a ; "C2025C00525VOL02"; ; "Therapeutic Goods Act 1989"@en; "AU"; "No. 21 of 1990"; "5 September 2025"; ; ; . a ; "5 September 2025"@en; ; "b68354eb76366e401f25518de6aa8b05ca7aac5c34fb38ae229b02bda15d60ba"; "Compilation information and notes on amendments, applications, saving, transitional provisions, editorial changes, presentational changes, modifications, and self-repealing provisions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.1"; . a ; ; ; ; . . a ; ; "Applicable"; "Classifies the text as a compilation of the Therapeutic Goods Act 1989."; "The text describes itself as a compilation."; "It is a compilation of the law."; "modalities::dl"; 1.0000; . . a ; ; "Applicable"; "Identifies the compilation date and contents."; "The text mentions the compilation date and contents."; "The compilation date is September 5, 2025, and it includes sections 1-41A and 41B-69."; "modalities::dl"; 1.0000; . . a ; ; "Applicable"; "Notes on amendments and uncommenced amendments."; "The text mentions uncommenced amendments."; "Uncommenced amendments are not shown in the text of the compiled law."; "modalities::dl"; 1.0000; . . a ; ; "Applicable"; "Application, saving, and transitional provisions."; "The text mentions applications, saving, and transitional provisions."; "Details are included in the endnotes."; "modalities::dl"; 1.0000; . . a ; ; "Applicable"; "Editorial changes and presentational changes."; "The text mentions editorial changes."; "Presentational changes are applied to give a more consistent look and feel."; "modalities::dl"; 1.0000; . . a ; ; "Applicable"; "Modifications and self-repealing provisions."; "The text mentions modifications."; "The compiled law operates as modified but the modification does not amend the text of the law."; "modalities::dl"; 1.0000; . a ; "41B General"@en; ; "6fb1546d5b2f221fc45e075216e418648b0a562af2889e9e691805ba419f3d6c"; "Ensures safety and satisfactory performance of medical devices"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.21"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "ensures"; "Guarantees safety and satisfactory performance"; "modalities::logic::deontic"; 1.0000; . a ; "41BA Requirements for medical devices (Parts 4-2 and 4-3)"@en; ; "dc57dd8a7d31b38ecb3d708078ea5248c704701d7c5b61eea5c2062f92908633"; "Requirements for medical devices must conform to safety and performance standards."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.21"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide requirements for medical devices."; "modalities::logic::deontic"; 1.0000; . a ; "41BB Administrative processes (Parts 4-4 to 4-10)"@en; ; "2817c4d28002c2863fbaa392bbef138701d0517d231fc6688466f8011ac40095"; "List of administrative processes under this Chapter"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.21"; . a ; ; ; ; . a ; "41BC Enforcement (Part 4-11)"@en; ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.22"; . a ; ; ; ; . a ; "41BD What is a medical device"@en; ; "7ea979964f89afcf338e8d56ef3a09e11a8a3a1e450d0d0ff4e34dcc53b39b30"; "Defines what constitutes a medical device."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.23"; . a ; ; ; ; ; . a ; "41BE Kinds of medical devices"@en; ; "c910d474dcd724bff83ddedeb06bf1eceaf9fb3af7c76bb282be057f36e6dffa"; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.25". a ; "41BE(1) Kinds of medical devices"@en; ; "961ac8886fad564c5503da21f91f9e347569d95718d72083d2a62372e96443c9"; ; "Medical devices of the same kind must have the same sponsor, manufacturer, device nomenclature system code, medical device classification, and other characteristics as prescribed by regulations."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.25"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "during"; "Characteristics prescribed by regulations apply during the same period"; "either generally or in relation to medical devices of the kind in question"; "are of the same kind"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "until"; "Characteristics prescribed by regulations apply until the end of the period"; "either generally or in relation to medical devices of the kind in question"; "are of the same kind"; "modalities::temporal_ltl"; 1.0000; . . a ; ; "if"; "Characteristics prescribed by regulations apply if certain conditions are met"; "(e) are the same in relation to such other characteristics as the regulations prescribe, either generally or in relation to medical devices of the kind in question."; "are of the same kind"; "modalities::logic::deontic"; 1.0000; . a ; "41BE(2) Kinds of medical devices"@en; ; "5d1f30d34007410354ac500daa9b0e520972beea575bca2d76dad01ee1c8e802"; ; "If a medical device is not of the same kind as any other medical device, this Chapter applies in relation to the device."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.25"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "if-then"; "Conditional obligation"; "If a medical device is not of the same kind as any other medical device."; "This Chapter applies in relation to the device."; "modalities::logic::deontic"; 0.5000; . . a ; ; "="; "Equivalence between kinds of devices"; "References in this Chapter to delivering a reasonable number of samples of the kind of device are taken to be references to delivering the device."; "Delivering the device is equivalent to delivering a reasonable number of samples of the kind of device."; "modalities::dl"; 0.5000; . . a ; ; ">="; "Temporal relation between delivering and delivering"; "References in this Chapter to delivering a reasonable number of samples of the kind of device are taken to be references to delivering the device."; "Delivering the device is temporally related to delivering a reasonable number of samples of the kind of device."; "modalities::interval_reasoning"; 0.5000; . . a ; ; "<="; "Temporal relation between delivering and delivering"; "References in this Chapter to delivering a reasonable number of samples of the kind of device are taken to be references to delivering the device."; "Delivering the device is temporally related to delivering a reasonable number of samples of the kind of device."; "modalities::temporal_ltl"; 0.5000; . . a ; ; "if-then"; "Conditional diffusion"; "If a medical device is not of the same kind as any other medical device, this Chapter applies in relation to the device."; "This Chapter diffuses to the device."; "modalities::diffusion"; 0.5000; . . a ; ; "="; "Equivalence between kinds of devices"; "References in this Chapter to delivering a reasonable number of samples of the kind of device are taken to be references to delivering the device."; "Delivering the device is equivalent to delivering a reasonable number of samples of the kind of device."; "sparql_library::parsers::chk_parser"; 0.5000; . a ; "41BE(3) Kinds of medical devices"@en; ; "011eaa18da19448372520e96b61e7ca5d89bf942aeb3f363d561894fb09d9895"; ; "Device nomenclature codes for medical devices may be determined by the Minister."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.25"; . a ; ; ; ; ; . . a ; ; "may"; "Permission to determine device nomenclature codes"; "modalities::logic::deontic"; 1.0000; . a ; "41BF System or procedure packs"@en; ; "b657e94d26791d98c791bec283cfd331c76b343a6df57548bb80ea0dc9dad9b3"; "Goods are a system or procedure pack if they are interconnected or combined for use in a medical or surgical procedure."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.26"; . a ; ; ; ; ; . a ; "41BG Manufacturers of medical devices"@en; ; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.26". a ; "41BG(1) Manufacturers of medical devices"@en; ; "6e8267949d0196d60cc5c48a54a2122c33f8f338ef29d6a7be4523c6d39867b9"; ; "Manufacturer is responsible for design, production, packaging and labelling of the device."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.26"; . a ; ; ; ; ; . . a ; ; "is"; "Manufacturer is responsible"; "Design, production, packaging and labelling are operations performed by the manufacturer."; "The manufacturer is responsible for those operations."; "modalities::logic::deontic"; 1.0000; . . a ; ; "during"; "Manufacturer's responsibility starts before device supply"; "Design, production, packaging and labelling occur before the device is supplied under the person’s name."; "The manufacturer's responsibility for design, production, packaging and labelling begins before the device is supplied."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "implies"; "Manufacturer's responsibility implies supply of device"; "If the manufacturer is responsible for design, production, packaging and labelling, then the device must be supplied under their name."; "The manufacturer's responsibility for design, production, packaging and labelling implies that the device must be supplied under their name."; "modalities::argumentation"; 1.0000; . . a ; ; "implies"; "Manufacturer's responsibility spreads to supply of device"; "The manufacturer's responsibility for design, production, packaging and labelling is not limited to the person themselves but also extends to other persons acting on their behalf."; "The manufacturer's responsibility for design, production, packaging and labelling implies that the device must be supplied under their name or another person acting on their behalf."; "modalities::diffusion"; 1.0000; . . a ; ; "implies"; "Manufacturer's responsibility is a cognitive action"; "The manufacturer's responsibility for design, production, packaging and labelling involves making decisions and taking actions."; "The manufacturer's responsibility for design, production, packaging and labelling is a cognitive action that implies the supply of the device."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "41BG(2) Manufacturers of medical devices"@en; ; "76f846af5ae035cb1b2a0697a4acb9b678d7b8487eecb8de77abc84c9173bb9c"; ; "Manufacturer must provide information about the device's purpose."; "Yes"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.26"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide information."; "modalities::logic::deontic"; 1.0000; . . a ; ; "hasPart"; "Device's purpose is described by the manufacturer."; "modalities::dl"; 1.0000; . a ; "41BG(3) Manufacturers of medical devices"@en; ; "e1255e59d9262230f97c8db65acfcf203f117497732d0240ab1535f16ac5a005"; ; "Exemptions for individuals assembling or adapting medical devices"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.26"; . a ; ; ; ; "borne by: State"; ; . a ; "41BG(4) Manufacturers of medical devices"@en; ; "5b48feb6132b6d5ff4ab89dd9b73daa69e1e3f97b2f74e69552708f27701d63d"; ; "Exempts individuals from being considered manufacturers of medical devices if they are part of a prescribed class."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.26"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Exemption"; "Exempts individuals from being considered manufacturers of medical devices."; "This section applies in relation to vaping goods that are a medical device."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Class definition"; "Defines a class of persons prescribed by regulations for the purposes of this subsection."; "The person is not the manufacturer of a medical device if the person is included in a class of persons prescribed by the regulations."; "modalities::dl"; 1.0000; . . a ; ; "Temporal exemption"; "Exempts individuals from being considered manufacturers of medical devices during the applicable period."; "This section applies in relation to vaping goods that are a medical device."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Temporal exemption"; "Exempts individuals from being considered manufacturers of medical devices during the applicable period."; "This section applies in relation to vaping goods that are a medical device."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Knowledge dissemination"; "Disseminates knowledge about exemptions from being considered manufacturers of medical devices."; "This section applies in relation to vaping goods that are a medical device."; "modalities::diffusion"; 1.0000; . . a ; ; "Artificial intelligence application"; "Applies artificial intelligence to determine exemptions from being considered manufacturers of medical devices."; "This section applies in relation to vaping goods that are a medical device."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "41BH Meaning of compliance with essential principles"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.27". a ; "41BH(1) Meaning of compliance with essential principles"@en; ; "ea914da814d961bcda836d1172084c1cce3451c3c2952d31b0da175599231846"; ; "A medical device complies with the essential principles if it does not contravene any of them."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.27"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "¬"; "Negation of a duty"; "The device does not contravene any of the essential principles."; "modalities::logic::deontic"; 1.0000; . a ; "41BH(2) Meaning of compliance with essential principles"@en; ; "7ed323b589b283d900b869a93c9759043e6aeea3b057cbdd9992f4dfa60da8b3"; ; "Compliance with medical device standards is sufficient for compliance with essential principles."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.27"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "implies"; "Medical device compliance with standards implies compliance with essential principles"; "modalities::logic::deontic"; 1.0000; . a ; "41BI Meaning of non-application of conformity assessment"@en; ; "d6447e23d6652bd9700a141845f56c0854fdc3de7a3d4610a131b5df2a58aa4b"; , , , , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.28". a ; "41BI(1) Meaning of non-application of conformity assessment"@en; ; "893e52b8d8c3ce5b7b3a3220e1c63dfd97e416e5ddad4022aa41fb2bea07bcd2"; ; "Defines overseas regulator A conformity assessment procedure is not applied if there has been a contravention of the procedures. A requirement that is comparable to a conformity assessment procedure is not applied if there has been a contravention of the requirement."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.28"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "not"; "Negative obligation"; "(1) A conformity assessment procedure is taken, for the purposes of this Chapter, not to have been applied..."; "...if there has been a contravention of the conformity assessment procedures."; "modalities::logic::deontic"; 1.0000; . . a ; ; "during"; "Temporal relation between contravention and assessment procedure"; "(a) there has been a contravention of the conformity assessment procedures; and (b) the contravention relates, wholly or partly, to that device or its manufacture."; "...there has been a contravention of the conformity assessment procedures during which the contravention relates, wholly or partly, to that device or its manufacture."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "during"; "Temporal relation between contravention and assessment procedure"; "(a) there has been a contravention of the conformity assessment procedures; and (b) the contravention relates, wholly or partly, to that device or its manufacture."; "...there has been a contravention of the conformity assessment procedures during which the contravention relates, wholly or partly, to that device or its manufacture."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "if"; "Conditional relation between contravention and assessment procedure"; "(a) there has been a contravention of the conformity assessment procedures; and (b) the contravention relates, wholly or partly, to that device or its manufacture."; "...there is a diffusion from the contravention to the assessment procedure if there has been a contravention of the conformity assessment procedures during which the contravention relates, wholly or partly, to that device or its manufacture."; "modalities::diffusion"; 1.0000; . . a ; ; "if"; "Conditional relation between contravention and assessment procedure"; "(a) there has been a contravention of the conformity assessment procedures; and (b) the contravention relates, wholly or partly, to that device or its manufacture."; "...there is a CogAI from the contravention to the assessment procedure if there has been a contravention of the conformity assessment procedures during which the contravention relates, wholly or partly, to that device or its manufacture."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "41BI(2) Meaning of non-application of conformity assessment"@en; ; "0037f5099e910a485dbab8e1cc82be0aeae8a0624bcfbc79b08811c2ad897252"; ; "The Secretary may determine a body for the purposes of subsection (1). Exemptions from conformity assessment requirements"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.28"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "exemption"; "Exemptions from conformity assessment requirements"; "modalities::logic::deontic"; 1.0000; . a ; "41BI(3) Meaning of non-application of conformity assessment"@en; ; "f4d544392825f5fc204a56c892b78a60aa26763d361b9a575de20a555b5de1f9"; ; "A conformity assessment standard only applies to specified parts of procedures. The Secretary may determine a body by reference to a designation, recognition, approval or authorization."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.28"; . a ; ; ; ; ; . . a ; ; "Obligate"; "A conformity assessment standard only applies to specified parts of procedures."; "modalities::logic::deontic"; 1.0000; . . a ; ; "relates to"; "Temporal relation between intervals"; "modalities::interval_reasoning"; 1.0000; . a ; "41BI(1) Meaning of non-application of conformity assessment"@en; ; "ca37534fd9aab92d9d7245822a9163988111ec834f03631f2bdb4bd7b52b88c3"; ; "Defines overseas regulator A conformity assessment procedure is not applied if there has been a contravention of the procedures. A requirement that is comparable to a conformity assessment procedure is not applied if there has been a contravention of the requirement."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.28"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "not"; "Negative obligation"; "(1) A conformity assessment procedure is taken, for the purposes of this Chapter, not to have been applied..."; "...if there has been a contravention of the conformity assessment procedures."; "modalities::logic::deontic"; 1.0000; . . a ; ; "during"; "Temporal relation between contravention and assessment procedure"; "(a) there has been a contravention of the conformity assessment procedures; and (b) the contravention relates, wholly or partly, to that device or its manufacture."; "...there has been a contravention of the conformity assessment procedures during which the contravention relates, wholly or partly, to that device or its manufacture."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "during"; "Temporal relation between contravention and assessment procedure"; "(a) there has been a contravention of the conformity assessment procedures; and (b) the contravention relates, wholly or partly, to that device or its manufacture."; "...there has been a contravention of the conformity assessment procedures during which the contravention relates, wholly or partly, to that device or its manufacture."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "if"; "Conditional relation between contravention and assessment procedure"; "(a) there has been a contravention of the conformity assessment procedures; and (b) the contravention relates, wholly or partly, to that device or its manufacture."; "...there is a diffusion from the contravention to the assessment procedure if there has been a contravention of the conformity assessment procedures during which the contravention relates, wholly or partly, to that device or its manufacture."; "modalities::diffusion"; 1.0000; . . a ; ; "if"; "Conditional relation between contravention and assessment procedure"; "(a) there has been a contravention of the conformity assessment procedures; and (b) the contravention relates, wholly or partly, to that device or its manufacture."; "...there is a CogAI from the contravention to the assessment procedure if there has been a contravention of the conformity assessment procedures during which the contravention relates, wholly or partly, to that device or its manufacture."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "41BI(2) Meaning of non-application of conformity assessment"@en; ; "2aa38e29c6f814ca7e871fb2caa6b3948b8b56506221cdd313191405de04a813"; ; "The Secretary may determine a body for the purposes of subsection (1). Exemptions from conformity assessment requirements"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.28"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "exemption"; "Exemptions from conformity assessment requirements"; "modalities::logic::deontic"; 1.0000; . a ; "41BI(1) Meaning of non-application of conformity assessment"@en; ; "2e12d7771e202b463a9831a6c8e2c33841f04ddc73e2d8167f056399ac727b32"; ; "Defines overseas regulator A conformity assessment procedure is not applied if there has been a contravention of the procedures. A requirement that is comparable to a conformity assessment procedure is not applied if there has been a contravention of the requirement."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.28"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "not"; "Negative obligation"; "(1) A conformity assessment procedure is taken, for the purposes of this Chapter, not to have been applied..."; "...if there has been a contravention of the conformity assessment procedures."; "modalities::logic::deontic"; 1.0000; . . a ; ; "during"; "Temporal relation between contravention and assessment procedure"; "(a) there has been a contravention of the conformity assessment procedures; and (b) the contravention relates, wholly or partly, to that device or its manufacture."; "...there has been a contravention of the conformity assessment procedures during which the contravention relates, wholly or partly, to that device or its manufacture."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "during"; "Temporal relation between contravention and assessment procedure"; "(a) there has been a contravention of the conformity assessment procedures; and (b) the contravention relates, wholly or partly, to that device or its manufacture."; "...there has been a contravention of the conformity assessment procedures during which the contravention relates, wholly or partly, to that device or its manufacture."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "if"; "Conditional relation between contravention and assessment procedure"; "(a) there has been a contravention of the conformity assessment procedures; and (b) the contravention relates, wholly or partly, to that device or its manufacture."; "...there is a diffusion from the contravention to the assessment procedure if there has been a contravention of the conformity assessment procedures during which the contravention relates, wholly or partly, to that device or its manufacture."; "modalities::diffusion"; 1.0000; . . a ; ; "if"; "Conditional relation between contravention and assessment procedure"; "(a) there has been a contravention of the conformity assessment procedures; and (b) the contravention relates, wholly or partly, to that device or its manufacture."; "...there is a CogAI from the contravention to the assessment procedure if there has been a contravention of the conformity assessment procedures during which the contravention relates, wholly or partly, to that device or its manufacture."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "41BI(2) Meaning of non-application of conformity assessment"@en; ; "d2ed811c0d8c04d387fe3897330a16172068874086513aaa37c6a8e7b74af708"; ; "The Secretary may determine a body for the purposes of subsection (1). Exemptions from conformity assessment requirements"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.28"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "exemption"; "Exemptions from conformity assessment requirements"; "modalities::logic::deontic"; 1.0000; . a ; "41BI(3) Meaning of non-application of conformity assessment"@en; ; "0d9ee7fe0e166737c14ac656758a1e8315c0b2d9368bce683b141437cb3d7520"; ; "A conformity assessment standard only applies to specified parts of procedures. The Secretary may determine a body by reference to a designation, recognition, approval or authorization."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.28"; . a ; ; ; ; ; . . a ; ; "Obligate"; "A conformity assessment standard only applies to specified parts of procedures."; "modalities::logic::deontic"; 1.0000; . . a ; ; "relates to"; "Temporal relation between intervals"; "modalities::interval_reasoning"; 1.0000; . a ; "41BK Application of the Criminal Code"@en; ; "17095f6330023e3523619fa12132f202153702263ea4d17f0e377eda4fc235e1"; "Chapter 2 of the Criminal Code applies to all offences against this Chapter."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.31"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "applies"; "Chapter 2 of the Criminal Code applies to all offences against this Chapter."; "modalities::logic::deontic"; 1.0000; . a ; "41C What this Part is about"@en; ; "e5d8fe802392df4faa97549b886f3a4204147be47326c32d26fdb3ae9f1f183f"; "Compliance with medical device standards is not required but can be used to establish compliance with essential principles."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.32"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must comply with medical device standards."; "Compliance is not required."; "Compliance can be used to establish compliance."; "modalities::logic::deontic"; 0.5000; . . a ; ; ">="; "The regulations may make provision for and in relation to the Secretary causing a database of unique device identifiers of medical devices to be established and maintained."; "The regulations are applicable."; "The database must be established and maintained."; "modalities::interval_reasoning"; 0.5000; . . a ; ; "IS_A"; "Dealing in medical devices that do not comply with the essential principles may be an offence or contravenes a civil penalty provision."; "The regulations are applicable."; "Dealing in non-compliant medical devices is prohibited."; "modalities::diffusion"; 0.5000; . . a ; ; "IS_A"; "The therapeutic goods act regulates dealing in medical devices."; "The regulations are applicable."; "Dealing in medical devices is regulated by the act."; "sparql_library::parsers::chk_parser"; 0.5000; . a ; "41CA Essential principles"@en; ; , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.33". a ; "41CA(1) Essential principles"@en; ; "3e6bc2d6309633509aa0c707034107a52cd631431f746b3e3f0ad9ad7a1bd6df"; ; "Requirements for medical devices may be set out by regulations."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.33"; . a ; ; ; ; "borne by: State"; ; . a ; "41CA(2) Essential principles"@en; ; "604c49371508ea3211c0746277f56d3cefd0cda0d533a3c14503895915a62858"; ; "These requirements are to be known as the essential principles."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.33"; . a ; ; ; ; . a ; "41CA(3) Essential principles"@en; ; "b34c8d875e99f29e16cdc172bfd97f945e3e3e03e77e3b811c5252cf050372f8"; ; "Requirements for unique device identifiers and medical devices in the database"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.33"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "requires"; "Requires unique device identifiers"; "(a) unique device identifiers of medical devices;"; "modalities::logic::deontic"; 1.0000; . . a ; ; "requires"; "Requires information about medical devices"; "(b) information relating to those unique device identifiers, those medical devices or the import, export, manufacture or supply of those medical devices."; "modalities::logic::deontic"; 1.0000; . a ; "41CA(4) Essential principles"@en; ; "c9f2fe32302d15a9bc3f8589f2d3ae27406bbe28869d0a9f9426ab76a9c2c218"; ; "Subsection (3) has effect subject to subsection 41CE(2)."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.33"; . a ; ; ; ; "borne by: State"; ; . a ; "41CA(5) Essential principles"@en; ; "7531707ba95d473ed900e179a41dc41ef66c17fdc4bc45eac8b8edb65e828695"; ; "Does not limit subsection (1)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.33"; . a ; ; ; ; "borne by: State"; ; . a ; "41CB Medical device standards"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.34". a ; "41CB(1) Medical device standards"@en; ; "9e8eff273ad318454aab11a9805fb5cfe5a2120e5fcff44522de9b5c7b908909"; ; "The Minister may make an order determining medical device standards."