistent requirements" ;
cml:premiseText "(2) If..." ;
cml:conclusionText "...the requirements referred to in paragraph (b) are, so far as they are inconsistent, to be disregarded for the purposes of this Act." ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-13-ss-3 a cml:Concept ;
skos:prefLabel "13(3) Special provisions relating to Ministerial standards and default"@en ;
cml:realizedBy doc:sec-13-ss-3 ;
cml:integrityHash "8fd75bf8793b773bc7f8f17d29d5f63613e01cdae4ebd564216332a966d4c24e" ;
values:partOf concept:therapeutic-goods-act-1989-sec-13 ;
skos:note "If two default standards apply to different parts of a class of therapeutic goods, the more restrictive standard applies." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.76" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-13-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-13-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-13-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-13-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-13-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-13-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "implies" ;
cml:logicSummary "If A implies B and C, then if A, B." ;
cml:premiseText "(a) a default standard applies to a class of therapeutic goods; (b) another default standard applies to only some of the therapeutic goods within that class; (c) those standards are inconsistent;" ;
cml:conclusionText "(3) If: (a) a default standard applies to a class of therapeutic goods; and (b) another default standard applies to only some of the therapeutic goods within that class; and (c) those standards are inconsistent; then the standard referred to in paragraph (a) does not apply in relation to the goods 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-13-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-13-ss-3-logic-descriptionlogic-2 .
concept:therapeutic-goods-act-1989-sec-13-ss-3-logic-descriptionlogic-2 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "subClassOf" ;
cml:logicSummary "The excerpt defines a subclass relationship between two default standards." ;
cml:premiseText "(a) a default standard applies to a class of therapeutic goods; and (b) another default standard applies to only some of the therapeutic goods within that class;" ;
cml:conclusionText "the standard referred to in paragraph (a) does not apply in relation to the goods 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-13-ss-4 a cml:Concept ;
skos:prefLabel "13(4) Special provisions relating to Ministerial standards and default"@en ;
cml:realizedBy doc:sec-13-ss-4 ;
cml:integrityHash "1f0db07ac9c9bdea3b0a16f8e700c028091444df12b3601ad52b8d2932553b96" ;
values:partOf concept:therapeutic-goods-act-1989-sec-13 ;
skos:note "Therapeutic goods with a mixture of ingredients or component parts do not have to meet the default standard." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.76" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-13-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-13-ss-4-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-13-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-13-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-13-ss-4-logic-alleninterval-1 .
concept:therapeutic-goods-act-1989-sec-13-ss-4-logic-alleninterval-1 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "<" ;
cml:logicSummary "Temporal interval for applicability" ;
cml:premiseText "(4) If a default standard is applicable to one or more of the ingredients or one or more of the component parts; and" ;
cml:conclusionText "The default standard does not apply if it is not applicable at the time of manufacture." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-13-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-13-ss-4-logic-ltl-2 .
concept:therapeutic-goods-act-1989-sec-13-ss-4-logic-ltl-2 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "<" ;
cml:logicSummary "Temporal interval for applicability" ;
cml:premiseText "(4) If a default standard is applicable to one or more of the ingredients or one or more of the component parts; and" ;
cml:conclusionText "The default standard does not apply if it is not applicable at the time of manufacture." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-13-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-13-ss-4-logic-deontic-3 .
concept:therapeutic-goods-act-1989-sec-13-ss-4-logic-deontic-3 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "=" ;
cml:logicSummary "Obligation to meet standard" ;
cml:premiseText "If a default standard is applicable to one or more of the ingredients or one or more of the component parts; and" ;
cml:conclusionText "The standard does not apply if it is not applicable at the time of manufacture." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-13-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-13-ss-4-logic-deontic-4 .
concept:therapeutic-goods-act-1989-sec-13-ss-4-logic-deontic-4 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "=" ;
cml:logicSummary "Obligation to meet standard" ;
cml:premiseText "(c) a default standard is applicable to the mixture or combination;" ;
cml:conclusionText "The standard does not apply if it is not applicable at the time of manufacture." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-13-ss-5 a cml:Concept ;
skos:prefLabel "13(5) Special provisions relating to Ministerial standards and default"@en ;
cml:realizedBy doc:sec-13-ss-5 ;
cml:integrityHash "2932628a3a4888bf1f25def413ec60b7ac4aaab51fdb46bc4514e2c91aba6d17" ;
values:partOf concept:therapeutic-goods-act-1989-sec-13 ;
skos:note "Minister may determine standard does not apply to therapeutic goods" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.76" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-13-ss-5-norm .
concept:therapeutic-goods-act-1989-sec-13-ss-5-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-13-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-13-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-13-ss-5-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-13-ss-5-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "May" ;
cml:logicSummary "Minister has the power to determine a standard does not apply" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-13-ss-6 a cml:Concept ;
skos:prefLabel "13(6) Special provisions relating to Ministerial standards and default"@en ;
cml:realizedBy doc:sec-13-ss-6 ;
cml:integrityHash "3660d52990970ec297d1549e994043b24ada243c3c47c17f4ff78fca70defa1b" ;
values:partOf concept:therapeutic-goods-act-1989-sec-13 ;
skos:note "An order under subsection (5) is not a legislative instrument." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.76" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-13-ss-6-norm .
concept:therapeutic-goods-act-1989-sec-13-ss-6-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-13-ss-6 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-13-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-13-ss-6-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-13-ss-6-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "not" ;
cml:logicSummary "Negative obligation" ;
cml:premiseText "(6) An order under subsection (5)" ;
cml:conclusionText "is not a legislative instrument." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-13-ss-7 a cml:Concept ;
skos:prefLabel "13(7) Special provisions relating to Ministerial standards and default"@en ;
cml:realizedBy doc:sec-13-ss-7 ;
cml:integrityHash "65ee93d28d0dc45a098a41c28a4a0434d6ea652e82c4139303b25b33e5d2a9b4" ;
values:partOf concept:therapeutic-goods-act-1989-sec-13 ;
skos:note "If multiple default standards apply, they are taken not to apply if goods conform with at least one but not all." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.76" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-13-ss-7-norm .
concept:therapeutic-goods-act-1989-sec-13-ss-7-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-13-ss-7 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-13-ss-7 cml:asserts concept:therapeutic-goods-act-1989-sec-13-ss-7-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-13-ss-7-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "¬" ;
cml:logicSummary "Negation of obligation" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-13a a cml:Concept ;
skos:prefLabel "13A Special provisions relating to homoeopathic standards and"@en ;
cml:realizedBy doc:sec-13a ;
cml:integrityHash "0550e76a3096121d9b65c4ac809b9b3e78d680315a4369bec6571140eb8170cf" ;
skos:note "If a statement in a monograph refers to another statement, the main statement includes the other statement." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.77" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-13a-norm .
concept:therapeutic-goods-act-1989-sec-13a-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-13a ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-13a cml:asserts concept:therapeutic-goods-act-1989-sec-13a-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-13a-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "includes" ;
cml:logicSummary "Includes other statement when referring to it" ;
cml:premiseText "Statement A refers to Statement B" ;
cml:conclusionText "Statement A includes Statement B" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-14 a cml:Concept ;
skos:prefLabel "14 Criminal offences for importing, supplying or exporting goods"@en ;
cml:realizedBy doc:sec-14 ;
cml:integrityHash "146ba93cf47044972733d189ffb9dd50623b84e42edb0be4b1c7ffbf24cfbd6c" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-14-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-14-ss-4 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-14-ss-4a ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-14-ss-4b ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-14-ss-5a ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-14-ss-6 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.78" .
concept:therapeutic-goods-act-1989-sec-14-ss-1 a cml:Concept ;
skos:prefLabel "14(1) Criminal offences for importing, supplying or exporting goods"@en ;
cml:realizedBy doc:sec-14-ss-1 ;
cml:integrityHash "6db59b3a7787c7b7949e29286cf2adf7cc24287b6440ec45dcad71d894c72dfe" ;
values:partOf concept:therapeutic-goods-act-1989-sec-14 ;
skos:note "Importing therapeutic goods without consent is prohibited." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.78" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-14-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-14-ss-1-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-14-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-14-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-14-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-14-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits the importation of therapeutic goods without consent." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-14-ss-4 a cml:Concept ;
skos:prefLabel "14(4) Criminal offences for importing, supplying or exporting goods"@en ;
cml:realizedBy doc:sec-14-ss-4 ;
cml:integrityHash "8105137565b962f08994a05e573000e3da86b8eeb489552872870c352fb4a031" ;
values:partOf concept:therapeutic-goods-act-1989-sec-14 ;
skos:note "Importing therapeutic goods without consent is prohibited." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.78" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-14-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-14-ss-4-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-14-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-14-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-14-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-14-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits importing therapeutic goods without consent." ;
cml:premiseText "(4) A person commits an offence if: (a) the person imports therapeutic goods into Australia; and (b) the goods are imported without the consent in writing of the Secretary; and (c) the goods do not conform with a standard applicable to the goods (other than by reason of a matter relating to labelling or packaging). Penalty: Imprisonment for 12 months or 1,000 penalty units, or both." ;
cml:conclusionText "The person commits an offence if they import therapeutic goods without consent." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-14-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-14-ss-4-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-14-ss-4-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "During" ;
cml:logicSummary "The prohibition applies during the time of importing therapeutic goods." ;
cml:premiseText "(4) A person commits an offence if: (a) the person imports therapeutic goods into Australia; and (b) the goods are imported without the consent in writing of the Secretary; and (c) the goods do not conform with a standard applicable to the goods (other than by reason of a matter relating to labelling or packaging). Penalty: Imprisonment for 12 months or 1,000 penalty units, or both." ;
cml:conclusionText "The person commits an offence if they import therapeutic goods during this time." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-14-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-14-ss-4-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-14-ss-4-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "Recurring" ;
cml:logicSummary "The prohibition is recurring and applies to each instance of importing therapeutic goods." ;
cml:premiseText "(4) A person commits an offence if: (a) the person imports therapeutic goods into Australia; and (b) the goods are imported without the consent in writing of the Secretary; and (c) the goods do not conform with a standard applicable to the goods (other than by reason of a matter relating to labelling or packaging). Penalty: Imprisonment for 12 months or 1,000 penalty units, or both." ;
cml:conclusionText "The person commits an offence if they import therapeutic goods repeatedly without consent." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-14-ss-4a a cml:Concept ;
skos:prefLabel "14(4A) Criminal offences for importing, supplying or exporting goods"@en ;
cml:realizedBy doc:sec-14-ss-4a ;
cml:integrityHash "24deb619fdf5af99d5c530f55e1fbd2ebff255142980fd67d944b62cc3be666d" ;
values:partOf concept:therapeutic-goods-act-1989-sec-14 ;
skos:note "Importing therapeutic goods without consent is prohibited." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.78" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-14-ss-4a-norm .
concept:therapeutic-goods-act-1989-sec-14-ss-4a-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-14-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-14-ss-4a cml:asserts concept:therapeutic-goods-act-1989-sec-14-ss-4a-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-14-ss-4a-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits importing therapeutic goods without consent." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-14-ss-4b a cml:Concept ;
skos:prefLabel "14(4B) Criminal offences for importing, supplying or exporting goods"@en ;
cml:realizedBy doc:sec-14-ss-4b ;
cml:integrityHash "3cac4e95c9afed2c934d246e7bd817391c105ec5ff2eefa27e5f0138720aaf71" ;
values:partOf concept:therapeutic-goods-act-1989-sec-14 ;
skos:note "Criminal offences for importing, supplying or exporting goods" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.78" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-14-ss-4b-norm .
concept:therapeutic-goods-act-1989-sec-14-ss-4b-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-14-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-14-ss-5a a cml:Concept ;
skos:prefLabel "14(5A) Criminal offences for importing, supplying or exporting goods"@en ;
cml:realizedBy doc:sec-14-ss-5a ;
cml:integrityHash "e24535683a70abf1ec97027ecfd1e44016444a0353f5be48e6d9c48c107ba62d" ;
values:partOf concept:therapeutic-goods-act-1989-sec-14 ;
skos:note "Exemptions from subsection (1), (4) or (4A)" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.78" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-14-ss-5a-norm .
concept:therapeutic-goods-act-1989-sec-14-ss-5a-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-14-ss-5a ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-14-ss-6 a cml:Concept ;
skos:prefLabel "14(6) Criminal offences for importing, supplying or exporting goods"@en ;
cml:realizedBy doc:sec-14-ss-6 ;
cml:integrityHash "c5002421e28cf9197e8ffe7b2a76f65fb42505f27c8584f0721c7f949c2b6b9d" ;
values:partOf concept:therapeutic-goods-act-1989-sec-14 ;
skos:note "Importing, supplying or exporting goods without a license is prohibited." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.78" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-14-ss-6-norm .
concept:therapeutic-goods-act-1989-sec-14-ss-6-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-14-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-14-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-14-ss-6-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-14-ss-6-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits the action." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-14a a cml:Concept ;
skos:prefLabel "14A Civil penalties for importing, supplying or exporting goods that"@en ;
cml:realizedBy doc:sec-14a ;
cml:integrityHash "2998c4a796a4431104998f73334e3243a0daebb3d5cab4fa3f1f97dbaa77ea49" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-14a-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-14a-ss-1a ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.83" .
concept:therapeutic-goods-act-1989-sec-14a-ss-1 a cml:Concept ;
skos:prefLabel "14A(1) Civil penalties for importing, supplying or exporting goods that"@en ;
cml:realizedBy doc:sec-14a-ss-1 ;
cml:integrityHash "da1032881be7e0afd95a923b5471ce1ba8f0ab613a906934fc2cdf2b962f2ebe" ;
values:partOf concept:therapeutic-goods-act-1989-sec-14a ;
skos:note "Importing therapeutic goods without consent" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.83" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-14a-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-14a-ss-1-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-14a-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-14a-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-14a-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-14a-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits importing therapeutic goods without consent" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-14a-ss-1a a cml:Concept ;
skos:prefLabel "14A(1A) Civil penalties for importing, supplying or exporting goods that"@en ;
cml:realizedBy doc:sec-14a-ss-1a ;
cml:integrityHash "e97730f6f59ca315b8423a45645713caa0dab27becaa4c0fb49115959128016f" ;
values:partOf concept:therapeutic-goods-act-1989-sec-14a ;
skos:note "Exempts biological goods from subsection (1) of section 14A(1)" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.83" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-14a-ss-1a-norm .
concept:therapeutic-goods-act-1989-sec-14a-ss-1a-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-14a-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-14b a cml:Concept ;
skos:prefLabel "14B Application of Customs Act 1901"@en ;
cml:realizedBy doc:sec-14b ;
cml:integrityHash "a8105a855cdd93f0bc5d7aed54867cb9cf8f3dc37367fc417c90ed912dcb1544" ;
skos:note "Customs Act 1901 applies to importation or exportation of goods if notified by Secretary." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.85" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-14b-norm .
concept:therapeutic-goods-act-1989-sec-14b-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-14b ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-14b cml:asserts concept:therapeutic-goods-act-1989-sec-14b-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-14b-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "obliges" ;
cml:logicSummary "Customs Act 1901 obliges the Secretary to notify Comptroller-General of Customs." ;
cml:premiseText "Secretary wishes Customs Act 1901 to apply." ;
cml:conclusionText "Customs Act 1901 has effect." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-14b cml:asserts concept:therapeutic-goods-act-1989-sec-14b-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-14b-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "during" ;
cml:logicSummary "Customs Act 1901 applies during importation or exportation." ;
cml:premiseText "Importation or exportation occurs." ;
cml:conclusionText "Customs Act 1901 has effect." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-14b cml:asserts concept:therapeutic-goods-act-1989-sec-14b-logic-argumentation-3 .
concept:therapeutic-goods-act-1989-sec-14b-logic-argumentation-3 a cml:LogicApplication ;
cml:modality cml:Argumentation ;
cml:operator "implies" ;
cml:logicSummary "Secretary's notification implies Customs Act 1901 applies." ;
cml:premiseText "Secretary notifies Comptroller-General of Customs." ;
cml:conclusionText "Customs Act 1901 has effect." ;
cml:executionSurface "modalities::argumentation" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-14b cml:asserts concept:therapeutic-goods-act-1989-sec-14b-logic-diffusion-4 .
concept:therapeutic-goods-act-1989-sec-14b-logic-diffusion-4 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "diffuses" ;
cml:logicSummary "Customs Act 1901 diffuses to goods described as forfeited to the Crown." ;
cml:premiseText "Goods are forfeited to the Crown." ;
cml:conclusionText "Goods are subject to Customs Act 1901." ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-14b cml:asserts concept:therapeutic-goods-act-1989-sec-14b-logic-cogai-5 .
concept:therapeutic-goods-act-1989-sec-14b-logic-cogai-5 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "recognizes" ;
cml:logicSummary "Customs Act 1901 recognizes goods described as forfeited to the Crown." ;
cml:premiseText "Goods are forfeited to the Crown." ;
cml:conclusionText "Goods are subject to Customs Act 1901." ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-15 a cml:Concept ;
skos:prefLabel "15 Criminal offences relating to breaching a condition of a consent"@en ;
cml:realizedBy doc:sec-15 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-15-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-15-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-15-ss-5 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-15-ss-6 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-15-ss-7 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.86" .
concept:therapeutic-goods-act-1989-sec-15-ss-1 a cml:Concept ;
skos:prefLabel "15(1) Criminal offences relating to breaching a condition of a consent"@en ;
cml:realizedBy doc:sec-15-ss-1 ;
cml:integrityHash "e9f53174d8ad57b088ad813529cbf7682e47916a6aa4cde79536c51b5b4a29a4" ;
values:partOf concept:therapeutic-goods-act-1989-sec-15 ;
skos:note "Secretary's consent may be given unconditionally or subject to conditions." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.86" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-15-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-15-ss-1-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-15-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-15-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-15-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-15-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-15-ss-2 a cml:Concept ;
skos:prefLabel "15(2) Criminal offences relating to breaching a condition of a consent"@en ;
cml:realizedBy doc:sec-15-ss-2 ;
cml:integrityHash "edf552051b0fdf7d71aa89b27a6ac030d5ee1c44f9c450b3ba8a6bc5a94a384e" ;
values:partOf concept:therapeutic-goods-act-1989-sec-15 ;
skos:note "A person commits an offence if they breach a condition of consent." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.86" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-15-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-15-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-15-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-15-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-15-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-15-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Obligation to not breach a condition of consent." ;
cml:premiseText "(2) A person commits an offence if: (a) the person does an act or omits to do an act; (b) the act or omission breaches a condition of a consent; (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 "A person commits an offence if they breach 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-15-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-15-ss-2-logic-deontic-2 .
concept:therapeutic-goods-act-1989-sec-15-ss-2-logic-deontic-2 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibition" ;
cml:logicSummary "Prohibition on breaching a condition of consent." ;
cml:premiseText "(2) A person commits an offence if: (a) the person does an act or omits to do an act; (b) the act or omission breaches a condition of a consent; (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 "Breaching a condition of consent is prohibited." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-15-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-15-ss-2-logic-alleninterval-3 .
concept:therapeutic-goods-act-1989-sec-15-ss-2-logic-alleninterval-3 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Between" ;
cml:logicSummary "Temporal relationship between the act and the harm." ;
cml:premiseText "(2) A person commits an offence if: (a) the person does an act or omits to do an act; (b) the act or omission breaches a condition of a consent; (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 "The act and the harm are temporally related." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-15-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-15-ss-2-logic-argumentation-4 .
concept:therapeutic-goods-act-1989-sec-15-ss-2-logic-argumentation-4 a cml:LogicApplication ;
cml:modality cml:Argumentation ;
cml:operator "Implication" ;
cml:logicSummary "Implication of breach on offence commitment." ;
cml:premiseText "(2) A person commits an offence if: (a) the person does an act or omits to do an act; (b) the act or omission breaches a condition of a consent; (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 "If the breach occurs, then the offence is committed." ;
cml:executionSurface "modalities::argumentation" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-15-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-15-ss-2-logic-diffusion-5 .
concept:therapeutic-goods-act-1989-sec-15-ss-2-logic-diffusion-5 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "Propagation" ;
cml:logicSummary "Propagating the effect of the breach." ;
cml:premiseText "(2) A person commits an offence if: (a) the person does an act or omits to do an act; (b) the act or omission breaches a condition of a consent; (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 "The effect of the breach propagates." ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-15-ss-5 a cml:Concept ;
skos:prefLabel "15(5) Criminal offences relating to breaching a condition of a consent"@en ;
cml:realizedBy doc:sec-15-ss-5 ;
cml:integrityHash "45e75e4326c17e797c9a167b273e0a2edaffbf73f0f6f211ab88d5522ef4547b" ;
values:partOf concept:therapeutic-goods-act-1989-sec-15 ;
skos:note "Breach of consent condition results in an offence." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.86" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-15-ss-5-norm .
concept:therapeutic-goods-act-1989-sec-15-ss-5-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-15-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-15-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-15-ss-5-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-15-ss-5-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Obligation to comply with consent conditions." ;
cml:premiseText "(5) 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." ;
cml:conclusionText "If an act or omission breaches a consent condition, it is an offence." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-15-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-15-ss-5-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-15-ss-5-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Between" ;
cml:logicSummary "Temporal interval for breach of consent." ;
cml:premiseText "(5) 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." ;
cml:conclusionText "The temporal interval for breach of consent is not specified." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-15-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-15-ss-5-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-15-ss-5-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "Until" ;
cml:logicSummary "Temporal logic for consent conditions." ;
cml:premiseText "(5) 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." ;
cml:conclusionText "The temporal logic for consent conditions is not specified." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-15-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-15-ss-5-logic-diffusion-4 .
concept:therapeutic-goods-act-1989-sec-15-ss-5-logic-diffusion-4 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "Diffuses" ;
cml:logicSummary "Diffusion of obligation to comply with consent conditions." ;
cml:premiseText "(5) 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." ;
cml:conclusionText "The diffusion of obligation is not specified." ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-15-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-15-ss-5-logic-cogai-5 .
concept:therapeutic-goods-act-1989-sec-15-ss-5-logic-cogai-5 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "Recognizes" ;
cml:logicSummary "Cognitive AI application for consent conditions." ;
cml:premiseText "(5) 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." ;
cml:conclusionText "The cognitive AI application is not specified." ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-15-ss-6 a cml:Concept ;
skos:prefLabel "15(6) Criminal offences relating to breaching a condition of a consent"@en ;
cml:realizedBy doc:sec-15-ss-6 ;
cml:integrityHash "dbe3e761dc82b25eebd0f41013235d7926cf7a520fdd04c03dbd34b6939fb325" ;
values:partOf concept:therapeutic-goods-act-1989-sec-15 ;
skos:note "Breach of consent condition results in an offence." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.86" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-15-ss-6-norm .
concept:therapeutic-goods-act-1989-sec-15-ss-6-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-15-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-15-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-15-ss-6-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-15-ss-6-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Obligation to comply with consent conditions." ;
cml:premiseText "(6) 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." ;
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-15-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-15-ss-6-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-15-ss-6-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Between" ;
cml:logicSummary "Temporal interval for breach of consent." ;
cml:premiseText "(6) 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." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-15-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-15-ss-6-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-15-ss-6-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "Until" ;
cml:logicSummary "Temporal constraint for breach of consent." ;
cml:premiseText "(6) 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." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-15-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-15-ss-6-logic-diffusion-4 .
concept:therapeutic-goods-act-1989-sec-15-ss-6-logic-diffusion-4 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "If" ;
cml:logicSummary "Conditional diffusion for breach of consent." ;
cml:premiseText "(6) 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." ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-15-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-15-ss-6-logic-cogai-5 .
concept:therapeutic-goods-act-1989-sec-15-ss-6-logic-cogai-5 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "Knowledge" ;
cml:logicSummary "Artificial agent's knowledge for breach of consent." ;
cml:premiseText "(6) 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." ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-15-ss-7 a cml:Concept ;
skos:prefLabel "15(7) Criminal offences relating to breaching a condition of a consent"@en ;
cml:realizedBy doc:sec-15-ss-7 ;
cml:integrityHash "727895f476d6aed02d887698725dd1d057890ea468669e0028a1994062171172" ;
values:partOf concept:therapeutic-goods-act-1989-sec-15 ;
skos:note "An offence against subsection (6) is an offence of strict liability." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.86" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-15-ss-7-norm .
concept:therapeutic-goods-act-1989-sec-15-ss-7-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-15-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-15-ss-7 cml:asserts concept:therapeutic-goods-act-1989-sec-15-ss-7-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-15-ss-7-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-15aa a cml:Concept ;
skos:prefLabel "15AA Civil penalty relating to breaching a condition of a consent"@en ;
cml:realizedBy doc:sec-15aa ;
cml:integrityHash "403b5a583aea68df9f5daef94dd707ce3350b594a6a1d12ba820d54c616294d0" ;
skos:note "Breach of consent condition results in civil penalty" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.87" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-15aa-norm .
concept:therapeutic-goods-act-1989-sec-15aa-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-15aa ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-15aa cml:asserts concept:therapeutic-goods-act-1989-sec-15aa-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-15aa-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "forbid" ;
cml:logicSummary "Prohibits breach of consent condition" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-15ab a cml:Concept ;
skos:prefLabel "15AB Conditions relating to exceptional release of biologicals"@en ;
cml:realizedBy doc:sec-15ab ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-15ab-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-15ab-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-15ab-ss-3 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.87" .
concept:therapeutic-goods-act-1989-sec-15ab-ss-1 a cml:Concept ;
skos:prefLabel "15AB(1) Conditions relating to exceptional release of biologicals"@en ;
cml:realizedBy doc:sec-15ab-ss-1 ;
cml:integrityHash "f783e0dd36667991e06cd9227a2b734381fd5ea7db420cb7fb6ce8aa30a7d204" ;
values:partOf concept:therapeutic-goods-act-1989-sec-15ab ;
skos:note "Regulations may prescribe conditions for the supply of a biological after specified circumstances have occurred." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.87" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-15ab-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-15ab-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-15ab-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-15ab-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-15ab-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-15ab-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "may" ;
cml:logicSummary "Regulations may prescribe conditions." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-15ab-ss-2 a cml:Concept ;
skos:prefLabel "15AB(2) Conditions relating to exceptional release of biologicals"@en ;
cml:realizedBy doc:sec-15ab-ss-2 ;
cml:integrityHash "2f10fdee5add1510e2666b5af57b6761ae6cd4445d7cd630d3f5c526bcbf8c9f" ;
values:partOf concept:therapeutic-goods-act-1989-sec-15ab ;
skos:note "Conditions must apply only to the person supplying biologicals." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.87" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-15ab-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-15ab-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-15ab-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-15ab-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-15ab-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-15ab-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "mustApply" ;
cml:logicSummary "Mandatory application of conditions." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-15ab-ss-3 a cml:Concept ;
skos:prefLabel "15AB(3) Conditions relating to exceptional release of biologicals"@en ;
cml:realizedBy doc:sec-15ab-ss-3 ;
cml:integrityHash "3289f94d2efc39766757dcb95689fff0ea08ceaccf81afff9e502962bd7758c4" ;
values:partOf concept:therapeutic-goods-act-1989-sec-15ab ;
skos:note "Committing an offence for breach of conditions" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.87" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-15ab-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-15ab-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-15ab-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-15ab-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-15ab-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-15ab-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Obligation to comply with conditions" ;
cml:premiseText "(3) A person commits an offence if: (a) the person does an act or omits to do an act;" ;
cml:conclusionText "Penalty for contravention of this subsection:60 penalty units." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-15ab-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-15ab-ss-3-logic-deontic-2 .
concept:therapeutic-goods-act-1989-sec-15ab-ss-3-logic-deontic-2 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibition" ;
cml:logicSummary "Prohibition on breach of conditions" ;
cml:premiseText "(3) A person commits an offence if: (a) the person does an act or omits to do an act;" ;
cml:conclusionText "Penalty for contravention of this subsection:60 penalty units." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-15ab-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-15ab-ss-3-logic-alleninterval-3 .
concept:therapeutic-goods-act-1989-sec-15ab-ss-3-logic-alleninterval-3 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Between" ;
cml:logicSummary "Temporal relationship between breach and penalty" ;
cml:premiseText "(3) A person commits an offence if: (a) the person does an act or omits to do an act;" ;
cml:conclusionText "Penalty for contravention of this subsection:60 penalty units." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-15ab-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-15ab-ss-3-logic-ltl-4 .
concept:therapeutic-goods-act-1989-sec-15ab-ss-3-logic-ltl-4 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "Recurring" ;
cml:logicSummary "Recurring trace of breach and penalty" ;
cml:premiseText "(3) A person commits an offence if: (a) the person does an act or omits to do an act;" ;
cml:conclusionText "Penalty for contravention of this subsection:60 penalty units." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-15a a cml:Concept ;
skos:prefLabel "15A Part does not apply to a medical device"@en ;
cml:realizedBy doc:sec-15a ;
cml:integrityHash "19af70f5b76fbab4ad94ec5b26b972ed1461e7b81c80bcf1ed0b001995e240ef" ;
skos:note "Part does not apply to medical devices." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.88" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-15a-norm .
concept:therapeutic-goods-act-1989-sec-15a-norm a values:Undertaking ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-15a ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-15b a cml:Concept ;
skos:prefLabel "15B Application of this Part to a biological"@en ;
cml:realizedBy doc:sec-15b ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-15b-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-15b-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-15b-ss-3 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.88" .
concept:therapeutic-goods-act-1989-sec-15b-ss-1 a cml:Concept ;
skos:prefLabel "15B(1) Application of this Part to a biological"@en ;
cml:realizedBy doc:sec-15b-ss-1 ;
cml:integrityHash "ceaebbfa15de5ef0c1e21b9a06d3867738b66cfa5a690bf3d85708cf47258d83" ;
values:partOf concept:therapeutic-goods-act-1989-sec-15b ;
skos:note "Application of this Part to biologicals on and after commencement." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.88" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-15b-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-15b-ss-1-norm a values:Undertaking ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-15b-ss-1 ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-15b-ss-2 a cml:Concept ;
skos:prefLabel "15B(2) Application of this Part to a biological"@en ;
cml:realizedBy doc:sec-15b-ss-2 ;
cml:integrityHash "00b2be5e15867c0126189de54add995d634823985495fd252910d2800ab0b5f6" ;
values:partOf concept:therapeutic-goods-act-1989-sec-15b ;
skos:note "Continues application of this Part to biological goods after commencement." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.88" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-15b-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-15b-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-15b-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-15b-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-15b-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-15b-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "CONTINUES" ;
cml:logicSummary "Continues application of this Part." ;
cml:premiseText "(2) If, immediately before the commencement of this section," ;
cml:conclusionText "this Part continues to apply to the biological on and after that commencement until the time the biological is included in the Register under Part 3-2A." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-15b-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-15b-ss-2-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-15b-ss-2-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "BEFORE" ;
cml:logicSummary "Temporal relationship between commencement and application." ;
cml:premiseText "(2) If, immediately before the commencement of this section," ;
cml:conclusionText "this Part continues to apply to the biological on and after that commencement until the time the biological is included in the Register under Part 3-2A." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-15b-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-15b-ss-2-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-15b-ss-2-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "UNTIL" ;
cml:logicSummary "Temporal relationship between application and inclusion in Register." ;
cml:premiseText "(2) If, immediately before the commencement of this section," ;
cml:conclusionText "this Part continues to apply to the biological on and after that commencement until the time the biological is included in the Register under Part 3-2A." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-15b-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-15b-ss-2-logic-diffusion-4 .
concept:therapeutic-goods-act-1989-sec-15b-ss-2-logic-diffusion-4 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "CONTINUES" ;
cml:logicSummary "Continued application of this Part." ;
cml:premiseText "(2) If, immediately before the commencement of this section," ;
cml:conclusionText "this Part continues to apply to the biological on and after that commencement until the time the biological is included in the Register under Part 3-2A." ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-15b-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-15b-ss-2-logic-cogai-5 .
concept:therapeutic-goods-act-1989-sec-15b-ss-2-logic-cogai-5 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "CLASSIFICATION" ;
cml:logicSummary "Classification of biological goods." ;
cml:premiseText "(2) If, immediately before the commencement of this section," ;
cml:conclusionText "the therapeutic goods that are a biological were registered goods or listed goods." ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-15b-ss-3 a cml:Concept ;
skos:prefLabel "15B(3) Application of this Part to a biological"@en ;
cml:realizedBy doc:sec-15b-ss-3 ;
cml:integrityHash "730f6b1ece8c1746fc6f32b1978f698f0b7018f4a61a2e21b66bb4f6817197e2" ;
values:partOf concept:therapeutic-goods-act-1989-sec-15b ;
skos:note "Continuation of Part application to biological on commencement" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.88" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-15b-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-15b-ss-3-norm a values:Undertaking ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-15b-ss-3 ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-16 a cml:Concept ;
skos:prefLabel "16 Therapeutic goods and gazetted groups"@en ;
cml:realizedBy doc:sec-16 ;
cml:integrityHash "332e821bf3e340d296550535e75847a6b2321f16e76111ab1ed0f75d5815c2bb" ;
skos:note "Therapeutic goods must be taken to be separate and distinct from other therapeutic goods if they have a different formulation, composition or design specification; or a different strength or size (disregarding pack size); or a different dosage form or model; or a different name;" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.89" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-16-norm .
concept:therapeutic-goods-act-1989-sec-16-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-16 ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-16 cml:asserts concept:therapeutic-goods-act-1989-sec-16-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-16-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "!" ;
cml:logicSummary "Imposes an obligation to classify therapeutic goods based on the specified criteria." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-18 a cml:Concept ;
skos:prefLabel "18 Exempt goods"@en ;
cml:realizedBy doc:sec-18 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-18-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-18-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-18-ss-3 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.91" .
concept:therapeutic-goods-act-1989-sec-18-ss-1 a cml:Concept ;
skos:prefLabel "18(1) Exempt goods"@en ;
cml:realizedBy doc:sec-18-ss-1 ;
cml:integrityHash "f1f3a97704900f630fe0291ca069034029de2321979335422aacfe39d055df6c" ;
values:partOf concept:therapeutic-goods-act-1989-sec-18 ;
skos:note "Exempts therapeutic goods from operation of this Part" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.91" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-18-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-18-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-18-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-18-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-18-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-18-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "exempt" ;
cml:logicSummary "Imposes duty to exempt goods" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-18-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-18-ss-1-logic-descriptionlogic-2 .
concept:therapeutic-goods-act-1989-sec-18-ss-1-logic-descriptionlogic-2 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "subclassOf" ;
cml:logicSummary "Classifies goods into subclasses" ;
cml:premiseText "(a) all therapeutic goods, except those included in a class of goods prescribed for the purposes of this paragraph;" ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-18-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-18-ss-1-logic-descriptionlogic-3 .
concept:therapeutic-goods-act-1989-sec-18-ss-1-logic-descriptionlogic-3 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "subclassOf" ;
cml:logicSummary "Classifies goods into subclasses" ;
cml:premiseText "(b) specified therapeutic goods;" ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-18-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-18-ss-1-logic-descriptionlogic-4 .
concept:therapeutic-goods-act-1989-sec-18-ss-1-logic-descriptionlogic-4 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "subclassOf" ;
cml:logicSummary "Classifies goods into subclasses" ;
cml:premiseText "(c) a specified class of therapeutic goods;" ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-18-ss-2 a cml:Concept ;
skos:prefLabel "18(2) Exempt goods"@en ;
cml:realizedBy doc:sec-18-ss-2 ;
cml:integrityHash "ccea44de4d3e5717f6b5659b3a70f6aed420bfe899c6c06b16ce5fdf6a32455a" ;
values:partOf concept:therapeutic-goods-act-1989-sec-18 ;
skos:note "Exemptions apply only to specified classes of persons." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.91" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-18-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-18-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-18-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-18-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-18-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-18-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "onlyIf" ;
cml:logicSummary "Conditional obligation" ;
cml:premiseText "(2) An exemption in terms of paragraph (1)(a)" ;
cml:conclusionText "has effect only in relation to such classes of persons as are prescribed for the purposes of this subsection." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-18-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-18-ss-2-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-18-ss-2-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "during" ;
cml:logicSummary "Temporal scope of exemptions" ;
cml:premiseText "(2) An exemption in terms of paragraph (1)(a)" ;
cml:conclusionText "relation to such classes of persons as are prescribed for the purposes of this subsection." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-18-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-18-ss-2-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-18-ss-2-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "during" ;
cml:logicSummary "Temporal scope of exemptions" ;
cml:premiseText "(2) An exemption in terms of paragraph (1)(a)" ;
cml:conclusionText "relation to such classes of persons as are prescribed for the purposes of this subsection." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-18-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-18-ss-2-logic-diffusion-4 .
concept:therapeutic-goods-act-1989-sec-18-ss-2-logic-diffusion-4 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "influence" ;
cml:logicSummary "Scope of exemptions" ;
cml:premiseText "(2) An exemption in terms of paragraph (1)(a)" ;
cml:conclusionText "relation to such classes of persons as are prescribed for the purposes of this subsection." ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-18-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-18-ss-2-logic-cogai-5 .
concept:therapeutic-goods-act-1989-sec-18-ss-2-logic-cogai-5 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "classify" ;
cml:logicSummary "Classification of exempt goods" ;
cml:premiseText "(2) An exemption in terms of paragraph (1)(a)" ;
cml:conclusionText "relation to such classes of persons as are prescribed for the purposes of this subsection." ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-18-ss-3 a cml:Concept ;
skos:prefLabel "18(3) Exempt goods"@en ;
cml:realizedBy doc:sec-18-ss-3 ;
cml:integrityHash "6ee535136cad7fb5c40f8d191714985357ea21ddbe128482ca1206f4a098fd0c" ;
values:partOf concept:therapeutic-goods-act-1989-sec-18 ;
skos:note "Revocation of exemption takes effect after 28 days" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.91" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-18-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-18-ss-3-norm a values:Undertaking ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-18-ss-3 ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-18-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-18-ss-3-logic-alleninterval-1 .
concept:therapeutic-goods-act-1989-sec-18-ss-3-logic-alleninterval-1 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Applicable" ;
cml:logicSummary "Defines temporal interval for revocation" ;
cml:premiseText "Revocation takes effect on a specified day" ;
cml:conclusionText "After 28 days from the regulations' effective date" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-18a a cml:Concept ;
skos:prefLabel "18A Exemption because of emergency"@en ;
cml:realizedBy doc:sec-18a ;
cml:integrityHash "855832e8c9d7a0db0654b5ff5c17af11d4771b4a7c0464e925ef4d02b8957ce0" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-18a-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-18a-ss-1a ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-18a-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.91" .
concept:therapeutic-goods-act-1989-sec-18a-ss-1 a cml:Concept ;
skos:prefLabel "18A(1) Exemption because of emergency"@en ;
cml:realizedBy doc:sec-18a-ss-1 ;
cml:integrityHash "c81c2842e24f2928f3352765250aa4233b3d148a051fd55fcab3bebd118600f0" ;
values:partOf concept:therapeutic-goods-act-1989-sec-18a ;
skos:note "Exemption from Division 2 operation due to emergency" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.91" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-18a-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-18a-ss-1-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-18a-ss-1 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-18a-ss-1a a cml:Concept ;
skos:prefLabel "18A(1A) Exemption because of emergency"@en ;
cml:realizedBy doc:sec-18a-ss-1a ;
cml:integrityHash "07a26f6deb728139e5c268838e4418ede582d4279165f8b93742e68ff55431a6" ;
values:partOf concept:therapeutic-goods-act-1989-sec-18a ;
skos:note "Exemption from goods under subsection (1) based on Minister's satisfaction" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.91" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-18a-ss-1a-norm .
concept:therapeutic-goods-act-1989-sec-18a-ss-1a-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-18a-ss-1a ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-18a-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-18a-ss-1a-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-18a-ss-1a-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Permit" ;
cml:logicSummary "Granting permission" ;
cml:premiseText "(1A) The Minister may exempt goods under subsection (1)" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-18a-ss-2 a cml:Concept ;
skos:prefLabel "18A(2) Exemption because of emergency"@en ;
cml:realizedBy doc:sec-18a-ss-2 ;
cml:integrityHash "11bc4262c67a7abab627c65b11af1cb8240f0ca85b44f87eadc124421da02563" ;
values:partOf concept:therapeutic-goods-act-1989-sec-18a ;
skos:note "Exemption for stockpiling goods in emergency" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.91" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-18a-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-18a-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-18a-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-18a-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-18a-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-18a-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Creates an obligation for the state to make exemptions" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-19 a cml:Concept ;
skos:prefLabel "19 Approvals or authorities for certain uses"@en ;
cml:realizedBy doc:sec-19 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-19-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-19-ss-1a ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-19-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-19-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-19-ss-4 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-19-ss-4a ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-19-ss-4b ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.96" .
concept:therapeutic-goods-act-1989-sec-19-ss-1 a cml:Concept ;
skos:prefLabel "19(1) Approvals or authorities for certain uses"@en ;
cml:realizedBy doc:sec-19-ss-1 ;
cml:integrityHash "418b7252fa321a961fc1c830f772b554b5cbf8872395358bf998768b77ff1dbc" ;
values:partOf concept:therapeutic-goods-act-1989-sec-19 ;
skos:note "Approval for therapeutic goods importation or exportation with conditions." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.96" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-19-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-19-ss-1-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-19-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-19-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-19-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-19-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Grant" ;
cml:logicSummary "Approval grant" ;
cml:premiseText "Secretary may 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-19-ss-1a a cml:Concept ;
skos:prefLabel "19(1A) Approvals or authorities for certain uses"@en ;
cml:realizedBy doc:sec-19-ss-1a ;
cml:integrityHash "fdeda0cb1012356e741509244d21cb2c05e18bcaba6b6fa927f2c5efaa52455b" ;
values:partOf concept:therapeutic-goods-act-1989-sec-19 ;
skos:note "Approval conditions are subject to additional regulations." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.96" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-19-ss-1a-norm .
concept:therapeutic-goods-act-1989-sec-19-ss-1a-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-19-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-19-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-19-ss-1a-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-19-ss-1a-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "SUBJUNCTIVE" ;
cml:logicSummary "Conditional obligation" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-19-ss-2 a cml:Concept ;
skos:prefLabel "19(2) Approvals or authorities for certain uses"@en ;
cml:realizedBy doc:sec-19-ss-2 ;
cml:integrityHash "0b8e578f3db5a8de62b31c3747a5eeb555da57071d6f3b281f59880be47d7daf" ;
values:partOf concept:therapeutic-goods-act-1989-sec-19 ;
skos:note "Application for approval must be made to the Secretary and meet certain requirements." ;
dc:description "Information relating to goods subject to application, evaluation fee" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.96" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-19-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-19-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-19-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-19-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-19-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-19-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Application must be made" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-19-ss-3 a cml:Concept ;
skos:prefLabel "19(3) Approvals or authorities for certain uses"@en ;
cml:realizedBy doc:sec-19-ss-3 ;
cml:integrityHash "4d7b37901aba5715cfc400b300b48b7c6653e8fbf504a69b5595ff05c350bcf1" ;
values:partOf concept:therapeutic-goods-act-1989-sec-19 ;
skos:note "Approval conditions may include charges for therapeutic goods." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.96" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-19-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-19-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-19-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-19-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-19-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-19-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "includes" ;
cml:logicSummary "Includes charges in approval conditions." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-19-ss-4 a cml:Concept ;
skos:prefLabel "19(4) Approvals or authorities for certain uses"@en ;
cml:realizedBy doc:sec-19-ss-4 ;
cml:integrityHash "2444276c81866ecd86b77a89a253735c272a7de395f037589e5c55cbc5e0431a" ;
values:partOf concept:therapeutic-goods-act-1989-sec-19 ;
skos:note "Notify applicant of decision on approval within 28 days." ;
dc:description "Reasons for decision (if not granting approval)" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.96" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-19-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-19-ss-4-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-19-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-19-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-19-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-19-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Must notify applicant within 28 days." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-19-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-19-ss-4-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-19-ss-4-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator ">=" ;
cml:logicSummary "Temporal interval for decision notification." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-19-ss-4a a cml:Concept ;
skos:prefLabel "19(4A) Approvals or authorities for certain uses"@en ;
cml:realizedBy doc:sec-19-ss-4a ;
cml:integrityHash "a177de48d7bb05c6f28600096f16b73964fc7ac3dd87eaaf6d96583823b8b545" ;
values:partOf concept:therapeutic-goods-act-1989-sec-19 ;
skos:note "Conditions for experimental use of therapeutic goods in humans" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.96" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-19-ss-4a-norm .
concept:therapeutic-goods-act-1989-sec-19-ss-4a-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-19-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-19-ss-4a cml:asserts concept:therapeutic-goods-act-1989-sec-19-ss-4a-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-19-ss-4a-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Regulation of experimental use" ;
cml:premiseText "Use by a person for experimental purposes in humans" ;
cml:conclusionText "is subject to the conditions specified in the regulations" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-19-ss-4b a cml:Concept ;
skos:prefLabel "19(4B) Approvals or authorities for certain uses"@en ;
cml:realizedBy doc:sec-19-ss-4b ;
cml:integrityHash "cd149ce253051ebb6df79648b8b080665d31575241ad02e46e5119769459f25d" ;
values:partOf concept:therapeutic-goods-act-1989-sec-19 ;
skos:note "Request for variation of therapeutic goods approval" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.96" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-19-ss-4b-norm .
concept:therapeutic-goods-act-1989-sec-19-ss-4b-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-19-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-19a a cml:Concept ;
skos:prefLabel "19A Approvals where unavailability etc. of therapeutic goods"@en ;
cml:realizedBy doc:sec-19a ;
cml:integrityHash "c08d18d286923cefe07aafbd020c063b168a8af45954d7225017ab722404396e" ;
skos:note "Secretary may grant approval for importation or supply of therapeutic goods under certain conditions." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.101" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-19a-norm .
concept:therapeutic-goods-act-1989-sec-19a-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-19a ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-19a cml:asserts concept:therapeutic-goods-act-1989-sec-19a-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-19a-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 goods that are the subject of the application are registered or approved for general marketing..." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-19a cml:asserts concept:therapeutic-goods-act-1989-sec-19a-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-19a-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "during" ;
cml:logicSummary "Approval is granted during a specific period" ;
cml:premiseText "(1) The Secretary may, by notice in writing..." ;
cml:conclusionText "...the goods that are the subject of the application are registered or approved for general marketing in at least one foreign country specified by the Secretary in a determination under subsection (3);..." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-19a cml:asserts concept:therapeutic-goods-act-1989-sec-19a-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-19a-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "everywhere" ;
cml:logicSummary "Approval applies to all therapeutic goods" ;
cml:premiseText "(1) The Secretary may, by notice in writing..." ;
cml:conclusionText "...the goods that are the subject of the application are registered or approved for general marketing in at least one foreign country specified by the Secretary in a determination under subsection (3);..." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-19a cml:asserts concept:therapeutic-goods-act-1989-sec-19a-logic-diffusion-4 .
concept:therapeutic-goods-act-1989-sec-19a-logic-diffusion-4 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "if-then" ;
cml:logicSummary "Approval is conditional on certain conditions being met" ;
cml:premiseText "(a) registered goods that could act as a substitute for the goods..." ;
cml:conclusionText "...the Secretary is satisfied that: (i) the goods that are the subject of the application are registered or approved for general marketing in at least one foreign country specified by the Secretary in a determination under subsection (3); or..." ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-19a cml:asserts concept:therapeutic-goods-act-1989-sec-19a-logic-cogai-5 .
concept:therapeutic-goods-act-1989-sec-19a-logic-cogai-5 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "if-then" ;
cml:logicSummary "Approval is conditional on preliminary assessment of registration application" ;
cml:premiseText "(b) either: (i) the goods that are the subject of the application are registered or approved for general marketing in at least one foreign country specified by the Secretary in a determination under subsection (3); or..." ;
cml:conclusionText "...an application under section 23 has been made for registration of the goods and the application has passed preliminary assessment;..." ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-19b a cml:Concept ;
skos:prefLabel "19B Criminal offences relating to registration or listing etc. of"@en ;
cml:realizedBy doc:sec-19b ;
cml:integrityHash "6850b34595c7a4d6d003c209d3752a27321057f49c1488728829f39ad45044a8" ;
skos:note "Offences relating to importing, exporting, manufacturing or supplying goods for use in humans" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.105" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-19b-norm .
concept:therapeutic-goods-act-1989-sec-19b-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-19b ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-19b cml:asserts concept:therapeutic-goods-act-1989-sec-19b-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-19b-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits importing, exporting, manufacturing or supplying goods for use in humans" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-19c a cml:Concept ;
skos:prefLabel "19C Notice required to adduce evidence in support of exception"@en ;
cml:realizedBy doc:sec-19c ;
cml:integrityHash "77146b6ede20dfed3c542c124cb75182179bf06dcb289624c7d97eac832e7e37" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-19c-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-19c-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.109" .
concept:therapeutic-goods-act-1989-sec-19c-ss-1 a cml:Concept ;
skos:prefLabel "19C(1) Notice required to adduce evidence in support of exception"@en ;
cml:realizedBy doc:sec-19c-ss-1 ;
cml:integrityHash "4180d440edbd45c3262d8e19038554bc4d417754b5a341c6e2fc8e504082ef06" ;
values:partOf concept:therapeutic-goods-act-1989-sec-19c ;
skos:note "Defendant must be informed of requirements and given a copy of the section." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.109" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-19c-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-19c-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-19c-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-19c-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-19c-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-19c-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Defendant must be informed." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-19c-ss-2 a cml:Concept ;
skos:prefLabel "19C(2) Notice required to adduce evidence in support of exception"@en ;
cml:realizedBy doc:sec-19c-ss-2 ;
cml:integrityHash "2fb5cdbb61f9ca020106a6a2397abe081a92e8e8a25dcb5dc0e23a20f570769e" ;
values:partOf concept:therapeutic-goods-act-1989-sec-19c ;
skos:note "No evidence in support of exception can be adduced without notice." ;
dc:description "Notice of particulars of the exception" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.109" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-19c-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-19c-ss-2-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-19c-ss-2 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-19c-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-19c-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-19c-ss-2-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-19d a cml:Concept ;
skos:prefLabel "19D Civil penalties relating to registration or listing etc. of imported,"@en ;
cml:realizedBy doc:sec-19d ;
cml:integrityHash "59dab709ccb4e7fa63b38d836473d44d9caed4b97b62abf5b77fbc560f14b7d9" ;
skos:note "Importing, exporting, manufacturing or supplying therapeutic goods for use in humans is prohibited." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.111" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-19d-norm .
concept:therapeutic-goods-act-1989-sec-19d-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-19d ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-19d cml:asserts concept:therapeutic-goods-act-1989-sec-19d-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-19d-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibition of importing, exporting, manufacturing or supplying therapeutic goods for use in humans." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-20 a cml:Concept ;
skos:prefLabel "20 Criminal offences relating to notifying the Secretary and to"@en ;
cml:realizedBy doc:sec-20 ;
cml:integrityHash "e85aa15a1d9a68ba4e48d2e1d94c83fec7cb2f92ec2cb8bdcdedd6821d6c9770" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-20-ss-1b ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-20-ss-1c ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-20-ss-2a ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-20-ss-2b ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-20-ss-2c ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-20-ss-2d ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.114" .
concept:therapeutic-goods-act-1989-sec-20-ss-1b a cml:Concept ;
skos:prefLabel "20(1B) Criminal offences relating to notifying the Secretary and to"@en ;
cml:realizedBy doc:sec-20-ss-1b ;
cml:integrityHash "394de7b75dbb4ab307e3656a4f9fe8961e04f95d6396b3d76453698101245ad8" ;
values:partOf concept:therapeutic-goods-act-1989-sec-20 ;
skos:note "Importing, exporting, manufacturing, or supplying therapeutic goods without proper notification is prohibited." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.114" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-20-ss-1b-norm .
concept:therapeutic-goods-act-1989-sec-20-ss-1b-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-20-ss-1b ;
values:borneBy values:Agent ;
skos:scopeNote "borne by: Agent" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-20-ss-1b cml:asserts concept:therapeutic-goods-act-1989-sec-20-ss-1b-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-20-ss-1b-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibition of actions" ;
cml:premiseText "The person has not properly notified..." ;
cml:conclusionText "An offence is committed." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-20-ss-1c a cml:Concept ;
skos:prefLabel "20(1C) Criminal offences relating to notifying the Secretary and to"@en ;
cml:realizedBy doc:sec-20-ss-1c ;
cml:integrityHash "2cc560039442327b97230baf25cfa97b64f4a0a793ac94735660b2d0a6e71d87" ;
values:partOf concept:therapeutic-goods-act-1989-sec-20 ;
skos:note "Manufacturer and premises must be notified to the Secretary." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.114" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-20-ss-1c-norm .
concept:therapeutic-goods-act-1989-sec-20-ss-1c-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-20-ss-1c ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-20-ss-1c cml:asserts concept:therapeutic-goods-act-1989-sec-20-ss-1c-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-20-ss-1c-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Must provide notification" ;
cml:premiseText "Notification is required" ;
cml:conclusionText "Manufacturer and premises must be notified" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-20-ss-2a a cml:Concept ;
skos:prefLabel "20(2A) Criminal offences relating to notifying the Secretary and to"@en ;
cml:realizedBy doc:sec-20-ss-2a ;
cml:integrityHash "41a35cb1369c61a41878ff59b79e8d2d1625130314effd8dbba8066893e511cb" ;
values:partOf concept:therapeutic-goods-act-1989-sec-20 ;
skos:note "Importation of therapeutic goods into Australia without exemption breaches a condition." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.114" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-20-ss-2a-norm .
concept:therapeutic-goods-act-1989-sec-20-ss-2a-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-20-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-20-ss-2a cml:asserts concept:therapeutic-goods-act-1989-sec-20-ss-2a-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-20-ss-2a-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits importation of therapeutic goods without exemption." ;
cml:premiseText "(2A) A person commits an offence..." ;
cml:conclusionText "...breaches a condition of the exemption." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-20-ss-2a cml:asserts concept:therapeutic-goods-act-1989-sec-20-ss-2a-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-20-ss-2a-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Overlap" ;
cml:logicSummary "Identifies overlap between exemption conditions and importation." ;
cml:premiseText "(2A) A person commits an offence..." ;
cml:conclusionText "...if the importation breaches a condition of the exemption." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-20-ss-2a cml:asserts concept:therapeutic-goods-act-1989-sec-20-ss-2a-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-20-ss-2a-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "Recurring" ;
cml:logicSummary "Identifies recurring breach of exemption conditions." ;
cml:premiseText "(2A) A person commits an offence..." ;
cml:conclusionText "...if the goods are exempt under section 18A; and..." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-20-ss-2a cml:asserts concept:therapeutic-goods-act-1989-sec-20-ss-2a-logic-diffusion-4 .
concept:therapeutic-goods-act-1989-sec-20-ss-2a-logic-diffusion-4 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "Diffuse" ;
cml:logicSummary "Diffuses breach of exemption conditions." ;
cml:premiseText "(2A) A person commits an offence..." ;
cml:conclusionText "...breaches a condition of the exemption." ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-20-ss-2a cml:asserts concept:therapeutic-goods-act-1989-sec-20-ss-2a-logic-cogai-5 .
concept:therapeutic-goods-act-1989-sec-20-ss-2a-logic-cogai-5 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "Analyze" ;
cml:logicSummary "Analyzes importation of therapeutic goods without exemption." ;
cml:premiseText "(2A) A person commits an offence..." ;
cml:conclusionText "...if the goods are exempt under section 18A; and..." ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-20-ss-2b a cml:Concept ;
skos:prefLabel "20(2B) Criminal offences relating to notifying the Secretary and to"@en ;
cml:realizedBy doc:sec-20-ss-2b ;
cml:integrityHash "06c2dde25a0e5b60ef8b0edea23d964be73ec2915121b83191402e72d78a55fc" ;
values:partOf concept:therapeutic-goods-act-1989-sec-20 ;
skos:note "Prohibition on strict liability for notifying the Secretary" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.114" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-20-ss-2b-norm .
concept:therapeutic-goods-act-1989-sec-20-ss-2b-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-20-ss-2b ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-20-ss-2b cml:asserts concept:therapeutic-goods-act-1989-sec-20-ss-2b-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-20-ss-2b-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "forbid" ;
cml:logicSummary "Prohibits strict liability" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-20-ss-2c a cml:Concept ;
skos:prefLabel "20(2C) Criminal offences relating to notifying the Secretary and to"@en ;
cml:realizedBy doc:sec-20-ss-2c ;
cml:integrityHash "c4e02d263c7e4448227aaca4673c59435d2f0ad502c42258889e6b3be9ec92a6" ;
values:partOf concept:therapeutic-goods-act-1989-sec-20 ;
skos:note "Importation of therapeutic goods exempt under section 18A breaches a condition, committing an offence." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.114" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-20-ss-2c-norm .
concept:therapeutic-goods-act-1989-sec-20-ss-2c-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-20-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-20-ss-2c cml:asserts concept:therapeutic-goods-act-1989-sec-20-ss-2c-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-20-ss-2c-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibition" ;
cml:logicSummary "Prohibits importation of therapeutic goods exempt under section 18A." ;
cml:premiseText "(2C) A person commits an offence if: (a) the person imports therapeutic goods into Australia; and (b) the goods are exempt under section 18A; and (c) the importation breaches a condition of the exemption." ;
cml:conclusionText "Penalty: 60 penalty units." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-20-ss-2c cml:asserts concept:therapeutic-goods-act-1989-sec-20-ss-2c-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-20-ss-2c-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "During" ;
cml:logicSummary "Importation occurs during the period when therapeutic goods are exempt." ;
cml:premiseText "(a) The person imports therapeutic goods into Australia; and (b) the goods are exempt under section 18A; and (c) the importation breaches a condition of the exemption." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-20-ss-2c cml:asserts concept:therapeutic-goods-act-1989-sec-20-ss-2c-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-20-ss-2c-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "Recurring" ;
cml:logicSummary "Importation is a recurring action that breaches a condition." ;
cml:premiseText "(a) The person imports therapeutic goods into Australia; and (b) the goods are exempt under section 18A; and (c) the importation breaches a condition of the exemption." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-20-ss-2c cml:asserts concept:therapeutic-goods-act-1989-sec-20-ss-2c-logic-diffusion-4 .
concept:therapeutic-goods-act-1989-sec-20-ss-2c-logic-diffusion-4 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "Spreads" ;
cml:logicSummary "Importation spreads to other actions that breach a condition." ;
cml:premiseText "(a) The person imports therapeutic goods into Australia; and (b) the goods are exempt under section 18A; and (c) the importation breaches a condition of the exemption." ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-20-ss-2c cml:asserts concept:therapeutic-goods-act-1989-sec-20-ss-2c-logic-argumentation-5 .
concept:therapeutic-goods-act-1989-sec-20-ss-2c-logic-argumentation-5 a cml:LogicApplication ;
cml:modality cml:Argumentation ;
cml:operator "Implicates" ;
cml:logicSummary "Importation implies that therapeutic goods are not exempt." ;
cml:premiseText "(a) The person imports therapeutic goods into Australia; and (b) the goods are exempt under section 18A; and (c) the importation breaches a condition of the exemption." ;
cml:executionSurface "modalities::argumentation" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-20-ss-2d a cml:Concept ;
skos:prefLabel "20(2D) Criminal offences relating to notifying the Secretary and to"@en ;
cml:realizedBy doc:sec-20-ss-2d ;
cml:integrityHash "424ce4198ecfe8e2b9899030254aa8c31f45ef861c75b66ca3521f684be522d9" ;
values:partOf concept:therapeutic-goods-act-1989-sec-20 ;
skos:note "Offence of strict liability for notifying the Secretary and to" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.114" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-20-ss-2d-norm .
concept:therapeutic-goods-act-1989-sec-20-ss-2d-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-20-ss-2d ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-20-ss-2d cml:asserts concept:therapeutic-goods-act-1989-sec-20-ss-2d-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-20-ss-2d-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits an offence under subsection (2C)" ;
cml:premiseText "An offence under subsection (2C) 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-20a a cml:Concept ;
skos:prefLabel "20A Civil penalty relating to the importation, exportation,"@en ;
cml:realizedBy doc:sec-20a ;
cml:integrityHash "ecf0722fc03846acb3de4646f504b1ec898509d4ee2f5f32d638badf7515224c" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-20a-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-20a-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.116" .
concept:therapeutic-goods-act-1989-sec-20a-ss-1 a cml:Concept ;
skos:prefLabel "20A(1) Civil penalty relating to the importation, exportation,"@en ;
cml:realizedBy doc:sec-20a-ss-1 ;
cml:integrityHash "2f05e789932ca7d0915d53f2e2fd4447137431616a5040d13b97259676fb91fb" ;
values:partOf concept:therapeutic-goods-act-1989-sec-20a ;
skos:note "Importation, exportation, manufacture, or supply of therapeutic goods without proper notification." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.116" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-20a-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-20a-ss-1-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-20a-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-20a-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-20a-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-20a-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibition" ;
cml:premiseText "Importation, exportation, manufacture, or supply of therapeutic goods without proper notification." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-20a-ss-2 a cml:Concept ;
skos:prefLabel "20A(2) Civil penalty relating to the importation, exportation,"@en ;
cml:realizedBy doc:sec-20a-ss-2 ;
cml:integrityHash "d1307bd01e6066d904a59bb2fff2e3062280512ba57781437d1c6e60fa12c8e7" ;
values:partOf concept:therapeutic-goods-act-1989-sec-20a ;
skos:note "Manufacturer and premises must be notified to the Secretary." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.116" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-20a-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-20a-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-20a-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-20a-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-20a-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-20a-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "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-21 a cml:Concept ;
skos:prefLabel "21 Offence relating to wholesale supply"@en ;
cml:realizedBy doc:sec-21 ;
cml:integrityHash "391f25ba88de1d2d063a88a388d620f5e82b39f41093ee3b129290f5b63c787a" ;
skos:note "Supplying therapeutic goods without proper authorization is prohibited." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.117" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-21-norm .
concept:therapeutic-goods-act-1989-sec-21-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-21 ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-21 cml:asserts concept:therapeutic-goods-act-1989-sec-21-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-21-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits supplying therapeutic goods without proper authorization." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-21a a cml:Concept ;
skos:prefLabel "21A General criminal offences relating to this Part"@en ;
cml:realizedBy doc:sec-21a ;
cml:integrityHash "3761e724949345bd4afb4fd92f44ec3fcb1847967ffca46dc3929cafdd314a2f" ;
skos:note "Making false or misleading statements in certification is prohibited." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.117" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-21a-norm .
concept:therapeutic-goods-act-1989-sec-21a-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-21a ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-21a cml:asserts concept:therapeutic-goods-act-1989-sec-21a-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-21a-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits making false or misleading statements in certification." ;
cml:premiseText "The statement is made in or in connection with a certification." ;
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-21a cml:asserts concept:therapeutic-goods-act-1989-sec-21a-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-21a-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Overlap" ;
cml:logicSummary "The use of the medicine has resulted in, will result in, or is likely to result in harm or injury." ;
cml:premiseText "(i) the use of the medicine has resulted in, will result in, or is likely to result in, harm or injury to any person;" ;
cml:conclusionText "...or (ii)" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-21a cml:asserts concept:therapeutic-goods-act-1989-sec-21a-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-21a-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "Recurring" ;
cml:logicSummary "The use of the medicine would result in, or would be likely to result in, harm or injury." ;
cml:premiseText "(ii) the use of the medicine, if the medicine were used, would result in, or would be likely to result in, harm or injury to any person." ;
cml:conclusionText "...or (ii)" ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-21a cml:asserts concept:therapeutic-goods-act-1989-sec-21a-logic-deontic-4 .
concept:therapeutic-goods-act-1989-sec-21a-logic-deontic-4 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "The use of the medicine has resulted in, will result in, or is likely to result in harm or injury." ;
cml:premiseText "(i) the use of the medicine has resulted in, will result in, or is likely to result in, harm or injury to any person;" ;
cml:conclusionText "...or (ii)" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-21a cml:asserts concept:therapeutic-goods-act-1989-sec-21a-logic-deontic-5 .
concept:therapeutic-goods-act-1989-sec-21a-logic-deontic-5 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "The use of the medicine would result in, or would be likely to result in, harm or injury." ;
cml:premiseText "(ii) the use of the medicine, if the medicine were used, would result in, or would be likely to result in, harm or injury to any person." ;
cml:conclusionText "...or (ii)" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-21b a cml:Concept ;
skos:prefLabel "21B General civil penalties relating to this Part"@en ;
cml:realizedBy doc:sec-21b ;
cml:integrityHash "e1d360b5c055794f8a5d4e6715fac0309559f3686cfb9507387e6bd5d2560737" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-21b-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-21b-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-21b-ss-3 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.125" .
concept:therapeutic-goods-act-1989-sec-21b-ss-1 a cml:Concept ;
skos:prefLabel "21B(1) General civil penalties relating to this Part"@en ;
cml:realizedBy doc:sec-21b-ss-1 ;
cml:integrityHash "5654818f433c59f7fba0e5366d700314120c685e9a70ae8110cef3116d9b3efd" ;
values:partOf concept:therapeutic-goods-act-1989-sec-21b ;
skos:note "False statement in certification is prohibited" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.125" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-21b-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-21b-ss-1-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-21b-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-21b-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-21b-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-21b-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibition of false statements" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-21b-ss-2 a cml:Concept ;
skos:prefLabel "21B(2) General civil penalties relating to this Part"@en ;
cml:realizedBy doc:sec-21b-ss-2 ;
cml:integrityHash "732dd41ef3110f51ce07e89c4f1fa569244b4eb5d1c55fe1b612f88f9afc2170" ;
values:partOf concept:therapeutic-goods-act-1989-sec-21b ;
skos:note "Falsely representing therapeutic goods is prohibited." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.125" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-21b-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-21b-ss-2-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-21b-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-21b-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-21b-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-21b-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibition of falsely representing therapeutic goods." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-21b-ss-3 a cml:Concept ;
skos:prefLabel "21B(3) General civil penalties relating to this Part"@en ;
cml:realizedBy doc:sec-21b-ss-3 ;
cml:integrityHash "5ae534a444e1562b7e341cf81cea721083655f755b11516b1b9c53643b0b7f91" ;
values:partOf concept:therapeutic-goods-act-1989-sec-21b ;
skos:note "Representing false information about therapeutic goods is prohibited." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.125" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-21b-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-21b-ss-3-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-21b-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-21b-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-21b-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-21b-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibition of representing false information about therapeutic goods." ;
cml:premiseText "Representing false information is generally prohibited." ;
cml:conclusionText "This subsection prohibits representing false information about therapeutic goods." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22 a cml:Concept ;
skos:prefLabel "22 General offences relating to this Part"@en ;
cml:realizedBy doc:sec-22 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-22-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-22-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-22-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-22-ss-5 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-22-ss-5a ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-22-ss-6 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.126" .
concept:therapeutic-goods-act-1989-sec-22-ss-1 a cml:Concept ;
skos:prefLabel "22(1) General offences relating to this Part"@en ;
cml:realizedBy doc:sec-22-ss-1 ;
cml:integrityHash "54d5b430fdb6c3b945f0ff94fd083c3ba094f4b3e461c5651e3e41e8a3f87562" ;
values:partOf concept:therapeutic-goods-act-1989-sec-22 ;
skos:note "Do not misrepresent therapeutic goods registration numbers." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.126" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-22-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-22-ss-1-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-22-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-22-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-22-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-22-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibition of false representation" ;
cml:premiseText "Registration number misrepresentation" ;
cml:conclusionText "No registration number may be misrepresented." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22-ss-2 a cml:Concept ;
skos:prefLabel "22(2) General offences relating to this Part"@en ;
cml:realizedBy doc:sec-22-ss-2 ;
cml:integrityHash "dbcd5760e78b3c3a7190f3dbcee8df4ec25ebdf312e54152201f302c48c76995" ;
values:partOf concept:therapeutic-goods-act-1989-sec-22 ;
skos:note "Advertising therapeutic goods for an unaccepted indication without harm risk" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.126" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-22-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-22-ss-2-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-22-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-22-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-22-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-22-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibition of advertising therapeutic goods for an unaccepted indication without harm risk" ;
cml:premiseText "(a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion;" ;
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-22-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-22-ss-2-logic-descriptionlogic-2 .
concept:therapeutic-goods-act-1989-sec-22-ss-2-logic-descriptionlogic-2 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "Classify" ;
cml:logicSummary "Classification of therapeutic goods based on indications" ;
cml:premiseText "(a) the use of the goods for the advertised indication has resulted in, will result in, or is likely to result in, harm or injury to any person; or (ii) the use of the goods for the advertised indication, if the goods were so used, would result in, or would be likely to result in, harm or injury to any person." ;
cml:conclusionText "The therapeutic goods are included in the Register;" ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-22-ss-2-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-22-ss-2-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "Trace" ;
cml:logicSummary "Temporal tracing of advertising and harm risk" ;
cml:premiseText "(a) the person, by any means, advertises therapeutic goods for an indication; (b) the therapeutic goods are included in the Register; (c) the indication is not an indication accepted in relation to that inclusion;" ;
cml:conclusionText "The use of the goods for the advertised indication has resulted in, will result in, or is likely to result in, harm or injury to any person;" ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-22-ss-2-logic-deontic-4 .
concept:therapeutic-goods-act-1989-sec-22-ss-2-logic-deontic-4 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibition of advertising therapeutic goods for an unaccepted indication without harm risk" ;
cml:premiseText "(a) the use of the goods for the advertised indication has resulted in, will result in, or is likely to result in, harm or injury to any person; or (ii) the use of the goods for the advertised indication, if the goods were so used, would result in, or would be likely to result in, harm or injury to any person." ;
cml:conclusionText "The therapeutic goods are 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-22-ss-3 a cml:Concept ;
skos:prefLabel "22(3) General offences relating to this Part"@en ;
cml:realizedBy doc:sec-22-ss-3 ;
cml:integrityHash "ffa113ba0089f551015b8288bca27c98c78fb43fc47bc4159150aa74f8f8b534" ;
values:partOf concept:therapeutic-goods-act-1989-sec-22 ;
skos:note "Advertising therapeutic goods for an unaccepted indication is prohibited." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.126" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-22-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-22-ss-3-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-22-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-22-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-22-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-22-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibition of advertising therapeutic goods for an unaccepted indication." ;
cml:premiseText "(3) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion." ;
cml:conclusionText "(3) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-22-ss-3-logic-descriptionlogic-2 .
concept:therapeutic-goods-act-1989-sec-22-ss-3-logic-descriptionlogic-2 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "Classify" ;
cml:logicSummary "Classification of advertising as a general offence relating to this Part." ;
cml:premiseText "(3) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion." ;
cml:conclusionText "(3) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion." ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-22-ss-3-logic-alleninterval-3 .
concept:therapeutic-goods-act-1989-sec-22-ss-3-logic-alleninterval-3 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Temporal Interval" ;
cml:logicSummary "Temporal interval of prohibited advertising." ;
cml:premiseText "(3) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion." ;
cml:conclusionText "(3) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-22-ss-3-logic-ltl-4 .
concept:therapeutic-goods-act-1989-sec-22-ss-3-logic-ltl-4 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "Recurring Trace" ;
cml:logicSummary "Recurring trace of prohibited advertising." ;
cml:premiseText "(3) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion." ;
cml:conclusionText "(3) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-22-ss-3-logic-diffusion-5 .