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.34"; . a ; ; ; ; ; . . a ; ; "May"; "Permission to make an order"; "modalities::logic::deontic"; 1.0000; . . a ; ; "During"; "Order may commence at any time"; "Note: Section 12 of the Legislation Act 2003 deals with when a legislative instrument commences."; "modalities::interval_reasoning"; 1.0000; . a ; "41CB(2) Medical device standards"@en; ; "7afd5ee5e461a3c4a67e086f8c1616e7047c4e563eca7c18df02752fb0b9d2e7"; ; "Variation or revocation of orders by Minister"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.34"; . a ; ; ; ; ; . . a ; ; "may"; "Granting permission to vary or revoke orders"; "modalities::logic::deontic"; 1.0000; . a ; "41CB(3) Medical device standards"@en; ; "4c3eed0c4aaf1d570d7b20570f4287e4f37c66899758a65d78d811c3f2b532bc"; ; "Allows for incorporation of existing instruments or writings into an order or variation thereof."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.34"; . a ; ; ; ; . a ; "41CC Content of medical device standards"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.34". a ; "41CC(1) Content of medical device standards"@en; ; "355300d881e5fca51b1d54b15e4bd1da51da0b765dc27a2828be7da22fc7f4d9"; ; "Specifies how medical device standards can be established."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.34"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "specifies"; "Establishes a standard for medical devices."; "(1) Without limiting the scope of section 41CB, an order establishing a medical device standard..."; "...may be specified by reference to..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "between"; "Establishes temporal intervals."; "(f) such other matters as the Minister thinks fit."; "...or (e) a standard published by a standards organisation; or..."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "implies"; "Establishes implications for medical device standards."; "(1) Without limiting the scope of section 41CB, an order establishing a medical device standard..."; "...may be specified by reference to..."; "modalities::argumentation"; 1.0000; . . a ; ; "diffuses"; "Spreads information about medical device standards."; "(f) such other matters as the Minister thinks fit."; "...or (e) a standard published by a standards organisation; or..."; "modalities::diffusion"; 1.0000; . . a ; ; "recognises"; "Recognizes patterns in medical device standards."; "(f) such other matters as the Minister thinks fit."; "...or (e) a standard published by a standards organisation; or..."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "41CC(2) Content of medical device standards"@en; ; "b13d436579ba8cef3753900f5f937e7722bd089d7342eb1493af78c1d29f2b96"; ; "List of organisations that can declare standards"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.34"; . a ; ; ; ; . a ; "41CD Inconsistencies between medical device standards"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.35". a ; "41CD(1) Inconsistencies between medical device standards"@en; ; "d43d85122f7c6e83529e35a36f18583018e171a0fb3922a5cecfb8e87dd20883"; ; "A medical device standard that is inconsistent with another standard has no effect."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.35"; . a ; ; ; ; ; . . a ; ; "Prohibit"; "Prohibits the application of inconsistent standards."; "(a) applies to a kind of medical device; and (b) is inconsistent with another medical device standard that applies only to some of the devices of that kind;"; "is, to the extent of the inconsistency, of no effect in relation to the devices referred to in paragraph (b)."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Classify"; "Classifies inconsistent standards as having no effect."; "(a) applies to a kind of medical device; and (b) is inconsistent with another medical device standard that applies only to some of the devices of that kind;"; "is, to the extent of the inconsistency, of no effect in relation to the devices referred to in paragraph (b)."; "modalities::dl"; 1.0000; . . a ; ; "Overlap"; "Overlaps inconsistent standards."; "(a) applies to a kind of medical device; and (b) is inconsistent with another medical device standard that applies only to some of the devices of that kind;"; "is, to the extent of the inconsistency, of no effect in relation to the devices referred to in paragraph (b)."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Overlap"; "Overlaps inconsistent standards."; "(a) applies to a kind of medical device; and (b) is inconsistent with another medical device standard that applies only to some of the devices of that kind;"; "is, to the extent of the inconsistency, of no effect in relation to the devices referred to in paragraph (b)."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Influence"; "Influences inconsistent standards."; "(a) applies to a kind of medical device; and (b) is inconsistent with another medical device standard that applies only to some of the devices of that kind;"; "is, to the extent of the inconsistency, of no effect in relation to the devices referred to in paragraph (b)."; "modalities::diffusion"; 1.0000; . . a ; ; "Classify"; "Classifies inconsistent standards as having no effect."; "(a) applies to a kind of medical device; and (b) is inconsistent with another medical device standard that applies only to some of the devices of that kind;"; "is, to the extent of the inconsistency, of no effect in relation to the devices referred to in paragraph (b)."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "41CD(2) Inconsistencies between medical device standards"@en; ; "51437262c401bbe0350840dc034168ee555a94219c9cc9653a5713bcd018caec"; ; "A medical device standard for a combination of component parts takes precedence over standards for individual parts."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.35"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "takes precedence"; "Priority obligation"; "(2) A medical device standard..."; "...over any medical device standard..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "subclass hierarchy"; "Combination of component parts as a subclass of individual parts"; "(2) A medical device standard..."; "...applies to the component parts."; "modalities::dl"; 1.0000; . a ; "41CE Database of unique device identifiers of medical devices"@en; ; , , , , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.36". a ; "41CE(1) Database of unique device identifiers of medical devices"@en; ; "77256df3b448722d9c733e43502243b5c1099888ff2843fc5ab70c0fff4c74c7"; ; "Establishment of a database for unique device identifiers of medical devices"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.36"; . a ; ; ; ; . a ; "41CE(2) Database of unique device identifiers of medical devices"@en; ; "4e05992bf704b0aba6855da4b700c8ab58503df1a4bdb542bd32de75c58d65e4"; ; "Personal information must not be included in the database unless certain conditions are met."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.36"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "="; "Class hierarchy for devices and representatives"; "Device → Representative"; "Representative → Device"; "modalities::dl"; 1.0000; . . a ; ; "<="; "Temporal relationship between device registration and personal information collection"; "Device registered → Personal Information Collection"; "Personal Information Collection → Device Registered"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "="; "Obligation to exclude personal information from the database"; "State → Obligation to Exclude Personal Information"; "Obligation to Exclude Personal Information → State"; "modalities::logic::deontic"; 1.0000; . . a ; ; "<="; "Temporal relationship between device registration and personal information collection"; "Device registered → Personal Information Collection"; "Personal Information Collection → Device Registered"; "modalities::temporal_ltl"; 1.0000; . . a ; ; "="; "Artificial intelligence application for device registration and personal information collection"; "Device Registration → Personal Information Collection"; "Personal Information Collection → Device Registration"; "sparql_library::parsers::chk_parser"; 1.0000; . . a ; ; "="; "Schema-based validation for device registration and personal information collection"; "Device Registration → Personal Information Collection"; "Personal Information Collection → Device Registration"; "modalities::logic::shacl"; 1.0000; . a ; "41CE(3) Database of unique device identifiers of medical devices"@en; ; "3658ef41d5efe6c6118bfbae5fd597c56b92974a6310065bef9ecff9d578d76e"; ; "Regulations may provide for removal of information from database."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.36"; . a ; ; ; ; "borne by: State"; ; . a ; "41CE(4) Database of unique device identifiers of medical devices"@en; ; "f2558408776c8ffb85edb7a93f3171b0d7009fe0f77d1a923dd5eb2f5c71755c"; ; "Making the database available"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.36"; . a ; ; ; ; . a ; "41CE(5) Database of unique device identifiers of medical devices"@en; ; "37dc8ad494c7d816b4549eb99fd6814086947bc90a48b2e002b8ca7e888c2684"; ; "Database of unique device identifiers of medical devices may be made available to specified persons, authorities or bodies."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.36"; . a ; ; ; ; ; . a ; "41CE(6) Database of unique device identifiers of medical devices"@en; ; "1665ba29db319739e2819bdcd044aaa10d6a333bbb6c311c2c7c0965861ad7df"; ; "Personal information must not be made publicly available."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.36"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits public disclosure of personal information."; "modalities::logic::deontic"; 1.0000; . a ; "41CE(7) Database of unique device identifiers of medical devices"@en; ; "af2f04c201bfbf8ed83925213a797fced55d8d390422c72747724041ea032b77"; ; "Database of unique device identifiers of medical devices is not a legislative instrument."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.36"; . a ; ; ; ; . a ; "41CE(8) Database of unique device identifiers of medical devices"@en; ; "04b6ffdae28df89b496fb8a0b2a40239a89bbac0baaa10b4aaad25a512c8893b"; ; "Database of unique device identifiers of medical devices is not a legislative instrument."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.36"; . a ; ; ; ; . a ; "41D What this Part is about"@en; ; "f2d950a4a205a25ba2345c7ec89d5e533df4c8d0b95edeaa02de9fbe8ef6566f"; "Compliance with applicable conformity assessment standards is not required, but it is one way to establish that one or more parts of the conformity assessment procedures have been applied."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.38"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must comply with applicable standards"; "modalities::logic::deontic"; 1.0000; . a ; "41DA Conformity assessment procedures"@en; ; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.39". a ; "41DA(1) Conformity assessment procedures"@en; ; "3197d12821c35fdcd4f19baa0bdae72953c02a126ffa7a881048331eaefccd3d"; ; "Manufacturers of medical devices must comply with regulations."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.39"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Expresses a duty"; "modalities::logic::deontic"; 1.0000; . a ; "41DA(2) Conformity assessment procedures"@en; ; "badb323fd758869b373480d85486a31b72dcd74dbab440f660ef627f2a140192"; ; "Conformity assessment procedures"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.39"; . a ; ; ; ; . . a ; ; "Applicable"; "Requires temporal intervals for conformity assessment procedures"; "Temporal interval relation"; "Undertaking"; "modalities::interval_reasoning"; 1.0000; . a ; "41DA(3) Conformity assessment procedures"@en; ; "b2a51c867618649e1613262631e4bd86ad6040a68460766d475b6da3ba4d1652"; ; "Conformity assessment procedures may be limited or apply differently to different classifications."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.39"; . a ; ; ; ; ; . . a ; ; "or"; "Procedure may be limited or apply differently"; "modalities::linear"; 0.5000; . . a ; ; "may"; "Permission to limit procedure application"; "modalities::logic::deontic"; 0.5000; . . a ; ; "during"; "Procedure may be limited in time"; "modalities::interval_reasoning"; 0.5000; . a ; "41DA(4) Conformity assessment procedures"@en; ; "a50ddd77a7df7adaa0a700a5e23e2ee25d85ec53e7cc35ac67a14013d123553d"; ; "Regulations may relate to conformity assessment procedures for medical devices."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.39"; . a ; ; ; ; "borne by: State"; ; . a ; "41DB Medical device classifications"@en; ; "ea0e7dc46f81b93af73c06af678dba71c2625ed7c78080146a087aceff6831ad"; "Classifications and matters related to medical device classifications"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.40"; . a ; ; ; ; . a ; "41DC Conformity assessment standards"@en; ; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.41". a ; "41DC(1) Conformity assessment standards"@en; ; "e163d8ddd7069306298a8b56ea2d1810ee66987dec9aedfbfba7dd435ee797d0"; ; "Minister may make an order determining conformity assessment standards."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.41"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "May"; "Minister has the power to make an order."; "modalities::logic::deontic"; 1.0000; . a ; "41DC(2) Conformity assessment standards"@en; ; "490dd7857c19a543d1616331878d334f9b9f0053d9f2a62d2bd94ec0f83d3535"; ; "A conformity assessment standard may be limited to particular kinds of medical devices."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.41"; . a ; ; ; ; ; . a ; "41DC(3) Conformity assessment standards"@en; ; "815c593313f9ee84ce708f1df2dfd08a7a70434fd8297c8850e9f6b74d36a7ae"; ; "Minister may vary or revoke orders made under subsection (1)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.41"; . a ; ; ; ; . . a ; ; "May"; "Minister may vary or revoke orders"; "modalities::logic::deontic"; 1.0000; . a ; "41DC(4) Conformity assessment standards"@en; ; "f204e87118e03f338d8f942622e13fe7aa873a32b3d50a0b171d99f2a5c0c077"; ; "Allows for provision in relation to a matter by applying, adopting or incorporating an existing instrument or writing."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.41"; . a ; ; ; ; . a ; "41DD Content of conformity assessment standards"@en; ; "c1703b55d1ca02420abfffb5cf8f3460e9e414c159b6d8d591aaca8a4001ca82"; "Specifies how an order establishing a conformity assessment standard for a kind of medical device may be specified."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.41"; . a ; ; ; ; . a ; "41DE Inconsistencies between conformity assessment standards"@en; ; "20dc965ccfe51ffcf7503baf65b1bc6a34539833a496d0f97f6a6d07bad08194"; "Inconsistencies between conformity assessment standards are of no effect."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.42"; . a ; ; ; ; ; . . a ; ; "Prohibition"; "Prohibits inconsistency between conformity assessment standards."; "modalities::logic::deontic"; 1.0000; . a ; "41E What this Part is about"@en; ; "cfc3e5bf72bdd4739a2981ce5d04cb0b3806bdc6bf78e08dbe8cf53253ad0b83"; "Secretary can issue conformity assessment certificate for medical devices"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.43"; . a ; ; ; ; "borne by: State"; ; . a ; "41EA When conformity assessment certificates are required"@en; ; "df362d4590cd5809b9292d81039dd75e02c270c3a65fe9ad6eb2b4da5f9bc91e"; "Regulations may prescribe requirements for manufacturers and medical devices."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.44"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Regulations must be prescribed."; "modalities::logic::deontic"; 1.0000; . a ; "41EB Applications"@en; ; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.44". a ; "41EB(1) Applications"@en; ; "84da071d80331b00a13e339cb954e55267cd4d77409fe87467d2d23a489a6036"; ; "Application for conformity assessment certificate must be made in a specific manner."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.44"; . a ; ; ; ; "borne by: LegalPerson"; ; . . a ; ; "MUST"; "Application must be made in accordance with a form approved by the Secretary."; "modalities::logic::deontic"; 1.0000; . a ; "41EB(2) Applications"@en; ; "18b6825f35534ed77f61254da65172ee34d1f83610b8e35bcd0a8e3ffafbd786"; ; "Application is not effective if fee or false information is provided."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.44"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Application cannot be effective."; "Prescribed fee not paid or false information in application."; "modalities::logic::deontic"; 1.0000; . a ; "41EB(3) Applications"@en; ; "87da6b39abfca9e679160251c950ccb8b15aae35223b5de559d2df144a8efa33"; ; "Application may be given in accordance with specified software requirements."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.44"; . a ; ; ; ; "borne by: State"; ; . a ; "41EB(4) Applications"@en; ; "c52cba30a80ef6fe666ffd4895f3d58ff65eb441f7099dc5bfcbe1ac0f639530"; ; "Inspect premises and equipment for medical devices"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.44"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Allow"; "Grant permission to inspect"; "(4) The Secretary may..."; "...require the applicant to allow an authorised person..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Temporal relation"; "Specify reasonable time for inspection"; "...at any reasonable time specified in the notice..."; "...to inspect at that time."; "modalities::interval_reasoning"; 1.0000; . a ; "41EC Considering applications"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.45". a ; "41EC(1) Considering applications"@en; ; "0db1c3df32026e4fc32a4510cf46cf666444c3e4775621a72a18580b69bfb377"; ; "Secretary must decide whether to issue conformity assessment certificate."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.45"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must decide"; "issue conformity assessment certificate"; "modalities::logic::deontic"; 1.0000; . a ; "41EC(2) Considering applications"@en; ; "8e9f348a6bad7b1e37b6fb173c26c57707555cf69c3bcd7e156c2a57a7a7e1d2"; ; "Consider conformity assessment procedures when issuing a certificate."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.45"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must consider certain aspects"; "(2) In deciding..."; "must consider..."; "modalities::logic::deontic"; 1.0000; . a ; "41EC(3) Considering applications"@en; ; "876c07d72714aaf74266ff26e586ad00f7d3a661274ce87d1631a04cf1f7578d"; ; "Consider applicant's eligibility when issuing certificate"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.45"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must consider applicant's eligibility"; "(3) In deciding whether to issue the certificate, the Secretary must also..."; "modalities::logic::deontic"; 1.0000; . a ; "41ED Time for making decisions on applications"@en; ; "f780d6beb45a45183421d233eaedb0e1dca61a4e6216564bee9edc5c9513b56c"; "Decision on application must be made within a prescribed period."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.49"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide decision within prescribed period."; "modalities::logic::deontic"; 1.0000; . a ; "41EE Procedure following making a decision whether to issue"@en; ; "03d66dd08835c1ca3f128cceacd1f31ac94163096b20f445ae84285bc0832d72"; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.49". a ; "41EE(1) Procedure following making a decision whether to issue"@en; ; "0242e559c47ebc263dc8c15a458cc1944e74bf6ad82449df3fdea656dbfde880"; ; "Secretary must notify applicant of decision within 20 working days."; "Reasons for decision if not issuing certificate."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.49"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Secretary must perform action."; "modalities::logic::deontic"; 1.0000; . a ; "41EE(2) Procedure following making a decision whether to issue"@en; ; "d6f88d8a47eb0e0114278185f7dcacd3916112aa9dea69a81170a85b011ed9ed"; ; "Manufacturer must specify covered medical devices on conformity assessment certificate."; "Yes"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.49"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Obligation to specify covered medical devices."; "modalities::logic::deontic"; 1.0000; . a ; "41EE(3) Procedure following making a decision whether to issue"@en; ; "dc5bbcb3eddddb045b4515f2263d377ed61d9ece61555a1e00acbf2b97e63710"; ; "Must contain prescribed information"; "Yes"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.49"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Obligation to provide information"; "modalities::logic::deontic"; 1.0000; . a ; "41EF Duration of certificate"@en; ; , , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.50". a ; "41EF(1) Duration of certificate"@en; ; "1e29325c23e3c4dd1522272376b5abf9e57d7b7510cf72df64218601c55cc299"; ; "Certificate commences on specified day and must be in force for no longer than 5 years."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.50"; . a ; ; ; ; . . a ; ; "during"; "Specifies temporal interval"; "modalities::interval_reasoning"; 1.0000; . a ; "41EF(2) Duration of certificate"@en; ; "37d1b59e7580fa236071c2528b2e414d5356ab0f77455c1508f5f3eac9c8028c"; ; "Certificate validity period"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.50"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligate"; "Certificate validity period"; "modalities::logic::deontic"; 1.0000; . . a ; ; ">="; "Temporal interval"; "modalities::interval_reasoning"; 1.0000; . a ; "41EF(3) Duration of certificate"@en; ; "1c3a5fbdff3f593d4231c6d901b81e5bad54efd07659a07e454b9e37255d12b1"; ; "Secretary may extend certificate period"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.50"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Permissive obligation"; "modalities::logic::deontic"; 1.0000; . a ; "41EF(4) Duration of certificate"@en; ; "28e2177cb671f3378a9ed48afbdbcc91023b1134504d3f5f161795201b9b0944"; ; "Extension duration limit"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.50"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "="; "Must be no longer than 12 months"; "(4) An extension must be no longer than 12 months."; "modalities::logic::deontic"; 1.0000; . a ; "41EF(5) Duration of certificate"@en; ; "6ca1af0e2cb395a027e3d777725c78e666e337774f7be827d6fb8841d4fad59b"; ; "Only one extension may be given."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.50"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Single Extension"; "Single extension obligation"; "(5) Only one extension may be given."; "modalities::logic::deontic"; 1.0000; . a ; "41EF(6) Duration of certificate"@en; ; "261258a93c6211fd9182d8f49c27388cb8c4cc26ab298512e1a435bb9ce7c667"; ; "Secretary must give notice of extension to manufacturer and applicant."; "Notice"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.50"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Secretary must give notice."; "modalities::logic::deontic"; 1.0000; . a ; "41EG Lapsing of applications"@en; ; "4d0afb11c901b7cfd66016ece4ab190936c8ea886a6d5377f57392a1373057f3"; "Failure to comply with certain requirements results in lapse of application."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.50"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "Prohibit"; "Prohibition"; "Failure to comply with requirements."; "Lapse of application."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Classify"; "Classification of applications based on compliance"; "Applications are classified as compliant or non-compliant."; "Lapse of application if non-compliant."; "modalities::dl"; 1.0000; . a ; "41EH Treating applications as having been refused"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.51". a ; "41EH(1) Treating applications as having been refused"@en; ; "75009c47e7d13c6494a39c6ce44ce9957f923ce17d4b0094127703568d4405c4"; ; "Applicant may treat application as refused if no decision is made within a period."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.51"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Applicant has an obligation to treat application as refused if no decision is made within a period."; "(a) a period is prescribed under paragraph 63(2)(dc) for making a decision on the application; and (b) at the end of the period, the applicant has not been notified of a decision whether to issue the certificate."; "modalities::logic::deontic"; 1.0000; . a ; "41EH(2) Treating applications as having been refused"@en; ; "bcc02e7196104a80bfa939760d14fa95d636ad01c3ffa8aca8a7b76d3fc8066a"; ; "The notice may be given at any time before the applicant is notified of the decision."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.51"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MAY"; "May be given at any time"; "modalities::logic::deontic"; 1.0000; . . a ; ; "ANYTIME"; "Before applicant is notified of decision"; "modalities::epistemic"; 1.0000; . a ; "41EH(3) Treating applications as having been refused"@en; ; "8d753510a3d92eabd2a0a0519b50d45dfce85e559682994e530981e4049801e8"; ; "Act has no effect as if notice was given"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.51"; . a ; ; ; ; ; . . a ; ; "Prohibition"; "Prohibits the Act from having effect"; "Notice has been given"; "Act has no effect"; "modalities::logic::deontic"; 1.0000; . a ; "41EI Criminal offences for making a false statement"@en; ; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.52". a ; "41EI(1) Criminal offences for making a false statement"@en; ; "8822ed975f5ec8b8354dc730eaa2a9a13aed713aabde37ca9c640de48526d4ae"; ; "Making false statements in an application for a conformity assessment certificate is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.52"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits making false statements in an application for a conformity assessment certificate."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Classify"; "Classifies the statement as false or misleading in a material particular."; "modalities::dl"; 1.0000; . a ; "41EI(4) Criminal offences for making a false statement"@en; ; "90fb6bb40296cbad08ef39f96077763b10b7b96ceb0c222f5834fefbdcfe2e5b"; ; "Making false statements in an application for a conformity assessment certificate is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.52"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of making false statements"; "The person knows that the statement is false or misleading in a material particular."; "The person commits an offence if..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Temporal relation"; "Temporal relation between the making of false statements and the committing of an offence"; "(c) The person knows that the statement is false or misleading in a material particular."; "The person commits an offence if..."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Implication"; "Implication of making false statements on committing an offence"; "(a) The person makes a statement (whether orally, in a document or in any other way); and"; "The person commits an offence if..."; "modalities::argumentation"; 1.0000; . . a ; ; "Propagation"; "Propagation of the prohibition to related statements"; "(b) The statement is in or in connection with an application for a conformity assessment certificate; and"; "The person commits an offence if..."; "modalities::diffusion"; 1.0000; . . a ; ; "Entity recognition"; "Recognition of entities involved in the making of false statements"; "(a) The person makes a statement (whether orally, in a document or in any other way); and"; "The person commits an offence if..."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "41EI(5) Criminal offences for making a false statement"@en; ; "1d530bffed87e77406188ab7f66779167a4bcfdb5e23eb9d034489a2c227eaff"; ; "Making false statements in an application for a conformity assessment certificate is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.52"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits making false statements in an application for a conformity assessment certificate."; "(5) A person commits an offence if: (a) the person makes a statement (whether orally, in a document or in any other way); and (b) the statement is in or in connection with an application for a conformity assessment certificate; and (c) the statement is false or misleading in a material particular."; "(Penalty: 100 penalty units.)"; "modalities::logic::deontic"; 1.0000; . a ; "41EI(6) Criminal offences for making a false statement"@en; ; "8aca9f6b9929541ce9832f9c101208b6939102829c3a414562388d34ea7e6fc7"; ; "Making a false statement in an application for conformity assessment certificate is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.52"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits making a false statement in an application for conformity assessment certificate."; "modalities::logic::deontic"; 1.0000; . a ; "41EJ Automatic conditions on conformity assessment certificates"@en; ; "d57d24863257f78d813bb2ec53818398eb3625ff3a4def44d4e6379ee8c3a12e"; , , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.54". a ; "41EJ(1) Automatic conditions on conformity assessment certificates"@en; ; "3594d90bd3d66ab37c66ccc04a0860fb55ae727b00260cb1f33b653931ed7455"; ; "Manufacturer must allow inspection and examination of premises and medical devices."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.54"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Must"; "Manufacturer must allow inspection."; "modalities::logic::deontic"; 1.0000; . a ; "41EJ(2) Automatic conditions on conformity assessment certificates"@en; ; "1277c3624d0fe8de37b9dcb633227226f8d37f1aa30bd397227926bb57d2787d"; ; "Manufacturer must cooperate in review of conformity assessment certificate"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.54"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Obligation to cooperate"; "modalities::logic::deontic"; 1.0000; . a ; "41EJ(3) Automatic conditions on conformity assessment certificates"@en; ; "2c3d226f1964b67236eacf6a10afe98d76d902f833e352fe30360b6a98739434"; ; "Notify Secretary of substantial changes to quality management systems, product range, or medical device design."; "Notification in writing"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.54"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Obligation to notify"; "modalities::logic::deontic"; 1.0000; . a ; "41EJ(4) Automatic conditions on conformity assessment certificates"@en; ; "d99cb854cee644760b2f511369768e0c08582fdf3f33b8157e1c45cf459fd7d8"; ; "Applicant must pay fee for review of conformity assessment certificate"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.54"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide payment"; "modalities::logic::deontic"; 1.0000; . . a ; ; "during"; "Fee payment occurs during review process"; "(4) A conformity assessment certificate is subject to the condition that..."; "...when the fee becomes due and payable."; "modalities::interval_reasoning"; 1.0000; . a ; "41EJ(5) Automatic conditions on conformity assessment certificates"@en; ; "86a42c08d4468baad771cd08f2e7d35c9c89598dbf86f6ec9a6a94f6a8308f56"; ; "Prescribe different levels of fees for manufacturers and medical devices."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.54"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "shall"; "Imposes a duty on the state."; "modalities::logic::deontic"; 1.0000; . a ; "41EJ(5A) Automatic conditions on conformity assessment certificates"@en; ; "1f896a894ce7a1fbf9b6d5468bbe81db5ac38f0b8cc53a486f06e157976a9293"; ; "Conformity assessment certificates are subject to conditions prescribed by regulations."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.54"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "SUBJUNCTIVE MODO"; "Prescription of conditions"; "modalities::logic::deontic"; 1.0000; . a ; "41EK Conditions imposed when conformity assessment certificates"@en; ; "eebd33e829a035b275eda36ccdeb2e59e2ebc7e277bbe4f7dd098c95d2684e50"; "Conditions imposed on conformity assessment certificates"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.56"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "imposes"; "States a duty"; "modalities::logic::deontic"; 1.0000; . a ; "41EL Conditions imposed after issuing a conformity assessment"@en; ; "03d66dd08835c1ca3f128cceacd1f31ac94163096b20f445ae84285bc0832d72"; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.56". a ; "41EL(1) Conditions imposed after issuing a conformity assessment"@en; ; "9d448505160c54e0f180fb1519fc7a09edca88b8fac034d2486a1a980adb19cc"; ; "Secretary may impose new conditions on a conformity assessment certificate."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.56"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Imposes obligation on the manufacturer."; "modalities::logic::deontic"; 1.0000; . a ; "41EL(2) Conditions imposed after issuing a conformity assessment"@en; ; "af692abab97d51cf3472951b4230ca549b1f0e000ac5ccd6f1cddf63e15d8e3e"; ; "Conditions imposed after issuing a conformity assessment take effect on the specified day."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.56"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "takesEffect"; "Conditions take effect when specified"; "The imposition, variation or removal of a condition under this section takes effect on the day on which the notice is given to the person; or"; "The condition takes effect on the specified day."; "modalities::logic::deontic"; 1.0000; . . a ; ; "during"; "Conditions occur during the specified time period"; "The imposition, variation or removal of a condition under this section takes effect on the day on which the notice is given to the person; or"; "The condition occurs during the specified time period."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "during"; "Conditions occur during the specified time period"; "The imposition, variation or removal of a condition under this section takes effect on the day on which the notice is given to the person; or"; "The condition occurs during the specified time period."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "during"; "Conditions occur during the specified time period"; "The imposition, variation or removal of a condition under this section takes effect on the day on which the notice is given to the person; or"; "The condition occurs during the specified time period."; "modalities::diffusion"; 1.0000; . . a ; ; "during"; "Conditions occur during the specified time period"; "The imposition, variation or removal of a condition under this section takes effect on the day on which the notice is given to the person; or"; "The condition occurs during the specified time period."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "41EL(3) Conditions imposed after issuing a conformity assessment"@en; ; "9ab341489a5bf8cb5c88934696d6fc8979f886f7f964b4accda992096e6a4960"; ; "The earlier day must not be earlier than the day the notice is given to the person."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.56"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MustNot"; "The earlier day must not be earlier than the day the notice is given to the person."; "modalities::logic::deontic"; 1.0000; . a ; "41EM Suspension of conformity assessment certificates"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.58". a ; "41EM(1) Suspension of conformity assessment certificates"@en; ; "2837462d4f0b6405c144f59bb4c8dce1885b4a328dec39ab87443d12975feb9f"; ; "Secretary may suspend conformity assessment certificate"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.58"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Implies obligation"; "modalities::logic::deontic"; 1.0000; . a ; "41EM(2) Suspension of conformity assessment certificates"@en; ; "04a44707a978a8d6ce51ca88f493188c737f2425b204b703a96e2c38dcdacab3"; ; "Suspension of conformity assessment certificates may be limited to some medical devices."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.58"; . a ; ; ; ; ; . a ; "41EM(3) Suspension of conformity assessment certificates"@en; ; "8f9e7755b6652ae1e70eb049db0e57327fef38722a3c6d1bf6dd8795a2959b22"; ; "Specify period of suspension not exceeding 6 months."; "Notice specifying period of suspension"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.58"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Specify period of suspension"; "modalities::logic::deontic"; 1.0000; . a ; "41EN Notice of proposed suspension"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.58". a ; "41EN(1) Notice of proposed suspension"@en; ; "70f309aba95269f94fdc43a1c85a950aa3ffb2d532fee12bd1219478f93d838d"; ; "Secretary must inform person of proposed suspension and give reasonable opportunity to make submissions."; "Notice, reasons for suspension"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.58"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Secretary must perform action"; "modalities::logic::deontic"; 1.0000; . a ; "41EN(2) Notice of proposed suspension"@en; ; "299f2d39b86f593eff59286b20216ccd34c6a6b574bd888886e11025f0472a78"; ; "Secretary must consider submissions before making a decision."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.58"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must consider submissions"; "modalities::logic::deontic"; 1.0000; . a ; "41EN(3) Notice of proposed suspension"@en; ; "d86f46a7770655dec213494145489b19389cbf31ae2d69161e96dfab192149c5"; ; "Exemption from section 41EN(3) if notice under section 41EM states suspension is necessary to prevent imminent risk of death, serious illness or serious injury."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.58"; . a ; ; ; ; ; . . a ; ; "Prohibition"; "Prohibits section 41EN(3) application if notice under section 41EM states suspension is necessary to prevent imminent risk of death, serious illness or serious injury."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlaps"; "Section 41EN(3) does not apply if notice under section 41EM states suspension is necessary to prevent imminent risk of death, serious illness or serious injury."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Overlaps"; "Section 41EN(3) does not apply if notice under section 41EM states suspension is necessary to prevent imminent risk of death, serious illness or serious injury."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Overlaps"; "Section 41EN(3) does not apply if notice under section 41EM states suspension is necessary to prevent imminent risk of death, serious illness or serious injury."; "modalities::diffusion"; 1.0000; . . a ; ; "Overlaps"; "Section 41EN(3) does not apply if notice under section 41EM states suspension is necessary to prevent imminent risk of death, serious illness or serious injury."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "41EO Duration of suspension"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.59". a ; "41EO(1) Duration of suspension"@en; ; "c118404ba7204b5872342af8c8d0df6b6c3b6a7a62eada6c2976900ea9a105c0"; ; "Suspension takes effect on specified day after notice is given."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.59"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "takesEffect"; "Suspension takes effect on specified day after notice is given."; "(1) The suspension takes effect: (a) if the notice under section 41EM states that the suspension is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the notice is given to the person; or (b) in any other case—on the day specified for the purpose in the notice, being a day not earlier than 20 working days after the notice is given to the person."; "(1) The suspension takes effect: (a) if the notice under section 41EM states that the suspension is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the notice is given to the person; or (b) in any other case—on the day specified for the purpose in the notice, being a day not earlier than 20 working days after the notice is given to the person."; "modalities::logic::deontic"; 1.0000; . . a ; ; "during"; "Suspension takes effect on a specified day after notice is given."; "(1) The suspension takes effect: (a) if the notice under section 41EM states that the suspension is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the notice is given to the person; or (b) in any other case—on the day specified for the purpose in the notice, being a day not earlier than 20 working days after the notice is given to the person."; "(1) The suspension takes effect: (a) if the notice under section 41EM states that the suspension is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the notice is given to the person; or (b) in any other case—on the day specified for the purpose in the notice, being a day not earlier than 20 working days after the notice is given to the person."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "during"; "Suspension takes effect on a specified day after notice is given."; "(1) The suspension takes effect: (a) if the notice under section 41EM states that the suspension is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the notice is given to the person; or (b) in any other case—on the day specified for the purpose in the notice, being a day not earlier than 20 working days after the notice is given to the person."; "(1) The suspension takes effect: (a) if the notice under section 41EM states that the suspension is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the notice is given to the person; or (b) in any other case—on the day specified for the purpose in the notice, being a day not earlier than 20 working days after the notice is given to the person."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "ifThen"; "Suspension takes effect if notice states suspension is necessary."; "(1) The suspension takes effect: (a) if the notice under section 41EM states that the suspension is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the notice is given to the person; or (b) in any other case—on the day specified for the purpose in the notice, being a day not earlier than 20 working days after the notice is given to the person."; "(1) The suspension takes effect: (a) if the notice under section 41EM states that the suspension is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the notice is given to the person; or (b) in any other case—on the day specified for the purpose in the notice, being a day not earlier than 20 working days after the notice is given to the person."; "modalities::logic::deontic"; 1.0000; . . a ; ; "or"; "Suspension takes effect on specified day after notice is given."; "(1) The suspension takes effect: (a) if the notice under section 41EM states that the suspension is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the notice is given to the person; or (b) in any other case—on the day specified for the purpose in the notice, being a day not earlier than 20 working days after the notice is given to the person."; "(1) The suspension takes effect: (a) if the notice under section 41EM states that the suspension is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the notice is given to the person; or (b) in any other case—on the day specified for the purpose in the notice, being a day not earlier than 20 working days after the notice is given to the person."; "modalities::paraconsistent"; 1.0000; . a ; "41EO(2) Duration of suspension"@en; ; "005ef4878063ee027effe5153ca5a509d46abe14f014db52388b91eaa0190b06"; ; "Suspension duration"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.59"; . a ; ; ; ; . a ; "41EO(3) Duration of suspension"@en; ; "b31346b6564c4702e2b0e14558620baca520515253cad055ff58ceba9d63a02c"; ; "Extension of period for addressing grounds for revoking medical device certificate"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.59"; . a ; ; ; ; "borne by: State"; ; . a ; "41EP Revocation of suspension"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.59". a ; "41EP(1) Revocation of suspension"@en; ; "a8dd7880c35376d90cbba755983148b619aad27298bf96169fc48ce8e11bdf10"; ; "Must revoke suspension if grounds no longer apply and no other grounds for suspension exist."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.59"; . a ; ; ; ; ; . . a ; ; "MUST"; "Obligation to revoke suspension"; "(a) the ground on which the conformity assessment certificate was suspended no longer applies; and (b) there are no other grounds for suspending the certificate."; "The Secretary must revoke the suspension."; "modalities::logic::deontic"; 1.0000; . . a ; ; "BETWEEN"; "Temporal interval of revocation obligation"; "(1) The Secretary must revoke the suspension if the Secretary is satisfied that: (a) the ground on which the conformity assessment certificate was suspended no longer applies; and (b) there are no other grounds for suspending the certificate."; "Revocation obligation applies between specified temporal intervals"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "BETWEEN"; "Temporal interval of revocation obligation"; "(1) The Secretary must revoke the suspension if the Secretary is satisfied that: (a) the ground on which the conformity assessment certificate was suspended no longer applies; and (b) there are no other grounds for suspending the certificate."; "Revocation obligation applies between specified temporal intervals"; "modalities::temporal_ltl"; 1.0000; . a ; "41EP(2) Revocation of suspension"@en; ; "6e77be1ae681ecae4417109d8de4f35a2b3c13f53cf82b9f5c81cf3206e499e3"; ; "Exercise of power to revoke suspension"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.59"; . a ; ; ; ; . a ; "41EQ Powers of revocation of conformity assessment certificates"@en; ; "7298a246841d9715feeba96a04bba28f224a6389c22f90f89e3bf1c64f9bb7bc"; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.60". a ; "41EQ(1) Powers of revocation of conformity assessment certificates"@en; ; "55270756b2c6c4bc6c3f95d398c44b690391653bf209690c9829b699e3ada48c"; ; "Does not affect Secretary's powers to revoke conformity assessment certificates"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.60"; . a ; ; ; ; . a ; "41EQ(2) Powers of revocation of conformity assessment certificates"@en; ; "907877fde0548372982cbca08adf7db3f8ec170dd41dbe6cdd75bb4db5c0267a"; ; "Suspension ceases to have effect if revocation relates to conformity assessment certificate"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.60"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "ceases"; "Obligation ceases"; "(2) To the extent that a suspension under this Division relates to a conformity assessment certificate to which such a revocation relates"; "Suspension ceases to have effect"; "modalities::logic::deontic"; 1.0000; . . a ; ; "during"; "Temporal interval relation"; "(2) To the extent that a suspension under this Division relates to a conformity assessment certificate to which such a revocation relates"; "Suspension ceases to have effect during revocation period"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "during"; "Temporal interval relation"; "(2) To the extent that a suspension under this Division relates to a conformity assessment certificate to which such a revocation relates"; "Suspension ceases to have effect during revocation period"; "modalities::temporal_ltl"; 1.0000; . . a ; ; "if"; "Conditional diffusion"; "(2) To the extent that a suspension under this Division relates to a conformity assessment certificate to which such a revocation relates"; "Suspension ceases to have effect if revocation relates to conformity assessment certificate"; "modalities::diffusion"; 1.0000; . . a ; ; "if"; "Conditional CogAI"; "(2) To the extent that a suspension under this Division relates to a conformity assessment certificate to which such a revocation relates"; "Suspension ceases to have effect if revocation relates to conformity assessment certificate"; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "41ER Automatic revocation of conformity assessment certificates"@en; ; "d388086aaf85dd8df60999f1ea4b03200759d1416fb35dbb2a831d90eec7878d"; "Revocation of conformity assessment certificates upon expiration of suspension period"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.61"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits revocation without notice"; "modalities::logic::deontic"; 1.0000; . a ; "41ES Immediate revocation of conformity assessment certificates"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.61". a ; "41ES(1) Immediate revocation of conformity assessment certificates"@en; ; "fc0f5d9c76e6fcef3d846068941754b6998f5139a1c02633a8ab3f8bda458717"; ; "Manufacturer must request revocation of certificate."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.61"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Manufacturer's request is an obligation."; "modalities::logic::deontic"; 1.0000; . a ; "41ES(2) Immediate revocation of conformity assessment certificates"@en; ; "26e529231b0edf7ab443cb0769604a19dec4dab5999850f2bdbe76dcdc20db60"; ; "Secretary may withdraw revocation upon request and payment of fee."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.61"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Describes the Secretary's discretion to withdraw revocation."; "modalities::logic::deontic"; 1.0000; . a ; "41ES(3) Immediate revocation of conformity assessment certificates"@en; ; "75b3ce082b95874acbba1a6c78f547392f635a2a2497ddcc5de2379b2aa26606"; ; "Revocation of conformity assessment certificates is taken never to have occurred if withdrawn."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.61"; . a ; ; ; ; . a ; "41ET Revocation of conformity assessment certificates after notice"@en; ; "41c56eeba96bce4446c5184c9d8fe4aa56992df1d9bc438c32aba574ff2a0e94"; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.62". a ; "41ET(1) Revocation of conformity assessment certificates after notice"@en; ; "b8394f4590110769fdf90e81f3d27f4ae05be33d49472a1d295e959713b09cfe"; ; "Revocation of conformity assessment certificates after notice"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.62"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibit"; "Revocation for non-compliance with conditions"; "(b) the manufacturer in relation to whom the certificate is issued refuses or fails to comply with a condition to which the certificate is subject;"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibit"; "Revocation for breach of conformity assessment document conditions"; "(viii) breached a condition of a conformity assessment document;"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Within"; "Temporal interval for revocation after notice"; "within a further 10 working days from the day specified in that notice;"; "modalities::interval_reasoning"; 1.0000; . a ; "41ET(1A) Revocation of conformity assessment certificates after notice"@en; ; "a7ccd73a8675309cd6c7c0f38f97b0efd07695c3922c0869794b1e062c9952ee"; ; "A reference to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.62"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "includes"; "The text implies a duty on authorities to refer to persons with outstanding orders."; "Section 19B of the Crimes Act 1914 empowers courts to take action without proceeding to record a conviction."; "A reference to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence."; "modalities::logic::deontic"; 1.0000; . . a ; ; "includes"; "The text defines a class hierarchy for persons with outstanding orders."; "A person convicted of an offence is included in this class."; "A reference to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence."; "modalities::dl"; 1.0000; . . a ; ; "includes"; "The text implies a temporal relationship between convictions and outstanding orders."; "An order has been made relating to the offence under section 19B of the Crimes Act 1914."; "A reference to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "includes"; "The text implies a recurring trace between convictions and outstanding orders."; "An order has been made relating to the offence under section 19B of the Crimes Act 1914."; "A reference to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "includes"; "The text implies a diffusion of information between convictions and outstanding orders."; "A court that has found a person to have committed an offence can take action without proceeding to record a conviction."; "A reference to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence."; "modalities::diffusion"; 1.0000; . . a ; ; "includes"; "The text implies a cognitive process of referencing persons with outstanding orders."; "A court that has found a person to have committed an offence can take action without proceeding to record a conviction."; "A reference to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "41ET(1B) Revocation of conformity assessment certificates after notice"@en; ; "6a0151983ab8c82d0d802984e05b0806c08e2302bc00e618ef7162986ef58d26"; ; "Paragraph (1)(e) does not limit paragraph (1)(f)."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.62"; . a ; ; ; ; ; . . a ; ; "implies"; "Paragraph (1)(e) implies paragraph (1)(f)"; "(1B)"; "(1)(e)"; "modalities::logic::deontic"; 0.5000; . a ; "41ET(2) Revocation of conformity assessment certificates after notice"@en; ; "83eea9b42b8271bc3c73f69e60f5f4ce4ae1b1ca7d2fb3573c8c6bf291504e6e"; ; "Secretary must inform and give opportunity to make submissions before revoking conformity assessment certificate."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.62"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Secretary must inform and give opportunity to make submissions before revoking conformity assessment certificate."; "modalities::logic::deontic"; 1.0000; . . a ; ; "OBLIGATION"; "Secretary has obligation to inform and give opportunity to make submissions before revoking conformity assessment certificate."; "modalities::epistemic"; 1.0000; . a ; "41EU Limiting revocation of conformity assessment certificates to"@en; ; "f8519e4b3a4e40ca9f6ff3212c99befe3a76e760cbb9726a60472c01aa2b5ba4"; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.64". a ; "41EU(1) Limiting revocation of conformity assessment certificates to"@en; ; "298439893534c6f24fe8198a0eebd8270296836cb83f3d3faca66ae71fa4a7a2"; ; "Limiting revocation of conformity assessment certificates to certain medical devices"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.64"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "limitation"; "Limiting revocation"; "(1) If the Secretary is satisfied..."; "...the Secretary must limit..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "between"; "Temporal interval between revocation and limitation"; "(1) If the Secretary is satisfied..."; "...the Secretary must limit...only to those medical devices"; "modalities::interval_reasoning"; 1.0000; . a ; "41EU(2) Limiting revocation of conformity assessment certificates to"@en; ; "cf5a21f9c5fe797d2f3a672c731032c674e6bbe7fca8d2316fd2f4e1d3123cd8"; ; "Secretary must vary certificate to remove medical devices from scope"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.64"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Obligation to vary certificate"; "modalities::logic::deontic"; 1.0000; . a ; "41EV Publication of revocation etc. of conformity assessment"@en; ; "a9e85fa95e8e0d4c8a85e0d8d9c06c1303004da65061cfec80492023c9083d24"; "Publish notice of revocation or variation of conformity assessment certificate."; "Notice setting out particulars of the revocation or variation."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.64"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Obligation to publish notice."; "modalities::logic::deontic"; 1.0000; . a ; "41EW Date of effect of revocation etc. of conformity assessment"@en; ; "5af45a80c2bae6b70c6569e91b434873a690d63e59bf4b21f5f0caae7c906dff"; "Date of effect for revocation or variation of conformity assessment certificate"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.65"; . a ; ; ; ; . a ; "41F What this Part is about"@en; ; "31cfed3971b7703e206891fb100d673a48d9b4cb7fc4c66b937209bf54730f61"; "Medical devices must comply with certain principles and requirements to be included in the Register."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.72"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must comply with principles and requirements"; "modalities::logic::deontic"; 1.0000; . a ; "41FA What this Division is about"@en; ; "1e1d20f72fd61bf6562686ba308318d4ccdd13a027c62d7104a08dc512864d12"; "Applications for medical devices must pass preliminary assessment."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.73"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Application must pass preliminary assessment."; "modalities::logic::deontic"; 1.0000; . . a ; ; "IS_A"; "Kind of medical device is included in the Register if application passes preliminary assessment."; "modalities::dl"; 1.0000; . a ; "41FC Making an application"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.73". a ; "41FC(1) Making an application"@en; ; "e7cb257bd7f867501a12c7c87ef50d0a03aa6897162ceedf912eba634a99a6d2"; ; "A person may make an application to the Secretary for a kind of medical device to be included in the Register."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.73"; . a ; ; ; ; "borne by: NaturalPerson"; ; . . a ; ; "May"; "Permission to make an application"; "modalities::logic::deontic"; 1.0000; . . a ; ; "ClassInclusion"; "Application for a kind of medical device"; "modalities::dl"; 1.0000; . a ; "41FC(2) Making an application"@en; ; "3882e507e97ed7e00d03e5f6bc2ba40196dfafc6000ab75eecedd608bcfcfc75"; ; "Application must not contain false or misleading information."