concept:therapeutic-goods-act-1989-sec-22-ss-3-logic-diffusion-5 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "Spread" ;
cml:logicSummary "Spread of prohibited advertising." ;
cml:premiseText "(3) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion." ;
cml:conclusionText "(3) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion." ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-22-ss-3-logic-cogai-6 .
concept:therapeutic-goods-act-1989-sec-22-ss-3-logic-cogai-6 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "Knowledge Representation" ;
cml:logicSummary "Knowledge representation of prohibited advertising." ;
cml:premiseText "(3) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion." ;
cml:conclusionText "(3) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion." ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22-ss-5 a cml:Concept ;
skos:prefLabel "22(5) General offences relating to this Part"@en ;
cml:realizedBy doc:sec-22-ss-5 ;
cml:integrityHash "c35dcb58492b8de241e7c81065177917123b379b0406afa519eeb4c7c4cdf5b1" ;
values:partOf concept:therapeutic-goods-act-1989-sec-22 ;
skos:note "Advertising therapeutic goods for an unaccepted indication is prohibited." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.126" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-22-ss-5-norm .
concept:therapeutic-goods-act-1989-sec-22-ss-5-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-22-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-22-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-22-ss-5-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-22-ss-5-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibition of advertising therapeutic goods for an unaccepted indication." ;
cml:premiseText "(5) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication 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-22-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-22-ss-5-logic-descriptionlogic-2 .
concept:therapeutic-goods-act-1989-sec-22-ss-5-logic-descriptionlogic-2 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "Classify" ;
cml:logicSummary "Classification of therapeutic goods into the Register." ;
cml:premiseText "(5) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion." ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-22-ss-5-logic-alleninterval-3 .
concept:therapeutic-goods-act-1989-sec-22-ss-5-logic-alleninterval-3 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Temporal Interval" ;
cml:logicSummary "Temporal interval for advertising therapeutic goods." ;
cml:premiseText "(5) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-22-ss-5-logic-ltl-4 .
concept:therapeutic-goods-act-1989-sec-22-ss-5-logic-ltl-4 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "Recurring Trace" ;
cml:logicSummary "Recurring trace of advertising therapeutic goods for unaccepted indications." ;
cml:premiseText "(5) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-22-ss-5-logic-diffusion-5 .
concept:therapeutic-goods-act-1989-sec-22-ss-5-logic-diffusion-5 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "Diffusion" ;
cml:logicSummary "Diffusion of advertising therapeutic goods for unaccepted indications." ;
cml:premiseText "(5) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion." ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-22-ss-5-logic-cogai-6 .
concept:therapeutic-goods-act-1989-sec-22-ss-5-logic-cogai-6 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "Classification" ;
cml:logicSummary "Classification of therapeutic goods into the Register." ;
cml:premiseText "(5) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion." ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22-ss-5a a cml:Concept ;
skos:prefLabel "22(5A) General offences relating to this Part"@en ;
cml:realizedBy doc:sec-22-ss-5a ;
cml:integrityHash "e09c665a178aca4b049ce40bda0aa53930d46c5574c03e3eb64db2a017233315" ;
values:partOf concept:therapeutic-goods-act-1989-sec-22 ;
skos:note "An offence against subsection (5) is an obligation." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.126" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-22-ss-5a-norm .
concept:therapeutic-goods-act-1989-sec-22-ss-5a-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-22-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-22-ss-5a cml:asserts concept:therapeutic-goods-act-1989-sec-22-ss-5a-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-22-ss-5a-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "is" ;
cml:logicSummary "Definition of Obligation" ;
cml:premiseText "(5A) An offence against subsection (5)" ;
cml:conclusionText "An offence against subsection (5) is an obligation." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22-ss-6 a cml:Concept ;
skos:prefLabel "22(6) General offences relating to this Part"@en ;
cml:realizedBy doc:sec-22-ss-6 ;
cml:integrityHash "d257c190edbdc2f77cd7a39630dd351fd63b47ea722e6d21eef4efc528fccd1e" ;
values:partOf concept:therapeutic-goods-act-1989-sec-22 ;
skos:note "Committing an offence requires doing or omitting an act." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.126" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-22-ss-6-norm .
concept:therapeutic-goods-act-1989-sec-22-ss-6-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-22-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-22-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-22-ss-6-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-22-ss-6-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibition" ;
cml:logicSummary "Prohibits committing an offence." ;
cml:premiseText "Doing or omitting an act." ;
cml:conclusionText "Committing an offence." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-22-ss-6-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-22-ss-6-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Overlaps" ;
cml:logicSummary "The act or omission must overlap with the provision's scope." ;
cml:premiseText "Doing or omitting an act." ;
cml:conclusionText "Act or omission overlaps with the provision's scope." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-22-ss-6-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-22-ss-6-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "Recurring" ;
cml:logicSummary "The act or omission must be recurring." ;
cml:premiseText "Committing an offence requires doing or omitting an act." ;
cml:conclusionText "Act or omission is recurring." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22aa a cml:Concept ;
skos:prefLabel "22AA Civil penalty for breaching conditions"@en ;
cml:realizedBy doc:sec-22aa ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-22aa-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-22aa-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.130" .
concept:therapeutic-goods-act-1989-sec-22aa-ss-1 a cml:Concept ;
skos:prefLabel "22AA(1) Civil penalty for breaching conditions"@en ;
cml:realizedBy doc:sec-22aa-ss-1 ;
cml:integrityHash "68247ae45874e7a0674f2963b2d4aaa990e9665a2d6ec0a18871ba9adfb33325" ;
values:partOf concept:therapeutic-goods-act-1989-sec-22aa ;
skos:note "Civil penalty for breaching conditions" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.130" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-22aa-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-22aa-ss-1-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-22aa-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-22aa-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-22aa-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-22aa-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits breach of conditions" ;
cml:premiseText "(1) A person contravenes this subsection..." ;
cml:conclusionText "...breaches a condition of the exemption." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22aa-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-22aa-ss-1-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-22aa-ss-1-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Overlap" ;
cml:logicSummary "Identifies overlapping conditions and exemptions" ;
cml:premiseText "(b) the goods are exempt under section 18A;" ;
cml:conclusionText "...and (c) the act or omission breaches a condition of the exemption." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22aa-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-22aa-ss-1-logic-argumentation-3 .
concept:therapeutic-goods-act-1989-sec-22aa-ss-1-logic-argumentation-3 a cml:LogicApplication ;
cml:modality cml:Argumentation ;
cml:operator "Imply" ;
cml:logicSummary "Implies breach of conditions from exemptions" ;
cml:premiseText "(b) the goods are exempt under section 18A;" ;
cml:conclusionText "...and (c) the act or omission breaches a condition of the exemption." ;
cml:executionSurface "modalities::argumentation" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22aa-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-22aa-ss-1-logic-diffusion-4 .
concept:therapeutic-goods-act-1989-sec-22aa-ss-1-logic-diffusion-4 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "Spread" ;
cml:logicSummary "Spreads breach of conditions to exemptions" ;
cml:premiseText "(a) the person does an act or omits to do an act in relation to..." ;
cml:conclusionText "...and (c) the act or omission breaches a condition of the exemption." ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22aa-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-22aa-ss-1-logic-cogai-5 .
concept:therapeutic-goods-act-1989-sec-22aa-ss-1-logic-cogai-5 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "Analyze" ;
cml:logicSummary "Analyzes breach of conditions from exemptions" ;
cml:premiseText "(a) the person does an act or omits to do an act in relation to..." ;
cml:conclusionText "...and (c) the act or omission breaches a condition of the exemption." ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22aa-ss-2 a cml:Concept ;
skos:prefLabel "22AA(2) Civil penalty for breaching conditions"@en ;
cml:realizedBy doc:sec-22aa-ss-2 ;
cml:integrityHash "a1535276d08396c59681d0e10995ffb98b3ddf0c7b54d483a553e2df14e1abe6" ;
values:partOf concept:therapeutic-goods-act-1989-sec-22aa ;
skos:note "Civil penalty for breaching conditions" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.130" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-22aa-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-22aa-ss-2-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-22aa-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-22aa-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-22aa-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-22aa-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibition of breach" ;
cml:premiseText "(2) A person contravenes this subsection if..." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22a a cml:Concept ;
skos:prefLabel "22A Criminal offences for false statements in applications for"@en ;
cml:realizedBy doc:sec-22a ;
cml:integrityHash "29c9c30e0604515ced98b3d14fd88751a8f8e4b9bc69d483a67a257c14ab79fb" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-22a-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-22a-ss-4 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-22a-ss-5 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.131" .
concept:therapeutic-goods-act-1989-sec-22a-ss-1 a cml:Concept ;
skos:prefLabel "22A(1) Criminal offences for false statements in applications for"@en ;
cml:realizedBy doc:sec-22a-ss-1 ;
cml:integrityHash "662884e28ecce9081f048e40281cd39c73ba0665ebcc627ad28e1bba309cf43e" ;
values:partOf concept:therapeutic-goods-act-1989-sec-22a ;
skos:note "Making false statements in applications for registration of therapeutic goods is a criminal offence." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.131" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-22a-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-22a-ss-1-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-22a-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-22a-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-22a-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-22a-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits making false statements in applications for registration of therapeutic goods." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22a-ss-4 a cml:Concept ;
skos:prefLabel "22A(4) Criminal offences for false statements in applications for"@en ;
cml:realizedBy doc:sec-22a-ss-4 ;
cml:integrityHash "082f04dd0b6ef2215af9bc84d5f568991c60b5d61ca2d8520a28a159714a9555" ;
values:partOf concept:therapeutic-goods-act-1989-sec-22a ;
skos:note "Making false statements in applications for registration of therapeutic goods is a criminal offence." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.131" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-22a-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-22a-ss-4-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-22a-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-22a-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-22a-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-22a-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibition" ;
cml:logicSummary "Prohibits making false statements in applications for registration of therapeutic goods." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22a-ss-5 a cml:Concept ;
skos:prefLabel "22A(5) Criminal offences for false statements in applications for"@en ;
cml:realizedBy doc:sec-22a-ss-5 ;
cml:integrityHash "992bedebf57a8075066fb0135c2c5b6d2166a2389f5bf0211c1f3d8656fa3a9c" ;
values:partOf concept:therapeutic-goods-act-1989-sec-22a ;
skos:note "Making false statements in applications for registration of therapeutic goods is an offence." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.131" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-22a-ss-5-norm .
concept:therapeutic-goods-act-1989-sec-22a-ss-5-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-22a-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-22a-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-22a-ss-5-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-22a-ss-5-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits making false statements in applications for registration of therapeutic goods." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22b a cml:Concept ;
skos:prefLabel "22B Civil penalty for false statements in applications for registration"@en ;
cml:realizedBy doc:sec-22b ;
cml:integrityHash "1a762350399cc1c40c28a02315063a9ed2fe57a68b0824e2c1261159b1befd30" ;
skos:note "False statements in applications for registration are prohibited." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.132" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-22b-norm .
concept:therapeutic-goods-act-1989-sec-22b-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-22b ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22b cml:asserts concept:therapeutic-goods-act-1989-sec-22b-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-22b-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibition of false statements" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22c a cml:Concept ;
skos:prefLabel "22C Applications for provisional determination"@en ;
cml:realizedBy doc:sec-22c ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-22c-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-22c-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-22c-ss-3 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.133" .
concept:therapeutic-goods-act-1989-sec-22c-ss-1 a cml:Concept ;
skos:prefLabel "22C(1) Applications for provisional determination"@en ;
cml:realizedBy doc:sec-22c-ss-1 ;
cml:integrityHash "4dda2e01c7e735393bea367da3573dc5dc0526ee053c1e541e2629a199dc2d11" ;
values:partOf concept:therapeutic-goods-act-1989-sec-22c ;
skos:note "Application for provisional determination of a medicine" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.133" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-22c-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-22c-ss-1-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-22c-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-22c-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-22c-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-22c-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "May" ;
cml:logicSummary "Permission to apply for provisional determination" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22c-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-22c-ss-1-logic-descriptionlogic-2 .
concept:therapeutic-goods-act-1989-sec-22c-ss-1-logic-descriptionlogic-2 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "HasPart" ;
cml:logicSummary "Relates to a medicine of a kind prescribed by the regulations" ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22c-ss-2 a cml:Concept ;
skos:prefLabel "22C(2) Applications for provisional determination"@en ;
cml:realizedBy doc:sec-22c-ss-2 ;
cml:integrityHash "9c707f812b209b7cf457b62d7bed9e72c93f7bedde417e1dad6d9fdeef90999b" ;
values:partOf concept:therapeutic-goods-act-1989-sec-22c ;
skos:note "Application requirements for provisional determination" ;
dc:description "Information, application fee, and required documents" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.133" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-22c-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-22c-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-22c-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-22c-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-22c-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-22c-ss-2-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-22c-ss-3 a cml:Concept ;
skos:prefLabel "22C(3) Applications for provisional determination"@en ;
cml:realizedBy doc:sec-22c-ss-3 ;
cml:integrityHash "87da6b39abfca9e679160251c950ccb8b15aae35223b5de559d2df144a8efa33" ;
values:partOf concept:therapeutic-goods-act-1989-sec-22c ;
skos:note "Application for provisional determination may be required or permitted" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.133" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-22c-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-22c-ss-3-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-22c-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-22d a cml:Concept ;
skos:prefLabel "22D Provisional determinations"@en ;
cml:realizedBy doc:sec-22d ;
cml:integrityHash "87f857880be4cab55d90a591fec34adfd14e773dfaf78197a4393079675dbd1c" ;
skos:note "Secretary must decide on provisional determination" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.133" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-22d-norm .
concept:therapeutic-goods-act-1989-sec-22d-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-22d ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22d cml:asserts concept:therapeutic-goods-act-1989-sec-22d-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-22d-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Must decide" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22e a cml:Concept ;
skos:prefLabel "22E Period during which provisional determination is in force"@en ;
cml:realizedBy doc:sec-22e ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-22e-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-22e-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-22e-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-22e-ss-4 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-22e-ss-5 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-22e-ss-6 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-22e-ss-7 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-22e-ss-8 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-22e-ss-9 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.134" .
concept:therapeutic-goods-act-1989-sec-22e-ss-1 a cml:Concept ;
skos:prefLabel "22E(1) Period during which provisional determination is in force"@en ;
cml:realizedBy doc:sec-22e-ss-1 ;
cml:integrityHash "affeeff2c4ee29d130531cbc207a9402886e3efacbecb702896a42bdb21640df" ;
values:partOf concept:therapeutic-goods-act-1989-sec-22e ;
skos:note "Provisional determination period" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.134" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-22e-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-22e-ss-1-norm a values:Undertaking ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-22e-ss-1 ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22e-ss-2 a cml:Concept ;
skos:prefLabel "22E(2) Period during which provisional determination is in force"@en ;
cml:realizedBy doc:sec-22e-ss-2 ;
cml:integrityHash "ce929780af9e9bf0e53882c2f822223230f644b899fd4c2f839c18d6c00a73a4" ;
values:partOf concept:therapeutic-goods-act-1989-sec-22e ;
skos:note "Defines initial period for provisional determination" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.134" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-22e-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-22e-ss-2-norm a values:Undertaking ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-22e-ss-2 ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22e-ss-3 a cml:Concept ;
skos:prefLabel "22E(3) Period during which provisional determination is in force"@en ;
cml:realizedBy doc:sec-22e-ss-3 ;
cml:integrityHash "3c6bbedecdd3447ef33f2be6151b74c5e23feb2e6ef4aa2001c6b02c7391ed1e" ;
values:partOf concept:therapeutic-goods-act-1989-sec-22e ;
skos:note "Application for extension of initial period" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.134" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-22e-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-22e-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-22e-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-22e-ss-4 a cml:Concept ;
skos:prefLabel "22E(4) Period during which provisional determination is in force"@en ;
cml:realizedBy doc:sec-22e-ss-4 ;
cml:integrityHash "12b161e48b41a98012d242e0dd18254e485050fc7c2a5f89ede0216ac6bfaeb3" ;
values:partOf concept:therapeutic-goods-act-1989-sec-22e ;
skos:note "Application requirements for provisional determination" ;
dc:description "Application must be in a form approved by the Secretary, accompanied by the prescribed application fee, and made at least 28 days before the determination would otherwise cease to be in force." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.134" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-22e-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-22e-ss-4-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-22e-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-22e-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-22e-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-22e-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Application must meet certain requirements" ;
cml:premiseText "The application must be in a form approved by the Secretary, accompanied by the prescribed application fee, and made at least 28 days before the determination would otherwise cease to be in force." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22e-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-22e-ss-4-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-22e-ss-4-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "BETWEEN" ;
cml:logicSummary "Application must be made within a certain time frame" ;
cml:premiseText "(4) The application must: (a) be in a form approved, in writing, by the Secretary; and (b) be made at least 28 days before the determination would otherwise cease to be in force; and (c) be accompanied by the prescribed application fee." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22e-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-22e-ss-4-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-22e-ss-4-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "BETWEEN" ;
cml:logicSummary "Application must be made within a certain time frame" ;
cml:premiseText "(4) The application must: (a) be in a form approved, in writing, by the Secretary; and (b) be made at least 28 days before the determination would otherwise cease to be in force; and (c) be accompanied by the prescribed application fee." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22e-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-22e-ss-4-logic-deontic-4 .
concept:therapeutic-goods-act-1989-sec-22e-ss-4-logic-deontic-4 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Application must meet certain requirements" ;
cml:premiseText "(4) The application must: (a) be in a form approved, in writing, by the Secretary; and (b) be made at least 28 days before the determination would otherwise cease to be in force; and (c) be accompanied by the prescribed application fee." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22e-ss-5 a cml:Concept ;
skos:prefLabel "22E(5) Period during which provisional determination is in force"@en ;
cml:realizedBy doc:sec-22e-ss-5 ;
cml:integrityHash "ca5dcb8e0d429a42c7934d32375851bd9bbea7e5ebe940e3cb6b3f8cfe84f028" ;
values:partOf concept:therapeutic-goods-act-1989-sec-22e ;
skos:note "Secretary must decide to extend or refuse initial period" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.134" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-22e-ss-5-norm .
concept:therapeutic-goods-act-1989-sec-22e-ss-5-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-22e-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-22e-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-22e-ss-5-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-22e-ss-5-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Must decide" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22e-ss-6 a cml:Concept ;
skos:prefLabel "22E(6) Period during which provisional determination is in force"@en ;
cml:realizedBy doc:sec-22e-ss-6 ;
cml:integrityHash "ef6b322e66683f73924ac0e2bc293e5fdbdd1c21753ce3ea514c481eeb35f336" ;
values:partOf concept:therapeutic-goods-act-1989-sec-22e ;
skos:note "Secretary may extend provisional determination period" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.134" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-22e-ss-6-norm .
concept:therapeutic-goods-act-1989-sec-22e-ss-6-norm a values:Undertaking ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-22e-ss-6 ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22e-ss-7 a cml:Concept ;
skos:prefLabel "22E(7) Period during which provisional determination is in force"@en ;
cml:realizedBy doc:sec-22e-ss-7 ;
cml:integrityHash "4b39dba13b3eaf23a89b13ba1464d4193489158b52342185068fe247c4414af8" ;
values:partOf concept:therapeutic-goods-act-1989-sec-22e ;
skos:note "Provide written notice of decision and reasons for refusal" ;
dc:description "yes" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.134" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-22e-ss-7-norm .
concept:therapeutic-goods-act-1989-sec-22e-ss-7-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-22e-ss-7 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22e-ss-7 cml:asserts concept:therapeutic-goods-act-1989-sec-22e-ss-7-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-22e-ss-7-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Obligation to provide notice" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22e-ss-8 a cml:Concept ;
skos:prefLabel "22E(8) Period during which provisional determination is in force"@en ;
cml:realizedBy doc:sec-22e-ss-8 ;
cml:integrityHash "97c8ccbdda1df675ef8bd42aebb8672a2c3679eec4cf43ac95fd715162f95313" ;
values:partOf concept:therapeutic-goods-act-1989-sec-22e ;
skos:note "Limitation on extension of provisional determination" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.134" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-22e-ss-8-norm .
concept:therapeutic-goods-act-1989-sec-22e-ss-8-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-22e-ss-8 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22e-ss-8 cml:asserts concept:therapeutic-goods-act-1989-sec-22e-ss-8-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-22e-ss-8-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "NOT" ;
cml:logicSummary "Prohibition on multiple extensions" ;
cml:premiseText "(8) 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-22e-ss-9 a cml:Concept ;
skos:prefLabel "22E(9) Period during which provisional determination is in force"@en ;
cml:realizedBy doc:sec-22e-ss-9 ;
cml:integrityHash "95b48c87e78c0ae0de468d5923bda9e164e0eaa888b2655c58c57c60120349d1" ;
values:partOf concept:therapeutic-goods-act-1989-sec-22e ;
skos:note "Provisional determination remains in force until application for provisional registration is made." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.134" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-22e-ss-9-norm .
concept:therapeutic-goods-act-1989-sec-22e-ss-9-norm a values:Undertaking ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-22e-ss-9 ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22f a cml:Concept ;
skos:prefLabel "22F Revocation of provisional determination"@en ;
cml:realizedBy doc:sec-22f ;
cml:integrityHash "6e75ab479905bdbba7c1e57d0311cfe9c0adf3a3549977464ca792bb1bc13261" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-22f-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-22f-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-22f-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-22f-ss-4 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.136" .
concept:therapeutic-goods-act-1989-sec-22f-ss-1 a cml:Concept ;
skos:prefLabel "22F(1) Revocation of provisional determination"@en ;
cml:realizedBy doc:sec-22f-ss-1 ;
cml:integrityHash "c3b7ea528766e0821229958c2cf1d38d8b708e206b8ab94e364d749725fc17d5" ;
values:partOf concept:therapeutic-goods-act-1989-sec-22f ;
skos:note "Secretary may revoke provisional determination under certain conditions." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.136" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-22f-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-22f-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-22f-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-22f-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-22f-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-22f-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "may" ;
cml:logicSummary "May revoke" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22f-ss-2 a cml:Concept ;
skos:prefLabel "22F(2) Revocation of provisional determination"@en ;
cml:realizedBy doc:sec-22f-ss-2 ;
cml:integrityHash "a4ab95190e8d5ff118255f57b6eb037858ddf791bcb3093e9304c4cb63e11422" ;
values:partOf concept:therapeutic-goods-act-1989-sec-22f ;
skos:note "Secretary must revoke provisional determination upon request." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.136" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-22f-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-22f-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-22f-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-22f-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-22f-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-22f-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Must provide revocation notice" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22f-ss-3 a cml:Concept ;
skos:prefLabel "22F(3) Revocation of provisional determination"@en ;
cml:realizedBy doc:sec-22f-ss-3 ;
cml:integrityHash "6095127f050bb015300261ecf66d7e52f36db9a6dfe01734cae98fcb1d137eaf" ;
values:partOf concept:therapeutic-goods-act-1989-sec-22f ;
skos:note "Secretary must give written notice of revocation and set out reasons for revocation." ;
dc:description "written notice, reasons for revocation" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.136" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-22f-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-22f-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-22f-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-22f-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-22f-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-22f-ss-3-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-22f-ss-4 a cml:Concept ;
skos:prefLabel "22F(4) Revocation of provisional determination"@en ;
cml:realizedBy doc:sec-22f-ss-4 ;
cml:integrityHash "dc91b0f05e016673379c8d9c81d7e78899ac2988f4c99c5b96784cfeb60a8495" ;
values:partOf concept:therapeutic-goods-act-1989-sec-22f ;
skos:note "Revocation of provisional determination takes effect on the day notice is given." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.136" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-22f-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-22f-ss-4-norm a values:Undertaking ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-22f-ss-4 ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22f-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-22f-ss-4-logic-alleninterval-1 .
concept:therapeutic-goods-act-1989-sec-22f-ss-4-logic-alleninterval-1 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Applicable" ;
cml:logicSummary "Defines temporal interval for revocation" ;
cml:premiseText "day on which the Secretary gives notice" ;
cml:conclusionText "revocation takes effect" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22g a cml:Concept ;
skos:prefLabel "22G Scientific advice about aspects of quality, safety or efficacy of"@en ;
cml:realizedBy doc:sec-22g ;
cml:integrityHash "afd816f87ccc696c3c4988fa0d05b4e252baa3d8553d2eb28dbc025d5dd95af9" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-22g-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-22g-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-22g-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-22g-ss-4 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-22g-ss-5 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-22g-ss-6 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-22g-ss-7 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-22g-ss-8 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-22g-ss-9 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.138" .
concept:therapeutic-goods-act-1989-sec-22g-ss-1 a cml:Concept ;
skos:prefLabel "22G(1) Scientific advice about aspects of quality, safety or efficacy of"@en ;
cml:realizedBy doc:sec-22g-ss-1 ;
cml:integrityHash "a1a105729d985285f9cbc7d58614901743ba1d8e2abc83703567692dab733afc" ;
values:partOf concept:therapeutic-goods-act-1989-sec-22g ;
skos:note "Request for scientific advice on medicine registration" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.138" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-22g-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-22g-ss-1-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-22g-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-22g-ss-2 a cml:Concept ;
skos:prefLabel "22G(2) Scientific advice about aspects of quality, safety or efficacy of"@en ;
cml:realizedBy doc:sec-22g-ss-2 ;
cml:integrityHash "71f84d30a406b36156816a50aab1879bf5a771a54880484aa492e2c826c8a0ea" ;
values:partOf concept:therapeutic-goods-act-1989-sec-22g ;
skos:note "Each request must relate only to one aspect of the quality of the medicine." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.138" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-22g-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-22g-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-22g-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-22g-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-22g-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-22g-ss-2-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-22g-ss-3 a cml:Concept ;
skos:prefLabel "22G(3) Scientific advice about aspects of quality, safety or efficacy of"@en ;
cml:realizedBy doc:sec-22g-ss-3 ;
cml:integrityHash "e58faf240cb32f14cdb7698290a3ac8aacc1dba17ebfdd7ccd1a310a21b8bc9e" ;
values:partOf concept:therapeutic-goods-act-1989-sec-22g ;
skos:note "Request for scientific advice on medicine safety" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.138" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-22g-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-22g-ss-3-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-22g-ss-3 ;
values:borneBy values:NaturalPerson ;
skos:scopeNote "borne by: NaturalPerson" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22g-ss-4 a cml:Concept ;
skos:prefLabel "22G(4) Scientific advice about aspects of quality, safety or efficacy of"@en ;
cml:realizedBy doc:sec-22g-ss-4 ;
cml:integrityHash "83523cde186747144d290f2f30bd275bbc2022b9a1f77919610b86d042584783" ;
values:partOf concept:therapeutic-goods-act-1989-sec-22g ;
skos:note "Each request must relate only to one aspect of the safety of the medicine." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.138" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-22g-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-22g-ss-4-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-22g-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-22g-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-22g-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-22g-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Must relate only to one aspect" ;
cml:premiseText "(4) Each request under subsection (3)" ;
cml:conclusionText "relate only to one aspect of the safety of the medicine." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22g-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-22g-ss-4-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-22g-ss-4-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "CONTAINS" ;
cml:logicSummary "Temporal interval for requests" ;
cml:premiseText "(4) Each request under subsection (3)" ;
cml:conclusionText "relate only to one aspect of the safety of the medicine." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22g-ss-5 a cml:Concept ;
skos:prefLabel "22G(5) Scientific advice about aspects of quality, safety or efficacy of"@en ;
cml:realizedBy doc:sec-22g-ss-5 ;
cml:integrityHash "bce34df4beb3e28ba1371beaf9c6105bf711c811446adbbe44c4b58838547165" ;
values:partOf concept:therapeutic-goods-act-1989-sec-22g ;
skos:note "Request for scientific advice on efficacy of medicine" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.138" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-22g-ss-5-norm .
concept:therapeutic-goods-act-1989-sec-22g-ss-5-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-22g-ss-5 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22g-ss-6 a cml:Concept ;
skos:prefLabel "22G(6) Scientific advice about aspects of quality, safety or efficacy of"@en ;
cml:realizedBy doc:sec-22g-ss-6 ;
cml:integrityHash "466daec0fa29be269fb72a9f5a1b00bea9925ae3764dab2f441f98b68d3b98bb" ;
values:partOf concept:therapeutic-goods-act-1989-sec-22g ;
skos:note "Each request must relate only to one aspect of the efficacy of the medicine." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.138" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-22g-ss-6-norm .
concept:therapeutic-goods-act-1989-sec-22g-ss-6-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-22g-ss-6 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22g-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-22g-ss-6-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-22g-ss-6-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Must relate only to one aspect" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22g-ss-7 a cml:Concept ;
skos:prefLabel "22G(7) Scientific advice about aspects of quality, safety or efficacy of"@en ;
cml:realizedBy doc:sec-22g-ss-7 ;
cml:integrityHash "bd19c8840e08f2c8f1af0bb37cb1c1248628be60723330353160c6c68ca72aa0" ;
values:partOf concept:therapeutic-goods-act-1989-sec-22g ;
skos:note "Secretary must provide scientific advice in response to a request." ;
dc:description "true" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.138" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-22g-ss-7-norm .
concept:therapeutic-goods-act-1989-sec-22g-ss-7-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-22g-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-22g-ss-7 cml:asserts concept:therapeutic-goods-act-1989-sec-22g-ss-7-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-22g-ss-7-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Must provide" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22g-ss-8 a cml:Concept ;
skos:prefLabel "22G(8) Scientific advice about aspects of quality, safety or efficacy of"@en ;
cml:realizedBy doc:sec-22g-ss-8 ;
cml:integrityHash "db64be2ec6c5d53a6ef27be46264f411cdacf5cf95066766e37980917ec05cb3" ;
values:partOf concept:therapeutic-goods-act-1989-sec-22g ;
skos:note "Request must be made in accordance with a form approved by the Secretary and accompanied by the prescribed fee." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.138" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-22g-ss-8-norm .
concept:therapeutic-goods-act-1989-sec-22g-ss-8-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-22g-ss-8 ;
values:borneBy values:LegalPerson ;
skos:scopeNote "borne by: LegalPerson" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-22g-ss-8 cml:asserts concept:therapeutic-goods-act-1989-sec-22g-ss-8-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-22g-ss-8-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Request 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-22g-ss-9 a cml:Concept ;
skos:prefLabel "22G(9) Scientific advice about aspects of quality, safety or efficacy of"@en ;
cml:realizedBy doc:sec-22g-ss-9 ;
cml:integrityHash "062617911cbf7c95db18ffa777342e5a7c8216bf9553bf512d857dc3af2fb6e0" ;
values:partOf concept:therapeutic-goods-act-1989-sec-22g ;
skos:note "Request for information or document may be required or permitted" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.138" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-22g-ss-9-norm .
concept:therapeutic-goods-act-1989-sec-22g-ss-9-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-22g-ss-9 ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-23 a cml:Concept ;
skos:prefLabel "23 Applications generally"@en ;
cml:realizedBy doc:sec-23 ;
cml:integrityHash "4f955fa3c7f22b223a79bdb3ba521358595094ca89f65b56b08ab9b16a1a1d1b" ;
skos:note "A person may make an application to the Secretary for registration or listing of therapeutic goods." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.140" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-23-norm .
concept:therapeutic-goods-act-1989-sec-23-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-23 ;
values:borneBy values:NaturalPerson ;
skos:scopeNote "borne by: NaturalPerson" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-23 cml:asserts concept:therapeutic-goods-act-1989-sec-23-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-23-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-23aa a cml:Concept ;
skos:prefLabel "23AA Applications for provisional registration of medicine"@en ;
cml:realizedBy doc:sec-23aa ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-23aa-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-23aa-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.140" .
concept:therapeutic-goods-act-1989-sec-23aa-ss-1 a cml:Concept ;
skos:prefLabel "23AA(1) Applications for provisional registration of medicine"@en ;
cml:realizedBy doc:sec-23aa-ss-1 ;
cml:integrityHash "42792cb26f1d5310ba0ae38be4928487747a40aeafd7e7610f6e4697afb78c88" ;
values:partOf concept:therapeutic-goods-act-1989-sec-23aa ;
skos:note "Application for provisional registration of medicine is taken to be an application for provisional registration if certain conditions are met." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.140" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-23aa-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-23aa-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-23aa-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-23aa-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-23aa-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-23aa-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator ">" ;
cml:logicSummary "Conditional obligation" ;
cml:premiseText "Application made under section 23 for registration of medicine" ;
cml:conclusionText "Provisional determination under section 22D is in force" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-23aa-ss-2 a cml:Concept ;
skos:prefLabel "23AA(2) Applications for provisional registration of medicine"@en ;
cml:realizedBy doc:sec-23aa-ss-2 ;
cml:integrityHash "c098c6f9015f9e24b099736913b5ab7e5703ef9bc9e2bc0499e0c2f2518ac41b" ;
values:partOf concept:therapeutic-goods-act-1989-sec-23aa ;
skos:note "Application for provisional registration of new medicine must be made before end of provisional registration period." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.140" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-23aa-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-23aa-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-23aa-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-23aa-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-23aa-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-23aa-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Application for provisional registration of new medicine must be made before end of provisional registration period." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-23a a cml:Concept ;
skos:prefLabel "23A Classes of therapeutic goods"@en ;
cml:realizedBy doc:sec-23a ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-23a-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-23a-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.141" .
concept:therapeutic-goods-act-1989-sec-23a-ss-1 a cml:Concept ;
skos:prefLabel "23A(1) Classes of therapeutic goods"@en ;
cml:realizedBy doc:sec-23a-ss-1 ;
cml:integrityHash "4290e768cb89c6f3368142c7ebbedc4de9a52b29f7d4c6101291122206f62510" ;
values:partOf concept:therapeutic-goods-act-1989-sec-23a ;
skos:note "The Secretary may specify different classes of therapeutic goods." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.141" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-23a-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-23a-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-23a-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-23a-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-23a-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-23a-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "May" ;
cml:logicSummary "Permits the Secretary to take action." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-23a-ss-2 a cml:Concept ;
skos:prefLabel "23A(2) Classes of therapeutic goods"@en ;
cml:realizedBy doc:sec-23a-ss-2 ;
cml:integrityHash "92cbcde2bcea90e50109c19d0e70dbc7de3b940367d14687de4e1098a48418c4" ;
values:partOf concept:therapeutic-goods-act-1989-sec-23a ;
skos:note "Specifies classes of therapeutic goods by reference to certain matters." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.141" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-23a-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-23a-ss-2-norm a values:Undertaking ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-23a-ss-2 ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-23b a cml:Concept ;
skos:prefLabel "23B Requirements relating to applications for registration of"@en ;
cml:realizedBy doc:sec-23b ;
cml:integrityHash "f7974b3170ae19f70aa86c6f735ac1423d5e09a3482dcd31a792b5bd0ad3229d" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-23b-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-23b-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.141" .
concept:therapeutic-goods-act-1989-sec-23b-ss-1 a cml:Concept ;
skos:prefLabel "23B(1) Requirements relating to applications for registration of"@en ;
cml:realizedBy doc:sec-23b-ss-1 ;
cml:integrityHash "8added4c93d31143b91d0609033975740caf58f4ff3161ea4a4ef8ccba22f106" ;
values:partOf concept:therapeutic-goods-act-1989-sec-23b ;
skos:note "Secretary must carry out assessment of requirements met in relation to application." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.141" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-23b-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-23b-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-23b-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-23b-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-23b-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-23b-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Must carry out assessment" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-23b-ss-2 a cml:Concept ;
skos:prefLabel "23B(2) Requirements relating to applications for registration of"@en ;
cml:realizedBy doc:sec-23b-ss-2 ;
cml:integrityHash "a6c54513db3ad429f47018e9afa6ba4efd0fea68c8af347aab2660327db39069" ;
values:partOf concept:therapeutic-goods-act-1989-sec-23b ;
skos:note "Application must be made in a specific manner" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.141" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-23b-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-23b-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-23b-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-23b-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-23b-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-23b-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Must be made in accordance with the approved form" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-23b-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-23b-ss-2-logic-descriptionlogic-2 .
concept:therapeutic-goods-act-1989-sec-23b-ss-2-logic-descriptionlogic-2 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "IS" ;
cml:logicSummary "Application must be made in a manner that is approved by the Secretary" ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-23c a cml:Concept ;
skos:prefLabel "23C Requirements relating to applications for listing of therapeutic"@en ;
cml:realizedBy doc:sec-23c ;
cml:integrityHash "6cbcba44011f176dc0c6a57bda4e764b1df7b821038bfa37bbba63d9e1603dd9" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-23c-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-23c-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-23c-ss-3 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.144" .
concept:therapeutic-goods-act-1989-sec-23c-ss-1 a cml:Concept ;
skos:prefLabel "23C(1) Requirements relating to applications for listing of therapeutic"@en ;
cml:realizedBy doc:sec-23c-ss-1 ;
cml:integrityHash "b5fc69726bca042e3a2b94d11247026b151677e880c34963cb8573d9d012fee2" ;
values:partOf concept:therapeutic-goods-act-1989-sec-23c ;
skos:note "Application requirement for listing of therapeutic goods under section 26 or 26A." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.144" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-23c-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-23c-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-23c-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-23c-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-23c-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-23c-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Application requirement" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-23c-ss-2 a cml:Concept ;
skos:prefLabel "23C(2) Requirements relating to applications for listing of therapeutic"@en ;
cml:realizedBy doc:sec-23c-ss-2 ;
cml:integrityHash "6f4e6b6a0e110c11650053374d4c34403c4842a6ca20d297562c7da1af2b791c" ;
values:partOf concept:therapeutic-goods-act-1989-sec-23c ;
skos:note "Application must comply with requirements to be listed." ;
dc:description "Information, application fee, and samples (if required)" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.144" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-23c-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-23c-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-23c-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-23c-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-23c-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-23c-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Application must comply with requirements." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-23c-ss-3 a cml:Concept ;
skos:prefLabel "23C(3) Requirements relating to applications for listing of therapeutic"@en ;
cml:realizedBy doc:sec-23c-ss-3 ;
cml:integrityHash "82e864f2842157e8494809278fcd23f48d8d88f14221cf111bd7bf76ca8d1db6" ;
values:partOf concept:therapeutic-goods-act-1989-sec-23c ;
skos:note "Secretary may determine forms of information for application purposes." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.144" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-23c-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-23c-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-23c-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-23c-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-23c-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-23c-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "may" ;
cml:logicSummary "May impose 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-24 a cml:Concept ;
skos:prefLabel "24 Applications for registration"@en ;
cml:realizedBy doc:sec-24 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-24-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-24-ss-1a ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-24-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-24-ss-3 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.146" .
concept:therapeutic-goods-act-1989-sec-24-ss-1 a cml:Concept ;
skos:prefLabel "24(1) Applications for registration"@en ;
cml:realizedBy doc:sec-24-ss-1 ;
cml:integrityHash "10ecacdc7e418ce44ea412d07190077cbba0d5da5321f0540a57d10e276cd213" ;
values:partOf concept:therapeutic-goods-act-1989-sec-24 ;
skos:note "Application for registration of therapeutic goods under section 23 is required if certain conditions are met." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.146" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-24-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-24-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-24-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-24-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-24-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-24-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "requires" ;
cml:logicSummary "Application for registration is required" ;
cml:premiseText "(a) an application is made for the registration of therapeutic goods under section 23; and (b) the goods are goods that are required to be registered; and (c) the application has passed preliminary assessment." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-24-ss-1a a cml:Concept ;
skos:prefLabel "24(1A) Applications for registration"@en ;
cml:realizedBy doc:sec-24-ss-1a ;
cml:integrityHash "971553f423bfcf98dde61294ecbf4d903af1b6df7b029363826b84f2f71f8862" ;
values:partOf concept:therapeutic-goods-act-1989-sec-24 ;
skos:note "Applicant must pay evaluation fee" ;
dc:description "evaluation fee amount" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.146" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-24-ss-1a-norm .
concept:therapeutic-goods-act-1989-sec-24-ss-1a-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-24-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-24-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-24-ss-1a-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-24-ss-1a-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Duty to pay evaluation fee" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-24-ss-2 a cml:Concept ;
skos:prefLabel "24(2) Applications for registration"@en ;
cml:realizedBy doc:sec-24-ss-2 ;
cml:integrityHash "d2966e67656883a64279bc5ef7ad530015eb760ff07bbf8c85500d060c96906b" ;
values:partOf concept:therapeutic-goods-act-1989-sec-24 ;
skos:note "Application for registration lapses if fee remains unpaid or application contains inaccurate information." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.146" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-24-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-24-ss-2-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-24-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-24-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-24-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-24-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Application lapse due to non-payment or inaccuracy." ;
cml:premiseText "(2) An application for registration of therapeutic goods lapses if..." ;
cml:conclusionText "...the amount became due and payable;" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-24-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-24-ss-2-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-24-ss-2-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Overlap" ;
cml:logicSummary "Temporal overlap between application lapse and fee payment deadline." ;
cml:premiseText "(2) An application for registration of therapeutic goods lapses if..." ;
cml:conclusionText "...the day on which the amount became due and payable;" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-24-ss-3 a cml:Concept ;
skos:prefLabel "24(3) Applications for registration"@en ;
cml:realizedBy doc:sec-24-ss-3 ;
cml:integrityHash "494eb062214fcc052f393d4f3e64b7a1da9022983fe2ab21ced2e5fd7a9a572b" ;
values:partOf concept:therapeutic-goods-act-1989-sec-24 ;
skos:note "Defines individual patient data in relation to therapeutic goods." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.146" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-24-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-24-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-24-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-24-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-24-ss-3-logic-descriptionlogic-1 .
concept:therapeutic-goods-act-1989-sec-24-ss-3-logic-descriptionlogic-1 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "=" ;
cml:logicSummary "Classifies individuals into categories" ;
cml:premiseText "Demographic, biochemical and haematological information" ;
cml:conclusionText "Individual patient data" ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-24-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-24-ss-3-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-24-ss-3-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "during" ;
cml:logicSummary "Describes temporal relationship between administration of goods and collection of data" ;
cml:premiseText "Before, during and after the administration of the goods" ;
cml:conclusionText "Clinical trials" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-24a a cml:Concept ;
skos:prefLabel "24A When evaluation fee due for payment"@en ;
cml:realizedBy doc:sec-24a ;
cml:integrityHash "5d41302046d2bfaeaf44faf648e24df6fb80b3609d14f35c4a682b5eedf22970" ;
skos:note "Evaluation fee due on notification of amount" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.147" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-24a-norm .
concept:therapeutic-goods-act-1989-sec-24a-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-24a ;
values:borneBy values:NaturalPerson ;
skos:scopeNote "borne by: NaturalPerson" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-24a cml:asserts concept:therapeutic-goods-act-1989-sec-24a-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-24a-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "due" ;
cml:logicSummary "Obligation to pay evaluation fee" ;
cml:premiseText "Section 24A" ;
cml:conclusionText "Evaluation fee is due" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-24b a cml:Concept ;
skos:prefLabel "24B Payment of evaluation fee by instalments"@en ;
cml:realizedBy doc:sec-24b ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-24b-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-24b-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-24b-ss-3 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.147" .
concept:therapeutic-goods-act-1989-sec-24b-ss-1 a cml:Concept ;
skos:prefLabel "24B(1) Payment of evaluation fee by instalments"@en ;
cml:realizedBy doc:sec-24b-ss-1 ;
cml:integrityHash "3ff021854052314d2c78c33224804bd5a95fbca00826dfd624103a5824025f2e" ;
values:partOf concept:therapeutic-goods-act-1989-sec-24b ;
skos:note "Payment of evaluation fee by instalments" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.147" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-24b-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-24b-ss-1-norm a values:Undertaking ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-24b-ss-1 ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-24b-ss-2 a cml:Concept ;
skos:prefLabel "24B(2) Payment of evaluation fee by instalments"@en ;
cml:realizedBy doc:sec-24b-ss-2 ;
cml:integrityHash "a5c45b8502bc913b48db234371b20106053773ca8b0946330636de263ed7c1a6" ;
values:partOf concept:therapeutic-goods-act-1989-sec-24b ;
skos:note "Payment of evaluation fee by instalments is not allowed if part of an instalment is unpaid." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.147" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-24b-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-24b-ss-2-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-24b-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-24b-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-24b-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-24b-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-24b-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-24b-ss-2-logic-linearlogic-2 .
concept:therapeutic-goods-act-1989-sec-24b-ss-2-logic-linearlogic-2 a cml:LogicApplication ;
cml:modality cml:LinearLogic ;
cml:operator "¬(A ∧ B)" ;
cml:logicSummary "Payment of evaluation fee by instalments is not allowed if part of an instalment is unpaid." ;
cml:premiseText "(2) Regulations made for the purposes of subsection (1) may provide that a person is not allowed to pay an evaluation fee under section 24 by instalments..." ;
cml:executionSurface "modalities::linear" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-24b-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-24b-ss-2-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-24b-ss-2-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "¬(A ∧ B)" ;
cml:logicSummary "Payment of evaluation fee by instalments is not allowed if part of an instalment is unpaid." ;
cml:premiseText "(2) Regulations made for the purposes of subsection (1) may provide that a person is not allowed to pay an evaluation fee under section 24 by instalments..." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-24b-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-24b-ss-2-logic-deontic-4 .
concept:therapeutic-goods-act-1989-sec-24b-ss-2-logic-deontic-4 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "forbid" ;
cml:logicSummary "Payment of evaluation fee by instalments is not allowed if part of an instalment is unpaid." ;
cml:premiseText "(2) Regulations made for the purposes of subsection (1) may provide that a person is not allowed to pay an evaluation fee under section 24 by instalments..." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-24b-ss-3 a cml:Concept ;
skos:prefLabel "24B(3) Payment of evaluation fee by instalments"@en ;
cml:realizedBy doc:sec-24b-ss-3 ;
cml:integrityHash "839e5e1c70551a66043469b8456639715beffad0fa9e8be7a933dc8a9ed61c2b" ;
values:partOf concept:therapeutic-goods-act-1989-sec-24b ;
skos:note "Payment of evaluation fee by instalments is obligatory." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.147" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-24b-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-24b-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-24b-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-24b-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-24b-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-24b-ss-3-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-24c a cml:Concept ;
skos:prefLabel "24C Recovery of evaluation fee"@en ;
cml:realizedBy doc:sec-24c ;
cml:integrityHash "fba16f99658a71db745e501a7b23381ce395fe98522fff70bf077e79f6030772" ;
skos:note "Recovery of evaluation fee is an obligation for the Commonwealth." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.147" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-24c-norm .
concept:therapeutic-goods-act-1989-sec-24c-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-24c ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-24c cml:asserts concept:therapeutic-goods-act-1989-sec-24c-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-24c-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Recovery of evaluation fee is an obligation." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-24d a cml:Concept ;
skos:prefLabel "24D Refund of evaluation fee where evaluation not completed within"@en ;
cml:realizedBy doc:sec-24d ;
cml:integrityHash "94b0ba2c6c13c6b14bde96e2e5e97185fabb752195134d21bd27ba5aa69e166a" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-24d-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-24d-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-24d-ss-3 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.148" .
concept:therapeutic-goods-act-1989-sec-24d-ss-1 a cml:Concept ;
skos:prefLabel "24D(1) Refund of evaluation fee where evaluation not completed within"@en ;
cml:realizedBy doc:sec-24d-ss-1 ;
cml:integrityHash "95cfa43c47d084701d28652008ad57d5378b002f363c79c04e405829cb04eb7d" ;
values:partOf concept:therapeutic-goods-act-1989-sec-24d ;
skos:note "This section applies to an application under section 23 in relation to therapeutic goods for the evaluation of which a period is prescribed under paragraph 63(2)(da)." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.148" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-24d-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-24d-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-24d-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-24d-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-24d-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-24d-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "applies" ;
cml:logicSummary "Section applies to an application under section 23" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-24d-ss-2 a cml:Concept ;
skos:prefLabel "24D(2) Refund of evaluation fee where evaluation not completed within"@en ;
cml:realizedBy doc:sec-24d-ss-2 ;
cml:integrityHash "5147612c8740267eb21450819f4011215e386e6ab11273dadcd0fbcbc1c70648" ;
values:partOf concept:therapeutic-goods-act-1989-sec-24d ;
skos:note "Refund of evaluation fee if not completed within period" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.148" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-24d-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-24d-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-24d-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-24d-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-24d-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-24d-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Obligation to refund evaluation fee" ;
cml:premiseText "(2) If..." ;
cml:conclusionText "25% of the evaluation fee must be refunded" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-24d-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-24d-ss-2-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-24d-ss-2-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator ">=" ;
cml:logicSummary "Evaluation period is a temporal interval" ;
cml:premiseText "but not within the period referred to in subsection (1)" ;
cml:conclusionText "25% of the evaluation fee must be refunded" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-24d-ss-3 a cml:Concept ;
skos:prefLabel "24D(3) Refund of evaluation fee where evaluation not completed within"@en ;
cml:realizedBy doc:sec-24d-ss-3 ;
cml:integrityHash "24f07e24a4cb3612037cc43e78d4a9273426742a4a55df84962d96208ea96d15" ;
values:partOf concept:therapeutic-goods-act-1989-sec-24d ;
skos:note "Notification of decision constitutes completion of evaluation." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.148" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-24d-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-24d-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-24d-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-24d-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-24d-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-24d-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligate" ;
cml:logicSummary "Notification of decision constitutes completion of evaluation." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-24e a cml:Concept ;
skos:prefLabel "24E Deemed refusal of application"@en ;
cml:realizedBy doc:sec-24e ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-24e-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-24e-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-24e-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-24e-ss-4 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.148" .
concept:therapeutic-goods-act-1989-sec-24e-ss-1 a cml:Concept ;
skos:prefLabel "24E(1) Deemed refusal of application"@en ;
cml:realizedBy doc:sec-24e-ss-1 ;
cml:integrityHash "7b74f3a4359e7edc46c5f6e3d9d5e24044d4e8db0e2c168a0c9b3342627f8adb" ;
values:partOf concept:therapeutic-goods-act-1989-sec-24e ;
skos:note "Deemed refusal of application" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.148" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-24e-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-24e-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-24e-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-24e-ss-2 a cml:Concept ;
skos:prefLabel "24E(2) Deemed refusal of application"@en ;
cml:realizedBy doc:sec-24e-ss-2 ;
cml:integrityHash "7982b950bc59e92bafa420f3da92d0b12f8ec4a1575aefa9b0c90c2dd535dc9d" ;
values:partOf concept:therapeutic-goods-act-1989-sec-24e ;
skos:note "Applicant may give notice to treat application as refused if evaluation not completed" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.148" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-24e-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-24e-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-24e-ss-2 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-24e-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-24e-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-24e-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "May" ;
cml:logicSummary "Applicant may give notice to treat application as refused" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-24e-ss-3 a cml:Concept ;
skos:prefLabel "24E(3) Deemed refusal of application"@en ;
cml:realizedBy doc:sec-24e-ss-3 ;
cml:integrityHash "e40c2499dea7ec1bcbc5ba602e3825b3015dabd80002dc59b55c2eed361c701e" ;
values:partOf concept:therapeutic-goods-act-1989-sec-24e ;
skos:note "Notice may be given at any time before evaluation is completed." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.148" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-24e-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-24e-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-24e-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-24e-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-24e-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-24e-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "may" ;
cml:logicSummary "Permission to give notice at any time" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-24e-ss-4 a cml:Concept ;
skos:prefLabel "24E(4) Deemed refusal of application"@en ;
cml:realizedBy doc:sec-24e-ss-4 ;
cml:integrityHash "4b5fa4a40f2f3ccb0d4ea9106b99d35608c7cfd2e677414343f75e8cec84f29e" ;
values:partOf concept:therapeutic-goods-act-1989-sec-24e ;
skos:note "Deemed refusal of application" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.148" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-24e-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-24e-ss-4-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-24e-ss-4 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-25 a cml:Concept ;
skos:prefLabel "25 Evaluation of therapeutic goods"@en ;
cml:realizedBy doc:sec-25 ;
cml:integrityHash "20c3419d869a5e99429a6f76dde03bc8beb01c71c6ee4018189f44a0c5894d12" ;
skos:note "The Secretary must evaluate therapeutic goods for registration having regard to the quality, safety and efficacy of the goods." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.149" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-25-norm .
concept:therapeutic-goods-act-1989-sec-25-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-25 ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-25 cml:asserts concept:therapeutic-goods-act-1989-sec-25-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-25-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "The Secretary must evaluate therapeutic goods for registration." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-25aa a cml:Concept ;
skos:prefLabel "25AA Approved product information for medicine"@en ;
cml:realizedBy doc:sec-25aa ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-25aa-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-25aa-ss-1a ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-25aa-ss-1b ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-25aa-ss-1c ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.155" .
concept:therapeutic-goods-act-1989-sec-25aa-ss-1 a cml:Concept ;
skos:prefLabel "25AA(1) Approved product information for medicine"@en ;
cml:realizedBy doc:sec-25aa-ss-1 ;
cml:integrityHash "6217d2f4ee109a8e598cc5b8c958538a06d58af1397d084a712e2af173bb5e03" ;
values:partOf concept:therapeutic-goods-act-1989-sec-25aa ;
skos:note "The Secretary must approve product information for therapeutic goods if certain conditions are met." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.155" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-25aa-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-25aa-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-25aa-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-25aa-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-25aa-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-25aa-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "The Secretary has a duty to approve product information." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-25aa-ss-1a a cml:Concept ;
skos:prefLabel "25AA(1A) Approved product information for medicine"@en ;
cml:realizedBy doc:sec-25aa-ss-1a ;
cml:integrityHash "7bc01a0f2127b6482167ca2e450bdf3a7aea953b08e8ec65355aa798f5708858" ;
values:partOf concept:therapeutic-goods-act-1989-sec-25aa ;
skos:note "Secretary must approve product information reflecting basis for registration." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.155" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-25aa-ss-1a-norm .
concept:therapeutic-goods-act-1989-sec-25aa-ss-1a-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-25aa-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-25aa-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-25aa-ss-1a-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-25aa-ss-1a-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Must" ;
cml:logicSummary "Mandatory approval requirement." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-25aa-ss-1b a cml:Concept ;
skos:prefLabel "25AA(1B) Approved product information for medicine"@en ;
cml:realizedBy doc:sec-25aa-ss-1b ;
cml:integrityHash "95359503a63fbbe32182c682d6dcb104b635a7f58d3969943207ed0fbc3c93eb" ;
values:partOf concept:therapeutic-goods-act-1989-sec-25aa ;
skos:note "Require person to provide product information for restricted medicine." ;
dc:description "Yes" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.155" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-25aa-ss-1b-norm .
concept:therapeutic-goods-act-1989-sec-25aa-ss-1b-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-25aa-ss-1b ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-25aa-ss-1b cml:asserts concept:therapeutic-goods-act-1989-sec-25aa-ss-1b-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-25aa-ss-1b-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Must provide product information." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-25aa-ss-1c a cml:Concept ;
skos:prefLabel "25AA(1C) Approved product information for medicine"@en ;
cml:realizedBy doc:sec-25aa-ss-1c ;
cml:integrityHash "fda5cb4deeade7e8d990a8377df5e7c8bed8c39057f3407219fab5f50082121b" ;
values:partOf concept:therapeutic-goods-act-1989-sec-25aa ;
skos:note "Secretary must approve product information if person complies with subsection (1B)" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.155" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-25aa-ss-1c-norm .
concept:therapeutic-goods-act-1989-sec-25aa-ss-1c-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-25aa-ss-1c ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-25aa-ss-1c cml:asserts concept:therapeutic-goods-act-1989-sec-25aa-ss-1c-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-25aa-ss-1c-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Obligation to approve product information" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-25ab a cml:Concept ;
skos:prefLabel "25AB Registration of therapeutic goods etc."@en ;
cml:realizedBy doc:sec-25ab ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-25ab-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-25ab-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-25ab-ss-4 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-25ab-ss-5 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-25ab-ss-6 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.158" .
concept:therapeutic-goods-act-1989-sec-25ab-ss-2 a cml:Concept ;
skos:prefLabel "25AB(2) Registration of therapeutic goods etc."@en ;
cml:realizedBy doc:sec-25ab-ss-2 ;
cml:integrityHash "ec25583240eb7e3b0beabe5d66938d812cd43234cb3a9b0d30a1bf9b0806a443" ;
values:partOf concept:therapeutic-goods-act-1989-sec-25ab ;
skos:note "Secretary must notify applicant within 28 days of decision to register therapeutic goods." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.158" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-25ab-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-25ab-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-25ab-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-25ab-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-25ab-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-25ab-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Must notify applicant within 28 days." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-25ab-ss-3 a cml:Concept ;
skos:prefLabel "25AB(3) Registration of therapeutic goods etc."@en ;
cml:realizedBy doc:sec-25ab-ss-3 ;
cml:integrityHash "292bccc54f2e81f998f6d13cbf9beea6c6611335e635e05dfe521c749b2c275b" ;
values:partOf concept:therapeutic-goods-act-1989-sec-25ab ;
skos:note "The notice must set out certain information about the decision to register goods." ;
dc:description "(a) and (b)" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.158" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-25ab-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-25ab-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-25ab-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-25ab-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-25ab-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-25ab-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "The notice must contain certain information." ;
cml:conclusionText "(a) and (b)" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-25ab-ss-4 a cml:Concept ;
skos:prefLabel "25AB(4) Registration of therapeutic goods etc."@en ;
cml:realizedBy doc:sec-25ab-ss-4 ;
cml:integrityHash "0067ef10fc13f30c1d483d857a96a5f5dd6adff2563f9efd794136c1e2d27603" ;
values:partOf concept:therapeutic-goods-act-1989-sec-25ab ;
skos:note "Secretary must include goods in Register and give applicant a certificate of registration." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.158" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-25ab-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-25ab-ss-4-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-25ab-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-25ab-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-25ab-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-25ab-ss-4-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-25ab-ss-5 a cml:Concept ;
skos:prefLabel "25AB(5) Registration of therapeutic goods etc."@en ;
cml:realizedBy doc:sec-25ab-ss-5 ;
cml:integrityHash "05af4b5e647941efa1fb795999f12f0f1d566e635ae548fc6b1d7bb1e453b7a6" ;
values:partOf concept:therapeutic-goods-act-1989-sec-25ab ;
skos:note "Secretary must register therapeutic goods without inquiry into correctness of certificate or notice." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.158" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-25ab-ss-5-norm .
concept:therapeutic-goods-act-1989-sec-25ab-ss-5-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-25ab-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-25ab-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-25ab-ss-5-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-25ab-ss-5-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Secretary must register therapeutic goods." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-25ab-ss-6 a cml:Concept ;
skos:prefLabel "25AB(6) Registration of therapeutic goods etc."@en ;
cml:realizedBy doc:sec-25ab-ss-6 ;
cml:integrityHash "3b080a46097b485b8df65f1f2dfd6a9aaee0bf621bc71ee7766af04a4c3e389a" ;
values:partOf concept:therapeutic-goods-act-1989-sec-25ab ;
skos:note "Commencement of therapeutic goods registration" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.158" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-25ab-ss-6-norm .
concept:therapeutic-goods-act-1989-sec-25ab-ss-6-norm a values:Undertaking ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-25ab-ss-6 ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-25ab-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-25ab-ss-6-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-25ab-ss-6-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "begins" ;
cml:logicSummary "Indicates the start of a process" ;
cml:premiseText "(6) The registration of therapeutic goods commences on the day specified in the certificate of registration." ;
cml:conclusionText "The registration of therapeutic goods begins 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-25ab-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-25ab-ss-6-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-25ab-ss-6-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "during" ;
cml:logicSummary "Indicates a temporal relationship between two events" ;
cml:premiseText "(6) The registration of therapeutic goods commences on the day specified in the certificate of registration." ;
cml:conclusionText "The registration occurs during the specified day." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-25ab-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-25ab-ss-6-logic-linearlogic-3 .
concept:therapeutic-goods-act-1989-sec-25ab-ss-6-logic-linearlogic-3 a cml:LogicApplication ;
cml:modality cml:LinearLogic ;
cml:operator "then" ;
cml:logicSummary "Indicates a causal relationship between two events" ;
cml:premiseText "(6) The registration of therapeutic goods commences on the day specified in the certificate of registration." ;
cml:conclusionText "The registration then occurs on the specified day." ;
cml:executionSurface "modalities::linear" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-25ab-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-25ab-ss-6-logic-diffusion-4 .
concept:therapeutic-goods-act-1989-sec-25ab-ss-6-logic-diffusion-4 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "through" ;
cml:logicSummary "Indicates a means of transmission or application" ;
cml:premiseText "(6) The registration of therapeutic goods commences on the day specified in the certificate of registration." ;
cml:conclusionText "The registration is transmitted through the specified day." ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-25ab-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-25ab-ss-6-logic-cogai-5 .
concept:therapeutic-goods-act-1989-sec-25ab-ss-6-logic-cogai-5 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "by" ;
cml:logicSummary "Indicates a means of processing or application" ;
cml:premiseText "(6) The registration of therapeutic goods commences on the day specified in the certificate of registration." ;
cml:conclusionText "The registration is processed by the specified day." ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-25ac a cml:Concept ;
skos:prefLabel "25AC Notice of decision not to register therapeutic goods"@en ;
cml:realizedBy doc:sec-25ac ;
cml:integrityHash "4e912b5f5cb0d5f08ec2b8eceb6af21d16ad74e7d70585e9b4e75db392838891" ;
skos:note "Secretary must notify applicant of decision within 28 days." ;
dc:description "Reasons for the decision" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.159" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-25ac-norm .
concept:therapeutic-goods-act-1989-sec-25ac-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-25ac ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-25ac cml:asserts concept:therapeutic-goods-act-1989-sec-25ac-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-25ac-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Secretary must notify applicant" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-25a a cml:Concept ;
skos:prefLabel "25A When the Secretary must not use protected information"@en ;
cml:realizedBy doc:sec-25a ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-25a-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-25a-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.159" .
concept:therapeutic-goods-act-1989-sec-25a-ss-1 a cml:Concept ;
skos:prefLabel "25A(1) When the Secretary must not use protected information"@en ;
cml:realizedBy doc:sec-25a-ss-1 ;
cml:integrityHash "bf6f9de40221e0563f4ca7f7376725c0321a64b4e754d6bc026a1342e72b19ee" ;
values:partOf concept:therapeutic-goods-act-1989-sec-25a ;
skos:note "Prohibition on using protected information when evaluating therapeutic goods for registration" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.159" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-25a-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-25a-ss-1-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-25a-ss-1 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-25a-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-25a-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-25a-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "prohibition" ;
cml:logicSummary "Prohibition on using protected information" ;
cml:premiseText "(1) When evaluating therapeutic goods for registration, the Secretary must not use information about other therapeutic goods that is protected information." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-25a-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-25a-ss-1-logic-deontic-2 .
concept:therapeutic-goods-act-1989-sec-25a-ss-1-logic-deontic-2 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "duty" ;
cml:logicSummary "Duty to refrain from using protected information" ;
cml:premiseText "(1) When evaluating therapeutic goods for registration, the Secretary must not use information about other therapeutic goods that is protected information." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-25a-ss-2 a cml:Concept ;
skos:prefLabel "25A(2) When the Secretary must not use protected information"@en ;
cml:realizedBy doc:sec-25a-ss-2 ;
cml:integrityHash "36dba8202ce7dde4df81709557e366180f8ab28e7ae9771ca5daf5ffd43a9888" ;
values:partOf concept:therapeutic-goods-act-1989-sec-25a ;
skos:note "The Secretary must not use protected information." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.159" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-25a-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-25a-ss-2-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-25a-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-25a-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-25a-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-25a-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibition of using protected information." ;
cml:premiseText "(2) Information is protected information if..." ;
cml:conclusionText "...the Secretary must not use protected information." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26 a cml:Concept ;
skos:prefLabel "26 Listing of therapeutic goods"@en ;
cml:realizedBy doc:sec-26 ;
cml:integrityHash "44c0529b7264dced4a0ece3601f18204662a12e4409cf6c5f0ffe7966ed228e2" ;
skos:note "Listing of therapeutic goods" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.160" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26-norm .
concept:therapeutic-goods-act-1989-sec-26-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26 ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26 cml:asserts concept:therapeutic-goods-act-1989-sec-26-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-26-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligate" ;
cml:logicSummary "Listing of therapeutic goods" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26 cml:asserts concept:therapeutic-goods-act-1989-sec-26-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-26-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-26a a cml:Concept ;
skos:prefLabel "26A Listing of certain medicines"@en ;
cml:realizedBy doc:sec-26a ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26a-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26a-ss-1a ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26a-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.164" .
concept:therapeutic-goods-act-1989-sec-26a-ss-1 a cml:Concept ;
skos:prefLabel "26A(1) Listing of certain medicines"@en ;
cml:realizedBy doc:sec-26a-ss-1 ;
cml:integrityHash "e81659a540d8704c660672ae1267969a8e6fe990e8e2bbc175a279f242cc063e" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26a ;
skos:note "The Secretary must list a medicine if certain conditions are met." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.164" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26a-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-26a-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26a-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-26a-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-26a-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-26a-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "The Secretary must list the medicine." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26a-ss-1a a cml:Concept ;
skos:prefLabel "26A(1A) Listing of certain medicines"@en ;
cml:realizedBy doc:sec-26a-ss-1a ;
cml:integrityHash "9ff40943e2a0b5a4d6b49fc6f4076251ffb3bcd6f77f9fdad7bd77e2476e6620" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26a ;
skos:note "Secretary must list medicine under subsection (1) without inquiring into the correctness of the certificate or notice." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.164" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26a-ss-1a-norm .
concept:therapeutic-goods-act-1989-sec-26a-ss-1a-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26a-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-26a-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-26a-ss-1a-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-26a-ss-1a-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Duty to list medicine" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26a-ss-2 a cml:Concept ;
skos:prefLabel "26A(2) Listing of certain medicines"@en ;
cml:realizedBy doc:sec-26a-ss-2 ;
cml:integrityHash "9c1fedd11d1abcd16718e171e420984dd6eb27bbcc389bee81caf6bb81161adf" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26a ;
skos:note "Certify that medicine meets certain requirements." ;
dc:description "Certification of eligibility, safety, and presentation." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.164" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26a-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-26a-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26a-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-26a-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-26a-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-26a-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Obligation to certify" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26ab a cml:Concept ;
skos:prefLabel "26AB Application for listing of certain medicines following efficacy"@en ;
cml:realizedBy doc:sec-26ab ;
cml:integrityHash "50d1c4821a4146f9310da915d494bfd8462576196622274227ede249165f5053" ;
skos:note "Application for listing of certain medicines following efficacy" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.169" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26ab-norm .
concept:therapeutic-goods-act-1989-sec-26ab-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26ab ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26ac a cml:Concept ;
skos:prefLabel "26AC Evaluation fees for listing of medicine under section 26AE"@en ;
cml:realizedBy doc:sec-26ac ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26ac-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26ac-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26ac-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26ac-ss-4 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26ac-ss-5 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.173" .
concept:therapeutic-goods-act-1989-sec-26ac-ss-1 a cml:Concept ;
skos:prefLabel "26AC(1) Evaluation fees for listing of medicine under section 26AE"@en ;
cml:realizedBy doc:sec-26ac-ss-1 ;
cml:integrityHash "c181b04960a50b57f2c454e94403406233eeb7d1d7ce6b9379377cc703b15d18" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26ac ;
skos:note "Application must pass preliminary assessment to be eligible for listing under section 26AE." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.173" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26ac-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-26ac-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26ac-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-26ac-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-26ac-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-26ac-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Application must pass preliminary assessment." ;
cml:premiseText "Section 23 application" ;
cml:conclusionText "Eligible for listing under section 26AE." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26ac-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-26ac-ss-1-logic-linearlogic-2 .
concept:therapeutic-goods-act-1989-sec-26ac-ss-1-logic-linearlogic-2 a cml:LogicApplication ;
cml:modality cml:LinearLogic ;
cml:operator "⇒" ;
cml:logicSummary "Preliminary assessment is a necessary condition for listing under section 26AE." ;
cml:premiseText "Section 23 application" ;
cml:conclusionText "Eligible for listing under section 26AE." ;
cml:executionSurface "modalities::linear" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26ac-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-26ac-ss-1-logic-alleninterval-3 .
concept:therapeutic-goods-act-1989-sec-26ac-ss-1-logic-alleninterval-3 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "BETWEEN" ;
cml:logicSummary "Preliminary assessment must occur before listing under section 26AE." ;
cml:premiseText "Section 23 application" ;
cml:conclusionText "Eligible for listing under section 26AE." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26ac-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-26ac-ss-1-logic-cogai-4 .
concept:therapeutic-goods-act-1989-sec-26ac-ss-1-logic-cogai-4 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "IS_A" ;
cml:logicSummary "Preliminary assessment is a type of evaluation required for listing under section 26AE." ;
cml:premiseText "Section 23 application" ;
cml:conclusionText "Eligible for listing under section 26AE." ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26ac-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-26ac-ss-1-logic-shacl-5 .
concept:therapeutic-goods-act-1989-sec-26ac-ss-1-logic-shacl-5 a cml:LogicApplication ;
cml:modality cml:SHACL ;
cml:operator "IS_A" ;
cml:logicSummary "Preliminary assessment is a schema required for listing under section 26AE." ;
cml:premiseText "Section 23 application" ;
cml:conclusionText "Eligible for listing under section 26AE." ;
cml:executionSurface "modalities::logic::shacl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26ac-ss-2 a cml:Concept ;
skos:prefLabel "26AC(2) Evaluation fees for listing of medicine under section 26AE"@en ;
cml:realizedBy doc:sec-26ac-ss-2 ;
cml:integrityHash "916ff028b072f3ab1a45a59e9888e6782d61e03ea3da501b3a80b44ed002845b" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26ac ;
skos:note "Payable evaluation fee for listing of medicine under section 26AE" ;
dc:description "Evaluation fee" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.173" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26ac-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-26ac-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26ac-ss-2 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26ac-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-26ac-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-26ac-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Payable obligation" ;
cml:conclusionText "Pay evaluation fee" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26ac-ss-3 a cml:Concept ;
skos:prefLabel "26AC(3) Evaluation fees for listing of medicine under section 26AE"@en ;
cml:realizedBy doc:sec-26ac-ss-3 ;
cml:integrityHash "13af40081538133bbea3700fe7abfc64c0763839b100a23411b3b3d3c419fc9f" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26ac ;
skos:note "Secretary must notify applicant of evaluation fee amount." ;
dc:description "Evaluation fee amount" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.173" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26ac-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-26ac-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26ac-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-26ac-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-26ac-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-26ac-ss-3-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-26ac-ss-4 a cml:Concept ;
skos:prefLabel "26AC(4) Evaluation fees for listing of medicine under section 26AE"@en ;
cml:realizedBy doc:sec-26ac-ss-4 ;
cml:integrityHash "6e22db43b6d5bd8f4cca91af9ae2cdd09989370eb4ef58fc22e2aff6150873ec" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26ac ;
skos:note "Evaluation fee payable by applicant on notification of evaluation fee amount" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.173" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26ac-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-26ac-ss-4-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26ac-ss-4 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26ac-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-26ac-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-26ac-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "due" ;
cml:logicSummary "Due payment obligation" ;
cml:premiseText "(4) The evaluation fee payable by an applicant:" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26ac-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-26ac-ss-4-logic-deontic-2 .