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.73"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of false or misleading information"; "Application must not contain false or misleading information."; "modalities::logic::deontic"; 1.0000; . a ; "41FD Matters to be certified"@en; ; "f91e47bd573ce812ded32a3b98bfeffd92d9bc87fdad6538011e901c75b0e9f0"; "Applicant must certify that devices are medical devices."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.73"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide certification"; "Applicant must certify that devices are medical devices."; "modalities::logic::deontic"; 1.0000; . a ; "41FE Criminal offences for making a false statement"@en; ; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.78". a ; "41FE(1) Criminal offences for making a false statement"@en; ; "741eb7ed0dbd53c2eccb894fd3e788c082c9dbc6bf2b062ddfa5aeac30f19711"; ; "Making false statements in connection with medical devices is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.78"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of false statements"; "Statement is false or misleading"; "Offence committed"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Classify"; "Classification of medical devices"; "Device included in Register"; "Device type determined"; "modalities::dl"; 1.0000; . a ; "41FE(4) Criminal offences for making a false statement"@en; ; "b7081dccd98deae3888496e60d7cd668059044a800cf64d5bc3764036dbb2718"; ; "Making false statements in connection with medical device applications or certifications is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.78"; . a ; ; ; ; ; . . a ; ; "Prohibit"; "Prohibits making false statements in specified contexts."; "(a) the person makes a statement (whether orally, in a document or in any other way); and (b) the person knows that the statement is false or misleading in a material particular;"; "The person commits an offence if..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Classify"; "Classifies statements as true or false based on knowledge."; "(b) the person knows that the statement is false or misleading in a material particular;"; "The person knows that the statement is false or misleading in a material particular;"; "modalities::dl"; 1.0000; . . a ; ; "Temporal overlap"; "Requires temporal overlap between statements and their context."; "(c) the statement is in or in connection with: (i) an application for including a kind of medical device in the Register under this Chapter; or (ii) a certification or purported certification under section 41FD."; "The statement is in or in connection with..."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Recurring trace"; "Requires recurring traces of statements and their context."; "(c) the statement is in or in connection with: (i) an application for including a kind of medical device in the Register under this Chapter; or (ii) a certification or purported certification under section 41FD."; "The statement is in or in connection with..."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Obligation"; "Imposes an obligation to avoid making false statements in specified contexts."; "(a) the person makes a statement (whether orally, in a document or in any other way); and (b) the person knows that the statement is false or misleading in a material particular;"; "The person commits an offence if..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibition"; "Prohibits making false statements in specified contexts."; "(a) the person makes a statement (whether orally, in a document or in any other way); and (b) the person knows that the statement is false or misleading in a material particular;"; "The person commits an offence if..."; "modalities::logic::deontic"; 1.0000; . a ; "41FE(5) Criminal offences for making a false statement"@en; ; "d88131e06caada2c090f92e0ca7ca2c33a98a4b364e69947bdbfdc6a5ccc8fd4"; ; "Making false statements in certain contexts is an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.78"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits making false statements in certain contexts."; "(5) A person commits an offence if..."; "...Penalty: 100 penalty units."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Classify"; "Classifies the provision as a prohibition."; "A person commits an offence if..."; "...Penalty: 100 penalty units."; "modalities::dl"; 1.0000; . a ; "41FE(6) Criminal offences for making a false statement"@en; ; "fded07edb2a9975502e8f6fe9f3b17aff17cfda13aa15236940e859477f08da3"; ; "An offence against subsection (5) is an offence of strict liability."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.78"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "is"; "Strict liability"; "(5)"; "(6)"; "modalities::logic::deontic"; 1.0000; . a ; "41FF Obligation to include kinds of medical devices in the Register"@en; ; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.80". a ; "41FF(1) Obligation to include kinds of medical devices in the Register"@en; ; "3935e84d41bf78398a7efd4329381b98a439414904e400ae0d51680f5cd5d628"; ; "Secretary must include kind of medical device in Register if application has passed preliminary assessment and not selected for audit."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.80"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Obligation to include kind of medical device in Register"; "(1) If:..."; "...the Secretary must include the kind of device in the Register in relation to the person."; "modalities::logic::deontic"; 1.0000; . . a ; ; "SUBCLASS OF"; "Classifies medical devices as part of the Register"; "(1) If:..."; "...the kind of device in the Register in relation to the person."; "modalities::dl"; 1.0000; . . a ; ; "BETWEEN"; "Temporal interval for inclusion in Register"; "(1) If:..."; "...the Secretary must include the kind of device in the Register in relation to the person."; "modalities::interval_reasoning"; 0.5000; . . a ; ; "IMPLIES"; "Inference from preliminary assessment and audit selection"; "(a) an application for a kind of medical device..."; "...the Secretary must include the kind of device in the Register in relation to the person."; "modalities::argumentation"; 0.5000; . . a ; ; "SPREADS TO"; "Influence on audit selection and inclusion in Register"; "(b) the application has not been selected for audit under section 41FH;"; "...the Secretary must include the kind of device in the Register in relation to the person."; "modalities::diffusion"; 0.5000; . . a ; ; "REQUIRES"; "Artificial intelligence application for medical device inclusion"; "(1) If:..."; "...the Secretary must include the kind of device in the Register in relation to the person."; "sparql_library::parsers::chk_parser"; 0.5000; . a ; "41FF(1A) Obligation to include kinds of medical devices in the Register"@en; ; "b128783c21371f1bc2c66fdb0e60a04284419ac0635e883b56c22358263434ae"; ; "The Secretary must not include a device in the Register if it is to be used exclusively for purposes specified under section 41BEA."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.80"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits including a device in the Register if it is to be used exclusively for specified purposes."; "The Secretary must not include..."; "...the kind of device in the Register."; "modalities::logic::deontic"; 1.0000; . . a ; ; "ClassInclusion"; "Includes devices that are not to be included in the Register if used exclusively for specified purposes."; "The kind of device is to be used exclusively..."; "...the kind of device in the Register."; "modalities::dl"; 1.0000; . . a ; ; "TemporalExclusion"; "Excludes devices from the Register if they are to be used exclusively for specified purposes during a certain time period."; "The kind of device is to be used exclusively..."; "...the kind of device in the Register."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "TemporalExclusion"; "Excludes devices from the Register if they are to be used exclusively for specified purposes during a certain time period."; "The kind of device is to be used exclusively..."; "...the kind of device in the Register."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "TemporalExclusion"; "Excludes devices from the Register if they are to be used exclusively for specified purposes during a certain time period."; "The kind of device is to be used exclusively..."; "...the kind of device in the Register."; "modalities::diffusion"; 1.0000; . . a ; ; "TemporalExclusion"; "Excludes devices from the Register if they are to be used exclusively for specified purposes during a certain time period."; "The kind of device is to be used exclusively..."; "...the kind of device in the Register."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "41FF(2) Obligation to include kinds of medical devices in the Register"@en; ; "f1127fa868a80c7fbe5b619e79897cf27de75fa634c89743b98a801c610b6eb7"; ; "The Secretary must provide a certificate of inclusion to the applicant."; "Yes"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.80"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "The Secretary must provide a certificate."; "modalities::logic::deontic"; 1.0000; . . a ; ; "hasPartOf"; "The Register has part of the device included."; "modalities::dl"; 1.0000; . a ; "41FF(3) Obligation to include kinds of medical devices in the Register"@en; ; "fc2eac3d9bd56c724c62373428fb7ee38f4700793a3384c59bcf9047b68a6f43"; ; "Specify commencement day for inclusion of medical devices in the Register"; "Yes"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.80"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Specify commencement day"; "modalities::logic::deontic"; 1.0000; . . a ; ; "SPECIFY"; "Specify the day on which the inclusion of the kind of device in the Register commences."; "modalities::dl"; 1.0000; . a ; "41FG Notification of unsuccessful applications"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.81". a ; "41FG(1) Notification of unsuccessful applications"@en; ; "8d805aa79fa862613002fc474434673192077588e1e6d9846ae9c39f65c099bf"; ; "Notification of unsuccessful applications for medical device inclusion in the Register"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.81"; . a ; ; ; ; "borne by: State"; ; . a ; "41FG(2) Notification of unsuccessful applications"@en; ; "1493779e679a868e7212cf78b4d93a2deafea7e8a2114684118768a674e4171b"; ; "Secretary must notify applicant in writing within 20 working days after application is received and fee is paid."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.81"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must notify applicant"; "modalities::logic::deontic"; 1.0000; . a ; "41FH Selecting applications for auditing"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.81". a ; "41FH(1A) Selecting applications for auditing"@en; ; "44b17a58508b7e157a4b1bd964c1a726c03b848da7945158e2fd1d0b3a4bbcfa"; ; "This section applies to applications that have passed preliminary assessment."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.81"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "applies"; "Section applies to specified applications."; "(1A) This section applies to applications that have passed preliminary assessment."; "modalities::logic::deontic"; 1.0000; . a ; "41FH(1) Selecting applications for auditing"@en; ; "bf4d192a88b393238b07c489443701523591233e9fe78eabe5c95c036049d4f6"; ; "Secretary must select applications for auditing."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.81"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must select applications."; "modalities::logic::deontic"; 1.0000; . . a ; ; "IS_A"; "Selects applications of a kind prescribed by regulations."; "modalities::dl"; 1.0000; . a ; "41FH(2) Selecting applications for auditing"@en; ; "8536d4d4f5fd77c61a573183c8f4ceda10c77683da40aa2e5111c094cbded674"; ; "Secretary must give applicant a written notice upon selection for auditing."; "written notice"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.81"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Secretary must give applicant a written notice."; "modalities::logic::deontic"; 1.0000; . a ; "41FI Auditing of applications"@en; ; , , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.82". a ; "41FI(1) Auditing of applications"@en; ; "e394a33370306f48b9a873bcd5bf8274cc25a74f12c4edc6d3682b10da04a48f"; ; "The Secretary may consider certain aspects of an application during auditing. Secretary may have regard to certificate in auditing application"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.82"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "May consider certain aspects"; "modalities::logic::deontic"; 0.5000; . . a ; ; "May"; "Permits Secretary to consider certificate"; "(a) a section 41FC application is made for a kind of medical device..."; "The Secretary may have regard to the certificate in auditing the application."; "modalities::logic::deontic"; 0.5000; . . a ; ; "Has been issued consistently with"; "Certificate must be consistent with conformity assessment body determination"; "(e) if the conformity assessment body determination that relates to the body is limited as mentioned in paragraph 41EWA(4)(b)—the Secretary is satisfied that the certificate has been issued..."; "The Secretary is satisfied that the certificate has been issued consistently with the determination."; "modalities::dl"; 0.5000; . . a ; ; "Within a specified time frame"; "Certificate must be given to Secretary within a specified timeframe"; "(d) the certificate has been given to the Secretary;"; "The certificate was issued within a specified timeframe."; "modalities::interval_reasoning"; 0.5000; . . a ; ; "Recurring trace"; "Certificate must be audited as part of recurring audit process"; "(b) the application has been selected for audit;"; "The certificate is part of a recurring audit process."; "modalities::temporal_ltl"; 0.5000; . . a ; ; "Must consider"; "Secretary must consider certificate in auditing application"; "(1) If..."; "The Secretary must consider the certificate in auditing the application."; "modalities::logic::deontic"; 0.5000; . . a ; ; "Is a requirement for audit"; "Certificate is a requirement for audit of section 41FC application"; "(1) If..."; "The certificate is a requirement for the audit."; "modalities::dl"; 0.5000; . a ; "41FI(1A) Auditing of applications"@en; ; "906b4c6892dd439c50c25cd970aeb0557ae11a454e83be0635023a4f95b91127"; ; "The applicant must deliver a reasonable number of samples within 14 days after receiving the notice."; "Yes"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.82"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "The applicant must deliver samples"; "modalities::logic::deontic"; 1.0000; . . a ; ; "hasPart"; "The application has a part that requires delivery of samples"; "modalities::dl"; 1.0000; . a ; "41FI(2) Auditing of applications"@en; ; "4168657e1057e591c4eb77b234d52c101d992bbd2962820486dae0506927e9c4"; ; "The Secretary must decide to include a device in the Register. The Secretary may have regard for matters beyond the scope of this section."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.82"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "The Secretary must decide."; "modalities::logic::deontic"; 1.0000; . . a ; ; "IS_A"; "The device is included in the Register."; "modalities::dl"; 1.0000; . a ; "41FI(3) Auditing of applications"@en; ; "74ad2d22f37fa181f1e1d22d0ff86285d2a4bfaa45dd2f394bd4c0aff073a7e0"; ; "Secretary must decide not to include device in Register if not satisfied."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.82"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Secretary must decide"; "modalities::logic::deontic"; 1.0000; . . a ; ; "IS_A"; "Device type is a kind of device"; "modalities::dl"; 1.0000; . a ; "41FI(1) Auditing of applications"@en; ; "b8692134e7105bca16acf901c7cc6e0ca1fb92fe35ed6d08b3e5fe4f6a32b86e"; ; "The Secretary may consider certain aspects of an application during auditing. Secretary may have regard to certificate in auditing application"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.82"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "May consider certain aspects"; "modalities::logic::deontic"; 0.5000; . . a ; ; "May"; "Permits Secretary to consider certificate"; "(a) a section 41FC application is made for a kind of medical device..."; "The Secretary may have regard to the certificate in auditing the application."; "modalities::logic::deontic"; 0.5000; . . a ; ; "Has been issued consistently with"; "Certificate must be consistent with conformity assessment body determination"; "(e) if the conformity assessment body determination that relates to the body is limited as mentioned in paragraph 41EWA(4)(b)—the Secretary is satisfied that the certificate has been issued..."; "The Secretary is satisfied that the certificate has been issued consistently with the determination."; "modalities::dl"; 0.5000; . . a ; ; "Within a specified time frame"; "Certificate must be given to Secretary within a specified timeframe"; "(d) the certificate has been given to the Secretary;"; "The certificate was issued within a specified timeframe."; "modalities::interval_reasoning"; 0.5000; . . a ; ; "Recurring trace"; "Certificate must be audited as part of recurring audit process"; "(b) the application has been selected for audit;"; "The certificate is part of a recurring audit process."; "modalities::temporal_ltl"; 0.5000; . . a ; ; "Must consider"; "Secretary must consider certificate in auditing application"; "(1) If..."; "The Secretary must consider the certificate in auditing the application."; "modalities::logic::deontic"; 0.5000; . . a ; ; "Is a requirement for audit"; "Certificate is a requirement for audit of section 41FC application"; "(1) If..."; "The certificate is a requirement for the audit."; "modalities::dl"; 0.5000; . a ; "41FI(2) Auditing of applications"@en; ; "8c8370c270ac917b9dbd6f61141f779e9ccbcc4a19b7257710f2e4a31e7e1533"; ; "The Secretary must decide to include a device in the Register. The Secretary may have regard for matters beyond the scope of this section."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.82"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "The Secretary must decide."; "modalities::logic::deontic"; 1.0000; . . a ; ; "IS_A"; "The device is included in the Register."; "modalities::dl"; 1.0000; . a ; "41FJ Procedure following audits"@en; ; "0c578b05f1c711a460af00234e745f7a6d3188f0537353bbba26d6a39b8c3889"; "Notify applicant of decision within 20 working days and state reasons for non-inclusion in Register if applicable."; "Decision notice with reasons"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.83"; . a ; ; ; ; ; . . a ; ; "MUST"; "Obligation to notify applicant"; "modalities::logic::deontic"; 1.0000; . . a ; ; "IS_A"; "Definition of decision notice"; "modalities::dl"; 1.0000; . a ; "41FK Lapsing of applications"@en; ; "654b823b96ca904c0b00173568d87c84e5b82987f5bd012a647b6983eebe3555"; , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.84". a ; "41FK(1) Lapsing of applications"@en; ; "1cf1a99ce980f4bc1bf2abfe5899339e4908de8350d4cad087dbdd94cb1b73ae"; ; "Regulations may empower Secretary to make medical devices priority applicant determinations."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.84"; . a ; ; ; ; . a ; "41FK(2) Lapsing of applications"@en; ; "c2937f5ac7b008aadb8e1b078719d36302be931ab42d7afb99ae4893fcda0586"; ; "A medical devices (priority applicant) determination is a specified person's priority applicant in relation to any section 41FC application."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.84"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "hasPriorityApplicant"; "Has priority applicant"; "modalities::logic::deontic"; 1.0000; . a ; "41FK(3) Lapsing of applications"@en; ; "ddb07a3ae8346a7a4622fda2d775e880575f0b74351dd4c3c031e7280310e914"; ; "Regulations may make provision for and in relation to applications for medical devices."; "specified information or documents within a specified period"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.84"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide specified information or documents"; "modalities::logic::deontic"; 1.0000; . a ; "41FK(4) Lapsing of applications"@en; ; "d059d9fc252d67d028135dac57469a5d515eecf1848577496146dbd4bc066caf"; ; "Regulations may revoke medical devices priority applicant determination"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.84"; . a ; ; ; ; "borne by: State"; ; . a ; "41FK(5) Lapsing of applications"@en; ; "8bce7bb1d83b91072e12d1f8e3745eaed7d486b18e91d4c434d3696b0fc4e5e4"; ; "Subsections (3) and (4) do not limit subsection (1)."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.84"; . a ; ; ; ; "borne by: State"; ; . a ; "41FL Device number"@en; ; "88725673f11b29f9cee023ec6ff2c2390b60a5f301c1d3d407a3b11abaf045c8"; "Secretary must assign unique device number to included medical devices."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.86"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide a unique device number."; "modalities::logic::deontic"; 1.0000; . . a ; ; "CLASSIFICATION"; "Classification of medical devices in the Register."; "modalities::dl"; 1.0000; . a ; "41FM Duration of inclusion in the Register"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.87". a ; "41FM(1) Duration of inclusion in the Register"@en; ; "38db98b46e3014ffc0b7ac8c93a7dcbe03d5b725a7e175450c39ee61de4f1eb4"; ; "Commences on a specified day"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.87"; . a ; ; ; ; . a ; "41FM(2) Duration of inclusion in the Register"@en; ; "7dde180eff88634b267877f2d265c24f5182a1289f4f9d4d441de3241a7453d8"; ; "Device must be included in Register until cancellation or suspension."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.87"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Device must be included in Register."; "modalities::logic::deontic"; 1.0000; . . a ; ; "ClassInclusion"; "Device is included in Register."; "modalities::dl"; 1.0000; . a ; "41FN Conditions applying automatically"@en; ; "d57d24863257f78d813bb2ec53818398eb3625ff3a4def44d4e6379ee8c3a12e"; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.88". a ; "41FN(1) Conditions applying automatically"@en; ; "ad97e685861be299317f695bf6cca9ade20bf75f0efcda21046f6679c233a3ae"; ; "Allow authorised person to inspect premises and devices"; "true"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.88"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Allow"; "Grant permission to inspect premises and devices"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Classify"; "Classify devices into categories"; "modalities::dl"; 1.0000; . a ; "41FN(2) Conditions applying automatically"@en; ; "c3ec7104dc51faa8531239029ba366d8246ceb4bf4ca2f944899eb0b25759edc"; ; "Deliver a reasonable number of samples if requested by the Secretary."; "Yes"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.88"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must deliver samples"; "The Secretary requests samples"; "Deliver a reasonable number of samples"; "modalities::logic::deontic"; 1.0000; . . a ; ; "IS_A"; "Condition for inclusion in the Register"; "The kind of device is included in the Register"; "Subject to a condition"; "modalities::dl"; 1.0000; . a ; "41FN(3) Conditions applying automatically"@en; ; "ab4a50648c4c9c52a7884061063b0d5e3c20e3590c1c6caecbab873ded5a391b"; ; "Conditions for inclusion of medical devices in the Register"; "sufficient information to substantiate compliance with essential principles and conformity assessment procedures"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.88"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "must"; "Obligation to provide sufficient information"; "modalities::logic::deontic"; 1.0000; . . a ; ; "has"; "Description of conditions for inclusion in the Register"; "(i) has available sufficient information to substantiate compliance with the essential principles; or (ii) has procedures in place, including a written agreement with the manufacturer of the kind of device, to ensure that such information can be obtained from the manufacturer within 20 working days;"; "modalities::dl"; 1.0000; . . a ; ; "within"; "Temporal interval for obtaining information from the manufacturer"; "(ii) has procedures in place, including a written agreement with the manufacturer of the kind of device, to ensure that such information can be obtained from the manufacturer within 20 working days;"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "until"; "Temporal interval for obtaining information from the manufacturer"; "(ii) has procedures in place, including a written agreement with the manufacturer of the kind of device, to ensure that such information can be obtained from the manufacturer within 20 working days;"; "modalities::temporal_ltl"; 1.0000; . . a ; ; "must"; "Obligation to provide sufficient information for conformity assessment procedures"; "(i) has available sufficient information to substantiate that the conformity assessment procedures have been applied to the kind of medical device or that requirements, comparable to those procedures, have been applied to the kind of medical device to the satisfaction of an overseas regulator; or (ii) has procedures in place, including a written agreement with the manufacturer of the kind of device, to ensure that such information can be obtained from the manufacturer within 20 working days;"; "modalities::logic::deontic"; 1.0000; . . a ; ; "has"; "Description of conditions for inclusion in the Register"; "(i) has available sufficient information to substantiate that the conformity assessment procedures have been applied to the kind of medical device or that requirements, comparable to those procedures, have been applied to the kind of medical device to the satisfaction of an overseas regulator; or (ii) has procedures in place, including a written agreement with the manufacturer of the kind of device, to ensure that such information can be obtained from the manufacturer within 20 working days;"; "modalities::dl"; 1.0000; . a ; "41FO Conditions imposed when kinds of medical devices are"@en; ; "75859b98e655040e4d3a3e95b01a30a97cf5e98446251a6e9be43cec5722c760"; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.91". a ; "41FO(1) Conditions imposed when kinds of medical devices are"@en; ; "4aa47fc79c6f3bf2f65bc4899e61f87aa4da93fd331e3b53d9e9eb300360cd5c"; ; "Secretary may impose conditions on medical device inclusion in Register"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.91"; . a ; ; ; ; ; . . a ; ; "May"; "Permits Secretary to impose conditions"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Classifies"; "Classifies medical devices by type"; "modalities::dl"; 1.0000; . a ; "41FO(2) Conditions imposed when kinds of medical devices are"@en; ; "81aa35475abe6907eba26eb5aca229efead4f92925b23b79b690aca4eaf6da67"; ; "Conditions for medical devices"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.91"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligate"; "Conditions for medical devices"; "modalities::logic::deontic"; 1.0000; . . a ; ; ">="; "Temporal interval for tracking and location of devices"; "modalities::interval_reasoning"; 1.0000; . a ; "41FP Conditions imposed after kinds of medical devices are"@en; ; "75859b98e655040e4d3a3e95b01a30a97cf5e98446251a6e9be43cec5722c760"; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.92". a ; "41FP(1) Conditions imposed after kinds of medical devices are"@en; ; "e8602784d2ca7a1ebdedb948e8ee1ea8612607659a53b5d5c53850f5270c35f4"; ; "Secretary may impose new conditions on medical devices"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.92"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Imposes obligation"; "modalities::logic::deontic"; 1.0000; . . a ; ; "includes"; "Classifies medical devices"; "modalities::dl"; 1.0000; . a ; "41FP(2) Conditions imposed after kinds of medical devices are"@en; ; "22c24635143241369bd97dd2b3e24837c9d0afa4e705eba66f40d4d40272c7d9"; ; "Conditions for imposition, variation or removal of conditions under this section"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.92"; . a ; ; ; ; . a ; "41FP(3) Conditions imposed after kinds of medical devices are"@en; ; "cc1f91a9f105ba9e0eb510145cf8f238fd07e6391924a5fcec9d72b0bceef0b6"; ; "The earlier day must not be earlier than the day the notice is given to the person."