concept:therapeutic-goods-act-1989-sec-26ac-ss-4-logic-deontic-2 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "recoverable" ;
cml:logicSummary "Recoverable debt due to Commonwealth" ;
cml:premiseText "(b) may be recovered by the Commonwealth as a debt due to the Commonwealth." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26ac-ss-5 a cml:Concept ;
skos:prefLabel "26AC(5) Evaluation fees for listing of medicine under section 26AE"@en ;
cml:realizedBy doc:sec-26ac-ss-5 ;
cml:integrityHash "1d01f11d5556c8a7d7b129bb4dbce2c96fc117499c1977db49193d905b960050" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26ac ;
skos:note "Pay evaluation fee before listing medicine under section 26AE" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.173" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26ac-ss-5-norm .
concept:therapeutic-goods-act-1989-sec-26ac-ss-5-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26ac-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-26ac-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-26ac-ss-5-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-26ac-ss-5-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Must pay evaluation fee" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26ad a cml:Concept ;
skos:prefLabel "26AD Lapsing and deemed refusal of applications for listing of"@en ;
cml:realizedBy doc:sec-26ad ;
cml:integrityHash "68f39f5b384d9e42a9e3cb3607877a04c5a02447c47a83d8f1956cb38f3ba234" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26ad-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26ad-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26ad-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26ad-ss-4 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.174" .
concept:therapeutic-goods-act-1989-sec-26ad-ss-1 a cml:Concept ;
skos:prefLabel "26AD(1) Lapsing and deemed refusal of applications for listing of"@en ;
cml:realizedBy doc:sec-26ad-ss-1 ;
cml:integrityHash "2f48ee7c329bb51cdd1133b86228ee5acca88aee897c51817b7a0b59b3cf72e0" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26ad ;
skos:note "Application lapses if evaluation fee remains unpaid or application contains inaccurate information." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.174" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26ad-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-26ad-ss-1-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26ad-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-26ad-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-26ad-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-26ad-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Forbid" ;
cml:logicSummary "Application lapses if evaluation fee remains unpaid or application contains inaccurate information." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26ad-ss-2 a cml:Concept ;
skos:prefLabel "26AD(2) Lapsing and deemed refusal of applications for listing of"@en ;
cml:realizedBy doc:sec-26ad-ss-2 ;
cml:integrityHash "1465f4763738f52663786d329b843c55880f4d2a367b5953af304d465390f57c" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26ad ;
skos:note "Applicant may give notice to treat application as refused if evaluation not completed within prescribed period." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.174" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26ad-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-26ad-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26ad-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-26ad-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-26ad-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-26ad-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Obligation to complete evaluation within prescribed period." ;
cml:premiseText "(2) If..." ;
cml:conclusionText "the applicant may give the Secretary written notice..." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26ad-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-26ad-ss-2-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-26ad-ss-2-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Temporal Interval" ;
cml:logicSummary "Prescribed period within which evaluation must be completed." ;
cml:premiseText "(a) regulations made for the purposes of paragraph 63(2)(daaaa)..." ;
cml:conclusionText "...the applicant may give the Secretary written notice..." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26ad-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-26ad-ss-2-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-26ad-ss-2-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "Recurring Trace" ;
cml:logicSummary "Evaluation must be completed within prescribed period." ;
cml:premiseText "(b) at the end of that period, the evaluation has not been completed;" ;
cml:conclusionText "...the applicant may give the Secretary written notice..." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26ad-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-26ad-ss-2-logic-cogai-4 .
concept:therapeutic-goods-act-1989-sec-26ad-ss-2-logic-cogai-4 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "Knowledge Representation" ;
cml:logicSummary "Classification and evaluation process." ;
cml:premiseText "(2) If..." ;
cml:conclusionText "...the applicant wishes to treat the application as having been refused." ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26ad-ss-3 a cml:Concept ;
skos:prefLabel "26AD(3) Lapsing and deemed refusal of applications for listing of"@en ;
cml:realizedBy doc:sec-26ad-ss-3 ;
cml:integrityHash "f6935edd328a78ea5580293618e2d1cf082e2be98d62e6e5126d9a47add65522" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26ad ;
skos:note "Notice may be given at any time before evaluation is completed." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.174" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26ad-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-26ad-ss-3-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26ad-ss-3 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26ad-ss-4 a cml:Concept ;
skos:prefLabel "26AD(4) Lapsing and deemed refusal of applications for listing of"@en ;
cml:realizedBy doc:sec-26ad-ss-4 ;
cml:integrityHash "d6c60b67c7ca0387b59b91f297b815ad1334a0a74ded09b97115d5a5ebad5263" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26ad ;
skos:note "Refusal of listing of medicine without notice" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.174" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26ad-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-26ad-ss-4-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26ad-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-26ad-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-26ad-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-26ad-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits listing of medicine" ;
cml:premiseText "(4) If a notice has been given" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26ae a cml:Concept ;
skos:prefLabel "26AE Evaluation and listing of certain medicines"@en ;
cml:realizedBy doc:sec-26ae ;
cml:integrityHash "163e44b102626149bbbfb058eee4fcfa7748b40949629e0a1a4ff058f3bb548b" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26ae-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26ae-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26ae-ss-3 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.175" .
concept:therapeutic-goods-act-1989-sec-26ae-ss-1 a cml:Concept ;
skos:prefLabel "26AE(1) Evaluation and listing of certain medicines"@en ;
cml:realizedBy doc:sec-26ae-ss-1 ;
cml:integrityHash "9b69e3def574e8f5c29ce54751d651e6f2612a0034eda1269ef7cb0028f356f1" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26ae ;
skos:note "The Secretary must evaluate a medicine if an application has passed preliminary assessment." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.175" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26ae-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-26ae-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26ae-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-26ae-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-26ae-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-26ae-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "The Secretary must evaluate the medicine." ;
cml:premiseText "(a) an application is made under section 23 for the listing of a medicine in relation to a person under this section; and (b) the application has passed preliminary assessment;" ;
cml:conclusionText "the Secretary must evaluate the medicine having regard to..." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26ae-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-26ae-ss-1-logic-deontic-2 .
concept:therapeutic-goods-act-1989-sec-26ae-ss-1-logic-deontic-2 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST NOT" ;
cml:logicSummary "The Secretary must not use restricted information when evaluating the medicine." ;
cml:premiseText "Note: The Secretary must not use restricted information when evaluating the medicine for listing: see section 26AF;" ;
cml:conclusionText "the Secretary must not use restricted information when evaluating the medicine for listing:" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26ae-ss-2 a cml:Concept ;
skos:prefLabel "26AE(2) Evaluation and listing of certain medicines"@en ;
cml:realizedBy doc:sec-26ae-ss-2 ;
cml:integrityHash "40ab2f3548db614f935a5dfd982f4aef037e638a26f61ca94c89f7ea6524dd1a" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26ae ;
skos:note "Evaluation must be completed within a prescribed period." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.175" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26ae-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-26ae-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26ae-ss-2 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26ae-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-26ae-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-26ae-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Obligation to complete evaluation" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26ae-ss-3 a cml:Concept ;
skos:prefLabel "26AE(3) Evaluation and listing of certain medicines"@en ;
cml:realizedBy doc:sec-26ae-ss-3 ;
cml:integrityHash "f28faf5bb7ab09fd3a30c3a441182bc6cb7f981f893590a039e154124a85f148" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26ae ;
skos:note "Secretary must decide whether to list a medicine after evaluation." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.175" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26ae-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-26ae-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26ae-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-26ae-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-26ae-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-26ae-ss-3-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-26af a cml:Concept ;
skos:prefLabel "26AF When the Secretary must not use restricted information in"@en ;
cml:realizedBy doc:sec-26af ;
cml:integrityHash "43ce1ef0621d8809a8ecb431e9fa340a57a6cb806b8cb042cc97695bdd5a0706" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26af-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26af-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.177" .
concept:therapeutic-goods-act-1989-sec-26af-ss-1 a cml:Concept ;
skos:prefLabel "26AF(1) When the Secretary must not use restricted information in"@en ;
cml:realizedBy doc:sec-26af-ss-1 ;
cml:integrityHash "e7f720c8a8d60d6b73ef9ca7f7b452a6db512553edc7cc455076b0251a8ac7b1" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26af ;
skos:note "Must not use restricted information in evaluating a medicine under section 26AE." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.177" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26af-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-26af-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26af-ss-1 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26af-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-26af-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-26af-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MustNotUse" ;
cml:logicSummary "Prohibition on using restricted information" ;
cml:premiseText "Application for listing a medicine under section 26AE" ;
cml:conclusionText "Evaluating the medicine under section 26AE" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26af-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-26af-ss-1-logic-deontic-2 .
concept:therapeutic-goods-act-1989-sec-26af-ss-1-logic-deontic-2 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MustNotUse" ;
cml:logicSummary "Prohibition on using restricted information in evaluating a medicine under section 26AE" ;
cml:premiseText "Section 23 application for listing a medicine under section 26AE" ;
cml:conclusionText "Evaluating the medicine under section 26AE" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26af-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-26af-ss-1-logic-alleninterval-3 .
concept:therapeutic-goods-act-1989-sec-26af-ss-1-logic-alleninterval-3 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "During" ;
cml:logicSummary "Use of restricted information during evaluation of a medicine under section 26AE" ;
cml:premiseText "Section 23 application for listing a medicine under section 26AE" ;
cml:conclusionText "Evaluating the medicine under section 26AE" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26af-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-26af-ss-1-logic-ltl-4 .
concept:therapeutic-goods-act-1989-sec-26af-ss-1-logic-ltl-4 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "Until" ;
cml:logicSummary "Prohibition on using restricted information until evaluation of a medicine under section 26AE is complete" ;
cml:premiseText "Section 23 application for listing a medicine under section 26AE" ;
cml:conclusionText "Evaluating the medicine under section 26AE" ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26af-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-26af-ss-1-logic-diffusion-5 .
concept:therapeutic-goods-act-1989-sec-26af-ss-1-logic-diffusion-5 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "Through" ;
cml:logicSummary "Use of restricted information through evaluation of a medicine under section 26AE" ;
cml:premiseText "Section 23 application for listing a medicine under section 26AE" ;
cml:conclusionText "Evaluating the medicine under section 26AE" ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26af-ss-2 a cml:Concept ;
skos:prefLabel "26AF(2) When the Secretary must not use restricted information in"@en ;
cml:realizedBy doc:sec-26af-ss-2 ;
cml:integrityHash "dbb6878db05404f908585085eea8323583b86aeb5a17c9906e0188639571b4a6" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26af ;
skos:note "The Secretary must not use restricted information in certain circumstances." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.177" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26af-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-26af-ss-2-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26af-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-26af-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-26af-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-26af-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibition of using restricted information" ;
cml:premiseText "The Secretary must not use..." ;
cml:conclusionText "...in certain circumstances." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26b a cml:Concept ;
skos:prefLabel "26B Certificates required in relation to patents"@en ;
cml:realizedBy doc:sec-26b ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26b-ss-1a ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26b-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26b-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.179" .
concept:therapeutic-goods-act-1989-sec-26b-ss-1a a cml:Concept ;
skos:prefLabel "26B(1A) Certificates required in relation to patents"@en ;
cml:realizedBy doc:sec-26b-ss-1a ;
cml:integrityHash "ed55e9d6a79bca6142602eabd59f29f105e4645adcdfb40631e9c8b228bfa42e" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26b ;
skos:note "Applicant must provide evidence or information submitted by another person." ;
dc:description "true" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.179" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26b-ss-1a-norm .
concept:therapeutic-goods-act-1989-sec-26b-ss-1a-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26b-ss-1a ;
values:borneBy values:Agent ;
skos:scopeNote "borne by: Agent" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26b-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-26b-ss-1a-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-26b-ss-1a-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Must provide evidence or information." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26b-ss-1 a cml:Concept ;
skos:prefLabel "26B(1) Certificates required in relation to patents"@en ;
cml:realizedBy doc:sec-26b-ss-1 ;
cml:integrityHash "071618007d9b8ebfa61f8300f2734914f1920b3ff24afe5803bc941043342ffd" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26b ;
skos:note "Applicant must provide a certificate stating their intentions regarding patent infringement." ;
dc:description "true" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.179" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26b-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-26b-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26b-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-26b-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-26b-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-26b-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Applicant has an obligation to provide a certificate." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26b-ss-2 a cml:Concept ;
skos:prefLabel "26B(2) Certificates required in relation to patents"@en ;
cml:realizedBy doc:sec-26b-ss-2 ;
cml:integrityHash "4455acf9b7cc062b151d65536562f766bf2d2696559a2ac8e18fc150f50ececd" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26b ;
skos:note "Giving a false or misleading certificate is an offence." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.179" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26b-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-26b-ss-2-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26b-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-26b-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-26b-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-26b-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibition" ;
cml:logicSummary "Prohibits giving a false or misleading certificate." ;
cml:premiseText "The person gives a certificate required under subsection (1)." ;
cml:conclusionText "The person commits an offence if the certificate 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-26b-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-26b-ss-2-logic-deontic-2 .
concept:therapeutic-goods-act-1989-sec-26b-ss-2-logic-deontic-2 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Requires giving a true and accurate certificate." ;
cml:premiseText "A person commits an offence if: (a) the person gives a certificate required under subsection (1);" ;
cml:conclusionText "The person must give a true and accurate certificate." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26ba a cml:Concept ;
skos:prefLabel "26BA Approved form for notices"@en ;
cml:realizedBy doc:sec-26ba ;
cml:integrityHash "107fe1080d93d8dcb19b8cbd489e47095a2c992666a2796b36e35ec7004a1e6e" ;
skos:note "Permits notice to be given in accordance with specified software requirements." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.180" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26ba-norm .
concept:therapeutic-goods-act-1989-sec-26ba-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26ba ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26ba cml:asserts concept:therapeutic-goods-act-1989-sec-26ba-logic-descriptionlogic-1 .
concept:therapeutic-goods-act-1989-sec-26ba-logic-descriptionlogic-1 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "hasClass" ;
cml:logicSummary "Defines a class for notices" ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26ba cml:asserts concept:therapeutic-goods-act-1989-sec-26ba-logic-deontic-2 .
concept:therapeutic-goods-act-1989-sec-26ba-logic-deontic-2 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "requires" ;
cml:logicSummary "Requires notice to be given in accordance with specified software requirements" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26bb a cml:Concept ;
skos:prefLabel "26BB Permissible ingredients"@en ;
cml:realizedBy doc:sec-26bb ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26bb-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26bb-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26bb-ss-2a ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26bb-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26bb-ss-4 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26bb-ss-5 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26bb-ss-6 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26bb-ss-7 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26bb-ss-8 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.180" .
concept:therapeutic-goods-act-1989-sec-26bb-ss-1 a cml:Concept ;
skos:prefLabel "26BB(1) Permissible ingredients"@en ;
cml:realizedBy doc:sec-26bb-ss-1 ;
cml:integrityHash "ba7878164f2bb10c2137ff23c805d417a5530147eac4af48d6a0c0aec38c7f82" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bb ;
skos:note "The Minister may make a determination specifying ingredients for medicine." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.180" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26bb-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-26bb-ss-1-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bb-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-26bb-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-26bb-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-26bb-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "May" ;
cml:logicSummary "Permission to specify ingredients" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26bb-ss-2 a cml:Concept ;
skos:prefLabel "26BB(2) Permissible ingredients"@en ;
cml:realizedBy doc:sec-26bb-ss-2 ;
cml:integrityHash "8665877e41f5718d6e1d1fd747f4b4d2fbd3bae58eb640c860cf226496fcbc6b" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bb ;
skos:note "Permits particular ingredients not being contained in particular medicine." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.180" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26bb-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-26bb-ss-2-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bb-ss-2 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26bb-ss-2a a cml:Concept ;
skos:prefLabel "26BB(2A) Permissible ingredients"@en ;
cml:realizedBy doc:sec-26bb-ss-2a ;
cml:integrityHash "7521c10892f3eda896cba3e154b1b789dff2de2a0238e3e87ef96cccc92d212f" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bb ;
skos:note "Permits specific circumstances for a particular ingredient in medicine." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.180" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26bb-ss-2a-norm .
concept:therapeutic-goods-act-1989-sec-26bb-ss-2a-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bb-ss-2a ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26bb-ss-2a cml:asserts concept:therapeutic-goods-act-1989-sec-26bb-ss-2a-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-26bb-ss-2a-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Permit" ;
cml:logicSummary "Allows specified conditions." ;
cml:premiseText "(2A) The requirements referred to in paragraph (1)(b)" ;
cml:conclusionText "may relate to a particular ingredient being contained in particular medicine only in the circumstances specified in the determination in relation to the ingredient." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26bb-ss-2a cml:asserts concept:therapeutic-goods-act-1989-sec-26bb-ss-2a-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-26bb-ss-2a-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Temporal Interval" ;
cml:logicSummary "Defines temporal scope." ;
cml:premiseText "(2A) The requirements referred to in paragraph (1)(b)" ;
cml:conclusionText "The requirements relate to a particular ingredient being contained in particular medicine only in the circumstances specified in the determination in relation to the ingredient at some point in time." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26bb-ss-2a cml:asserts concept:therapeutic-goods-act-1989-sec-26bb-ss-2a-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-26bb-ss-2a-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "Temporal Trace" ;
cml:logicSummary "Defines temporal relationship." ;
cml:premiseText "(2A) The requirements referred to in paragraph (1)(b)" ;
cml:conclusionText "The requirements relate to a particular ingredient being contained in particular medicine only in the circumstances specified in the determination in relation to the ingredient over some period of time." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26bb-ss-2a cml:asserts concept:therapeutic-goods-act-1989-sec-26bb-ss-2a-logic-diffusion-4 .
concept:therapeutic-goods-act-1989-sec-26bb-ss-2a-logic-diffusion-4 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "Spread" ;
cml:logicSummary "Describes information spread." ;
cml:premiseText "(2A) The requirements referred to in paragraph (1)(b)" ;
cml:conclusionText "The requirements relate to a particular ingredient being contained in particular medicine only in the circumstances specified in the determination in relation to the ingredient over some period of time." ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26bb-ss-2a cml:asserts concept:therapeutic-goods-act-1989-sec-26bb-ss-2a-logic-cogai-5 .
concept:therapeutic-goods-act-1989-sec-26bb-ss-2a-logic-cogai-5 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "Knowledge Representation" ;
cml:logicSummary "Describes knowledge representation." ;
cml:premiseText "(2A) The requirements referred to in paragraph (1)(b)" ;
cml:conclusionText "The requirements relate to a particular ingredient being contained in particular medicine only in the circumstances specified in the determination in relation to the ingredient." ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26bb-ss-3 a cml:Concept ;
skos:prefLabel "26BB(3) Permissible ingredients"@en ;
cml:realizedBy doc:sec-26bb-ss-3 ;
cml:integrityHash "82770451d008d3e4c99d12ae829f37cff24889c0fed3cf28fdc7f6e115925c98" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bb ;
skos:note "Permitted concentrations or amounts of ingredients" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.180" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26bb-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-26bb-ss-3-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bb-ss-3 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26bb-ss-4 a cml:Concept ;
skos:prefLabel "26BB(4) Permissible ingredients"@en ;
cml:realizedBy doc:sec-26bb-ss-4 ;
cml:integrityHash "0c0f873f053d93d59b3548a490b51855491ffe4c035fcd61335842393bac9306" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bb ;
skos:note "Permits certain subsections not to limit paragraph (1)(b)" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.180" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26bb-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-26bb-ss-4-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bb-ss-4 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26bb-ss-5 a cml:Concept ;
skos:prefLabel "26BB(5) Permissible ingredients"@en ;
cml:realizedBy doc:sec-26bb-ss-5 ;
cml:integrityHash "19884e377c89833f95c869e92e9dc112940c4d1ba6f1aac5d6c8a8cd18d0a041" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bb ;
skos:note "Determination may make different provision for different classes of medicine." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.180" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26bb-ss-5-norm .
concept:therapeutic-goods-act-1989-sec-26bb-ss-5-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bb-ss-5 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26bb-ss-6 a cml:Concept ;
skos:prefLabel "26BB(6) Permissible ingredients"@en ;
cml:realizedBy doc:sec-26bb-ss-6 ;
cml:integrityHash "3fa0ee0c720e8758aa40b7ec16366baaf6f2b348d97eace792a19025a9717e06" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bb ;
skos:note "The Minister may make a determination specifying ingredients and requirements." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.180" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26bb-ss-6-norm .
concept:therapeutic-goods-act-1989-sec-26bb-ss-6-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bb-ss-6 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26bb-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-26bb-ss-6-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-26bb-ss-6-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "May" ;
cml:logicSummary "Permission to determine ingredients and requirements." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26bb-ss-7 a cml:Concept ;
skos:prefLabel "26BB(7) Permissible ingredients"@en ;
cml:realizedBy doc:sec-26bb-ss-7 ;
cml:integrityHash "7859e7bceecb6375c80ad8aaf63a4cd1dd9f520f4aad3f84e405e9135efe5917" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bb ;
skos:note "Different classes of medicine may be treated differently under a determination." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.180" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26bb-ss-7-norm .
concept:therapeutic-goods-act-1989-sec-26bb-ss-7-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bb-ss-7 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26bb-ss-8 a cml:Concept ;
skos:prefLabel "26BB(8) Permissible ingredients"@en ;
cml:realizedBy doc:sec-26bb-ss-8 ;
cml:integrityHash "4dd6abff750264d632080eddaa6c5475d4fb2271f02d2090219e8b3b51544bb2" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bb ;
skos:note "Allows provision in relation to a matter by applying, adopting or incorporating any matter contained in an instrument or other writing." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.180" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26bb-ss-8-norm .
concept:therapeutic-goods-act-1989-sec-26bb-ss-8-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bb-ss-8 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26bc a cml:Concept ;
skos:prefLabel "26BC Variation of determination under section 26BB—Minister’s"@en ;
cml:realizedBy doc:sec-26bc ;
cml:integrityHash "aa223413af93e4bd5dd2e0f8bfd83361070a7b4940487ea33cded984058a88c9" ;
skos:note "Minister may vary a determination under section 26BB." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.181" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26bc-norm .
concept:therapeutic-goods-act-1989-sec-26bc-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bc ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26bc cml:asserts concept:therapeutic-goods-act-1989-sec-26bc-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-26bc-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "may" ;
cml:logicSummary "Expresses permission or obligation." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26bd a cml:Concept ;
skos:prefLabel "26BD Requirements relating to an application for variation of a"@en ;
cml:realizedBy doc:sec-26bd ;
cml:integrityHash "826752f897ea707fdb0078f8a1e2183d31cbfd89102d983eacf57c0aeadd17f7" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26bd-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26bd-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26bd-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26bd-ss-4 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26bd-ss-5 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26bd-ss-6 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26bd-ss-7 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26bd-ss-8 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26bd-ss-9 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.182" .
concept:therapeutic-goods-act-1989-sec-26bd-ss-1 a cml:Concept ;
skos:prefLabel "26BD(1) Requirements relating to an application for variation of a"@en ;
cml:realizedBy doc:sec-26bd-ss-1 ;
cml:integrityHash "4e5ebf4e4e4aca5852ae141ee97a6099b1f93d56ba0c1fb577a2a4ddd65c752d" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bd ;
skos:note "A person may make an application to the Secretary for a recommendation by the Secretary that the Minister vary a section 26BB determination." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.182" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26bd-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-26bd-ss-1-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bd-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-26bd-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-26bd-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-26bd-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-26bd-ss-2 a cml:Concept ;
skos:prefLabel "26BD(2) Requirements relating to an application for variation of a"@en ;
cml:realizedBy doc:sec-26bd-ss-2 ;
cml:integrityHash "4865dd3262bdc814229929d9b3aa6d6ffce445db5e998d0b98a740555dbf58e9" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bd ;
skos:note "Secretary must carry out assessment of requirements met in relation to application." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.182" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26bd-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-26bd-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bd-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-26bd-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-26bd-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-26bd-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Must carry out assessment" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26bd-ss-3 a cml:Concept ;
skos:prefLabel "26BD(3) Requirements relating to an application for variation of a"@en ;
cml:realizedBy doc:sec-26bd-ss-3 ;
cml:integrityHash "0b3f93b32a4e8b70cb85387c9cb421eddaa7c9c5f01fd828b433fbae4df6d62c" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bd ;
skos:note "Application requirements for variation of a" ;
dc:description "information determined under subsection (8) and in a form determined under subsection (9)" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.182" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26bd-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-26bd-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bd-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-26bd-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-26bd-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-26bd-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Application must meet certain requirements" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26bd-ss-4 a cml:Concept ;
skos:prefLabel "26BD(4) Requirements relating to an application for variation of a"@en ;
cml:realizedBy doc:sec-26bd-ss-4 ;
cml:integrityHash "dd9e85813a1135c98b20a4dd3133f1139f0213616a37164dda5d35ef4577567f" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bd ;
skos:note "The Secretary must be satisfied that the requirements have been met." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.182" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26bd-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-26bd-ss-4-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bd-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-26bd-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-26bd-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-26bd-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Satisfies" ;
cml:logicSummary "The Secretary must be satisfied." ;
cml:premiseText "(a) has carried out an assessment, under subsection (2), in relation to the application;" ;
cml:conclusionText "is satisfied that the requirements set out in subsection (3) have been met in relation to the application." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26bd-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-26bd-ss-4-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-26bd-ss-4-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "During" ;
cml:logicSummary "The assessment must occur during a specific time period." ;
cml:premiseText "(a) has carried out an assessment, under subsection (2), in relation to the application;" ;
cml:conclusionText "The assessment occurs during this time period." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26bd-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-26bd-ss-4-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-26bd-ss-4-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "Until" ;
cml:logicSummary "The requirements must be met until a specific point in time." ;
cml:premiseText "(b) is satisfied that the requirements set out in subsection (3) have been met in relation to the application;" ;
cml:conclusionText "The requirements are met until this point in time." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26bd-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-26bd-ss-4-logic-diffusion-4 .
concept:therapeutic-goods-act-1989-sec-26bd-ss-4-logic-diffusion-4 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "If-Then" ;
cml:logicSummary "There is a conditional relationship between the assessment and the satisfaction of the requirements." ;
cml:premiseText "(a) has carried out an assessment, under subsection (2), in relation to the application;" ;
cml:conclusionText "The assessment implies that the requirements are met." ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26bd-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-26bd-ss-4-logic-cogai-5 .
concept:therapeutic-goods-act-1989-sec-26bd-ss-4-logic-cogai-5 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "Implication" ;
cml:logicSummary "There is a logical implication between the assessment and the satisfaction of the requirements." ;
cml:premiseText "(a) has carried out an assessment, under subsection (2), in relation to the application;" ;
cml:conclusionText "The assessment implies that the requirements are met." ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26bd-ss-5 a cml:Concept ;
skos:prefLabel "26BD(5) Requirements relating to an application for variation of a"@en ;
cml:realizedBy doc:sec-26bd-ss-5 ;
cml:integrityHash "99b6420ae381d337f0cec7f9a615034a6a7da0d49ef5bba366c5df3d05a284f7" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bd ;
skos:note "Secretary must give written notice to applicant stating application has passed preliminary assessment." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.182" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26bd-ss-5-norm .
concept:therapeutic-goods-act-1989-sec-26bd-ss-5-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bd-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-26bd-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-26bd-ss-5-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-26bd-ss-5-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Must provide written notice" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26bd-ss-6 a cml:Concept ;
skos:prefLabel "26BD(6) Requirements relating to an application for variation of a"@en ;
cml:realizedBy doc:sec-26bd-ss-6 ;
cml:integrityHash "4af6faddd57aa78b39caea73786da008c49bf5ffaa54393fc7e99ac75bbd5e1f" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bd ;
skos:note "Refuse application if not passed preliminary assessment." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.182" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26bd-ss-6-norm .
concept:therapeutic-goods-act-1989-sec-26bd-ss-6-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bd-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-26bd-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-26bd-ss-6-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-26bd-ss-6-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibition" ;
cml:premiseText "Application not passed preliminary assessment." ;
cml:conclusionText "Refuse application." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26bd-ss-7 a cml:Concept ;
skos:prefLabel "26BD(7) Requirements relating to an application for variation of a"@en ;
cml:realizedBy doc:sec-26bd-ss-7 ;
cml:integrityHash "75a11d8a79a2046b5b20f3257cf5a647f5c3879beafc817725217589c37e01d7" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bd ;
skos:note "Specify software requirements for an application or information" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.182" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26bd-ss-7-norm .
concept:therapeutic-goods-act-1989-sec-26bd-ss-7-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bd-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-26bd-ss-7 cml:asserts concept:therapeutic-goods-act-1989-sec-26bd-ss-7-logic-descriptionlogic-1 .
concept:therapeutic-goods-act-1989-sec-26bd-ss-7-logic-descriptionlogic-1 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "requires" ;
cml:logicSummary "Requires specified software requirements" ;
cml:premiseText "(7) An approval of a form mentioned in paragraph (3)(a)" ;
cml:conclusionText "may require or permit an application or information to be given in accordance with specified software requirements" ;
cml:executionSurface "modalities::dl" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26bd-ss-8 a cml:Concept ;
skos:prefLabel "26BD(8) Requirements relating to an application for variation of a"@en ;
cml:realizedBy doc:sec-26bd-ss-8 ;
cml:integrityHash "203c97d1ed94269c5f3ff77b062e0ad8fc31958c0029b0819328247ba2d7c696" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bd ;
skos:note "The Secretary may determine a kind of information for the purposes of subparagraph (3)(e)(i)." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.182" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26bd-ss-8-norm .
concept:therapeutic-goods-act-1989-sec-26bd-ss-8-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bd-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-26bd-ss-9 a cml:Concept ;
skos:prefLabel "26BD(9) Requirements relating to an application for variation of a"@en ;
cml:realizedBy doc:sec-26bd-ss-9 ;
cml:integrityHash "ac3e3500ed495d6adcf72e74f38f7a60de5690ffeb14ebf85d01088b6565ee37" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bd ;
skos:note "Application lapse due to inaccurate or misleading information" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.182" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26bd-ss-9-norm .
concept:therapeutic-goods-act-1989-sec-26bd-ss-9-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bd-ss-9 ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26bd-ss-9 cml:asserts concept:therapeutic-goods-act-1989-sec-26bd-ss-9-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-26bd-ss-9-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibition of application lapse due to inaccurate or misleading information" ;
cml:premiseText "(9) The Secretary may, by legislative instrument, determine a form of information for the purposes of subparagraph (3)(e)(ii)." ;
cml:conclusionText "If an application made under subsection 26BD(1) has passed preliminary assessment, the application lapses if: (a) the application contains information that is inaccurate or misleading in a material particular; or (b) information given to the Secretary by, or on behalf of, the applicant in connection with the application is inaccurate or misleading in a material particular; or (c) the evaluation fee prescribed for the purposes of paragraph 26BE(3)(b) has not been paid before the end of the period worked out in accordance with the regulations." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26be a cml:Concept ;
skos:prefLabel "26BE Evaluation of whether to make recommendation for variation"@en ;
cml:realizedBy doc:sec-26be ;
cml:integrityHash "4be8d46dc3eea9a5b5b56bbde3f96fdb7a4c62395b4739bc204ea641a27e685e" ;
skos:note "Evaluation of whether to make recommendation for variation of a section 26BB determination" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.183" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26be-norm .
concept:therapeutic-goods-act-1989-sec-26be-norm a values:Undertaking ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26be ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26be cml:asserts concept:therapeutic-goods-act-1989-sec-26be-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-26be-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Applicable" ;
cml:logicSummary "Classifies the legal effect as Undertaking" ;
cml:premiseText "No obligation, prohibition, permission, or right explicitly stated" ;
cml:conclusionText "Undertaking" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26bf a cml:Concept ;
skos:prefLabel "26BF Permissible indications"@en ;
cml:realizedBy doc:sec-26bf ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26bf-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26bf-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26bf-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26bf-ss-4 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26bf-ss-5 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26bf-ss-6 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.186" .
concept:therapeutic-goods-act-1989-sec-26bf-ss-1 a cml:Concept ;
skos:prefLabel "26BF(1) Permissible indications"@en ;
cml:realizedBy doc:sec-26bf-ss-1 ;
cml:integrityHash "7eff2b77f392683d67fc42274a51be6d338b76471e590121f0f0c2d3573782a4" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bf ;
skos:note "The Minister may make a determination in relation to indications." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.186" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26bf-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-26bf-ss-1-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bf-ss-1 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26bf-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-26bf-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-26bf-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "may" ;
cml:logicSummary "Permission to make a determination" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26bf-ss-2 a cml:Concept ;
skos:prefLabel "26BF(2) Permissible indications"@en ;
cml:realizedBy doc:sec-26bf-ss-2 ;
cml:integrityHash "9c2e6715f958e751000f9ebe6f459a5525c44b6c49a03c73db2e96a5849dcc66" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bf ;
skos:note "The Minister may consider therapeutic uses of a substance when making a determination." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.186" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26bf-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-26bf-ss-2-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bf-ss-2 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26bf-ss-3 a cml:Concept ;
skos:prefLabel "26BF(3) Permissible indications"@en ;
cml:realizedBy doc:sec-26bf-ss-3 ;
cml:integrityHash "327dd4082c69aff601db35b25cc8ca4c1e0cd37105d2db593fa78663cdaacd6f" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bf ;
skos:note "The Minister may have regard in deciding whether to make a determination under subsection (1) in relation to a particular indication." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.186" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26bf-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-26bf-ss-3-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bf-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-26bf-ss-4 a cml:Concept ;
skos:prefLabel "26BF(4) Permissible indications"@en ;
cml:realizedBy doc:sec-26bf-ss-4 ;
cml:integrityHash "c7779374c793053dbffa3d62f0f8ea4ab7b43519194b92a777d6f4cda3312988" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bf ;
skos:note "Permits use of particular indications in specified circumstances or under certain conditions." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.186" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26bf-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-26bf-ss-4-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bf-ss-4 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26bf-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-26bf-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-26bf-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "permittedBy" ;
cml:logicSummary "Specifies the permitted use of particular indications." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26bf-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-26bf-ss-4-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-26bf-ss-4-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "during" ;
cml:logicSummary "Describes the temporal relationship between the use of indications and specified circumstances or conditions." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26bf-ss-5 a cml:Concept ;
skos:prefLabel "26BF(5) Permissible indications"@en ;
cml:realizedBy doc:sec-26bf-ss-5 ;
cml:integrityHash "633729ca32b6b1bf9b86a2a76d6dfa2ae7de9b53fb8c054f35ae2e8ff62242a7" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bf ;
skos:note "Permits different classes of medicines to have varying determinations." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.186" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26bf-ss-5-norm .
concept:therapeutic-goods-act-1989-sec-26bf-ss-5-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bf-ss-5 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26bf-ss-6 a cml:Concept ;
skos:prefLabel "26BF(6) Permissible indications"@en ;
cml:realizedBy doc:sec-26bf-ss-6 ;
cml:integrityHash "d19355e47e9764bec9ee3e6e7aa48788613f60a8905b0e811e1e0fd852061fad" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bf ;
skos:note "Allows for incorporation of existing instruments or writings with modifications." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.186" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26bf-ss-6-norm .
concept:therapeutic-goods-act-1989-sec-26bf-ss-6-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bf-ss-6 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26bf-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-26bf-ss-6-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-26bf-ss-6-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "permitted" ;
cml:logicSummary "Permits modification of incorporated matter" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26bg a cml:Concept ;
skos:prefLabel "26BG Limitations on determination under section 26BF"@en ;
cml:realizedBy doc:sec-26bg ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26bg-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26bg-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26bg-ss-3 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.187" .
concept:therapeutic-goods-act-1989-sec-26bg-ss-1 a cml:Concept ;
skos:prefLabel "26BG(1) Limitations on determination under section 26BF"@en ;
cml:realizedBy doc:sec-26bg-ss-1 ;
cml:integrityHash "cf8a7a4a80269ac1742af096ad71343c0543721a6e38ed5195de68ade5419462" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bg ;
skos:note "Minister may make a determination specifying indications that must not be covered by a determination under section 26BF(1)(a)." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.187" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26bg-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-26bg-ss-1-norm a values:Undertaking ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bg-ss-1 ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26bg-ss-2 a cml:Concept ;
skos:prefLabel "26BG(2) Limitations on determination under section 26BF"@en ;
cml:realizedBy doc:sec-26bg-ss-2 ;
cml:integrityHash "358a95c4c8f2b513d6037e4ba8c5ebc57dc1e0a807a182ad7f9c52f9603e370c" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bg ;
skos:note "The determination may specify an indication either generally or in relation to specified circumstances." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.187" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26bg-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-26bg-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bg-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-26bg-ss-3 a cml:Concept ;
skos:prefLabel "26BG(3) Limitations on determination under section 26BF"@en ;
cml:realizedBy doc:sec-26bg-ss-3 ;
cml:integrityHash "0c947be8ae6ab2447fe1e4fb5c80854f82cf4d310cdac2cf53a38f316135f6ae" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bg ;
skos:note "Minister may vary or revoke determination under subsection (1)" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.187" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26bg-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-26bg-ss-3-norm a values:Undertaking ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bg-ss-3 ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26bg-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-26bg-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-26bg-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "May" ;
cml:logicSummary "Permission to vary or revoke" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26bh a cml:Concept ;
skos:prefLabel "26BH Variation of determination under section 26BF—Minister’s"@en ;
cml:realizedBy doc:sec-26bh ;
cml:integrityHash "ae6d1a8efc50b19ca236485d16087bfb9ab4aa67faea141c63a0aa0ca4bf5abb" ;
skos:note "Minister may vary determination under section 26BF on own initiative." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.187" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26bh-norm .
concept:therapeutic-goods-act-1989-sec-26bh-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bh ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26bh cml:asserts concept:therapeutic-goods-act-1989-sec-26bh-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-26bh-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "may" ;
cml:logicSummary "Expresses permission or obligation." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26bj a cml:Concept ;
skos:prefLabel "26BJ Variation of determination under section 26BF—application"@en ;
cml:realizedBy doc:sec-26bj ;
cml:integrityHash "083a12edc12ec8f343425200158471c55facfef6bea0775f80f1422db91eb7c3" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26bj-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26bj-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26bj-ss-3 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.188" .
concept:therapeutic-goods-act-1989-sec-26bj-ss-1 a cml:Concept ;
skos:prefLabel "26BJ(1) Variation of determination under section 26BF—application"@en ;
cml:realizedBy doc:sec-26bj-ss-1 ;
cml:integrityHash "e6c5ce48a6ed40e23edb2993d189961dd03583ffebb15835d5a48a533f11803f" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bj ;
skos:note "A person may apply for a recommendation to vary a determination under section 26BF." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.188" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26bj-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-26bj-ss-1-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bj-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-26bj-ss-2 a cml:Concept ;
skos:prefLabel "26BJ(2) Variation of determination under section 26BF—application"@en ;
cml:realizedBy doc:sec-26bj-ss-2 ;
cml:integrityHash "5fb9645a59ea8dbb365dcb95ab1c84ebda22167cd4ae10e048ddada157e9ff57" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bj ;
skos:note "Application requirements for variation of determination under section 26BF" ;
dc:description "Form, application fee (if any), recommendation sought" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.188" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26bj-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-26bj-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bj-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-26bj-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-26bj-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-26bj-ss-2-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-26bj-ss-3 a cml:Concept ;
skos:prefLabel "26BJ(3) Variation of determination under section 26BF—application"@en ;
cml:realizedBy doc:sec-26bj-ss-3 ;
cml:integrityHash "32e582816daf7b7eec9abd7f4e546ad7156c991113057ddaf9a387ef7f5630ce" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bj ;
skos:note "Cannot make an application for a recommendation that would affect certain types of indications." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.188" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26bj-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-26bj-ss-3-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26bj-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-26bj-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-26bj-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-26bj-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibition on making an application for a recommendation that would affect certain types of indications." ;
cml:premiseText "(3) A person cannot make an application under subsection (1)" ;
cml:conclusionText "for the effect of which would be for the determination to cover any of the following:" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26c a cml:Concept ;
skos:prefLabel "26C Certificates required in relation to patent infringement"@en ;
cml:realizedBy doc:sec-26c ;
cml:integrityHash "f99c1f9de7186d02a99b51c9f669796df1494134a4005827ae9ab9c68b6630f6" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26c-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26c-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26c-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26c-ss-4 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.191" .
concept:therapeutic-goods-act-1989-sec-26c-ss-1 a cml:Concept ;
skos:prefLabel "26C(1) Certificates required in relation to patent infringement"@en ;
cml:realizedBy doc:sec-26c-ss-1 ;
cml:integrityHash "4df6de79faf9f73f8dd5ba0ad8c86c72b9d3847150376d0c0e88924e0c1b81e5" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26c ;
skos:note "Certificate required for therapeutic goods patent infringement proceedings" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.191" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26c-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-26c-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26c-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-26c-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-26c-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-26c-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "requires" ;
cml:logicSummary "Requires certificate for patent infringement proceedings" ;
cml:premiseText "(1) This section applies if: (a) a person gives a certificate required under subsection 26B(1) in relation to therapeutic goods; and (b) another person (the second person) intends to commence proceedings under the Patents Act 1990 against the person referred to in paragraph (1)(a) for infringement of a patent that has been granted in relation to the therapeutic goods (the proceedings)." ;
cml:conclusionText "(1) This section applies if: (a) a person gives a certificate required under subsection 26B(1) in relation to therapeutic goods; and (b) another person (the second person) intends to commence proceedings under the Patents Act 1990 against the person referred to in paragraph (1)(a) for infringement of a patent that has been granted in relation to the therapeutic goods (the proceedings)." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26c-ss-2 a cml:Concept ;
skos:prefLabel "26C(2) Certificates required in relation to patent infringement"@en ;
cml:realizedBy doc:sec-26c-ss-2 ;
cml:integrityHash "0718d97cd83999db20929ad35f3c1720ec8e0eb7f3be6dca718b5c25f19a3191" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26c ;
skos:note "Second person must provide certificate before commencement of proceedings." ;
dc:description "true" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.191" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26c-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-26c-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26c-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-26c-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-26c-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-26c-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Must provide certificate" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26c-ss-3 a cml:Concept ;
skos:prefLabel "26C(3) Certificates required in relation to patent infringement"@en ;
cml:realizedBy doc:sec-26c-ss-3 ;
cml:integrityHash "a8efc7800acff85e6e8526ecc0471e74ac6a5beae8db86b39daded0aef1be30f" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26c ;
skos:note "Certificate must be signed in good faith, with reasonable prospects of success, and without unreasonable delay." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.191" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26c-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-26c-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26c-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-26c-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-26c-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-26c-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Obligation to sign certificate in good faith, with reasonable prospects of success, and without unreasonable delay." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26c-ss-4 a cml:Concept ;
skos:prefLabel "26C(4) Certificates required in relation to patent infringement"@en ;
cml:realizedBy doc:sec-26c-ss-4 ;
cml:integrityHash "3fdd302be19ff048790ef4e14bde03c71525035c2b60ae2298589306dc58f287" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26c ;
skos:note "Second person must have reasonable grounds for proceedings to have a chance of success" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.191" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26c-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-26c-ss-4-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26c-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-26c-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-26c-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-26c-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Second person must have reasonable grounds" ;
cml:premiseText "Reasonable prospects of success" ;
cml:conclusionText "Second person has a duty to investigate" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26c-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-26c-ss-4-logic-epistemic-2 .
concept:therapeutic-goods-act-1989-sec-26c-ss-4-logic-epistemic-2 a cml:LogicApplication ;
cml:modality cml:Epistemic ;
cml:operator "Possibility" ;
cml:logicSummary "Second person must know the circumstances" ;
cml:premiseText "Circumstances known to the second person" ;
cml:conclusionText "Second person has knowledge of circumstances" ;
cml:executionSurface "modalities::epistemic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26d a cml:Concept ;
skos:prefLabel "26D Requirements for interlocutory injunction"@en ;
cml:realizedBy doc:sec-26d ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26d-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-26d-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.193" .
concept:therapeutic-goods-act-1989-sec-26d-ss-1 a cml:Concept ;
skos:prefLabel "26D(1) Requirements for interlocutory injunction"@en ;
cml:realizedBy doc:sec-26d-ss-1 ;
cml:integrityHash "ca9f7c82eda87c0bfbe75e90bdcc67c4a61fc47e4c961938bbac033642df912f" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26d ;
skos:note "Notice to patentee required before applying for interlocutory injunction." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.193" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26d-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-26d-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26d-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-26d-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-26d-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-26d-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Requires" ;
cml:logicSummary "Notice is a requirement." ;
cml:premiseText "Application for interlocutory injunction." ;
cml:conclusionText "Patentee must be notified." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-26d-ss-2 a cml:Concept ;
skos:prefLabel "26D(2) Requirements for interlocutory injunction"@en ;
cml:realizedBy doc:sec-26d-ss-2 ;
cml:integrityHash "d1ab0007d75009ce24c298cb4ab482344771156203706773bc0fd2934fb3ce7e" ;
values:partOf concept:therapeutic-goods-act-1989-sec-26d ;
skos:note "No application for interlocutory relief can be instituted without prior notification to the Attorney-General." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.193" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-26d-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-26d-ss-2-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-26d-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-26d-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-26d-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-26d-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibition of instituting an application without prior notification." ;
cml:premiseText "The patentee must notify the Attorney-General before applying for interlocutory relief." ;
cml:conclusionText "No application can be instituted without prior notification." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-27 a cml:Concept ;
skos:prefLabel "27 Registration or listing number"@en ;
cml:realizedBy doc:sec-27 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-27-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-27-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.195" .
concept:therapeutic-goods-act-1989-sec-27-ss-1 a cml:Concept ;
skos:prefLabel "27(1) Registration or listing number"@en ;
cml:realizedBy doc:sec-27-ss-1 ;
cml:integrityHash "db768849f074aa0a2828d48279455d60839b46e4a9c8fd2ccf08837ce1a1b2a7" ;
values:partOf concept:therapeutic-goods-act-1989-sec-27 ;
skos:note "Secretary must assign a unique registration or listing number to therapeutic goods included in the Register." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.195" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-27-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-27-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-27-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-27-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-27-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-27-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-27-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-27-ss-1-logic-descriptionlogic-2 .
concept:therapeutic-goods-act-1989-sec-27-ss-1-logic-descriptionlogic-2 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "CLASSIFICATION" ;
cml:logicSummary "Classification of therapeutic goods" ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-27-ss-2 a cml:Concept ;
skos:prefLabel "27(2) Registration or listing number"@en ;
cml:realizedBy doc:sec-27-ss-2 ;
cml:integrityHash "f91e1a408a10181c956fc5c519a6556ad0dffd7b29f009cce56db015bc7b6ec4" ;
values:partOf concept:therapeutic-goods-act-1989-sec-27 ;
skos:note "Secretary must assign a unique registration or listing number to grouped therapeutic goods." ;
dc:description "Registration or listing number" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.195" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-27-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-27-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-27-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-27-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-27-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-27-ss-2-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-27-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-27-ss-2-logic-descriptionlogic-2 .
concept:therapeutic-goods-act-1989-sec-27-ss-2-logic-descriptionlogic-2 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "CLASSIFICATION" ;
cml:logicSummary "Classification of grouped therapeutic goods" ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-28 a cml:Concept ;
skos:prefLabel "28 Conditions of registration or listing"@en ;
cml:realizedBy doc:sec-28 ;
cml:integrityHash "66608fdbbc94f9ee48ed49abe82a4da01de111b29cc23d64e6ddab2fa3a13d47" ;
skos:note "Conditions for registration or listing of therapeutic goods" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.195" ;
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-28a a cml:Concept ;
skos:prefLabel "28A Certification of manufacturing steps outside Australia following"@en ;
cml:realizedBy doc:sec-28a ;
cml:integrityHash "fd495c787aca056546d56e043ceeb42ae077d3498c3eca4ed8cb4cac45ee5589" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-28a-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-28a-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-28a-ss-3 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.201" .
concept:therapeutic-goods-act-1989-sec-28a-ss-1 a cml:Concept ;
skos:prefLabel "28A(1) Certification of manufacturing steps outside Australia following"@en ;
cml:realizedBy doc:sec-28a-ss-1 ;
cml:integrityHash "0f921068e0c20fc906333d62e7d3474808ccf870ee565c97887cefc0453c0e66" ;
values:partOf concept:therapeutic-goods-act-1989-sec-28a ;
skos:note "Certification required for manufacture of medicine outside Australia" ;
dc:description "Step in manufacture of medicine to be carried out outside Australia" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.201" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-28a-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-28a-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-28a-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-28a-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-28a-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-28a-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Obligation to provide certification" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-28a-ss-2 a cml:Concept ;
skos:prefLabel "28A(2) Certification of manufacturing steps outside Australia following"@en ;
cml:realizedBy doc:sec-28a-ss-2 ;
cml:integrityHash "c40ca69ba68dc6d1acb628395d5b4a6c34c19231ff493bebb89e7487c8768289" ;
values:partOf concept:therapeutic-goods-act-1989-sec-28a ;
skos:note "Secretary must give written notice of certification." ;
dc:description "written notice" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.201" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-28a-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-28a-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-28a-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-28a-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-28a-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-28a-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Must provide written notice." ;
cml:conclusionText "The Secretary must give the person written notice of the certification." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-28a-ss-3 a cml:Concept ;
skos:prefLabel "28A(3) Certification of manufacturing steps outside Australia following"@en ;
cml:realizedBy doc:sec-28a-ss-3 ;
cml:integrityHash "fd3e9539d9da12836ef942494f0b87df0739534b2f39123d784dec1c86f1db43" ;
values:partOf concept:therapeutic-goods-act-1989-sec-28a ;
skos:note "Certification requirement for manufacturing steps outside Australia" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.201" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-28a-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-28a-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-28a-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-28a-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-28a-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-28a-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Certification is required" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-29 a cml:Concept ;
skos:prefLabel "29 Duration of registration or listing"@en ;
cml:realizedBy doc:sec-29 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-29-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-29-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-29-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-29-ss-3a ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-29-ss-4 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-29-ss-5 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.202" .
concept:therapeutic-goods-act-1989-sec-29-ss-1 a cml:Concept ;
skos:prefLabel "29(1) Duration of registration or listing"@en ;
cml:realizedBy doc:sec-29-ss-1 ;
cml:integrityHash "8287395b6a5825496bceb82e8d2b62ad7a0e897875f0b14ff2e18f1473cc11bf" ;
values:partOf concept:therapeutic-goods-act-1989-sec-29 ;
skos:note "Goods remain in the Register until registration or listing is cancelled." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.202" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-29-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-29-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-29-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-29-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-29-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-29-ss-1-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-29-ss-2 a cml:Concept ;
skos:prefLabel "29(2) Duration of registration or listing"@en ;
cml:realizedBy doc:sec-29-ss-2 ;
cml:integrityHash "bf10e9e5a0ae6265b6df1f851103b819014fde4c19142e23630452a02112435c" ;
values:partOf concept:therapeutic-goods-act-1989-sec-29 ;
skos:note "Medicine provisional registration period" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.202" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-29-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-29-ss-2-norm a values:Undertaking ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-29-ss-2 ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-29-ss-3 a cml:Concept ;
skos:prefLabel "29(3) Duration of registration or listing"@en ;
cml:realizedBy doc:sec-29-ss-3 ;
cml:integrityHash "b35f241a759e4f4093406d84cc6b3a78fa51e60f6eaca234489d1da9eb441745" ;
values:partOf concept:therapeutic-goods-act-1989-sec-29 ;
skos:note "Defines provisional registration period for medicines" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.202" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-29-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-29-ss-3-norm a values:Undertaking ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-29-ss-3 ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-29-ss-3a a cml:Concept ;
skos:prefLabel "29(3A) Duration of registration or listing"@en ;
cml:realizedBy doc:sec-29-ss-3a ;
cml:integrityHash "92beafd442b62c52a761527ff9bd7f5ded74102583818ae92c2e83e582c74ad4" ;
values:partOf concept:therapeutic-goods-act-1989-sec-29 ;
skos:note "Defines provisional registration period for a new medicine" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.202" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-29-ss-3a-norm .
concept:therapeutic-goods-act-1989-sec-29-ss-3a-norm a values:Undertaking ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-29-ss-3a ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-29-ss-3a cml:asserts concept:therapeutic-goods-act-1989-sec-29-ss-3a-logic-alleninterval-1 .
concept:therapeutic-goods-act-1989-sec-29-ss-3a-logic-alleninterval-1 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "⊆" ;
cml:logicSummary "Defines a temporal interval for the provisional registration period" ;
cml:premiseText "(3A) Subject to this section, the provisional registration period..." ;
cml:conclusionText "The original period" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-29-ss-4 a cml:Concept ;
skos:prefLabel "29(4) Duration of registration or listing"@en ;
cml:realizedBy doc:sec-29-ss-4 ;
cml:integrityHash "fcff9bd55c8a4a785bc69f0bebfbcddf437b89af3bd3b41d85d9bba9c51fea23" ;
values:partOf concept:therapeutic-goods-act-1989-sec-29 ;
skos:note "Application for extension of provisional registration period" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.202" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-29-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-29-ss-4-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-29-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-29-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-29-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-29-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MAY" ;
cml:logicSummary "May apply" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-29-ss-5 a cml:Concept ;
skos:prefLabel "29(5) Duration of registration or listing"@en ;
cml:realizedBy doc:sec-29-ss-5 ;
cml:integrityHash "0b6eb52cddbaae195bd9e85bce5904e07721897b98080eac127e0e9a329530f0" ;
values:partOf concept:therapeutic-goods-act-1989-sec-29 ;
skos:note "Application must be in a specific form and contain required information." ;
dc:description "The application must be in a form approved by the Secretary and contain all required information." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.202" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-29-ss-5-norm .
concept:therapeutic-goods-act-1989-sec-29-ss-5-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-29-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-29-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-29-ss-5-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-29-ss-5-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Application must meet specific requirements." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-29a a cml:Concept ;
skos:prefLabel "29A Criminal offence for failing to notify adverse effects etc. of"@en ;
cml:realizedBy doc:sec-29a ;
cml:integrityHash "089857f9c407941715faed7f7321a5534f6f825b0d2c074d86e62ffe95071d76" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-29a-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-29a-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.206" .
concept:therapeutic-goods-act-1989-sec-29a-ss-1 a cml:Concept ;
skos:prefLabel "29A(1) Criminal offence for failing to notify adverse effects etc. of"@en ;
cml:realizedBy doc:sec-29a-ss-1 ;
cml:integrityHash "93646423d42b264996701ca0cc9181a2d819065ab88639e5d0e66cca40e9c0ec" ;
values:partOf concept:therapeutic-goods-act-1989-sec-29a ;
skos:note "Notify adverse effects of therapeutic goods to the Secretary." ;
dc:description "Information of a kind mentioned in subsection (2)" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.206" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-29a-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-29a-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-29a-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-29a-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-29a-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-29a-ss-1-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-29a-ss-2 a cml:Concept ;
skos:prefLabel "29A(2) Criminal offence for failing to notify adverse effects etc. of"@en ;
cml:realizedBy doc:sec-29a-ss-2 ;
cml:integrityHash "abc9f684f0006313e6699e947e5181a291c583244611539e91c9278e1b3e311b" ;
values:partOf concept:therapeutic-goods-act-1989-sec-29a ;
skos:note "Failing to notify adverse effects of goods may be a criminal offence." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.206" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-29a-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-29a-ss-2-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-29a-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-29a-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-29a-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-29a-ss-2-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-29aa a cml:Concept ;
skos:prefLabel "29AA Civil penalty for failing to notify adverse effects etc. of goods"@en ;
cml:realizedBy doc:sec-29aa ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-29aa-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-29aa-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.207" .
concept:therapeutic-goods-act-1989-sec-29aa-ss-1 a cml:Concept ;
skos:prefLabel "29AA(1) Civil penalty for failing to notify adverse effects etc. of goods"@en ;
cml:realizedBy doc:sec-29aa-ss-1 ;
cml:integrityHash "570100f7ee8bc5d4a57af0690f857b3da7e3cf809012340739fc96154eb748c7" ;
values:partOf concept:therapeutic-goods-act-1989-sec-29aa ;
skos:note "Failure to notify adverse effects of goods is prohibited." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.207" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-29aa-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-29aa-ss-1-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-29aa-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-29aa-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-29aa-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-29aa-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-29aa-ss-2 a cml:Concept ;
skos:prefLabel "29AA(2) Civil penalty for failing to notify adverse effects etc. of goods"@en ;
cml:realizedBy doc:sec-29aa-ss-2 ;
cml:integrityHash "52f2e2963cbf20d8ec7488cb535eda2b21a878c6eebfb017b0bd5a6c83d32631" ;
values:partOf concept:therapeutic-goods-act-1989-sec-29aa ;
skos:note "Failing to notify adverse effects of goods is a civil penalty." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.207" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-29aa-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-29aa-ss-2-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-29aa-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-29aa-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-29aa-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-29aa-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits failing to notify adverse effects of goods." ;
cml:premiseText "The person under this Act must provide information about adverse effects." ;
cml:conclusionText "Failing to do so is a civil penalty." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-29b a cml:Concept ;
skos:prefLabel "29B Notification of adverse effects etc. where application withdrawn"@en ;
cml:realizedBy doc:sec-29b ;
cml:integrityHash "2710565d187731f292c10ed89d60ea440515d5e3bd308eced61cf8ab126a2d78" ;
skos:note "Secretary must give applicant written notice requiring action upon withdrawal or lapse of application." ;
dc:description "written notice" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.207" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-29b-norm .
concept:therapeutic-goods-act-1989-sec-29b-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-29b ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-29b cml:asserts concept:therapeutic-goods-act-1989-sec-29b-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-29b-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Must provide written notice" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-29c a cml:Concept ;
skos:prefLabel "29C Civil penalties for failing to notify adverse effects etc. where"@en ;
cml:realizedBy doc:sec-29c ;
cml:integrityHash "26f7008a3e14c5f1b0690933aaf97973ebb7934e05f46482c7347b1adb2ee083" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-29c-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-29c-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.208" .
concept:therapeutic-goods-act-1989-sec-29c-ss-1 a cml:Concept ;
skos:prefLabel "29C(1) Civil penalties for failing to notify adverse effects etc. where"@en ;
cml:realizedBy doc:sec-29c-ss-1 ;
cml:integrityHash "5d2f03421854eb95932bca8b8a9745ad59d5b3584592c17b495b8748d0f99504" ;
values:partOf concept:therapeutic-goods-act-1989-sec-29c ;
skos:note "Failure to comply with notice requirements within 30 days" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.208" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-29c-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-29c-ss-1-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-29c-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-29c-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-29c-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-29c-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibition of non-compliance" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-29c-ss-2 a cml:Concept ;
skos:prefLabel "29C(2) Civil penalties for failing to notify adverse effects etc. where"@en ;
cml:realizedBy doc:sec-29c-ss-2 ;
cml:integrityHash "f6ef292cd31616c8905449b6efe4ea4289f5e9675cc4bed307eebbd347926ff5" ;
values:partOf concept:therapeutic-goods-act-1989-sec-29c ;
skos:note "False or misleading information in purported compliance with a notice" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.208" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-29c-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-29c-ss-2-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-29c-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-29c-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-29c-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-29c-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 "Subsection 29B(1) notice" ;
cml:conclusionText "Contravention of subsection (2)" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-29d a cml:Concept ;
skos:prefLabel "29D Suspension of registration or listing"@en ;
cml:realizedBy doc:sec-29d ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-29d-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-29d-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.209" .
concept:therapeutic-goods-act-1989-sec-29d-ss-1 a cml:Concept ;
skos:prefLabel "29D(1) Suspension of registration or listing"@en ;
cml:realizedBy doc:sec-29d-ss-1 ;
cml:integrityHash "7b74bacb80fba500bae21a8cc90a5ef8ad69d5186155d06bac11b95d9f749e8d" ;
values:partOf concept:therapeutic-goods-act-1989-sec-29d ;
skos:note "Suspension of registration or listing of therapeutic goods" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.209" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-29d-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-29d-ss-1-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-29d-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-29d-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-29d-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-29d-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibition on therapeutic goods registration or listing" ;
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-29d-ss-2 a cml:Concept ;
skos:prefLabel "29D(2) Suspension of registration or listing"@en ;
cml:realizedBy doc:sec-29d-ss-2 ;
cml:integrityHash "46cbd9488123908351a439511c1a95545723d5fca818cb88c11365866e5c0168" ;
values:partOf concept:therapeutic-goods-act-1989-sec-29d ;
skos:note "Secretary must inform person of proposed suspension and set out reasons." ;
dc:description "written notice, reasons for suspension" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.209" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-29d-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-29d-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-29d-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-29d-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-29d-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-29d-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Duty 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-29e a cml:Concept ;
skos:prefLabel "29E When suspension takes effect etc."@en ;
cml:realizedBy doc:sec-29e ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-29e-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-29e-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-29e-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-29e-ss-4 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.210" .
concept:therapeutic-goods-act-1989-sec-29e-ss-1 a cml:Concept ;
skos:prefLabel "29E(1) When suspension takes effect etc."@en ;
cml:realizedBy doc:sec-29e-ss-1 ;
cml:integrityHash "cba423e600d82e1f45b03d58012f254bff011358071708dde38319ee51448ec1" ;
values:partOf concept:therapeutic-goods-act-1989-sec-29e ;
skos:note "Suspension takes effect on specified day under certain conditions." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.210" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-29e-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-29e-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-29e-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-29e-ss-2 a cml:Concept ;
skos:prefLabel "29E(2) When suspension takes effect etc."@en ;
cml:realizedBy doc:sec-29e-ss-2 ;
cml:integrityHash "83d06539aa0a3c49b1f560b99af37efce17469cedc280413553841a535e98474" ;
values:partOf concept:therapeutic-goods-act-1989-sec-29e ;
skos:note "Suspension duration" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.210" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-29e-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-29e-ss-2-norm a values:Undertaking ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-29e-ss-2 ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-29e-ss-3 a cml:Concept ;
skos:prefLabel "29E(3) When suspension takes effect etc."@en ;
cml:realizedBy doc:sec-29e-ss-3 ;
cml:integrityHash "c9dbaddeef8d6eb7a6e1a20e9488e5a857b99a4b0ca63e010f2e2b699c2c3262" ;
values:partOf concept:therapeutic-goods-act-1989-sec-29e ;
skos:note "Secretary may extend period specified in notice under subsection 29D(4) by a further specified period not exceeding 6 months." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.210" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-29e-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-29e-ss-3-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-29e-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-29e-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-29e-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-29e-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "May" ;
cml:logicSummary "Permission to extend period" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-29e-ss-4 a cml:Concept ;
skos:prefLabel "29E(4) When suspension takes effect etc."@en ;
cml:realizedBy doc:sec-29e-ss-4 ;
cml:integrityHash "d91547cb39b8cbb3d58b5a732d2affffb9f911813a926990a52ac66e539d57e6" ;
values:partOf concept:therapeutic-goods-act-1989-sec-29e ;
skos:note "Publish notice of extension particulars" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.210" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-29e-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-29e-ss-4-norm a values:Undertaking ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-29e-ss-4 ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-29f a cml:Concept ;
skos:prefLabel "29F Revocation of suspension"@en ;
cml:realizedBy doc:sec-29f ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-29f-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-29f-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-29f-ss-3 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.211" .
concept:therapeutic-goods-act-1989-sec-29f-ss-1 a cml:Concept ;
skos:prefLabel "29F(1) Revocation of suspension"@en ;
cml:realizedBy doc:sec-29f-ss-1 ;
cml:integrityHash "625a62824dfbab0eba69eed7192c2630727b6b1fec410aadcfd690313d091aa1" ;
values:partOf concept:therapeutic-goods-act-1989-sec-29f ;
skos:note "Secretary must revoke suspension upon certain conditions." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.211" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-29f-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-29f-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-29f-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-29f-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-29f-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-29f-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Obligation to revoke suspension" ;
cml:premiseText "(1) The Secretary must..." ;
cml:conclusionText "...revocation of suspension under section 29D" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-29f-ss-2 a cml:Concept ;
skos:prefLabel "29F(2) Revocation of suspension"@en ;
cml:realizedBy doc:sec-29f-ss-2 ;
cml:integrityHash "4d6e54f170f95c6da10d96f9de6fc1bae0d626ab2fef65424b69122ad6ea278d" ;
values:partOf concept:therapeutic-goods-act-1989-sec-29f ;
skos:note "Secretary's power to revoke suspension may be exercised" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.211" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-29f-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-29f-ss-2-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-29f-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-29f-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-29f-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-29f-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "may" ;
cml:logicSummary "Permission granted by Secretary" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-29f-ss-3 a cml:Concept ;
skos:prefLabel "29F(3) Revocation of suspension"@en ;
cml:realizedBy doc:sec-29f-ss-3 ;
cml:integrityHash "9dd33d88f45a6cb8d03d1adc13b339fdc9babc9b6f33b2e6507a32f794529e00" ;
values:partOf concept:therapeutic-goods-act-1989-sec-29f ;
skos:note "Publish notice of revocation within a specified timeframe." ;
dc:description "Notice setting out particulars of the revocation" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.211" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-29f-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-29f-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-29f-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-29f-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-29f-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-29f-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Duty to publish notice" ;
cml:conclusionText "The Secretary must cause to be published..." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-29g a cml:Concept ;
skos:prefLabel "29G Effect of suspension"@en ;
cml:realizedBy doc:sec-29g ;
cml:integrityHash "19687dbf3cf6f1062248d965b09d18c5d743e786c2bff4af60c96a3328943ff2" ;
skos:note "Therapeutic goods not included in Register during suspension." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.212" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-29g-norm .
concept:therapeutic-goods-act-1989-sec-29g-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-29g ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-29g cml:asserts concept:therapeutic-goods-act-1989-sec-29g-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-29g-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits dealing with suspended goods." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30 a cml:Concept ;
skos:prefLabel "30 Cancellation of registration or listing"@en ;
cml:realizedBy doc:sec-30 ;
cml:integrityHash "4e72502e6fb9343ecefe28b8caf513a45b082c92ff54bc6b276ea90bdb69186d" ;
skos:note "Cancellation of registration or listing of therapeutic goods under certain conditions." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.212" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30-norm .
concept:therapeutic-goods-act-1989-sec-30-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30 ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
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-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator ">" ;
cml:logicSummary "Risk assessment for cancellation" ;
cml:premiseText "it appears to the Secretary that failure to cancel the registration or listing would create an imminent risk of death..." ;
cml:conclusionText "the person requests in writing the cancellation of the registration or listing" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30 cml:asserts concept:therapeutic-goods-act-1989-sec-30-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-30-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "<" ;
cml:logicSummary "Timeframe for record availability" ;
cml:premiseText "if the person was requested under that paragraph to make the record in question available at or before a requested time—before the end of the period of 24 hours after that time;" ;
cml:conclusionText "within 24 hours after the request was made" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^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 "=" ;
cml:logicSummary "Certification requirements for medicines" ;
cml:premiseText "in the case of a medicine listed under section 26A, it appears to the Secretary that any of the certifications under paragraph 26A(2)(a), (ca), (cb), (e), (fba), (fd), (fe) or (g) are incorrect or..." ;
cml:conclusionText "the requirements under subsection 26A(3) or (4A) are not fulfilled" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30 cml:asserts concept:therapeutic-goods-act-1989-sec-30-logic-deontic-4 .
concept:therapeutic-goods-act-1989-sec-30-logic-deontic-4 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "=" ;
cml:logicSummary "Advertising regulations" ;
cml:premiseText "there is a breach, involving the goods, of an applicable provision of the Therapeutic Goods Advertising Code or any other requirement relating to advertising applicable under" ;
cml:conclusionText "the Secretary is satisfied that the contravention is significant" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30a a cml:Concept ;
skos:prefLabel "30A Revocation of cancellation of registration or listing upon"@en ;
cml:realizedBy doc:sec-30a ;
cml:integrityHash "1f58b9145b24d108d7ac38887338b3ea3229833b9c1e418250343f907bfd1047" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30a-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30a-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.218" .
concept:therapeutic-goods-act-1989-sec-30a-ss-1 a cml:Concept ;
skos:prefLabel "30A(1) Revocation of cancellation of registration or listing upon"@en ;
cml:realizedBy doc:sec-30a-ss-1 ;
cml:integrityHash "9415c9481d005faa05b017cb71ee6c4770af06641187d127ed223dd41881753a" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30a ;
skos:note "Secretary may revoke cancellation upon request and payment of fee." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.218" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30a-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-30a-ss-1-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30a-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-30a-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-30a-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30a-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "May" ;
cml:logicSummary "Permits Secretary to revoke cancellation." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30a-ss-2 a cml:Concept ;
skos:prefLabel "30A(2) Revocation of cancellation of registration or listing upon"@en ;
cml:realizedBy doc:sec-30a-ss-2 ;
cml:integrityHash "50d87d298ae1a68ff51ca0ac5bcb60d83c6b4f5f49779a13a62cfec134a353b1" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30a ;
skos:note "Cancellation is taken never to have occurred upon revocation." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.218" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30a-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-30a-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30a-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-30a-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-30a-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30a-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Implies" ;
cml:logicSummary "If cancellation is revoked, then it is never taken to have occurred." ;
cml:premiseText "Cancellation is revoked." ;
cml:conclusionText "Cancellation is taken never to have occurred." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30aa a cml:Concept ;
skos:prefLabel "30AA Revocation of cancellation of registration or listing—payment"@en ;
cml:realizedBy doc:sec-30aa ;
cml:integrityHash "0e6b489dd51eb00a9693aac35d8d430ea01aacd680fdec31cb9aa822bacb1ce7" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30aa-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30aa-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.218" .
concept:therapeutic-goods-act-1989-sec-30aa-ss-1 a cml:Concept ;
skos:prefLabel "30AA(1) Revocation of cancellation of registration or listing—payment"@en ;
cml:realizedBy doc:sec-30aa-ss-1 ;
cml:integrityHash "aa30612e6b2aa57ffa3636fc3d692223d32d80ada135b2cf4f4f142b8398397e" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30aa ;
skos:note "Secretary may revoke cancellation of registration or listing under certain conditions." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.218" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30aa-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-30aa-ss-1-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30aa-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-30aa-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-30aa-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30aa-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "may" ;
cml:logicSummary "Permission to revoke cancellation" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30aa-ss-2 a cml:Concept ;
skos:prefLabel "30AA(2) Revocation of cancellation of registration or listing—payment"@en ;
cml:realizedBy doc:sec-30aa-ss-2 ;
cml:integrityHash "b1611a3c24d0d13560943610afc0164bb00527499bc6d6823ba3d4c9f02febaa" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30aa ;
skos:note "If cancellation is revoked, it is taken never to have occurred." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.218" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30aa-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-30aa-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30aa-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-30aa-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-30aa-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30aa-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Implies" ;
cml:logicSummary "If A, then B." ;
cml:premiseText "Cancellation is revoked." ;
cml:conclusionText "It is taken never to have occurred." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30aa-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-30aa-ss-2-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-30aa-ss-2-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Overlaps" ;
cml:logicSummary "Temporal interval overlap." ;
cml:premiseText "Cancellation is revoked." ;
cml:conclusionText "It is taken never to have occurred." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30b a cml:Concept ;
skos:prefLabel "30B Publication of cancellation of registration or listing"@en ;
cml:realizedBy doc:sec-30b ;
cml:integrityHash "da3c41bf8618cf831752cc7369f69e9a7718aa59c156fc5d028d8208542e4530" ;
skos:note "Secretary must publish notice after cancellation of registration or listing." ;
dc:description "Notice setting out particulars of the cancellation." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.219" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30b-norm .
concept:therapeutic-goods-act-1989-sec-30b-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30b ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30b cml:asserts concept:therapeutic-goods-act-1989-sec-30b-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30b-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-30c a cml:Concept ;
skos:prefLabel "30C Consultation with Gene Technology Regulator"@en ;
cml:realizedBy doc:sec-30c ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30c-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30c-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30c-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30c-ss-4 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30c-ss-5 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.219" .
concept:therapeutic-goods-act-1989-sec-30c-ss-1 a cml:Concept ;
skos:prefLabel "30C(1) Consultation with Gene Technology Regulator"@en ;
cml:realizedBy doc:sec-30c-ss-1 ;
cml:integrityHash "ebad6a12a5cc3d786c241e27c5a98f5a8722450c5783e072f06905566dfe9b39" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30c ;
skos:note "Application for listing or registration of a therapeutic good must pass preliminary assessment." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.219" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30c-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-30c-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30c-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-30c-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-30c-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30c-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Therapeutic good must meet conditions." ;
cml:premiseText "(1) This section applies to an application for listing or registration of a therapeutic good under section 23 if:" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30c-ss-2 a cml:Concept ;
skos:prefLabel "30C(2) Consultation with Gene Technology Regulator"@en ;
cml:realizedBy doc:sec-30c-ss-2 ;
cml:integrityHash "72f4b66640772a86767f0b5d10f6a70d034e87a7de72257b9ecf0218ca53659e" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30c ;
skos:note "Secretary must give written notice to Gene Technology Regulator about application." ;
dc:description "Advice on application" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.219" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30c-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-30c-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30c-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-30c-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-30c-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30c-ss-2-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-30c-ss-3 a cml:Concept ;
skos:prefLabel "30C(3) Consultation with Gene Technology Regulator"@en ;
cml:realizedBy doc:sec-30c-ss-3 ;
cml:integrityHash "3d5d299bf76932c099e508d0af6ee43fab79648ef5191cf7bc1c4b603ebec156" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30c ;
skos:note "The Gene Technology Regulator must provide written advice to the Secretary about a gene technology application." ;
dc:description "Yes" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.219" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30c-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-30c-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30c-ss-3 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30c-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-30c-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30c-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "The Gene Technology Regulator must provide written advice." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30c-ss-4 a cml:Concept ;
skos:prefLabel "30C(4) Consultation with Gene Technology Regulator"@en ;
cml:realizedBy doc:sec-30c-ss-4 ;
cml:integrityHash "00b1b875e100436c290e3e2970316321c0a13934db4ea38ff0fbcf8885da1a15" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30c ;
skos:note "Consultation with Gene Technology Regulator within specified period." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.219" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30c-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-30c-ss-4-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30c-ss-4 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30c-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-30c-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30c-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Must provide consultation" ;
cml:premiseText "The advice is to be given within the period specified in the notice." ;
cml:conclusionText "Obligation to consult" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30c-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-30c-ss-4-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-30c-ss-4-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "CONTAINS" ;
cml:logicSummary "Temporal interval for consultation" ;
cml:premiseText "The advice is to be given within the period specified in the notice." ;
cml:conclusionText "Period defined as containing the time of consultation" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30c-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-30c-ss-4-logic-argumentation-3 .
concept:therapeutic-goods-act-1989-sec-30c-ss-4-logic-argumentation-3 a cml:LogicApplication ;
cml:modality cml:Argumentation ;
cml:operator "IMPLIES" ;
cml:logicSummary "Implication from consultation requirement" ;
cml:premiseText "The advice is to be given within the period specified in the notice." ;
cml:conclusionText "If advice is given, then it must be within a period" ;
cml:executionSurface "modalities::argumentation" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30c-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-30c-ss-4-logic-diffusion-4 .
concept:therapeutic-goods-act-1989-sec-30c-ss-4-logic-diffusion-4 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "IS_A" ;
cml:logicSummary "Definition of consultation as giving advice" ;
cml:premiseText "The advice is to be given within the period specified in the notice." ;
cml:conclusionText "Consultation defined as giving advice" ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30c-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-30c-ss-4-logic-cogai-5 .
concept:therapeutic-goods-act-1989-sec-30c-ss-4-logic-cogai-5 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "IS_A" ;
cml:logicSummary "Definition of consultation as a cognitive process" ;
cml:premiseText "The advice is to be given within the period specified in the notice." ;
cml:conclusionText "Consultation defined as a cognitive process" ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30c-ss-5 a cml:Concept ;
skos:prefLabel "30C(5) Consultation with Gene Technology Regulator"@en ;
cml:realizedBy doc:sec-30c-ss-5 ;
cml:integrityHash "5f40412a2d7255cdc752c18f3acd09164aeec6439f54ee3a019896d4338fb35a" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30c ;
skos:note "No notification required for therapeutic goods belonging to a class with an active advice from the Gene Technology Regulator." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.219" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30c-ss-5-norm .
concept:therapeutic-goods-act-1989-sec-30c-ss-5-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30c-ss-5 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30c-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-30c-ss-5-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30c-ss-5-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "exemption" ;
cml:logicSummary "Exemption from notification" ;
cml:premiseText "Advice from the Gene Technology Regulator is in force" ;
cml:conclusionText "No notification required" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30c-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-30c-ss-5-logic-descriptionlogic-2 .
concept:therapeutic-goods-act-1989-sec-30c-ss-5-logic-descriptionlogic-2 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "subclassOf" ;
cml:logicSummary "Therapeutic goods belonging to a class with an active advice" ;
cml:premiseText "Class of therapeutic goods" ;
cml:conclusionText "Subclass of goods subject to exemption" ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30d a cml:Concept ;
skos:prefLabel "30D Secretary may seek advice about classes of GM products or"@en ;
cml:realizedBy doc:sec-30d ;
cml:integrityHash "07160fce713519494f31c57c608d3f2ff3f06e3142cabdc1488cb0a3b72e5d52" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30d-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30d-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30d-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30d-ss-4 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.220" .
concept:therapeutic-goods-act-1989-sec-30d-ss-1 a cml:Concept ;
skos:prefLabel "30D(1) Secretary may seek advice about classes of GM products or"@en ;
cml:realizedBy doc:sec-30d-ss-1 ;
cml:integrityHash "a7c4a188b8b20aee2456a64d4ada4f5ef001bb855227829c8a4bff6468d77441" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30d ;
skos:note "The Secretary may request advice from the Gene Technology Regulator." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.220" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30d-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-30d-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30d-ss-1 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30d-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-30d-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30d-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MAY" ;
cml:logicSummary "The Secretary may request advice." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30d-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-30d-ss-1-logic-descriptionlogic-2 .
concept:therapeutic-goods-act-1989-sec-30d-ss-1-logic-descriptionlogic-2 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "CLASSIFICATION" ;
cml:logicSummary "Classes of GM products specified in the request." ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30d-ss-2 a cml:Concept ;
skos:prefLabel "30D(2) Secretary may seek advice about classes of GM products or"@en ;
cml:realizedBy doc:sec-30d-ss-2 ;
cml:integrityHash "4e51265a78ab04cf4897d038214b8031a92317bf59ed9b320dea0926eea7ef14" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30d ;
skos:note "Request for advice must specify matters to which the advice is to relate." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.220" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30d-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-30d-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30d-ss-2 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30d-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-30d-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30d-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Specify matters for advice" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30d-ss-3 a cml:Concept ;
skos:prefLabel "30D(3) Secretary may seek advice about classes of GM products or"@en ;
cml:realizedBy doc:sec-30d-ss-3 ;
cml:integrityHash "97b1b5fb649ef20fc4b0e5063ef3b7785799626f322d932d1e0d1119efefc4e4" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30d ;
skos:note "Secretary must seek advice from Gene Technology Regulator on specified matters." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.220" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30d-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-30d-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30d-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-30d-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-30d-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30d-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Must provide written advice" ;
cml:premiseText "Secretary requests advice" ;
cml:conclusionText "Gene Technology Regulator must provide written advice" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30d-ss-4 a cml:Concept ;
skos:prefLabel "30D(4) Secretary may seek advice about classes of GM products or"@en ;
cml:realizedBy doc:sec-30d-ss-4 ;
cml:integrityHash "2fe027cec6dac4534a3352fab9e417bee5b6d8e2f9cbbef87e72de4a0e43dafd" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30d ;
skos:note "Advice from the Gene Technology Regulator remains in force until withdrawn." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.220" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30d-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-30d-ss-4-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30d-ss-4 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30d-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-30d-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30d-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "holds" ;
cml:logicSummary "Holds advice from the Gene Technology Regulator." ;
cml:premiseText "The Gene Technology Regulator gives advice to the Secretary." ;
cml:conclusionText "The advice remains in force until it is withdrawn by the Gene Technology Regulator." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30d-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-30d-ss-4-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-30d-ss-4-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "during" ;
cml:logicSummary "Advice from the Gene Technology Regulator lasts during its validity." ;
cml:premiseText "The Gene Technology Regulator gives advice to the Secretary." ;
cml:conclusionText "The advice remains in force until it is withdrawn by the Gene Technology Regulator." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30d-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-30d-ss-4-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-30d-ss-4-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "until" ;
cml:logicSummary "Advice from the Gene Technology Regulator ends when it is withdrawn." ;
cml:premiseText "The Gene Technology Regulator gives advice to the Secretary." ;
cml:conclusionText "The advice remains in force until it is withdrawn by the Gene Technology Regulator." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30d-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-30d-ss-4-logic-diffusion-4 .
concept:therapeutic-goods-act-1989-sec-30d-ss-4-logic-diffusion-4 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "diffuses" ;
cml:logicSummary "Advice from the Gene Technology Regulator diffuses to the Secretary." ;
cml:premiseText "The Gene Technology Regulator gives advice to the Secretary." ;
cml:conclusionText "The advice remains in force until it is withdrawn by the Gene Technology Regulator." ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30d-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-30d-ss-4-logic-cogai-5 .
concept:therapeutic-goods-act-1989-sec-30d-ss-4-logic-cogai-5 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "cognizes" ;
cml:logicSummary "The Secretary cognizes the advice from the Gene Technology Regulator." ;
cml:premiseText "The Gene Technology Regulator gives advice to the Secretary." ;
cml:conclusionText "The advice remains in force until it is withdrawn by the Gene Technology Regulator." ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30e a cml:Concept ;
skos:prefLabel "30E Secretary to take advice into account"@en ;
cml:realizedBy doc:sec-30e ;
cml:integrityHash "67fbe04aaecb63a7368b814ab4868ec8f0e93a1c24186726976d9aa9da80a685" ;
skos:note "Secretary must take advice from Gene Technology Regulator into account when making decisions on applications." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.220" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30e-norm .
concept:therapeutic-goods-act-1989-sec-30e-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30e ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30e cml:asserts concept:therapeutic-goods-act-1989-sec-30e-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30e-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Must take advice into account" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30ea a cml:Concept ;
skos:prefLabel "30EA Public notification, and recall, of therapeutic goods"@en ;
cml:realizedBy doc:sec-30ea ;
cml:integrityHash "4a6afbc25782c17398578517ec52cd4708bf096662781acd0e79f5e34d20e5af" ;
skos:note "The Secretary may impose requirements on a person if certain circumstances occur." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.222" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30ea-norm .
concept:therapeutic-goods-act-1989-sec-30ea-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30ea ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30ea cml:asserts concept:therapeutic-goods-act-1989-sec-30ea-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30ea-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "may" ;
cml:logicSummary "Imposition of obligations" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30eb a cml:Concept ;
skos:prefLabel "30EB Publication of requirements"@en ;
cml:realizedBy doc:sec-30eb ;
cml:integrityHash "6a70553c8ba374b646e76201e821ab7a6738d0f477c89994bc75deb29fdccf39" ;
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 <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.225" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30eb-norm .
concept:therapeutic-goods-act-1989-sec-30eb-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30eb ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30eb cml:asserts concept:therapeutic-goods-act-1989-sec-30eb-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30eb-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-30ec a cml:Concept ;
skos:prefLabel "30EC Criminal offences for non-compliance with requirements"@en ;
cml:realizedBy doc:sec-30ec ;
cml:integrityHash "aa9e8da167b724dedc1ceb78d37a2628eb968d9e15a7b83639367e504584667f" ;
skos:note "Non-compliance with requirements is a criminal offence." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.225" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30ec-norm .
concept:therapeutic-goods-act-1989-sec-30ec-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30ec ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30ec cml:asserts concept:therapeutic-goods-act-1989-sec-30ec-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30ec-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibition" ;
cml:logicSummary "Prohibits non-compliance with requirements." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30ed a cml:Concept ;
skos:prefLabel "30ED Powers of suspension and cancellation unaffected"@en ;
cml:realizedBy doc:sec-30ed ;
cml:integrityHash "ace2650e20504c390da801ccbb21fc5276a82d4d80ae1d3df7af9379452c8f36" ;
skos:note "Imposition of requirement under section 30EA does not affect suspension or cancellation power." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.226" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30ed-norm .
concept:therapeutic-goods-act-1989-sec-30ed-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30ed ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30ee a cml:Concept ;
skos:prefLabel "30EE Saving of other laws"@en ;
cml:realizedBy doc:sec-30ee ;
cml:integrityHash "d60e452d40d4d8c4426e32e3f836a586f2a94e7ff1468a6edf7dd0a4fff87758" ;
skos:note "No exclusion or limitation of other laws" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.227" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30ee-norm .
concept:therapeutic-goods-act-1989-sec-30ee-norm a values:Undertaking ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30ee ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30ef a cml:Concept ;
skos:prefLabel "30EF Reporting medicine shortages"@en ;
cml:realizedBy doc:sec-30ef ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30ef-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30ef-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30ef-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30ef-ss-4 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30ef-ss-5 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30ef-ss-6 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30ef-ss-7 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.228" .
concept:therapeutic-goods-act-1989-sec-30ef-ss-1 a cml:Concept ;
skos:prefLabel "30EF(1) Reporting medicine shortages"@en ;
cml:realizedBy doc:sec-30ef-ss-1 ;
cml:integrityHash "95b8ebe35e4c3a8234bb3382362faba4062f8690716f99ada4e8c9e90b7b91c7" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30ef ;
skos:note "Notify shortage of reportable medicine within 2 working days or 10 working days." ;
dc:description "True" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.228" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30ef-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-30ef-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30ef-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-30ef-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-30ef-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30ef-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Must notify shortage within specified timeframe." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30ef-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-30ef-ss-1-logic-epistemic-2 .
concept:therapeutic-goods-act-1989-sec-30ef-ss-1-logic-epistemic-2 a cml:LogicApplication ;
cml:modality cml:Epistemic ;
cml:operator "OUGHT" ;
cml:logicSummary "Ought to reasonably know of shortage before notification." ;
cml:executionSurface "modalities::epistemic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30ef-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-30ef-ss-1-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-30ef-ss-1-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "BUT" ;
cml:logicSummary "Notification within timeframe is but not required." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30ef-ss-2 a cml:Concept ;
skos:prefLabel "30EF(2) Reporting medicine shortages"@en ;
cml:realizedBy doc:sec-30ef-ss-2 ;
cml:integrityHash "84e50dfdc8a41df32e280e548f7857692dee6891ba1c14bde4a57327ddc91ad4" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30ef ;
skos:note "Reporting medicine shortages when included in an instrument under section 30EJ has a critical impact." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.228" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30ef-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-30ef-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30ef-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-30ef-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-30ef-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30ef-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Reporting medicine shortages when included in an instrument under section 30EJ is obligatory." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30ef-ss-3 a cml:Concept ;
skos:prefLabel "30EF(3) Reporting medicine shortages"@en ;
cml:realizedBy doc:sec-30ef-ss-3 ;
cml:integrityHash "7ac0ba3169eb2c95069a0f5e26e8acb21180f253e2e88711070cce6d3b07a992" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30ef ;
skos:note "Reporting medicine shortages when there is a critical impact on health or functioning." ;
dc:description "Notification requirements" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.228" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30ef-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-30ef-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30ef-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-30ef-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-30ef-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30ef-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Reporting medicine shortages is a duty." ;
cml:conclusionText "Notification requirements must be provided." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30ef-ss-4 a cml:Concept ;
skos:prefLabel "30EF(4) Reporting medicine shortages"@en ;
cml:realizedBy doc:sec-30ef-ss-4 ;
cml:integrityHash "6768b9138dc76e3662afbba407f7e5c9fdcfefd8eeb623392a966f3ba2ec9567" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30ef ;
skos:note "Notification requirements for medicine shortages" ;
dc:description "Specific period of shortage, approved form, and required information" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.228" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30ef-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-30ef-ss-4-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30ef-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-30ef-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-30ef-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30ef-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Notification requirements are mandatory" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30ef-ss-5 a cml:Concept ;
skos:prefLabel "30EF(5) Reporting medicine shortages"@en ;
cml:realizedBy doc:sec-30ef-ss-5 ;
cml:integrityHash "b8c5f3469c62488d5780db16e22ef8bacfcec121411b26a021cd3d8170126b9f" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30ef ;
skos:note "Specify software requirements for reporting medicine shortages" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.228" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30ef-ss-5-norm .
concept:therapeutic-goods-act-1989-sec-30ef-ss-5-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30ef-ss-5 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30ef-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-30ef-ss-5-logic-descriptionlogic-1 .
concept:therapeutic-goods-act-1989-sec-30ef-ss-5-logic-descriptionlogic-1 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "hasClass" ;
cml:logicSummary "Classifies the provision as a descriptive clause" ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30ef-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-30ef-ss-5-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-30ef-ss-5-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "during" ;
cml:logicSummary "Describes the temporal relationship between software requirements and reporting medicine shortages" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30ef-ss-6 a cml:Concept ;
skos:prefLabel "30EF(6) Reporting medicine shortages"@en ;
cml:realizedBy doc:sec-30ef-ss-6 ;
cml:integrityHash "4f8907e2f2adadcaf6ae9fd8ec831e5902ba6b417846ebbccb3a77a6976a31c5" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30ef ;
skos:note "Reporting medicine shortages is prohibited for individuals and bodies corporate." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.228" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30ef-ss-6-norm .
concept:therapeutic-goods-act-1989-sec-30ef-ss-6-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30ef-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-30ef-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-30ef-ss-6-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30ef-ss-6-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibition of reporting medicine shortages" ;
cml:premiseText "(6) A person contravenes this subsection..." ;
cml:conclusionText "...the person contravenes the requirement." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30ef-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-30ef-ss-6-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-30ef-ss-6-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Temporal Interval" ;
cml:logicSummary "Temporal interval of reporting medicine shortages" ;
cml:premiseText "(6) A person contravenes this subsection..." ;
cml:conclusionText "...if the person is subject to a requirement under subsection (1);" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30ef-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-30ef-ss-6-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-30ef-ss-6-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "Recurring Trace" ;
cml:logicSummary "Recurring trace of reporting medicine shortages" ;
cml:premiseText "(6) A person contravenes this subsection..." ;
cml:conclusionText "...and the person contravenes the requirement." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30ef-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-30ef-ss-6-logic-diffusion-4 .
concept:therapeutic-goods-act-1989-sec-30ef-ss-6-logic-diffusion-4 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "Information Diffusion" ;
cml:logicSummary "Information diffusion of reporting medicine shortages" ;
cml:premiseText "(6) A person contravenes this subsection..." ;
cml:conclusionText "...Maximum civil penalty:" ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30ef-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-30ef-ss-6-logic-cogai-5 .
concept:therapeutic-goods-act-1989-sec-30ef-ss-6-logic-cogai-5 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "Knowledge Representation" ;
cml:logicSummary "Knowledge representation of reporting medicine shortages" ;
cml:premiseText "(a) for an individual—100 penalty units;" ;
cml:conclusionText "...and (b) for a body corporate—1,000 penalty units." ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30ef-ss-7 a cml:Concept ;
skos:prefLabel "30EF(7) Reporting medicine shortages"@en ;
cml:realizedBy doc:sec-30ef-ss-7 ;
cml:integrityHash "84dca6a9dc05ab382ffc6ec10369fe89824c2a24b938d13d0c3a92edc35d59aa" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30ef ;
skos:note "Exemption from reporting medicine shortages under certain conditions" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.228" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30ef-ss-7-norm .
concept:therapeutic-goods-act-1989-sec-30ef-ss-7-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30ef-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-1-2 a cml:Concept ;
skos:prefLabel "1 March 2024 and end on 31 March 2024 (see section 30EIA)."@en ;
cml:realizedBy doc:sec-1-2 ;
cml:integrityHash "7da61ec8257aaa582608977966ad0c9149e0140aa5adedaf3fbf582576aee212" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-1-2-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-1-2-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-1-2-ss-3 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.230" .
concept:therapeutic-goods-act-1989-sec-1-2-ss-1 a cml:Concept ;
skos:prefLabel "1(1) March 2024 and end on 31 March 2024 (see section 30EIA)."@en ;
cml:realizedBy doc:sec-1-2-ss-1 ;
cml:integrityHash "40d2d33a7e6be84a207c948218e1594bf2413d7bb115f1a84c7a0417ae293294" ;
values:partOf concept:therapeutic-goods-act-1989-sec-1-2 ;
skos:note "Notify Secretary of change to medicine shortage period within specified timeframe." ;
dc:description "Change in medicine shortage period" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.230" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-1-2-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-1-2-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-1-2-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-1-2-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-1-2-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-1-2-ss-1-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-1-2-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-1-2-ss-1-logic-epistemic-2 .
concept:therapeutic-goods-act-1989-sec-1-2-ss-1-logic-epistemic-2 a cml:LogicApplication ;
cml:modality cml:Epistemic ;
cml:operator "KNOWS" ;
cml:logicSummary "Knowledge of change in shortage period" ;
cml:executionSurface "modalities::epistemic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-1-2-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-1-2-ss-1-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-1-2-ss-1-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "BUT" ;
cml:logicSummary "Temporal relation between notification and change" ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-1-2-ss-2 a cml:Concept ;
skos:prefLabel "1(2) March 2024 and end on 31 March 2024 (see section 30EIA)."@en ;
cml:realizedBy doc:sec-1-2-ss-2 ;
cml:integrityHash "c35d734da0032e3da13b1979a37b90c823c76a0658b6f49ccdb40027387708b7" ;
values:partOf concept:therapeutic-goods-act-1989-sec-1-2 ;
skos:note "Notify Secretary of shortage resolution within 2 working days or 10 working days." ;
dc:description "Notification requirements" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.230" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-1-2-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-1-2-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-1-2-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-1-2-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-1-2-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-1-2-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Must notify within specified timeframe." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-1-2-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-1-2-ss-2-logic-epistemic-2 .
concept:therapeutic-goods-act-1989-sec-1-2-ss-2-logic-epistemic-2 a cml:LogicApplication ;
cml:modality cml:Epistemic ;
cml:operator "OUGHT" ;
cml:logicSummary "Should reasonably know of shortage end date." ;
cml:executionSurface "modalities::epistemic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-1-2-ss-3 a cml:Concept ;
skos:prefLabel "1(3) March 2024 and end on 31 March 2024 (see section 30EIA)."@en ;
cml:realizedBy doc:sec-1-2-ss-3 ;
cml:integrityHash "f2ed0c809243e4194ba323e83bef5b14136131c501cec07d519da68ae98c99d9" ;
values:partOf concept:therapeutic-goods-act-1989-sec-1-2 ;
skos:note "Notification requirements for shortage of medicine in Australia." ;
dc:description "period of shortage, day period ended" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.230" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-1-2-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-1-2-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-1-2-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-1-2-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-1-2-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-1-2-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Notification requirements" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30eg a cml:Concept ;
skos:prefLabel "30EG Reporting discontinuation of supply of medicine"@en ;
cml:realizedBy doc:sec-30eg ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30eg-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30eg-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30eg-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30eg-ss-4 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30eg-ss-5 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.232" .
concept:therapeutic-goods-act-1989-sec-30eg-ss-1 a cml:Concept ;
skos:prefLabel "30EG(1) Reporting discontinuation of supply of medicine"@en ;
cml:realizedBy doc:sec-30eg-ss-1 ;
cml:integrityHash "bf74c473feacd22cde9142e2446695cf2b6ce677c8affac5d107f50f4f9e0916" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30eg ;
skos:note "Notify Secretary of discontinuation decision at least 6 months before proposed date." ;
dc:description "Notification" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.232" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30eg-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-30eg-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30eg-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-30eg-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-30eg-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30eg-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Obligation to notify" ;
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-30eg-ss-2 a cml:Concept ;
skos:prefLabel "30EG(2) Reporting discontinuation of supply of medicine"@en ;
cml:realizedBy doc:sec-30eg-ss-2 ;
cml:integrityHash "f2326cf88c21d968142d34ffded3a31569e9fea2b00a43551edca39d0294adb5" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30eg ;
skos:note "Reporting required when discontinuation of supply of medicine is made under section 30EJ" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.232" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30eg-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-30eg-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30eg-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-30eg-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-30eg-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30eg-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Reporting obligation" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30eg-ss-3 a cml:Concept ;
skos:prefLabel "30EG(3) Reporting discontinuation of supply of medicine"@en ;
cml:realizedBy doc:sec-30eg-ss-3 ;
cml:integrityHash "99725bfdf337ec6cead73e3b28093e14583c283b10758142733fd7f450956830" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30eg ;
skos:note "Notify discontinuation of medicine supply if critical impact on health or functioning" ;
dc:description "Notification requirements" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.232" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30eg-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-30eg-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30eg-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-30eg-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-30eg-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30eg-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Obligation to notify" ;
cml:conclusionText "Notification requirements" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30eg-ss-4 a cml:Concept ;
skos:prefLabel "30EG(4) Reporting discontinuation of supply of medicine"@en ;
cml:realizedBy doc:sec-30eg-ss-4 ;
cml:integrityHash "3acffbbc2ebffe89830e45850da3bb277456d4896f09d66e34114f0bce09598b" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30eg ;
skos:note "Notification must be in a specified form and contain required information." ;
dc:description "true" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.232" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30eg-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-30eg-ss-4-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30eg-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-30eg-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-30eg-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30eg-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Notification must be in a specified form." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30eg-ss-5 a cml:Concept ;
skos:prefLabel "30EG(5) Reporting discontinuation of supply of medicine"@en ;
cml:realizedBy doc:sec-30eg-ss-5 ;
cml:integrityHash "bae4623a085cbac5127c1e9c7709ff9582d0e50d4443beccaa7c29426095a2b5" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30eg ;
skos:note "Specify software requirements for information transmission" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.232" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30eg-ss-5-norm .
concept:therapeutic-goods-act-1989-sec-30eg-ss-5-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30eg-ss-5 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30eg-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-30eg-ss-5-logic-descriptionlogic-1 .
concept:therapeutic-goods-act-1989-sec-30eg-ss-5-logic-descriptionlogic-1 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "hasClass" ;
cml:logicSummary "Classifies the provision as a descriptive clause" ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30eg-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-30eg-ss-5-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-30eg-ss-5-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "during" ;
cml:logicSummary "Identifies the temporal relation of software requirements" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30eh a cml:Concept ;
skos:prefLabel "30EH What is a reportable medicine?"@en ;
cml:realizedBy doc:sec-30eh ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30eh-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30eh-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30eh-ss-3 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.234" .
concept:therapeutic-goods-act-1989-sec-30eh-ss-1 a cml:Concept ;
skos:prefLabel "30EH(1) What is a reportable medicine?"@en ;
cml:realizedBy doc:sec-30eh-ss-1 ;
cml:integrityHash "99ee0448839d858230ff9f8ae3c57bc17d3196970b88c8dca4062939bc3927d9" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30eh ;
skos:note "Defines reportable medicine under the Act." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.234" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30eh-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-30eh-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30eh-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-30eh-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-30eh-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30eh-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "is" ;
cml:logicSummary "Identifies a reportable medicine." ;
cml:premiseText "(1) For the purposes of this Act, registered goods are a reportable medicine if:" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30eh-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-30eh-ss-1-logic-linearlogic-2 .
concept:therapeutic-goods-act-1989-sec-30eh-ss-1-logic-linearlogic-2 a cml:LogicApplication ;
cml:modality cml:LinearLogic ;
cml:operator "and" ;
cml:logicSummary "Combines conditions for a reportable medicine." ;
cml:premiseText "(a) the goods are medicine; and (b) either: (i) the medicine contains one or more substances included in Schedule 4 or 8 to the current Poisons Standard;" ;
cml:executionSurface "modalities::linear" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30eh-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-30eh-ss-1-logic-alleninterval-3 .
concept:therapeutic-goods-act-1989-sec-30eh-ss-1-logic-alleninterval-3 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "contains" ;
cml:logicSummary "Includes temporal intervals for substance inclusion." ;
cml:premiseText "(i) the medicine contains one or more substances included in Schedule 4 or 8 to the current Poisons Standard;" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30eh-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-30eh-ss-1-logic-ltl-4 .
concept:therapeutic-goods-act-1989-sec-30eh-ss-1-logic-ltl-4 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "or" ;
cml:logicSummary "Combines conditions for a reportable medicine using LTL." ;
cml:premiseText "(b) either: (i) the medicine contains one or more substances included in Schedule 4 or 8 to the current Poisons Standard;" ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30eh-ss-2 a cml:Concept ;
skos:prefLabel "30EH(2) What is a reportable medicine?"@en ;
cml:realizedBy doc:sec-30eh-ss-2 ;
cml:integrityHash "1ab08086a83a617121c624f1422aea9258dd94b2da663a9800d03a9f62f47128" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30eh ;
skos:note "The Minister may determine medicine for the purposes of subparagraph (1)(b)(ii)." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.234" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30eh-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-30eh-ss-2-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30eh-ss-2 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30eh-ss-3 a cml:Concept ;
skos:prefLabel "30EH(3) What is a reportable medicine?"@en ;
cml:realizedBy doc:sec-30eh-ss-3 ;
cml:integrityHash "c8fb71c934cc946f15f71ce26a2c1a1dd862f9657e32864fde8e983b0c948c72" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30eh ;
skos:note "The Minister must determine a medicine if it is critical to patient health and notification of shortage would be in public health interests." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.234" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30eh-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-30eh-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30eh-ss-3 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30eh-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-30eh-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30eh-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "The Minister must determine a medicine." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30eh-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-30eh-ss-3-logic-epistemic-2 .
concept:therapeutic-goods-act-1989-sec-30eh-ss-3-logic-epistemic-2 a cml:LogicApplication ;
cml:modality cml:Epistemic ;
cml:operator "SUFFICIENT" ;
cml:logicSummary "Notification of shortage would be in public health interests." ;
cml:executionSurface "modalities::epistemic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30ei a cml:Concept ;
skos:prefLabel "30EI When is there a medicine shortage?"@en ;
cml:realizedBy doc:sec-30ei ;
cml:integrityHash "5d36f41962dbdf774fea3bb2f538fed7976bd88299fde489f7247769747f6162" ;
skos:note "Defines when there is a medicine shortage in Australia." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.235" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30ei-norm .
concept:therapeutic-goods-act-1989-sec-30ei-norm a values:Undertaking ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30ei ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30ej a cml:Concept ;
skos:prefLabel "30EJ Medicines Watch List"@en ;
cml:realizedBy doc:sec-30ej ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30ej-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30ej-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.235" .
concept:therapeutic-goods-act-1989-sec-30ej-ss-1 a cml:Concept ;
skos:prefLabel "30EJ(1) Medicines Watch List"@en ;
cml:realizedBy doc:sec-30ej-ss-1 ;
cml:integrityHash "6c6b540490e1b6eb6544ed6f2ea5a70fc7cbb9ddc12ce92c27010a7657b9b25a" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30ej ;
skos:note "Minister may determine medicine for purposes of subsections 30EF(2) and 30EG(2)" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.235" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30ej-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-30ej-ss-1-norm a values:Undertaking ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30ej-ss-1 ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30ej-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-30ej-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30ej-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "May" ;
cml:logicSummary "Expresses permission or obligation" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30ej-ss-2 a cml:Concept ;
skos:prefLabel "30EJ(2) Medicines Watch List"@en ;
cml:realizedBy doc:sec-30ej-ss-2 ;
cml:integrityHash "169175bcb72b0ca425464212e44bdb364db8109345991e9e872bb814425a026e" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30ej ;
skos:note "The Minister must not determine a medicine unless certain conditions are met." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.235" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30ej-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-30ej-ss-2-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30ej-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-30ej-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-30ej-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30ej-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibition" ;
cml:logicSummary "Prohibits the Minister from determining a medicine without satisfying certain conditions." ;
cml:premiseText "(2) The Minister must not determine a medicine..." ;
cml:conclusionText "...unless the Minister is satisfied that any shortage of the medicine..." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30ej-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-30ej-ss-2-logic-deontic-2 .
concept:therapeutic-goods-act-1989-sec-30ej-ss-2-logic-deontic-2 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Imposes an obligation on the Minister to satisfy certain conditions before determining a medicine." ;
cml:premiseText "(2) The Minister must not determine a medicine..." ;
cml:conclusionText "...unless the Minister is satisfied that any shortage of the medicine..." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30ej-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-30ej-ss-2-logic-alleninterval-3 .
concept:therapeutic-goods-act-1989-sec-30ej-ss-2-logic-alleninterval-3 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "TemporalOverlap" ;
cml:logicSummary "Defines a temporal overlap between the conditions and the determination of a medicine." ;
cml:premiseText "(2) The Minister must not determine a medicine unless..." ;
cml:conclusionText "...the Minister is satisfied that any shortage of the medicine..." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30ej-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-30ej-ss-2-logic-ltl-4 .
concept:therapeutic-goods-act-1989-sec-30ej-ss-2-logic-ltl-4 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "TemporalRelevance" ;
cml:logicSummary "Defines a temporal relevance between the conditions and the determination of a medicine." ;
cml:premiseText "(2) The Minister must not determine a medicine unless..." ;
cml:conclusionText "...the Minister is satisfied that any shortage of the medicine..." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30ej-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-30ej-ss-2-logic-diffusion-5 .
concept:therapeutic-goods-act-1989-sec-30ej-ss-2-logic-diffusion-5 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "InformationFlow" ;
cml:logicSummary "Defines an information flow between the conditions and the determination of a medicine." ;
cml:premiseText "(2) The Minister must not determine a medicine unless..." ;
cml:conclusionText "...the Minister is satisfied that any shortage of the medicine..." ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30ek a cml:Concept ;
skos:prefLabel "30EK Minister may declare a serious scarcity of medicine"@en ;
cml:realizedBy doc:sec-30ek ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30ek-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30ek-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30ek-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30ek-ss-4 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30ek-ss-5 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.236" .
concept:therapeutic-goods-act-1989-sec-30ek-ss-1 a cml:Concept ;
skos:prefLabel "30EK(1) Minister may declare a serious scarcity of medicine"@en ;
cml:realizedBy doc:sec-30ek-ss-1 ;
cml:integrityHash "4ec81030918796be37dfed2396affbdb96f07956004e877d1543c8161dbe195d" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30ek ;
skos:note "Minister may declare a serious scarcity of medicine and specify substitution rules." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.236" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30ek-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-30ek-ss-1-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30ek-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-30ek-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-30ek-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30ek-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Permit" ;
cml:logicSummary "Permission to dispense substitutable medicine." ;
cml:premiseText "(a) declare that there is a serious scarcity of specified medicine" ;
cml:conclusionText "(b) specify the medicine (the substitutable medicine)" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30ek-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-30ek-ss-1-logic-deontic-2 .
concept:therapeutic-goods-act-1989-sec-30ek-ss-1-logic-deontic-2 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Permit" ;
cml:logicSummary "Pharmacists permitted to dispense substitutable medicine under specified circumstances." ;
cml:premiseText "(b) specify the circumstances in which that substitution is permitted." ;
cml:conclusionText "Substitution permitted under specified circumstances." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30ek-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-30ek-ss-1-logic-deontic-3 .
concept:therapeutic-goods-act-1989-sec-30ek-ss-1-logic-deontic-3 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "No prohibition on declaring scarcity or specifying substitution rules." ;
cml:premiseText "(a) declare that there is a serious scarcity of specified medicine" ;
cml:conclusionText "No prohibition." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30ek-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-30ek-ss-1-logic-alleninterval-4 .
concept:therapeutic-goods-act-1989-sec-30ek-ss-1-logic-alleninterval-4 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Overlaps" ;
cml:logicSummary "Temporal overlap between declaration and substitution rules." ;
cml:premiseText "The Minister may, by legislative instrument:" ;
cml:conclusionText "The declaration and substitution rules overlap in time." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30ek-ss-2 a cml:Concept ;
skos:prefLabel "30EK(2) Minister may declare a serious scarcity of medicine"@en ;
cml:realizedBy doc:sec-30ek-ss-2 ;
cml:integrityHash "82f6cab193e4fa5ca0fc106f936ebcca71ce553ac4b44d8d5787f3061fa7b03e" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30ek ;
skos:note "The Minister may declare a serious scarcity of medicine under certain conditions." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.236" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30ek-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-30ek-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30ek-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-30ek-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-30ek-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30ek-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "may" ;
cml:logicSummary "The Minister may declare a serious scarcity of medicine." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30ek-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-30ek-ss-2-logic-descriptionlogic-2 .
concept:therapeutic-goods-act-1989-sec-30ek-ss-2-logic-descriptionlogic-2 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "is" ;
cml:logicSummary "The supply of the scarce medicine in Australia is not currently meeting the demand for that medicine for all of the patients in Australia who take that medicine." ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30ek-ss-3 a cml:Concept ;
skos:prefLabel "30EK(3) Minister may declare a serious scarcity of medicine"@en ;
cml:realizedBy doc:sec-30ek-ss-3 ;
cml:integrityHash "353db3cf2dfc558c32066008a7118345b92bbc01dcc9222a78ac2531db96c63d" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30ek ;
skos:note "Minister must declare a serious scarcity of medicine if certain conditions are met." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.236" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30ek-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-30ek-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30ek-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-30ek-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-30ek-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30ek-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Minister must declare a serious scarcity of medicine" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30ek-ss-4 a cml:Concept ;
skos:prefLabel "30EK(4) Minister may declare a serious scarcity of medicine"@en ;
cml:realizedBy doc:sec-30ek-ss-4 ;
cml:integrityHash "ee65e7460a69cf871e4254de4ffae69ac73382ad0ab003c397a74c0b5237352e" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30ek ;
skos:note "Minister must declare a serious scarcity of medicine under certain circumstances." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.236" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30ek-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-30ek-ss-4-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30ek-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-30ek-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-30ek-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30ek-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Minister must declare a serious scarcity of medicine." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30ek-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-30ek-ss-4-logic-descriptionlogic-2 .
concept:therapeutic-goods-act-1989-sec-30ek-ss-4-logic-descriptionlogic-2 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "CLASSIFICATION" ;
cml:logicSummary "Classification of persons for whom the substitutable medicine is suitable or not suitable." ;
cml:premiseText "(a) the class of persons for whom the substitutable medicine is suitable; or (b) the class of persons for whom the substitutable medicine is not suitable." ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30ek-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-30ek-ss-4-logic-alleninterval-3 .
concept:therapeutic-goods-act-1989-sec-30ek-ss-4-logic-alleninterval-3 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "CONTAINS" ;
cml:logicSummary "Temporal interval for declaration." ;
cml:premiseText "(4)" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30ek-ss-5 a cml:Concept ;
skos:prefLabel "30EK(5) Minister may declare a serious scarcity of medicine"@en ;
cml:realizedBy doc:sec-30ek-ss-5 ;
cml:integrityHash "03c7a4fbec5a96cb32536c7060d85a52b116d1ecd0ef680d99131211dc80f760" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30ek ;
skos:note "Instrument remains in force for a specified period unless revoked." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.236" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30ek-ss-5-norm .
concept:therapeutic-goods-act-1989-sec-30ek-ss-5-norm a values:Undertaking ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30ek-ss-5 ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30el a cml:Concept ;
skos:prefLabel "30EL Substitution of prescription medicine by pharmacists"@en ;
cml:realizedBy doc:sec-30el ;
cml:integrityHash "c1d84a9818ab11e0b4164982262f55745a49c3189648d669af73769211591214" ;
skos:note "Pharmacist may dispense scarce medicine in substitution for another" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.237" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30el-norm .
concept:therapeutic-goods-act-1989-sec-30el-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30el ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30el cml:asserts concept:therapeutic-goods-act-1989-sec-30el-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30el-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "may" ;
cml:logicSummary "Permission to dispense" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30f a cml:Concept ;
skos:prefLabel "30F Criminal offences for goods exempt under section 18A not"@en ;
cml:realizedBy doc:sec-30f ;
cml:integrityHash "12d2b2e35f3f849925d69a8145ed8cc043746662e2c469a65057c21a308818c6" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30f-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30f-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30f-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30f-ss-4 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30f-ss-4a ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30f-ss-4b ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30f-ss-5 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30f-ss-6 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.238" .
concept:therapeutic-goods-act-1989-sec-30f-ss-1 a cml:Concept ;
skos:prefLabel "30F(1) Criminal offences for goods exempt under section 18A not"@en ;
cml:realizedBy doc:sec-30f-ss-1 ;
cml:integrityHash "684290c8df2613239f3f4e9bbc08d67e3cd3adb7530f8d6ed68b460cb78fc14d" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30f ;
skos:note "Supplying goods of a particular kind that do not conform to a standard or are not fit for their intended purposes is prohibited." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.238" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30f-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-30f-ss-1-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30f-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-30f-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-30f-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30f-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibition of supplying goods that do not conform to a standard or are not fit for their intended purposes." ;
cml:premiseText "(a) therapeutic goods of a particular kind are exempt under section 18A; and (b) a person supplies a batch of goods of that kind; and (c) the Secretary is satisfied that the goods included in that batch: ..." ;
cml:conclusionText "...is prohibited." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30f-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-30f-ss-1-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-30f-ss-1-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Overlap" ;
cml:logicSummary "Temporal overlap between the supply of goods and the Secretary's satisfaction that the goods included in that batch do not conform to a standard or are not fit for their intended purposes." ;
cml:premiseText "(c) the Secretary is satisfied that the goods included in that batch: ..." ;
cml:conclusionText "...overlap with the supply of goods." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30f-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-30f-ss-1-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-30f-ss-1-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "Recurring" ;
cml:logicSummary "Recurring trace of supplying goods that do not conform to a standard or are not fit for their intended purposes." ;
cml:premiseText "(a) therapeutic goods of a particular kind are exempt under section 18A; and (b) a person supplies a batch of goods of that kind; and (c) the Secretary is satisfied that the goods included in that batch: ..." ;
cml:conclusionText "...are recurring traces of supplying goods that do not conform to a standard or are not fit for their intended purposes." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30f-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-30f-ss-1-logic-diffusion-4 .
concept:therapeutic-goods-act-1989-sec-30f-ss-1-logic-diffusion-4 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "Diffuse" ;
cml:logicSummary "Diffusion of the prohibition on supplying goods that do not conform to a standard or are not fit for their intended purposes." ;
cml:premiseText "(a) therapeutic goods of a particular kind are exempt under section 18A; and (b) a person supplies a batch of goods of that kind; and (c) the Secretary is satisfied that the goods included in that batch: ..." ;
cml:conclusionText "...diffuse to all persons." ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30f-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-30f-ss-1-logic-cogai-5 .
concept:therapeutic-goods-act-1989-sec-30f-ss-1-logic-cogai-5 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "Classify" ;
cml:logicSummary "Classification of goods as not conforming to a standard or being unfit for their intended purposes using artificial intelligence." ;
cml:premiseText "(i) do not conform to a standard applicable to goods of that kind; or (ii) are otherwise not fit to be used for their intended purposes." ;
cml:conclusionText "...are classified as not conforming to a standard or being unfit for their intended purposes." ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30f-ss-2 a cml:Concept ;
skos:prefLabel "30F(2) Criminal offences for goods exempt under section 18A not"@en ;
cml:realizedBy doc:sec-30f-ss-2 ;
cml:integrityHash "9f35d6f2d147971a01ec064964497ca0a7efcc26818342c7c0149bc8322652ff" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30f ;
skos:note "Require person to take steps to recall goods" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.238" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30f-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-30f-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30f-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-30f-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-30f-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30f-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "require" ;
cml:logicSummary "Imposes a duty on the state" ;
cml:conclusionText "The person must take steps to recall the goods" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30f-ss-3 a cml:Concept ;
skos:prefLabel "30F(3) Criminal offences for goods exempt under section 18A not"@en ;
cml:realizedBy doc:sec-30f-ss-3 ;
cml:integrityHash "ac38ab52705ca8a59d3c56c85e414815518c888c35280f432819bc27670b3e89" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30f ;
skos:note "Specify steps for recall of goods" ;
dc:description "Steps to be taken, manner of taking, reasonable period" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.238" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30f-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-30f-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30f-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-30f-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-30f-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30f-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Specify steps for recall of goods" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30f-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-30f-ss-3-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-30f-ss-3-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "CONTAINS" ;
cml:logicSummary "Temporal interval for recall" ;
cml:premiseText "(a) the steps to be taken, (b) the manner in which the steps are to be taken, (c) a reasonable period within which the steps are to be taken" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30f-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-30f-ss-3-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-30f-ss-3-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "CONTAINS" ;
cml:logicSummary "Temporal interval for recall" ;
cml:premiseText "(a) the steps to be taken, (b) the manner in which the steps are to be taken, (c) a reasonable period within which the steps are to be taken" ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30f-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-30f-ss-3-logic-diffusion-4 .
concept:therapeutic-goods-act-1989-sec-30f-ss-3-logic-diffusion-4 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "CONTAINS" ;
cml:logicSummary "Diffusion of recall requirements" ;
cml:premiseText "(a) the steps to be taken, (b) the manner in which the steps are to be taken, (c) a reasonable period within which the steps are to be taken" ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30f-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-30f-ss-3-logic-cogai-5 .
concept:therapeutic-goods-act-1989-sec-30f-ss-3-logic-cogai-5 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "CONTAINS" ;
cml:logicSummary "Artificial intelligence application for recall requirements" ;
cml:premiseText "(a) the steps to be taken, (b) the manner in which the steps are to be taken, (c) a reasonable period within which the steps are to be taken" ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30f-ss-4 a cml:Concept ;
skos:prefLabel "30F(4) Criminal offences for goods exempt under section 18A not"@en ;
cml:realizedBy doc:sec-30f-ss-4 ;
cml:integrityHash "4f3df3e367af89fa108808bc58b426a849df68dbbe2aa0ed9001e9f611955ac1" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30f ;
skos:note "Publish notice in Gazette or Department's website" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.238" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30f-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-30f-ss-4-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30f-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-30f-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-30f-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30f-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Must publish notice" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30f-ss-4a a cml:Concept ;
skos:prefLabel "30F(4A) Criminal offences for goods exempt under section 18A not"@en ;
cml:realizedBy doc:sec-30f-ss-4a ;
cml:integrityHash "7ebd8475f22eec6693df87720bc9abe216cfe210b3f07867ef38be915a8f5704" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30f ;
skos:note "A written notice given to a person by the Secretary under this section is not a legislative instrument." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.238" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30f-ss-4a-norm .
concept:therapeutic-goods-act-1989-sec-30f-ss-4a-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30f-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-30f-ss-4a cml:asserts concept:therapeutic-goods-act-1989-sec-30f-ss-4a-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30f-ss-4a-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibition" ;
cml:logicSummary "Prohibits notices from being considered legislative instruments." ;
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-30f-ss-4b a cml:Concept ;
skos:prefLabel "30F(4B) Criminal offences for goods exempt under section 18A not"@en ;
cml:realizedBy doc:sec-30f-ss-4b ;
cml:integrityHash "0adfcc10519709f44bf4af8223516387f5bf4613d270c5d6ec9bbf75c440dbcd" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30f ;
skos:note "Failure to comply with a notice results in harm or injury." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.238" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30f-ss-4b-norm .
concept:therapeutic-goods-act-1989-sec-30f-ss-4b-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30f-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-30f-ss-4b cml:asserts concept:therapeutic-goods-act-1989-sec-30f-ss-4b-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30f-ss-4b-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibition" ;
cml:logicSummary "Prohibits non-compliance with a notice." ;
cml:premiseText "The Secretary gives a notice to the person under subsection (2); and" ;
cml:conclusionText "the person fails to comply with that requirement; and" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30f-ss-4b cml:asserts concept:therapeutic-goods-act-1989-sec-30f-ss-4b-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-30f-ss-4b-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Overlaps" ;
cml:logicSummary "The provision applies to temporal intervals where harm or injury occurs." ;
cml:premiseText "the harm or injury has resulted, will result, is likely to result, would result, or would be likely to result, because the person failed to comply with that requirement." ;
cml:conclusionText "because the person failed to comply with that requirement." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30f-ss-4b cml:asserts concept:therapeutic-goods-act-1989-sec-30f-ss-4b-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-30f-ss-4b-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "Repeats" ;
cml:logicSummary "The provision is repeated for each occurrence of harm or injury." ;
cml:premiseText "the use of the goods has resulted in, will result in, or is likely to result in, harm or injury to any person; or" ;
cml:conclusionText "or would be likely to result in, harm or injury to any person;" ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30f-ss-4b cml:asserts concept:therapeutic-goods-act-1989-sec-30f-ss-4b-logic-deontic-4 .
concept:therapeutic-goods-act-1989-sec-30f-ss-4b-logic-deontic-4 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Imposes an obligation on the person to comply with the notice." ;
cml:premiseText "A person commits an offence if:" ;
cml:conclusionText "the person fails to comply with that requirement; and" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30f-ss-4b cml:asserts concept:therapeutic-goods-act-1989-sec-30f-ss-4b-logic-deontic-5 .
concept:therapeutic-goods-act-1989-sec-30f-ss-4b-logic-deontic-5 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibition" ;
cml:logicSummary "Prohibits non-compliance with the notice." ;
cml:premiseText "A person commits an offence if:" ;
cml:conclusionText "the person fails to comply with that requirement; and" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30f-ss-5 a cml:Concept ;
skos:prefLabel "30F(5) Criminal offences for goods exempt under section 18A not"@en ;
cml:realizedBy doc:sec-30f-ss-5 ;
cml:integrityHash "9bf6e1ccd78a5af70f2576d50ed44578a9bb4897064514de4329a5064f740990" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30f ;
skos:note "Failure to comply with notice requirement is an offence." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.238" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30f-ss-5-norm .
concept:therapeutic-goods-act-1989-sec-30f-ss-5-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30f-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-30f-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-30f-ss-5-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30f-ss-5-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Obligation to comply with notice requirement." ;
cml:premiseText "The Secretary gives a notice to the person under subsection (2); and" ;
cml:conclusionText "the person fails to comply with that requirement." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30f-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-30f-ss-5-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-30f-ss-5-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Overlaps" ;
cml:logicSummary "Compliance with notice requirement overlaps with the offence of failing to comply." ;
cml:premiseText "The person commits an offence if: (a) the Secretary gives a notice to the person under subsection (2); and (b) the notice specifies a particular requirement mentioned in subsection (3); and" ;
cml:conclusionText "the person fails to comply with that requirement." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30f-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-30f-ss-5-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-30f-ss-5-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "Recurrently" ;
cml:logicSummary "Compliance with notice requirement is recurrently related to the offence of failing to comply." ;
cml:premiseText "The person commits an offence if: (a) the Secretary gives a notice to the person under subsection (2); and (b) the notice specifies a particular requirement mentioned in subsection (3); and" ;
cml:conclusionText "the person fails to comply with that requirement." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30f-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-30f-ss-5-logic-deontic-4 .
concept:therapeutic-goods-act-1989-sec-30f-ss-5-logic-deontic-4 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Obligation to pay penalty for failing to comply with notice requirement." ;
cml:premiseText "Penalty: Imprisonment for 12 months or 1,000 penalty units, or both." ;
cml:conclusionText "the person fails to comply with that requirement." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30f-ss-6 a cml:Concept ;
skos:prefLabel "30F(6) Criminal offences for goods exempt under section 18A not"@en ;
cml:realizedBy doc:sec-30f-ss-6 ;
cml:integrityHash "d99e1b7faf79f004b1adceba6aa6811994012fa3e8735c0cfbb34b9760458495" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30f ;
skos:note "A person commits an offence if the Secretary gives a notice to the person under subsection (2)" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.238" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30f-ss-6-norm .
concept:therapeutic-goods-act-1989-sec-30f-ss-6-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30f-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-30f-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-30f-ss-6-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30f-ss-6-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "hasObligation" ;
cml:logicSummary "Has obligation" ;
cml:premiseText "The Secretary gives a notice to the person under subsection (2)" ;
cml:conclusionText "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-30f-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-30f-ss-6-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-30f-ss-6-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "overlaps" ;
cml:logicSummary "Overlaps with" ;
cml:premiseText "Chapter 3 Medicines and other therapeutic goods that are not medical devices" ;
cml:conclusionText "Section 30F(6)" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30fa a cml:Concept ;
skos:prefLabel "30FA Civil penalty for goods exempt under section 18A not"@en ;
cml:realizedBy doc:sec-30fa ;
cml:integrityHash "77b8fdca45d638bf5b177ade91d457a92ac3577489fc403845880bebdf100cd4" ;
skos:note "Civil penalty for non-compliance with standards" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.240" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30fa-norm .
concept:therapeutic-goods-act-1989-sec-30fa-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30fa ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30fa cml:asserts concept:therapeutic-goods-act-1989-sec-30fa-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30fa-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits non-compliance" ;
cml:premiseText "Notice specifies requirement" ;
cml:conclusionText "Non-compliance is prohibited" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30g a cml:Concept ;
skos:prefLabel "30G Disposal of unused goods exempt under section 18A"@en ;
cml:realizedBy doc:sec-30g ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30g-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30g-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30g-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30g-ss-4 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.240" .
concept:therapeutic-goods-act-1989-sec-30g-ss-1 a cml:Concept ;
skos:prefLabel "30G(1) Disposal of unused goods exempt under section 18A"@en ;
cml:realizedBy doc:sec-30g-ss-1 ;
cml:integrityHash "6e2e8dfa43d1530ceee8e7978c257e33f22517102893b68af9405cf278cbba50" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30g ;
skos:note "Therapeutic goods must be used before an exemption ceases to have effect." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.240" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30g-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-30g-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30g-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-30g-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-30g-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30g-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Therapeutic goods must be used before an exemption 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-30g-ss-2 a cml:Concept ;
skos:prefLabel "30G(2) Disposal of unused goods exempt under section 18A"@en ;
cml:realizedBy doc:sec-30g-ss-2 ;
cml:integrityHash "08ce4156279bb1eda5c3a02a8ff3e5b56c6a38660ac584a1925924d7ba22c197" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30g ;
skos:note "The Secretary must arrange for disposal of unused goods." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.240" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30g-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-30g-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30g-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-30g-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-30g-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30g-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Obligation to arrange for disposal" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30g-ss-3 a cml:Concept ;
skos:prefLabel "30G(3) Disposal of unused goods exempt under section 18A"@en ;
cml:realizedBy doc:sec-30g-ss-3 ;
cml:integrityHash "a1e0e95f92fb5549863b8b26ca8a4510fedcdb25bb8c23418f213928778bfeca" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30g ;
skos:note "Methods for disposal of goods" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.240" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30g-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-30g-ss-3-norm a values:Undertaking ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30g-ss-3 ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30g-ss-4 a cml:Concept ;
skos:prefLabel "30G(4) Disposal of unused goods exempt under section 18A"@en ;
cml:realizedBy doc:sec-30g-ss-4 ;
cml:integrityHash "a623d3286b059b1169be944b65c7d87f1f83791abbd1270b6c325a9ae82f1759" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30g ;
skos:note "No benefit can be conferred on a person other than the owner of goods" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.240" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30g-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-30g-ss-4-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30g-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-30g-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-30g-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30g-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Cannot" ;
cml:logicSummary "No benefit can be conferred" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30h a cml:Concept ;
skos:prefLabel "30H Record for goods exempt under section 18A"@en ;
cml:realizedBy doc:sec-30h ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30h-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30h-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-30h-ss-3 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.241" .
concept:therapeutic-goods-act-1989-sec-30h-ss-1 a cml:Concept ;
skos:prefLabel "30H(1) Record for goods exempt under section 18A"@en ;
cml:realizedBy doc:sec-30h-ss-1 ;
cml:integrityHash "27130c3bc7c38cc95d5d24eddad3b11b0e85cb6db8df657450766e6d53a31556" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30h ;
skos:note "Keeping a record of therapeutic goods exempt under section 18A is required." ;
dc:description "Record keeping" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.241" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30h-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-30h-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30h-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-30h-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-30h-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30h-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Requires" ;
cml:logicSummary "The exemption requires record keeping." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30h-ss-2 a cml:Concept ;
skos:prefLabel "30H(2) Record for goods exempt under section 18A"@en ;
cml:realizedBy doc:sec-30h-ss-2 ;
cml:integrityHash "c9073f5b3de1691ba95af8e23d995cdd8ae82be111e22e0298152fe06cb21679" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30h ;
skos:note "Strict liability applies to paragraph (1)(b)" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.241" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30h-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-30h-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30h-ss-2 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30h-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-30h-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30h-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "applies" ;
cml:logicSummary "Strict liability obligation" ;
cml:premiseText "(2) Strict liability applies to paragraph (1)(b)" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-30h-ss-3 a cml:Concept ;
skos:prefLabel "30H(3) Record for goods exempt under section 18A"@en ;
cml:realizedBy doc:sec-30h-ss-3 ;
cml:integrityHash "bf53a44a3a35158ffc86b6e6c89d9b65271a7e82c0bde7dcf45418b160ec90c4" ;
values:partOf concept:therapeutic-goods-act-1989-sec-30h ;
skos:note "Keeping a record about therapeutic goods exempt under section 18A is required." ;
dc:description "Record keeping" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.241" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-30h-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-30h-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-30h-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-30h-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-30h-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-30h-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Obligation to keep a record" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-31 a cml:Concept ;
skos:prefLabel "31 Secretary may require information or documents"@en ;
cml:realizedBy doc:sec-31 ;
cml:integrityHash "877d7890c288f39381029382e437b17a4a8c948b846d530428db4b883869487b" ;
skos:note "The Secretary may require information or documents from a person." ;
dc:description "Yes" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.242" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-31-norm .
concept:therapeutic-goods-act-1989-sec-31-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-31 ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-31 cml:asserts concept:therapeutic-goods-act-1989-sec-31-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-31-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MAY" ;
cml:logicSummary "The 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-31a a cml:Concept ;
skos:prefLabel "31A Secretary may require information etc. about goods exempt"@en ;
cml:realizedBy doc:sec-31a ;
cml:integrityHash "e301885500dfdc53b65c9cbb5f7acd042e0e1b4a1d7440aef269bc1e24ef05db" ;
skos:note "Secretary may require sponsor to provide specified information about exempt goods for experimental purposes in humans." ;
dc:description "Yes" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.249" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-31a-norm .
concept:therapeutic-goods-act-1989-sec-31a-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-31a ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-31a cml:asserts concept:therapeutic-goods-act-1989-sec-31a-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-31a-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MAY" ;
cml:logicSummary "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-31aa a cml:Concept ;
skos:prefLabel "31AA Secretary may require information etc. about goods exempt"@en ;
cml:realizedBy doc:sec-31aa ;
cml:integrityHash "c6f998e68ddcbd55bff9d37cc2c21469aa6b9847c82f2c01efd57fcb40f3166f" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-31aa-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-31aa-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-31aa-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-31aa-ss-4 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.251" .
concept:therapeutic-goods-act-1989-sec-31aa-ss-1 a cml:Concept ;
skos:prefLabel "31AA(1) Secretary may require information etc. about goods exempt"@en ;
cml:realizedBy doc:sec-31aa-ss-1 ;
cml:integrityHash "2a88bb72301aeb106835c45bb9e9b857eda54b409eba5955273f301b737f470c" ;
values:partOf concept:therapeutic-goods-act-1989-sec-31aa ;
skos:note "Secretary may require information about goods exempt" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.251" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-31aa-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-31aa-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-31aa-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-31aa-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-31aa-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-31aa-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "requires" ;
cml:logicSummary "Requires information" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-31aa-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-31aa-ss-1-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-31aa-ss-1-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "between" ;
cml:logicSummary "Between a condition and a person" ;
cml:premiseText "(1) This section applies to a person who is required to comply with a condition of an exemption of therapeutic goods under section 18A." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-31aa-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-31aa-ss-1-logic-argumentation-3 .
concept:therapeutic-goods-act-1989-sec-31aa-ss-1-logic-argumentation-3 a cml:LogicApplication ;
cml:modality cml:Argumentation ;
cml:operator "may lead to" ;
cml:logicSummary "May lead to further action" ;
cml:executionSurface "modalities::argumentation" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-31aa-ss-2 a cml:Concept ;
skos:prefLabel "31AA(2) Secretary may require information etc. about goods exempt"@en ;
cml:realizedBy doc:sec-31aa-ss-2 ;
cml:integrityHash "36b1ad9b8454af6fe1c2721492cf409028277938fbc51a7a0e80738cb8286ac5" ;
values:partOf concept:therapeutic-goods-act-1989-sec-31aa ;
skos:note "The Secretary may require information from a person about goods exempt." ;
dc:description "true" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.251" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-31aa-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-31aa-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-31aa-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-31aa-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-31aa-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-31aa-ss-2-logic-deontic-1 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-31aa-ss-3 a cml:Concept ;
skos:prefLabel "31AA(3) Secretary may require information etc. about goods exempt"@en ;
cml:realizedBy doc:sec-31aa-ss-3 ;
cml:integrityHash "3cd028cc3fd5851f396c2f973817d7f67d4fdcff127b2b498288fa5ebd28643d" ;
values:partOf concept:therapeutic-goods-act-1989-sec-31aa ;
skos:note "Secretary must require information within a specified period." ;
dc:description "Information about goods exempt" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.251" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-31aa-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-31aa-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-31aa-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-31aa-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-31aa-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-31aa-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-31aa-ss-4 a cml:Concept ;
skos:prefLabel "31AA(4) Secretary may require information etc. about goods exempt"@en ;
cml:realizedBy doc:sec-31aa-ss-4 ;
cml:integrityHash "45c5d705dc7db097b5af7baa1404fcfef943b583f2a458671dd111da3090167b" ;
values:partOf concept:therapeutic-goods-act-1989-sec-31aa ;
skos:note "Secretary must require information about goods exempt" ;
dc:description "Information" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.251" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-31aa-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-31aa-ss-4-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-31aa-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-31aa-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-31aa-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-31aa-ss-4-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-31aa-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-31aa-ss-4-logic-descriptionlogic-2 .
concept:therapeutic-goods-act-1989-sec-31aa-ss-4-logic-descriptionlogic-2 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "hasPart" ;
cml:logicSummary "Classifies goods exempt" ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-31b a cml:Concept ;
skos:prefLabel "31B Secretary may require information relating to approvals and"@en ;
cml:realizedBy doc:sec-31b ;
cml:integrityHash "bef4ff44bc88275ff356fff89618a6d74be64a80d041fd0f95d83862153f4ad7" ;
skos:note "Secretary may require information from a person granted an approval under subsection 19(1)" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.251" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-31b-norm .
concept:therapeutic-goods-act-1989-sec-31b-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-31b ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-31ba a cml:Concept ;
skos:prefLabel "31BA Secretary may require information about therapeutic goods"@en ;
cml:realizedBy doc:sec-31ba ;
cml:integrityHash "04847e4713245e7bf2b31e2862d72f050a9af1ed10d7fc52de020585a81c0145" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-31ba-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-31ba-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-31ba-ss-3 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.254" .
concept:therapeutic-goods-act-1989-sec-31ba-ss-1 a cml:Concept ;
skos:prefLabel "31BA(1) Secretary may require information about therapeutic goods"@en ;
cml:realizedBy doc:sec-31ba-ss-1 ;
cml:integrityHash "ecea591eb90562e28916ecc1892fd15733206cc349ce01e41443d8f03393a448" ;
values:partOf concept:therapeutic-goods-act-1989-sec-31ba ;
skos:note "The Secretary may require information about therapeutic goods from a person granted an approval." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.254" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-31ba-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-31ba-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-31ba-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-31ba-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-31ba-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-31ba-ss-1-logic-deontic-1 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-31ba-ss-2 a cml:Concept ;
skos:prefLabel "31BA(2) Secretary may require information about therapeutic goods"@en ;
cml:realizedBy doc:sec-31ba-ss-2 ;
cml:integrityHash "ccefbed566d95dc3ff072f312dff877c801468012ecba837bb05cdde4b2488ec" ;
values:partOf concept:therapeutic-goods-act-1989-sec-31ba ;
skos:note "Must provide information within a specified period and in the form specified by the notice." ;
dc:description "true" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.254" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-31ba-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-31ba-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-31ba-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-31ba-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-31ba-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-31ba-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Must provide information 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-31ba-ss-3 a cml:Concept ;
skos:prefLabel "31BA(3) Secretary may require information about therapeutic goods"@en ;
cml:realizedBy doc:sec-31ba-ss-3 ;
cml:integrityHash "999e17e97c5dea127f3240fd393f3fe0ec24fd37d2d7e946d2d6490a19414b48" ;
values:partOf concept:therapeutic-goods-act-1989-sec-31ba ;
skos:note "Secretary may require information about therapeutic goods in specified ways." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.254" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-31ba-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-31ba-ss-3-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-31ba-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-31c a cml:Concept ;
skos:prefLabel "31C Criminal offences for failing to give information or documents"@en ;
cml:realizedBy doc:sec-31c ;
cml:integrityHash "a79e4cc5ec0d8659396307f90adb4e677b5b3cf6d2130ca8cdc48ad1956fe850" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-31c-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-31c-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-31c-ss-3 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.254" .
concept:therapeutic-goods-act-1989-sec-31c-ss-1 a cml:Concept ;
skos:prefLabel "31C(1) Criminal offences for failing to give information or documents"@en ;
cml:realizedBy doc:sec-31c-ss-1 ;
cml:integrityHash "95110c5aa0b88732c842cfd2be5e2368692158d7dd9dd8ce98c1743897268a7f" ;
values:partOf concept:therapeutic-goods-act-1989-sec-31c ;
skos:note "Failure to comply with a notice results in an offence." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.254" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-31c-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-31c-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-31c-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-31c-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-31c-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-31c-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-31c-ss-2 a cml:Concept ;
skos:prefLabel "31C(2) Criminal offences for failing to give information or documents"@en ;
cml:realizedBy doc:sec-31c-ss-2 ;
cml:integrityHash "1d41c1bb964d36ce3c30a7c01ca5d4af0cb52a022fcf85506e60f5b1dbb3c34d" ;
values:partOf concept:therapeutic-goods-act-1989-sec-31c ;
skos:note "Failure to comply with a notice results in an offence." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.254" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-31c-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-31c-ss-2-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-31c-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-31c-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-31c-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-31c-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibition" ;
cml:logicSummary "Prohibits failing to comply with a 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-31c-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-31c-ss-2-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-31c-ss-2-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Overlaps" ;
cml:logicSummary "Indicates that failing to comply with a notice overlaps with committing an offence." ;
cml:premiseText "(2) A person commits an offence if..." ;
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-31c-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-31c-ss-2-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-31c-ss-2-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "Repeats" ;
cml:logicSummary "Indicates that failing to comply with a notice repeats the action of committing an offence." ;
cml:premiseText "(2) A person commits an offence 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-31c-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-31c-ss-2-logic-diffusion-4 .
concept:therapeutic-goods-act-1989-sec-31c-ss-2-logic-diffusion-4 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "Diffuses" ;
cml:logicSummary "Diffuses the information that failing to comply with a notice results in an offence." ;
cml:premiseText "(2) A person commits an offence if..." ;
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-31c-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-31c-ss-2-logic-cogai-5 .
concept:therapeutic-goods-act-1989-sec-31c-ss-2-logic-cogai-5 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "Recognizes" ;
cml:logicSummary "Recognizes the pattern of failing to comply with a notice resulting in an offence." ;
cml:premiseText "(2) A person commits an offence if..." ;
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-31c-ss-3 a cml:Concept ;
skos:prefLabel "31C(3) Criminal offences for failing to give information or documents"@en ;
cml:realizedBy doc:sec-31c-ss-3 ;
cml:integrityHash "6399dd55215449c5a9d06b6bb311756ebbb1965b41b9ee0659fbcac6e7efa0c6" ;
values:partOf concept:therapeutic-goods-act-1989-sec-31c ;
skos:note "Duty to provide information or documents" ;
dc:description "true" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.254" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-31c-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-31c-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-31c-ss-3 ;
values:borneBy values:NaturalPerson ;
skos:scopeNote "borne by: NaturalPerson" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-31c-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-31c-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-31c-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "obligation" ;
cml:logicSummary "Obligation to 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-31d a cml:Concept ;
skos:prefLabel "31D False or misleading information"@en ;
cml:realizedBy doc:sec-31d ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-31d-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-31d-ss-1a ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.255" .
concept:therapeutic-goods-act-1989-sec-31d-ss-1 a cml:Concept ;
skos:prefLabel "31D(1) False or misleading information"@en ;
cml:realizedBy doc:sec-31d-ss-1 ;
cml:integrityHash "8cbd54068536a9b02bfae57ab442d07a7ae0837f774ddcda0e4a0ca5d623fa87" ;
values:partOf concept:therapeutic-goods-act-1989-sec-31d ;
skos:note "Giving false or misleading information in compliance with a notice is an offence." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.255" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-31d-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-31d-ss-1-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-31d-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-31d-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-31d-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-31d-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibition" ;
cml:logicSummary "Prohibits giving false or misleading information in compliance with a notice." ;
cml:premiseText "The person gives information to the Secretary in compliance or purported compliance with the notice." ;
cml:conclusionText "The person commits an offence if they do so knowing that the information is false or misleading." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-31d-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-31d-ss-1-logic-deontic-2 .
concept:therapeutic-goods-act-1989-sec-31d-ss-1-logic-deontic-2 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Imposes a duty on the person to not give false or misleading information in compliance with a notice." ;
cml:premiseText "The person does so knowing that the information is false or misleading." ;
cml:conclusionText "The person commits an offence if they do so." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-31d-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-31d-ss-1-logic-deontic-3 .
concept:therapeutic-goods-act-1989-sec-31d-ss-1-logic-deontic-3 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibition" ;
cml:logicSummary "Prohibits giving false or misleading information in purported compliance with a notice." ;
cml:premiseText "The person gives information to the Secretary in purported compliance with the notice." ;
cml:conclusionText "The person commits an offence if they do so knowing that the information is false or misleading." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-31d-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-31d-ss-1-logic-deontic-4 .
concept:therapeutic-goods-act-1989-sec-31d-ss-1-logic-deontic-4 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Imposes a duty on the person to not give false or misleading information in purported compliance with a notice." ;
cml:premiseText "The person gives information to the Secretary in purported compliance with the notice." ;
cml:conclusionText "The person commits an offence if they do so knowing that the information is false or misleading." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-31d-ss-1a a cml:Concept ;
skos:prefLabel "31D(1A) False or misleading information"@en ;
cml:realizedBy doc:sec-31d-ss-1a ;
cml:integrityHash "24067eb6b5d79f1a00096ce5ca92b5bdcbcd9832967eb89031b06ebde06e15cc" ;
values:partOf concept:therapeutic-goods-act-1989-sec-31d ;
skos:note "Giving false or misleading information after receiving a notice is an offence." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.255" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-31d-ss-1a-norm .
concept:therapeutic-goods-act-1989-sec-31d-ss-1a-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-31d-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-31d-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-31d-ss-1a-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-31d-ss-1a-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibition" ;
cml:logicSummary "Prohibits giving false or misleading information after receiving a notice." ;
cml:premiseText "The person gives information to the Secretary in compliance or purported compliance with the notice." ;
cml:conclusionText "The person commits an offence if the information is false or misleading." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-31d-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-31d-ss-1a-logic-deontic-2 .