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.92"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MustNot"; "The earlier day must not be earlier than the given day."; "modalities::logic::deontic"; 1.0000; . a ; "41G What this Part is about"@en; ; "a68f537923f96e3c1cd0a9b5629a612d08e1630ded0f256b8bfc902f33fab6f9"; "Inclusions in the Register may be suspended or cancelled under certain circumstances."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.93"; . a ; ; ; ; . . a ; ; "Applicable"; "Classifies inclusions in the Register"; "Inclusions in the Register may be suspended or cancelled."; "Classification of inclusions is possible"; "modalities::dl"; 1.0000; . . a ; ; "Applicable"; "Defines temporal intervals for suspension and cancellation"; "Suspension and cancellation occur under certain circumstances."; "Temporal intervals are defined"; "modalities::interval_reasoning"; 1.0000; . a ; "41GA Suspension of kinds of medical devices from the Register"@en; ; "334da9fac63999f10b5a25474cd4dd41808679e038039ae7605bc3648811ba08"; "Suspension of medical devices from the Register"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.93"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits suspension of medical devices"; "(1) The Secretary may, by written notice..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Classify"; "Classifies medical devices into the Register"; "(a) the Secretary is satisfied that..."; "modalities::dl"; 1.0000; . a ; "41GB Notice of proposed suspension must be given in certain cases"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.94". a ; "41GB(1) Notice of proposed suspension must be given in certain cases"@en; ; "5a3d7cf881f993fc6fb4376c3a7279f4a15051590fd2a59b772d2a2c3db4595f"; ; "Secretary must inform person of proposed suspension and give reasonable opportunity to make submissions."; "Notice, reasons for suspension"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.94"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Obligation to inform and provide reasons"; "modalities::logic::deontic"; 1.0000; . . a ; ; "SUBCLASS OF"; "Classifies as obligation under section 41GB(1)"; "modalities::dl"; 1.0000; . a ; "41GB(2) Notice of proposed suspension must be given in certain cases"@en; ; "299f2d39b86f593eff59286b20216ccd34c6a6b574bd888886e11025f0472a78"; ; "Secretary must consider submissions before making a decision on proposed suspension."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.94"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must consider submissions"; "Secretary is not to make a decision..."; "...until the Secretary has had regard..."; "modalities::logic::deontic"; 1.0000; . a ; "41GC Duration of suspension"@en; ; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.94". a ; "41GC(1) Duration of suspension"@en; ; "09674d4274e8ef9d1940b6d6b5d1a3f3f242e9253a8669041c8e4dd1e7f155ce"; ; "Suspension takes effect on specified day after notice is given to person."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.94"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "during"; "Suspension occurs during specified period"; "period"; "modalities::interval_reasoning"; 1.0000; . a ; "41GC(2) Duration of suspension"@en; ; "826672f262712e153782c704e8a46cfaa4492dbbbd809fbecd23841a0c7ecb7e"; ; "Suspension duration"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.94"; . a ; ; ; ; . a ; "41GC(3) Duration of suspension"@en; ; "e032af2e47e11da6e3981f1ee97a9447a42db8cd13c5296a55f27e486569c0d4"; ; "Extend period of suspension for medical device removal"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.94"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "obligation"; "Obligation to extend period of suspension"; "modalities::logic::deontic"; 1.0000; . . a ; ; "class"; "Classifies medical devices by type"; "modalities::dl"; 1.0000; . a ; "41GC(4) Duration of suspension"@en; ; "ddf6c97ca30a7dfade8989ca40552082ecba04b7ee0b1fb3990b19c82fb18763"; ; "Notice of extension publication"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.94"; . a ; ; ; ; . a ; "41GD Revocation of suspension"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.95". a ; "41GD(1) Revocation of suspension"@en; ; "6ea793a83ad30aadb484408e519e5ea3e2b9c1052bef2fbafcab64a91b8e7ac1"; ; "Revocation of suspension under specified conditions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.95"; . a ; ; ; ; ; . . a ; ; "MUST"; "Must revoke suspension"; "(1) The Secretary must revoke the suspension..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "IS_A"; "Device type is a medical device"; "(a) the ground on which the kind of medical device concerned was suspended from the Register no longer applies;"; "modalities::dl"; 1.0000; . . a ; ; "BETWEEN"; "Temporal interval for revocation"; "(1) The Secretary must revoke the suspension..."; "modalities::interval_reasoning"; 1.0000; . a ; "41GD(2) Revocation of suspension"@en; ; "6e77be1ae681ecae4417109d8de4f35a2b3c13f53cf82b9f5c81cf3206e499e3"; ; "Exercise of power to revoke suspension"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.95"; . a ; ; ; ; . a ; "41GE Treating applications for revocation as having been refused"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.96". a ; "41GE(1) Treating applications for revocation as having been refused"@en; ; "dc1819b663eb84d93f32505b68b1943d367f9cba170bf6e89b868a6e7e432f25"; ; "Applicant can treat application as refused if Secretary fails to decide within prescribed time."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.96"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "imposes"; "Duty to provide decision within time"; "modalities::logic::deontic"; 1.0000; . a ; "41GE(2) Treating applications for revocation as having been refused"@en; ; "ffe04f9a5547f6a08cc8c4c5a312863d2966e4616937a9406afc8e14c4405c62"; ; "Notice may be given at any time before decision on application."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.96"; . a ; ; ; ; "borne by: State"; ; . a ; "41GE(3) Treating applications for revocation as having been refused"@en; ; "48b78f43b36d3a58f278aae54b6bc7ae8e0c0f901dfd5d530e9fae5708a28939"; ; "If a notice has been given, the Act has no effect as if the Secretary had decided not to revoke the suspension."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.96"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Implies"; "If a notice has been given, then the Act has no effect as if the Secretary had decided not to revoke the suspension."; "Notice has been given."; "The Act has no effect as if the Secretary had decided not to revoke the suspension."; "modalities::logic::deontic"; 0.5000; . . a ; ; "Overlaps"; "The text describes a temporal interval where the notice being given overlaps with the day on which the Minister's decision was made."; "Notice has been given."; "The Minister's decision had been made on the day on which notice was given to the Secretary."; "modalities::interval_reasoning"; 0.5000; . . a ; ; "Repeats"; "The text describes a repeating pattern where the notice being given repeats indefinitely."; "Notice has been given."; "The Act has no effect as if the Secretary had decided not to revoke the suspension."; "modalities::temporal_ltl"; 0.5000; . . a ; ; "Implies"; "If a notice has been given, then the Minister's decision is confirmed by the Secretary."; "Notice has been given."; "The Minister's decision had been made on the day on which notice was given to the Secretary."; "modalities::logic::deontic"; 0.5000; . a ; "41GF Suspension where conformity assessment certificate"@en; ; "de2d423ac0393a3265f41f3dbb2ef0b7d8de3c9bcf90e777e6f9e768d351f01f"; , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.97". a ; "41GF(1) Suspension where conformity assessment certificate"@en; ; "c378395cb8ce234cf0c21cc6a787fdaeb6547f9860ec036e1fd771817211483b"; ; "Suspension of medical device from Register upon suspension of Australian conformity assessment body certificate or overseas regulator conformity assessment document. Secretary may suspend medical device from Register if conformity assessment certificate is suspended."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.97"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of medical device from Register upon suspension of relevant certificates."; "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator."; "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Classify"; "Classification of medical devices based on suspension of relevant certificates."; "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator."; "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator."; "modalities::dl"; 1.0000; . . a ; ; "During"; "Suspension occurs during suspension of relevant certificates."; "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator."; "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Until"; "Suspension continues until relevant certificates are reinstated."; "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator."; "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "If"; "Suspension occurs if relevant certificates are suspended."; "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator."; "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator."; "modalities::diffusion"; 1.0000; . . a ; ; "Classify"; "Classification of medical devices based on suspension of relevant certificates."; "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator."; "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator."; "sparql_library::parsers::chk_parser"; 1.0000; . . a ; ; "may"; "Implies obligation"; "modalities::logic::deontic"; 1.0000; . . a ; ; "is included in the Register"; "Classifies device as part of a set"; "modalities::dl"; 1.0000; . a ; "41GF(2) Suspension where conformity assessment certificate"@en; ; "bbf02e053fa4c0c75216c7097e5c20fbcca633faa9a36186a30bdf657c616203"; ; "Suspension under this section is limited to the same extent as suspension under Division 3 of Part 4-4. Secretary must take action before suspending a device from the Register"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.97"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "implies"; "If suspension under Division 3 of Part 4-4 is limited to some medical devices, then suspension under this section is also limited."; "Suspension under Division 3 of Part 4-4 is limited to some medical devices."; "Suspension under this section is limited to the same extent as suspension under Division 3 of Part 4-4."; "modalities::logic::deontic"; 1.0000; . a ; "41GF(3) Suspension where conformity assessment certificate"@en; ; "33a6585a57e6347acb64c1d7cc8921937d87be58a1d33c8a26114f5a7136f7df"; ; "Secretary must publish notice of suspension particulars."; "Notice setting out particulars of the suspension."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.97"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Secretary must publish notice."; "modalities::logic::deontic"; 1.0000; . a ; "41GF(1) Suspension where conformity assessment certificate"@en; ; "f31e237bc8d88a315fe3a61d1a9046c6b81da7071df38fe383a22e54ae81904e"; ; "Suspension of medical device from Register upon suspension of Australian conformity assessment body certificate or overseas regulator conformity assessment document. Secretary may suspend medical device from Register if conformity assessment certificate is suspended."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.97"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of medical device from Register upon suspension of relevant certificates."; "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator."; "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Classify"; "Classification of medical devices based on suspension of relevant certificates."; "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator."; "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator."; "modalities::dl"; 1.0000; . . a ; ; "During"; "Suspension occurs during suspension of relevant certificates."; "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator."; "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Until"; "Suspension continues until relevant certificates are reinstated."; "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator."; "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "If"; "Suspension occurs if relevant certificates are suspended."; "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator."; "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator."; "modalities::diffusion"; 1.0000; . . a ; ; "Classify"; "Classification of medical devices based on suspension of relevant certificates."; "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator."; "(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator."; "sparql_library::parsers::chk_parser"; 1.0000; . . a ; ; "may"; "Implies obligation"; "modalities::logic::deontic"; 1.0000; . . a ; ; "is included in the Register"; "Classifies device as part of a set"; "modalities::dl"; 1.0000; . a ; "41GF(2) Suspension where conformity assessment certificate"@en; ; "bbf60f0055493859d0bac39a4639feeefdb2f095a0acd646e5eebff67f5f4a48"; ; "Suspension under this section is limited to the same extent as suspension under Division 3 of Part 4-4. Secretary must take action before suspending a device from the Register"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.97"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "implies"; "If suspension under Division 3 of Part 4-4 is limited to some medical devices, then suspension under this section is also limited."; "Suspension under Division 3 of Part 4-4 is limited to some medical devices."; "Suspension under this section is limited to the same extent as suspension under Division 3 of Part 4-4."; "modalities::logic::deontic"; 1.0000; . a ; "41GG Duration of suspension"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.98". a ; "41GG(1) Duration of suspension"@en; ; "72ca4ff0608a19a61baf7899c5d34c21529196a3e3d8312da2676b92cf63bd9c"; ; "Commencement of suspension"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.98"; . a ; ; ; ; . a ; "41GG(2) Duration of suspension"@en; ; "8ad0e065f67bc10386559e386bc782b3f4ff128aa9ca9ed496671d4fa98b1e47"; ; "Duration of suspension"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.98"; . a ; ; ; ; . a ; "41GH Revocation of suspension"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.98". a ; "41GH(1) Revocation of suspension"@en; ; "45461ec0b92986ace18562ec383e6df8c4c07b145a2590d4e9cc49b50368987f"; ; "Secretary must revoke suspension under certain conditions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.98"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Obligation to revoke suspension"; "Secretary has power to revoke suspension"; "Suspension must be revoked"; "modalities::logic::deontic"; 1.0000; . . a ; ; "IS_A"; "Definition of revocation"; "Revocation is defined as cessation of effect"; "Cessation of effect is revocation"; "modalities::dl"; 1.0000; . a ; "41GH(1A) Revocation of suspension"@en; ; "d99d3a48ffa94b010bb9a55e6fbc9daa55ad5505c9207f2cb70da0cb7154783a"; ; "The Secretary may revoke a suspension under section 41GFA if certain conditions are met."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.98"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "The Secretary may revoke a suspension under section 41GFA."; "modalities::logic::deontic"; 1.0000; . . a ; ; "includes"; "The kind of medical device is included in the Register."; "modalities::dl"; 1.0000; . a ; "41GH(2) Revocation of suspension"@en; ; "1de5133029405503c5c816c6c89c4ff30850a1843eeaaf6d8bd57b23e28dbe81"; ; "Secretary must provide written notice and publish revocation notice within specified timeframe."; "Notice of revocation, publication in Gazette or website"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.98"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Obligation to provide notice and publish revocation"; "modalities::logic::deontic"; 1.0000; . . a ; ; "SUBCLASS OF"; "Classification of revocation as a subclass of suspension"; "modalities::dl"; 1.0000; . a ; "41GI Effect of suspension"@en; ; "3889513ab0f22b32bcd075bf226ff0fb3a3b8c43c4acc57a2b56f0be5883f96b"; "Medical devices of a particular kind are not included in the Register while suspension has effect."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.99"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits dealing in medical devices not included in the Register."; "modalities::logic::deontic"; 1.0000; . a ; "41GJ Powers of cancellation from Register unaffected"@en; ; "aeed5f9971e1f789ce2ab41c7f40d24cbb3b5fd59a8eb1636856dc8f89ada54c"; "Does not affect Secretary's powers to cancel medical device entries from Register"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.99"; . a ; ; ; ; . a ; "41GK Automatic cancellation of entries of kinds of medical devices"@en; ; "c6d86f1a6923df492080f306eb2d82402bad8a5777b2a89543a293bddc8a7a85"; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.100". a ; "41GK(1) Automatic cancellation of entries of kinds of medical devices"@en; ; "c6d574381a9ce19824affbff7633af739935325583d3002c7924462f96fd70e0"; ; "Secretary must cancel entry of medical device from Register under certain conditions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.100"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Secretary must cancel entry"; "modalities::logic::deontic"; 1.0000; . . a ; ; "hasPartOf"; "Relation to Register"; "Register"; "kind of medical device"; "modalities::dl"; 1.0000; . a ; "41GK(2) Automatic cancellation of entries of kinds of medical devices"@en; ; "7807d96c894396f62ebcfa222e81ce664457c57f3fd1bff8685ca87e9b82f839"; ; "Automatic cancellation of entries of kinds of medical devices if they contravene absolute prohibitions or conditions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.100"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Absolute prohibition on imports, exports, manufacture, and supplies."; "There are one or more absolute prohibitions in force for the purposes of subsection 9K(1) or (3)."; "Imports, exports, manufacture, and supplies would contravene one or more of those prohibitions."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibit"; "Conditioned prohibition on imports, exports, manufacture, and supplies."; "There are one or more prohibitions in force for the purposes of subsection 9K(1) or (3) that are subject to conditions."; "Imports, exports, manufacture, and supplies would contravene one or more of those conditions."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Classify"; "Classification of medical devices based on prohibitions and conditions."; "The Secretary must cancel the entry of the kind of device from the Register if..."; "The device is classified as prohibited or subject to conditions."; "modalities::dl"; 1.0000; . . a ; ; "Overlap"; "Temporal overlap between prohibitions and device manufacture/supplies."; "If there are one or more absolute prohibitions in force for the purposes of subsection 9K(1) or (3)."; "The device manufacture/supplies would contravene one or more of those prohibitions."; "modalities::interval_reasoning"; 0.5000; . . a ; ; "Recurring"; "Recurring trace of prohibited devices."; "There are one or more prohibitions in force for the purposes of subsection 9K(1) or (3)."; "The device would be subject to recurring prohibition."; "modalities::temporal_ltl"; 0.5000; . . a ; ; "Spread"; "Spread of prohibited devices through imports, exports, manufacture, and supplies."; "If there are one or more prohibitions in force for the purposes of subsection 9K(1) or (3)."; "The device would spread to other areas."; "modalities::diffusion"; 0.5000; . a ; "41GL Immediate cancellation of entries of kinds of medical devices"@en; ; "f62153ad257d879789e6b825650e66eea86f6b11e9e471f8d23cae56d8f58dc2"; "Cancellation of medical device entries from the Register"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.101"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition on continued inclusion of medical devices in the Register"; "The Secretary may cancel the entry of a kind of device from the Register if..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Classify"; "Classification of medical devices into therapeutic goods and medical devices"; "devices of that kind are no longer therapeutic goods; or"; "modalities::dl"; 1.0000; . a ; "41GM Cancellation of entries of kinds of medical devices from the"@en; ; "b9e62828abfd28c6a31138351f9d2abda0a4c1b2bda3498dcc4678ba133adba5"; "Cancellation of entries from medical device register upon non-compliance with notice."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.103"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits cancellation of entries without compliance."; "Notice given under section 41JA."; "Cancellation not permitted."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Classify"; "Classifies medical devices based on non-compliance with notice."; "Person fails to comply with notice under section 41JA."; "Device entry cancelled."; "modalities::dl"; 1.0000; . . a ; ; "Recurring"; "Recurring trace of non-compliance leads to cancellation."; "Notice given for ascertainment purposes."; "Cancellation upon repeated non-compliance."; "modalities::temporal_ltl"; 1.0000; . a ; "41GN Cancellation of entries of kinds of medical devices from the"@en; ; "853a9af14612eed65a1d0763c289e120255dd5e7f9bae31bb9d9b21c83e63351"; "The Secretary may cancel an entry of a kind of medical device from the Register under certain conditions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.104"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "can"; "The Secretary can cancel an entry of a kind of medical device from the Register."; "modalities::logic::deontic"; 1.0000; . . a ; ; "is-a"; "The cancellation is related to changes in the safety or performance of the device."; "modalities::dl"; 1.0000; . . a ; ; ">="; "The cancellation must occur within a certain timeframe after notice is given."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "<"; "The cancellation must occur before the device's conformity assessment document expires."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "must"; "The person in relation to whom the kind of medical device is included in the Register must comply with certain conditions."; "modalities::logic::deontic"; 1.0000; . . a ; ; "implies"; "The cancellation implies that the person has failed to comply with a condition or direction."; "modalities::argumentation"; 1.0000; . a ; "41GO Limiting cancellation of entries from Register to some"@en; ; "fa990293713b01e938971b745b1613bfff5cd7af3c6785fd54ab5dee391d4aae"; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.106". a ; "41GO(1) Limiting cancellation of entries from Register to some"@en; ; "e68abce408d29a18b517f505f52402504d39577fd92d0378d95e51e002f3321a"; ; "Secretary must limit cancellation of entries from Register to some medical devices."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.106"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide limit on cancellation."; "modalities::logic::deontic"; 1.0000; . . a ; ; "CLASSIFICATION"; "Classify medical devices into categories."; "modalities::dl"; 1.0000; . a ; "41GO(2) Limiting cancellation of entries from Register to some"@en; ; "c4682c28ae040f9dad49d18c711476e4cf30402eb69bfc9c906911c22572c462"; ; "Must vary entry in Register upon cancellation of medical device"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.106"; . a ; ; ; ; ; . . a ; ; "MUST"; "Obligation to vary entry in Register"; "(2) If the cancellation of the entry of a kind of medical device from the Register is limited to some medical devices of that kind..."; "...the Secretary: (a) must vary the entry in the Register accordingly;"; "modalities::logic::deontic"; 1.0000; . . a ; ; "SUBCLASS OF"; "Varying entry in Register is a subclass of obligation to update"; "(2) If the cancellation of the entry of a kind of medical device from the Register is limited to some medical devices of that kind..."; "...the Secretary: (a) must vary the entry in the Register accordingly;"; "modalities::dl"; 1.0000; . . a ; ; "CONTAINS"; "Varying entry in Register occurs within cancellation of medical device"; "(2) If the cancellation of the entry of a kind of medical device from the Register is limited to some medical devices of that kind..."; "...the Secretary: (a) must vary the entry in the Register accordingly;"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "CONTAINS"; "Varying entry in Register occurs within cancellation of medical device"; "(2) If the cancellation of the entry of a kind of medical device from the Register is limited to some medical devices of that kind..."; "...the Secretary: (a) must vary the entry in the Register accordingly;"; "modalities::temporal_ltl"; 1.0000; . . a ; ; "MUST NOT"; "Must not delete entry from Register upon cancellation of medical device"; "(2) If the cancellation of the entry of a kind of medical device from the Register is limited to some medical devices of that kind..."; "...the Secretary: (b) must not delete the entry from the Register because of the cancellation."; "modalities::logic::deontic"; 1.0000; . . a ; ; "SUBCLASS OF"; "Not deleting entry from Register is a subclass of obligation to preserve"; "(2) If the cancellation of the entry of a kind of medical device from the Register is limited to some medical devices of that kind..."; "...the Secretary: (b) must not delete the entry from the Register because of the cancellation."; "modalities::dl"; 1.0000; . a ; "41GP Publication of cancellation of entry from Register"@en; ; "e584f3c5b9d0f68cb805945dc2ff98262902c3a1f2551dfcb2483000f06ee7cd"; "Publish notice of cancellation from Register after cancelling medical device entry."; "Notice setting out particulars of cancellation."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.106"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Obligation to publish notice."; "modalities::logic::deontic"; 1.0000; . . a ; ; "SUBCLASS_OF"; "Publication of cancellation from Register is a subclass of obligation."; "modalities::dl"; 1.0000; . a ; "41GQ Date of effect of cancellation of entries from Register"@en; ; "3a64e9cca769ce053f9f99555c5b2e4a105c1de497a1c40cde6d7ca52703a571"; "Cancellation of medical device entries has a specified effective date."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.107"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "="; "Identifies the key"; "key"; "modalities::dl"; 1.0000; . . a ; ; ">="; "Specifies a later day"; "20 working days after notice is given"; "later day"; "modalities::interval_reasoning"; 1.0000; . a ; "41GR What this Part is about"@en; ; "eea092c90008fb9a07610d549021ba93cc906c12803cefde1bc9505ef67ad928"; "Exemption of medical devices from certain provisions"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.108"; . a ; ; ; ; ; . . a ; ; "Permit"; "Granting permission to exempt medical devices"; "The Minister may exempt certain medical devices"; "from various provisions of this Chapter"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Temporal Interval"; "Conditional commencement of exemptions"; "The Minister may exempt certain medical devices from various provisions of this Chapter so that the devices may be stockpiled to deal with possible future emergencies or made available urgently to deal with actual emergencies."; "Note 1:"; "modalities::interval_reasoning"; 0.5000; . . a ; ; "Recurring Trace"; "Recurring trace of exemptions under Part 41GR"; "The Minister may exempt certain medical devices from various provisions of this Chapter so that the devices may be stockpiled to deal with possible future emergencies or made available urgently to deal with actual emergencies."; "Note 2:"; "modalities::temporal_ltl"; 0.5000; . . a ; ; "Obligation"; "Obligation to provide information about exemptions under Part 41GR"; "Some of the other provisions of this Act about medical devices exempt under this Part are:"; "(a) section 41JCA (providing information to the Secretary); and (b) section 41KA (public notification and recall of medical devices);"; "modalities::logic::deontic"; 0.5000; . . a ; ; "Obligation"; "Obligation to provide information about exemptions under Part 41GR"; "Some of the other provisions of this Act about medical devices exempt under this Part are:"; "(c) section 46A (search of premises)."; "modalities::logic::deontic"; 0.5000; . a ; "41GS Minister may make exemptions"@en; ; , , , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.108". a ; "41GS(1) Minister may make exemptions"@en; ; "8f7d568322b92bc8d8367ae811ea9c692ee969d1754d033eabe0107f744c2a91"; ; "Minister may exempt specified kinds of medical devices from certain regulations."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.108"; . a ; ; ; ; ; . . a ; ; "may"; "Permission to exempt"; "modalities::logic::deontic"; 1.0000; . a ; "41GS(1A) Minister may make exemptions"@en; ; "3907b28cab63116b3cbcc615f3b28f6c6e173fb1ffc4af1ff36648ccbb7ceeed"; ; "Minister may grant exemptions under certain conditions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.108"; . a ; ; ; ; ; . . a ; ; "May"; "Permission to exempt devices"; "modalities::logic::deontic"; 0.5000; . a ; "41GS(2) Minister may make exemptions"@en; ; "be390aee62340ad3c21ff768660a4ac7d7f1949029be469e6246f8b30ade7fff"; ; "Minister may make exemptions in the national interest to stockpile medical devices quickly and provide them urgently in case of an emergency."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.108"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Minister has the obligation to make exemptions in the national interest."; "modalities::logic::deontic"; 1.0000; . a ; "41GS(2A) Minister may make exemptions"@en; ; "9fea32571133fa9883b178cce7b2d45ec76a839b767e8b02b2cc9632eb911b88"; ; "Exemption from certain requirements under national emergency declaration"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.108"; . a ; ; ; ; ; . . a ; ; "Permit"; "Granting permission"; "Minister has discretion to make exemptions"; "Exemption is permitted"; "modalities::logic::deontic"; 1.0000; . a ; "41GS(3) Minister may make exemptions"@en; ; "9a759f9f0ef6c9e3a02d4a6434ec4cf54bee790f0b59bcb86d74aac5fc192333"; ; "Exemptions come into force on specified day or later"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.108"; . a ; ; ; ; . a ; "41GS(4) Minister may make exemptions"@en; ; "ceab7404d3be37f63cfa109125924695ecbeb77b4b260e1477e9b093fd0a00e1"; ; "Exemptions remain in force for the specified period unless revoked earlier."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.108"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "holds"; "Holds true"; "modalities::logic::deontic"; 1.0000; . . a ; ; "subClassOf"; "Subclass of exemptions"; "modalities::dl"; 1.0000; . a ; "41GS(5) Minister may make exemptions"@en; ; "c862e06fc4f632cb6d930160b555a6456a373141c9b3b74c75e407f10a742923"; ; "Exemption ceases to have effect when device is included in the Register."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.108"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "ceases"; "Obligation ceases"; "(5) An exemption under subsection (1)"; "ceases to have effect in relation to a particular kind of medical device"; "modalities::logic::deontic"; 1.0000; . . a ; ; "includes"; "Device inclusion implies exclusion"; "(5) An exemption under subsection (1)"; "exemption ceases when device is included in the Register"; "modalities::dl"; 1.0000; . a ; "41GT Conditions of exemptions"@en; ; "a2f20c9a6d16e2b346d4805fcfebca92fa2232f36749b6566b2334812bd7ff46"; "Conditions for exemptions under section 41GS"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.110"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "must"; "Conditions must be met for exemptions"; "An exemption under section 41GS is subject to conditions"; "Those conditions must be met"; "modalities::logic::deontic"; 1.0000; . . a ; ; "is-a"; "Conditions are related to exemptions"; "The conditions specified in the exemption about any of the following:"; "Exemptions have conditions"; "modalities::dl"; 1.0000; . a ; "41GU Variation or revocation of exemption"@en; ; "c2f34d233068d447bce67a922c935760ef233255887c06da805ed973ebd562ed"; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.111". a ; "41GU(1) Variation or revocation of exemption"@en; ; "e413dd58d74872681fd6c61b0993929d07cab89937e224121c84d67faeb0f808"; ; "Variation of exemption by Minister"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.111"; . a ; ; ; ; ; . . a ; ; "may"; "Granting permission to vary exemptions"; "modalities::logic::deontic"; 1.0000; . a ; "41GU(2) Variation or revocation of exemption"@en; ; "afba112cf19953e9e04121cacb4674ff2fa9c3249dd2aa4efcb40e61c2926d81"; ; "Revocation of exemption by Minister"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.111"; . a ; ; ; ; ; . . a ; ; "Permit"; "Granting permission"; "(2) The Minister may, by writing..."; "The exemption is revoked."; "modalities::logic::deontic"; 1.0000; . a ; "41GU(3) Variation or revocation of exemption"@en; ; "a78195726c8076a4b1ff3191029b528c9107559d2525441f3bffbceff12a9959"; ; "Variation or revocation of exemption conditions"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.111"; . a ; ; ; ; ; . . a ; ; "may"; "Permission to vary or revoke exemptions"; "modalities::logic::deontic"; 1.0000; . a ; "41GU(4) Variation or revocation of exemption"@en; ; "6b984b4a1f8f1933cbe0bcba6343b5214fd57a9f65feaaef1381e6cdc443ee07"; ; "Variation or revocation of exemption takes effect under specified conditions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.111"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "obligation"; "Obligation to specify conditions for variation or revocation"; "Minister must state imminent risk"; "Variation or revocation takes effect under specified conditions"; "modalities::logic::deontic"; 1.0000; . . a ; ; "between"; "Temporal interval between variation or revocation and its effect"; "Variation or revocation is made on a specific day"; "Effect of variation or revocation occurs within 28 days after it is made"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "until"; "Temporal interval until effect of variation or revocation"; "Variation or revocation takes effect on a later day specified in the variation or revocation"; "Effect of variation or revocation occurs after specified day"; "modalities::temporal_ltl"; 1.0000; . . a ; ; "diffuses"; "Diffusion of information about variation or revocation"; "Minister states imminent risk in variation or revocation"; "Information about imminent risk diffuses to relevant parties"; "modalities::diffusion"; 1.0000; . . a ; ; "recognizes"; "CogAI recognizes variation or revocation as a subclass of exemption"; "Variation/Revocation is recognized as a subclass of Exemption by CogAI"; "Exemption has subclasses Variation and Revocation recognized by CogAI"; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "41GV Informing persons of exemption etc."@en; ; "3d3060966f168c012e40bbfd3e80c302f3a14ff4ddafd14633227d89c7f11b52"; "Must provide Chapter 4 Medical devices to persons covered by paragraph 41GT(c)"; "Yes"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.111"; . a ; ; ; ; ; . . a ; ; "MUST PROVIDE"; "Must provide Chapter 4 Medical devices"; "modalities::logic::deontic"; 1.0000; . . a ; ; "CONTAINS"; "The Minister must provide Chapter 4 Medical devices within a reasonable timeframe"; "modalities::interval_reasoning"; 1.0000; . a ; "41GW Notification and tabling"@en; ; "7d31b83313991d4c969b95ff28385ff891514dbe7a93c93c5db8145ad031420f"; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.112". a ; "41GW(1) Notification and tabling"@en; ; "29f9f12af4236a1244485a3ed5640c3b83ac59254f7fd0961b4ce4f336a461fe"; ; "Publish notice in Gazette within 5 working days after exemption, variation or revocation is made."; "Notice setting out particulars of exemption, variation or revocation"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.112"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must publish notice in Gazette"; "modalities::logic::deontic"; 1.0000; . a ; "41GW(2) Notification and tabling"@en; ; "b0cfa78d6c799a7c3a5e90b8595a9a77e89a701a27ef546659861844729cc045"; ; "Minister must table document within 5 sitting days of exemption, variation or revocation made."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.112"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Minister must table document"; "modalities::logic::deontic"; 1.0000; . a ; "41GY Disposal of unused medical devices"@en; ; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.113". a ; "41GY(1) Disposal of unused medical devices"@en; ; "5c53a1db42c9bbe45fd59af1893703f5ec2641ec737e07fffabb3ea545c2dd1e"; ; "Medical device must be disposed of if exemption ceases to have effect"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.113"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must be disposed of"; "(1) This section applies to a medical device..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "IS_A"; "Related to disposal of medical devices"; "(a) an exemption under section 41GS in relation to that kind of medical device ceases to have effect..."; "modalities::dl"; 1.0000; . . a ; ; ">="; "Cease to have effect before use"; "(b) the medical device has not been used before the exemption so ceases to have effect."; "modalities::interval_reasoning"; 1.0000; . a ; "41GY(2) Disposal of unused medical devices"@en; ; "210d8dfdc02f50afa3716069d8cd90d09753d229b853ef59b3f9e0770a1cb8a7"; ; "The Secretary may arrange for disposal of medical devices."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.113"; . a ; ; ; ; ; . . a ; ; "may"; "Implies obligation"; "modalities::logic::deontic"; 1.0000; . a ; "41GY(3) Disposal of unused medical devices"@en; ; "7a0a2c6b8f91ead93a1acd3f8a1de0a893a56d78d9f89cee35e3fa852bedb462"; ; "Methods for disposal of medical devices"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.113"; . a ; ; ; ; . a ; "41GY(4) Disposal of unused medical devices"@en; ; "b7d3ce3966fe9385b49a1128277bfc857753511ebf0cfa2c98090f389e126ffa"; ; "Prohibits benefit conferred on person other than owner of medical device"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.113"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "forbid"; "Prohibits benefit"; "(4) A method set out in the regulations under subsection (3)"; "must not enable or permit any benefit to be conferred on a person (including the Commonwealth) other than the owner of the medical device."; "modalities::logic::deontic"; 1.0000; . . a ; ; "during"; "Temporal scope of regulation"; "(4) A method set out in the regulations under subsection (3)"; "must not enable or permit any benefit to be conferred on a person (including the Commonwealth) other than the owner of the medical device."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "during"; "Temporal scope of regulation"; "(4) A method set out in the regulations under subsection (3)"; "must not enable or permit any benefit to be conferred on a person (including the Commonwealth) other than the owner of the medical device."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "during"; "Temporal scope of regulation"; "(4) A method set out in the regulations under subsection (3)"; "must not enable or permit any benefit to be conferred on a person (including the Commonwealth) other than the owner of the medical device."; "modalities::diffusion"; 1.0000; . . a ; ; "during"; "Temporal scope of regulation"; "(4) A method set out in the regulations under subsection (3)"; "must not enable or permit any benefit to be conferred on a person (including the Commonwealth) other than the owner of the medical device."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "41H What this Part is about"@en; ; "d0b9f3fba29013895845d7e6c428848ca9b2b43ce8d240438dc86a9e56a72764"; "Exemptions from prohibitions on dealing in medical devices"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.114"; . a ; ; ; ; "borne by: State"; ; . a ; "41HA Devices exempted from inclusion in the Register"@en; ; "7f1733ffac81395e1fe88e5199b597b0a861fb474b07d522a69c36da568b5ba0"; "Exemptions from Division 3 regulation"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.114"; . a ; ; ; ; . a ; "41HB Approvals for special and experimental uses"@en; ; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.115". a ; "41HB(1) Approvals for special and experimental uses"@en; ; "352553e576350966faea334f04b3711329e2fe10af10c657d62a8696203ce3c7"; ; "Grant of written approval for specified medical device use"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.115"; . a ; ; ; ; "borne by: State"; ; . a ; "41HB(1A) Approvals for special and experimental uses"@en; ; "d031f04ea0fe34f08843a7672884fbb9a910ab375ffcf47a77985b10fb0a7d1e"; ; "Approval for special and experimental uses must be granted only to health practitioners."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.115"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits granting approval to non-health practitioners."; "(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."; "Approval must be granted only to health practitioners."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Temporal Interval"; "Defines temporal interval for approval of special and experimental uses."; "(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."; "Approval of special and experimental uses has a specific temporal interval."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Temporal Interval"; "Defines temporal interval for approval of special and experimental uses."; "(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."; "Approval of special and experimental uses has a specific temporal interval."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Diffuse"; "Diffuses information about approval eligibility for special and experimental uses."; "(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."; "Approval eligibility for special and experimental uses is diffused through the system."; "modalities::diffusion"; 1.0000; . . a ; ; "Classify"; "Classifies approval for special and experimental uses as requiring health practitioner eligibility."; "(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."; "Approval for special and experimental uses requires health practitioner eligibility."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "41HB(2) Approvals for special and experimental uses"@en; ; "ab15e615cf1485736bcf912cca9402cd88cce451ea1945b0d851d5d74d6aa8f9"; ; "Breach of conditions may be an offence"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.115"; . a ; ; ; ; ; . . a ; ; "Prohibition"; "Prohibition of breach"; "Breach of conditions may be an offence"; "modalities::logic::deontic"; 1.0000; . a ; "41HB(3) Approvals for special and experimental uses"@en; ; "89cfe9e326c2ba342414f56352c8aa21cec0d89d9ef7f36fed9308dc51a3ede1"; ; "Conditions for approval of medical devices for experimental use in humans."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.115"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "requires"; "Requires preconditions"; "(a) the preconditions on another person’s use of devices of those kinds for those purposes;"; "modalities::logic::deontic"; 1.0000; . . a ; ; "for all"; "For all persons using medical devices"; "(a) the preconditions on another person’s use of devices of those kinds for those purposes;"; "modalities::temporal_ltl"; 1.0000; . . a ; ; "requires"; "Requires principles of device use"; "(b) the principles to be followed in another person’s use of devices of those kinds for those purposes;"; "modalities::logic::deontic"; 1.0000; . . a ; ; "during"; "During experimental use"; "The conditions may relate to one or more of the following:"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "requires"; "Requires relation to device types"; "The conditions may relate to one or more of the following:"; "modalities::logic::deontic"; 1.0000; . a ; "41HC Authorities for health practitioners"@en; ; , , , , , , , , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.118". a ; "41HC(1) Authorities for health practitioners"@en; ; "08e94b5aa0a6f89a75f4d49ee3e52328307cc53ed896431e7b1f9feb751be972"; ; "Secretary may authorise medical practitioner to supply medical devices."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.118"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Permission granted by the Secretary."; "modalities::logic::deontic"; 1.0000; . . a ; ; "hasPart"; "Class of recipients specified in the authorisation."; "modalities::dl"; 1.0000; . a ; "41HC(1A) Authorities for health practitioners"@en; ; "08807ce063a19d294a3e8ec5c4286cac61c2b55d571ffb679a457b7ada675751"; ; "Application for authority must be in approved form"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.118"; . a ; ; ; ; ; . . a ; ; "MUST"; "Must provide approved application form"; "modalities::logic::deontic"; 1.0000; . a ; "41HC(2) Authorities for health practitioners"@en; ; "41bbe3f7b0e8be4adc01ff2dfcf5c78e432b82c881576ba1a94b9417c5e330aa"; ; "Authority may be given subject to conditions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.118"; . a ; ; ; ; ; . a ; "41HC(3) Authorities for health practitioners"@en; ; "ab1be10173ebd250d4983f838d8f46c71bdbe68186b50e76f20802f15c174655"; ; "Secretary may impose conditions on health practitioners"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.118"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Imposes obligation"; "modalities::logic::deontic"; 1.0000; . a ; "41HC(4) Authorities for health practitioners"@en; ; "e1408ad811ceeab1bae29cde67bccf0e6c49ecbe1c04509f16f4c44064f33fc1"; ; "Authority for health practitioners may only be given under certain conditions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.118"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "onlyIf"; "Authority is conditional on meeting specific requirements."; "(a) and (b)"; "(c)"; "modalities::logic::deontic"; 1.0000; . . a ; ; "classOf"; "Authority applies to classes of medical practitioners."; "(a) and (c)"; "modalities::dl"; 1.0000; . a ; "41HC(5) Authorities for health practitioners"@en; ; "4127a130e53b5ae4701e57a453a09fba170f6af4c7e0bfc7bf1e43c2240f7b6b"; ; "Authority to prescribe circumstances for medical device supply"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.118"; . a ; ; ; ; ; . a ; "41HC(6) Authorities for health practitioners"@en; ; "a016e316ef1eef411c484cd78dd143922d11ef471445b79d7be7a588475fd4b8"; ; "The Minister may make rules authorising health practitioners to supply medical devices."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.118"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "May"; "Permission to supply medical devices"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Class inclusion"; "Rules specify class of health practitioners"; "Health practitioner included in a specified Medical device Chapter 4"; "modalities::dl"; 1.0000; . a ; "41HC(6A) Authorities for health practitioners"@en; ; "7c92974776fae4a198331df92c95469c340dbac72b28d11db8e12b38dbdba874"; ; "Comply with regulations' requirements, restrictions, and limitations."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.118"; . a ; ; ; ; ; . . a ; ; "Must"; "Minister must comply with regulations."; "(6A) In making rules under subsection (6), the Minister..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Within"; "Requirements, restrictions, and limitations are within regulations."; "(b) such restrictions (if any) as are prescribed by the regulations;"; "modalities::interval_reasoning"; 1.0000; . a ; "41HC(6B) Authorities for health practitioners"@en; ; "f8aff130f6ec9d4a93d62f804116cd2a51103c75b6df027e0083bcdc55c87cb3"; ; "Notify supply within 28 days after supplying medical device."; "true"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.118"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide notification."; "modalities::logic::deontic"; 1.0000; . . a ; ; "hasValue"; "Notification must be made within 28 days."; "modalities::dl"; 1.0000; . a ; "41HC(6C) Authorities for health practitioners"@en; ; "0db592c10b0d037eb185b179260eccb080b354894575a5eb0133929ddc80a90d"; ; "Notification requirements for health practitioners"; "Information as prescribed by regulations"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.118"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Notification requirement"; "modalities::logic::deontic"; 1.0000; . a ; "41HC(6D) Authorities for health practitioners"@en; ; "8e572ad786200e3e525ce99d60a484b86e1a5f35ac34f11d78b86ed0156b72e6"; ; "Approval of form may require or permit information to be given in accordance with specified software requirements."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.118"; . a ; ; ; ; ; . a ; "41HC(6E) Authorities for health practitioners"@en; ; "900c67275c14e5cc826153a8bbad159216cdcd1614cdc5ddb659282dbed31dc2"; ; "Offence for subject to requirement under subsection (6B)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.118"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "has"; "Subject is required"; "(6B)"; "(6E)"; "modalities::logic::deontic"; 1.0000; . a ; "41HD Approvals if substitutes for medical devices are unavailable"@en; ; "41b387a9617d9ffde9dc713bb94531bfc48d834db2fdc78d61c2040332d7bd35"; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.120". a ; "41HD(1) Approvals if substitutes for medical devices are unavailable"@en; ; "e7cef7375c9f89a509bce3be49afba081b69933ebc63b33164ff304e8e58a88d"; ; "Secretary may grant approval for importation and supply of medical device under certain conditions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.120"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Grant"; "Secretary grants approval."; "(1) The Secretary may, by notice in writing..."; "...the Secretary is satisfied that..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Classify"; "Medical devices included in the Register are classified as substitutes."; "(i) are unavailable or are in short supply;"; "...the kinds of medical devices included in the Register..."; "modalities::dl"; 1.0000; . . a ; ; "Temporal Interval"; "Medical device may become unavailable or be in short supply."; "(ii) may, in the reasonably foreseeable future, become unavailable or be in short supply;"; "...the medical device is specified in a determination under subsection (6);"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Obligation"; "Secretary must satisfy certain conditions before granting approval."; "(c) the kinds of medical devices included in the Register that..."; "...the Secretary is satisfied that..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Permission"; "Approval is necessary in the interests of public health."; "(f) the approval is necessary in the interests of public health."; "...the Secretary may, by notice in writing..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Permission"; "Medical device must be registered or approved for general marketing in at least one foreign country."; "(i) the medical device is registered or approved for general marketing in at least one foreign country specified in a determination under subsection (5);"; "...the Secretary may, by notice in writing..."; "modalities::logic::deontic"; 1.0000; . a ; "41HD(1A) Approvals if substitutes for medical devices are unavailable"@en; ; "3a0b306536ac9f6cbb91e0095344f956f9d726b79ee27e4bbc701e56980f2fc8"; ; "Secretary may grant approval for importation of medical device under certain conditions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.120"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Grant"; "Secretary grants approval"; "Secretary has discretion to grant approval"; "Approval granted"; "modalities::logic::deontic"; 1.0000; . a ; "41J What this Part is about"@en; ; "faacb78c69535bdc9c4ffe17e3ca844bfab4c9ce2f579d8f4f1310c7452b98a6"; "The Secretary may seek information or documents relating to certain matters."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.125"; . a ; ; ; ; "borne by: State"; ; . a ; "41JA Secretary may require information or documents"@en; ; "7f98bca1fec2c45eb979dafe67f6e595443e88d4d98c681e128437814c703285"; "The Secretary may require information or documents from a person related to medical devices."; "Yes"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.126"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "The Secretary must require information or documents."; "modalities::logic::deontic"; 1.0000; . . a ; ; "SUBCLASS_OF"; "The provision is part of the Therapeutic Goods Act 1989."; "modalities::dl"; 1.0000; . a ; "41JB Complying with the Secretary’s requirements"@en; ; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.129". a ; "41JB(1) Complying with the Secretary’s requirements"@en; ; "f40a56a96fa8cf5078cb2f4294413ee27c81a1ce883e0acdab714ac925caa5c8"; ; "Provide information or documents to the Secretary within a specified time and form."; "true"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.129"; . a ; ; ; ; "borne by: NaturalPerson"; ; . . a ; ; "MUST"; "Must provide information or documents"; "modalities::logic::deontic"; 1.0000; . a ; "41JB(2) Complying with the Secretary’s requirements"@en; ; "77b552611898c7df1dd7a8f2b1e5a0cf2b437e1ee6644377a49a686ef23c2658"; ; "Comply with specified software requirements for data processing device or electronic transmission."; "Offence for failing to comply with a notice"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.129"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must comply"; "modalities::logic::deontic"; 1.0000; . . a ; ; "IS-A"; "Complying with requirements is a form of compliance"; "modalities::dl"; 1.0000; . a ; "41JB(3) Complying with the Secretary’s requirements"@en; ; "1be65ce8f73e1c3edc90e7157f54221deda5c3748cc47ebc244be6fb4466746c"; ; "Failure to comply with notice leads to penalty and potential suspension/cancellation of certificates."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.129"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits failure to comply with notice."; "Given notice under section 41JA"; "Penalty of 500 penalty units."; "modalities::logic::deontic"; 1.0000; . . a ; ; "ClassInclusion"; "Includes conditions for suspension/cancellation of certificates."; "Divisions 3 and 4 of Part 4-4"; "Suspension or revocation of conformity assessment certificate."; "modalities::dl"; 1.0000; . . a ; ; "ClassInclusion"; "Includes conditions for suspension/cancellation of medical device entries."; "Part 4-6"; "Suspension or cancellation of entry in Register."; "modalities::dl"; 1.0000; . a ; "41JB(3A) Complying with the Secretary’s requirements"@en; ; "ae5718ef2fad1929dd66627f4740cb19826791ca95d6e9b1daffe9867f10d868"; ; "Must provide a reasonable excuse to avoid liability."; "Yes"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.129"; . a ; ; ; ; "borne by: NaturalPerson"; ; . . a ; ; "Obligation"; "Mandatory duty"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Belief"; "Defendant bears evidential burden"; "modalities::epistemic"; 1.0000; . a ; "41JC Self-incrimination"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.132". a ; "41JC(1) Self-incrimination"@en; ; "6dc0e568e288a9ba87b2fc9658ea425dcc9056e13b8318865be780af05429b77"; ; "No excuse for providing information under section 41JB"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.132"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "No excuse for providing information under section 41JB"; "modalities::logic::deontic"; 1.0000; . a ; "41JC(2) Self-incrimination"@en; ; "e808075d7ae733b02b1bc450dbc97d7b0acb11a1ed75c05d9387d15faec5f47e"; ; "Protection from self-incrimination in certain cases"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.132"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits admissibility of information in certain cases"; "(2) However, in the case of an individual:"; "modalities::logic::deontic"; 1.0000; . a ; "41JD Secretary may require information etc. about devices"@en; ; "8908984e2ff446167cb9a201367dc27e58c16af35de8872cffdae92437609f51"; "Secretary may give sponsor permission to exclude from Division 3 of Part 4-11"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.133"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Permission to exclude from Division 3 of Part 4-11"; "modalities::logic::deontic"; 0.5000; . a ; "41JE Secretary may require information relating to approvals"@en; ; "c55a6b7d2e4809fd866285fa0881f23ce036e8f46a84be94fefbd2c774940867"; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.135". a ; "41JE(1) Secretary may require information relating to approvals"@en; ; "804a57a914a738518eee0007c2eb10a155a5843bff9807eced3833eb550da271"; ; "The Secretary may require a person granted an approval to provide specified information or documents."; "true"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.135"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MAY"; "The Secretary may require the person to provide information."; "modalities::logic::deontic"; 1.0000; . a ; "41JE(2) Secretary may require information relating to approvals"@en; ; "5928f9f2c2bdfbe1600ef4b0901d0313dce23c25ab7a217a5cfd989153bc8ed6"; ; "Secretary may require information from a person using specified medical devices."