concept:therapeutic-goods-act-1989-sec-31d-ss-1a-logic-deontic-2 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Imposes an obligation on the person to give accurate information after receiving a notice." ;
cml:premiseText "The person is required to give 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-31d-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-31d-ss-1a-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-31d-ss-1a-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "TemporalInterval" ;
cml:logicSummary "Specifies the temporal interval for giving false or misleading information as after receiving a notice." ;
cml:premiseText "The person gives information to the Secretary in compliance or purported compliance with the notice." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-31d-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-31d-ss-1a-logic-deontic-4 .
concept:therapeutic-goods-act-1989-sec-31d-ss-1a-logic-deontic-4 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibition" ;
cml:logicSummary "Prohibits omitting any matter or thing without which the information is misleading." ;
cml:premiseText "The information omits any matter or thing 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-31d-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-31d-ss-1a-logic-deontic-5 .
concept:therapeutic-goods-act-1989-sec-31d-ss-1a-logic-deontic-5 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Imposes an obligation on the person to provide accurate information that includes all necessary matters and things." ;
cml:premiseText "The information must include all matter and thing 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-31e a cml:Concept ;
skos:prefLabel "31E False or misleading documents"@en ;
cml:realizedBy doc:sec-31e ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-31e-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-31e-ss-1a ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-31e-ss-1b ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-31e-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-31e-ss-3 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.256" .
concept:therapeutic-goods-act-1989-sec-31e-ss-1 a cml:Concept ;
skos:prefLabel "31E(1) False or misleading documents"@en ;
cml:realizedBy doc:sec-31e-ss-1 ;
cml:integrityHash "c95b51d234355cf6fd8c9ed88c8c7f046a1d317fe6943fad96fafee86187e23b" ;
values:partOf concept:therapeutic-goods-act-1989-sec-31e ;
skos:note "Producing false or misleading documents is an offence." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.256" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-31e-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-31e-ss-1-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-31e-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-31e-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-31e-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-31e-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits producing false or misleading documents." ;
cml:premiseText "The document is produced in compliance or purported compliance with a notice given under section 31A, 31AA, 31B or 31BA." ;
cml:conclusionText "The person commits an offence if the document is produced knowing that it is false or misleading." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-31e-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-31e-ss-1-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-31e-ss-1-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Temporal Interval" ;
cml:logicSummary "Defines a temporal interval for producing documents." ;
cml:premiseText "(1) A person commits an offence if: (a) the person produces a document to the Secretary; and (b) the person does so knowing that the document is false or misleading; and (c) the document is produced in compliance or purported compliance with a notice given under section 31A, 31AA, 31B or 31BA." ;
cml:conclusionText "The temporal interval for producing documents starts at (1)" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-31e-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-31e-ss-1-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-31e-ss-1-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "Recurring Trace" ;
cml:logicSummary "Defines a recurring trace of document production." ;
cml:premiseText "(1) A person commits an offence if: (a) the person produces a document to the Secretary; and (b) the person does so knowing that the document is false or misleading; and (c) the document is produced in compliance or purported compliance with a notice given under section 31A, 31AA, 31B or 31BA." ;
cml:conclusionText "The recurring trace of document production starts at (1)" ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-31e-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-31e-ss-1-logic-diffusion-4 .
concept:therapeutic-goods-act-1989-sec-31e-ss-1-logic-diffusion-4 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "Diffuse" ;
cml:logicSummary "Diffuses the prohibition to all agents." ;
cml:premiseText "(1) A person commits an offence if: (a) the person produces a document to the Secretary; and (b) the person does so knowing that the document is false or misleading; and (c) the document is produced in compliance or purported compliance with a notice given under section 31A, 31AA, 31B or 31BA." ;
cml:conclusionText "The prohibition diffuses to all agents who produce documents." ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-31e-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-31e-ss-1-logic-cogai-5 .
concept:therapeutic-goods-act-1989-sec-31e-ss-1-logic-cogai-5 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "Classify" ;
cml:logicSummary "Classifies the document as true or false/misleading using AI." ;
cml:premiseText "(1) A person commits an offence if: (a) the person produces a document to the Secretary; and (b) the person does so knowing that the document is false or misleading; and (c) the document is produced in compliance or purported compliance with a notice given under section 31A, 31AA, 31B or 31BA." ;
cml:conclusionText "The document is classified as true or false/misleading using AI." ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-31e-ss-1a a cml:Concept ;
skos:prefLabel "31E(1A) False or misleading documents"@en ;
cml:realizedBy doc:sec-31e-ss-1a ;
cml:integrityHash "6fa37081d617a2cbb57faf543ad7f53e2aed31a85e0cb1f63957878620214fe3" ;
values:partOf concept:therapeutic-goods-act-1989-sec-31e ;
skos:note "Producing false or misleading documents in compliance with a notice is an offence." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.256" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-31e-ss-1a-norm .
concept:therapeutic-goods-act-1989-sec-31e-ss-1a-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-31e-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-31e-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-31e-ss-1a-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-31e-ss-1a-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibition" ;
cml:logicSummary "Prohibits producing false or misleading documents in compliance with a notice." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-31e-ss-1b a cml:Concept ;
skos:prefLabel "31E(1B) False or misleading documents"@en ;
cml:realizedBy doc:sec-31e-ss-1b ;
cml:integrityHash "0e0cdce4f49bcdede84da2c8cb10ce3f352a4869982d14472853df3c1e9c44ee" ;
values:partOf concept:therapeutic-goods-act-1989-sec-31e ;
skos:note "Offence of strict liability for false or misleading documents" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.256" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-31e-ss-1b-norm .
concept:therapeutic-goods-act-1989-sec-31e-ss-1b-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-31e-ss-1b ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-31e-ss-1b cml:asserts concept:therapeutic-goods-act-1989-sec-31e-ss-1b-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-31e-ss-1b-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibition" ;
cml:logicSummary "Prohibits 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-31e-ss-2 a cml:Concept ;
skos:prefLabel "31E(2) False or misleading documents"@en ;
cml:realizedBy doc:sec-31e-ss-2 ;
cml:integrityHash "2c3d92b51b834d223d710dc2f8cb28326eb41d64fcde25fc0028c501ecee9d98" ;
values:partOf concept:therapeutic-goods-act-1989-sec-31e ;
skos:note "Defendant bears evidential burden in relation to the matter." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.256" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-31e-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-31e-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-31e-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-31e-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-31e-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-31e-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-31e-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-31e-ss-2-logic-epistemic-2 .
concept:therapeutic-goods-act-1989-sec-31e-ss-2-logic-epistemic-2 a cml:LogicApplication ;
cml:modality cml:Epistemic ;
cml:operator "evidential burden" ;
cml:logicSummary "Defendant has a duty to provide evidence." ;
cml:executionSurface "modalities::epistemic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-31e-ss-3 a cml:Concept ;
skos:prefLabel "31E(3) False or misleading documents"@en ;
cml:realizedBy doc:sec-31e-ss-3 ;
cml:integrityHash "e9336a74b01a2846118c1e33ea5bf36b037f1e7cc68e8ca2d19d0bae7640dffc" ;
values:partOf concept:therapeutic-goods-act-1989-sec-31e ;
skos:note "Exemption from subsection (1) or (1A) for documents accompanied by a written statement" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.256" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-31e-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-31e-ss-3-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-31e-ss-3 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-31f a cml:Concept ;
skos:prefLabel "31F Self-incrimination"@en ;
cml:realizedBy doc:sec-31f ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-31f-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-31f-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.257" .
concept:therapeutic-goods-act-1989-sec-31f-ss-1 a cml:Concept ;
skos:prefLabel "31F(1) Self-incrimination"@en ;
cml:realizedBy doc:sec-31f-ss-1 ;
cml:integrityHash "3ca17c1aeb0c96e40f199c8a0a5a55ba354878370dda88ab4f2005975b5e759f" ;
values:partOf concept:therapeutic-goods-act-1989-sec-31f ;
skos:note "No excuse for giving information under certain notices" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.257" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-31f-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-31f-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-31f-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-31f-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-31f-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-31f-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-31f-ss-2 a cml:Concept ;
skos:prefLabel "31F(2) Self-incrimination"@en ;
cml:realizedBy doc:sec-31f-ss-2 ;
cml:integrityHash "a5170f520055e58779cda61ab645c5d031f60c1f785bceb15f1f6d1987278dbc" ;
values:partOf concept:therapeutic-goods-act-1989-sec-31f ;
skos:note "Protection against self-incrimination in certain cases" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.257" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-31f-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-31f-ss-2-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-31f-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-31f-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-31f-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-31f-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-32 a cml:Concept ;
skos:prefLabel "32 What this Part is about"@en ;
cml:realizedBy doc:sec-32 ;
cml:integrityHash "d9a8a890a88c4335375c74126e592e00162f9ef87ec76e1c65f8a053958d2965" ;
skos:note "Regulates biologicals by providing a process for inclusion in the Register and enforcement through criminal offences and civil penalties." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.259" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32-norm .
concept:therapeutic-goods-act-1989-sec-32-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32 ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32 cml:asserts concept:therapeutic-goods-act-1989-sec-32-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "regulates" ;
cml:logicSummary "Establishes a regulatory framework for biologicals." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32 cml:asserts concept:therapeutic-goods-act-1989-sec-32-logic-linearlogic-2 .
concept:therapeutic-goods-act-1989-sec-32-logic-linearlogic-2 a cml:LogicApplication ;
cml:modality cml:LinearLogic ;
cml:operator "provides" ;
cml:logicSummary "Establishes administrative processes for regulating biologicals." ;
cml:executionSurface "modalities::linear" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32a a cml:Concept ;
skos:prefLabel "32A Meaning of biological"@en ;
cml:realizedBy doc:sec-32a ;
cml:integrityHash "688e347afe658c99d9c5d23183a0f1bd1dc0fe12bcbdceacc38180dda8ad2b58" ;
skos:note "Defines what constitutes a biological." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.259" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32a-norm .
concept:therapeutic-goods-act-1989-sec-32a-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32a ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32aa a cml:Concept ;
skos:prefLabel "32AA Biological classes"@en ;
cml:realizedBy doc:sec-32aa ;
cml:integrityHash "e24bc7f4db33f66737936ceb7363370b3bdde49ff986958622f13b846cfcb56a" ;
skos:note "Regulations may prescribe different classes of biologicals." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.260" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32aa-norm .
concept:therapeutic-goods-act-1989-sec-32aa-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32aa ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32aa cml:asserts concept:therapeutic-goods-act-1989-sec-32aa-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32aa-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "mayPrescribe" ;
cml:logicSummary "May prescribe different classes of biologicals." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32aa cml:asserts concept:therapeutic-goods-act-1989-sec-32aa-logic-descriptionlogic-2 .
concept:therapeutic-goods-act-1989-sec-32aa-logic-descriptionlogic-2 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "classify" ;
cml:logicSummary "Classify biologicals into different classes." ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ab a cml:Concept ;
skos:prefLabel "32AB When biologicals are separate and distinct from other"@en ;
cml:realizedBy doc:sec-32ab ;
cml:integrityHash "999e230b8a5219a386be04788b21dc41b76be03fa3db0662e21d85b66b4f80fc" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32ab-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32ab-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.260" .
concept:therapeutic-goods-act-1989-sec-32ab-ss-1 a cml:Concept ;
skos:prefLabel "32AB(1) When biologicals are separate and distinct from other"@en ;
cml:realizedBy doc:sec-32ab-ss-1 ;
cml:integrityHash "dbbc85cba0a091bb5625a683b02d981a6248ab1a5a3afeff7adc108ccf610d34" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ab ;
skos:note "Regulations may prescribe circumstances for separate and distinct biologicals." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.260" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32ab-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32ab-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ab-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-32ab-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32ab-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32ab-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "mayPrescribe" ;
cml:logicSummary "Regulations may prescribe circumstances." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ab-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32ab-ss-1-logic-descriptionlogic-2 .
concept:therapeutic-goods-act-1989-sec-32ab-ss-1-logic-descriptionlogic-2 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "classify" ;
cml:logicSummary "Classify biologicals by specified class." ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ab-ss-2 a cml:Concept ;
skos:prefLabel "32AB(2) When biologicals are separate and distinct from other"@en ;
cml:realizedBy doc:sec-32ab-ss-2 ;
cml:integrityHash "63a462d5bb4ff2836c2e8eaf8561d71bd4113089cadb5e3dea1e8a9e017d7c35" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ab ;
skos:note "Different provision for different classes of biologicals" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.260" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32ab-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-32ab-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ab-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-32b a cml:Concept ;
skos:prefLabel "32B What this Division is about"@en ;
cml:realizedBy doc:sec-32b ;
cml:integrityHash "80b0d0676bfee26056dd3ed5682eb90172a72b0377a09f89fdc83fa37e80de5e" ;
skos:note "Defines criminal offences and civil penalties relating to biologicals." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.262" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32b-norm .
concept:therapeutic-goods-act-1989-sec-32b-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32b ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32b cml:asserts concept:therapeutic-goods-act-1989-sec-32b-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32b-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "is" ;
cml:logicSummary "Identifies the subject of the obligation." ;
cml:conclusionText "State" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ba a cml:Concept ;
skos:prefLabel "32BA Criminal offences for importing a biological"@en ;
cml:realizedBy doc:sec-32ba ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32ba-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32ba-ss-4 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32ba-ss-4a ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.262" .
concept:therapeutic-goods-act-1989-sec-32ba-ss-1 a cml:Concept ;
skos:prefLabel "32BA(1) Criminal offences for importing a biological"@en ;
cml:realizedBy doc:sec-32ba-ss-1 ;
cml:integrityHash "792913e2e247ca1544884ddb576f19a480297b1fd960a111ee98ac14d30f9bc3" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ba ;
skos:note "Importing a biological for use in humans is prohibited unless certain exemptions apply." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.262" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32ba-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32ba-ss-1-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ba-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-32ba-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32ba-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32ba-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-32ba-ss-4 a cml:Concept ;
skos:prefLabel "32BA(4) Criminal offences for importing a biological"@en ;
cml:realizedBy doc:sec-32ba-ss-4 ;
cml:integrityHash "75e3ae16b65bc4be99c0bfe5a38edb2a77af9a56f383e1cf324483c156e628e3" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ba ;
skos:note "Importing a biological for use in humans is prohibited." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.262" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32ba-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-32ba-ss-4-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ba-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-32ba-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-32ba-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32ba-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits the importation of a biological for use in humans." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ba-ss-4a a cml:Concept ;
skos:prefLabel "32BA(4A) Criminal offences for importing a biological"@en ;
cml:realizedBy doc:sec-32ba-ss-4a ;
cml:integrityHash "7c3b346f39b4c32183e5432c92496807dcc4f187df7b72a3a9e198edd7b7d07c" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ba ;
skos:note "Importing a biological for use in humans without registration is an offence." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.262" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32ba-ss-4a-norm .
concept:therapeutic-goods-act-1989-sec-32ba-ss-4a-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ba-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-32ba-ss-4a cml:asserts concept:therapeutic-goods-act-1989-sec-32ba-ss-4a-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32ba-ss-4a-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits importing a biological for use in humans without registration." ;
cml:premiseText "(4A) A person commits an offence if: (a) the person imports into Australia a biological for use in humans; and (b) none of the following subparagraphs applies:" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ba-ss-4a cml:asserts concept:therapeutic-goods-act-1989-sec-32ba-ss-4a-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-32ba-ss-4a-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Temporal Interval" ;
cml:logicSummary "Defines the temporal interval during which importing a biological for use in humans without registration is an offence." ;
cml:premiseText "(4A) A person commits an offence if: (a) the person imports into Australia a biological for use in humans; and (b) none of the following subparagraphs applies:" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ba-ss-4a cml:asserts concept:therapeutic-goods-act-1989-sec-32ba-ss-4a-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-32ba-ss-4a-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "Recurring Trace" ;
cml:logicSummary "Defines a recurring trace of importing a biological for use in humans without registration as an offence." ;
cml:premiseText "(4A) A person commits an offence if: (a) the person imports into Australia a biological for use in humans; and (b) none of the following subparagraphs applies:" ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ba-ss-4a cml:asserts concept:therapeutic-goods-act-1989-sec-32ba-ss-4a-logic-cogai-4 .
concept:therapeutic-goods-act-1989-sec-32ba-ss-4a-logic-cogai-4 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "Knowledge Representation" ;
cml:logicSummary "Represents importing a biological for use in humans without registration as an offence using knowledge representation." ;
cml:premiseText "(4A) A person commits an offence if: (a) the person imports into Australia a biological for use in humans; and (b) none of the following subparagraphs applies:" ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ba-ss-4a cml:asserts concept:therapeutic-goods-act-1989-sec-32ba-ss-4a-logic-shacl-5 .
concept:therapeutic-goods-act-1989-sec-32ba-ss-4a-logic-shacl-5 a cml:LogicApplication ;
cml:modality cml:SHACL ;
cml:operator "Schema Definition" ;
cml:logicSummary "Defines a schema definition for importing a biological for use in humans without registration as an offence." ;
cml:premiseText "(4A) A person commits an offence if: (a) the person imports into Australia a biological for use in humans; and (b) none of the following subparagraphs applies:" ;
cml:executionSurface "modalities::logic::shacl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32bb a cml:Concept ;
skos:prefLabel "32BB Criminal offences for exporting a biological"@en ;
cml:realizedBy doc:sec-32bb ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32bb-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32bb-ss-4 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.265" .
concept:therapeutic-goods-act-1989-sec-32bb-ss-1 a cml:Concept ;
skos:prefLabel "32BB(1) Criminal offences for exporting a biological"@en ;
cml:realizedBy doc:sec-32bb-ss-1 ;
cml:integrityHash "0a7daf3409b0e6b2288a3ab4647159ebb3596e2e12fa3fadcfa8cf8e8560a081" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32bb ;
skos:note "Exporting a biological for use in humans is prohibited." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.265" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32bb-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32bb-ss-1-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32bb-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-32bb-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32bb-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32bb-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits the export of a biological for use in humans." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32bb-ss-4 a cml:Concept ;
skos:prefLabel "32BB(4) Criminal offences for exporting a biological"@en ;
cml:realizedBy doc:sec-32bb-ss-4 ;
cml:integrityHash "c70b93dd58444bebdddf2f4d6be0e391c76e7affac958fcaac505848b55542b0" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32bb ;
skos:note "Exporting a biological for use in humans is prohibited." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.265" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32bb-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-32bb-ss-4-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32bb-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-32bb-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-32bb-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32bb-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits exporting a biological for use in humans." ;
cml:premiseText "(4) A person commits an offence if: (a) the person exports from Australia a biological for use in humans; and (b) none of the following subparagraphs applies:" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32bb-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-32bb-ss-4-logic-linearlogic-2 .
concept:therapeutic-goods-act-1989-sec-32bb-ss-4-logic-linearlogic-2 a cml:LogicApplication ;
cml:modality cml:LinearLogic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits exporting a biological for use in humans." ;
cml:premiseText "(4) A person commits an offence if: (a) the person exports from Australia a biological for use in humans; and (b) none of the following subparagraphs applies:" ;
cml:executionSurface "modalities::linear" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32bc a cml:Concept ;
skos:prefLabel "32BC Criminal offences for manufacturing a biological"@en ;
cml:realizedBy doc:sec-32bc ;
cml:integrityHash "fae1f67ea011d907dd77b46b41db5e86fa815e6a2125ca9947534c13ae77466c" ;
skos:note "Manufacturing a biological without proper authorization is prohibited." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.267" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32bc-norm .
concept:therapeutic-goods-act-1989-sec-32bc-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32bc ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32bc cml:asserts concept:therapeutic-goods-act-1989-sec-32bc-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32bc-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits the manufacture of biologicals without authorization." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32bd a cml:Concept ;
skos:prefLabel "32BD Criminal offences for supplying a biological"@en ;
cml:realizedBy doc:sec-32bd ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32bd-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32bd-ss-4 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32bd-ss-4a ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.270" .
concept:therapeutic-goods-act-1989-sec-32bd-ss-1 a cml:Concept ;
skos:prefLabel "32BD(1) Criminal offences for supplying a biological"@en ;
cml:realizedBy doc:sec-32bd-ss-1 ;
cml:integrityHash "8bbbd90ec595085a508f5546c78a6c034cfc06ba6766f62bf0d133fd16153e8e" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32bd ;
skos:note "Supplying a biological for use in humans is prohibited." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.270" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32bd-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32bd-ss-1-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32bd-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-32bd-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32bd-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32bd-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits supplying a biological for use in humans." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32bd-ss-4 a cml:Concept ;
skos:prefLabel "32BD(4) Criminal offences for supplying a biological"@en ;
cml:realizedBy doc:sec-32bd-ss-4 ;
cml:integrityHash "de13f9ca81eba433192e7a927047958e7fbf31bab0e2b4aaaaffe226567dc11a" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32bd ;
skos:note "Supplying a biological for use in humans is an offence." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.270" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32bd-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-32bd-ss-4-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32bd-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-32bd-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-32bd-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32bd-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits supplying a biological for use in humans." ;
cml:premiseText "(4) A person commits an offence if..." ;
cml:conclusionText "The supply of a biological for use in humans is prohibited." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32bd-ss-4a a cml:Concept ;
skos:prefLabel "32BD(4A) Criminal offences for supplying a biological"@en ;
cml:realizedBy doc:sec-32bd-ss-4a ;
cml:integrityHash "ed3f858ccff6ab4d9e70c3a2422d0668db91b2f473004b0af7e92724ef3604a4" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32bd ;
skos:note "Supplying a biological for use in humans is prohibited." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.270" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32bd-ss-4a-norm .
concept:therapeutic-goods-act-1989-sec-32bd-ss-4a-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32bd-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-32bd-ss-4a cml:asserts concept:therapeutic-goods-act-1989-sec-32bd-ss-4a-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32bd-ss-4a-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits supplying a biological for use in humans." ;
cml:premiseText "(4A) A person commits an offence if: (a) the person supplies in Australia a biological for use in humans;" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32bd-ss-4a cml:asserts concept:therapeutic-goods-act-1989-sec-32bd-ss-4a-logic-ltl-2 .
concept:therapeutic-goods-act-1989-sec-32bd-ss-4a-logic-ltl-2 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "Trace" ;
cml:logicSummary "Traces supplying a biological for use in humans to an offence." ;
cml:premiseText "(4A) A person commits an offence if: (a) the person supplies in Australia a biological for use in humans;" ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32bd-ss-4a cml:asserts concept:therapeutic-goods-act-1989-sec-32bd-ss-4a-logic-alleninterval-3 .
concept:therapeutic-goods-act-1989-sec-32bd-ss-4a-logic-alleninterval-3 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Between" ;
cml:logicSummary "Places supplying a biological for use in humans between committing an offence." ;
cml:premiseText "(4A) A person commits an offence if: (a) the person supplies in Australia a biological for use in humans;" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32bd-ss-4a cml:asserts concept:therapeutic-goods-act-1989-sec-32bd-ss-4a-logic-diffusion-4 .
concept:therapeutic-goods-act-1989-sec-32bd-ss-4a-logic-diffusion-4 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "Diffuse" ;
cml:logicSummary "Diffuses the prohibition of supplying a biological for use in humans." ;
cml:premiseText "(4A) A person commits an offence if: (a) the person supplies in Australia a biological for use in humans;" ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32be a cml:Concept ;
skos:prefLabel "32BE Notice required to adduce evidence in support of exception to"@en ;
cml:realizedBy doc:sec-32be ;
cml:integrityHash "3b1136af07e5f03743ec4abe274eef1fe23ae5890e24a975247fc98d3bba8c9d" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32be-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32be-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32be-ss-3 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.273" .
concept:therapeutic-goods-act-1989-sec-32be-ss-1 a cml:Concept ;
skos:prefLabel "32BE(1) Notice required to adduce evidence in support of exception to"@en ;
cml:realizedBy doc:sec-32be-ss-1 ;
cml:integrityHash "4561beb3cff2e2ea0ab7dcdb8ffac4b184554075661bcdd00c8fd92694a3fa2f" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32be ;
skos:note "Defendant must be informed of requirements and given a copy of the section." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.273" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32be-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32be-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32be-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-32be-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32be-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32be-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Defendant must be informed." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32be-ss-2 a cml:Concept ;
skos:prefLabel "32BE(2) Notice required to adduce evidence in support of exception to"@en ;
cml:realizedBy doc:sec-32be-ss-2 ;
cml:integrityHash "068a90c5aa14cbfe6f2a4b7240d73f881042f23bd47c1428f94e8d12d353649b" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32be ;
skos:note "No evidence can be adduced without notice of particulars of the exception." ;
dc:description "Notice of particulars of the exception" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.273" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32be-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-32be-ss-2-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32be-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-32be-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32be-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32be-ss-2-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-32be-ss-3 a cml:Concept ;
skos:prefLabel "32BE(3) Notice required to adduce evidence in support of exception to"@en ;
cml:realizedBy doc:sec-32be-ss-3 ;
cml:integrityHash "0c456728e444ce6f5ecf6164c4d8b4189bec728333dd3f165447764ca9f8517f" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32be ;
skos:note "Defendant cannot call another person to give evidence without leave of the court." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.273" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32be-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-32be-ss-3-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32be-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-32be-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-32be-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32be-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibition on calling another person to give evidence." ;
cml:premiseText "(3) A defendant must not, without leave of the court..." ;
cml:conclusionText "...call any other person to give evidence in support of the exception unless..." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32be-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-32be-ss-3-logic-descriptionlogic-2 .
concept:therapeutic-goods-act-1989-sec-32be-ss-3-logic-descriptionlogic-2 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "Classify" ;
cml:logicSummary "Classification of individuals based on notice and address information." ;
cml:premiseText "(a) the notice under subsection (2) includes the name and address of the person or..." ;
cml:conclusionText "...the court is satisfied that the defendant before giving the notice took, and after giving the notice continued to take, all reasonable steps to ascertain the name or address;" ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32be-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-32be-ss-3-logic-alleninterval-3 .
concept:therapeutic-goods-act-1989-sec-32be-ss-3-logic-alleninterval-3 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Temporal relation" ;
cml:logicSummary "Temporal relation between notice and address information." ;
cml:premiseText "(b) if the name or the address is not included in the notice—the court is satisfied that..." ;
cml:conclusionText "...the defendant before giving the notice took, and after giving the notice continued to take, all reasonable steps to ascertain the name or address;" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32be-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-32be-ss-3-logic-ltl-4 .
concept:therapeutic-goods-act-1989-sec-32be-ss-3-logic-ltl-4 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "Recurring trace" ;
cml:logicSummary "Recurring trace of defendant's actions." ;
cml:premiseText "...the court is satisfied that the defendant before giving the notice took, and after giving the notice continued to take, all reasonable steps..." ;
cml:conclusionText "...the name or address; and" ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32be-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-32be-ss-3-logic-diffusion-5 .
concept:therapeutic-goods-act-1989-sec-32be-ss-3-logic-diffusion-5 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "Information dissemination" ;
cml:logicSummary "Dissemination of information about defendant's actions." ;
cml:premiseText "...the court is satisfied that the defendant before giving the notice took, and after giving the notice continued to take, all reasonable steps..." ;
cml:conclusionText "...to ascertain the name or address;" ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32be-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-32be-ss-3-logic-cogai-6 .
concept:therapeutic-goods-act-1989-sec-32be-ss-3-logic-cogai-6 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "Knowledge representation" ;
cml:logicSummary "Knowledge representation of defendant's actions." ;
cml:premiseText "(a) the notice under subsection (2) includes the name and address of the person or..." ;
cml:conclusionText "...the court is satisfied that the defendant before giving the notice took, and after giving the notice continued to take, all reasonable steps to ascertain the name or address;" ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32bf a cml:Concept ;
skos:prefLabel "32BF Civil penalties for importing, exporting, manufacturing or"@en ;
cml:realizedBy doc:sec-32bf ;
cml:integrityHash "0677747650a09431b56b23a3cfcf39c06feec3ef42ac2c67dd31bc9f3ca5873c" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32bf-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32bf-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.275" .
concept:therapeutic-goods-act-1989-sec-32bf-ss-1 a cml:Concept ;
skos:prefLabel "32BF(1) Civil penalties for importing, exporting, manufacturing or"@en ;
cml:realizedBy doc:sec-32bf-ss-1 ;
cml:integrityHash "7c5a4b9b281aab1b1b5fa77fccc9b4ce05e29e45641bd93c1faf84d92571c9d9" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32bf ;
skos:note "Importing, exporting, manufacturing biologicals for use in humans without approval is prohibited." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.275" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32bf-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32bf-ss-1-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32bf-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-32bf-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32bf-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32bf-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibition of importing, exporting, manufacturing biologicals for use in humans." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32bf-ss-2 a cml:Concept ;
skos:prefLabel "32BF(2) Civil penalties for importing, exporting, manufacturing or"@en ;
cml:realizedBy doc:sec-32bf-ss-2 ;
cml:integrityHash "b05e5e684e4d48ae020182b20a2e512fec863e36612d58bcaf0ab561111529f1" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32bf ;
skos:note "Exporting biologicals for human use without registration is prohibited." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.275" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32bf-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-32bf-ss-2-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32bf-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-32bf-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32bf-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32bf-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibition of exporting biologicals for human use without registration." ;
cml:premiseText "(2) A person contravenes this subsection if: (a) the person exports from Australia a biological for use in humans; and (b) none of the following subparagraphs applies:" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32bf-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32bf-ss-2-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-32bf-ss-2-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Temporal Interval" ;
cml:logicSummary "Temporal interval between export and registration." ;
cml:premiseText "(2) A person contravenes this subsection if: (a) the person exports from Australia a biological for use in humans; and (b) none of the following subparagraphs applies:" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32bf-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32bf-ss-2-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-32bf-ss-2-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "Recurring Trace" ;
cml:logicSummary "Recurring trace of unregistered exports." ;
cml:premiseText "(2) A person contravenes this subsection if: (a) the person exports from Australia a biological for use in humans; and (b) none of the following subparagraphs applies:" ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32bf-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32bf-ss-2-logic-diffusion-4 .
concept:therapeutic-goods-act-1989-sec-32bf-ss-2-logic-diffusion-4 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "Diffusion" ;
cml:logicSummary "Diffusion of prohibited knowledge." ;
cml:premiseText "(2) A person contravenes this subsection if: (a) the person exports from Australia a biological for use in humans; and (b) none of the following subparagraphs applies:" ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32bf-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32bf-ss-2-logic-cogai-5 .
concept:therapeutic-goods-act-1989-sec-32bf-ss-2-logic-cogai-5 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "Knowledge Graph" ;
cml:logicSummary "Knowledge graph representation of prohibited knowledge." ;
cml:premiseText "(2) A person contravenes this subsection if: (a) the person exports from Australia a biological for use in humans; and (b) none of the following subparagraphs applies:" ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32bg a cml:Concept ;
skos:prefLabel "32BG Criminal offences and civil penalty relating to a failure to"@en ;
cml:realizedBy doc:sec-32bg ;
cml:integrityHash "dd0fec9e174dd72cf2617f620da7b466f0c8086f4c0d38048ed657f6b0617646" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32bg-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32bg-ss-1a ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.279" .
concept:therapeutic-goods-act-1989-sec-32bg-ss-1 a cml:Concept ;
skos:prefLabel "32BG(1) Criminal offences and civil penalty relating to a failure to"@en ;
cml:realizedBy doc:sec-32bg-ss-1 ;
cml:integrityHash "cdd10a4b6c6b569aff8fbb260d98283c39b68ee1d324485dbf49111bd8fce541" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32bg ;
skos:note "Importing, exporting, manufacturing, or supplying a biological for use in humans without proper notification is prohibited." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.279" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32bg-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32bg-ss-1-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32bg-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-32bg-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32bg-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32bg-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-32bg-ss-1a a cml:Concept ;
skos:prefLabel "32BG(1A) Criminal offences and civil penalty relating to a failure to"@en ;
cml:realizedBy doc:sec-32bg-ss-1a ;
cml:integrityHash "25c3681cc8d63c95009d6e5acce789eb9e40d95e253fac00dc0c91be046ef64c" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32bg ;
skos:note "Importing or exporting biologicals for use in humans is prohibited." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.279" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32bg-ss-1a-norm .
concept:therapeutic-goods-act-1989-sec-32bg-ss-1a-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32bg-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-32bg-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-32bg-ss-1a-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32bg-ss-1a-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits the action." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32bh a cml:Concept ;
skos:prefLabel "32BH Criminal offence relating to wholesale supply"@en ;
cml:realizedBy doc:sec-32bh ;
cml:integrityHash "229ac0ee4086a71c767aa2db7da313557c305a292ced5d9370a1b3f5b9aff0a2" ;
skos:note "Supplying biologicals for use in humans without proper exemption or approval is prohibited." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.281" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32bh-norm .
concept:therapeutic-goods-act-1989-sec-32bh-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32bh ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32bh cml:asserts concept:therapeutic-goods-act-1989-sec-32bh-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32bh-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits supplying biologicals for use in humans without proper exemption or approval." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32bi a cml:Concept ;
skos:prefLabel "32BI Criminal offence for using a biological not included in the"@en ;
cml:realizedBy doc:sec-32bi ;
cml:integrityHash "bb7234ec12451361e6f35bcbe76de58e4350657fe60d1b96ace0947f59194083" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32bi-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32bi-ss-4 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.282" .
concept:therapeutic-goods-act-1989-sec-32bi-ss-1 a cml:Concept ;
skos:prefLabel "32BI(1) Criminal offence for using a biological not included in the"@en ;
cml:realizedBy doc:sec-32bi-ss-1 ;
cml:integrityHash "e9f99ef5c8e0821147a4dbc1e4d3b7b7f99cad157f27fca22180683c49526601" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32bi ;
skos:note "Using a biological without proper authorization is prohibited." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.282" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32bi-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32bi-ss-1-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32bi-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-32bi-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32bi-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32bi-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-32bi-ss-4 a cml:Concept ;
skos:prefLabel "32BI(4) Criminal offence for using a biological not included in the"@en ;
cml:realizedBy doc:sec-32bi-ss-4 ;
cml:integrityHash "24fae3178dc16ea3016c6f1e30101477f32e3e8b7040cd239b9f7100d294deb7" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32bi ;
skos:note "Using a biological not included in the Register for certain purposes is an offence." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.282" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32bi-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-32bi-ss-4-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32bi-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-32bi-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-32bi-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32bi-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibition" ;
cml:premiseText "The biological is used in the treatment of another person or solely for experimental purposes in humans." ;
cml:conclusionText "An offence has been committed." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32bj a cml:Concept ;
skos:prefLabel "32BJ General criminal offences relating to this Part"@en ;
cml:realizedBy doc:sec-32bj ;
cml:integrityHash "35b6bde922634858a35a80861a3ae5396245e7b18e562eff950c3ffcef6d7b4e" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32bj-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32bj-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32bj-ss-2a ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32bj-ss-2b ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.284" .
concept:therapeutic-goods-act-1989-sec-32bj-ss-1 a cml:Concept ;
skos:prefLabel "32BJ(1) General criminal offences relating to this Part"@en ;
cml:realizedBy doc:sec-32bj-ss-1 ;
cml:integrityHash "2d43b0126a6339b64168b11efb8960639cec616cbf1a5f792098a389c0441d51" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32bj ;
skos:note "Setting out false biological numbers on containers or labels is prohibited." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.284" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32bj-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32bj-ss-1-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32bj-ss-1 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32bj-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32bj-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32bj-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibition of false biological numbers" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32bj-ss-2 a cml:Concept ;
skos:prefLabel "32BJ(2) General criminal offences relating to this Part"@en ;
cml:realizedBy doc:sec-32bj-ss-2 ;
cml:integrityHash "02785f0cbc8942d64ddff8b6912a6c073c758f4336d86bd1af9feacb7f29d8cc" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32bj ;
skos:note "Defines what constitutes a number for the purposes of subsection (1)" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.284" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32bj-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-32bj-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32bj-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-32bj-ss-2a a cml:Concept ;
skos:prefLabel "32BJ(2A) General criminal offences relating to this Part"@en ;
cml:realizedBy doc:sec-32bj-ss-2a ;
cml:integrityHash "db99284500a8ae665df24129e2c0b062ce26441fc4dbd22fff1171fa4baf1489" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32bj ;
skos:note "Advertising a biological for an indication that is not accepted in relation to its inclusion in the Register is prohibited." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.284" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32bj-ss-2a-norm .
concept:therapeutic-goods-act-1989-sec-32bj-ss-2a-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32bj-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-32bj-ss-2a cml:asserts concept:therapeutic-goods-act-1989-sec-32bj-ss-2a-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32bj-ss-2a-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibition of advertising a biological for an indication that is not accepted in relation to its inclusion in the Register." ;
cml:premiseText "(2A) A person commits an offence if: (a) the person, by any means, advertises a biological for an indication; and (b) the biological is included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion; 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-32bj-ss-2a cml:asserts concept:therapeutic-goods-act-1989-sec-32bj-ss-2a-logic-descriptionlogic-2 .
concept:therapeutic-goods-act-1989-sec-32bj-ss-2a-logic-descriptionlogic-2 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "Classify" ;
cml:logicSummary "Classification of the advertisement as a prohibited act." ;
cml:premiseText "(2A) A person commits an offence if: (a) the person, by any means, advertises a biological for an indication; and (b) the biological is included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion; and" ;
cml:conclusionText "(d) either: (i) the use of the biological for the advertised indication has resulted in, will result in, or is likely to result in, harm or injury to any person; or (ii) the use of the biological for the advertised indication, if the biological were so used, would result in, or would be likely to result in, harm or injury to any person." ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32bj-ss-2b a cml:Concept ;
skos:prefLabel "32BJ(2B) General criminal offences relating to this Part"@en ;
cml:realizedBy doc:sec-32bj-ss-2b ;
cml:integrityHash "57aff9b490de1351e8d2d84ece74d5f207da48b05ce14bac99489aa611a9c75e" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32bj ;
skos:note "Advertising a biological for an indication without proper inclusion in the Register is prohibited." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.284" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32bj-ss-2b-norm .
concept:therapeutic-goods-act-1989-sec-32bj-ss-2b-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32bj-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-32bj-ss-2b cml:asserts concept:therapeutic-goods-act-1989-sec-32bj-ss-2b-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32bj-ss-2b-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibition of advertising a biological for an indication without proper inclusion in the Register." ;
cml:premiseText "(2B) A person commits an offence if: (a) the person, by any means, advertises a biological for an indication; and (b) the biological is included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion." ;
cml:conclusionText "(2B) A person commits an offence if: (a) the person, by any means, advertises a biological for an indication; and (b) the biological is included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32bk a cml:Concept ;
skos:prefLabel "32BK Civil penalty for making misrepresentations about biologicals"@en ;
cml:realizedBy doc:sec-32bk ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32bk-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32bk-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.286" .
concept:therapeutic-goods-act-1989-sec-32bk-ss-1 a cml:Concept ;
skos:prefLabel "32BK(1) Civil penalty for making misrepresentations about biologicals"@en ;
cml:realizedBy doc:sec-32bk-ss-1 ;
cml:integrityHash "e2540a4f20ec9e4332ab4f0dd4a35ee5afd712b91ddc904a454340576faaca0e" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32bk ;
skos:note "Making false or misleading representations about biologicals is prohibited." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.286" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32bk-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32bk-ss-1-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32bk-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-32bk-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32bk-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32bk-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits making false or misleading representations about biologicals." ;
cml:premiseText "(a) the person makes a representation of a kind referred to in subsection (2); and (b) the representation is false or misleading." ;
cml:conclusionText "(1) A 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-32bk-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32bk-ss-1-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-32bk-ss-1-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Temporal Interval" ;
cml:logicSummary "Defines a temporal interval for the prohibition." ;
cml:premiseText "(1) A person contravenes this section if:" ;
cml:conclusionText "...and (b) for an individual—5,000 penalty units; and" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32bk-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32bk-ss-1-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-32bk-ss-1-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "Temporal Interval" ;
cml:logicSummary "Defines a temporal interval for the prohibition." ;
cml:premiseText "(1) A person contravenes this section if:" ;
cml:conclusionText "...and (b) for a body corporate—50,000 penalty units." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32bk-ss-2 a cml:Concept ;
skos:prefLabel "32BK(2) Civil penalty for making misrepresentations about biologicals"@en ;
cml:realizedBy doc:sec-32bk-ss-2 ;
cml:integrityHash "06cd48fdb1ff12f5e99fc5f9cb34bcc7125ea6329ee289bc64eb65a9cedf7dcc" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32bk ;
skos:note "Making misrepresentations about biologicals is prohibited." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.286" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32bk-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-32bk-ss-2-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32bk-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-32bk-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32bk-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32bk-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibition of making misrepresentations about biologicals." ;
cml:premiseText "Subsection (1) applies to the following representations:" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32bl a cml:Concept ;
skos:prefLabel "32BL Civil penalty for advertising biological for an indication"@en ;
cml:realizedBy doc:sec-32bl ;
cml:integrityHash "3f0e9dca5ed0e450272c4a41587cee91108d4449fdc09162998d0291c7947e38" ;
skos:note "Advertising biological for an indication without proper registration is prohibited." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.287" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32bl-norm .
concept:therapeutic-goods-act-1989-sec-32bl-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32bl ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32bl cml:asserts concept:therapeutic-goods-act-1989-sec-32bl-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32bl-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits advertising biological for an indication without proper registration." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32bl cml:asserts concept:therapeutic-goods-act-1989-sec-32bl-logic-descriptionlogic-2 .
concept:therapeutic-goods-act-1989-sec-32bl-logic-descriptionlogic-2 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "Classify" ;
cml:logicSummary "Classifies advertisements as prohibited if they include unregistered biologicals." ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32c a cml:Concept ;
skos:prefLabel "32C What this Division is about"@en ;
cml:realizedBy doc:sec-32c ;
cml:integrityHash "c38bc359a91a2207e4a55da9309d6818217b55e4c65f0ef58a706fed4adb366f" ;
skos:note "Exemptions of biologicals under regulations, emergencies, special and experimental uses, and substitutes unavailable." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.288" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32c-norm .
concept:therapeutic-goods-act-1989-sec-32c-norm a values:Undertaking ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32c ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ca a cml:Concept ;
skos:prefLabel "32CA Exempt biologicals"@en ;
cml:realizedBy doc:sec-32ca ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32ca-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32ca-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32ca-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32ca-ss-5 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.288" .
concept:therapeutic-goods-act-1989-sec-32ca-ss-1 a cml:Concept ;
skos:prefLabel "32CA(1) Exempt biologicals"@en ;
cml:realizedBy doc:sec-32ca-ss-1 ;
cml:integrityHash "db9728862b6e72db922a14db963a70c825f350f38cadc4460643730e2fc05dd2" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ca ;
skos:note "Exempts specified persons from Division 4 operation in relation to specified biologicals." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.288" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32ca-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32ca-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ca-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-32ca-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32ca-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32ca-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "exemption" ;
cml:logicSummary "Exempts" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ca-ss-2 a cml:Concept ;
skos:prefLabel "32CA(2) Exempt biologicals"@en ;
cml:realizedBy doc:sec-32ca-ss-2 ;
cml:integrityHash "b0b15accc1ac77e0103634de3f6f0996f11acdae25fd87d75268c3e925b817f4" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ca ;
skos:note "Exempt biologicals from Division 4 operation." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.288" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32ca-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-32ca-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ca-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-32ca-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32ca-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32ca-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "exemption" ;
cml:logicSummary "Regulations may exempt specified biologicals." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ca-ss-3 a cml:Concept ;
skos:prefLabel "32CA(3) Exempt biologicals"@en ;
cml:realizedBy doc:sec-32ca-ss-3 ;
cml:integrityHash "7004e0a402d1dc126e0632c590e6cac5f00016297805b7289d36824db7da25f2" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ca ;
skos:note "Exemptions may be subject to conditions prescribed in regulations." ;
dc:references "sec-32CP" ;
dc:references "sec-32CQ" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.288" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32ca-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-32ca-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ca-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-32ca-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-32ca-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32ca-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "may" ;
cml:logicSummary "Permission to exempt biologicals with conditions." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ca-ss-5 a cml:Concept ;
skos:prefLabel "32CA(5) Exempt biologicals"@en ;
cml:realizedBy doc:sec-32ca-ss-5 ;
cml:integrityHash "2ca56c6529b8857c8521bb0ef230cb25379c9023e083819165ea2a7fde94ab34" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ca ;
skos:note "Revocation of exemption takes effect after specified day" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.288" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32ca-ss-5-norm .
concept:therapeutic-goods-act-1989-sec-32ca-ss-5-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ca-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-32ca-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-32ca-ss-5-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32ca-ss-5-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "takesEffect" ;
cml:logicSummary "Obligation to revoke exemption on specified day" ;
cml:premiseText "(5) If the regulations revoke an exemption, the revocation takes effect..." ;
cml:conclusionText "...than 28 days after the day on which the regulations revoking the exemption take effect." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ca-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-32ca-ss-5-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-32ca-ss-5-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "meetsBefore" ;
cml:logicSummary "Temporal relationship between revocation and commencement of revocation" ;
cml:premiseText "(5) If the regulations revoke an exemption, the revocation takes effect..." ;
cml:conclusionText "...than 28 days after the day on which the regulations revoking the exemption take effect." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ca-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-32ca-ss-5-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-32ca-ss-5-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "holdsForAll" ;
cml:logicSummary "Temporal relationship between revocation and commencement of revocation" ;
cml:premiseText "(5) If the regulations revoke an exemption, the revocation takes effect..." ;
cml:conclusionText "...than 28 days after the day on which the regulations revoking the exemption take effect." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ca-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-32ca-ss-5-logic-diffusion-4 .
concept:therapeutic-goods-act-1989-sec-32ca-ss-5-logic-diffusion-4 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "diffusesTo" ;
cml:logicSummary "Revocation of exemption diffuses to affected parties" ;
cml:premiseText "(5) If the regulations revoke an exemption, the revocation takes effect..." ;
cml:conclusionText "...than 28 days after the day on which the regulations revoking the exemption take effect." ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ca-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-32ca-ss-5-logic-cogai-5 .
concept:therapeutic-goods-act-1989-sec-32ca-ss-5-logic-cogai-5 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "recognizes" ;
cml:logicSummary "Revocation of exemption recognized by regulatory agency" ;
cml:premiseText "(5) If the regulations revoke an exemption, the revocation takes effect..." ;
cml:conclusionText "...than 28 days after the day on which the regulations revoking the exemption take effect." ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cb a cml:Concept ;
skos:prefLabel "32CB Minister may make exemptions"@en ;
cml:realizedBy doc:sec-32cb ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32cb-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32cb-ss-1a ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32cb-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32cb-ss-2a ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.289" .
concept:therapeutic-goods-act-1989-sec-32cb-ss-1 a cml:Concept ;
skos:prefLabel "32CB(1) Minister may make exemptions"@en ;
cml:realizedBy doc:sec-32cb-ss-1 ;
cml:integrityHash "3ddd512dd92caa45a244cff3b3718ed2673b78865b2036a98ec39057762193e8" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cb ;
skos:note "Minister may exempt specified biologicals from Division 4 operation." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.289" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32cb-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32cb-ss-1-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cb-ss-1 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cb-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32cb-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32cb-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-32cb-ss-1a a cml:Concept ;
skos:prefLabel "32CB(1A) Minister may make exemptions"@en ;
cml:realizedBy doc:sec-32cb-ss-1a ;
cml:integrityHash "fc5de5e42117aadbd69848069a4b5d9b3d6d2a5644eb3c1a7a7d76d1acbadecf" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cb ;
skos:note "Minister must make exemption under certain conditions." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.289" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32cb-ss-1a-norm .
concept:therapeutic-goods-act-1989-sec-32cb-ss-1a-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cb-ss-1a ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cb-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-32cb-ss-1a-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32cb-ss-1a-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Obligation to make exemption" ;
cml:premiseText "Minister is satisfied of the matter in subsection (2) or (2A)" ;
cml:conclusionText "Exemption must be made" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cb-ss-2 a cml:Concept ;
skos:prefLabel "32CB(2) Minister may make exemptions"@en ;
cml:realizedBy doc:sec-32cb-ss-2 ;
cml:integrityHash "b05959bf8079b221dc670546ec6ce03432a39d57646c600eddb0ccbefca70def" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cb ;
skos:note "Minister may make exemptions in national interest." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.289" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32cb-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-32cb-ss-2-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cb-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-32cb-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32cb-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32cb-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "may" ;
cml:logicSummary "Permission to make exemptions." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cb-ss-2a a cml:Concept ;
skos:prefLabel "32CB(2A) Minister may make exemptions"@en ;
cml:realizedBy doc:sec-32cb-ss-2a ;
cml:integrityHash "ff8a0ded51bb92009ddf22609c12fad77d7071c77e323f785ecd3e09ff211fd8" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cb ;
skos:note "Minister may make exemptions under certain conditions." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.289" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32cb-ss-2a-norm .
concept:therapeutic-goods-act-1989-sec-32cb-ss-2a-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cb-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-32cc a cml:Concept ;
skos:prefLabel "32CC Conditions of exemptions"@en ;
cml:realizedBy doc:sec-32cc ;
cml:integrityHash "c7b1c460731585fbba3a42855f586235f97ca637206d026d81d8378972880350" ;
skos:note "Conditions for exemptions under section 32CB" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.290" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32cc-norm .
concept:therapeutic-goods-act-1989-sec-32cc-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cc ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cc cml:asserts concept:therapeutic-goods-act-1989-sec-32cc-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32cc-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Conditions for exemptions" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cc cml:asserts concept:therapeutic-goods-act-1989-sec-32cc-logic-descriptionlogic-2 .
concept:therapeutic-goods-act-1989-sec-32cc-logic-descriptionlogic-2 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "ClassHierarchy" ;
cml:logicSummary "Exemptions under section 32CB are subject to conditions" ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cd a cml:Concept ;
skos:prefLabel "32CD Variation or revocation of exemption"@en ;
cml:realizedBy doc:sec-32cd ;
cml:integrityHash "c2f34d233068d447bce67a922c935760ef233255887c06da805ed973ebd562ed" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32cd-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32cd-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32cd-ss-3 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.291" .
concept:therapeutic-goods-act-1989-sec-32cd-ss-1 a cml:Concept ;
skos:prefLabel "32CD(1) Variation or revocation of exemption"@en ;
cml:realizedBy doc:sec-32cd-ss-1 ;
cml:integrityHash "a808afa79dd17f48b8286d2e12544726b8e037bfc3723762ddbcda78855e47a0" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cd ;
skos:note "Variation of exemption by Minister" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.291" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32cd-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32cd-ss-1-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cd-ss-1 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cd-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32cd-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32cd-ss-1-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-32cd-ss-2 a cml:Concept ;
skos:prefLabel "32CD(2) Variation or revocation of exemption"@en ;
cml:realizedBy doc:sec-32cd-ss-2 ;
cml:integrityHash "7135b280090a1ee49d6ee39b85effc23406959dd475285f0213043fe8a7ee440" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cd ;
skos:note "Revocation of exemption by Minister" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.291" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32cd-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-32cd-ss-2-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cd-ss-2 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cd-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32cd-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32cd-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "may" ;
cml:logicSummary "Permission to revoke exemption" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cd-ss-3 a cml:Concept ;
skos:prefLabel "32CD(3) Variation or revocation of exemption"@en ;
cml:realizedBy doc:sec-32cd-ss-3 ;
cml:integrityHash "b82d77970e909892b6afd3bffa069f89cbbe11fc192556d2e30e16f90e1824ff" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cd ;
skos:note "The Minister may vary or revoke the conditions of an exemption made under section 32CB." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.291" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32cd-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-32cd-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cd-ss-3 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cd-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-32cd-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32cd-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "may" ;
cml:logicSummary "Expresses permission or obligation." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ce a cml:Concept ;
skos:prefLabel "32CE Informing persons of exemption etc."@en ;
cml:realizedBy doc:sec-32ce ;
cml:integrityHash "9baa2ceddbda14d2cba328934dbb3080aff62d164434e59b6e7b9e7ef4ccdb34" ;
skos:note "Must inform persons of exemption under section 32CB" ;
dc:description "copy of exemption and variation/revocation" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.292" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32ce-norm .
concept:therapeutic-goods-act-1989-sec-32ce-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ce ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ce cml:asserts concept:therapeutic-goods-act-1989-sec-32ce-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32ce-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Obligation to inform" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cf a cml:Concept ;
skos:prefLabel "32CF Notification and tabling"@en ;
cml:realizedBy doc:sec-32cf ;
cml:integrityHash "7d31b83313991d4c969b95ff28385ff891514dbe7a93c93c5db8145ad031420f" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32cf-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32cf-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.292" .
concept:therapeutic-goods-act-1989-sec-32cf-ss-1 a cml:Concept ;
skos:prefLabel "32CF(1) Notification and tabling"@en ;
cml:realizedBy doc:sec-32cf-ss-1 ;
cml:integrityHash "ce6a18dbebdfe47b38ce43f46ae91dff34bf01ff26f24ea293802a44f4ca525b" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cf ;
skos:note "Publish notice in Gazette within 7 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 <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.292" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32cf-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32cf-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cf-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-32cf-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32cf-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32cf-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Must publish notice in Gazette within 7 days" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cf-ss-2 a cml:Concept ;
skos:prefLabel "32CF(2) Notification and tabling"@en ;
cml:realizedBy doc:sec-32cf-ss-2 ;
cml:integrityHash "f9881921d65ac7ae6a48921cd2c372fca1a183a6d66b823e903500383e73e720" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cf ;
skos:note "Notification and tabling of exemptions, variations, or revocations made under section 32CB." ;
dc:description "document setting out particulars" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.292" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32cf-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-32cf-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cf-ss-2 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cf-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32cf-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32cf-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Obligation to notify and table" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cg a cml:Concept ;
skos:prefLabel "32CG Disposal of unused biologicals"@en ;
cml:realizedBy doc:sec-32cg ;
cml:integrityHash "eb2a5e9863ba36f144ee4e3841286108c8fb08381bee777ce9c72a03e14257a4" ;
skos:note "This section applies to a biological if an exemption under section 32CB ceases to have effect." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.293" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32cg-norm .
concept:therapeutic-goods-act-1989-sec-32cg-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cg ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cj a cml:Concept ;
skos:prefLabel "32CJ Criminal offences and civil penalty for biologicals not"@en ;
cml:realizedBy doc:sec-32cj ;
cml:integrityHash "12d2b2e35f3f849925d69a8145ed8cc043746662e2c469a65057c21a308818c6" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32cj-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32cj-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32cj-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32cj-ss-4 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32cj-ss-5 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32cj-ss-6 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32cj-ss-7 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32cj-ss-9 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32cj-ss-10 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.294" .
concept:therapeutic-goods-act-1989-sec-32cj-ss-1 a cml:Concept ;
skos:prefLabel "32CJ(1) Criminal offences and civil penalty for biologicals not"@en ;
cml:realizedBy doc:sec-32cj-ss-1 ;
cml:integrityHash "d255966b5d50b94d0dcc3f4c82d24d87cebeca7a2162f2bfda0875c3a2e0915f" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cj ;
skos:note "Supplying non-conforming biologicals is prohibited." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.294" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32cj-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32cj-ss-1-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cj-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-32cj-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32cj-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32cj-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibition" ;
cml:premiseText "(a) a biological is exempt under section 32CB; and (b) a person supplies a batch of the biologicals;" ;
cml:conclusionText "Supplying non-conforming biologicals is prohibited." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cj-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32cj-ss-1-logic-linearlogic-2 .
concept:therapeutic-goods-act-1989-sec-32cj-ss-1-logic-linearlogic-2 a cml:LogicApplication ;
cml:modality cml:LinearLogic ;
cml:operator "Imply" ;
cml:logicSummary "Implication from exemption and supply" ;
cml:premiseText "(a) a biological is exempt under section 32CB; and (b) a person supplies a batch of the biologicals;" ;
cml:conclusionText "Supplying non-conforming biologicals implies violation of exemption." ;
cml:executionSurface "modalities::linear" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cj-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32cj-ss-1-logic-alleninterval-3 .
concept:therapeutic-goods-act-1989-sec-32cj-ss-1-logic-alleninterval-3 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Within" ;
cml:logicSummary "Temporal interval within supply period" ;
cml:premiseText "(c) the Secretary is satisfied that the biologicals included in that batch: (i) do not conform to a standard applicable to the biologicals; or (ii) are otherwise not fit to be used for their intended purposes." ;
cml:conclusionText "Supply period includes non-conforming biologicals." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cj-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32cj-ss-1-logic-diffusion-4 .
concept:therapeutic-goods-act-1989-sec-32cj-ss-1-logic-diffusion-4 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "Imply" ;
cml:logicSummary "Implication from supply and non-compliance" ;
cml:premiseText "(c) the Secretary is satisfied that the biologicals included in that batch: (i) do not conform to a standard applicable to the biologicals; or (ii) are otherwise not fit to be used for their intended purposes." ;
cml:conclusionText "Non-compliance implies supply." ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cj-ss-2 a cml:Concept ;
skos:prefLabel "32CJ(2) Criminal offences and civil penalty for biologicals not"@en ;
cml:realizedBy doc:sec-32cj-ss-2 ;
cml:integrityHash "c8b634d4ccd6b2a089a260e79adfce6e33899c4e378d8bfc263bbfd860b2b8aa" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cj ;
skos:note "Require person to take steps to recall biologicals" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.294" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32cj-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-32cj-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cj-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-32cj-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32cj-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32cj-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "require" ;
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-32cj-ss-3 a cml:Concept ;
skos:prefLabel "32CJ(3) Criminal offences and civil penalty for biologicals not"@en ;
cml:realizedBy doc:sec-32cj-ss-3 ;
cml:integrityHash "c9f828f3465dc1f8ac5c62c88f09d045c31c2d08e44cb0bf9a53a3e3913ed25f" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cj ;
skos:note "Requirements for recalling biologicals" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.294" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32cj-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-32cj-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cj-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-32cj-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-32cj-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32cj-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "requires" ;
cml:logicSummary "Requires steps to be taken" ;
cml:premiseText "(3) The notice may specify one or more of the following requirements:" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cj-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-32cj-ss-3-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-32cj-ss-3-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "within" ;
cml:logicSummary "Steps must be taken within a reasonable period" ;
cml:premiseText "c) a reasonable period within which the steps are to be taken." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cj-ss-4 a cml:Concept ;
skos:prefLabel "32CJ(4) Criminal offences and civil penalty for biologicals not"@en ;
cml:realizedBy doc:sec-32cj-ss-4 ;
cml:integrityHash "e50cf2ee04df7e945ee6224562b56c62abef9854ac8568bedd7ccdfc55391374" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cj ;
skos:note "Publish notice in Gazette or Department's website" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.294" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32cj-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-32cj-ss-4-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cj-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-32cj-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-32cj-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32cj-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Must publish notice" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cj-ss-5 a cml:Concept ;
skos:prefLabel "32CJ(5) Criminal offences and civil penalty for biologicals not"@en ;
cml:realizedBy doc:sec-32cj-ss-5 ;
cml:integrityHash "236643b62b82e86b3a70c2140edffdf78cd39d6079dc9c193e868b7894443351" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cj ;
skos:note "Notice given under subsection (2) is not a legislative instrument." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.294" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32cj-ss-5-norm .
concept:therapeutic-goods-act-1989-sec-32cj-ss-5-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cj-ss-5 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cj-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-32cj-ss-5-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32cj-ss-5-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibition" ;
cml:logicSummary "Prohibits notice given under subsection (2) from being a legislative instrument." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cj-ss-6 a cml:Concept ;
skos:prefLabel "32CJ(6) Criminal offences and civil penalty for biologicals not"@en ;
cml:realizedBy doc:sec-32cj-ss-6 ;
cml:integrityHash "78ab3acffacaca9381df72ef1e04017c8bcc0f3ab56d64213beb686bf8eb2153" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cj ;
skos:note "Failure to comply with notice requirement results in harm or injury." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.294" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32cj-ss-6-norm .
concept:therapeutic-goods-act-1989-sec-32cj-ss-6-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cj-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-32cj-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-32cj-ss-6-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32cj-ss-6-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibition" ;
cml:logicSummary "Prohibition of non-compliance with notice requirement." ;
cml:premiseText "The person fails to comply with the specified requirement." ;
cml:conclusionText "Harm or injury results." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cj-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-32cj-ss-6-logic-deontic-2 .
concept:therapeutic-goods-act-1989-sec-32cj-ss-6-logic-deontic-2 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Notice requirement is a duty." ;
cml:premiseText "The Secretary gives a notice to the person under subsection (2)." ;
cml:conclusionText "Compliance with notice requirement is required." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cj-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-32cj-ss-6-logic-alleninterval-3 .
concept:therapeutic-goods-act-1989-sec-32cj-ss-6-logic-alleninterval-3 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Overlaps" ;
cml:logicSummary "Temporal overlap between notice and harm/injury." ;
cml:premiseText "The use of any of the biologicals has resulted in, will result in, or is likely to result in, harm or injury to any person." ;
cml:conclusionText "Notice requirement overlaps with potential harm/injury." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cj-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-32cj-ss-6-logic-deontic-4 .
concept:therapeutic-goods-act-1989-sec-32cj-ss-6-logic-deontic-4 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibition" ;
cml:logicSummary "Non-compliance with notice requirement is prohibited." ;
cml:premiseText "(c) the person fails to comply with that requirement; and" ;
cml:conclusionText "Harm or injury results from non-compliance." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cj-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-32cj-ss-6-logic-deontic-5 .
concept:therapeutic-goods-act-1989-sec-32cj-ss-6-logic-deontic-5 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Compliance with notice requirement is a duty." ;
cml:premiseText "(a) the Secretary gives a notice to the person under subsection (2); and" ;
cml:conclusionText "Compliance with notice requirement is required." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cj-ss-7 a cml:Concept ;
skos:prefLabel "32CJ(7) Criminal offences and civil penalty for biologicals not"@en ;
cml:realizedBy doc:sec-32cj-ss-7 ;
cml:integrityHash "d97606b3646e0c55b11f306658674f3ce38bb019beaa2267212f86b749c46fc1" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cj ;
skos:note "Failure to comply with notice requirement is an offence." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.294" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32cj-ss-7-norm .
concept:therapeutic-goods-act-1989-sec-32cj-ss-7-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cj-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-32cj-ss-7 cml:asserts concept:therapeutic-goods-act-1989-sec-32cj-ss-7-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32cj-ss-7-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Obligation to comply with notice requirement." ;
cml:premiseText "(7) A person commits an offence if: (a) the Secretary gives a notice to the person under subsection (2); and (b) the notice specifies a particular requirement mentioned in subsection (3); and (c) the person fails to comply with that requirement." ;
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-32cj-ss-7 cml:asserts concept:therapeutic-goods-act-1989-sec-32cj-ss-7-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-32cj-ss-7-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Overlaps" ;
cml:logicSummary "The provision has an overlapping temporal interval." ;
cml:premiseText "(7) A person commits an offence if: (a) the Secretary gives a notice to the person under subsection (2); and (b) the notice specifies a particular requirement mentioned in subsection (3); and (c) the person fails to comply with that requirement." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cj-ss-7 cml:asserts concept:therapeutic-goods-act-1989-sec-32cj-ss-7-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-32cj-ss-7-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "Recurrently" ;
cml:logicSummary "The provision has a recurring trace." ;
cml:premiseText "(7) A person commits an offence if: (a) the Secretary gives a notice to the person under subsection (2); and (b) the notice specifies a particular requirement mentioned in subsection (3); and (c) the person fails to comply with that requirement." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cj-ss-7 cml:asserts concept:therapeutic-goods-act-1989-sec-32cj-ss-7-logic-argumentation-4 .
concept:therapeutic-goods-act-1989-sec-32cj-ss-7-logic-argumentation-4 a cml:LogicApplication ;
cml:modality cml:Argumentation ;
cml:operator "Implication" ;
cml:logicSummary "The provision implies a consequence if the person fails to comply." ;
cml:premiseText "(7) A person commits an offence if: (a) the Secretary gives a notice to the person under subsection (2); and (b) the notice specifies a particular requirement mentioned in subsection (3); and (c) the person fails to comply with that requirement." ;
cml:conclusionText "Penalty: Imprisonment for 12 months or 1,000 penalty units, or both." ;
cml:executionSurface "modalities::argumentation" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cj-ss-9 a cml:Concept ;
skos:prefLabel "32CJ(9) Criminal offences and civil penalty for biologicals not"@en ;
cml:realizedBy doc:sec-32cj-ss-9 ;
cml:integrityHash "d2e7ccd79a198b12bcc0a6c0d9e3a20b45a8cc09fc3e0d67681a19bc819f8a7d" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cj ;
skos:note "Failure to comply with notice requirement is an offence." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.294" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32cj-ss-9-norm .
concept:therapeutic-goods-act-1989-sec-32cj-ss-9-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cj-ss-9 ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cj-ss-9 cml:asserts concept:therapeutic-goods-act-1989-sec-32cj-ss-9-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32cj-ss-9-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "obligation" ;
cml:logicSummary "Obligation to comply with notice requirement." ;
cml:premiseText "(a) the Secretary gives a notice to the person under subsection (2); and (b) the notice specifies a particular requirement mentioned in subsection (3); and (c) the person fails to comply with that requirement." ;
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-32cj-ss-9 cml:asserts concept:therapeutic-goods-act-1989-sec-32cj-ss-9-logic-deontic-2 .
concept:therapeutic-goods-act-1989-sec-32cj-ss-9-logic-deontic-2 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "prohibition" ;
cml:logicSummary "Prohibition on non-compliance with notice requirement." ;
cml:premiseText "(9) A person commits an offence if: (a) the Secretary gives a notice to the person under subsection (2); and (b) the notice specifies a particular requirement mentioned in subsection (3); and (c) the person fails to comply with that requirement." ;
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-32cj-ss-9 cml:asserts concept:therapeutic-goods-act-1989-sec-32cj-ss-9-logic-linearlogic-3 .
concept:therapeutic-goods-act-1989-sec-32cj-ss-9-logic-linearlogic-3 a cml:LogicApplication ;
cml:modality cml:LinearLogic ;
cml:operator "implies" ;
cml:logicSummary "Implies penalty for non-compliance." ;
cml:premiseText "(9) A person commits an offence if: (a) the Secretary gives a notice to the person under subsection (2); and (b) the notice specifies a particular requirement mentioned in subsection (3); and (c) the person fails to comply with that requirement." ;
cml:conclusionText "Penalty: 100 penalty units." ;
cml:executionSurface "modalities::linear" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cj-ss-9 cml:asserts concept:therapeutic-goods-act-1989-sec-32cj-ss-9-logic-deontic-4 .
concept:therapeutic-goods-act-1989-sec-32cj-ss-9-logic-deontic-4 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "right" ;
cml:logicSummary "Right to receive notice from Secretary." ;
cml:premiseText "(9) A person commits an offence if: (a) the Secretary gives a notice to the person under subsection (2); and (b) the notice specifies a particular requirement mentioned in subsection (3); and (c) the person fails to comply with that requirement." ;
cml:conclusionText "The person has a right to receive notice from the Secretary." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cj-ss-10 a cml:Concept ;
skos:prefLabel "32CJ(10) Criminal offences and civil penalty for biologicals not"@en ;
cml:realizedBy doc:sec-32cj-ss-10 ;
cml:integrityHash "6d4597e8e796e3547be52a0119b80a81c0a8dcfdf06fbfa58269f392da9ff357" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cj ;
skos:note "An offence against subsection (9) is an offence of strict liability." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.294" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32cj-ss-10-norm .
concept:therapeutic-goods-act-1989-sec-32cj-ss-10-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cj-ss-10 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cj-ss-10 cml:asserts concept:therapeutic-goods-act-1989-sec-32cj-ss-10-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32cj-ss-10-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "is" ;
cml:logicSummary "Strict liability" ;
cml:premiseText "(9)" ;
cml:conclusionText "(10)" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ck a cml:Concept ;
skos:prefLabel "32CK Approvals for importing, exporting or supplying a biological"@en ;
cml:realizedBy doc:sec-32ck ;
cml:integrityHash "920370b334e486f0d3932b0a2f4f556fab654a43d9faa04f448fc4e998d0d339" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32ck-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32ck-ss-1a ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32ck-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32ck-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32ck-ss-4 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32ck-ss-5 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.296" .
concept:therapeutic-goods-act-1989-sec-32ck-ss-1 a cml:Concept ;
skos:prefLabel "32CK(1) Approvals for importing, exporting or supplying a biological"@en ;
cml:realizedBy doc:sec-32ck-ss-1 ;
cml:integrityHash "5e0cc969ca7a56fe8e77b34630c98c3d70f3f2d16bd9a3235f1d8fe10c35a79d" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ck ;
skos:note "Approval for importing, exporting or supplying a biological" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.296" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32ck-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32ck-ss-1-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ck-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-32ck-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32ck-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32ck-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "grant" ;
cml:logicSummary "Granting approval" ;
cml:premiseText "(1) The Secretary may, by notice in writing..." ;
cml:conclusionText "...a person for one or more of the following:" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ck-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32ck-ss-1-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-32ck-ss-1-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "during" ;
cml:logicSummary "Temporal relation for approval" ;
cml:premiseText "(1)(e) for use solely for experimental purposes in humans." ;
cml:conclusionText "...for variation of an approval..." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ck-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32ck-ss-1-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-32ck-ss-1-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "until" ;
cml:logicSummary "Conditional commencement" ;
cml:premiseText "For variation of an approval..." ;
cml:conclusionText "...see subsection (9A)." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ck-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32ck-ss-1-logic-deontic-4 .
concept:therapeutic-goods-act-1989-sec-32ck-ss-1-logic-deontic-4 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "forbid" ;
cml:logicSummary "Prohibition on experimental use" ;
cml:premiseText "(e) for use solely for experimental purposes in humans." ;
cml:conclusionText "...or for use in the treatment of another person;" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ck-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32ck-ss-1-logic-deontic-5 .
concept:therapeutic-goods-act-1989-sec-32ck-ss-1-logic-deontic-5 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "forbid" ;
cml:logicSummary "Prohibition on unauthorized use" ;
cml:premiseText "(d) for use in the treatment of another person." ;
cml:conclusionText "...or for use solely for experimental purposes in humans." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ck-ss-1a a cml:Concept ;
skos:prefLabel "32CK(1A) Approvals for importing, exporting or supplying a biological"@en ;
cml:realizedBy doc:sec-32ck-ss-1a ;
cml:integrityHash "8c229996e0fe7498af430b67cef2bc380e7c5735ae00e76470e4d78f04c6a06c" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ck ;
skos:note "Approval for use of a biological must be granted only to a health practitioner." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.296" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32ck-ss-1a-norm .
concept:therapeutic-goods-act-1989-sec-32ck-ss-1a-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ck-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-32ck-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-32ck-ss-1a-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32ck-ss-1a-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits granting approval unless the person is a health practitioner." ;
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:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ck-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-32ck-ss-1a-logic-deontic-2 .
concept:therapeutic-goods-act-1989-sec-32ck-ss-1a-logic-deontic-2 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Restrict" ;
cml:logicSummary "Restricts the approval to only those who are 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:executionSurface "modalities::logic::deontic" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ck-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-32ck-ss-1a-logic-alleninterval-3 .