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.135"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide information"; "modalities::logic::deontic"; 1.0000; . a ; "41JE(3) Secretary may require information relating to approvals"@en; ; "1ed799060013f2967b0bb2ec4d7920e1d03645c15f9e82c75e9ce5e7cfa3c173"; ; "Secretary must specify a reasonable period for compliance with notice."; "Notice period"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.135"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide a reasonable notice period"; "modalities::logic::deontic"; 1.0000; . a ; "41JF Secretary may require information relating to health"@en; ; "88cdc76151aa65970707898e204bfcb3bce1a33f576845baaa0fb2611beac8f1"; , , , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.136". a ; "41JF(1) Secretary may require information relating to health"@en; ; "6a3648b8b10cd3f2a0ce6f4fc3d1040122903c5b9127fea3a68ca934e990388b"; ; "Secretary may require specified information or documents from a person granted an approval. The Secretary may require information from a person granted an authority under subsection 41HC(1)"; "specified information or documents"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.136"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST PROVIDE"; "Must provide specified information or documents."; "modalities::logic::deontic"; 1.0000; . . a ; ; "CLASSIFICATION"; "Classification of medical devices."; "modalities::dl"; 1.0000; . . a ; ; "MAY"; "The Secretary may require information"; "modalities::logic::deontic"; 1.0000; . a ; "41JF(1A) Secretary may require information relating to health"@en; ; "2f7536359a2f6d7f133e51de97367d6733c57baa14f8c47a6b4fcb4ddba58fc4"; ; "The Secretary may require a person to provide specified information or documents."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.136"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MAY"; "The Secretary may require the person to provide information."; "modalities::logic::deontic"; 0.5000; . . a ; ; "IS_A"; "The provision is part of a class hierarchy for medical device regulations."; "modalities::dl"; 0.5000; . a ; "41JF(2) Secretary may require information relating to health"@en; ; "639e3531c8c40de38f8fd5a4908ef5f3cfd73c9ec0e677850406d27c697c6f8b"; ; "Secretary must require information within a specified period. Secretary must specify a reasonable period for compliance with notice."; "Yes"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.136"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide information"; "modalities::logic::deontic"; 1.0000; . a ; "41JF(3) Secretary may require information relating to health"@en; ; "b7b83037d7f5cb928bbdc0b32d99348e5ee6daf75bb85e1d2fc47f8c9f56c19f"; ; "Secretary may require information to be given in a specified way. Secretary may require information relating to health"; "true"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.136"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "requires"; "Requires information to be provided."; "modalities::logic::deontic"; 1.0000; . . a ; ; "has specified software requirements"; "Has specified software requirements."; "modalities::dl"; 1.0000; . . a ; ; "MUST"; "Must provide information"; "modalities::logic::deontic"; 1.0000; . . a ; ; "CLASSIFICATION"; "Classification of data processing devices and electronic transmissions"; "modalities::dl"; 1.0000; . a ; "41JF(1) Secretary may require information relating to health"@en; ; "01b1e38840e54a81d1e77e4818208cbbad983ea495eb5d4850925280a9f86e77"; ; "Secretary may require specified information or documents from a person granted an approval. The Secretary may require information from a person granted an authority under subsection 41HC(1)"; "specified information or documents"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.136"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST PROVIDE"; "Must provide specified information or documents."; "modalities::logic::deontic"; 1.0000; . . a ; ; "CLASSIFICATION"; "Classification of medical devices."; "modalities::dl"; 1.0000; . . a ; ; "MAY"; "The Secretary may require information"; "modalities::logic::deontic"; 1.0000; . a ; "41JF(2) Secretary may require information relating to health"@en; ; "6fb6ab7bf3223678571d89c02117f70fbf97955f583c78bf877b3885d7d721f4"; ; "Secretary must require information within a specified period. Secretary must specify a reasonable period for compliance with notice."; "Yes"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.136"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide information"; "modalities::logic::deontic"; 1.0000; . a ; "41JF(3) Secretary may require information relating to health"@en; ; "f115cc3278572e8236639771f183c330974f485984436da8de45204638be0e46"; ; "Secretary may require information to be given in a specified way. Secretary may require information relating to health"; "true"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.136"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "requires"; "Requires information to be provided."; "modalities::logic::deontic"; 1.0000; . . a ; ; "has specified software requirements"; "Has specified software requirements."; "modalities::dl"; 1.0000; . . a ; ; "MUST"; "Must provide information"; "modalities::logic::deontic"; 1.0000; . . a ; ; "CLASSIFICATION"; "Classification of data processing devices and electronic transmissions"; "modalities::dl"; 1.0000; . a ; "41JG Criminal offences for failing to give information or documents"@en; ; "087abf06b670b386b28e788d0cd6864ef844ac51e5b8306ab616d2838b0eef0b"; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.138". a ; "41JG(1) Criminal offences for failing to give information or documents"@en; ; "54b6ffd075c52116ab61e02c5ddf65c0f7739a9aad5d1386809f97ce4f646752"; ; "Failure to comply with notice results in penalty."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.138"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits failure to comply with notice."; "(a) the person is given a notice under section 41JCA, 41JD, 41JE, 41JF or 41JFA;"; "Penalty: 400 penalty units."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Obligation"; "Imposes obligation to comply with notice."; "(b) the person fails to comply with the notice."; "Penalty: 400 penalty units."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Applicable"; "Describes temporal interval for penalty application."; "(b) the person fails to comply with the notice."; "Penalty applies when person fails to comply."; "modalities::interval_reasoning"; 1.0000; . a ; "41JG(2) Criminal offences for failing to give information or documents"@en; ; "1d50b2c17c01f4440ba55d3e116f74bfb72b27e5802e5b8878e3b5866bbf42aa"; ; "Failure to comply with notice results in criminal offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.138"; . a ; ; ; ; "borne by: NaturalPerson"; ; . . a ; ; "Prohibition"; "Prohibits failure to comply with notice."; "(2) A person commits an offence if..."; "...Penalty: 100 penalty units."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlaps"; "Temporal overlap between notice and failure to comply."; "(2) A person commits an offence if: (a) the person is given a notice under section 41JCA, 41JD, 41JE, 41JF or 41JFA;"; "...and (b) the person fails to comply with the notice."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Until"; "Temporal relationship between notice and failure to comply."; "(2) A person commits an offence if: (a) the person is given a notice under section 41JCA, 41JD, 41JE, 41JF or 41JFA;"; "...and (b) the person fails to comply with the notice."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Diffuses"; "Diffusion of obligation from notice to failure to comply."; "(2) A person commits an offence if: (a) the person is given a notice under section 41JCA, 41JD, 41JE, 41JF or 41JFA;"; "...and (b) the person fails to comply with the notice."; "modalities::diffusion"; 1.0000; . . a ; ; "Enforces"; "Artificial agent enforces obligation to comply with notice."; "(2) A person commits an offence if: (a) the person is given a notice under section 41JCA, 41JD, 41JE, 41JF or 41JFA;"; "...and (b) the person fails to comply with the notice."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "41JG(3) Criminal offences for failing to give information or documents"@en; ; "6399dd55215449c5a9d06b6bb311756ebbb1965b41b9ee0659fbcac6e7efa0c6"; ; "Offence of strict liability for failing to give information or documents"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.138"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Imposes a duty on the state to prosecute"; "modalities::logic::deontic"; 1.0000; . a ; "41JH False or misleading information"@en; ; , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.138". a ; "41JH(1) False or misleading information"@en; ; "be1bb5d3b81ab23fa9c49be449ab6ea526f9e7410161e2bedddb3017df161881"; ; "Giving false or misleading information in compliance with a notice is an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.138"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Obligation to comply with a notice."; "The person gives information to the Secretary."; "The person commits an offence."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibition"; "Giving false or misleading information is prohibited."; "(a) the person gives information to the Secretary; and (b) the person knows that the information: (i) is false or misleading; or (ii) omits any matter or thing without which the information is misleading;"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Obligation"; "The person must provide accurate information."; "(c) the information is given in compliance or purported compliance with the notice."; "modalities::logic::deontic"; 1.0000; . a ; "41JH(2) False or misleading information"@en; ; "10522956b1cded6b9f0922de162302296ec9f2620a616dd5e38b004241c9fba1"; ; "Committing an offence for providing false or misleading information in compliance with a notice."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.138"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "Prohibit"; "Prohibits providing false or misleading information."; "The person gives information to the Secretary."; "The person commits an offence."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibit"; "Prohibits providing false or misleading information in compliance with a notice."; "The information is given in compliance or purported compliance with the notice."; "The person commits an offence if they provide false or misleading information in compliance with the notice."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibit"; "Prohibits providing false or misleading information to the Secretary."; "The person gives information to the Secretary."; "The person commits an offence if they provide false or misleading information to the Secretary."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibit"; "Prohibits providing false or misleading information without which it is misleading."; "The information omits any matter or thing without which the information is misleading."; "The person commits an offence if they provide false or misleading information without which it is misleading."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibit"; "Prohibits providing false or misleading information in any form."; "The information is false or misleading; or omits any matter or thing without which the information is misleading."; "The person commits an offence if they provide false or misleading information in any form."; "modalities::logic::deontic"; 1.0000; . a ; "41JH(3) False or misleading information"@en; ; "6399dd55215449c5a9d06b6bb311756ebbb1965b41b9ee0659fbcac6e7efa0c6"; ; "An offence against subsection (2) is an obligation."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.138"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "An obligation exists."; "(3) An offence against subsection (2) is an offence of strict liability."; "An offence against subsection (2) is an obligation."; "modalities::logic::deontic"; 1.0000; . a ; "41JH(4) False or misleading information"@en; ; "1c6facff6b57c15f53c7f0603b9b6c16b781c86278d8c6cf62b69cb7d88a2791"; ; "Exemption from subsection (1) or (2) if information is not false or misleading in a material particular."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.138"; . a ; ; ; ; "borne by: Agent"; ; . a ; "41JH(5) False or misleading information"@en; ; "d166ef5ab101cd5b5d1ee63a1fa45e3198f7c8474cc4328fa9aa4e3b9e295e09"; ; "Defendant bears evidential burden for information not omitting material particulars."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.138"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "obligation"; "Defendant bears evidential burden"; "modalities::logic::deontic"; 1.0000; . a ; "41JI False or misleading documents"@en; ; "492bf253db67f4083fe753e28b19f49bdfb623b7419d72e09b8b5ac972c3ce04"; "Producing false or misleading documents is an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.139"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits producing false or misleading documents."; "modalities::logic::deontic"; 1.0000; . a ; "41JJ Self-incrimination"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.140". a ; "41JJ(1) Self-incrimination"@en; ; "50297de30123633fb2fa6eb8d0ba5dddfec45ed969916e47b4b3b1e70c6d93e7"; ; "Must provide information or document under notice without claiming self-incrimination"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.140"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide information or document"; "modalities::logic::deontic"; 1.0000; . . a ; ; "CONTAINS"; "Contains information relating to medical devices covered by exemptions"; "modalities::interval_reasoning"; 1.0000; . a ; "41JJ(2) Self-incrimination"@en; ; "1dd22751b315445a890e35eae6ec14bffd15d363a09a00c851693d8f51d474c0"; ; "Protection from self-incrimination in certain cases"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.140"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits admissibility of self-incrimination evidence in certain cases"; "None"; "None"; "modalities::logic::deontic"; 1.0000; . a ; "41JK Simplified outline of this Part"@en; ; "b260062f8ba6fd8e1d7bf6c6a84d4c53f36aaf5816b7f6851e379b57b31c5939"; "Chief executive officer of a healthcare facility must report adverse events involving reportable medical devices."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.142"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide a report"; "modalities::logic::deontic"; 1.0000; . a ; "41JL Purposes of this Part"@en; ; "cc223507a91967353f45d94c790d78d919a2be2fdc863f0392de62c19ae87030"; "Facilitate monitoring and enforcing compliance with Chapter requirements."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.142"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Facilitate monitoring and enforcing compliance."; "modalities::logic::deontic"; 1.0000; . a ; "41JM Requirement to report adverse events involving reportable"@en; ; "c7820f15095fdca0e414146498540963260052da1c71f604998c30a2bc392f52"; , , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.143". a ; "41JM(1) Requirement to report adverse events involving reportable"@en; ; "f2e69c87219ad0bfe84fa5083950dc700ed8722dd6adb875093f879b71a30bd3"; ; "Healthcare facility must report adverse events to the Secretary."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.143"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "MUST"; "Duty obligation"; "modalities::logic::deontic"; 1.0000; . a ; "41JM(4) Requirement to report adverse events involving reportable"@en; ; "b98bae64bde826b5175cf81e7c4ef6620b7d350b30b90400163a787800419ff0"; ; "Healthcare facility must report adverse events involving reportable medical devices. Healthcare facility must report adverse events involving reportable medical devices and persons."; "Report requirements"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.143"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Duty to report"; "modalities::logic::deontic"; 1.0000; . a ; "41JM(2) Requirement to report adverse events involving reportable"@en; ; "8c7df46683adf5e49bf06b2b0a1a627c2b43498ddb0c8e54f787c3e288d86823"; ; "Healthcare facility must report adverse events involving reportable medical devices."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.143"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide information"; "modalities::logic::deontic"; 1.0000; . a ; "41JM(3) Requirement to report adverse events involving reportable"@en; ; "bccc84ef9dd46da64e70eff38389215d06716a7a0e812c59136b39800f8668f8"; ; "Healthcare facility must report adverse events involving reportable medical devices."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.143"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Mandatory reporting obligation."; "modalities::logic::deontic"; 1.0000; . a ; "41JM(4) Requirement to report adverse events involving reportable"@en; ; "0f2ecdac2d595ce0b0a08c0f6d4825b2272d393defe007b3999870b857e0344b"; ; "Healthcare facility must report adverse events involving reportable medical devices. Healthcare facility must report adverse events involving reportable medical devices and persons."; "Report requirements"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.143"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Duty to report"; "modalities::logic::deontic"; 1.0000; . a ; "41JM(5) Requirement to report adverse events involving reportable"@en; ; "45ee62fe7ac6021ef0a9df60b19696166dae399e42427dcfe452d04a7a347262"; ; "Report must include information about reportable medical device and person."; "Yes"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.143"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Obligation to report"; "modalities::logic::deontic"; 1.0000; . a ; "41K What this Part is about"@en; ; "afa864ca91e980ec4d85c8858dac087e6c1de7ccc1c4598f671d86c80d545a1c"; "The Secretary can require action to recall medical devices, or to inform the public about medical devices that do not comply with requirements or cannot lawfully be supplied."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.145"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "can"; "Expresses ability to perform an action"; "modalities::logic::deontic"; 1.0000; . a ; "41KA Public notification, and recall, of medical devices"@en; ; "7edb539aa22c79cd007af0f1ec97151eb1e92adb339f5369a50aee9eca6848fb"; "The Secretary may impose requirements on a person if certain circumstances occur."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.145"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Imposition of requirements is permitted."; "modalities::logic::deontic"; 1.0000; . . a ; ; "hasKindOf"; "Requirements apply to medical devices of a certain kind."; "modalities::dl"; 1.0000; . a ; "41KB Publication of requirements"@en; ; "6df2a63923ff9adf131b6e01cdb3862bd01dc69bc08d013a2627275389a29305"; "Secretary must publish notice after imposing requirement."; "Notice setting out particulars of the requirement"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.149"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Obligation to publish notice"; "modalities::logic::deontic"; 1.0000; . a ; "41KC Criminal offences for failing to comply with requirements"@en; ; "cc623b1a646f0826f5bc60985ff3799fc4259d93357a40f0168ac3e2e9348317"; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.149". a ; "41KC(1) Criminal offences for failing to comply with requirements"@en; ; "c21b8f26a2442d3847bb0a6717bb9f07b4e049e8c6614d28f57f547d3a6743e3"; ; "Offence for failing to comply with requirements"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.149"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits failure to comply with requirements"; "(1) A person commits an offence..."; "...breaches a requirement imposed on the person under section 41KA;"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Obligation"; "Imposes obligation to comply with requirements"; "(b) the act or omission breaches a requirement imposed on the person under section 41KA;"; "...breaches a requirement imposed on the person under section 41KA;"; "modalities::logic::deontic"; 1.0000; . . a ; ; "ResultedIn"; "States that act resulted in harm or injury to any person"; "(c) the act or omission has resulted in, will result in, or is likely to result in, harm or injury to any person."; "...will result in, or is likely to result in, harm or injury to any person."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Prohibition"; "Prohibits conviction of offence against subsection (4)"; "Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead:"; "...may convict the person of an offence against subsection (4) instead:"; "modalities::logic::deontic"; 0.5000; . a ; "41KC(4) Criminal offences for failing to comply with requirements"@en; ; "caf86916abb584b9d23d20e8ef16163a279bf1b6aa71fd28590271112c651f39"; ; "Failure to comply with requirements is a criminal offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.149"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Imposes an obligation on the state."; "modalities::logic::deontic"; 1.0000; . a ; "41KD Powers of suspension and cancellation unaffected"@en; ; "699b73ce85141d99e475e2e81174d3e5fae55f0030afe632ec11b9858864b7c3"; "Imposition of requirement under section 41KA does not affect suspension powers."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.150"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "excludes"; "Exclusion of suspension power from requirement imposition."; "Imposition of a requirement under section 41KA."; "Does not affect the Secretary's powers to suspend entry."; "modalities::logic::deontic"; 0.5000; . . a ; ; "subClassOf"; "Subclass relationship between suspension power and requirement imposition."; "Imposition of a requirement under section 41KA does not affect the Secretary’s powers to:"; "Powers of suspension and cancellation unaffected."; "modalities::dl"; 0.5000; . . a ; ; "includes"; "Inclusion of suspension power within Secretary's powers."; "The Secretary’s powers to:"; "Imposition of a requirement under section 41KA does not affect the Secretary’s powers to suspend entry."; "modalities::logic::deontic"; 0.5000; . . a ; ; "and"; "Conjunction of suspension power and requirement imposition."; "Imposition of a requirement under section 41KA does not affect the Secretary’s powers to:"; "Powers of suspension and cancellation unaffected."; "modalities::linear"; 0.5000; . . a ; ; "during"; "Temporal relationship between requirement imposition and suspension power."; "Imposition of a requirement under section 41KA does not affect the Secretary’s powers to:"; "Powers of suspension and cancellation unaffected."; "modalities::interval_reasoning"; 0.5000; . a ; "41KE Saving of other laws"@en; ; "61b7ba53b57fe8559936c4d7b04711566c16263a3c6f6af12bfa4c46eaef2acb"; "No exclusion or limitation of other laws"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.150"; . a ; ; ; ; ; . . a ; ; "Obligate"; "No exclusion or limitation of other laws"; "modalities::logic::deontic"; 1.0000; . a ; "41L What this Part is about"@en; ; "f64f606ebfdf8fd391ef598deb8e2d27162da36286810e7e5e179d4733f29218"; "Fees must be paid for consideration of applications and auditing."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.151"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Obligation to pay fees"; "modalities::logic::deontic"; 1.0000; . a ; "41LA Assessment fees"@en; ; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.151". a ; "41LA(1) Assessment fees"@en; ; "38c322c36f14f1e96853341d92ef447e988c853b7f25d39d3a5bb148584405f3"; ; "Payable assessment fee for application of conformity assessment certificate"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.151"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Payable assessment fee"; "modalities::logic::deontic"; 1.0000; . a ; "41LA(2) Assessment fees"@en; ; "f090a23f2c1457650ee8d97c5667b269b8d83e0bd91c8ce4715ba9d58ac2809e"; ; "Prescribe different levels of conformity assessment fees"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.151"; . a ; ; ; ; ; . a ; "41LA(3) Assessment fees"@en; ; "a3025b1ec1253f097ca634930f16d4234f26d33a7657d56799893092becdd4c3"; ; "Pay assessment fee for auditing medical device application"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.151"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must pay assessment fee"; "modalities::logic::deontic"; 1.0000; . . a ; ; "IS_A"; "Assessment fee is a type of payment"; "modalities::dl"; 1.0000; . a ; "41LA(4) Assessment fees"@en; ; "fc298ab6c52874d21c887ca532931c57787b5e263a4467ca5fe2f4e39a312ba1"; ; "Prescribes different levels of application audit assessment fees"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.151"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "prescribes"; "Imposes obligation on the state"; "modalities::logic::deontic"; 1.0000; . a ; "41LB When assessment fee due for payment"@en; ; "b3975c7ec544d2bf90d00c74866b6191bd7e483f0615d5e60361a1e72b517538"; "Assessment fee due on specified day and manner"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.152"; . a ; ; ; ; "borne by: LegalPerson"; ; . . a ; ; "due"; "Obligation to pay assessment fee"; "modalities::logic::deontic"; 1.0000; . a ; "41LC Payment of assessment fee by instalments"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.152". a ; "41LC(1) Payment of assessment fee by instalments"@en; ; "23aa7b3478e08ee71b1e77104e90b4a357196f7cc51a080cf14c2579b2eddf6a"; ; "Payment of assessment fee by instalments is obligatory."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.152"; . a ; ; ; ; "borne by: LegalPerson"; ; . . a ; ; "Obligation"; "Payment of assessment fee by instalments is obligatory."; "modalities::logic::deontic"; 1.0000; . a ; "41LC(2) Payment of assessment fee by instalments"@en; ; "b4fb0c2213322630ec9b0317e081720465600618086a4d9fdf61b4324ec763d8"; ; "Payment of assessment fee by instalments is not allowed if any part of an instalment is unpaid immediately after it became due."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.152"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of payment by instalments"; "(2) Regulations may provide that a person is not allowed to pay an assessment fee by instalments"; "if any part of an instalment is unpaid immediately after it became due."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlap"; "Temporal overlap between payment and evaluation fees"; "(a) that or any other assessment fee payable by the person; or (b) any evaluation fee under section 24 payable by the person;"; "was unpaid immediately after the time when it became due for payment."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Recurring"; "Recurring trace of unpaid instalments"; "(a) that or any other assessment fee payable by the person; or (b) any evaluation fee under section 24 payable by the person;"; "was unpaid immediately after the time when it became due for payment."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Diffuse"; "Diffusion of prohibition to related fees"; "(a) that or any other assessment fee payable by the person; or (b) any evaluation fee under section 24 payable by the person;"; "was unpaid immediately after the time when it became due for payment."; "modalities::diffusion"; 1.0000; . . a ; ; "Recognize"; "Recognition of prohibition in AI systems"; "(2) Regulations may provide that a person is not allowed to pay an assessment fee by instalments"; "if any part of an instalment is unpaid immediately after it became due."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "41LC(3) Payment of assessment fee by instalments"@en; ; "839e5e1c70551a66043469b8456639715beffad0fa9e8be7a933dc8a9ed61c2b"; ; "Payment of assessment fee by instalments is not limited by subsection (2)."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.152"; . a ; ; ; ; ; . . a ; ; "Implies"; "Payment of assessment fee is obligatory."; "Subsection (2) does not limit subsection (1)."; "Payment of assessment fee by instalments is obligatory."; "modalities::logic::deontic"; 0.5000; . . a ; ; "Implies"; "Payment of assessment fee is obligatory if it is due."; "Subsection (2) does not limit subsection (1)."; "Payment of assessment fee by instalments is obligatory if it is due."; "modalities::logic::deontic"; 0.5000; . . a ; ; "Implication"; "Payment of assessment fee implies obligation to pay."; "Subsection (2) does not limit subsection (1)."; "Payment of assessment fee by instalments implies obligation to pay."; "modalities::linear"; 0.5000; . . a ; ; "Implies"; "Payment of assessment fee is obligatory if it is due and paid."; "Subsection (2) does not limit subsection (1)."; "Payment of assessment fee by instalments is obligatory if it is due and paid."; "modalities::logic::deontic"; 0.5000; . a ; "41LD Recovery of assessment fee"@en; ; "245abdc32c690758fc507b40452950dd9c5ba5ab1f90188f789f215920ed0229"; "Recovery of assessment fee"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.152"; . a ; ; ; ; ; . . a ; ; "can"; "Can recover assessment fee"; "modalities::logic::deontic"; 1.0000; . a ; "41LE Reduction of conformity assessment fee where decision not"@en; ; "18180237252b64227757cffba307f718493f8d4ff089c0d677057d0a142b99c8"; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.153". a ; "41LE(1) Reduction of conformity assessment fee where decision not"@en; ; "69bb3b6ec8cb4c5d51d619a6cb33727225c959eba19a3c8fcd9eafe55e07f41e"; ; "Reduction of conformity assessment fee under certain conditions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.153"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Obligation to reduce conformity assessment fee."; "(1) Nothing in section 41LA, 41LB or 41LC requires the applicant to pay more than 3/4 of the conformity assessment fee before the making of the decision if:..