concept:therapeutic-goods-act-1989-sec-32ck-ss-1a-logic-alleninterval-3 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Temporal Restriction" ;
cml:logicSummary "Restricts the approval to only those who are health practitioners at the time of granting." ;
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:executionSurface "modalities::interval_reasoning" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ck-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-32ck-ss-1a-logic-deontic-4 .
concept:therapeutic-goods-act-1989-sec-32ck-ss-1a-logic-deontic-4 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Enforce" ;
cml:logicSummary "Ensures that only health practitioners are granted approval." ;
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:executionSurface "modalities::logic::deontic" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ck-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-32ck-ss-1a-logic-deontic-5 .
concept:therapeutic-goods-act-1989-sec-32ck-ss-1a-logic-deontic-5 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Justify" ;
cml:logicSummary "Justifies the restriction on approval to only those who are 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:executionSurface "modalities::logic::deontic" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ck-ss-2 a cml:Concept ;
skos:prefLabel "32CK(2) Approvals for importing, exporting or supplying a biological"@en ;
cml:realizedBy doc:sec-32ck-ss-2 ;
cml:integrityHash "ed431cd6aa277fa4e94694fa1abcffc211c5f1b94285e2ddf0bceafc4cf26552" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ck ;
skos:note "Exemption from subsection 32CA(1) for biologicals in the Register or under subsection 32CA(2)" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.296" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32ck-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-32ck-ss-2-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ck-ss-2 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ck-ss-3 a cml:Concept ;
skos:prefLabel "32CK(3) Approvals for importing, exporting or supplying a biological"@en ;
cml:realizedBy doc:sec-32ck-ss-3 ;
cml:integrityHash "6e176c2ed174eea921ab27fcb626351a859de766379b9c72e1453eaa3d9a738a" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ck ;
skos:note "Application for approval must be made to the Secretary and accompanied by required information." ;
dc:description "Information relating to the biological subject of the application" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.296" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32ck-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-32ck-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ck-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-32ck-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-32ck-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32ck-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Application must be made" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ck-ss-4 a cml:Concept ;
skos:prefLabel "32CK(4) Approvals for importing, exporting or supplying a biological"@en ;
cml:realizedBy doc:sec-32ck-ss-4 ;
cml:integrityHash "22046edada565bfb92398c70e6dc34ea332e3586881e3dac883d7e20ab1d1a73" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ck ;
skos:note "Application for approval must be made to the Secretary and meet certain requirements." ;
dc:description "Information relating to the biological subject of the application, prescribed evaluation fee" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.296" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32ck-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-32ck-ss-4-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ck-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-32ck-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-32ck-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32ck-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Application must be made" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ck-ss-5 a cml:Concept ;
skos:prefLabel "32CK(5) Approvals for importing, exporting or supplying a biological"@en ;
cml:realizedBy doc:sec-32ck-ss-5 ;
cml:integrityHash "1f01bb9a50b4abd4ae6370b9c2e964457ea7a388cba31f44448dc0ce383de087" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ck ;
skos:note "Secretary must notify applicant of decision on application as soon as practicable." ;
dc:description "Reasons for decision if not granting approval" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.296" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32ck-ss-5-norm .
concept:therapeutic-goods-act-1989-sec-32ck-ss-5-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ck-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-32ck-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-32ck-ss-5-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32ck-ss-5-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Secretary must notify applicant" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cl a cml:Concept ;
skos:prefLabel "32CL Conditions of use of biological for experimental purposes in"@en ;
cml:realizedBy doc:sec-32cl ;
cml:integrityHash "7e701d11574a534623c3bd1f6c743bdb945e3a815eb9934ef8470707c3a2f145" ;
skos:note "Use of biological for experimental purposes in humans subject to conditions specified in regulations." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.299" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32cl-norm .
concept:therapeutic-goods-act-1989-sec-32cl-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cl ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cl cml:asserts concept:therapeutic-goods-act-1989-sec-32cl-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32cl-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Imposes a duty on the experimenter." ;
cml:premiseText "The use by a person (the experimenter) for experimental purposes in humans of a biological..." ;
cml:conclusionText "is subject to the conditions specified in the regulations." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cl cml:asserts concept:therapeutic-goods-act-1989-sec-32cl-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-32cl-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Overlaps" ;
cml:logicSummary "Describes the temporal relationship between the regulation and its application." ;
cml:premiseText "The use by a person (the experimenter) for experimental purposes..." ;
cml:conclusionText "occurs during the period specified in the regulations." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cl cml:asserts concept:therapeutic-goods-act-1989-sec-32cl-logic-argumentation-3 .
concept:therapeutic-goods-act-1989-sec-32cl-logic-argumentation-3 a cml:LogicApplication ;
cml:modality cml:Argumentation ;
cml:operator "Implication" ;
cml:logicSummary "Describes the relationship between the regulation and its consequences." ;
cml:premiseText "The use by a person (the experimenter) for experimental purposes..." ;
cml:conclusionText "must comply with the conditions specified in the regulations." ;
cml:executionSurface "modalities::argumentation" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cl cml:asserts concept:therapeutic-goods-act-1989-sec-32cl-logic-diffusion-4 .
concept:therapeutic-goods-act-1989-sec-32cl-logic-diffusion-4 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "Propagation" ;
cml:logicSummary "Describes the spread of information about the regulation." ;
cml:premiseText "The use by a person (the experimenter) for experimental purposes..." ;
cml:conclusionText "is disseminated through the regulations." ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cl cml:asserts concept:therapeutic-goods-act-1989-sec-32cl-logic-cogai-5 .
concept:therapeutic-goods-act-1989-sec-32cl-logic-cogai-5 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "Inference" ;
cml:logicSummary "Describes the process of reasoning about the regulation." ;
cml:premiseText "The use by a person (the experimenter) for experimental purposes..." ;
cml:conclusionText "can be inferred from the regulations." ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cm a cml:Concept ;
skos:prefLabel "32CM Authorities for health practitioners"@en ;
cml:realizedBy doc:sec-32cm ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32cm-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32cm-ss-1a ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32cm-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32cm-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32cm-ss-4 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32cm-ss-5 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32cm-ss-6 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32cm-ss-7 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32cm-ss-7a ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32cm-ss-7b ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32cm-ss-7c ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32cm-ss-7d ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32cm-ss-7e ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.300" .
concept:therapeutic-goods-act-1989-sec-32cm-ss-1 a cml:Concept ;
skos:prefLabel "32CM(1) Authorities for health practitioners"@en ;
cml:realizedBy doc:sec-32cm-ss-1 ;
cml:integrityHash "2ebb04903485bb08c5b51c3121e90c32cbe4497f08f911ccec9070e58a7bfcb5" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cm ;
skos:note "The Secretary may authorise a medical practitioner to supply biologicals." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.300" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32cm-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32cm-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cm-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-32cm-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32cm-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32cm-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "authorise" ;
cml:logicSummary "Authorisation is an obligation." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cm-ss-1a a cml:Concept ;
skos:prefLabel "32CM(1A) Authorities for health practitioners"@en ;
cml:realizedBy doc:sec-32cm-ss-1a ;
cml:integrityHash "08807ce063a19d294a3e8ec5c4286cac61c2b55d571ffb679a457b7ada675751" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cm ;
skos:note "Application for authority must be in approved form" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.300" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32cm-ss-1a-norm .
concept:therapeutic-goods-act-1989-sec-32cm-ss-1a-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cm-ss-1a ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cm-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-32cm-ss-1a-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32cm-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-32cm-ss-2 a cml:Concept ;
skos:prefLabel "32CM(2) Authorities for health practitioners"@en ;
cml:realizedBy doc:sec-32cm-ss-2 ;
cml:integrityHash "bb3578d9ca0d71cea2c6fab3d924bf3110c723d2490b46fa2d16c6a19f03d746" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cm ;
skos:note "The Secretary may give an authority under subsection (1) subject to conditions." ;
dc:references "sec-32cp" ;
dc:references "sec-32cq" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.300" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32cm-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-32cm-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cm-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-32cm-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32cm-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32cm-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "may" ;
cml:logicSummary "Authority may be given subject to conditions." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cm-ss-3 a cml:Concept ;
skos:prefLabel "32CM(3) Authorities for health practitioners"@en ;
cml:realizedBy doc:sec-32cm-ss-3 ;
cml:integrityHash "95ca73c03a373e1fa34e1934febb8c07716d9d3c521f5c01b187a079608d7b43" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cm ;
skos:note "Secretary may impose conditions on an authority" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.300" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32cm-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-32cm-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cm-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-32cm-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-32cm-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32cm-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-32cm-ss-4 a cml:Concept ;
skos:prefLabel "32CM(4) Authorities for health practitioners"@en ;
cml:realizedBy doc:sec-32cm-ss-4 ;
cml:integrityHash "b6e70e5ca9265ef50145bf766b83db88f392181cb25baadcf9aa6544b0d11b9b" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cm ;
skos:note "Authority for medical practitioners to supply specified biologicals." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.300" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32cm-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-32cm-ss-4-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cm-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-32cm-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-32cm-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32cm-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "may only be given" ;
cml:logicSummary "Authority restriction" ;
cml:premiseText "(4) An authority under subsection (1)" ;
cml:conclusionText "to a medical practitioner" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cm-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-32cm-ss-4-logic-descriptionlogic-2 .
concept:therapeutic-goods-act-1989-sec-32cm-ss-4-logic-descriptionlogic-2 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "includes" ;
cml:logicSummary "Class of medical practitioners" ;
cml:premiseText "(a) who is included in a class of medical practitioners prescribed by the regulations" ;
cml:conclusionText "for the purposes of this paragraph" ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cm-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-32cm-ss-4-logic-deontic-3 .
concept:therapeutic-goods-act-1989-sec-32cm-ss-4-logic-deontic-3 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "has approval" ;
cml:logicSummary "Approval requirement for supply" ;
cml:premiseText "(b) who has the approval of an ethics committee to supply the specified biological" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cm-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-32cm-ss-4-logic-alleninterval-4 .
concept:therapeutic-goods-act-1989-sec-32cm-ss-4-logic-alleninterval-4 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "prescribed by" ;
cml:logicSummary "Temporal interval relation" ;
cml:premiseText "for the purposes of this subsection" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cm-ss-5 a cml:Concept ;
skos:prefLabel "32CM(5) Authorities for health practitioners"@en ;
cml:realizedBy doc:sec-32cm-ss-5 ;
cml:integrityHash "0410059304f5f30c95956712a465cad332945b73d82e8f778d078b997a87fe23" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cm ;
skos:note "Authority for health practitioners limited to prescribed classes of recipients." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.300" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32cm-ss-5-norm .
concept:therapeutic-goods-act-1989-sec-32cm-ss-5-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cm-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-32cm-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-32cm-ss-5-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32cm-ss-5-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "only" ;
cml:logicSummary "Limited authority" ;
cml:premiseText "(5) An authority under subsection (1)" ;
cml:conclusionText "may only be given in relation to a class or classes of recipients prescribed by the regulations" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cm-ss-6 a cml:Concept ;
skos:prefLabel "32CM(6) Authorities for health practitioners"@en ;
cml:realizedBy doc:sec-32cm-ss-6 ;
cml:integrityHash "9579659c8525d9cea0b9831f88fcda3e30fce38225012d45c3f23141d6f5e02f" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cm ;
skos:note "Regulations may prescribe circumstances for supplying biologicals under authority." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.300" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32cm-ss-6-norm .
concept:therapeutic-goods-act-1989-sec-32cm-ss-6-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cm-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-32cm-ss-7 a cml:Concept ;
skos:prefLabel "32CM(7) Authorities for health practitioners"@en ;
cml:realizedBy doc:sec-32cm-ss-7 ;
cml:integrityHash "9c072b796ea59494b11ce727710328635f1c5db95b75700f4db17dd2121a1046" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cm ;
skos:note "An authority under subsection (1) is not a legislative instrument." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.300" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32cm-ss-7-norm .
concept:therapeutic-goods-act-1989-sec-32cm-ss-7-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cm-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-32cm-ss-7a a cml:Concept ;
skos:prefLabel "32CM(7A) Authorities for health practitioners"@en ;
cml:realizedBy doc:sec-32cm-ss-7a ;
cml:integrityHash "72fbee116e9bcf24c7ddfea9fd972b87404fc52111ca4aa9d8b9c2ddef45e7a5" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cm ;
skos:note "The Minister may make rules authorising health practitioners to supply biologicals." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.300" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32cm-ss-7a-norm .
concept:therapeutic-goods-act-1989-sec-32cm-ss-7a-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cm-ss-7a ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cm-ss-7a cml:asserts concept:therapeutic-goods-act-1989-sec-32cm-ss-7a-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32cm-ss-7a-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "May" ;
cml:logicSummary "Permission to supply biologicals" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cm-ss-7a cml:asserts concept:therapeutic-goods-act-1989-sec-32cm-ss-7a-logic-descriptionlogic-2 .
concept:therapeutic-goods-act-1989-sec-32cm-ss-7a-logic-descriptionlogic-2 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "Class inclusion" ;
cml:logicSummary "Rules specify class of health practitioners and recipients" ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cm-ss-7b a cml:Concept ;
skos:prefLabel "32CM(7B) Authorities for health practitioners"@en ;
cml:realizedBy doc:sec-32cm-ss-7b ;
cml:integrityHash "5bf3e89932880e5235525b23527e7e83a18538df47d215d5a7796ba43d44e333" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cm ;
skos:note "Comply with regulations when making rules under subsection (7A)" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.300" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32cm-ss-7b-norm .
concept:therapeutic-goods-act-1989-sec-32cm-ss-7b-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cm-ss-7b ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cm-ss-7b cml:asserts concept:therapeutic-goods-act-1989-sec-32cm-ss-7b-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32cm-ss-7b-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Must" ;
cml:logicSummary "Minister must comply with regulations" ;
cml:premiseText "(7B) In making rules under subsection (7A), the Minister..." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cm-ss-7c a cml:Concept ;
skos:prefLabel "32CM(7C) Authorities for health practitioners"@en ;
cml:realizedBy doc:sec-32cm-ss-7c ;
cml:integrityHash "626e2da458734e9a587fa1a333a8ce482c07cf5cb3b0aa159a37d759f07bc9ff" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cm ;
skos:note "Notify supply to Secretary within 28 days after supply." ;
dc:description "true" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.300" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32cm-ss-7c-norm .
concept:therapeutic-goods-act-1989-sec-32cm-ss-7c-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cm-ss-7c ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cm-ss-7c cml:asserts concept:therapeutic-goods-act-1989-sec-32cm-ss-7c-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32cm-ss-7c-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-32cm-ss-7d a cml:Concept ;
skos:prefLabel "32CM(7D) Authorities for health practitioners"@en ;
cml:realizedBy doc:sec-32cm-ss-7d ;
cml:integrityHash "9b42e934c94e11a48a8ef0759413c3c09246e8376bb66e9467e07c5be3b0970f" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cm ;
skos:note "Notification requirements for health practitioners" ;
dc:description "Information as prescribed by regulations" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.300" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32cm-ss-7d-norm .
concept:therapeutic-goods-act-1989-sec-32cm-ss-7d-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cm-ss-7d ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cm-ss-7d cml:asserts concept:therapeutic-goods-act-1989-sec-32cm-ss-7d-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32cm-ss-7d-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-32cm-ss-7e a cml:Concept ;
skos:prefLabel "32CM(7E) Authorities for health practitioners"@en ;
cml:realizedBy doc:sec-32cm-ss-7e ;
cml:integrityHash "13b4eb4ec7297e75f064b8a2b5422a5f90ec01ed1880a070f751a6b812940a52" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cm ;
skos:note "Approval of a form may require or permit information to be given in accordance with specified software requirements." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.300" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32cm-ss-7e-norm .
concept:therapeutic-goods-act-1989-sec-32cm-ss-7e-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cm-ss-7e ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cn a cml:Concept ;
skos:prefLabel "32CN Criminal offences relating to the giving of an authority to a"@en ;
cml:realizedBy doc:sec-32cn ;
cml:integrityHash "73c01c8f80eb06d9ed352e080ae678a2a850abaa2b279eb92f5cd3e14cbf2fa5" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32cn-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32cn-ss-4 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32cn-ss-4a ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.302" .
concept:therapeutic-goods-act-1989-sec-32cn-ss-1 a cml:Concept ;
skos:prefLabel "32CN(1) Criminal offences relating to the giving of an authority to a"@en ;
cml:realizedBy doc:sec-32cn-ss-1 ;
cml:integrityHash "ac365f50da309abc6c9d0052f2f1357375363bb4b2c5abef4d4171bb640a41ca" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cn ;
skos:note "Supplying a biological without proper authority is prohibited." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.302" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32cn-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32cn-ss-1-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cn-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-32cn-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32cn-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32cn-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits supplying a biological without proper authority." ;
cml:premiseText "(a) the Secretary has authorised, under subsection 32CM(1), the person to supply a biological; and (b) the person supplies the biological;" ;
cml:conclusionText "The supply is not in accordance with the authority." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cn-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32cn-ss-1-logic-deontic-2 .
concept:therapeutic-goods-act-1989-sec-32cn-ss-1-logic-deontic-2 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits supplying a biological that would result in harm or injury to any person." ;
cml:premiseText "(d) either: (i) the use of the biological has resulted in, will result in, or is likely to result in, harm or injury to any person; or (ii) the use of the biological, if the biological 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." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cn-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32cn-ss-1-logic-linearlogic-3 .
concept:therapeutic-goods-act-1989-sec-32cn-ss-1-logic-linearlogic-3 a cml:LogicApplication ;
cml:modality cml:LinearLogic ;
cml:operator "Implication" ;
cml:logicSummary "If supplying a biological without proper authority would result in harm or injury, then it is prohibited." ;
cml:premiseText "(d) either: (i) the use of the biological has resulted in, will result in, or is likely to result in, harm or injury to any person; or (ii) the use of the biological, if the biological were used, would result in, or would be likely to result in, harm or injury to any person;" ;
cml:conclusionText "The supply is prohibited." ;
cml:executionSurface "modalities::linear" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cn-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32cn-ss-1-logic-deontic-4 .
concept:therapeutic-goods-act-1989-sec-32cn-ss-1-logic-deontic-4 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits supplying a biological that would not result in harm or injury to any person." ;
cml:premiseText "(e) the harm or injury has resulted, will result, is likely to result, would result, or would be likely to result, because: (i) the supply is not in accordance with the authority; or (ii) the supply is not in accordance with regulations made for the purpose of subsection 32CM(6)." ;
cml:conclusionText "The supply is not in accordance with the authority." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cn-ss-4 a cml:Concept ;
skos:prefLabel "32CN(4) Criminal offences relating to the giving of an authority to a"@en ;
cml:realizedBy doc:sec-32cn-ss-4 ;
cml:integrityHash "d8693c508ed83619a658d9a72823e3924846794dac950c5891a95e95b59e7a29" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cn ;
skos:note "Supplying a biological without proper authority is prohibited." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.302" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32cn-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-32cn-ss-4-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cn-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-32cn-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-32cn-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32cn-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits supplying a biological without proper authority." ;
cml:premiseText "(4) A person commits an offence if..." ;
cml:conclusionText "...the supply is not in accordance with the authority;" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cn-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-32cn-ss-4-logic-ltl-2 .
concept:therapeutic-goods-act-1989-sec-32cn-ss-4-logic-ltl-2 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "Recurring Trace" ;
cml:logicSummary "Requires recurring trace of supplying a biological." ;
cml:premiseText "(4) A person commits an offence if..." ;
cml:conclusionText "...the supply is not in accordance with the authority;" ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cn-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-32cn-ss-4-logic-deontic-3 .
concept:therapeutic-goods-act-1989-sec-32cn-ss-4-logic-deontic-3 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits supplying a biological without proper authority." ;
cml:premiseText "(4) A person commits an offence if..." ;
cml:conclusionText "...the supply is not in accordance with the regulations;" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cn-ss-4a a cml:Concept ;
skos:prefLabel "32CN(4A) Criminal offences relating to the giving of an authority to a"@en ;
cml:realizedBy doc:sec-32cn-ss-4a ;
cml:integrityHash "ebfadb98d821e301989e579a6841f062804b3dad877bf932b809869290444005" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cn ;
skos:note "Supplying a biological without authorization is prohibited." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.302" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32cn-ss-4a-norm .
concept:therapeutic-goods-act-1989-sec-32cn-ss-4a-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cn-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-32cn-ss-4a cml:asserts concept:therapeutic-goods-act-1989-sec-32cn-ss-4a-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32cn-ss-4a-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits supplying a biological." ;
cml:premiseText "(4A) A person commits an offence if..." ;
cml:conclusionText "...and (b) the person supplies the biological;" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cn-ss-4a cml:asserts concept:therapeutic-goods-act-1989-sec-32cn-ss-4a-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-32cn-ss-4a-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Temporal Interval" ;
cml:logicSummary "Defines temporal interval for supply of a biological." ;
cml:premiseText "(4A) A person commits an offence if..." ;
cml:conclusionText "...and (b) the person supplies the biological;" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cn-ss-4a cml:asserts concept:therapeutic-goods-act-1989-sec-32cn-ss-4a-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-32cn-ss-4a-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "Temporal Trace" ;
cml:logicSummary "Defines temporal trace for supply of a biological." ;
cml:premiseText "(4A) A person commits an offence if..." ;
cml:conclusionText "...and (c) either of the following applies:" ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cn-ss-4a cml:asserts concept:therapeutic-goods-act-1989-sec-32cn-ss-4a-logic-diffusion-4 .
concept:therapeutic-goods-act-1989-sec-32cn-ss-4a-logic-diffusion-4 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "Diffuse" ;
cml:logicSummary "Diffuses prohibition to related provisions." ;
cml:premiseText "(4A) A person commits an offence if..." ;
cml:conclusionText "...and (b) the person supplies the biological;" ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cn-ss-4a cml:asserts concept:therapeutic-goods-act-1989-sec-32cn-ss-4a-logic-cogai-5 .
concept:therapeutic-goods-act-1989-sec-32cn-ss-4a-logic-cogai-5 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "Recognize" ;
cml:logicSummary "Recognizes prohibition in supply of a biological." ;
cml:premiseText "(4A) A person commits an offence if..." ;
cml:conclusionText "...and (c) either of the following applies:" ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32co a cml:Concept ;
skos:prefLabel "32CO Approvals where substitutes for biologicals are unavailable"@en ;
cml:realizedBy doc:sec-32co ;
cml:integrityHash "6e8d2a37f80b515f57a83b73ef7002f557cbb6ced79347bb2b91cfa76fdb5541" ;
skos:note "Secretary may grant approval for importation of specified biologicals" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.305" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32co-norm .
concept:therapeutic-goods-act-1989-sec-32co-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32co ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cp a cml:Concept ;
skos:prefLabel "32CP Offences for breaching a condition of an exemption, approval"@en ;
cml:realizedBy doc:sec-32cp ;
cml:integrityHash "c64a21d0a209fed309ed557e74d2de66b7cf3f8fe947b6404e9fee17796b4c70" ;
skos:note "Offence for breaching a condition of an exemption, approval" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.309" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32cp-norm .
concept:therapeutic-goods-act-1989-sec-32cp-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cp ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cp cml:asserts concept:therapeutic-goods-act-1989-sec-32cp-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32cp-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits breaching a condition of an exemption, approval" ;
cml:premiseText "The person does an act or omits to do an act" ;
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-32cq a cml:Concept ;
skos:prefLabel "32CQ Civil penalty for breaching a condition of an exemption,"@en ;
cml:realizedBy doc:sec-32cq ;
cml:integrityHash "ea9efe8d6f0548fb8b1ca5664514395015c34dd9ce1b68313dbc4de1b98ebdca" ;
skos:note "Civil penalty for breaching a condition of an exemption" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.311" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32cq-norm .
concept:therapeutic-goods-act-1989-sec-32cq-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32cq ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32cq cml:asserts concept:therapeutic-goods-act-1989-sec-32cq-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32cq-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits breach of conditions" ;
cml:premiseText "Section 32CQ" ;
cml:conclusionText "Civil penalty for breaching a condition of an exemption" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32d a cml:Concept ;
skos:prefLabel "32D Simplified outline of this Division"@en ;
cml:realizedBy doc:sec-32d ;
cml:integrityHash "d6a66d4dcf8daac16316f4b3f2d7dd481383e31e46cee7a83282f1f0036a2df9" ;
skos:note "Application requirements for inclusion in the Register" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.313" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32d-norm .
concept:therapeutic-goods-act-1989-sec-32d-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32d ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32da a cml:Concept ;
skos:prefLabel "32DA Application for inclusion in the Register"@en ;
cml:realizedBy doc:sec-32da ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32da-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32da-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.313" .
concept:therapeutic-goods-act-1989-sec-32da-ss-1 a cml:Concept ;
skos:prefLabel "32DA(1) Application for inclusion in the Register"@en ;
cml:realizedBy doc:sec-32da-ss-1 ;
cml:integrityHash "2a935e6f709080b451ceea6e635220ff5b841846815173b7365fa48856fb0d73" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32da ;
skos:note "Application for inclusion in the Register" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.313" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32da-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32da-ss-1-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32da-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-32da-ss-2 a cml:Concept ;
skos:prefLabel "32DA(2) Application for inclusion in the Register"@en ;
cml:realizedBy doc:sec-32da-ss-2 ;
cml:integrityHash "ed470fc6b7d907740b8a04ebfda4134351ff148f8fd004d2e30d2a1a19104954" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32da ;
skos:note "Application must be made in accordance with a form approved by the Secretary and accompanied by a statement certifying matters." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.313" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32da-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-32da-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32da-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-32da-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32da-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32da-ss-2-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-32db a cml:Concept ;
skos:prefLabel "32DB Inclusion of Class 1 biological in the Register"@en ;
cml:realizedBy doc:sec-32db ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32db-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32db-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32db-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32db-ss-4 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.315" .
concept:therapeutic-goods-act-1989-sec-32db-ss-1 a cml:Concept ;
skos:prefLabel "32DB(1) Inclusion of Class 1 biological in the Register"@en ;
cml:realizedBy doc:sec-32db-ss-1 ;
cml:integrityHash "0cd60607d68faddb66ddcdf5a1b6cfea2d5bfd576862d0791d49994252e19d5e" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32db ;
skos:note "Secretary must include biological in Register if application is made." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.315" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32db-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32db-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32db-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-32db-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32db-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32db-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Must include biological" ;
cml:premiseText "Application made for inclusion" ;
cml:conclusionText "Biological included in Register" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32db-ss-2 a cml:Concept ;
skos:prefLabel "32DB(2) Inclusion of Class 1 biological in the Register"@en ;
cml:realizedBy doc:sec-32db-ss-2 ;
cml:integrityHash "aed08050be459a84549eba417bf185a03131b7ec10a31974aa21a76145b33350" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32db ;
skos:note "Secretary must assign a unique number to the biological if included in the Register." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.315" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32db-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-32db-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32db-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-32db-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32db-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32db-ss-2-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-32db-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32db-ss-2-logic-descriptionlogic-2 .
concept:therapeutic-goods-act-1989-sec-32db-ss-2-logic-descriptionlogic-2 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "CLASSIFICATION" ;
cml:logicSummary "Classification of biological in Register" ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32db-ss-3 a cml:Concept ;
skos:prefLabel "32DB(3) Inclusion of Class 1 biological in the Register"@en ;
cml:realizedBy doc:sec-32db-ss-3 ;
cml:integrityHash "70481819b3d475e5d1242f973adf65b6da177f0b12aadfff4187e1106c5797eb" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32db ;
skos:note "Secretary must provide certificate upon inclusion in Register" ;
dc:description "Certificate of inclusion" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.315" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32db-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-32db-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32db-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-32db-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-32db-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32db-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Must provide certificate" ;
cml:conclusionText "The Secretary must give to the applicant a certificate of the inclusion of the biological in the Register." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32db-ss-4 a cml:Concept ;
skos:prefLabel "32DB(4) Inclusion of Class 1 biological in the Register"@en ;
cml:realizedBy doc:sec-32db-ss-4 ;
cml:integrityHash "75f5e41b9253d96e0c996bc8f7f6379601dd1d665f03d1d81df9618afe79d631" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32db ;
skos:note "Specify biological number and commencement day for inclusion in Register" ;
dc:description "Yes" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.315" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32db-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-32db-ss-4-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32db-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-32db-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-32db-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32db-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Specify biological number and commencement day" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32dc a cml:Concept ;
skos:prefLabel "32DC Refusal to include Class 1 biological in the Register"@en ;
cml:realizedBy doc:sec-32dc ;
cml:integrityHash "030bfa7139c3b798884a92dcea25d6734d666111cce8c356ec4cedb8421e4ee0" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32dc-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32dc-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32dc-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32dc-ss-4 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.316" .
concept:therapeutic-goods-act-1989-sec-32dc-ss-1 a cml:Concept ;
skos:prefLabel "32DC(1) Refusal to include Class 1 biological in the Register"@en ;
cml:realizedBy doc:sec-32dc-ss-1 ;
cml:integrityHash "bc0add9eb99e3c70b9fcb7b17999e504392eb6bb880c8776a1bee8e2d1ca099d" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dc ;
skos:note "Application for inclusion of export only biological in the Register" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.316" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32dc-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32dc-ss-1-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dc-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-32dc-ss-2 a cml:Concept ;
skos:prefLabel "32DC(2) Refusal to include Class 1 biological in the Register"@en ;
cml:realizedBy doc:sec-32dc-ss-2 ;
cml:integrityHash "726a97035710c322a4d4ee310ec178a35b24edb51b574fed18dd63e8a06b80b9" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dc ;
skos:note "Application must be made in accordance with a form approved by the Secretary and accompanied by a statement certifying certain matters." ;
dc:description "Form, statement, and fee" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.316" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32dc-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-32dc-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dc-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-32dc-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32dc-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32dc-ss-2-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-32dc-ss-3 a cml:Concept ;
skos:prefLabel "32DC(3) Refusal to include Class 1 biological in the Register"@en ;
cml:realizedBy doc:sec-32dc-ss-3 ;
cml:integrityHash "19552b88733597f6894101a641fc94a2883f8200c93f2f7ee08b93ecc8dbc720" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dc ;
skos:note "Application may be required for approval of a form" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.316" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32dc-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-32dc-ss-3-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dc-ss-3 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32dc-ss-4 a cml:Concept ;
skos:prefLabel "32DC(4) Refusal to include Class 1 biological in the Register"@en ;
cml:realizedBy doc:sec-32dc-ss-4 ;
cml:integrityHash "65c9a987f7d93bd581dbd19411998ac53ecaede6219856118dc653b555ebd2d0" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dc ;
skos:note "Certification requirements for export only biologicals" ;
dc:description "Certification of safety, presentation, and compliance with standards" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.316" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32dc-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-32dc-ss-4-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dc-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-32dc-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-32dc-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32dc-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Certification is required" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32dd a cml:Concept ;
skos:prefLabel "32DD Application for inclusion in the Register"@en ;
cml:realizedBy doc:sec-32dd ;
cml:integrityHash "33ae6aa64cb0e566f9ce2df3ad9c925412693d3b7d0618cb8c424ad6e4fd59a5" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32dd-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32dd-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.321" .
concept:therapeutic-goods-act-1989-sec-32dd-ss-1 a cml:Concept ;
skos:prefLabel "32DD(1) Application for inclusion in the Register"@en ;
cml:realizedBy doc:sec-32dd-ss-1 ;
cml:integrityHash "c788cc7249a642b49014f9e427b583593e95e1785477f72f86b3884c709ca074" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dd ;
skos:note "Secretary must carry out assessment of application requirements" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.321" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32dd-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32dd-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dd-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-32dd-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32dd-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32dd-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Must perform assessment" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32dd-ss-2 a cml:Concept ;
skos:prefLabel "32DD(2) Application for inclusion in the Register"@en ;
cml:realizedBy doc:sec-32dd-ss-2 ;
cml:integrityHash "bde4e7b5ebeaec82471fbf3706906bb6c2d4be3a703c5159b7c25d46c075e3d2" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dd ;
skos:note "Application requirements for inclusion in the Register" ;
dc:description "Information of a kind determined under subsection (9) and in a form determined under subsection (10)" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.321" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32dd-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-32dd-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dd-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-32dd-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32dd-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32dd-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligate" ;
cml:logicSummary "Application requirements for inclusion in the Register" ;
cml:conclusionText "Information of a kind determined under subsection (9) and in a form determined under subsection (10)" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32dd-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32dd-ss-2-logic-descriptionlogic-2 .
concept:therapeutic-goods-act-1989-sec-32dd-ss-2-logic-descriptionlogic-2 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "hasClass" ;
cml:logicSummary "Application must be made in accordance with the approved form" ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32dd-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32dd-ss-2-logic-descriptionlogic-3 .
concept:therapeutic-goods-act-1989-sec-32dd-ss-2-logic-descriptionlogic-3 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "hasValue" ;
cml:logicSummary "Prescribed application fee must be paid" ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32dd-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32dd-ss-2-logic-alleninterval-4 .
concept:therapeutic-goods-act-1989-sec-32dd-ss-2-logic-alleninterval-4 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator ">=" ;
cml:logicSummary "Application must be delivered to an office of the Department within a reasonable time frame" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32de a cml:Concept ;
skos:prefLabel "32DE Evaluation of biologicals"@en ;
cml:realizedBy doc:sec-32de ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32de-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32de-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32de-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32de-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32de-ss-3 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.324" .
concept:therapeutic-goods-act-1989-sec-32de-ss-1 a cml:Concept ;
skos:prefLabel "32DE(1) Evaluation of biologicals"@en ;
cml:realizedBy doc:sec-32de-ss-1 ;
cml:integrityHash "4ee5ea41fc4a799f9008e7866dd1c3b9bc8c49d5d62a882753dcdda545903451" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32de ;
skos:note "The Secretary must evaluate a biological for inclusion in the Register, considering various factors. The regulations may empower the Secretary to make biologicals (priority applicant) determinations." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.324" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32de-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32de-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32de-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-32de-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32de-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32de-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "The Secretary must evaluate a biological." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32de-ss-2 a cml:Concept ;
skos:prefLabel "32DE(2) Evaluation of biologicals"@en ;
cml:realizedBy doc:sec-32de-ss-2 ;
cml:integrityHash "99e9c1954ec4e359da5ad661d9bd2d853844a6415cebfc5cd163feb8f3427396" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32de ;
skos:note "Determination of priority applicant for section 32DD applications Corresponding application of subsections for paragraph (1)(g)" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.324" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32de-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-32de-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32de-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-32de-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32de-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32de-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "has" ;
cml:logicSummary "Priority applicant designation" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32de-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32de-ss-2-logic-deontic-2 .
concept:therapeutic-goods-act-1989-sec-32de-ss-2-logic-deontic-2 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligate" ;
cml:logicSummary "Corresponding application of subsections for paragraph (1)(g)" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32de-ss-1 a cml:Concept ;
skos:prefLabel "32DE(1) Evaluation of biologicals"@en ;
cml:realizedBy doc:sec-32de-ss-1 ;
cml:integrityHash "1bc29360409d475956fbd13f3f46d1f292d95a9e629cf34fe13ed51fa2d0e850" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32de ;
skos:note "The Secretary must evaluate a biological for inclusion in the Register, considering various factors. The regulations may empower the Secretary to make biologicals (priority applicant) determinations." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.324" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32de-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32de-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32de-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-32de-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32de-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32de-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "The Secretary must evaluate a biological." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32de-ss-2 a cml:Concept ;
skos:prefLabel "32DE(2) Evaluation of biologicals"@en ;
cml:realizedBy doc:sec-32de-ss-2 ;
cml:integrityHash "d2c4d83022b84dde69fd5ceff6a4fb34781fab8b9882e60fe8c56e88f357cbdc" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32de ;
skos:note "Determination of priority applicant for section 32DD applications Corresponding application of subsections for paragraph (1)(g)" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.324" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32de-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-32de-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32de-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-32de-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32de-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32de-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "has" ;
cml:logicSummary "Priority applicant designation" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32de-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32de-ss-2-logic-deontic-2 .
concept:therapeutic-goods-act-1989-sec-32de-ss-2-logic-deontic-2 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligate" ;
cml:logicSummary "Corresponding application of subsections for paragraph (1)(g)" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32de-ss-3 a cml:Concept ;
skos:prefLabel "32DE(3) Evaluation of biologicals"@en ;
cml:realizedBy doc:sec-32de-ss-3 ;
cml:integrityHash "4bf75d3653197b779b9a5539c3b4561e103a0096760081a530defb8ca3dc2842" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32de ;
skos:note "Regulations for applications of biologicals" ;
dc:description "information that must accompany an application" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.324" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32de-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-32de-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32de-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-32de-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-32de-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32de-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST PROVIDE" ;
cml:logicSummary "Regulations require information to be provided" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32df a cml:Concept ;
skos:prefLabel "32DF Inclusion of biological in the Register"@en ;
cml:realizedBy doc:sec-32df ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32df-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32df-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32df-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32df-ss-4 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.327" .
concept:therapeutic-goods-act-1989-sec-32df-ss-1 a cml:Concept ;
skos:prefLabel "32DF(1) Inclusion of biological in the Register"@en ;
cml:realizedBy doc:sec-32df-ss-1 ;
cml:integrityHash "3e05419e98737dcc73b529db10cdb53fa0e5d7d8f5af1c7f2a5d91266d8d1ec7" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32df ;
skos:note "Secretary must include biological in Register if certain conditions met." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.327" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32df-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32df-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32df-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-32df-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32df-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32df-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Must provide" ;
cml:premiseText "(1) If..." ;
cml:conclusionText "the Secretary must include the biological in the Register." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32df-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32df-ss-1-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-32df-ss-1-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator ">=" ;
cml:logicSummary "Evaluation must occur before inclusion" ;
cml:premiseText "(b) the Secretary decides that it is appropriate to include the biological in the Register after an evaluation under section 32DE;" ;
cml:conclusionText "the evaluation must occur before inclusion." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32df-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32df-ss-1-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-32df-ss-1-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "<=" ;
cml:logicSummary "Evaluation fee must be paid before inclusion" ;
cml:premiseText "(c) no part of an evaluation fee under section 32DI that is due and payable by the person remains unpaid;" ;
cml:conclusionText "the evaluation fee must be paid before inclusion." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32df-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32df-ss-1-logic-deontic-4 .
concept:therapeutic-goods-act-1989-sec-32df-ss-1-logic-deontic-4 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "No exceptions allowed" ;
cml:premiseText "(1) If..." ;
cml:conclusionText "no exceptions are allowed." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32df-ss-2 a cml:Concept ;
skos:prefLabel "32DF(2) Inclusion of biological in the Register"@en ;
cml:realizedBy doc:sec-32df-ss-2 ;
cml:integrityHash "aed08050be459a84549eba417bf185a03131b7ec10a31974aa21a76145b33350" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32df ;
skos:note "Secretary must assign a unique number to the biological if included in the Register." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.327" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32df-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-32df-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32df-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-32df-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32df-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32df-ss-2-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-32df-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32df-ss-2-logic-descriptionlogic-2 .
concept:therapeutic-goods-act-1989-sec-32df-ss-2-logic-descriptionlogic-2 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "CLASSIFICATION" ;
cml:logicSummary "Classification of biological in the Register" ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32df-ss-3 a cml:Concept ;
skos:prefLabel "32DF(3) Inclusion of biological in the Register"@en ;
cml:realizedBy doc:sec-32df-ss-3 ;
cml:integrityHash "70481819b3d475e5d1242f973adf65b6da177f0b12aadfff4187e1106c5797eb" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32df ;
skos:note "Secretary must provide certificate upon inclusion in Register" ;
dc:description "Certificate of inclusion" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.327" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32df-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-32df-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32df-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-32df-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-32df-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32df-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Must provide certificate" ;
cml:conclusionText "The Secretary must give to the applicant a certificate of the inclusion of the biological in the Register." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32df-ss-4 a cml:Concept ;
skos:prefLabel "32DF(4) Inclusion of biological in the Register"@en ;
cml:realizedBy doc:sec-32df-ss-4 ;
cml:integrityHash "75f5e41b9253d96e0c996bc8f7f6379601dd1d665f03d1d81df9618afe79d631" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32df ;
skos:note "Specifies requirements for a certificate's content regarding biological inclusion in the Register." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.327" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32df-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-32df-ss-4-norm a values:Undertaking ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32df-ss-4 ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32dg a cml:Concept ;
skos:prefLabel "32DG Refusal to include biological in the Register"@en ;
cml:realizedBy doc:sec-32dg ;
cml:integrityHash "35d6590932023d91330c68b047f37499e2bf4593bab974bf4dbfaf5806d3373d" ;
skos:note "Secretary must provide notice after refusing application to include biological in the Register." ;
dc:description "Notice of refusal and reasons for refusal" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.328" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32dg-norm .
concept:therapeutic-goods-act-1989-sec-32dg-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dg ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32dg cml:asserts concept:therapeutic-goods-act-1989-sec-32dg-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32dg-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Must" ;
cml:logicSummary "Secretary must provide notice" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32dh a cml:Concept ;
skos:prefLabel "32DH Lapsing of application"@en ;
cml:realizedBy doc:sec-32dh ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32dh-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32dh-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.328" .
concept:therapeutic-goods-act-1989-sec-32dh-ss-1 a cml:Concept ;
skos:prefLabel "32DH(1) Lapsing of application"@en ;
cml:realizedBy doc:sec-32dh-ss-1 ;
cml:integrityHash "21734f645e98b0804e0e0348aa6cb0d634e2519147b432f72d6a23a34173fa86" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dh ;
skos:note "Application lapse due to unpaid fee, false information, or non-compliance with patient data requirements." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.328" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32dh-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32dh-ss-1-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dh-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-32dh-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32dh-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32dh-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibition of application lapse due to unpaid fee." ;
cml:premiseText "Unpaid fee" ;
cml:conclusionText "Application lapse." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32dh-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32dh-ss-1-logic-deontic-2 .
concept:therapeutic-goods-act-1989-sec-32dh-ss-1-logic-deontic-2 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibition of application lapse due to false information." ;
cml:premiseText "False information" ;
cml:conclusionText "Application lapse." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32dh-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32dh-ss-1-logic-deontic-3 .
concept:therapeutic-goods-act-1989-sec-32dh-ss-1-logic-deontic-3 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibition of application lapse due to non-compliance with patient data requirements." ;
cml:premiseText "Non-compliance with patient data requirements" ;
cml:conclusionText "Application lapse." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32dh-ss-2 a cml:Concept ;
skos:prefLabel "32DH(2) Lapsing of application"@en ;
cml:realizedBy doc:sec-32dh-ss-2 ;
cml:integrityHash "a43ad6992fe4cc3dd6e55a6a25052952eb6a696ff2f6bda506851e5a5c545b93" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dh ;
skos:note "Defines patient data in relation to a biological." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.328" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32dh-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-32dh-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dh-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-32dh-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32dh-ss-2-logic-descriptionlogic-1 .
concept:therapeutic-goods-act-1989-sec-32dh-ss-2-logic-descriptionlogic-1 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "=" ;
cml:logicSummary "Identifies specific information types" ;
cml:premiseText "patient data, in relation to a biological" ;
cml:conclusionText "information derived from clinical trials" ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32dh-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32dh-ss-2-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-32dh-ss-2-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "during" ;
cml:logicSummary "Describes temporal relationship" ;
cml:premiseText "before, during and after" ;
cml:conclusionText "clinical trials" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32di a cml:Concept ;
skos:prefLabel "32DI Evaluation fee"@en ;
cml:realizedBy doc:sec-32di ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32di-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32di-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.329" .
concept:therapeutic-goods-act-1989-sec-32di-ss-1 a cml:Concept ;
skos:prefLabel "32DI(1) Evaluation fee"@en ;
cml:realizedBy doc:sec-32di-ss-1 ;
cml:integrityHash "e0018270574c19239785c7fbfeee5a3aaba6aac71fe1bc7312c82b14017d9133" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32di ;
skos:note "Pay evaluation fee for biological inclusion in Register" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.329" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32di-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32di-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32di-ss-1 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32di-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32di-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32di-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Duty to pay evaluation fee" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32di-ss-2 a cml:Concept ;
skos:prefLabel "32DI(2) Evaluation fee"@en ;
cml:realizedBy doc:sec-32di-ss-2 ;
cml:integrityHash "afa4101debfec40f8f26adaa4642f7c90183727c9cc9e8d40484a1d4ba7f9c25" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32di ;
skos:note "The Secretary must notify the applicant in writing of the evaluation fee." ;
dc:description "yes" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.329" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32di-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-32di-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32di-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-32di-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32di-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32di-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "The Secretary must notify the applicant in writing of the evaluation fee." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32dj a cml:Concept ;
skos:prefLabel "32DJ When evaluation fee due for payment"@en ;
cml:realizedBy doc:sec-32dj ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32dj-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32dj-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.329" .
concept:therapeutic-goods-act-1989-sec-32dj-ss-1 a cml:Concept ;
skos:prefLabel "32DJ(1) When evaluation fee due for payment"@en ;
cml:realizedBy doc:sec-32dj-ss-1 ;
cml:integrityHash "1120492f9496e87c45d6a6cabf1b373d23f28c6467d23b573f2fc7bdf9b3120c" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dj ;
skos:note "Evaluation fee due on notification of amount" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.329" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32dj-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32dj-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dj-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-32dj-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32dj-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32dj-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "due" ;
cml:logicSummary "Obligation to pay evaluation fee" ;
cml:premiseText "(1) Subject to sections 32DK and 32DM, an evaluation fee payable by an applicant is due and payable on the day on which the applicant is notified of the amount of the evaluation fee." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32dj-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32dj-ss-1-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-32dj-ss-1-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "on" ;
cml:logicSummary "Temporal relation between notification and payment" ;
cml:premiseText "(1) Subject to sections 32DK and 32DM, an evaluation fee payable by an applicant is due and payable on the day on which the applicant is notified of the amount of the evaluation fee." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32dj-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32dj-ss-1-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-32dj-ss-1-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "on" ;
cml:logicSummary "Temporal trace between notification and payment" ;
cml:premiseText "(1) Subject to sections 32DK and 32DM, an evaluation fee payable by an applicant is due and payable on the day on which the applicant is notified of the amount of the evaluation fee." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32dj-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32dj-ss-1-logic-diffusion-4 .
concept:therapeutic-goods-act-1989-sec-32dj-ss-1-logic-diffusion-4 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "on" ;
cml:logicSummary "Spread of obligation to pay evaluation fee" ;
cml:premiseText "(1) Subject to sections 32DK and 32DM, an evaluation fee payable by an applicant is due and payable on the day on which the applicant is notified of the amount of the evaluation fee." ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32dj-ss-2 a cml:Concept ;
skos:prefLabel "32DJ(2) When evaluation fee due for payment"@en ;
cml:realizedBy doc:sec-32dj-ss-2 ;
cml:integrityHash "0cc8694786fc1b02c8150cd49896bd52e4b6040881ee57fdf51d5d1f5e042449" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dj ;
skos:note "Evaluation fee must be paid in the manner prescribed by regulations." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.329" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32dj-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-32dj-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dj-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-32dj-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32dj-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32dj-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Obligation to pay evaluation fee" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32dk a cml:Concept ;
skos:prefLabel "32DK Payment of evaluation fee by instalments"@en ;
cml:realizedBy doc:sec-32dk ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32dk-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32dk-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32dk-ss-3 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.329" .
concept:therapeutic-goods-act-1989-sec-32dk-ss-1 a cml:Concept ;
skos:prefLabel "32DK(1) Payment of evaluation fee by instalments"@en ;
cml:realizedBy doc:sec-32dk-ss-1 ;
cml:integrityHash "f81f85ab9e8ee0e7303e5b8e6817715ee7e4fb0b4cdd0aea1c19bd2820dfbd4d" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dk ;
skos:note "Payment of evaluation fee by instalments is obligatory." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.329" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32dk-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32dk-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dk-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-32dk-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32dk-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32dk-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Payment of evaluation 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-32dk-ss-2 a cml:Concept ;
skos:prefLabel "32DK(2) Payment of evaluation fee by instalments"@en ;
cml:realizedBy doc:sec-32dk-ss-2 ;
cml:integrityHash "900dedc4f8227348093cd3474005c7e84ecee1256e67a428392d5e0d18a61db9" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dk ;
skos:note "Payment of evaluation fee by instalments is not allowed if any part of an instalment was unpaid immediately after it became due for payment." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.329" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32dk-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-32dk-ss-2-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dk-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-32dk-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32dk-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32dk-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits payment of evaluation fee by instalments if any part was unpaid immediately after it became due." ;
cml:premiseText "(2) Regulations may provide that a person is not allowed to pay an evaluation fee by instalments..." ;
cml:conclusionText "...if any part of an instalment of that or any other evaluation fee payable by the person was unpaid immediately after the time when it became due for payment." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32dk-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32dk-ss-2-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-32dk-ss-2-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Overlaps" ;
cml:logicSummary "Payment of evaluation fee by instalments overlaps with the condition that any part of an instalment was unpaid immediately after it became due." ;
cml:premiseText "(2) Regulations may provide that a person is not allowed to pay an evaluation fee by instalments..." ;
cml:conclusionText "...if any part of an instalment of that or any other evaluation fee payable by the person 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-32dk-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32dk-ss-2-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-32dk-ss-2-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "Contains" ;
cml:logicSummary "Payment of evaluation fee by instalments contains the condition that any part of an instalment was unpaid immediately after it became due." ;
cml:premiseText "(2) Regulations may provide that a person is not allowed to pay an evaluation fee by instalments..." ;
cml:conclusionText "...if any part of an instalment of that or any other evaluation fee payable by the person 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-32dk-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32dk-ss-2-logic-diffusion-4 .
concept:therapeutic-goods-act-1989-sec-32dk-ss-2-logic-diffusion-4 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "Diffuses" ;
cml:logicSummary "Payment of evaluation fee by instalments diffuses to all persons who are not allowed to pay an evaluation fee by instalments if any part was unpaid immediately after it became due." ;
cml:premiseText "(2) Regulations may provide that a person is not allowed to pay an evaluation fee by instalments..." ;
cml:conclusionText "...if any part of an instalment of that or any other evaluation fee payable by the person 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-32dk-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32dk-ss-2-logic-cogai-5 .
concept:therapeutic-goods-act-1989-sec-32dk-ss-2-logic-cogai-5 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "Recognizes" ;
cml:logicSummary "Payment of evaluation fee by instalments is recognized as a prohibited action if any part was unpaid immediately after it became due." ;
cml:premiseText "(2) Regulations may provide that a person is not allowed to pay an evaluation fee by instalments..." ;
cml:conclusionText "...if any part of an instalment of that or any other evaluation fee payable by the person was unpaid immediately after the time when it became due for payment." ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32dk-ss-3 a cml:Concept ;
skos:prefLabel "32DK(3) Payment of evaluation fee by instalments"@en ;
cml:realizedBy doc:sec-32dk-ss-3 ;
cml:integrityHash "256c422ca8d35e3f5d3c14fe4842f835d07799df690a0160457a57caca8cee70" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dk ;
skos:note "Payment of evaluation fee by instalments" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.329" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32dk-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-32dk-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dk-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-32dk-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-32dk-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32dk-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Must pay evaluation fee" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32dl a cml:Concept ;
skos:prefLabel "32DL Recovery of evaluation fee"@en ;
cml:realizedBy doc:sec-32dl ;
cml:integrityHash "12b041b79bd55dfe569f500412a8f8fcb6fd50ac36630d59e1e0ad7b369fd486" ;
skos:note "The Commonwealth may recover an evaluation fee as a debt." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.330" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32dl-norm .
concept:therapeutic-goods-act-1989-sec-32dl-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dl ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32dl cml:asserts concept:therapeutic-goods-act-1989-sec-32dl-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32dl-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-32dm a cml:Concept ;
skos:prefLabel "32DM Reduction of evaluation fee where evaluation not completed"@en ;
cml:realizedBy doc:sec-32dm ;
cml:integrityHash "96c601b27894655e1c8e45a83ce1461ee33eb8540bf3dc01ec901a777733e9ba" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32dm-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32dm-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32dm-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32dm-ss-4 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32dm-ss-5 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32dm-ss-6 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.330" .
concept:therapeutic-goods-act-1989-sec-32dm-ss-1 a cml:Concept ;
skos:prefLabel "32DM(1) Reduction of evaluation fee where evaluation not completed"@en ;
cml:realizedBy doc:sec-32dm-ss-1 ;
cml:integrityHash "df27b2d0d8a2e5be5d89680e0fe31979edc7b340f43141ebef3a21d0c12dc03e" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dm ;
skos:note "No payment of more than 3/4 evaluation fee before completion if a period is prescribed for completing the evaluation." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.330" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32dm-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32dm-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dm-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-32dm-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32dm-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32dm-ss-1-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-32dm-ss-2 a cml:Concept ;
skos:prefLabel "32DM(2) Reduction of evaluation fee where evaluation not completed"@en ;
cml:realizedBy doc:sec-32dm-ss-2 ;
cml:integrityHash "2e33b8338063be603cd123109ced2e6550788de196c748b20fe796bcf92179f7" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dm ;
skos:note "Secretary must notify applicant of evaluation completion date" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.330" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32dm-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-32dm-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dm-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-32dm-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32dm-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32dm-ss-2-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-32dm-ss-3 a cml:Concept ;
skos:prefLabel "32DM(3) Reduction of evaluation fee where evaluation not completed"@en ;
cml:realizedBy doc:sec-32dm-ss-3 ;
cml:integrityHash "607b83da3744add83581b1875dcd57d58262e4714cbc97da3ce67c5c019c9d89" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dm ;
skos:note "Reduction of evaluation fee if evaluation not completed within period" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.330" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32dm-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-32dm-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dm-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-32dm-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-32dm-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32dm-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "if" ;
cml:logicSummary "Conditional obligation" ;
cml:premiseText "(evaluation not completed within period)" ;
cml:conclusionText "(evaluation fee is reduced)" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32dm-ss-4 a cml:Concept ;
skos:prefLabel "32DM(4) Reduction of evaluation fee where evaluation not completed"@en ;
cml:realizedBy doc:sec-32dm-ss-4 ;
cml:integrityHash "538eb0ce1ba29a88261e889469b6aa62b01a38a18b70cfed6123c781c05c491a" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dm ;
skos:note "Payment of unpaid evaluation fee upon completion of evaluation." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.330" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32dm-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-32dm-ss-4-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dm-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-32dm-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-32dm-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32dm-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-32dm-ss-5 a cml:Concept ;
skos:prefLabel "32DM(5) Reduction of evaluation fee where evaluation not completed"@en ;
cml:realizedBy doc:sec-32dm-ss-5 ;
cml:integrityHash "24b601ca5d1956414b630885c30c09a3ecdd222182668435f3e95d01aae60134" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dm ;
skos:note "Evaluation fee reduction where report is given to applicant or committee." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.330" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32dm-ss-5-norm .
concept:therapeutic-goods-act-1989-sec-32dm-ss-5-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dm-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-32dm-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-32dm-ss-5-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32dm-ss-5-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Duty to pay full evaluation fee if applicant withdraws after report is given." ;
cml:premiseText "(5) For the purposes of this section, if a copy of the evaluation report..." ;
cml:conclusionText "then the evaluation is taken to be completed immediately before the first copy or summary is so given." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32dm-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-32dm-ss-5-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-32dm-ss-5-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Overlaps" ;
cml:logicSummary "Evaluation fee reduction applies when report is given within a specified period." ;
cml:premiseText "(5) For the purposes of this section, if a copy of the evaluation report..." ;
cml:conclusionText "then the evaluation is taken to be completed immediately before the first copy or summary is so given." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32dm-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-32dm-ss-5-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-32dm-ss-5-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "Until" ;
cml:logicSummary "Evaluation fee reduction applies until report is given to applicant or committee." ;
cml:premiseText "(5) For the purposes of this section, if a copy of the evaluation report..." ;
cml:conclusionText "then the evaluation is taken to be completed immediately before the first copy or summary is so given." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32dm-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-32dm-ss-5-logic-diffusion-4 .
concept:therapeutic-goods-act-1989-sec-32dm-ss-5-logic-diffusion-4 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "Diffuses" ;
cml:logicSummary "Report being given to applicant or committee diffuses the obligation to pay full evaluation fee." ;
cml:premiseText "(5) For the purposes of this section, if a copy of the evaluation report..." ;
cml:conclusionText "then the evaluation is taken to be completed immediately before the first copy or summary is so given." ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32dm-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-32dm-ss-5-logic-argumentation-5 .
concept:therapeutic-goods-act-1989-sec-32dm-ss-5-logic-argumentation-5 a cml:LogicApplication ;
cml:modality cml:Argumentation ;
cml:operator "Implication" ;
cml:logicSummary "Withdrawal after report being given implies obligation to pay full evaluation fee." ;
cml:premiseText "(5) For the purposes of this section, if a copy of the evaluation report..." ;
cml:conclusionText "then the evaluation is taken to be completed immediately before the first copy or summary is so given." ;
cml:executionSurface "modalities::argumentation" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32dm-ss-6 a cml:Concept ;
skos:prefLabel "32DM(6) Reduction of evaluation fee where evaluation not completed"@en ;
cml:realizedBy doc:sec-32dm-ss-6 ;
cml:integrityHash "4ccfe30a0aaa914bfdcd080309140d4ac02b4f0d5907986d36cfce1c46d2048d" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dm ;
skos:note "Notification under subsection (2) is not a legislative instrument." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.330" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32dm-ss-6-norm .
concept:therapeutic-goods-act-1989-sec-32dm-ss-6-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dm-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-32dn a cml:Concept ;
skos:prefLabel "32DN Transitional provisions for existing biologicals"@en ;
cml:realizedBy doc:sec-32dn ;
cml:integrityHash "63bdba36929143db55d07872f5c19c018addd7c331ddd71bd69e4763933339a9" ;
skos:note "Secretary must cancel inclusion of goods in part and include biological in Register under Part" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.331" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32dn-norm .
concept:therapeutic-goods-act-1989-sec-32dn-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dn ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32dn cml:asserts concept:therapeutic-goods-act-1989-sec-32dn-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32dn-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-32do a cml:Concept ;
skos:prefLabel "32DO Criminal offences for false statements in applications for"@en ;
cml:realizedBy doc:sec-32do ;
cml:integrityHash "76894ee034b29d5f53608365656279a356af0f53ab78b8501ea4da7ea00c8034" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32do-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32do-ss-4 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32do-ss-5 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32do-ss-6 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.334" .
concept:therapeutic-goods-act-1989-sec-32do-ss-1 a cml:Concept ;
skos:prefLabel "32DO(1) Criminal offences for false statements in applications for"@en ;
cml:realizedBy doc:sec-32do-ss-1 ;
cml:integrityHash "5c316cfe4548b797e61b6a6bd98656e70dd6b1c0211b2b1248d7befb3a85f129" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32do ;
skos:note "Making false statements in applications for biological inclusion is a criminal offence." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.334" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32do-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32do-ss-1-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32do-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-32do-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32do-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32do-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits making false statements in applications for biological inclusion." ;
cml:premiseText "The statement is made in, or in connection with, an application for inclusion of a biological in the Register." ;
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-32do-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32do-ss-1-logic-deontic-2 .
concept:therapeutic-goods-act-1989-sec-32do-ss-1-logic-deontic-2 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits harm or injury to any person resulting from the use of the biological." ;
cml:premiseText "(i) the use of the biological has resulted in, will result in, or is likely to result in, harm or injury to any person;" ;
cml:conclusionText "or (ii) the use of the biological, if the biological were 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-32do-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32do-ss-1-logic-linearlogic-3 .
concept:therapeutic-goods-act-1989-sec-32do-ss-1-logic-linearlogic-3 a cml:LogicApplication ;
cml:modality cml:LinearLogic ;
cml:operator "Imply" ;
cml:logicSummary "Implies that the provision is related to harm or injury." ;
cml:premiseText "(i) the use of the biological has resulted in, will result in, or is likely to result in, harm or injury to any person;" ;
cml:conclusionText "or (ii) the use of the biological, if the biological were used, would result in, or would be likely to result in, harm or injury to any person." ;
cml:executionSurface "modalities::linear" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32do-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32do-ss-1-logic-deontic-4 .
concept:therapeutic-goods-act-1989-sec-32do-ss-1-logic-deontic-4 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits making false statements in applications for biological inclusion." ;
cml:premiseText "(a) the person makes a statement;" ;
cml:conclusionText "and (b) the statement is made in, or in connection with, an application for inclusion of a biological in the Register." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32do-ss-4 a cml:Concept ;
skos:prefLabel "32DO(4) Criminal offences for false statements in applications for"@en ;
cml:realizedBy doc:sec-32do-ss-4 ;
cml:integrityHash "abd03b6bef0384250a00315152f44b464c65d81267309c327bc131579675cfba" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32do ;
skos:note "Making false statements in applications for inclusion of biologicals in the Register is an offence." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.334" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32do-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-32do-ss-4-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32do-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-32do-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-32do-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32do-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibition of false statements" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32do-ss-5 a cml:Concept ;
skos:prefLabel "32DO(5) Criminal offences for false statements in applications for"@en ;
cml:realizedBy doc:sec-32do-ss-5 ;
cml:integrityHash "2a7e830472a7cb8df801467a1ec8b2cfb10c6634fbbe645f2eb9274c3b649237" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32do ;
skos:note "Making false statements in applications for inclusion of a biological in the Register is an offence." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.334" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32do-ss-5-norm .
concept:therapeutic-goods-act-1989-sec-32do-ss-5-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32do-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-32do-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-32do-ss-5-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32do-ss-5-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibition" ;
cml:logicSummary "Prohibits making false statements in applications." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32do-ss-6 a cml:Concept ;
skos:prefLabel "32DO(6) Criminal offences for false statements in applications for"@en ;
cml:realizedBy doc:sec-32do-ss-6 ;
cml:integrityHash "c385da7f11ff5e7f14e072e858989feb81f5b1c13125da3beda70e38518df21e" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32do ;
skos:note "An offence against subsection (5) is an offence of strict liability." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.334" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32do-ss-6-norm .
concept:therapeutic-goods-act-1989-sec-32do-ss-6-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32do-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-32do-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-32do-ss-6-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32do-ss-6-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-32dp a cml:Concept ;
skos:prefLabel "32DP Civil penalty for false statements in applications for including"@en ;
cml:realizedBy doc:sec-32dp ;
cml:integrityHash "b48caf5e8f12bcfef45d2983b175ffba1bba31d96c654fa06b18c89ab8610697" ;
skos:note "False statements in applications for inclusion of biologicals in the Register" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.335" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32dp-norm .
concept:therapeutic-goods-act-1989-sec-32dp-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dp ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32dp cml:asserts concept:therapeutic-goods-act-1989-sec-32dp-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32dp-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibition on false statements" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32dq a cml:Concept ;
skos:prefLabel "32DQ Criminal offence and civil penalty for failing to notify adverse"@en ;
cml:realizedBy doc:sec-32dq ;
cml:integrityHash "df485be7af1475b18b8908e5d1492812ab83aa3d0c56e543cade0fff9e83ba1e" ;
skos:note "Failure to notify adverse effects of a biological included in the Register is an offence." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.335" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32dq-norm .
concept:therapeutic-goods-act-1989-sec-32dq-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dq ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32dq cml:asserts concept:therapeutic-goods-act-1989-sec-32dq-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32dq-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Obligation to notify adverse effects of a biological 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-32dr a cml:Concept ;
skos:prefLabel "32DR Criminal offences and civil penalties for failing to notify"@en ;
cml:realizedBy doc:sec-32dr ;
cml:integrityHash "0b09453967a471070eda69bc1f6ccc39569366942a29a8fc9da335c9d8834c44" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32dr-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32dr-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32dr-ss-3 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.337" .
concept:therapeutic-goods-act-1989-sec-32dr-ss-1 a cml:Concept ;
skos:prefLabel "32DR(1) Criminal offences and civil penalties for failing to notify"@en ;
cml:realizedBy doc:sec-32dr-ss-1 ;
cml:integrityHash "cb367538ff1b72f75dae54f1f629fe812935b989af68bf86168b2a6c0025c862" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dr ;
skos:note "Notify the Secretary of known information within 14 days after application withdrawal or lapse." ;
dc:description "Yes" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.337" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32dr-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32dr-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dr-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-32dr-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32dr-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32dr-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "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-32dr-ss-2 a cml:Concept ;
skos:prefLabel "32DR(2) Criminal offences and civil penalties for failing to notify"@en ;
cml:realizedBy doc:sec-32dr-ss-2 ;
cml:integrityHash "75e78fdbe2f2bf101f8c3428f2cf4923be4c3cf7f08d3e5b94b2664b0e694517" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dr ;
skos:note "Failing to notify of certain information may result in criminal offences or civil penalties." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.337" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32dr-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-32dr-ss-2-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dr-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-32dr-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32dr-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32dr-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibition of failing to notify" ;
cml:premiseText "Notification is required" ;
cml:conclusionText "Failing to notify is prohibited" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32dr-ss-3 a cml:Concept ;
skos:prefLabel "32DR(3) Criminal offences and civil penalties for failing to notify"@en ;
cml:realizedBy doc:sec-32dr-ss-3 ;
cml:integrityHash "297ab860e3a368cd97201d81e906f6d8660efd6b3f6528361e1fa6083216b8bb" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dr ;
skos:note "Failure to comply with notice within 30 days results in imprisonment or penalty units." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.337" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32dr-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-32dr-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dr-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-32dr-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-32dr-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32dr-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "obligation" ;
cml:logicSummary "Obligation to comply with notice." ;
cml:premiseText "Secretary gives notice." ;
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-32ds a cml:Concept ;
skos:prefLabel "32DS Consultation with Gene Technology Regulator"@en ;
cml:realizedBy doc:sec-32ds ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32ds-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32ds-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32ds-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32ds-ss-4 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32ds-ss-5 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32ds-ss-6 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.339" .
concept:therapeutic-goods-act-1989-sec-32ds-ss-1 a cml:Concept ;
skos:prefLabel "32DS(1) Consultation with Gene Technology Regulator"@en ;
cml:realizedBy doc:sec-32ds-ss-1 ;
cml:integrityHash "f387d14888fbef829a846a503f263e392d71b3b563832942ec94d309433d79b6" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ds ;
skos:note "Application for inclusion of a biological in the Register must consult with the Gene Technology Regulator." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.339" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32ds-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32ds-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ds-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-32ds-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32ds-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32ds-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Application must comply with consultation requirement." ;
cml:premiseText "The application for inclusion of a biological in the Register..." ;
cml:conclusionText "...must consult with the Gene Technology Regulator." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ds-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32ds-ss-1-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-32ds-ss-1-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator ">=" ;
cml:logicSummary "Consultation must occur before the application is processed." ;
cml:premiseText "The application for inclusion of a biological in the Register..." ;
cml:conclusionText "...must consult with the Gene Technology Regulator." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ds-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32ds-ss-1-logic-argumentation-3 .
concept:therapeutic-goods-act-1989-sec-32ds-ss-1-logic-argumentation-3 a cml:LogicApplication ;
cml:modality cml:Argumentation ;
cml:operator "IMPLIES" ;
cml:logicSummary "Consultation implies that the application is not exempt from regulation." ;
cml:premiseText "The application for inclusion of a biological in the Register..." ;
cml:conclusionText "...must consult with the Gene Technology Regulator." ;
cml:executionSurface "modalities::argumentation" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ds-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32ds-ss-1-logic-diffusion-4 .
concept:therapeutic-goods-act-1989-sec-32ds-ss-1-logic-diffusion-4 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "IS_A" ;
cml:logicSummary "Consultation is a necessary step for the regulation of genetic modification." ;
cml:premiseText "The application for inclusion of a biological in the Register..." ;
cml:conclusionText "...must consult with the Gene Technology Regulator." ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ds-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32ds-ss-1-logic-cogai-5 .
concept:therapeutic-goods-act-1989-sec-32ds-ss-1-logic-cogai-5 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "IS_A" ;
cml:logicSummary "Consultation is an artificial intelligence-powered regulation mechanism." ;
cml:premiseText "The application for inclusion of a biological in the Register..." ;
cml:conclusionText "...must consult with the Gene Technology Regulator." ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ds-ss-2 a cml:Concept ;
skos:prefLabel "32DS(2) Consultation with Gene Technology Regulator"@en ;
cml:realizedBy doc:sec-32ds-ss-2 ;
cml:integrityHash "72f4b66640772a86767f0b5d10f6a70d034e87a7de72257b9ecf0218ca53659e" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ds ;
skos:note "The Secretary must give written notice to the Gene Technology Regulator." ;
dc:description "Yes" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.339" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32ds-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-32ds-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ds-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-32ds-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32ds-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32ds-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "The 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-32ds-ss-3 a cml:Concept ;
skos:prefLabel "32DS(3) Consultation with Gene Technology Regulator"@en ;
cml:realizedBy doc:sec-32ds-ss-3 ;
cml:integrityHash "3d5d299bf76932c099e508d0af6ee43fab79648ef5191cf7bc1c4b603ebec156" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ds ;
skos:note "The Gene Technology Regulator must provide written advice to the Secretary about a gene technology application." ;
dc:description "Yes" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.339" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32ds-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-32ds-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ds-ss-3 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ds-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-32ds-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32ds-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "The Gene Technology Regulator must provide written advice." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ds-ss-4 a cml:Concept ;
skos:prefLabel "32DS(4) Consultation with Gene Technology Regulator"@en ;
cml:realizedBy doc:sec-32ds-ss-4 ;
cml:integrityHash "00b1b875e100436c290e3e2970316321c0a13934db4ea38ff0fbcf8885da1a15" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ds ;
skos:note "Consultation with Gene Technology Regulator within specified period." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.339" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32ds-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-32ds-ss-4-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ds-ss-4 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ds-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-32ds-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32ds-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Must provide consultation" ;
cml:premiseText "The advice is to be given within the period specified in the notice." ;
cml:conclusionText "Consultation with Gene Technology Regulator within specified period." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ds-ss-5 a cml:Concept ;
skos:prefLabel "32DS(5) Consultation with Gene Technology Regulator"@en ;
cml:realizedBy doc:sec-32ds-ss-5 ;
cml:integrityHash "9ab5b6d3d6a1a80352b64b13ee57680a39735774676b084e0b3e9ee3cdde29a5" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ds ;
skos:note "No notification required for applications within a class of biologicals subject to Gene Technology Regulator advice." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.339" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32ds-ss-5-norm .
concept:therapeutic-goods-act-1989-sec-32ds-ss-5-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ds-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-32ds-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-32ds-ss-5-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32ds-ss-5-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Exemption" ;
cml:logicSummary "No notification required for applications within a class of biologicals subject to Gene Technology Regulator advice." ;
cml:premiseText "(5) If an advice from the Gene Technology Regulator is in force under section 32DT in relation to a class of biologicals, the Secretary is not required to notify the Gene Technology Regulator under this section in relation to an application for inclusion in the Register of a biological belonging to that class." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ds-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-32ds-ss-5-logic-descriptionlogic-2 .
concept:therapeutic-goods-act-1989-sec-32ds-ss-5-logic-descriptionlogic-2 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "Class Inclusion" ;
cml:logicSummary "The Secretary is not required to notify the Gene Technology Regulator under this section in relation to an application for inclusion in the Register of a biological belonging to that class." ;
cml:premiseText "(5) If an advice from the Gene Technology Regulator is in force under section 32DT in relation to a class of biologicals, the Secretary is not required to notify the Gene Technology Regulator under this section in relation to an application for inclusion in the Register of a biological belonging to that class." ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ds-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-32ds-ss-5-logic-alleninterval-3 .
concept:therapeutic-goods-act-1989-sec-32ds-ss-5-logic-alleninterval-3 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Temporal Exemption" ;
cml:logicSummary "The exemption applies only within the scope of Gene Technology Regulator advice under section 32DT." ;
cml:premiseText "(5) If an advice from the Gene Technology Regulator is in force under section 32DT in relation to a class of biologicals, the Secretary is not required to notify the Gene Technology Regulator under this section in relation to an application for inclusion in the Register of a biological belonging to that class." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ds-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-32ds-ss-5-logic-ltl-4 .
concept:therapeutic-goods-act-1989-sec-32ds-ss-5-logic-ltl-4 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "Temporal Exemption" ;
cml:logicSummary "The exemption applies only within the scope of Gene Technology Regulator advice under section 32DT." ;
cml:premiseText "(5) If an advice from the Gene Technology Regulator is in force under section 32DT in relation to a class of biologicals, the Secretary is not required to notify the Gene Technology Regulator under this section in relation to an application for inclusion in the Register of a biological belonging to that class." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ds-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-32ds-ss-5-logic-diffusion-5 .
concept:therapeutic-goods-act-1989-sec-32ds-ss-5-logic-diffusion-5 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "Information Dissemination" ;
cml:logicSummary "The exemption applies only within the scope of Gene Technology Regulator advice under section 32DT." ;
cml:premiseText "(5) If an advice from the Gene Technology Regulator is in force under section 32DT in relation to a class of biologicals, the Secretary is not required to notify the Gene Technology Regulator under this section in relation to an application for inclusion in the Register of a biological belonging to that class." ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ds-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-32ds-ss-5-logic-cogai-6 .
concept:therapeutic-goods-act-1989-sec-32ds-ss-5-logic-cogai-6 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "Knowledge Representation" ;
cml:logicSummary "The exemption applies only within the scope of Gene Technology Regulator advice under section 32DT." ;
cml:premiseText "(5) If an advice from the Gene Technology Regulator is in force under section 32DT in relation to a class of biologicals, the Secretary is not required to notify the Gene Technology Regulator under this section in relation to an application for inclusion in the Register of a biological belonging to that class." ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ds-ss-6 a cml:Concept ;
skos:prefLabel "32DS(6) Consultation with Gene Technology Regulator"@en ;
cml:realizedBy doc:sec-32ds-ss-6 ;
cml:integrityHash "f16a590d4fbc3da687afd54d8da954039fe5daa94f2328a3b86ce03614eec63b" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ds ;
skos:note "Notice under subsection (2) is not a legislative instrument." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.339" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32ds-ss-6-norm .
concept:therapeutic-goods-act-1989-sec-32ds-ss-6-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ds-ss-6 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32dt a cml:Concept ;
skos:prefLabel "32DT Secretary may seek advice about classes of GM products or"@en ;
cml:realizedBy doc:sec-32dt ;
cml:integrityHash "8b9f3a54fe96d74cd996e8477e33a6ea12d240d714f3bdf2cd697b3e7d18ab19" ;
skos:note "The Secretary may request advice from the Gene Technology Regulator about specific GM products or organisms." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.339" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32dt-norm .
concept:therapeutic-goods-act-1989-sec-32dt-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32dt ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32du a cml:Concept ;
skos:prefLabel "32DU Secretary to take advice into account"@en ;
cml:realizedBy doc:sec-32du ;
cml:integrityHash "1197cb1929b5c8073f900c10e133b790e91c1ee4285eeaeae25a7eccd5e314bc" ;
skos:note "Secretary must take advice into account when making a decision on an application." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.340" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32du-norm .
concept:therapeutic-goods-act-1989-sec-32du-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32du ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32du cml:asserts concept:therapeutic-goods-act-1989-sec-32du-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32du-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Secretary must take advice into account." ;
cml:premiseText "The Secretary receives advice from the Gene Technology Regulator." ;
cml:conclusionText "The Secretary must ensure that the advice is taken into account in making a decision on the application." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32du cml:asserts concept:therapeutic-goods-act-1989-sec-32du-logic-deontic-2 .
concept:therapeutic-goods-act-1989-sec-32du-logic-deontic-2 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Secretary informs the Gene Technology Regulator of the decision on the application." ;
cml:premiseText "The Secretary must inform the Gene Technology Regulator of the decision on the application." ;
cml:conclusionText "The Secretary must inform the Gene Technology Regulator of the decision on the application." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32e a cml:Concept ;
skos:prefLabel "32E What this Division is about"@en ;
cml:realizedBy doc:sec-32e ;
cml:integrityHash "55c7893eefc5e4d3c641701e1c1f27f33d7a6e5f1d2c7bd23186a7663cda6f9f" ;
skos:note "Exemptions from automatic conditions for inclusions of biologicals in the Register" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.341" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32e-norm .
concept:therapeutic-goods-act-1989-sec-32e-norm a values:Undertaking ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32e ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ea a cml:Concept ;
skos:prefLabel "32EA Conditions applying automatically"@en ;
cml:realizedBy doc:sec-32ea ;
cml:integrityHash "9a37c6652c9fa43f76135a5e1330bf7596828e100acc1afd10924f9758c91fdc" ;
skos:note "Allow entry and inspection of premises for authorized persons." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.341" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32ea-norm .
concept:therapeutic-goods-act-1989-sec-32ea-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ea ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ea cml:asserts concept:therapeutic-goods-act-1989-sec-32ea-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32ea-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Allow" ;
cml:logicSummary "Grant permission for entry and inspection." ;
cml:premiseText "The person in relation to whom the biological is included in the Register..." ;
cml:conclusionText "...to allow an authorised person to enter, inspect, and examine." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ea cml:asserts concept:therapeutic-goods-act-1989-sec-32ea-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-32ea-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "During" ;
cml:logicSummary "Entry is allowed during reasonable hours." ;
cml:premiseText "at any reasonable time" ;
cml:conclusionText "...to enter, inspect, and examine at any reasonable time." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32eb a cml:Concept ;
skos:prefLabel "32EB Certification of manufacturing steps outside Australia"@en ;
cml:realizedBy doc:sec-32eb ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32eb-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32eb-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32eb-ss-3 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.345" .
concept:therapeutic-goods-act-1989-sec-32eb-ss-1 a cml:Concept ;
skos:prefLabel "32EB(1) Certification of manufacturing steps outside Australia"@en ;
cml:realizedBy doc:sec-32eb-ss-1 ;
cml:integrityHash "6a544b077b0642b6bbe0f5f0922c82bf6721cc2ab660c508e7f4104d1e2bbd04" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32eb ;
skos:note "Application for certification of manufacturing steps outside Australia" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.345" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32eb-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32eb-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32eb-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-32eb-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32eb-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32eb-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "obligation" ;
cml:logicSummary "Obligation to apply for certification" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32eb-ss-2 a cml:Concept ;
skos:prefLabel "32EB(2) Certification of manufacturing steps outside Australia"@en ;
cml:realizedBy doc:sec-32eb-ss-2 ;
cml:integrityHash "c40ca69ba68dc6d1acb628395d5b4a6c34c19231ff493bebb89e7487c8768289" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32eb ;
skos:note "Secretary must certify manufacturing procedures upon request." ;
dc:description "written notice" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.345" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32eb-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-32eb-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32eb-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-32eb-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32eb-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32eb-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Must provide written notice" ;
cml:conclusionText "The Secretary must give the person written notice of the certification." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32eb-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32eb-ss-2-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-32eb-ss-2-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "BETWEEN" ;
cml:logicSummary "Certification is within a specific time frame" ;
cml:premiseText "(2) If an application is made to the Secretary under this section, the Secretary may, by writing, certify that the manufacturing and quality control procedures used in that step are acceptable." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32eb-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32eb-ss-2-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-32eb-ss-2-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "BETWEEN" ;
cml:logicSummary "Certification is within a specific time frame" ;
cml:premiseText "(2) If an application is made to the Secretary under this section, the Secretary may, by writing, certify that the manufacturing and quality control procedures used in that step are acceptable." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32eb-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32eb-ss-2-logic-diffusion-4 .
concept:therapeutic-goods-act-1989-sec-32eb-ss-2-logic-diffusion-4 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "IS_A" ;
cml:logicSummary "Certification is a form of diffusion" ;
cml:premiseText "(2) If an application is made to the Secretary under this section, the Secretary may, by writing, certify that the manufacturing and quality control procedures used in that step are acceptable." ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32eb-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32eb-ss-2-logic-cogai-5 .
concept:therapeutic-goods-act-1989-sec-32eb-ss-2-logic-cogai-5 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "IS_A" ;
cml:logicSummary "Certification is a form of artificial intelligence" ;
cml:premiseText "(2) If an application is made to the Secretary under this section, the Secretary may, by writing, certify that the manufacturing and quality control procedures used in that step are acceptable." ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32eb-ss-3 a cml:Concept ;
skos:prefLabel "32EB(3) Certification of manufacturing steps outside Australia"@en ;
cml:realizedBy doc:sec-32eb-ss-3 ;
cml:integrityHash "8cb955a1a6cd49d7d0286a80cedabe527c61578e40b8c2c44a51ca0d6816352f" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32eb ;
skos:note "Applying subsections for certification decision" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.345" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32eb-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-32eb-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32eb-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-32eb-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-32eb-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32eb-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "apply" ;
cml:logicSummary "Applying relevant rules" ;
cml:premiseText "Subsections apply for certification decision" ;
cml:conclusionText "Decision made under subsections" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ec a cml:Concept ;
skos:prefLabel "32EC Imposition of conditions by legislative instrument"@en ;
cml:realizedBy doc:sec-32ec ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32ec-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32ec-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32ec-ss-3 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.345" .
concept:therapeutic-goods-act-1989-sec-32ec-ss-1 a cml:Concept ;
skos:prefLabel "32EC(1) Imposition of conditions by legislative instrument"@en ;
cml:realizedBy doc:sec-32ec-ss-1 ;
cml:integrityHash "095fc5d3954f931f447ef18dfc29bdde641e3127078abcb074a3bdd4ea2ee2aa" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ec ;
skos:note "Conditions for inclusion of a biological in the Register" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.345" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32ec-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32ec-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ec-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-32ec-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32ec-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32ec-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "imposes" ;
cml:logicSummary "Imposes conditions on inclusion of a biological in the Register" ;
cml:premiseText "(1) The inclusion of a biological in the Register is subject to the conditions set out in a determination under subsection (2)." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ec-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32ec-ss-1-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-32ec-ss-1-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "during" ;
cml:logicSummary "Conditions apply during the process of inclusion" ;
cml:premiseText "(1) The inclusion of a biological in the Register is subject to the conditions set out in a determination under subsection (2)." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ec-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32ec-ss-1-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-32ec-ss-1-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "during" ;
cml:logicSummary "Conditions apply during the process of inclusion" ;
cml:premiseText "(1) The inclusion of a biological in the Register is subject to the conditions set out in a determination under subsection (2)." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ec-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32ec-ss-1-logic-diffusion-4 .
concept:therapeutic-goods-act-1989-sec-32ec-ss-1-logic-diffusion-4 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "appliesTo" ;
cml:logicSummary "Applies to the process of inclusion" ;
cml:premiseText "(1) The inclusion of a biological in the Register is subject to the conditions set out in a determination under subsection (2)." ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ec-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32ec-ss-1-logic-cogai-5 .
concept:therapeutic-goods-act-1989-sec-32ec-ss-1-logic-cogai-5 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "appliesTo" ;
cml:logicSummary "Applies to the process of inclusion" ;
cml:premiseText "(1) The inclusion of a biological in the Register is subject to the conditions set out in a determination under subsection (2)." ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ec-ss-2 a cml:Concept ;
skos:prefLabel "32EC(2) Imposition of conditions by legislative instrument"@en ;
cml:realizedBy doc:sec-32ec-ss-2 ;
cml:integrityHash "b5c3bce67e48221bdab79e01ffe56e87b2445380655aee821082ec24a53be544" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ec ;
skos:note "Minister may impose conditions on the manufacture, custody, use, supply, disposal or destruction of a biological." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.345" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32ec-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-32ec-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ec-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-32ec-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32ec-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32ec-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "may" ;
cml:logicSummary "Imposition of conditions" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ec-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32ec-ss-2-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-32ec-ss-2-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "between" ;
cml:logicSummary "Temporal intervals for conditions" ;
cml:premiseText "(2) The Minister may, by legislative instrument, make a determination setting out conditions for the purposes of subsection (1);" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ec-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32ec-ss-2-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-32ec-ss-2-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "for all" ;
cml:logicSummary "Temporal scope of conditions" ;
cml:premiseText "(2) The Minister may, by legislative instrument, make a determination setting out conditions for the purposes of subsection (1);" ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ec-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32ec-ss-2-logic-deontic-4 .
concept:therapeutic-goods-act-1989-sec-32ec-ss-2-logic-deontic-4 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "must be met" ;
cml:logicSummary "Conditions for the biological" ;
cml:premiseText "(a) the manufacture of the biological; or (b) the custody, use, supply, disposal or destruction of the biological;" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ec-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32ec-ss-2-logic-deontic-5 .
concept:therapeutic-goods-act-1989-sec-32ec-ss-2-logic-deontic-5 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "must be met" ;
cml:logicSummary "Reporting requirements for the biological" ;
cml:premiseText "(ca) reporting requirements relating to the biological;" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ec-ss-3 a cml:Concept ;
skos:prefLabel "32EC(3) Imposition of conditions by legislative instrument"@en ;
cml:realizedBy doc:sec-32ec-ss-3 ;
cml:integrityHash "cd58bb3bdc13d9d1de75a21101598577b73da47ceaf17de393a506887cd7f9f2" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ec ;
skos:note "Different conditions may be specified for different classes of biologicals." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.345" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32ec-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-32ec-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ec-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-32ed a cml:Concept ;
skos:prefLabel "32ED Imposition of conditions at time biological included in the"@en ;
cml:realizedBy doc:sec-32ed ;
cml:integrityHash "bb7234ec12451361e6f35bcbe76de58e4350657fe60d1b96ace0947f59194083" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32ed-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32ed-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.346" .
concept:therapeutic-goods-act-1989-sec-32ed-ss-1 a cml:Concept ;
skos:prefLabel "32ED(1) Imposition of conditions at time biological included in the"@en ;
cml:realizedBy doc:sec-32ed-ss-1 ;
cml:integrityHash "120197c6fb4635544726606aa001608922f893bb3f86d968571bca61abe61049" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ed ;
skos:note "Secretary may impose conditions on inclusion of biological in Register" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.346" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32ed-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32ed-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ed-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-32ed-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32ed-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32ed-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-32ed-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32ed-ss-1-logic-descriptionlogic-2 .
concept:therapeutic-goods-act-1989-sec-32ed-ss-1-logic-descriptionlogic-2 a cml:LogicApplication ;
cml:modality cml:DescriptionLogic ;
cml:operator "includes" ;
cml:logicSummary "Includes biological in Register" ;
cml:executionSurface "modalities::dl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ed-ss-2 a cml:Concept ;
skos:prefLabel "32ED(2) Imposition of conditions at time biological included in the"@en ;
cml:realizedBy doc:sec-32ed-ss-2 ;
cml:integrityHash "aa9e9e5083928beca4beead99c50e3f05db93cce8047b6c6e76bac9f994d71cf" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ed ;
skos:note "A notice under subsection (1) is not a legislative instrument." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.346" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32ed-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-32ed-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ed-ss-2 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ed-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32ed-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32ed-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "not" ;
cml:logicSummary "Negative obligation" ;
cml:premiseText "A notice under subsection (1) is a legislative instrument." ;
cml:conclusionText "A notice under subsection (1) is not a legislative instrument." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ee a cml:Concept ;
skos:prefLabel "32EE Imposition or variation or removal of conditions after"@en ;
cml:realizedBy doc:sec-32ee ;
cml:integrityHash "192f53ccf8e81fc2ddf34ea930612e71df94f2fc6a74286380042ff20c268714" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32ee-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32ee-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32ee-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32ee-ss-3a ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32ee-ss-4 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.346" .
concept:therapeutic-goods-act-1989-sec-32ee-ss-1 a cml:Concept ;
skos:prefLabel "32EE(1) Imposition or variation or removal of conditions after"@en ;
cml:realizedBy doc:sec-32ee-ss-1 ;
cml:integrityHash "5ff133b09281fbfe91327b6f5ded4f8992e0cd55d3fb626946d4eece03a587ce" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ee ;
skos:note "Secretary may impose new conditions on biological inclusion" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.346" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32ee-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32ee-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ee-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-32ee-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32ee-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32ee-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-32ee-ss-2 a cml:Concept ;
skos:prefLabel "32EE(2) Imposition or variation or removal of conditions after"@en ;
cml:realizedBy doc:sec-32ee-ss-2 ;
cml:integrityHash "a5a6ce2eadcd3e61ec692bb4b6ed4527096f63e6a35fdf3eea34bc88e8b1925d" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ee ;
skos:note "Request must be accompanied by prescribed fee." ;
dc:description "fee" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.346" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32ee-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-32ee-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ee-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-32ee-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32ee-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32ee-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Obligation to provide fee" ;
cml:conclusionText "fee must be provided" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ee-ss-3 a cml:Concept ;
skos:prefLabel "32EE(3) Imposition or variation or removal of conditions after"@en ;
cml:realizedBy doc:sec-32ee-ss-3 ;
cml:integrityHash "91cbf126ac4c0e4989cfef61aa763d5d524182628560f11ba746d6b71c19fa3b" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ee ;
skos:note "Conditions for imposition or variation of conditions after notice is given to the person." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.346" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32ee-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-32ee-ss-3-norm a values:Undertaking ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ee-ss-3 ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ee-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-32ee-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32ee-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "takes effect" ;
cml:logicSummary "Imposition or variation takes effect on specified day." ;
cml:premiseText "(3) The imposition or variation or removal of a condition under subsection (1) takes effect:" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ee-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-32ee-ss-3-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-32ee-ss-3-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "within interval" ;
cml:logicSummary "Notice specifies start date for imposition or variation." ;
cml:premiseText "(aa) in the case of an imposition or variation requested by the person, and to which paragraph (a) does not apply—on the day specified in the notice, which must be at least 28 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-32ee-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-32ee-ss-3-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-32ee-ss-3-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "recurring trace" ;
cml:logicSummary "Notice specifies recurring pattern for imposition or variation." ;
cml:premiseText "(ab) in the case of a removal to which paragraph (a) does not apply—on the day specified in the notice, which must be at least 28 days after the notice is given to the person, unless the person has agreed to an earlier day;" ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ee-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-32ee-ss-3-logic-deontic-4 .
concept:therapeutic-goods-act-1989-sec-32ee-ss-3-logic-deontic-4 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "must provide" ;
cml:logicSummary "Person must agree to earlier start date for imposition or variation." ;
cml:premiseText "unless the person has agreed to an earlier day;" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ee-ss-3a a cml:Concept ;
skos:prefLabel "32EE(3A) Imposition or variation or removal of conditions after"@en ;
cml:realizedBy doc:sec-32ee-ss-3a ;
cml:integrityHash "b3e7aec7d80b3b465518a1c49459c596ab5eb3c6fea84242c2190afcecb73f4c" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ee ;
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 <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.346" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32ee-ss-3a-norm .
concept:therapeutic-goods-act-1989-sec-32ee-ss-3a-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ee-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-32ee-ss-3a cml:asserts concept:therapeutic-goods-act-1989-sec-32ee-ss-3a-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32ee-ss-3a-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator ">=" ;
cml:logicSummary "Temporal constraint" ;
cml:premiseText "The earlier day must not be earlier than the given day." ;
cml:conclusionText "The notice must be given on or after the given day." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ee-ss-3a cml:asserts concept:therapeutic-goods-act-1989-sec-32ee-ss-3a-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-32ee-ss-3a-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "=" ;
cml:logicSummary "Temporal relation" ;
cml:premiseText "The earlier day is a temporal interval before the given day." ;
cml:conclusionText "The notice must be given on or after the day before the given day." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ee-ss-4 a cml:Concept ;
skos:prefLabel "32EE(4) Imposition or variation or removal of conditions after"@en ;
cml:realizedBy doc:sec-32ee-ss-4 ;
cml:integrityHash "0931782cccff8e870982346a7802e881886319db33b6f9d0f235a8445e82b99e" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ee ;
skos:note "Legislative instrument notice is not a legislative instrument." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.346" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32ee-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-32ee-ss-4-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ee-ss-4 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ee-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-32ee-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32ee-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibition" ;
cml:logicSummary "Prohibits notices from being legislative instruments." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ef a cml:Concept ;
skos:prefLabel "32EF Criminal offences for breach of condition"@en ;
cml:realizedBy doc:sec-32ef ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32ef-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32ef-ss-4 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32ef-ss-5 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.347" .
concept:therapeutic-goods-act-1989-sec-32ef-ss-1 a cml:Concept ;
skos:prefLabel "32EF(1) Criminal offences for breach of condition"@en ;
cml:realizedBy doc:sec-32ef-ss-1 ;
cml:integrityHash "df2dbde40d25ef264b7fa56ea092c432ad1a6c234511ddfb65ab4be89d644e25" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ef ;
skos:note "Breach of condition results in harm or injury to any person." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.347" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32ef-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32ef-ss-1-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ef-ss-1 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ef-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32ef-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32ef-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibition" ;
cml:logicSummary "Prohibits breach of condition." ;
cml:premiseText "(1) A person commits an offence if: (a) a biological is included in the Register in relation to the person; and (b) the person does an act or omits to do an act; and (c) the act or omission breaches a condition of the inclusion of the biological in the Register; and (d) 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: 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-32ef-ss-4 a cml:Concept ;
skos:prefLabel "32EF(4) Criminal offences for breach of condition"@en ;
cml:realizedBy doc:sec-32ef-ss-4 ;
cml:integrityHash "e7d1c45bd6ae131d2b2c6d1f6f5f0348ef943e62bbadfec0a8a412755dc447e5" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ef ;
skos:note "Breach of condition results in criminal offence" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.347" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32ef-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-32ef-ss-4-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ef-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-32ef-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-32ef-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32ef-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Obligation to comply with conditions" ;
cml:premiseText "(a) a biological is included in the Register in relation to the person; and (b) the person does an act or omits to do an act;" ;
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-32ef-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-32ef-ss-4-logic-deontic-2 .
concept:therapeutic-goods-act-1989-sec-32ef-ss-4-logic-deontic-2 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibition" ;
cml:logicSummary "Prohibition on breach of conditions" ;
cml:premiseText "(c) the act or omission breaches a condition of the inclusion of the biological in the Register." ;
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-32ef-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-32ef-ss-4-logic-alleninterval-3 .
concept:therapeutic-goods-act-1989-sec-32ef-ss-4-logic-alleninterval-3 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Between" ;
cml:logicSummary "Temporal interval for breach of conditions" ;
cml:premiseText "(c) the act or omission breaches a condition of the inclusion of the biological in the Register." ;
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-32ef-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-32ef-ss-4-logic-ltl-4 .
concept:therapeutic-goods-act-1989-sec-32ef-ss-4-logic-ltl-4 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "Until" ;
cml:logicSummary "Temporal constraint on breach of conditions" ;
cml:premiseText "(c) the act or omission breaches a condition of the inclusion of the biological 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-32ef-ss-5 a cml:Concept ;
skos:prefLabel "32EF(5) Criminal offences for breach of condition"@en ;
cml:realizedBy doc:sec-32ef-ss-5 ;
cml:integrityHash "d15f98236552d89268460bca51b98a23109290bf5608869c6666368de6dcdf45" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ef ;
skos:note "Breach of condition results in criminal offence" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.347" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32ef-ss-5-norm .
concept:therapeutic-goods-act-1989-sec-32ef-ss-5-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ef-ss-5 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ef-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-32ef-ss-5-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32ef-ss-5-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibition" ;
cml:logicSummary "Prohibits breach of condition" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32eg a cml:Concept ;
skos:prefLabel "32EG Civil penalty for breach of condition"@en ;
cml:realizedBy doc:sec-32eg ;
cml:integrityHash "7fa8daa875f693606dac1f66e80cc1c841475b7bfa27a433726c47ffd1113418" ;
skos:note "Civil penalty for breach of condition" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.348" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32eg-norm .
concept:therapeutic-goods-act-1989-sec-32eg-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32eg ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32eg cml:asserts concept:therapeutic-goods-act-1989-sec-32eg-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32eg-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits breach of condition" ;
cml:premiseText "A person contravenes this section if..." ;
cml:conclusionText "...breaches a condition of the inclusion of the biological in the Register." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32eg cml:asserts concept:therapeutic-goods-act-1989-sec-32eg-logic-deontic-2 .
concept:therapeutic-goods-act-1989-sec-32eg-logic-deontic-2 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits breach of condition for individuals and bodies corporate" ;
cml:premiseText "Maximum civil penalty: (a) for an individual—5,000 penalty units; and (b) for a body corporate—50,000 penalty units." ;
cml:conclusionText "...for an individual—5,000 penalty units; and (b) for a body corporate—50,000 penalty units." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32eg cml:asserts concept:therapeutic-goods-act-1989-sec-32eg-logic-linearlogic-3 .
concept:therapeutic-goods-act-1989-sec-32eg-logic-linearlogic-3 a cml:LogicApplication ;
cml:modality cml:LinearLogic ;
cml:operator "Imply" ;
cml:logicSummary "Implicates breach of condition on inclusion in Register" ;
cml:premiseText "(a) a biological is included in the Register in relation to the person; and (b) the person does an act or omits to do an act;" ;
cml:conclusionText "...breaches a condition..." ;
cml:executionSurface "modalities::linear" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32eg cml:asserts concept:therapeutic-goods-act-1989-sec-32eg-logic-alleninterval-4 .
concept:therapeutic-goods-act-1989-sec-32eg-logic-alleninterval-4 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Within" ;
cml:logicSummary "Indicates temporal interval for breach of condition" ;
cml:premiseText "(a) a biological is included in the Register in relation to the person; and (b) the person does an act or omits to do an act;" ;
cml:conclusionText "...breaches a condition..." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32eg cml:asserts concept:therapeutic-goods-act-1989-sec-32eg-logic-deontic-5 .
concept:therapeutic-goods-act-1989-sec-32eg-logic-deontic-5 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits breach of condition for individuals and bodies corporate" ;
cml:premiseText "(a) for an individual—5,000 penalty units; (b) for a body corporate—50,000 penalty units." ;
cml:conclusionText "...for an individual—5,000 penalty units; and (b) for a body corporate—50,000 penalty units." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32f a cml:Concept ;
skos:prefLabel "32F What this Division is about"@en ;
cml:realizedBy doc:sec-32f ;
cml:integrityHash "ac0dda23769b7df38fc8a7abc292acafcf3a25565272f95283c498928b6c5df2" ;
skos:note "The Secretary may suspend biologicals from the Register in certain circumstances." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.349" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32f-norm .
concept:therapeutic-goods-act-1989-sec-32f-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32f ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32fa a cml:Concept ;
skos:prefLabel "32FA Suspension of biological from the Register"@en ;
cml:realizedBy doc:sec-32fa ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32fa-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32fa-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.349" .
concept:therapeutic-goods-act-1989-sec-32fa-ss-1 a cml:Concept ;
skos:prefLabel "32FA(1) Suspension of biological from the Register"@en ;
cml:realizedBy doc:sec-32fa-ss-1 ;
cml:integrityHash "1027dca81d738088861b624c86143b20172a910d8a7d8c8e1b428f1cd02e1eea" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32fa ;
skos:note "Suspension of biological from the Register is allowed under certain conditions." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.349" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32fa-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32fa-ss-1-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32fa-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-32fa-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32fa-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32fa-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits suspension of biological from the Register." ;
cml:premiseText "(1) The Secretary may, by written notice given to a person in relation to whom a biological 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-32fa-ss-2 a cml:Concept ;
skos:prefLabel "32FA(2) Suspension of biological from the Register"@en ;
cml:realizedBy doc:sec-32fa-ss-2 ;
cml:integrityHash "c31aa5b44e3464818b578e7e643b4317217f87e58bf99287da9303b230594298" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32fa ;
skos:note "Secretary must suspend biological from Register before cancelling entry under section 32GC" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.349" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32fa-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-32fa-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32fa-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-32fa-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32fa-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32fa-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Duty to suspend biological from Register" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32fb a cml:Concept ;
skos:prefLabel "32FB When suspension takes effect etc."@en ;
cml:realizedBy doc:sec-32fb ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32fb-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32fb-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32fb-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32fb-ss-4 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32fb-ss-5 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.350" .
concept:therapeutic-goods-act-1989-sec-32fb-ss-1 a cml:Concept ;
skos:prefLabel "32FB(1) When suspension takes effect etc."@en ;
cml:realizedBy doc:sec-32fb-ss-1 ;
cml:integrityHash "a90b40959a4ff8a7d408b129a20babf0dfe424ab622da3da26d8998054f4538d" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32fb ;
skos:note "Suspension of therapeutic goods takes effect under certain conditions." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.350" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32fb-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32fb-ss-1-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32fb-ss-1 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32fb-ss-2 a cml:Concept ;
skos:prefLabel "32FB(2) When suspension takes effect etc."@en ;
cml:realizedBy doc:sec-32fb-ss-2 ;
cml:integrityHash "267166a6bb7d152e252abd18346157d2d8c973960ba8eac30c665ddca84e2c89" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32fb ;
skos:note "Suspension duration" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.350" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32fb-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-32fb-ss-2-norm a values:Undertaking ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32fb-ss-2 ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32fb-ss-3 a cml:Concept ;
skos:prefLabel "32FB(3) When suspension takes effect etc."@en ;
cml:realizedBy doc:sec-32fb-ss-3 ;
cml:integrityHash "092f1d6f85a4ec4e43cda04bfef82820c935dbaeb09ef6ae4fdb954d3d765f25" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32fb ;
skos:note "Secretary may extend period specified under subsection 32FA(4) by a further specified period not exceeding 6 months." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.350" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32fb-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-32fb-ss-3-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32fb-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-32fb-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-32fb-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32fb-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "May" ;
cml:logicSummary "Permission to extend period" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32fb-ss-4 a cml:Concept ;
skos:prefLabel "32FB(4) When suspension takes effect etc."@en ;
cml:realizedBy doc:sec-32fb-ss-4 ;
cml:integrityHash "b27c4e7bd78f2371fa366001f60f75e5c1fd8dfb8ad7bbea84d606cb3337a2d2" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32fb ;
skos:note "Publish notice of extension particulars" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.350" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32fb-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-32fb-ss-4-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32fb-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-32fb-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-32fb-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32fb-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Must publish notice" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32fb-ss-5 a cml:Concept ;
skos:prefLabel "32FB(5) When suspension takes effect etc."@en ;
cml:realizedBy doc:sec-32fb-ss-5 ;
cml:integrityHash "56037ee4b951a607910640ec197dbec5ccb71dc71a9b13532f28d1649ac6d345" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32fb ;
skos:note "Notice under subsection (3) is not a legislative instrument." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.350" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32fb-ss-5-norm .
concept:therapeutic-goods-act-1989-sec-32fb-ss-5-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32fb-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-32fc a cml:Concept ;
skos:prefLabel "32FC Revocation of suspension"@en ;
cml:realizedBy doc:sec-32fc ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32fc-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32fc-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.351" .
concept:therapeutic-goods-act-1989-sec-32fc-ss-1 a cml:Concept ;
skos:prefLabel "32FC(1) Revocation of suspension"@en ;
cml:realizedBy doc:sec-32fc-ss-1 ;
cml:integrityHash "204713cdecd1e823eeb33858d50d881492193f47e8bb977f926cf082f8796dc5" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32fc ;
skos:note "Secretary must revoke suspension under certain conditions." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.351" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32fc-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32fc-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32fc-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-32fc-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32fc-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32fc-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Must" ;
cml:logicSummary "Secretary must revoke suspension" ;
cml:premiseText "Ground on which biological was suspended no longer applies" ;
cml:conclusionText "Revocation required" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32fc-ss-2 a cml:Concept ;
skos:prefLabel "32FC(2) Revocation of suspension"@en ;
cml:realizedBy doc:sec-32fc-ss-2 ;
cml:integrityHash "384bbaeef74d5dc7c38d97bb1a3e131fe1ba990d28daaef3fc5a1f3b2b47d7e1" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32fc ;
skos:note "Exercise of power by Secretary" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.351" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32fc-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-32fc-ss-2-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32fc-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-32fd a cml:Concept ;
skos:prefLabel "32FD Effect of suspension"@en ;
cml:realizedBy doc:sec-32fd ;
cml:integrityHash "a2d5f0c0c50f79eef3d0f6d304c15f2ca9053c4a1b87a067a6ce345c54b24253" ;
skos:note "Dealing in a biological not included in the Register may be a criminal offence or contravene a civil penalty provision." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.352" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32fd-norm .
concept:therapeutic-goods-act-1989-sec-32fd-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32fd ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32fd cml:asserts concept:therapeutic-goods-act-1989-sec-32fd-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32fd-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits dealing in a biological 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-32g a cml:Concept ;
skos:prefLabel "32G What this Division is about"@en ;
cml:realizedBy doc:sec-32g ;
cml:integrityHash "f249cc31560c19b037e8ffe51e95fc561d461a5d73ccbf715839d13240457a1f" ;
skos:note "Secretary may cancel inclusions of biologicals in the Register under certain circumstances." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.353" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32g-norm .
concept:therapeutic-goods-act-1989-sec-32g-norm a values:Undertaking ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32g ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ga a cml:Concept ;
skos:prefLabel "32GA Immediate cancellation of biological from the Register in"@en ;
cml:realizedBy doc:sec-32ga ;
cml:integrityHash "746132fb58f62e028c03dfb237f56d3b7522c6cbb47312b62ea238b212de1be6" ;
skos:note "Cancellation of biological entry from Register under specified circumstances." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.353" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32ga-norm .
concept:therapeutic-goods-act-1989-sec-32ga-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ga ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ga cml:asserts concept:therapeutic-goods-act-1989-sec-32ga-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32ga-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibition on biological entry" ;
cml:premiseText "The Secretary may cancel the entry of a biological from the Register." ;
cml:conclusionText "The entry must be cancelled." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ga cml:asserts concept:therapeutic-goods-act-1989-sec-32ga-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-32ga-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Temporal Interval" ;
cml:logicSummary "Temporal interval for cancellation" ;
cml:premiseText "The cancellation is effective immediately." ;
cml:conclusionText "The cancellation is effective from the date of notice." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32gb a cml:Concept ;
skos:prefLabel "32GB Immediate cancellation of biological from the Register after"@en ;
cml:realizedBy doc:sec-32gb ;
cml:integrityHash "c23ccface09347eb1f7020aadef0ed419d583a0626704f21b4060a169fbc1586" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32gb-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32gb-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.355" .
concept:therapeutic-goods-act-1989-sec-32gb-ss-1 a cml:Concept ;
skos:prefLabel "32GB(1) Immediate cancellation of biological from the Register after"@en ;
cml:realizedBy doc:sec-32gb-ss-1 ;
cml:integrityHash "bddd4caf49460b3a1fe83ce8f784fe4b2693d20faea0a6261024a02a0c44a9b1" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32gb ;
skos:note "The Secretary may cancel a biological entry from the Register if the person fails to comply with a notice." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.355" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32gb-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32gb-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32gb-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-32gb-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32gb-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32gb-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "obligation" ;
cml:logicSummary "The Secretary has an obligation to cancel the biological entry." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32gb-ss-2 a cml:Concept ;
skos:prefLabel "32GB(2) Immediate cancellation of biological from the Register after"@en ;
cml:realizedBy doc:sec-32gb-ss-2 ;
cml:integrityHash "9e5c1f325f13d686bc3c64dc55fdab3f1fcefc998c2d1df33bc9d9d86ef4f6d8" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32gb ;
skos:note "Secretary must provide notice to person before cancelling biological entry from Register." ;
dc:description "Notice under section 32JA" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.355" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32gb-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-32gb-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32gb-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-32gb-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32gb-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32gb-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Secretary must provide notice" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32gc a cml:Concept ;
skos:prefLabel "32GC Cancellation of biological from the Register after notice of"@en ;
cml:realizedBy doc:sec-32gc ;
cml:integrityHash "0e0f66cdcf3e53140072d4eb880d4b5a77b303a15de0e787b1995b0aebfb740f" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32gc-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32gc-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32gc-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32gc-ss-4 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.356" .
concept:therapeutic-goods-act-1989-sec-32gc-ss-1 a cml:Concept ;
skos:prefLabel "32GC(1) Cancellation of biological from the Register after notice of"@en ;
cml:realizedBy doc:sec-32gc-ss-1 ;
cml:integrityHash "27cd471a8ef8458364f3b58e9f0966a34967b1f88a69e01cf4ec9df73d4e2b90" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32gc ;
skos:note "Cancellation of biological from the Register after notice of unacceptable quality, safety or efficacy." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.356" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32gc-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32gc-ss-1-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32gc-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-32gc-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32gc-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32gc-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibition" ;
cml:premiseText "The Secretary may cancel the entry of the biological from the Register." ;
cml:conclusionText "The person must not include the biological in the Register." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32gc-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32gc-ss-1-logic-deontic-2 .
concept:therapeutic-goods-act-1989-sec-32gc-ss-1-logic-deontic-2 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibition of advertising" ;
cml:premiseText "The person contravenes subsection 32DQ(1) or (2) in relation to the biological." ;
cml:conclusionText "The person must not advertise the biological." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32gc-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32gc-ss-1-logic-deontic-3 .
concept:therapeutic-goods-act-1989-sec-32gc-ss-1-logic-deontic-3 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibition of advertising by related body corporate" ;
cml:premiseText "If the person is a body corporate, a related body corporate contravenes a direction or condition given to the related body corporate under subsection 42DV(1) in relation to the advertising of the biological." ;
cml:conclusionText "The related body corporate must not advertise the biological." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32gc-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32gc-ss-1-logic-deontic-4 .
concept:therapeutic-goods-act-1989-sec-32gc-ss-1-logic-deontic-4 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibition of non-compliance with Therapeutic Goods Advertising Code" ;
cml:premiseText "Either of the following has not been complied with in relation to the biological: an applicable provision of the Therapeutic Goods Advertising Code; any other requirement relating to advertising applicable under Part 5-1 or under the regulations." ;
cml:conclusionText "The person 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-32gc-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32gc-ss-1-logic-deontic-5 .
concept:therapeutic-goods-act-1989-sec-32gc-ss-1-logic-deontic-5 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibition of non-compliance with regulatory requirements" ;
cml:premiseText "The person contravenes subsection 32DQ(1) or (2) in relation to the biological." ;
cml:conclusionText "The person must comply with regulatory requirements." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32gc-ss-2 a cml:Concept ;
skos:prefLabel "32GC(2) Cancellation of biological from the Register after notice of"@en ;
cml:realizedBy doc:sec-32gc-ss-2 ;
cml:integrityHash "328985119a7fcda959f3ba4bfe4a2e74d9e88f4297a6317a8bda16cabf1599e4" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32gc ;
skos:note "Secretary must inform person of proposed cancellation and invite written submissions." ;
dc:description "written notice, written submissions" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.356" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32gc-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-32gc-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32gc-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-32gc-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32gc-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32gc-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Secretary must inform person of proposed cancellation." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32gc-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32gc-ss-2-logic-epistemic-2 .
concept:therapeutic-goods-act-1989-sec-32gc-ss-2-logic-epistemic-2 a cml:LogicApplication ;
cml:modality cml:Epistemic ;
cml:operator "OBLIGES" ;
cml:logicSummary "Secretary is obligated to inform person of proposed cancellation." ;
cml:executionSurface "modalities::epistemic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32gc-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32gc-ss-2-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-32gc-ss-2-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "CONTAINS" ;
cml:logicSummary "Cancellation must be made within a specified period after notice." ;
cml:premiseText "28 days after day notice is given." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32gc-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32gc-ss-2-logic-argumentation-4 .
concept:therapeutic-goods-act-1989-sec-32gc-ss-2-logic-argumentation-4 a cml:LogicApplication ;
cml:modality cml:Argumentation ;
cml:operator "REQUIRES" ;
cml:logicSummary "Person must provide written submissions in response to notice." ;
cml:executionSurface "modalities::argumentation" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32gc-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32gc-ss-2-logic-alleninterval-5 .
concept:therapeutic-goods-act-1989-sec-32gc-ss-2-logic-alleninterval-5 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "DURING" ;
cml:logicSummary "Cancellation period is specified as a duration after notice." ;
cml:premiseText "28 days after day notice is given." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32gc-ss-3 a cml:Concept ;
skos:prefLabel "32GC(3) Cancellation of biological from the Register after notice of"@en ;
cml:realizedBy doc:sec-32gc-ss-3 ;
cml:integrityHash "725f05f931ef82d37eb6dff6dcbcefcb6622f9c06135470fa63571733416a4f3" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32gc ;
skos:note "Secretary must consider submissions before making a decision on cancellation." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.356" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32gc-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-32gc-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32gc-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-32gc-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-32gc-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32gc-ss-3-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-32gc-ss-4 a cml:Concept ;
skos:prefLabel "32GC(4) Cancellation of biological from the Register after notice of"@en ;
cml:realizedBy doc:sec-32gc-ss-4 ;
cml:integrityHash "0931782cccff8e870982346a7802e881886319db33b6f9d0f235a8445e82b99e" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32gc ;
skos:note "A notice under subsection (1) must not be a legislative instrument." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.356" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32gc-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-32gc-ss-4-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32gc-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-32gc-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-32gc-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32gc-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MustNot" ;
cml:logicSummary "Prohibition of notice being a legislative instrument." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32gd a cml:Concept ;
skos:prefLabel "32GD Revocation of cancellation of biological upon request"@en ;
cml:realizedBy doc:sec-32gd ;
cml:integrityHash "e7590ed4953ed0a9be12e0af8b07efd787cdc4b79c8b4f1e37e8c583ba32a5df" ;
skos:note "Request for revocation of cancellation of biological upon request" ;
dc:description "Application fee" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.357" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32gd-norm .
concept:therapeutic-goods-act-1989-sec-32gd-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32gd ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ge a cml:Concept ;
skos:prefLabel "32GE Publication of cancellation of entry from Register"@en ;
cml:realizedBy doc:sec-32ge ;
cml:integrityHash "bb3dee238e862e9591907502045fe8abe26e8332e4af67384d0018b09c2c591d" ;
skos:note "Publish notice of cancellation from Register" ;
dc:description "Notice with particulars of cancellation" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.358" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32ge-norm .
concept:therapeutic-goods-act-1989-sec-32ge-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ge ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ge cml:asserts concept:therapeutic-goods-act-1989-sec-32ge-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32ge-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Publish notice" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32gf a cml:Concept ;
skos:prefLabel "32GF Date of effect of cancellation of entries from Register"@en ;
cml:realizedBy doc:sec-32gf ;
cml:integrityHash "f3c1b824fa0e5215268d6e9df4c4ec3fcfb803aac1b834e88b7fc9d2d1c5134d" ;
skos:note "Date of effect of cancellation of entries from Register" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.359" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32gf-norm .
concept:therapeutic-goods-act-1989-sec-32gf-norm a values:Undertaking ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32gf ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32h a cml:Concept ;
skos:prefLabel "32H What this Division is about"@en ;
cml:realizedBy doc:sec-32h ;
cml:integrityHash "0bc42af7187106f0ddfe272cc39ce589044d2d16a8819adcbbfad95bd7216088" ;
skos:note "The Secretary may require a person to recall biologicals or inform the public about non-compliant biologicals." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.360" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32h-norm .
concept:therapeutic-goods-act-1989-sec-32h-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32h ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32h cml:asserts concept:therapeutic-goods-act-1989-sec-32h-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32h-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "require" ;
cml:logicSummary "Imposes a duty on the Secretary to require recall or notification." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ha a cml:Concept ;
skos:prefLabel "32HA Public notification, and recall, of biologicals"@en ;
cml:realizedBy doc:sec-32ha ;
cml:integrityHash "b8704ece98d6847693b714453eb76eadcc8f17405d135858207e62dc7fca44f1" ;
skos:note "The Secretary may impose requirements on a person supplying a biological if certain circumstances occur." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.360" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32ha-norm .
concept:therapeutic-goods-act-1989-sec-32ha-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ha ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ha cml:asserts concept:therapeutic-goods-act-1989-sec-32ha-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32ha-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "may" ;
cml:logicSummary "Imposition of requirements is an obligation." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32hb a cml:Concept ;
skos:prefLabel "32HB Publication of requirements"@en ;
cml:realizedBy doc:sec-32hb ;
cml:integrityHash "131f1f748ac79b2a1a4c8c5097ce6ccd49674fc4a3fc4ab5719bf8fa5416ab08" ;
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 <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.364" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32hb-norm .
concept:therapeutic-goods-act-1989-sec-32hb-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32hb ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32hb cml:asserts concept:therapeutic-goods-act-1989-sec-32hb-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32hb-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-32hc a cml:Concept ;
skos:prefLabel "32HC Criminal offences for non-compliance with requirements"@en ;
cml:realizedBy doc:sec-32hc ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32hc-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32hc-ss-4 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32hc-ss-5 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32hc-ss-6 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.364" .
concept:therapeutic-goods-act-1989-sec-32hc-ss-1 a cml:Concept ;
skos:prefLabel "32HC(1) Criminal offences for non-compliance with requirements"@en ;
cml:realizedBy doc:sec-32hc-ss-1 ;
cml:integrityHash "142a5b4d275f2c214421434ecc494d4d566ce50c84eda65b012fdbe44a06aa89" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32hc ;
skos:note "Non-compliance with requirements is a criminal offence." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.364" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32hc-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32hc-ss-1-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32hc-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-32hc-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32hc-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32hc-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibition" ;
cml:logicSummary "Prohibits non-compliance with requirements." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32hc-ss-4 a cml:Concept ;
skos:prefLabel "32HC(4) Criminal offences for non-compliance with requirements"@en ;
cml:realizedBy doc:sec-32hc-ss-4 ;
cml:integrityHash "229487f58195951d90ed41d51336d2c97f7cad67c576d72e87f9ab2473a2c3e1" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32hc ;
skos:note "Non-compliance with section 32HA requirements is an offence." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.364" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32hc-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-32hc-ss-4-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32hc-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-32hc-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-32hc-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32hc-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "is" ;
cml:logicSummary "Definition of obligation" ;
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-32hc-ss-5 a cml:Concept ;
skos:prefLabel "32HC(5) Criminal offences for non-compliance with requirements"@en ;
cml:realizedBy doc:sec-32hc-ss-5 ;
cml:integrityHash "c3b6793ae0c5f7575a0eb95afd1d0deb92515aca8d6a4c6f7a31b66e75be7164" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32hc ;
skos:note "Offence for non-compliance with requirements" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.364" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32hc-ss-5-norm .
concept:therapeutic-goods-act-1989-sec-32hc-ss-5-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32hc-ss-5 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32hc-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-32hc-ss-5-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32hc-ss-5-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibition" ;
cml:logicSummary "Prohibits non-compliance with requirements" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32hc-ss-6 a cml:Concept ;
skos:prefLabel "32HC(6) Criminal offences for non-compliance with requirements"@en ;
cml:realizedBy doc:sec-32hc-ss-6 ;
cml:integrityHash "c385da7f11ff5e7f14e072e858989feb81f5b1c13125da3beda70e38518df21e" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32hc ;
skos:note "Offence of strict liability for non-compliance with requirements" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.364" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32hc-ss-6-norm .
concept:therapeutic-goods-act-1989-sec-32hc-ss-6-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32hc-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-32hc-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-32hc-ss-6-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32hc-ss-6-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "is" ;
cml:logicSummary "Definition of strict liability" ;
cml:premiseText "(6) An offence against subsection (5)" ;
cml:conclusionText "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-32hd a cml:Concept ;
skos:prefLabel "32HD Civil penalty for non-compliance with requirements"@en ;
cml:realizedBy doc:sec-32hd ;
cml:integrityHash "0afe274f1b9cb51789e56ca199fa8691156b60af901ec51c0d420ad1ece62701" ;
skos:note "Civil penalty for non-compliance with requirements" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.365" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32hd-norm .
concept:therapeutic-goods-act-1989-sec-32hd-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32hd ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32hd cml:asserts concept:therapeutic-goods-act-1989-sec-32hd-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32hd-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits civil penalty for non-compliance" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32he a cml:Concept ;
skos:prefLabel "32HE Powers of suspension and cancellation unaffected"@en ;
cml:realizedBy doc:sec-32he ;
cml:integrityHash "670f28f015de613c6cb7f719e5306c6ddf7e39dd2dc0770ad3382f8acbcb0adf" ;
skos:note "Powers of suspension and cancellation unaffected" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.365" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32he-norm .
concept:therapeutic-goods-act-1989-sec-32he-norm a values:Undertaking ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32he ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32hf a cml:Concept ;
skos:prefLabel "32HF Saving of other laws"@en ;
cml:realizedBy doc:sec-32hf ;
cml:integrityHash "d60e452d40d4d8c4426e32e3f836a586f2a94e7ff1468a6edf7dd0a4fff87758" ;
skos:note "No exclusion or limitation of other laws" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.365" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32hf-norm .
concept:therapeutic-goods-act-1989-sec-32hf-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32hf ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32hf cml:asserts concept:therapeutic-goods-act-1989-sec-32hf-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32hf-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "prohibition" ;
cml:logicSummary "Prohibiting exclusion" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32j a cml:Concept ;
skos:prefLabel "32J What this Division is about"@en ;
cml:realizedBy doc:sec-32j ;
cml:integrityHash "a4b8b329d56528433ed5a3b2f123d18a50c9b3e1c1762789996b5547bdb92100" ;
skos:note "The Secretary may seek information or documents from applicants, biologicals included in the Register, and suppliers of exempted biologicals." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.366" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32j-norm .
concept:therapeutic-goods-act-1989-sec-32j-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32j ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32j cml:asserts concept:therapeutic-goods-act-1989-sec-32j-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32j-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "may" ;
cml:logicSummary "The Secretary may seek information or documents." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32j cml:asserts concept:therapeutic-goods-act-1989-sec-32j-logic-epistemic-2 .
concept:therapeutic-goods-act-1989-sec-32j-logic-epistemic-2 a cml:LogicApplication ;
cml:modality cml:Epistemic ;
cml:operator "must provide" ;
cml:logicSummary "There are penalties for failing to comply with a notice." ;
cml:executionSurface "modalities::epistemic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32j cml:asserts concept:therapeutic-goods-act-1989-sec-32j-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-32j-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "for" ;
cml:logicSummary "The Secretary may seek information or documents from applicants, biologicals included in the Register, and suppliers of exempted biologicals." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32j cml:asserts concept:therapeutic-goods-act-1989-sec-32j-logic-argumentation-4 .
concept:therapeutic-goods-act-1989-sec-32j-logic-argumentation-4 a cml:LogicApplication ;
cml:modality cml:Argumentation ;
cml:operator "for" ;
cml:logicSummary "There are criminal offences for failing to comply with a notice and civil penalties for giving false or misleading information or documents." ;
cml:executionSurface "modalities::argumentation" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ja a cml:Concept ;
skos:prefLabel "32JA Secretary may require information or documents"@en ;
cml:realizedBy doc:sec-32ja ;
cml:integrityHash "950f43f5b377e730c40bc5ad3ffedcf87d834eff985bf7155fa3bdd8b3202857" ;
skos:note "The Secretary may require information or documents from a person." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.366" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32ja-norm .
concept:therapeutic-goods-act-1989-sec-32ja-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ja ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ja cml:asserts concept:therapeutic-goods-act-1989-sec-32ja-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32ja-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MAY" ;
cml:logicSummary "May require" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32jb a cml:Concept ;
skos:prefLabel "32JB Criminal offences for failing to comply with a notice etc."@en ;
cml:realizedBy doc:sec-32jb ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32jb-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32jb-ss-1a ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32jb-ss-1b ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32jb-ss-1c ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32jb-ss-1d ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32jb-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.368" .
concept:therapeutic-goods-act-1989-sec-32jb-ss-1 a cml:Concept ;
skos:prefLabel "32JB(1) Criminal offences for failing to comply with a notice etc."@en ;
cml:realizedBy doc:sec-32jb-ss-1 ;
cml:integrityHash "834aad409511818db7b636c62aa1cdc7d69501fdd8d481fe2aafcbd603c8ba35" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jb ;
skos:note "Failure to comply with a notice results in an offence." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.368" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32jb-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32jb-ss-1-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jb-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-32jb-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32jb-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32jb-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
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-32jb-ss-1a a cml:Concept ;
skos:prefLabel "32JB(1A) Criminal offences for failing to comply with a notice etc."@en ;
cml:realizedBy doc:sec-32jb-ss-1a ;
cml:integrityHash "2cb61cef44f2feec7a5162ffaacd0a1b61bfed3032ae9af83f4ab66923913940" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jb ;
skos:note "Defendant bears evidential burden for reasonable excuse" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.368" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32jb-ss-1a-norm .
concept:therapeutic-goods-act-1989-sec-32jb-ss-1a-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jb-ss-1a ;
values:borneBy values:NaturalPerson ;
skos:scopeNote "borne by: NaturalPerson" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32jb-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-32jb-ss-1a-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32jb-ss-1a-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Defendant has an obligation to provide a reasonable excuse" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32jb-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-32jb-ss-1a-logic-epistemic-2 .
concept:therapeutic-goods-act-1989-sec-32jb-ss-1a-logic-epistemic-2 a cml:LogicApplication ;
cml:modality cml:Epistemic ;
cml:operator "Burden of Proof" ;
cml:logicSummary "Defendant bears the burden of proof for their excuse" ;
cml:executionSurface "modalities::epistemic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32jb-ss-1b a cml:Concept ;
skos:prefLabel "32JB(1B) Criminal offences for failing to comply with a notice etc."@en ;
cml:realizedBy doc:sec-32jb-ss-1b ;
cml:integrityHash "610d949501cee19d59d9673b7b20aaec8a1ced323afb537483e32cbc644ea722" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jb ;
skos:note "Failure to comply with a notice results in an offence." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.368" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32jb-ss-1b-norm .
concept:therapeutic-goods-act-1989-sec-32jb-ss-1b-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jb-ss-1b ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32jb-ss-1b cml:asserts concept:therapeutic-goods-act-1989-sec-32jb-ss-1b-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32jb-ss-1b-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibition" ;
cml:logicSummary "Prohibits failing to comply with a notice." ;
cml:premiseText "(a) the person is given a notice under section 32JA; and (b) the person is covered by paragraph 32JA(1)(b) or (c); and (c) the person fails to comply with the notice." ;
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-32jb-ss-1b cml:asserts concept:therapeutic-goods-act-1989-sec-32jb-ss-1b-logic-deontic-2 .
concept:therapeutic-goods-act-1989-sec-32jb-ss-1b-logic-deontic-2 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Imposes an obligation to comply with a notice." ;
cml:premiseText "(c) the person fails to comply with the notice." ;
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-32jb-ss-1b cml:asserts concept:therapeutic-goods-act-1989-sec-32jb-ss-1b-logic-alleninterval-3 .
concept:therapeutic-goods-act-1989-sec-32jb-ss-1b-logic-alleninterval-3 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Overlaps" ;
cml:logicSummary "Defines the temporal interval during which the obligation to comply applies." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32jb-ss-1c a cml:Concept ;
skos:prefLabel "32JB(1C) Criminal offences for failing to comply with a notice etc."@en ;
cml:realizedBy doc:sec-32jb-ss-1c ;
cml:integrityHash "87bd57090867c0a019d17047639634d39580d81b441962e88fb655ec9def4b9d" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jb ;
skos:note "Offence of strict liability for failing to comply with a notice." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.368" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32jb-ss-1c-norm .
concept:therapeutic-goods-act-1989-sec-32jb-ss-1c-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jb-ss-1c ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32jb-ss-1c cml:asserts concept:therapeutic-goods-act-1989-sec-32jb-ss-1c-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32jb-ss-1c-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-32jb-ss-1d a cml:Concept ;
skos:prefLabel "32JB(1D) Criminal offences for failing to comply with a notice etc."@en ;
cml:realizedBy doc:sec-32jb-ss-1d ;
cml:integrityHash "7485e0ee217f5a0694c170cc1ebf34b763480f3d34b972a1a9c605cedc525cf0" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jb ;
skos:note "Defendant bears evidential burden for reasonable excuse" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.368" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32jb-ss-1d-norm .
concept:therapeutic-goods-act-1989-sec-32jb-ss-1d-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jb-ss-1d ;
values:borneBy values:Agent ;
skos:scopeNote "borne by: Agent" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32jb-ss-1d cml:asserts concept:therapeutic-goods-act-1989-sec-32jb-ss-1d-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32jb-ss-1d-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "has" ;
cml:logicSummary "Bearing of evidential burden" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32jb-ss-1d cml:asserts concept:therapeutic-goods-act-1989-sec-32jb-ss-1d-logic-epistemic-2 .
concept:therapeutic-goods-act-1989-sec-32jb-ss-1d-logic-epistemic-2 a cml:LogicApplication ;
cml:modality cml:Epistemic ;
cml:operator "justification" ;
cml:logicSummary "Reasonable excuse justification" ;
cml:executionSurface "modalities::epistemic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32jb-ss-2 a cml:Concept ;
skos:prefLabel "32JB(2) Criminal offences for failing to comply with a notice etc."@en ;
cml:realizedBy doc:sec-32jb-ss-2 ;
cml:integrityHash "9a368a19045f6eb2d5e072218149b9dc2d347e69c9ce808f278e71f34f650a03" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jb ;
skos:note "Failure to comply with a notice results in an offence." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.368" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32jb-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-32jb-ss-2-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jb-ss-2 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32jb-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32jb-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32jb-ss-2-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-32jc a cml:Concept ;
skos:prefLabel "32JC Civil penalty for giving false or misleading information or"@en ;
cml:realizedBy doc:sec-32jc ;
cml:integrityHash "7fe630bd5d110b2510f427c893db8f5f8276c70b90d083460f0deb05a112cb65" ;
skos:note "Giving false or misleading information in compliance with a notice is prohibited." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.370" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32jc-norm .
concept:therapeutic-goods-act-1989-sec-32jc-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jc ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32jc cml:asserts concept:therapeutic-goods-act-1989-sec-32jc-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32jc-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 32JA." ;
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-32jd a cml:Concept ;
skos:prefLabel "32JD Self-incrimination"@en ;
cml:realizedBy doc:sec-32jd ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32jd-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32jd-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.371" .
concept:therapeutic-goods-act-1989-sec-32jd-ss-1 a cml:Concept ;
skos:prefLabel "32JD(1) Self-incrimination"@en ;
cml:realizedBy doc:sec-32jd-ss-1 ;
cml:integrityHash "c23e01f6202e12db94e967ba2c599cc5521c24bac1af8b5bc7ff705261c50c71" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jd ;
skos:note "No excuse for self-incrimination" ;
dc:description "Information or document" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.371" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32jd-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32jd-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jd-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-32jd-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32jd-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32jd-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-32jd-ss-2 a cml:Concept ;
skos:prefLabel "32JD(2) Self-incrimination"@en ;
cml:realizedBy doc:sec-32jd-ss-2 ;
cml:integrityHash "e45e91c9c5d468cc6a3b43573c85d0b4a5a80870845f23f21c5415557ea9d6d9" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jd ;
skos:note "Exemptions from self-incrimination in certain cases" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.371" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32jd-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-32jd-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jd-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-32jd-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32jd-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32jd-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Exemptions from self-incrimination" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32je a cml:Concept ;
skos:prefLabel "32JE Secretary may require information etc. about biologicals"@en ;
cml:realizedBy doc:sec-32je ;
cml:integrityHash "9c4bcc3c6143357646c6d62fe8052ce1e7559b8b8f0e9e01db059e337b02690e" ;
skos:note "Secretary may require information about biologicals from exempt persons." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.371" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32je-norm .
concept:therapeutic-goods-act-1989-sec-32je-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32je ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32je cml:asserts concept:therapeutic-goods-act-1989-sec-32je-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32je-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 "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32jf a cml:Concept ;
skos:prefLabel "32JF Secretary may require information etc. about biologicals"@en ;
cml:realizedBy doc:sec-32jf ;
cml:integrityHash "951edf9d3466603b4bbc319403325ec19bcd4ce43be4fededd8adf6fbcd9114e" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32jf-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32jf-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32jf-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32jf-ss-4 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.373" .
concept:therapeutic-goods-act-1989-sec-32jf-ss-1 a cml:Concept ;
skos:prefLabel "32JF(1) Secretary may require information etc. about biologicals"@en ;
cml:realizedBy doc:sec-32jf-ss-1 ;
cml:integrityHash "2bd9c5c95f4e1aa3209d5b20c20f1705b0e508c1c64519d67c9ada84ebb0e3e5" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jf ;
skos:note "Secretary may require information about biologicals" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.373" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32jf-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32jf-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jf-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-32jf-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32jf-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32jf-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "requires" ;
cml:logicSummary "Requires information from a person" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32jf-ss-2 a cml:Concept ;
skos:prefLabel "32JF(2) Secretary may require information etc. about biologicals"@en ;
cml:realizedBy doc:sec-32jf-ss-2 ;
cml:integrityHash "cba4779bd457384b251ed47cdfc3dd47cd59c7f51595933bf7484a6708408913" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jf ;
skos:note "The Secretary may require information or documents from a person." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.373" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32jf-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-32jf-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jf-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-32jf-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32jf-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32jf-ss-2-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-32jf-ss-3 a cml:Concept ;
skos:prefLabel "32JF(3) Secretary may require information etc. about biologicals"@en ;
cml:realizedBy doc:sec-32jf-ss-3 ;
cml:integrityHash "bf46f61c9d8b1916d13b5ace9c6406ba4df80a3b00fd70ad1b3ca70d1bc67ba2" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jf ;
skos:note "Must provide information within a specified period and in a specified form." ;
dc:description "true" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.373" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32jf-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-32jf-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jf-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-32jf-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-32jf-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32jf-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST PROVIDE" ;
cml:logicSummary "Must provide information within a specified period and in a specified form." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32jf-ss-4 a cml:Concept ;
skos:prefLabel "32JF(4) Secretary may require information etc. about biologicals"@en ;
cml:realizedBy doc:sec-32jf-ss-4 ;
cml:integrityHash "18ca6b122c71e30b4094c7b46b2a3453441b59a1b0e35b59076fdc572147bc70" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jf ;
skos:note "The form may require or permit the information to be given, or the documents to be produced, in accordance with specified software requirements." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.373" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32jf-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-32jf-ss-4-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jf-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-32jg a cml:Concept ;
skos:prefLabel "32JG Secretary may require information etc. about biologicals"@en ;
cml:realizedBy doc:sec-32jg ;
cml:integrityHash "035dc4c95da45dab66b56525f7b2329edbd7c535e729b26a31efb045e9f1dc84" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32jg-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32jg-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32jg-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32jg-ss-3a ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32jg-ss-4 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.374" .
concept:therapeutic-goods-act-1989-sec-32jg-ss-1 a cml:Concept ;
skos:prefLabel "32JG(1) Secretary may require information etc. about biologicals"@en ;
cml:realizedBy doc:sec-32jg-ss-1 ;
cml:integrityHash "74d7127dc2b6a0df299f251e6173b9bf3134209b98fc4feccc5d155dd5e2f956" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jg ;
skos:note "The Secretary may require information from a person granted an approval under subsection 32CK(1) in relation to a biological." ;
dc:description "specified information or documents relating to the supply, handling, monitoring of the supply, and results of the supply of the biological" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.374" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32jg-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32jg-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jg-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-32jg-ss-2 a cml:Concept ;
skos:prefLabel "32JG(2) Secretary may require information etc. about biologicals"@en ;
cml:realizedBy doc:sec-32jg-ss-2 ;
cml:integrityHash "e17853c491ba004ddb7ab409a450904d262a32bcc2889b8398d5da4d4ac0dfe4" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jg ;
skos:note "The Secretary may require information etc. about biologicals." ;
dc:description "specified information or documents relating to the use of the biological" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.374" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32jg-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-32jg-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jg-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-32jg-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32jg-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32jg-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MAY" ;
cml:logicSummary "The Secretary may require information etc." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32jg-ss-3 a cml:Concept ;
skos:prefLabel "32JG(3) Secretary may require information etc. about biologicals"@en ;
cml:realizedBy doc:sec-32jg-ss-3 ;
cml:integrityHash "865eb9a8a536603ed962b86ff3d6713cd6f1bc146aa69edd1533e0cd62761b1a" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jg ;
skos:note "The Secretary may require specified information or documents from a person granted an authority under subsection 32CM(1) in relation to a biological." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.374" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32jg-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-32jg-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jg-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-32jg-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-32jg-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32jg-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MAY" ;
cml:logicSummary "The Secretary may require 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-32jg-ss-3a a cml:Concept ;
skos:prefLabel "32JG(3A) Secretary may require information etc. about biologicals"@en ;
cml:realizedBy doc:sec-32jg-ss-3a ;
cml:integrityHash "daf8784c70415796d96fcfc2d54c2d57c5432fd98b900485d64958cb10a91a79" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jg ;
skos:note "Secretary may require specified information or documents from a person authorized to supply a biological." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.374" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32jg-ss-3a-norm .
concept:therapeutic-goods-act-1989-sec-32jg-ss-3a-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jg-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-32jg-ss-3a cml:asserts concept:therapeutic-goods-act-1989-sec-32jg-ss-3a-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32jg-ss-3a-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-32jg-ss-4 a cml:Concept ;
skos:prefLabel "32JG(4) Secretary may require information etc. about biologicals"@en ;
cml:realizedBy doc:sec-32jg-ss-4 ;
cml:integrityHash "d96684780b351f277267e40151005b6127b6b6feaa4ed15373d62beff9e55e6e" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jg ;
skos:note "Must provide information or documents within a specified period and in a specified form." ;
dc:description "true" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.374" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32jg-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-32jg-ss-4-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jg-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-32jg-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-32jg-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32jg-ss-4-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 a specified form." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32jh a cml:Concept ;
skos:prefLabel "32JH Secretary may require information etc. about biologicals"@en ;
cml:realizedBy doc:sec-32jh ;
cml:integrityHash "6fab7489960b7192508ea09834f88c92a26f20fa6d5632b23e19de699909004e" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32jh-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32jh-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32jh-ss-3 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.376" .
concept:therapeutic-goods-act-1989-sec-32jh-ss-1 a cml:Concept ;
skos:prefLabel "32JH(1) Secretary may require information etc. about biologicals"@en ;
cml:realizedBy doc:sec-32jh-ss-1 ;
cml:integrityHash "cb020c8217eafdb02f15265a4d14bb8c4e3dd116c3f033428dffcee435025f0a" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jh ;
skos:note "The Secretary may require information about a biological." ;
dc:description "(a) the supply of the biological; (b) the handling of the biological; (c) the monitoring of the supply of the biological; (d) the results of the supply of the biological; (e) any other matter prescribed by the regulations for the purposes of this paragraph in relation to a biological of that kind." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.376" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32jh-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32jh-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jh-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-32jh-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32jh-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32jh-ss-1-logic-deontic-1 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-32jh-ss-2 a cml:Concept ;
skos:prefLabel "32JH(2) Secretary may require information etc. about biologicals"@en ;
cml:realizedBy doc:sec-32jh-ss-2 ;
cml:integrityHash "eca9aa41925f7d9df5ae799e1abeef637d6b3eb6402ce884374238203d61342f" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jh ;
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 <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.376" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32jh-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-32jh-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jh-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-32jh-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32jh-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32jh-ss-2-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-32jh-ss-3 a cml:Concept ;
skos:prefLabel "32JH(3) Secretary may require information etc. about biologicals"@en ;
cml:realizedBy doc:sec-32jh-ss-3 ;
cml:integrityHash "999e17e97c5dea127f3240fd393f3fe0ec24fd37d2d7e946d2d6490a19414b48" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jh ;
skos:note "The form may require or permit the information to be given, or the documents to be produced in accordance with specified software requirements." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.376" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32jh-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-32jh-ss-3-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jh-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-32ji a cml:Concept ;
skos:prefLabel "32JI Criminal offences for failing to comply with a notice etc."@en ;
cml:realizedBy doc:sec-32ji ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32ji-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32ji-ss-1a ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32ji-ss-1b ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32ji-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32ji-ss-3 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.377" .
concept:therapeutic-goods-act-1989-sec-32ji-ss-1 a cml:Concept ;
skos:prefLabel "32JI(1) Criminal offences for failing to comply with a notice etc."@en ;
cml:realizedBy doc:sec-32ji-ss-1 ;
cml:integrityHash "185ac3a82132bbc2293d8905c1beda94f248fbbeb4c7fd10833fff0acb6d953c" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ji ;
skos:note "Failure to comply with a notice results in an offence." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.377" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32ji-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32ji-ss-1-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ji-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-32ji-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32ji-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32ji-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibition" ;
cml:logicSummary "Prohibits failing to comply with a notice." ;
cml:premiseText "(a) the person is given a notice under section 32JE, 32JF, 32JG or 32JH; and (b) the person fails to comply with the notice." ;
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-32ji-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32ji-ss-1-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-32ji-ss-1-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Overlaps" ;
cml:logicSummary "Defines a temporal interval during which failing to comply with a notice results in an offence." ;
cml:premiseText "(a) the person is given a notice under section 32JE, 32JF, 32JG or 32JH; and (b) the person fails to comply with the notice." ;
cml:conclusionText "...and penalty: 500 penalty units." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ji-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32ji-ss-1-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-32ji-ss-1-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "Recurrently" ;
cml:logicSummary "Defines a recurring obligation to comply with notices." ;
cml:premiseText "(a) the person is given a notice under section 32JE, 32JF, 32JG or 32JH; and (b) the person fails to comply with the notice." ;
cml:conclusionText "...and penalty: 500 penalty units." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ji-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32ji-ss-1-logic-deontic-4 .
concept:therapeutic-goods-act-1989-sec-32ji-ss-1-logic-deontic-4 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Imposes an obligation on persons to comply with notices." ;
cml:premiseText "(a) the person is given a notice under section 32JE, 32JF, 32JG or 32JH; and (b) the person fails to comply with the notice." ;
cml:conclusionText "...and 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-32ji-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32ji-ss-1-logic-argumentation-5 .
concept:therapeutic-goods-act-1989-sec-32ji-ss-1-logic-argumentation-5 a cml:LogicApplication ;
cml:modality cml:Argumentation ;
cml:operator "Implication" ;
cml:logicSummary "Justifies the imposition of a penalty for failing to comply with notices." ;
cml:premiseText "(a) the person is given a notice under section 32JE, 32JF, 32JG or 32JH; and (b) the person fails to comply with the notice." ;
cml:conclusionText "...and penalty: 500 penalty units." ;
cml:executionSurface "modalities::argumentation" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ji-ss-1a a cml:Concept ;
skos:prefLabel "32JI(1A) Criminal offences for failing to comply with a notice etc."@en ;
cml:realizedBy doc:sec-32ji-ss-1a ;
cml:integrityHash "e85ba99d9ef15022ed2ba3dc569edc8d681d88740be85b181c3c121abf452ba3" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ji ;
skos:note "Failure to comply with a notice results in an offence." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.377" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32ji-ss-1a-norm .
concept:therapeutic-goods-act-1989-sec-32ji-ss-1a-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ji-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-32ji-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-32ji-ss-1a-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32ji-ss-1a-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibition" ;
cml:logicSummary "Prohibits failing to comply with a notice." ;
cml:premiseText "(a) the person is given a notice under section 32JE, 32JF, 32JG or 32JH; and (b) the person fails to comply with the notice." ;
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-32ji-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-32ji-ss-1a-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-32ji-ss-1a-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Overlaps" ;
cml:logicSummary "Notices issued under sections 32JE, 32JF, 32JG or 32JH overlap with the offence." ;
cml:premiseText "(1A) A person commits an offence if: (a) the person is given a notice under section 32JE, 32JF, 32JG or 32JH; and" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ji-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-32ji-ss-1a-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-32ji-ss-1a-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "Repeats" ;
cml:logicSummary "Notice must be repeated for each failure to comply." ;
cml:premiseText "(1A) A person commits an offence if: (a) the person is given a notice under section 32JE, 32JF, 32JG or 32JH; and" ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ji-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-32ji-ss-1a-logic-deontic-4 .
concept:therapeutic-goods-act-1989-sec-32ji-ss-1a-logic-deontic-4 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Imposes an obligation to comply with the notice." ;
cml:premiseText "(1A) A person commits an offence if: (a) the person is given a notice under section 32JE, 32JF, 32JG or 32JH; and" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ji-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-32ji-ss-1a-logic-deontic-5 .
concept:therapeutic-goods-act-1989-sec-32ji-ss-1a-logic-deontic-5 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibition" ;
cml:logicSummary "Prohibits failure to comply with the notice." ;
cml:premiseText "(1A) A person commits an offence if: (a) the person is given a notice under section 32JE, 32JF, 32JG or 32JH; and" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ji-ss-1b a cml:Concept ;
skos:prefLabel "32JI(1B) Criminal offences for failing to comply with a notice etc."@en ;
cml:realizedBy doc:sec-32ji-ss-1b ;
cml:integrityHash "0e0cdce4f49bcdede84da2c8cb10ce3f352a4869982d14472853df3c1e9c44ee" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ji ;
skos:note "Offence of strict liability for failing to comply with a notice" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.377" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32ji-ss-1b-norm .
concept:therapeutic-goods-act-1989-sec-32ji-ss-1b-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ji-ss-1b ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ji-ss-1b cml:asserts concept:therapeutic-goods-act-1989-sec-32ji-ss-1b-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32ji-ss-1b-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibition" ;
cml:logicSummary "Prohibits an offence of strict liability" ;
cml:premiseText "(1B) An offence against subsection (1A)" ;
cml:conclusionText "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-32ji-ss-2 a cml:Concept ;
skos:prefLabel "32JI(2) Criminal offences for failing to comply with a notice etc."@en ;
cml:realizedBy doc:sec-32ji-ss-2 ;
cml:integrityHash "a2c8711943ee9f6cacad211b7224d6047adaafeab3d1df75a58f105cb84af182" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ji ;
skos:note "Failing to comply with a notice results in an offence." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.377" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32ji-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-32ji-ss-2-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ji-ss-2 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32ji-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32ji-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32ji-ss-2-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-32ji-ss-3 a cml:Concept ;
skos:prefLabel "32JI(3) Criminal offences for failing to comply with a notice etc."@en ;
cml:realizedBy doc:sec-32ji-ss-3 ;
cml:integrityHash "b12846970c34a3d1360202f8dcd64a0e8fb411e932564440c7ac73823a87fe67" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ji ;
skos:note "Offence for failing to comply with a notice" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.377" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32ji-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-32ji-ss-3-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32ji-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-32ji-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-32ji-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32ji-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits failure 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-32jj a cml:Concept ;
skos:prefLabel "32JJ Civil penalty for giving false or misleading information or"@en ;
cml:realizedBy doc:sec-32jj ;
cml:integrityHash "4fb152d0f61815fed84acf184caa1c9b05ddfc83a1798985bc019c1bf439bddd" ;
skos:note "Giving false or misleading information in compliance with a notice is prohibited." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.378" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32jj-norm .
concept:therapeutic-goods-act-1989-sec-32jj-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jj ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32jj cml:asserts concept:therapeutic-goods-act-1989-sec-32jj-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32jj-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits giving false or misleading information in compliance with a notice." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32jk a cml:Concept ;
skos:prefLabel "32JK Self-incrimination"@en ;
cml:realizedBy doc:sec-32jk ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32jk-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32jk-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.378" .
concept:therapeutic-goods-act-1989-sec-32jk-ss-1 a cml:Concept ;
skos:prefLabel "32JK(1) Self-incrimination"@en ;
cml:realizedBy doc:sec-32jk-ss-1 ;
cml:integrityHash "c0137937764612eb65b2162dc614b9d948ba242c6145c598acbbe3b796fb7ce7" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jk ;
skos:note "No excuse for self-incrimination" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.378" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32jk-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32jk-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jk-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-32jk-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32jk-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32jk-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-32jk-ss-2 a cml:Concept ;
skos:prefLabel "32JK(2) Self-incrimination"@en ;
cml:realizedBy doc:sec-32jk-ss-2 ;
cml:integrityHash "c90302cc6bdad7bdb74b2882b4f4cb9f67fa280648908d982dabd2d26ccb1331" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jk ;
skos:note "Exemptions from self-incrimination in certain circumstances" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.378" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32jk-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-32jk-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jk-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-32jk-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32jk-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32jk-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Exemptions from self-incrimination" ;
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-32jl a cml:Concept ;
skos:prefLabel "32JL Secretary may inspect and copy documents"@en ;
cml:realizedBy doc:sec-32jl ;
cml:integrityHash "725ea2ad7cb0c0c5c8009d8159826a6af422ecee8b5c94f3ce18dfdcdfed21a4" ;
skos:note "Inspect and copy documents produced under certain sections." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.379" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32jl-norm .
concept:therapeutic-goods-act-1989-sec-32jl-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jl ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32jl cml:asserts concept:therapeutic-goods-act-1989-sec-32jl-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32jl-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "can" ;
cml:logicSummary "Permits inspection and copying." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32jm a cml:Concept ;
skos:prefLabel "32JM Secretary may retain documents"@en ;
cml:realizedBy doc:sec-32jm ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32jm-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32jm-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32jm-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-32jm-ss-4 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.379" .
concept:therapeutic-goods-act-1989-sec-32jm-ss-1 a cml:Concept ;
skos:prefLabel "32JM(1) Secretary may retain documents"@en ;
cml:realizedBy doc:sec-32jm-ss-1 ;
cml:integrityHash "4f6a24541790728efb9dfccfb99ab443171e619f7a163ac16edebf83437b5d62" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jm ;
skos:note "The Secretary may retain documents for a reasonable period." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.379" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32jm-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-32jm-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jm-ss-1 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32jm-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32jm-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32jm-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "may" ;
cml:logicSummary "Permission to retain documents" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32jm-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-32jm-ss-1-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-32jm-ss-1-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "during" ;
cml:logicSummary "Temporal relation to document retention" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32jm-ss-2 a cml:Concept ;
skos:prefLabel "32JM(2) Secretary may retain documents"@en ;
cml:realizedBy doc:sec-32jm-ss-2 ;
cml:integrityHash "39b840de0aebe6d9fbfe33d0f47cc203c4c340e15b499956df9f62d8bf008099" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jm ;
skos:note "Secretary must provide a copy of the document upon request." ;
dc:description "true" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.379" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32jm-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-32jm-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jm-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-32jm-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-32jm-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32jm-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Secretary has an obligation to provide a copy of the document." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32jm-ss-3 a cml:Concept ;
skos:prefLabel "32JM(3) Secretary may retain documents"@en ;
cml:realizedBy doc:sec-32jm-ss-3 ;
cml:integrityHash "80d9d59a2778a064332ad3fc46e2fc877e01a794c24bccd78e99d9487675d217" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jm ;
skos:note "The certified copy must be received as evidence." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.379" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32jm-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-32jm-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jm-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-32jm-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-32jm-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32jm-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Obligation to receive certified copy" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32jm-ss-4 a cml:Concept ;
skos:prefLabel "32JM(4) Secretary may retain documents"@en ;
cml:realizedBy doc:sec-32jm-ss-4 ;
cml:integrityHash "65c05402790361096b09ba5075c5d77f23b1f7d378696fbdfa09353c6c41b3ef" ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jm ;
skos:note "Must provide access to documents for inspection and copying." ;
dc:description "Yes" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.379" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-32jm-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-32jm-ss-4-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-32jm-ss-4 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-32jm-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-32jm-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-32jm-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-33a a cml:Concept ;
skos:prefLabel "33A Part does not apply to a medical device"@en ;
cml:realizedBy doc:sec-33a ;
cml:integrityHash "19af70f5b76fbab4ad94ec5b26b972ed1461e7b81c80bcf1ed0b001995e240ef" ;
skos:note "Part does not apply to medical devices." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.380" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-33a-norm .
concept:therapeutic-goods-act-1989-sec-33a-norm a values:Undertaking ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-33a ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-33b a cml:Concept ;
skos:prefLabel "33B Application of this Part to biologicals"@en ;
cml:realizedBy doc:sec-33b ;
cml:integrityHash "4186ce48132d2af1439d776bca7f86d2455abe4512c2ce182d37313f35f93545" ;
skos:note "This Part does not apply to a Class 1 biological." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.380" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-33b-norm .
concept:therapeutic-goods-act-1989-sec-33b-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-33b ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-34 a cml:Concept ;
skos:prefLabel "34 Exempt goods and exempt persons"@en ;
cml:realizedBy doc:sec-34 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-34-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-34-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-34-ss-3 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.380" .
concept:therapeutic-goods-act-1989-sec-34-ss-1 a cml:Concept ;
skos:prefLabel "34(1) Exempt goods and exempt persons"@en ;
cml:realizedBy doc:sec-34-ss-1 ;
cml:integrityHash "786a06541bb52f02f105a18a1e3a0b4aa1783901f8318311bf68cd213a5a7f4d" ;
values:partOf concept:therapeutic-goods-act-1989-sec-34 ;
skos:note "Therapeutic goods may be exempt from the operation of this Part." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.380" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-34-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-34-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-34-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-34-ss-2 a cml:Concept ;
skos:prefLabel "34(2) Exempt goods and exempt persons"@en ;
cml:realizedBy doc:sec-34-ss-2 ;
cml:integrityHash "9ab9fb76f2cf483d964d7f0656328c852c65650e0813ebfd22c73f60633dc8dd" ;
values:partOf concept:therapeutic-goods-act-1989-sec-34 ;
skos:note "Exempts a person from the operation of this Part in relation to the manufacture or a step in the manufacture of therapeutic goods." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.380" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-34-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-34-ss-2-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-34-ss-2 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-34-ss-3 a cml:Concept ;
skos:prefLabel "34(3) Exempt goods and exempt persons"@en ;
cml:realizedBy doc:sec-34-ss-3 ;
cml:integrityHash "e1f5ef79b2831a36434bc9810b239259a7db61409570f48c7cc993da91208010" ;
values:partOf concept:therapeutic-goods-act-1989-sec-34 ;
skos:note "Revocation of exemption takes effect after 28 days" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.380" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-34-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-34-ss-3-norm a values:Undertaking ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-34-ss-3 ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-35 a cml:Concept ;
skos:prefLabel "35 Criminal offences relating to manufacturing therapeutic goods"@en ;
cml:realizedBy doc:sec-35 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-35-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-35-ss-4 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.380" .
concept:therapeutic-goods-act-1989-sec-35-ss-1 a cml:Concept ;
skos:prefLabel "35(1) Criminal offences relating to manufacturing therapeutic goods"@en ;
cml:realizedBy doc:sec-35-ss-1 ;
cml:integrityHash "b1de34011cad22794f135fc6399b702d41f6209f1af6b75ef056cd88dba8045e" ;
values:partOf concept:therapeutic-goods-act-1989-sec-35 ;
skos:note "Manufacturing therapeutic goods without proper authorization is prohibited." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.380" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-35-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-35-ss-1-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-35-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-35-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-35-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-35-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits the manufacture of therapeutic goods without proper authorization." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-35-ss-4 a cml:Concept ;
skos:prefLabel "35(4) Criminal offences relating to manufacturing therapeutic goods"@en ;
cml:realizedBy doc:sec-35-ss-4 ;
cml:integrityHash "2eedcd7b145ded277170dd0edcfb7b550e7a046b97421d7edc657e7ceeb92000" ;
values:partOf concept:therapeutic-goods-act-1989-sec-35 ;
skos:note "Manufacturing therapeutic goods without proper license" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.380" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-35-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-35-ss-4-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-35-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-35-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-35-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-35-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits manufacturing therapeutic goods without license" ;
cml:premiseText "(a) the person, at premises in Australia, carries out a step in the manufacture of therapeutic goods..." ;
cml:conclusionText "...and none of the following applies: (i) the goods are exempt goods;" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-35-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-35-ss-4-logic-deontic-2 .
concept:therapeutic-goods-act-1989-sec-35-ss-4-logic-deontic-2 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits manufacturing therapeutic goods without proper license" ;
cml:premiseText "(b) the goods are for supply for use in humans;" ;
cml:conclusionText "...and none of the following applies: (i) the goods are exempt goods;" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-35-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-35-ss-4-logic-deontic-3 .
concept:therapeutic-goods-act-1989-sec-35-ss-4-logic-deontic-3 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits manufacturing therapeutic goods without proper license" ;
cml:premiseText "(c) none of the following applies:" ;
cml:conclusionText "...and none of the following applies: (i) the goods are exempt goods;" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-35-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-35-ss-4-logic-deontic-4 .
concept:therapeutic-goods-act-1989-sec-35-ss-4-logic-deontic-4 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits manufacturing therapeutic goods without proper license" ;
cml:premiseText "(iii) the person is the holder of a licence that is in force that authorises the carrying out of that step in relation to the goods at those premises." ;
cml:conclusionText "...and none of the following applies: (i) the goods are exempt goods;" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-35a a cml:Concept ;
skos:prefLabel "35A Civil penalties relating to manufacturing therapeutic goods"@en ;
cml:realizedBy doc:sec-35a ;
cml:integrityHash "a6516c6e428c0e28849bb916246584c3e7cfe60c5adadb39a9dba91976623015" ;
skos:note "Carrying out steps in manufacturing therapeutic goods at Australian premises is prohibited." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.383" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-35a-norm .
concept:therapeutic-goods-act-1989-sec-35a-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-35a ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-35a cml:asserts concept:therapeutic-goods-act-1989-sec-35a-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-35a-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibition of manufacturing therapeutic goods at Australian premises." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-35b a cml:Concept ;
skos:prefLabel "35B Criminal offences relating to breaching a condition of a licence"@en ;
cml:realizedBy doc:sec-35b ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-35b-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-35b-ss-4 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-35b-ss-5 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-35b-ss-6 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.384" .
concept:therapeutic-goods-act-1989-sec-35b-ss-1 a cml:Concept ;
skos:prefLabel "35B(1) Criminal offences relating to breaching a condition of a licence"@en ;
cml:realizedBy doc:sec-35b-ss-1 ;
cml:integrityHash "a0866b55206427146969c1ca4cfaef2310b0ee1235e944b4a4b670e808d96406" ;
values:partOf concept:therapeutic-goods-act-1989-sec-35b ;
skos:note "A person commits an offence if they hold a licence and breach a condition of the licence." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.384" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-35b-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-35b-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-35b-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-35b-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-35b-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-35b-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "has" ;
cml:logicSummary "Licence is a necessary condition for committing an offence." ;
cml:premiseText "The person holds a licence." ;
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-35b-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-35b-ss-1-logic-deontic-2 .
concept:therapeutic-goods-act-1989-sec-35b-ss-1-logic-deontic-2 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "has" ;
cml:logicSummary "Breach of the licence's condition is a necessary condition for committing an offence." ;
cml:premiseText "The act or omission has resulted in, will result in, or is likely to result in harm or injury to any person." ;
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-35b-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-35b-ss-1-logic-deontic-3 .
concept:therapeutic-goods-act-1989-sec-35b-ss-1-logic-deontic-3 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "has" ;
cml:logicSummary "Imprisonment for 5 years or 4,000 penalty units is a possible consequence of committing an offence." ;
cml:premiseText "A person commits an offence if: (a) the person holds a licence; and (b) the person does an act or omits to do an act; and (c) the act or omission breaches a condition of the licence; and (d) the act or omission has resulted in, will result in, or is likely to result in harm or injury to any person." ;
cml:conclusionText "The penalty for committing an offence is imprisonment for 5 years or 4,000 penalty units." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-35b-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-35b-ss-1-logic-deontic-4 .
concept:therapeutic-goods-act-1989-sec-35b-ss-1-logic-deontic-4 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "has" ;
cml:logicSummary "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:premiseText "A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A." ;
cml:conclusionText "The court has discretion to acquit or convict a person of an offence." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-35b-ss-4 a cml:Concept ;
skos:prefLabel "35B(4) Criminal offences relating to breaching a condition of a licence"@en ;
cml:realizedBy doc:sec-35b-ss-4 ;
cml:integrityHash "15f35ff81eb6354aee60ddf3261c9599a2a2d07b21338f162d852f7e34368830" ;
values:partOf concept:therapeutic-goods-act-1989-sec-35b ;
skos:note "Breach of licence condition is an offence." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.384" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-35b-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-35b-ss-4-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-35b-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-35b-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-35b-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-35b-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "is" ;
cml:logicSummary "Licence breach is a duty." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-35b-ss-5 a cml:Concept ;
skos:prefLabel "35B(5) Criminal offences relating to breaching a condition of a licence"@en ;
cml:realizedBy doc:sec-35b-ss-5 ;
cml:integrityHash "ff44ee5f30ea16bf3d52007a11ae5e0c5b8054fcbcb05394469c0b715439aedf" ;
values:partOf concept:therapeutic-goods-act-1989-sec-35b ;
skos:note "Breach of licence condition is an offence." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.384" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-35b-ss-5-norm .
concept:therapeutic-goods-act-1989-sec-35b-ss-5-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-35b-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-35b-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-35b-ss-5-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-35b-ss-5-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "is" ;
cml:logicSummary "Licence breach is a duty." ;
cml:premiseText "(5) A person commits an offence if: (a) the person holds a licence; and (b) the person does an act or omits to do an act; and (c) the act or omission breaches a condition of the licence." ;
cml:conclusionText "The person is obligated to comply with the licence conditions." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-35b-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-35b-ss-5-logic-linearlogic-2 .
concept:therapeutic-goods-act-1989-sec-35b-ss-5-logic-linearlogic-2 a cml:LogicApplication ;
cml:modality cml:LinearLogic ;
cml:operator "=>" ;
cml:logicSummary "Licence breach implies obligation to comply." ;
cml:premiseText "(5) A person commits an offence if: (a) the person holds a licence; and (b) the person does an act or omits to do an act; and (c) the act or omission breaches a condition of the licence." ;
cml:conclusionText "The person is obligated to comply with the licence conditions." ;
cml:executionSurface "modalities::linear" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-35b-ss-5 cml:asserts concept:therapeutic-goods-act-1989-sec-35b-ss-5-logic-alleninterval-3 .
concept:therapeutic-goods-act-1989-sec-35b-ss-5-logic-alleninterval-3 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "during" ;
cml:logicSummary "Licence breach occurs during licence period." ;
cml:premiseText "(5) A person commits an offence if: (a) the person holds a licence; and (b) the person does an act or omits to do an act; and (c) the act or omission breaches a condition of the licence." ;
cml:conclusionText "The licence breach occurs during the licence period." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-35b-ss-6 a cml:Concept ;
skos:prefLabel "35B(6) Criminal offences relating to breaching a condition of a licence"@en ;
cml:realizedBy doc:sec-35b-ss-6 ;
cml:integrityHash "c385da7f11ff5e7f14e072e858989feb81f5b1c13125da3beda70e38518df21e" ;
values:partOf concept:therapeutic-goods-act-1989-sec-35b ;
skos:note "An offence against subsection (5) is an offence of strict liability." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.384" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-35b-ss-6-norm .
concept:therapeutic-goods-act-1989-sec-35b-ss-6-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-35b-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-35b-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-35b-ss-6-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-35b-ss-6-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-35c a cml:Concept ;
skos:prefLabel "35C Civil penalty relating to breaching a condition of a licence"@en ;
cml:realizedBy doc:sec-35c ;
cml:integrityHash "671e5d890c39839dbd99093eb324ea5ebca9dae4d723ac6e4c9f63cc6d7c7bfb" ;
skos:note "Breach of licence condition results in civil penalty" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.385" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-35c-norm .
concept:therapeutic-goods-act-1989-sec-35c-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-35c ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-35c cml:asserts concept:therapeutic-goods-act-1989-sec-35c-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-35c-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "forbid" ;
cml:logicSummary "Prohibits breaching a licence condition" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-36 a cml:Concept ;
skos:prefLabel "36 Manufacturing principles"@en ;
cml:realizedBy doc:sec-36 ;
cml:integrityHash "72cf1a68212b3c8fd3686d80789139dee349192aa9ba572146cea7da9d7ff879" ;
skos:note "The Minister may determine written principles for the manufacture of therapeutic goods." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.385" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-36-norm .
concept:therapeutic-goods-act-1989-sec-36-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-36 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-36 cml:asserts concept:therapeutic-goods-act-1989-sec-36-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-36-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "may" ;
cml:logicSummary "Permission to determine principles" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-37 a cml:Concept ;
skos:prefLabel "37 Application for licence"@en ;
cml:realizedBy doc:sec-37 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-37-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-37-ss-1a ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-37-ss-1b ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.386" .
concept:therapeutic-goods-act-1989-sec-37-ss-1 a cml:Concept ;
skos:prefLabel "37(1) Application for licence"@en ;
cml:realizedBy doc:sec-37-ss-1 ;
cml:integrityHash "823f4f6b0f643d1bcfe08c522bd12ef4ba714c764eb10b82f774902e8051f288" ;
values:partOf concept:therapeutic-goods-act-1989-sec-37 ;
skos:note "Application for licence must be made in accordance with a form approved by the Secretary." ;
dc:description "a form approved by the Secretary, identification of therapeutic goods or classes of therapeutic goods, manufacturing sites, steps in manufacture, and control measures" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.386" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-37-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-37-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-37-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-37-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-37-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-37-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-37-ss-1a a cml:Concept ;
skos:prefLabel "37(1A) Application for licence"@en ;
cml:realizedBy doc:sec-37-ss-1a ;
cml:integrityHash "016a603df80d896b076ce6511461926e36d66ad645de63df75237a37039c746f" ;
values:partOf concept:therapeutic-goods-act-1989-sec-37 ;
skos:note "Application must relate to one manufacturing site only." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.386" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-37-ss-1a-norm .
concept:therapeutic-goods-act-1989-sec-37-ss-1a-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-37-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-37-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-37-ss-1a-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-37-ss-1a-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligate" ;
cml:logicSummary "Application must relate to one manufacturing site only." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-37-ss-1a cml:asserts concept:therapeutic-goods-act-1989-sec-37-ss-1a-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-37-ss-1a-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "during" ;
cml:logicSummary "Temporal relation between manufacturing sites" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-37-ss-1b a cml:Concept ;
skos:prefLabel "37(1B) Application for licence"@en ;
cml:realizedBy doc:sec-37-ss-1b ;
cml:integrityHash "05346525101c5634d6cd94847acc9cbfdb381de12153f5717d2c5c790bcac7a9" ;
values:partOf concept:therapeutic-goods-act-1989-sec-37 ;
skos:note "Applicant may identify multiple manufacturing sites in application." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.386" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-37-ss-1b-norm .
concept:therapeutic-goods-act-1989-sec-37-ss-1b-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-37-ss-1b ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-38 a cml:Concept ;
skos:prefLabel "38 Grant of licence"@en ;
cml:realizedBy doc:sec-38 ;
cml:integrityHash "a59be4096747b5017b36442b420d51e6c633d29fc64950d2817c749b3604bcfe" ;
skos:note "Grant of licence for manufacturing therapeutic goods" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.388" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-38-norm .
concept:therapeutic-goods-act-1989-sec-38-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-38 ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-38 cml:asserts concept:therapeutic-goods-act-1989-sec-38-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-38-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligate" ;
cml:logicSummary "Grant of licence for manufacturing therapeutic goods" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-38a a cml:Concept ;
skos:prefLabel "38A Guidelines for multi-site licences"@en ;
cml:realizedBy doc:sec-38a ;
cml:integrityHash "e400ba6304d4a70588635168adb1ab7598bffca80dbc120fe43d7f9fce1134f0" ;
skos:note "The Secretary must make guidelines for multi-site licences." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.391" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-38a-norm .
concept:therapeutic-goods-act-1989-sec-38a-norm a values:Undertaking ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-38a ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-38b a cml:Concept ;
skos:prefLabel "38B Splitting multi-site licences"@en ;
cml:realizedBy doc:sec-38b ;
cml:integrityHash "5369fcecd8ee3b9d96311368fb5dddfe92ac96ddc86096dd9040eccea6e64e2b" ;
skos:note "This section applies if a licence (the old licence):" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.391" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-38b-norm .
concept:therapeutic-goods-act-1989-sec-38b-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-38b ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-39 a cml:Concept ;
skos:prefLabel "39 Term of licence"@en ;
cml:realizedBy doc:sec-39 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-39-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-39-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-39-ss-3 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.394" .
concept:therapeutic-goods-act-1989-sec-39-ss-1 a cml:Concept ;
skos:prefLabel "39(1) Term of licence"@en ;
cml:realizedBy doc:sec-39-ss-1 ;
cml:integrityHash "2d4f6788c93008a0616fe5e8e8fae7a8912126f8587b0a2c421738cf9c9e15e2" ;
values:partOf concept:therapeutic-goods-act-1989-sec-39 ;
skos:note "Licence commencement and duration" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.394" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-39-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-39-ss-1-norm a values:Undertaking ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-39-ss-1 ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-39-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-39-ss-1-logic-alleninterval-1 .
concept:therapeutic-goods-act-1989-sec-39-ss-1-logic-alleninterval-1 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Applicable" ;
cml:logicSummary "Defines temporal interval for licence commencement" ;
cml:premiseText "Commencement day is specified" ;
cml:conclusionText "Licence commences on specified day" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-39-ss-2 a cml:Concept ;
skos:prefLabel "39(2) Term of licence"@en ;
cml:realizedBy doc:sec-39-ss-2 ;
cml:integrityHash "e88995f51c5daf9ef2c10254f3e07fec174d40e020b80e6949ec8da16c7f4244" ;
values:partOf concept:therapeutic-goods-act-1989-sec-39 ;
skos:note "Licence ceases to be in force if goods cease to be exempt under section 18A." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.394" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-39-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-39-ss-2-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-39-ss-2 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-39-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-39-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-39-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "cease" ;
cml:logicSummary "Ceases to be in force" ;
cml:premiseText "(2) If the licence covers therapeutic goods that are exempt under section 18A; and those goods cease to be exempt under that section before the licence is revoked;" ;
cml:conclusionText "the licence ceases to be in force in relation to those goods when those goods cease to be exempt under that section." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-39-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-39-ss-2-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-39-ss-2-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "during" ;
cml:logicSummary "Temporal relation between exemption and licence revocation" ;
cml:premiseText "(b) those goods cease to be exempt under that section before the licence is revoked;" ;
cml:conclusionText "when those goods cease to be exempt under that section." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-39-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-39-ss-2-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-39-ss-2-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "during" ;
cml:logicSummary "Temporal relation between exemption and licence revocation" ;
cml:premiseText "(b) those goods cease to be exempt under that section before the licence is revoked;" ;
cml:conclusionText "when those goods cease to be exempt under that section." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-39-ss-3 a cml:Concept ;
skos:prefLabel "39(3) Term of licence"@en ;
cml:realizedBy doc:sec-39-ss-3 ;
cml:integrityHash "41f378cf70f82afbc42eae902f636bae38c0898972f0b3da17b6f39b8412b177" ;
values:partOf concept:therapeutic-goods-act-1989-sec-39 ;
skos:note "Licence ceases in force if biological ceases to be exempt under section 32CB." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.394" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-39-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-39-ss-3-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-39-ss-3 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-39-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-39-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-39-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "CEASES" ;
cml:logicSummary "Ceases in force" ;
cml:premiseText "(a) the licence covers a biological that is exempt under section 32CB; and (b) the biological ceases to be exempt under that section before the licence is revoked;" ;
cml:conclusionText "the licence ceases to be in force in relation to the biological when the biological ceases to be exempt under that section." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-39-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-39-ss-3-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-39-ss-3-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "MEETS" ;
cml:logicSummary "Biological ceases to be exempt under section 32CB before licence is revoked" ;
cml:premiseText "(b) the biological ceases to be exempt under that section before the licence is revoked;" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "0.8000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-39-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-39-ss-3-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-39-ss-3-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "MEETS" ;
cml:logicSummary "Biological ceases to be exempt under section 32CB at some point in time" ;
cml:premiseText "(b) the biological ceases to be exempt under that section before the licence is revoked;" ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "0.8000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-39-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-39-ss-3-logic-diffusion-4 .
concept:therapeutic-goods-act-1989-sec-39-ss-3-logic-diffusion-4 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "MEETS" ;
cml:logicSummary "Licence ceases in force when biological ceases to be exempt under section 32CB" ;
cml:premiseText "(a) the licence covers a biological that is exempt under section 32CB; and (b) the biological ceases to be exempt under that section before the licence is revoked;" ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "0.8000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-39-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-39-ss-3-logic-cogai-5 .
concept:therapeutic-goods-act-1989-sec-39-ss-3-logic-cogai-5 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "MEETS" ;
cml:logicSummary "Licence ceases in force when biological ceases to be exempt under section 32CB" ;
cml:premiseText "(a) the licence covers a biological that is exempt under section 32CB; and (b) the biological ceases to be exempt under that section before the licence is revoked;" ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "0.8000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-40 a cml:Concept ;
skos:prefLabel "40 Conditions of licences"@en ;
cml:realizedBy doc:sec-40 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-40-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-40-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-40-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-40-ss-3a ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-40-ss-4 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.394" .
concept:therapeutic-goods-act-1989-sec-40-ss-1 a cml:Concept ;
skos:prefLabel "40(1) Conditions of licences"@en ;
cml:realizedBy doc:sec-40-ss-1 ;
cml:integrityHash "bce90fa1856c50d45b98e0d7fc2792ab10fdeead0db86b4ee9b831954df28db4" ;
values:partOf concept:therapeutic-goods-act-1989-sec-40 ;
skos:note "Conditions for granting a licence" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.394" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-40-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-40-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-40-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-40-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-40-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-40-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "shall" ;
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-40-ss-2 a cml:Concept ;
skos:prefLabel "40(2) Conditions of licences"@en ;
cml:realizedBy doc:sec-40-ss-2 ;
cml:integrityHash "ed9e6a9364bc4439a62594c58cb050f71dd622e9e95956e8f336e1d0aee8829a" ;
values:partOf concept:therapeutic-goods-act-1989-sec-40 ;
skos:note "Secretary may impose new conditions on a licence." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.394" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-40-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-40-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-40-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-40-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-40-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-40-ss-2-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-40-ss-3 a cml:Concept ;
skos:prefLabel "40(3) Conditions of licences"@en ;
cml:realizedBy doc:sec-40-ss-3 ;
cml:integrityHash "76fd027f3c8145fe227cea6a3e17dbdac713cb3a92e126229b8ae8f03f8f7e4d" ;
values:partOf concept:therapeutic-goods-act-1989-sec-40 ;
skos:note "Conditions for imposing, varying or removing conditions on licences." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.394" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-40-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-40-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-40-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-40-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-40-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-40-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Imposition of obligations." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-40-ss-3a a cml:Concept ;
skos:prefLabel "40(3A) Conditions of licences"@en ;
cml:realizedBy doc:sec-40-ss-3a ;
cml:integrityHash "e9297eb92871c46d7b5997d4608a86576567b30fa9749516395fb4a7c6673573" ;
values:partOf concept:therapeutic-goods-act-1989-sec-40 ;
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 <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.394" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-40-ss-3a-norm .
concept:therapeutic-goods-act-1989-sec-40-ss-3a-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-40-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-40-ss-3a cml:asserts concept:therapeutic-goods-act-1989-sec-40-ss-3a-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-40-ss-3a-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Necessity" ;
cml:logicSummary "The earlier day must be on or after the notice day." ;
cml:premiseText "(3A) For the purposes of paragraph (3)(b), the earlier day must not be earther than the day the notice is given to the person." ;
cml:conclusionText "(3A) For the purposes of paragraph (3)(b), the earlier day must be on or after the notice day." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-40-ss-3a cml:asserts concept:therapeutic-goods-act-1989-sec-40-ss-3a-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-40-ss-3a-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "Meets" ;
cml:logicSummary "The earlier day meets the notice day." ;
cml:premiseText "(3A) For the purposes of paragraph (3)(b), the earlier day must not be earther than the day the notice is given to the person." ;
cml:conclusionText "(3A) For the purposes of paragraph (3)(b), the earlier day meets the notice day." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-40-ss-3a cml:asserts concept:therapeutic-goods-act-1989-sec-40-ss-3a-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-40-ss-3a-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "Meets" ;
cml:logicSummary "The earlier day meets the notice day." ;
cml:premiseText "(3A) For the purposes of paragraph (3)(b), the earlier day must not be earther than the day the notice is given to the person." ;
cml:conclusionText "(3A) For the purposes of paragraph (3)(b), the earlier day meets the notice day." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-40-ss-3a cml:asserts concept:therapeutic-goods-act-1989-sec-40-ss-3a-logic-diffusion-4 .
concept:therapeutic-goods-act-1989-sec-40-ss-3a-logic-diffusion-4 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "Meets" ;
cml:logicSummary "The earlier day meets the notice day." ;
cml:premiseText "(3A) For the purposes of paragraph (3)(b), the earlier day must not be earther than the day the notice is given to the person." ;
cml:conclusionText "(3A) For the purposes of paragraph (3)(b), the earlier day meets the notice day." ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-40-ss-3a cml:asserts concept:therapeutic-goods-act-1989-sec-40-ss-3a-logic-cogai-5 .
concept:therapeutic-goods-act-1989-sec-40-ss-3a-logic-cogai-5 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "Meets" ;
cml:logicSummary "The earlier day meets the notice day." ;
cml:premiseText "(3A) For the purposes of paragraph (3)(b), the earlier day must not be earther than the day the notice is given to the person." ;
cml:conclusionText "(3A) For the purposes of paragraph (3)(b), the earlier day meets the notice day." ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-40-ss-4 a cml:Concept ;
skos:prefLabel "40(4) Conditions of licences"@en ;
cml:realizedBy doc:sec-40-ss-4 ;
cml:integrityHash "42ef28113032f666f0038448350849101b897571dcf66524a16c62cee5d36acd" ;
values:partOf concept:therapeutic-goods-act-1989-sec-40 ;
skos:note "Ensure goods conform to standards and follow manufacturing principles." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.394" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-40-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-40-ss-4-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-40-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-40-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-40-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-40-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "must" ;
cml:logicSummary "Ensure compliance with standards and principles." ;
cml:premiseText "The holder of the licence must ensure that..." ;
cml:conclusionText "...the goods conform to any standard applicable to the goods; and the holder of the licence observes the manufacturing principles in carrying out any steps in the manufacture of the goods under the licence." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-40-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-40-ss-4-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-40-ss-4-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "during" ;
cml:logicSummary "Manufacturing principles apply during the manufacture of goods." ;
cml:premiseText "The holder of the licence observes the manufacturing principles in carrying out any steps in the manufacture of the goods under the licence;" ;
cml:conclusionText "...the goods conform to any standard applicable to the goods; and..." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-40-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-40-ss-4-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-40-ss-4-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "until" ;
cml:logicSummary "Manufacturing principles apply until the circumstances prescribed by the regulations have occurred." ;
cml:premiseText "The holder of the licence observes the manufacturing principles in carrying out any steps in the manufacture of the goods under the licence;" ;
cml:conclusionText "...the goods are a biological and are for supply after the circumstances prescribed by the regulations..." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-40-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-40-ss-4-logic-diffusion-4 .
concept:therapeutic-goods-act-1989-sec-40-ss-4-logic-diffusion-4 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "if" ;
cml:logicSummary "Manufacturing principles apply if certain conditions are met." ;
cml:premiseText "The holder of the licence will: (a) ensure that:..." ;
cml:conclusionText "...the goods conform to any standard applicable to the goods; and..." ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-40-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-40-ss-4-logic-cogai-5 .
concept:therapeutic-goods-act-1989-sec-40-ss-4-logic-cogai-5 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "has" ;
cml:logicSummary "Goods have a certain property if they conform to standards." ;
cml:premiseText "(i) the goods conform to any standard applicable to the goods;" ;
cml:conclusionText "...the goods are a biological and are for supply after the circumstances prescribed by the regulations..." ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-40a a cml:Concept ;
skos:prefLabel "40A Variation of manufacturing site authorisations—Secretary’s"@en ;
cml:realizedBy doc:sec-40a ;
cml:integrityHash "772cef773de65c05e8af2d38d0f6ff0d833e257ee5dd5d0377e439cbc856c9f0" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-40a-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-40a-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.397" .
concept:therapeutic-goods-act-1989-sec-40a-ss-1 a cml:Concept ;
skos:prefLabel "40A(1) Variation of manufacturing site authorisations—Secretary’s"@en ;
cml:realizedBy doc:sec-40a-ss-1 ;
cml:integrityHash "b430ea172eaaeeceee938df8bfd0ad160a5176cae5e33acfecd69175bca45c1d" ;
values:partOf concept:therapeutic-goods-act-1989-sec-40a ;
skos:note "The Secretary may vary a manufacturing site authorisation on their own initiative." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.397" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-40a-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-40a-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-40a-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-40a-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-40a-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-40a-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "May" ;
cml:logicSummary "The Secretary has the power to vary a manufacturing site authorisation." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-40a-ss-2 a cml:Concept ;
skos:prefLabel "40A(2) Variation of manufacturing site authorisations—Secretary’s"@en ;
cml:realizedBy doc:sec-40a-ss-2 ;
cml:integrityHash "28501499e725b83d0c0781e8a473b6af811f5d6adbbd9bfc4c211b32d75b4d04" ;
values:partOf concept:therapeutic-goods-act-1989-sec-40a ;
skos:note "Variation of manufacturing site authorisations—Secretary’s" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.397" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-40a-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-40a-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-40a-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-40a-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-40a-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-40a-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "takes effect" ;
cml:logicSummary "Effectiveness of variation" ;
cml:premiseText "(2) A variation under subsection (1)" ;
cml:conclusionText "Chapter 3 Medicines and other therapeutic goods that are not medical devices" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-40a-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-40a-ss-2-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-40a-ss-2-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "begins at" ;
cml:logicSummary "Temporal relationship of variation effectiveness" ;
cml:premiseText "(2) A variation under subsection (1)" ;
cml:conclusionText "Chapter 3 Medicines and other therapeutic goods that are not medical devices" ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-40a-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-40a-ss-2-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-40a-ss-2-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "is a trace of" ;
cml:logicSummary "Recurring relationship of variation effectiveness" ;
cml:premiseText "(2) A variation under subsection (1)" ;
cml:conclusionText "Chapter 3 Medicines and other therapeutic goods that are not medical devices" ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-40a-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-40a-ss-2-logic-diffusion-4 .
concept:therapeutic-goods-act-1989-sec-40a-ss-2-logic-diffusion-4 a cml:LogicApplication ;
cml:modality cml:Diffusion ;
cml:operator "diffuses to" ;
cml:logicSummary "Spread of variation effectiveness" ;
cml:premiseText "(2) A variation under subsection (1)" ;
cml:conclusionText "Chapter 3 Medicines and other therapeutic goods that are not medical devices" ;
cml:executionSurface "modalities::diffusion" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-40a-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-40a-ss-2-logic-cogai-5 .
concept:therapeutic-goods-act-1989-sec-40a-ss-2-logic-cogai-5 a cml:LogicApplication ;
cml:modality cml:CogAI ;
cml:operator "is a capability of" ;
cml:logicSummary "Artificial intelligence application for variation effectiveness" ;
cml:premiseText "(2) A variation under subsection (1)" ;
cml:conclusionText "Chapter 3 Medicines and other therapeutic goods that are not medical devices" ;
cml:executionSurface "sparql_library::parsers::chk_parser" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-40b a cml:Concept ;
skos:prefLabel "40B Variation of licences—application by licence holder"@en ;
cml:realizedBy doc:sec-40b ;
cml:integrityHash "23631f5b408e0ffe207e9d7d35b987d75af7fcaa23985e24c729e62b43b1aec9" ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-40b-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-40b-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-40b-ss-3 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-40b-ss-4 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-40b-ss-5 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-40b-ss-6 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-40b-ss-7 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-40b-ss-8 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-40b-ss-9 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.398" .
concept:therapeutic-goods-act-1989-sec-40b-ss-1 a cml:Concept ;
skos:prefLabel "40B(1) Variation of licences—application by licence holder"@en ;
cml:realizedBy doc:sec-40b-ss-1 ;
cml:integrityHash "873f1327535160237468c62c43837f8983a4632fc26c255cbe57b149229c7d32" ;
values:partOf concept:therapeutic-goods-act-1989-sec-40b ;
skos:note "Licence holder may apply for variation of licence to cover additional manufacturing sites." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.398" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-40b-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-40b-ss-1-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-40b-ss-1 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-40b-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-40b-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-40b-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "May" ;
cml:logicSummary "Permission granted by the holder." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-40b-ss-2 a cml:Concept ;
skos:prefLabel "40B(2) Variation of licences—application by licence holder"@en ;
cml:realizedBy doc:sec-40b-ss-2 ;
cml:integrityHash "faa1a26da7eb49ec0db13d71d4d9f80f27f94a11a3993f901a1e019c3804e7c1" ;
values:partOf concept:therapeutic-goods-act-1989-sec-40b ;
skos:note "Application requirements for variation of licences" ;
dc:description "information relating to manufacturing steps, quality control measures, and personnel" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.398" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-40b-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-40b-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-40b-ss-2 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-40b-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-40b-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-40b-ss-2-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-40b-ss-3 a cml:Concept ;
skos:prefLabel "40B(3) Variation of licences—application by licence holder"@en ;
cml:realizedBy doc:sec-40b-ss-3 ;
cml:integrityHash "e7712ac023a994b706e250c553d86608eb5531268109ba62cde98d6ce020d7ab" ;
values:partOf concept:therapeutic-goods-act-1989-sec-40b ;
skos:note "Variation of licences—application by licence holder" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.398" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-40b-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-40b-ss-3-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-40b-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-40b-ss-4 a cml:Concept ;
skos:prefLabel "40B(4) Variation of licences—application by licence holder"@en ;
cml:realizedBy doc:sec-40b-ss-4 ;
cml:integrityHash "b2326fd704e1f95cfebdca810bf196177fe62d7548945f5ff45c348d0471df8f" ;
values:partOf concept:therapeutic-goods-act-1989-sec-40b ;
skos:note "The Secretary must vary the licence to authorise the holder of the licence to carry out specified steps in the manufacture of specified therapeutic goods at that manufacturing site." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.398" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-40b-ss-4-norm .
concept:therapeutic-goods-act-1989-sec-40b-ss-4-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-40b-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-40b-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-40b-ss-4-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-40b-ss-4-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "The Secretary must vary the licence." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-40b-ss-4 cml:asserts concept:therapeutic-goods-act-1989-sec-40b-ss-4-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-40b-ss-4-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "AT A SPECIFIED MANUFACTURING SITE" ;
cml:logicSummary "The variation is specified for each manufacturing site." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-40b-ss-5 a cml:Concept ;
skos:prefLabel "40B(5) Variation of licences—application by licence holder"@en ;
cml:realizedBy doc:sec-40b-ss-5 ;
cml:integrityHash "afe440d48bb49c15f08205465ab4c80277d0ccdefa5d869501128dc2b178e984" ;
values:partOf concept:therapeutic-goods-act-1989-sec-40b ;
skos:note "Variation of manufacturing site authorisations takes effect on the day notice is given to the holder." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.398" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-40b-ss-5-norm .
concept:therapeutic-goods-act-1989-sec-40b-ss-5-norm a values:Undertaking ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-40b-ss-5 ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-40b-ss-6 a cml:Concept ;
skos:prefLabel "40B(6) Variation of licences—application by licence holder"@en ;
cml:realizedBy doc:sec-40b-ss-6 ;
cml:integrityHash "4c26da67d5139314367ed4a64774cb67de5864acb5579d9e73f899cab4b54c6e" ;
values:partOf concept:therapeutic-goods-act-1989-sec-40b ;
skos:note "Holder of a licence may apply for variation of manufacturing site authorisation." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.398" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-40b-ss-6-norm .
concept:therapeutic-goods-act-1989-sec-40b-ss-6-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-40b-ss-6 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-40b-ss-6 cml:asserts concept:therapeutic-goods-act-1989-sec-40b-ss-6-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-40b-ss-6-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "May" ;
cml:logicSummary "Permission to apply for variation" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-40b-ss-7 a cml:Concept ;
skos:prefLabel "40B(7) Variation of licences—application by licence holder"@en ;
cml:realizedBy doc:sec-40b-ss-7 ;
cml:integrityHash "5d7a365a6b97644a4d1c8c3e4c821040ec1216decebf484535a660d3dddf4a8c" ;
values:partOf concept:therapeutic-goods-act-1989-sec-40b ;
skos:note "Application for variation of licence must be made in accordance with a form approved by the Secretary." ;
dc:description "Form, application fee" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.398" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-40b-ss-7-norm .
concept:therapeutic-goods-act-1989-sec-40b-ss-7-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-40b-ss-7 ;
values:borneBy values:LegalPerson ;
skos:scopeNote "borne by: LegalPerson" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-40b-ss-7 cml:asserts concept:therapeutic-goods-act-1989-sec-40b-ss-7-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-40b-ss-7-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-40b-ss-8 a cml:Concept ;
skos:prefLabel "40B(8) Variation of licences—application by licence holder"@en ;
cml:realizedBy doc:sec-40b-ss-8 ;
cml:integrityHash "699014c0bd3df205b9cf2a07d90402955b12cd0cc189ca0b182a1817f7de60d6" ;
values:partOf concept:therapeutic-goods-act-1989-sec-40b ;
skos:note "Secretary may vary manufacturing site authorisation upon application and payment of inspection fees." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.398" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-40b-ss-8-norm .
concept:therapeutic-goods-act-1989-sec-40b-ss-8-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-40b-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-40b-ss-8 cml:asserts concept:therapeutic-goods-act-1989-sec-40b-ss-8-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-40b-ss-8-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "May" ;
cml:logicSummary "Permits variation of manufacturing site authorisation." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-40b-ss-9 a cml:Concept ;
skos:prefLabel "40B(9) Variation of licences—application by licence holder"@en ;
cml:realizedBy doc:sec-40b-ss-9 ;
cml:integrityHash "983e7d9928431ae3c9422c83e47eb4b86d19ab75ad442a9f77801e2994f2ec64" ;
values:partOf concept:therapeutic-goods-act-1989-sec-40b ;
skos:note "Variation of licences—application by licence holder" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.398" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-40b-ss-9-norm .
concept:therapeutic-goods-act-1989-sec-40b-ss-9-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-40b-ss-9 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-40b-ss-9 cml:asserts concept:therapeutic-goods-act-1989-sec-40b-ss-9-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-40b-ss-9-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "takes effect" ;
cml:logicSummary "Effectiveness of variation" ;
cml:premiseText "(9) A variation under subsection (8) takes effect on the day on which the notice is given to the holder." ;
cml:conclusionText "The variation takes effect on the specified day." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-40b-ss-9 cml:asserts concept:therapeutic-goods-act-1989-sec-40b-ss-9-logic-alleninterval-2 .
concept:therapeutic-goods-act-1989-sec-40b-ss-9-logic-alleninterval-2 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "specifies temporal interval" ;
cml:logicSummary "Temporal specification of variation" ;
cml:premiseText "(9) A variation under subsection (8) takes effect on the day on which the notice is given to the holder." ;
cml:conclusionText "The variation's effectiveness is tied to a specific date." ;
cml:executionSurface "modalities::interval_reasoning" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-40b-ss-9 cml:asserts concept:therapeutic-goods-act-1989-sec-40b-ss-9-logic-ltl-3 .
concept:therapeutic-goods-act-1989-sec-40b-ss-9-logic-ltl-3 a cml:LogicApplication ;
cml:modality cml:LTL ;
cml:operator "specifies trace" ;
cml:logicSummary "Tracing variation application" ;
cml:premiseText "(9) A variation under subsection (8) takes effect on the day on which the notice is given to the holder." ;
cml:conclusionText "The variation's application can be traced back to its notification date." ;
cml:executionSurface "modalities::temporal_ltl" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-40b-ss-9 cml:asserts concept:therapeutic-goods-act-1989-sec-40b-ss-9-logic-deontic-4 .
concept:therapeutic-goods-act-1989-sec-40b-ss-9-logic-deontic-4 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "applies to licence holder" ;
cml:logicSummary "Application of variation obligation" ;
cml:premiseText "(9) A variation under subsection (8) takes effect on the day on which the notice is given to the holder." ;
cml:conclusionText "The licence holder must comply with the variation's terms." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-40b-ss-9 cml:asserts concept:therapeutic-goods-act-1989-sec-40b-ss-9-logic-deontic-5 .
concept:therapeutic-goods-act-1989-sec-40b-ss-9-logic-deontic-5 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "specifies variation type" ;
cml:logicSummary "Variation type specification" ;
cml:premiseText "(9) A variation under subsection (8) takes effect on the day on which the notice is given to the holder." ;
cml:conclusionText "The variation's application is subject to specific rules." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-41 a cml:Concept ;
skos:prefLabel "41 Revocation and suspension of licences"@en ;
cml:realizedBy doc:sec-41 ;
cml:integrityHash "f6fbda13eb4b0aa914a819e81dadaddea46f623e8f2b38a0025ed1e084bef85d" ;
skos:note "Revocation or suspension of a licence for specified reasons" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.401" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-41-norm .
concept:therapeutic-goods-act-1989-sec-41-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-41 ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-41 cml:asserts concept:therapeutic-goods-act-1989-sec-41-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-41-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits revocation or suspension of a licence for specified reasons" ;
cml:premiseText "(1) Subject to subsection (2), 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-41 cml:asserts concept:therapeutic-goods-act-1989-sec-41-logic-deontic-2 .
concept:therapeutic-goods-act-1989-sec-41-logic-deontic-2 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibits breach of a condition of a manufacturing licence" ;
cml:premiseText "(viii) breached a condition of a manufacturing licence;" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-41aa a cml:Concept ;
skos:prefLabel "41AA Spent convictions scheme"@en ;
cml:realizedBy doc:sec-41aa ;
cml:integrityHash "26a042a4750a2b1bf06d170e8a3c7ea9fa8618b617f178ccd724915efff5183c" ;
skos:note "Relieves persons from the requirement to disclose spent convictions and require persons aware of such convictions to disregard them." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.404" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-41aa-norm .
concept:therapeutic-goods-act-1989-sec-41aa-norm a values:Undertaking ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-41aa ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-41ab a cml:Concept ;
skos:prefLabel "41AB Secretary may require information or documents"@en ;
cml:realizedBy doc:sec-41ab ;
cml:integrityHash "0ca2016bc197b39b16f90526eac02e1923fc9e38107c7fe8a65be79ed4588ddd" ;
skos:note "The Secretary may require a person to provide information or documents." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.404" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-41ab-norm .
concept:therapeutic-goods-act-1989-sec-41ab-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-41ab ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-41ab cml:asserts concept:therapeutic-goods-act-1989-sec-41ab-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-41ab-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MAY" ;
cml:logicSummary "The Secretary may require the person to 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-41ac a cml:Concept ;
skos:prefLabel "41AC Criminal offence for contravening a requirement in a notice"@en ;
cml:realizedBy doc:sec-41ac ;
cml:integrityHash "ef30cf0b81e2401c874c7ab17c67d338f6b72782dd25e9f6da05399b8de4cf2c" ;
skos:note "Failure to comply with a notice results in an offence." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.406" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-41ac-norm .
concept:therapeutic-goods-act-1989-sec-41ac-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-41ac ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-41ac cml:asserts concept:therapeutic-goods-act-1989-sec-41ac-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-41ac-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "obligation" ;
cml:logicSummary "Obligation to comply with a notice." ;
cml:premiseText "Given a notice under section 41AB, the person must do an act." ;
cml:conclusionText "Failure to do so results in an offence." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-41ad a cml:Concept ;
skos:prefLabel "41AD False or misleading information—offence"@en ;
cml:realizedBy doc:sec-41ad ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-41ad-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-41ad-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-41ad-ss-3 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.406" .
concept:therapeutic-goods-act-1989-sec-41ad-ss-1 a cml:Concept ;
skos:prefLabel "41AD(1) False or misleading information—offence"@en ;
cml:realizedBy doc:sec-41ad-ss-1 ;
cml:integrityHash "68fb03c08ec4388464058e1e49f6cd31708b56694ee5fbde63e61ed967f6e7fb" ;
values:partOf concept:therapeutic-goods-act-1989-sec-41ad ;
skos:note "Providing false or misleading information to the Secretary is an offence." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.406" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-41ad-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-41ad-ss-1-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-41ad-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-41ad-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41ad-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-41ad-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibition of providing false or misleading information." ;
cml:premiseText "The person gives information to the Secretary in compliance, or purported compliance, with the notice." ;
cml:conclusionText "Providing false or misleading information is an offence." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-41ad-ss-2 a cml:Concept ;
skos:prefLabel "41AD(2) False or misleading information—offence"@en ;
cml:realizedBy doc:sec-41ad-ss-2 ;
cml:integrityHash "00463da5e36b809eefe73703a5d76091f56af79e3a0b85b6081466cb894b9799" ;
values:partOf concept:therapeutic-goods-act-1989-sec-41ad ;
skos:note "Defendant bears evidential burden in relation to the matter." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.406" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-41ad-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-41ad-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-41ad-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-41ad-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41ad-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-41ad-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-41ad-ss-3 a cml:Concept ;
skos:prefLabel "41AD(3) False or misleading information—offence"@en ;
cml:realizedBy doc:sec-41ad-ss-3 ;
cml:integrityHash "1a5be959c6c9488e39376b2fca0368adff330d7c123f7c13fd0ea6fbbfb951e4" ;
values:partOf concept:therapeutic-goods-act-1989-sec-41ad ;
skos:note "Defendant bears evidential burden in relation to matter in subsection (3)" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.406" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-41ad-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-41ad-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-41ad-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-41ad-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41ad-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-41ad-ss-3-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-41ae a cml:Concept ;
skos:prefLabel "41AE False or misleading documents—offence"@en ;
cml:realizedBy doc:sec-41ae ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-41ae-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-41ae-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.407" .
concept:therapeutic-goods-act-1989-sec-41ae-ss-1 a cml:Concept ;
skos:prefLabel "41AE(1) False or misleading documents—offence"@en ;
cml:realizedBy doc:sec-41ae-ss-1 ;
cml:integrityHash "edb41603b3fd0906de1fb04f347ac3b95445dc5becc7e21f67301fd8d8a5b023" ;
values:partOf concept:therapeutic-goods-act-1989-sec-41ae ;
skos:note "Producing false or misleading documents is an offence." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.407" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-41ae-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-41ae-ss-1-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-41ae-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-41ae-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41ae-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-41ae-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibition" ;
cml:logicSummary "Prohibits producing false or misleading documents." ;
cml:premiseText "(1) A person commits an offence if..." ;
cml:conclusionText "...the document is produced in compliance, or purported compliance, with a notice given under section 41AB." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-41ae-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41ae-ss-1-logic-deontic-2 .
concept:therapeutic-goods-act-1989-sec-41ae-ss-1-logic-deontic-2 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Imposes an obligation to not produce false or misleading documents." ;
cml:premiseText "(1) A person commits an offence if..." ;
cml:conclusionText "...the document is produced in compliance, or purported compliance, with a notice given under section 41AB." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-41ae-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41ae-ss-1-logic-deontic-3 .
concept:therapeutic-goods-act-1989-sec-41ae-ss-1-logic-deontic-3 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibition" ;
cml:logicSummary "Prohibits knowing that the document is false or misleading." ;
cml:premiseText "(a) the person produces a document to the Secretary; and" ;
cml:conclusionText "...the person does so knowing that the document is false or misleading;" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-41ae-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41ae-ss-1-logic-deontic-4 .
concept:therapeutic-goods-act-1989-sec-41ae-ss-1-logic-deontic-4 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibition" ;
cml:logicSummary "Prohibits producing in compliance with a notice given under section 41AB." ;
cml:premiseText "(c) the document is produced in compliance, or purported compliance, with a notice given under section 41AB." ;
cml:conclusionText "...the document is produced in compliance, or purported compliance, with a notice given under section 41AB." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-41ae-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41ae-ss-1-logic-deontic-5 .
concept:therapeutic-goods-act-1989-sec-41ae-ss-1-logic-deontic-5 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibition" ;
cml:logicSummary "Imposes an obligation to not produce false or misleading documents." ;
cml:premiseText "(b) the person does so knowing that the document is false or misleading;" ;
cml:conclusionText "...the document is produced in compliance, or purported compliance, with a notice given under section 41AB." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-41ae-ss-2 a cml:Concept ;
skos:prefLabel "41AE(2) False or misleading documents—offence"@en ;
cml:realizedBy doc:sec-41ae-ss-2 ;
cml:integrityHash "11f701f33a6e0c4b2334d197a377629f94ed394eed38a98d95411fcc6227ab09" ;
values:partOf concept:therapeutic-goods-act-1989-sec-41ae ;
skos:note "Defendant bears evidential burden in relation to the matter." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.407" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-41ae-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-41ae-ss-2-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-41ae-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-41ae-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41ae-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-41ae-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-41ae-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41ae-ss-2-logic-epistemic-2 .
concept:therapeutic-goods-act-1989-sec-41ae-ss-2-logic-epistemic-2 a cml:LogicApplication ;
cml:modality cml:Epistemic ;
cml:operator "evidential burden" ;
cml:logicSummary "Defendant must provide evidence." ;
cml:executionSurface "modalities::epistemic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-41af a cml:Concept ;
skos:prefLabel "41AF False or misleading information or documents—civil penalty"@en ;
cml:realizedBy doc:sec-41af ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-41af-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-41af-ss-2 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.408" .
concept:therapeutic-goods-act-1989-sec-41af-ss-1 a cml:Concept ;
skos:prefLabel "41AF(1) False or misleading information or documents—civil penalty"@en ;
cml:realizedBy doc:sec-41af-ss-1 ;
cml:integrityHash "e162c3b8ffa8130cdaa8f8e4d9e6fcfa989bec4ac616c178da9c83db44db9b28" ;
values:partOf concept:therapeutic-goods-act-1989-sec-41af ;
skos:note "Giving false or misleading information in compliance with a notice is prohibited." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.408" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-41af-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-41af-ss-1-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-41af-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-41af-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41af-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-41af-ss-1-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibit" ;
cml:logicSummary "Prohibition of false or misleading information" ;
cml:premiseText "Notice under section 41AB" ;
cml:conclusionText "Civil penalty for contravention" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-41af-ss-2 a cml:Concept ;
skos:prefLabel "41AF(2) False or misleading information or documents—civil penalty"@en ;
cml:realizedBy doc:sec-41af-ss-2 ;
cml:integrityHash "e0ea8e1628c670cb2195f568025d16ae6aba0b036b13f64c061e8e4251979fb0" ;
values:partOf concept:therapeutic-goods-act-1989-sec-41af ;
skos:note "Exemption from subsection (1) for documents accompanied by a written statement" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.408" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-41af-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-41af-ss-2-norm a values:Permission ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-41af-ss-2 ;
values:borneBy values:Agent ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-41ag a cml:Concept ;
skos:prefLabel "41AG Self-incrimination"@en ;
cml:realizedBy doc:sec-41ag ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-41ag-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-41ag-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-41ag-ss-1 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-41ag-ss-2 ;
cml:hasPart concept:therapeutic-goods-act-1989-sec-41ag-ss-3 ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.409" .
concept:therapeutic-goods-act-1989-sec-41ag-ss-1 a cml:Concept ;
skos:prefLabel "41AG(1) Self-incrimination"@en ;
cml:realizedBy doc:sec-41ag-ss-1 ;
cml:integrityHash "cbef972a1e2aa68b325447ce3fdda8df3a2ea2ecff8ca74d2cdd4239c0175b67" ;
values:partOf concept:therapeutic-goods-act-1989-sec-41ag ;
skos:note "Regulations may make provision for the transfer of licences. No excuse for giving information or producing a document under a section 41AB notice" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.409" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-41ag-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-41ag-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-41ag-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-41ag-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41ag-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-41ag-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-41ag-ss-2 a cml:Concept ;
skos:prefLabel "41AG(2) Self-incrimination"@en ;
cml:realizedBy doc:sec-41ag-ss-2 ;
cml:integrityHash "dd1eb486ffe39512fe187787171a926ba6d016768f564bf75a7961b51c02b891" ;
values:partOf concept:therapeutic-goods-act-1989-sec-41ag ;
skos:note "Self-incrimination protection for individuals in criminal proceedings. Regulations may make provision for and in relation to the making of an application, payment of a fee, assessment of an application, conditions of a licence upon transfer, and review of decisions." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.409" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-41ag-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-41ag-ss-2-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-41ag-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-41ag-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibition" ;
cml:logicSummary "Prohibits admissibility of self-incrimination evidence in criminal proceedings." ;
cml:premiseText "(2) However, in the case of an individual:" ;
cml:conclusionText "is not admissible in evidence in: (d) criminal proceedings against the individual, except proceedings under, or arising out of, section 41AD or 41AE;" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-41ag-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-2 .
concept:therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-2 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibition" ;
cml:logicSummary "Prohibits admissibility of self-incrimination evidence in pecuniary penalty order proceedings." ;
cml:premiseText "(e) proceedings for a pecuniary penalty order against the individual for a contravention of a civil penalty provision." ;
cml:conclusionText "is not admissible in evidence in: (e) proceedings for a pecuniary penalty order against the individual for a contravention of a civil penalty provision." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-41ag-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-3 .
concept:therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-3 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Permission" ;
cml:logicSummary "Permits admissibility of self-incrimination evidence in certain proceedings." ;
cml:premiseText "(d) criminal proceedings against the individual, except proceedings under, or arising out of, section 41AD or 41AE;" ;
cml:conclusionText "is admissible in evidence in: (d) criminal proceedings against the individual, except proceedings under, or arising out of, section 41AD or 41AE;" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-41ag-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-4 .
concept:therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-4 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Permission" ;
cml:logicSummary "Permits admissibility of self-incrimination evidence in certain proceedings." ;
cml:premiseText "(e) proceedings for a pecuniary penalty order against the individual for a contravention of a civil penalty provision." ;
cml:conclusionText "is admissible in evidence in: (e) proceedings for a pecuniary penalty order against the individual for a contravention of a civil penalty provision;" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-41ag-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-5 .
concept:therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-5 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Right" ;
cml:logicSummary "Establishes right to self-incrimination protection." ;
cml:premiseText "(2) However, in the case of an individual:" ;
cml:conclusionText "the information given or the document produced; or the giving of the information or the production of the document; or any information, document or thing obtained as a direct or indirect consequence of giving the information or producing the document; is not admissible in evidence in: (d) criminal proceedings against the individual, except proceedings under, or arising out of, section 41AD or 41AE;" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-41ag-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-6 .
concept:therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-6 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Undertaking" ;
cml:logicSummary "Establishes undertaking to protect self-incrimination." ;
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-41ag-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-7 .
concept:therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-7 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Permit" ;
cml:logicSummary "Regulations may make provision for and in relation to the making of an application, payment of a fee, assessment of an application, conditions of a licence upon transfer, and review of decisions." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-41ag-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41ag-ss-2-logic-alleninterval-8 .
concept:therapeutic-goods-act-1989-sec-41ag-ss-2-logic-alleninterval-8 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "during" ;
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-41ag-ss-1 a cml:Concept ;
skos:prefLabel "41AG(1) Self-incrimination"@en ;
cml:realizedBy doc:sec-41ag-ss-1 ;
cml:integrityHash "86ba820229c358c5e336e42a26817a09128e60d398c5ebef22bcc484fc9404fb" ;
values:partOf concept:therapeutic-goods-act-1989-sec-41ag ;
skos:note "Regulations may make provision for the transfer of licences. No excuse for giving information or producing a document under a section 41AB notice" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.409" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-41ag-ss-1-norm .
concept:therapeutic-goods-act-1989-sec-41ag-ss-1-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-41ag-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-41ag-ss-1 cml:asserts concept:therapeutic-goods-act-1989-sec-41ag-ss-1-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-41ag-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-41ag-ss-2 a cml:Concept ;
skos:prefLabel "41AG(2) Self-incrimination"@en ;
cml:realizedBy doc:sec-41ag-ss-2 ;
cml:integrityHash "dad8d7fe1a31736697720a3c28cfaa6ef9b187bb6b8408eef6b34f944c0c3a1f" ;
values:partOf concept:therapeutic-goods-act-1989-sec-41ag ;
skos:note "Self-incrimination protection for individuals in criminal proceedings. Regulations may make provision for and in relation to the making of an application, payment of a fee, assessment of an application, conditions of a licence upon transfer, and review of decisions." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.409" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-41ag-ss-2-norm .
concept:therapeutic-goods-act-1989-sec-41ag-ss-2-norm a values:Prohibition ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-41ag-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-41ag-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibition" ;
cml:logicSummary "Prohibits admissibility of self-incrimination evidence in criminal proceedings." ;
cml:premiseText "(2) However, in the case of an individual:" ;
cml:conclusionText "is not admissible in evidence in: (d) criminal proceedings against the individual, except proceedings under, or arising out of, section 41AD or 41AE;" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-41ag-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-2 .
concept:therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-2 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Prohibition" ;
cml:logicSummary "Prohibits admissibility of self-incrimination evidence in pecuniary penalty order proceedings." ;
cml:premiseText "(e) proceedings for a pecuniary penalty order against the individual for a contravention of a civil penalty provision." ;
cml:conclusionText "is not admissible in evidence in: (e) proceedings for a pecuniary penalty order against the individual for a contravention of a civil penalty provision." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-41ag-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-3 .
concept:therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-3 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Permission" ;
cml:logicSummary "Permits admissibility of self-incrimination evidence in certain proceedings." ;
cml:premiseText "(d) criminal proceedings against the individual, except proceedings under, or arising out of, section 41AD or 41AE;" ;
cml:conclusionText "is admissible in evidence in: (d) criminal proceedings against the individual, except proceedings under, or arising out of, section 41AD or 41AE;" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-41ag-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-4 .
concept:therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-4 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Permission" ;
cml:logicSummary "Permits admissibility of self-incrimination evidence in certain proceedings." ;
cml:premiseText "(e) proceedings for a pecuniary penalty order against the individual for a contravention of a civil penalty provision." ;
cml:conclusionText "is admissible in evidence in: (e) proceedings for a pecuniary penalty order against the individual for a contravention of a civil penalty provision;" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-41ag-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-5 .
concept:therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-5 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Right" ;
cml:logicSummary "Establishes right to self-incrimination protection." ;
cml:premiseText "(2) However, in the case of an individual:" ;
cml:conclusionText "the information given or the document produced; or the giving of the information or the production of the document; or any information, document or thing obtained as a direct or indirect consequence of giving the information or producing the document; is not admissible in evidence in: (d) criminal proceedings against the individual, except proceedings under, or arising out of, section 41AD or 41AE;" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-41ag-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-6 .
concept:therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-6 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Undertaking" ;
cml:logicSummary "Establishes undertaking to protect self-incrimination." ;
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-41ag-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-7 .
concept:therapeutic-goods-act-1989-sec-41ag-ss-2-logic-deontic-7 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Permit" ;
cml:logicSummary "Regulations may make provision for and in relation to the making of an application, payment of a fee, assessment of an application, conditions of a licence upon transfer, and review of decisions." ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-41ag-ss-2 cml:asserts concept:therapeutic-goods-act-1989-sec-41ag-ss-2-logic-alleninterval-8 .
concept:therapeutic-goods-act-1989-sec-41ag-ss-2-logic-alleninterval-8 a cml:LogicApplication ;
cml:modality cml:AllenInterval ;
cml:operator "during" ;
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-41ag-ss-3 a cml:Concept ;
skos:prefLabel "41AG(3) Self-incrimination"@en ;
cml:realizedBy doc:sec-41ag-ss-3 ;
cml:integrityHash "bfd25a533a72a1956b04bf71c90e85bb613debf83c81b1ea2c5e0c52b11def21" ;
values:partOf concept:therapeutic-goods-act-1989-sec-41ag ;
skos:note "No self-incrimination for subsection (1) beyond what is limited by subsection (2)" ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.409" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-41ag-ss-3-norm .
concept:therapeutic-goods-act-1989-sec-41ag-ss-3-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-41ag-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-41ag-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41ag-ss-3-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-41ag-ss-3-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Imposes obligation on the state" ;
cml:premiseText "Subsection (2) does not limit subsection (1)" ;
cml:conclusionText "State must not incriminate under subsection (1)" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-41ag-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41ag-ss-3-logic-deontic-2 .
concept:therapeutic-goods-act-1989-sec-41ag-ss-3-logic-deontic-2 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Permission" ;
cml:logicSummary "Permits self-incrimination under subsection (1)" ;
cml:premiseText "Subsection (2) does not limit subsection (1)" ;
cml:conclusionText "State may incriminate under subsection (1)" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-41ag-ss-3 cml:asserts concept:therapeutic-goods-act-1989-sec-41ag-ss-3-logic-deontic-3 .
concept:therapeutic-goods-act-1989-sec-41ag-ss-3-logic-deontic-3 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "Obligation" ;
cml:logicSummary "Imposes obligation on the state to limit self-incrimination under subsection (1)" ;
cml:premiseText "Subsection (2) does not limit subsection (1)" ;
cml:conclusionText "State must limit self-incrimination under subsection (1)" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "0.5000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-41a a cml:Concept ;
skos:prefLabel "41A Publication of list of manufacturers etc."@en ;
cml:realizedBy doc:sec-41a ;
cml:integrityHash "75e00883133ed60b78187fdbe07620aef47d843d4b735ef804a87ffa57ef1c5d" ;
skos:note "The Secretary must publish a list of licensed persons and goods." ;
cml:curationStatus cml:Proposed ;
cml:schemaVersion "2" ;
cml:proposedBy <https://ns.webcivics.net/tools/legis2cml> ;
prov:wasDerivedFrom <therapeutic-goods-act-1989.pdf> ;
dc:source "therapeutic-goods-act-1989.pdf, p.410" ;
cml:asserts concept:therapeutic-goods-act-1989-sec-41a-norm .
concept:therapeutic-goods-act-1989-sec-41a-norm a values:Obligation ;
cml:modality cml:Deontic ;
values:partOf concept:therapeutic-goods-act-1989-sec-41a ;
values:borneBy values:State ;
skos:scopeNote "borne by: State" ;
values:deonticStatus values:HeuristicDerived ;
cml:curationStatus cml:Proposed .
concept:therapeutic-goods-act-1989-sec-41a cml:asserts concept:therapeutic-goods-act-1989-sec-41a-logic-deontic-1 .
concept:therapeutic-goods-act-1989-sec-41a-logic-deontic-1 a cml:LogicApplication ;
cml:modality cml:Deontic ;
cml:operator "MUST" ;
cml:logicSummary "Obligation to publish" ;
cml:executionSurface "modalities::logic::deontic" ;
cml:confidence "1.0000"^^xsd:decimal ;
cml:curationStatus cml:Proposed .