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Temporal Interval"; "Temporal interval for reduction of conformity assessment fee."; "(a) the application is for the issuing of a conformity assessment certificate under Part 4-4; and (b) consideration of the application will involve an examination of the design of medical devices; and (c) a period is prescribed under paragraph 63(2)(dc) for making a decision on the application."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Recurring Trace"; "Recurring trace of reduction of conformity assessment fee."; "(a) the application is for the issuing of a conformity assessment certificate under Part 4-4; and (b) consideration of the application will involve an examination of the design of medical devices; and (c) a period is prescribed under paragraph 63(2)(dc) for making a decision on the application."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Diffusion"; "Diffusion of reduction of conformity assessment fee."; "(a) the application is for the issuing of a conformity assessment certificate under Part 4-4; and (b) consideration of the application will involve an examination of the design of medical devices; and (c) a period is prescribed under paragraph 63(2)(dc) for making a decision on the application."; "modalities::diffusion"; 1.0000; . . a ; ; "Classification"; "Classification of reduction of conformity assessment fee using CogAI."; "(a) the application is for the issuing of a conformity assessment certificate under Part 4-4; and (b) consideration of the application will involve an examination of the design of medical devices; and (c) a period is prescribed under paragraph 63(2)(dc) for making a decision on the application."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "41LE(2) Reduction of conformity assessment fee where decision not"@en; ; "c1f9f18fa437e9d09f4fa12f69722e7c0ae0e123cd8ff21264bb563e20a7e4db"; ; "Conformity assessment fee reduction upon non-decision within period"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.153"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "obligation"; "Obligation to pay reduced fee upon non-decision"; "modalities::logic::deontic"; 1.0000; . a ; "41LE(3) Reduction of conformity assessment fee where decision not"@en; ; "4eb5b92da4aa3f7574b2e7636f6f8707ef5eb1d98a86e43dbc572bf61f5e2e98"; ; "Payment of part of conformity assessment fee becomes due upon decision making."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.153"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Imposes a duty on the state."; "The state must pay the fee."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlaps"; "Describes a temporal relationship between payment and decision making."; "(3) If: (a) the decision is made within that period; and (b) part of the conformity assessment fee under section 41LA is, because of subsection (1) of this section, unpaid when the decision is made;"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Until"; "Describes a temporal relationship between payment and decision making."; "(3) If: (a) the decision is made within that period; and (b) part of the conformity assessment fee under section 41LA is, because of subsection (1) of this section, unpaid when the decision is made;"; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Diffuses"; "Describes a relationship between payment and decision making."; "(3) If: (a) the decision is made within that period; and (b) part of the conformity assessment fee under section 41LA is, because of subsection (1) of this section, unpaid when the decision is made;"; "modalities::diffusion"; 1.0000; . . a ; ; "Recognizes"; "Describes a relationship between payment and decision making."; "(3) If: (a) the decision is made within that period; and (b) part of the conformity assessment fee under section 41LA is, because of subsection (1) of this section, unpaid when the decision is made;"; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "41LE(4) Reduction of conformity assessment fee where decision not"@en; ; "d7a299a08ff6ae02fddd446332848429b5f1a6ee2c25bf32cac1025f68d75b94"; ; "Decision is taken when applicant notified of Secretary's decision on application."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.153"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "TAKE"; "Decision is taken"; "Applicant notified of Secretary's decision on application."; "Decision is made"; "modalities::logic::deontic"; 1.0000; . a ; "41M What this Part is about"@en; ; "f1304f83d26611e913926e628e91b3f4a8606c67b2e46636875a8b971086cb34"; "Ensure conformity with essential principles and administrative processes."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.154"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Ensure compliance"; "The essential principles must be complied with."; "There is an obligation to comply with the essential principles."; "modalities::logic::deontic"; 1.0000; . a ; "41MA Criminal offences for importing, supplying or exporting a"@en; ; "74de24467bb2f3534934b35542942718c71a4add1bff7cd4f8c1e22f1afa0cc7"; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.155". a ; "41MA(1) Criminal offences for importing, supplying or exporting a"@en; ; "ba3028ec3a941520fa36be964785767ae4804ff0c18bab01d58b04f8a2f98860"; ; "Importing a non-compliant medical device is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.155"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits the importation of non-compliant medical devices."; "modalities::logic::deontic"; 1.0000; . a ; "41MA(4) Criminal offences for importing, supplying or exporting a"@en; ; "4397d23f22b646f027cf8573aecbd9b4715571eaa878b6a1daba08d8a42ed3eb"; ; "Committing an offence for importing a medical device into Australia"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.155"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Obligation to comply with import regulations"; "Importing a medical device into Australia without permission is prohibited."; "A person commits an offence if they import a medical device into Australia."; "modalities::logic::deontic"; 1.0000; . a ; "41MB Exceptions"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.160". a ; "41MB(1) Exceptions"@en; ; "53d099984c456943da4fcf632a44a1b0ca0c270c02bb388206c4cfad9f17ef0d"; ; "Exceptions for medical devices that comply with standards and fail to comply only in respect of specific principles."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.160"; . a ; ; ; ; ; . . a ; ; "<"; "Defines the temporal interval for which the exemption applies."; "(a) the medical device complies with one or more medical device standards that apply to it;"; "The exemption is valid only if the medical device meets the specified standard."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "<"; "Specifies the temporal relationship between the exemption and the non-compliance."; "(b) the medical device fails to comply with the essential principles only in respect of a part or parts of the essential principles."; "The exemption is valid only if the non-compliance occurs within the specified interval."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "="; "Classifies the type of duty or obligation."; "(a) the medical device complies with one or more medical device standards that apply to it;"; "The exemption is a permission for the medical device to comply with specific standards."; "modalities::logic::deontic"; 1.0000; . . a ; ; "="; "Classifies the type of duty or obligation."; "(b) the medical device fails to comply with the essential principles only in respect of a part or parts of the essential principles."; "The exemption is a permission for the medical device to fail to comply with specific principles."; "modalities::logic::deontic"; 1.0000; . a ; "41MB(2) Exceptions"@en; ; "38d7f895eb2dd8fdde51a1820a8fd3c17de21946e14365cf3ff2375a2b60b9e3"; ; "Defendant bears evidential burden in prosecution for offence."; "Evidence of matters in section 13.3(3) of Criminal Code."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.160"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Defendant bears evidential burden."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Burden of Proof"; "Defendant must prove matters in section."; "modalities::epistemic"; 1.0000; . a ; "41MC Criminal offences relating to breaching a condition of a"@en; ; "12423e0482f3e81cb1d23230664e95bb3d11b9f34f06fc199e588d4cdab6e4d4"; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.161". a ; "41MC(1) Criminal offences relating to breaching a condition of a"@en; ; "9eb695633a113001cdc696f83f2399bf14a4e3722596b38d2d124daf2f157d4d"; ; "Secretary's consent may be given unconditionally or subject to conditions for certain medical devices."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.161"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Permission granted by the Secretary."; "modalities::logic::deontic"; 1.0000; . a ; "41MC(2) Criminal offences relating to breaching a condition of a"@en; ; "e25a15afb595033ac1e9319d90b7b77dedc14e0cb02ab5ccac71923696601361"; ; "Breach of consent results in harm or injury to a person."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.161"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits breach of consent."; "(2) A person commits an offence if: (a) the person does an act or omits to do an act; and (b) the act or omission breaches a condition of a consent; and (c) the act or omission has resulted in, will result in, or is likely to result in, harm or injury to any person."; "(Penalty: 2,000 penalty units.)"; "modalities::logic::deontic"; 1.0000; . a ; "41MD Treating medical devices as prohibited imports or exports"@en; ; "df7b3f7cd112cffe73791aefc7ab96ae16ca757782834a4c9386676c21d02dda"; "Importation or exportation of medical devices is prohibited if notified to Customs Act 1901."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.162"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibition of importation or exportation."; "modalities::logic::deontic"; 1.0000; . a ; "41ME Criminal offences for failing to apply conformity assessment"@en; ; "2d1dc090f456f9e6b95561e26738bfbaacf30596eb21ec8721607a8119ea4911"; , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.164". a ; "41ME(1) Criminal offences for failing to apply conformity assessment"@en; ; "587e4cbcf2e1c6a7e8b903b0ac702109f542c55c6c92eeac03cd4f82ed2d3201"; ; "Manufacturing, supplying or using a non-exempt medical device without conformity assessment"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.164"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits the manufacture, supply or use of non-exempt medical devices without conformity assessment"; "(ca) the device is not of a kind covered by an exemption in force under section 41GS; and (d) either: (i) the use of the device has resulted in, will result in, or is likely to result in, harm or injury to any person; or (ii) the use of the device, if the device were used, would result in, or would be likely to result in, harm or injury to any person;"; "(1) A person commits an offence..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Temporal relation"; "Establishes a temporal relationship between the manufacture/supply/use of medical devices and conformity assessment"; "(c) the conformity assessment procedures have not been applied to the device; and (d) either: (i) the use of the device has resulted in, will result in, or is likely to result in, harm or injury to any person; or (ii) the use of the device, if the device were used, would result in, or would be likely to result in, harm or injury to any person;"; "(1) A person commits an offence..."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Recurring trace"; "Establishes a recurring trace of the use of medical devices and conformity assessment"; "(d) either: (i) the use of the device has resulted in, will result in, or is likely to result in, harm or injury to any person; or (ii) the use of the device, if the device were used, would result in, or would be likely to result in, harm or injury to any person;"; "(1) A person commits an offence..."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Diffuse"; "Diffuses the obligation to comply with conformity assessment across all parties involved"; "(d) either: (i) the use of the device has resulted in, will result in, or is likely to result in, harm or injury to any person; or (ii) the use of the device, if the device were used, would result in, or would be likely to result in, harm or injury to any person;"; "(1) A person commits an offence..."; "modalities::diffusion"; 1.0000; . . a ; ; "Reasoning"; "Applies artificial intelligence to reason about the obligations and consequences of conformity assessment"; "(d) either: (i) the use of the device has resulted in, will result in, or is likely to result in, harm or injury to any person; or (ii) the use of the device, if the device were used, would result in, or would be likely to result in, harm or injury to any person;"; "(1) A person commits an offence..."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "41ME(4) Criminal offences for failing to apply conformity assessment"@en; ; "e4df68a8a03ad5558d2605e90a5225b97a7d7f4b558e18d7862508de01f1302a"; ; "Failure to apply conformity assessment procedures for medical devices is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.164"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of failing to apply conformity assessment procedures."; "(4) A person commits an offence if..."; "...the device is not of a kind covered by an exemption in force under section 41GS."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Temporal relation"; "Temporal relation between conformity assessment procedures and medical devices."; "(4) A person commits an offence if..."; "...the device is not of a kind covered by an exemption in force under section 41GS."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Recurring trace"; "Recurring trace of conformity assessment procedures for medical devices."; "(4) A person commits an offence if..."; "...the device is not of a kind covered by an exemption in force under section 41GS."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Knowledge representation"; "Knowledge representation of medical devices and conformity assessment procedures."; "(4) A person commits an offence if..."; "...the device is not of a kind covered by an exemption in force under section 41GS."; "sparql_library::parsers::chk_parser"; 1.0000; . . a ; ; "Schema validation"; "Schema validation of medical devices and conformity assessment procedures."; "(4) A person commits an offence if..."; "...the device is not of a kind covered by an exemption in force under section 41GS."; "modalities::logic::shacl"; 1.0000; . a ; "41ME(4A) Criminal offences for failing to apply conformity assessment"@en; ; "5d3668ecbca4e4f15a4bb33c01deb65edbdea9142c8d36e7a396a251febddd65"; ; "Manufacturing or supplying a medical device without conformity assessment"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.164"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits manufacturing or supplying a medical device without conformity assessment"; "(4A) A person commits an offence..."; "...Penalty: 100 penalty units."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Temporal Interval"; "Defines the temporal interval during which the action of manufacturing or supplying a medical device without conformity assessment is prohibited"; "(4A) A person commits an offence..."; "...Penalty: 100 penalty units."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Recurring Trace"; "Defines the recurring trace of actions that must be prevented or prohibited"; "(4A) A person commits an offence..."; "...Penalty: 100 penalty units."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Diffuse"; "Diffuses the prohibition to all relevant parties and entities"; "(4A) A person commits an offence..."; "...Penalty: 100 penalty units."; "modalities::diffusion"; 1.0000; . . a ; ; "Recognize"; "Recognizes the need for conformity assessment in medical device manufacturing and supply"; "(4A) A person commits an offence..."; "...Penalty: 100 penalty units."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "41ME(4B) Criminal offences for failing to apply conformity assessment"@en; ; "5551bcd3e7a6ada4f94ffcdfdf7d0d679300c3ea1f3ddb2aaa3a44291c74cd5a"; ; "Offences relating to exporting a medical device are prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.164"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits exporting a medical device."; "(4B) An offence against subsection (4A) is an offence of strict liability."; "modalities::logic::deontic"; 1.0000; . a ; "41ME(5) Criminal offences for failing to apply conformity assessment"@en; ; "3a4a7e0f2fbe1541e7043d3fdf3bfbe58222be482d79c8d80943706a3bfa8287"; ; "Manufacturing, exporting, or using a medical device without conformity assessment is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.164"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition"; "(5) A person commits an offence..."; "modalities::logic::deontic"; 1.0000; . a ; "41MF Criminal offences for failing to apply conformity assessment"@en; ; "cbf8176d0902527ea3a2b0e16e7d506c2ed5c496cb861d18eb01236f115bbc17"; "Offences relating to supplying a medical device"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.167"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits supplying a medical device"; "modalities::logic::deontic"; 1.0000; . a ; "41MG Exceptions"@en; ; "693b1de23cd9dc3f6bbd1467d101a2055fc005876d2cdd6979058cdf5abacdc4"; "Exceptions for certain conformity assessment standards"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.170"; . a ; ; ; ; ; . a ; "41MH Criminal offence for making false statements in declarations"@en; ; "1a64bffa7442bdd9fc7ed83bf732c2ce641760dac5eef034050dbfe9a9944505"; "Making false statements in declarations is a criminal offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.170"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits making false statements in declarations."; "modalities::logic::deontic"; 1.0000; . a ; "41MI Criminal offences for importing, exporting, supplying or"@en; ; "efc501e51c71d5c391eaad0b7e591236ce7c9f03219fecedfd7da26eeed3c237"; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.172". a ; "41MI(1) Criminal offences for importing, exporting, supplying or"@en; ; "38bb781e6319f116eb82d30915b36a7c502ba853d1841f94a76e49de7c547f29"; ; "Importing, exporting, supplying or manufacturing a medical device without proper authorization is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.172"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of actions"; "modalities::logic::deontic"; 1.0000; . a ; "41MI(4) Criminal offences for importing, exporting, supplying or"@en; ; "457363627257efd6420f6055af007417ab3304f6bb26281a62a4252c87124204"; ; "Importing, exporting, supplying or manufacturing a medical device without proper approval is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.172"; . a ; ; ; ; ; . . a ; ; "Prohibit"; "Prohibition"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Temporal Interval"; "Temporal interval for approval requirements"; "(4) A person commits an offence if: (a) the person: (i) imports a medical device into Australia; or (ii) exports a medical device from Australia; or (iii) supplies a medical device in Australia; or (iv) manufactures a medical device in Australia;"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Recurring Trace"; "Recurring trace for approval requirements"; "(4) A person commits an offence if: (a) the person: (i) imports a medical device into Australia; or (ii) exports a medical device from Australia; or (iii) supplies a medical device in Australia; or (iv) manufactures a medical device in Australia;"; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Obligation"; "Obligation to obtain approval"; "(4) A person commits an offence if: (a) the person: (i) imports a medical device into Australia; or (ii) exports a medical device from Australia; or (iii) supplies a medical device in Australia; or (iv) manufactures a medical device in Australia;"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Implication"; "Implication of non-compliance with approval requirements"; "(4) A person commits an offence if: (a) the person: (i) imports a medical device into Australia; or (ii) exports a medical device from Australia; or (iii) supplies a medical device in Australia; or (iv) manufactures a medical device in Australia;"; "modalities::argumentation"; 1.0000; . a ; "41MI(5) Criminal offences for importing, exporting, supplying or"@en; ; "f6b87d3275578fa773786e2758c7e50f92fcbb284c9f4afd3e402694ed8689aa"; ; "Importing, exporting, supplying or manufacturing a medical device without permission is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.172"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits the action of importing, exporting, supplying or manufacturing a medical device."; "(5) A person commits an offence if: (a) the person: (i) imports a medical device into Australia; or (ii) exports a medical device from Australia; or (iii) supplies a medical device in Australia; or (iv) manufactures a medical device in Australia;"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibit"; "Prohibits the action of importing, exporting, supplying or manufacturing a medical device."; "(5) A person commits an offence if: (a) the person: (i) imports a medical device into Australia; or (ii) exports a medical device from Australia; or (iii) supplies a medical device in Australia; or (iv) manufactures a medical device in Australia;"; "modalities::temporal_ltl"; 1.0000; . a ; "41MJ Treating medical devices as prohibited imports or exports"@en; ; "86629d48258807888de94a5cb47bbaf27cf7f5bda93d4cef0b2406a0160e008b"; "Medical devices are prohibited imports or exports."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.177"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits medical devices as imports or exports."; "modalities::logic::deontic"; 1.0000; . a ; "41MK Wholesale supply of medical devices not included in the"@en; ; "f7551261f0543b2d1c74a5eba2175c6fad281599de2fc30f60c8a1a7ec0c7d9b"; "Supplying medical devices not included in the Register is an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.178"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits supplying medical devices not included in the Register."; "modalities::logic::deontic"; 1.0000; . a ; "41ML False advertising about medical devices"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.179". a ; "41ML(1) False advertising about medical devices"@en; ; "7d97223634ad49ac5f7f4f782aeee404d190bacf8b7cb51a412520e190f9d535"; ; "False advertising about medical devices is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.179"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits false advertising about medical devices."; "(a) the person, by any means, advertises a medical device as being for a purpose;"; "False advertising about medical devices is prohibited."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Classify"; "Classifies medical devices in the Register."; "(b) the device is of a kind included in the Register;"; "The device must be classified as being for a purpose accepted in relation to its inclusion in the Register."; "modalities::dl"; 1.0000; . . a ; ; "Prohibit"; "Prohibits harm or injury resulting from false advertising."; "(d) either: (i) the use of the medical device for the advertised purpose has resulted in, will result in, or is likely to result in, harm or injury to any person;"; "The use of the medical device for the advertised purpose must not result in harm or injury."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Imply"; "Implies that false advertising is prohibited if it results in harm or injury."; "(d) either: (i) the use of the medical device for the advertised purpose has resulted in, will result in, or is likely to result in, harm or injury to any person;"; "False advertising about medical devices is prohibited if it results in harm or injury."; "modalities::linear"; 1.0000; . . a ; ; "Classify"; "Classifies the device as being for a purpose accepted in relation to its inclusion in the Register."; "(c) the purpose is not a purpose accepted in relation to that inclusion;"; "The device must be classified as being for a purpose accepted in relation to its inclusion in the Register."; "modalities::dl"; 1.0000; . a ; "41ML(2) False advertising about medical devices"@en; ; "0efe32e297eb600df1e33eaf6d48c894b0267f37723a65b0880334819203e777"; ; "False advertising about medical devices is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.179"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits false advertising about medical devices."; "(2) A person commits an offence if: (a) the person, by any means, advertises a medical device as being for a purpose; and (b) the device is of a kind included in the Register; and (c) the purpose is not a purpose accepted in relation to that inclusion."; "(Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.)"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Classify"; "Classifies medical devices as those included in the Register."; "(b) the device is of a kind included in the Register;"; "modalities::dl"; 1.0000; . a ; "41ML(3) False advertising about medical devices"@en; ; "48f19afe1e0a5597e9d91332cfba6a9aff9af3f7d8146b82a5e76f8d15216573"; ; "False advertising about medical devices is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.179"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits false advertising about medical devices."; "(3) A person commits an offence if: (a) the person, by any means, advertises a medical device as being for a purpose; and (b) the device is of a kind included in the Register; and (c) the purpose is not a purpose accepted in relation to that inclusion."; "(Penalty: 100 penalty units.)"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Classify"; "Classifies medical devices into categories based on their purposes."; "(3) A person commits an offence if: (a) the person, by any means, advertises a medical device as being for a purpose; and (b) the device is of a kind included in the Register; and (c) the purpose is not a purpose accepted in relation to that inclusion."; "(The device is of a kind included in the Register.)"; "modalities::dl"; 1.0000; . . a ; ; "Temporal overlap"; "Requires temporal overlap between advertising and medical device registration."; "(3) A person commits an offence if: (a) the person, by any means, advertises a medical device as being for a purpose; and (b) the device is of a kind included in the Register; and (c) the purpose is not a purpose accepted in relation to that inclusion."; "(The advertising must occur after registration.)"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Recurring trace"; "Requires recurring traces of false advertising and medical device registration."; "(3) A person commits an offence if: (a) the person, by any means, advertises a medical device as being for a purpose; and (b) the device is of a kind included in the Register; and (c) the purpose is not a purpose accepted in relation to that inclusion."; "(The advertising must recur over time.)"; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Diffusion"; "Requires diffusion of information about medical device registration."; "(3) A person commits an offence if: (a) the person, by any means, advertises a medical device as being for a purpose; and (b) the device is of a kind included in the Register; and (c) the purpose is not a purpose accepted in relation to that inclusion."; "(The information must be diffused widely.)"; "modalities::diffusion"; 1.0000; . . a ; ; "Rebuttal"; "Requires rebuttal of false advertising claims."; "(3) A person commits an offence if: (a) the person, by any means, advertises a medical device as being for a purpose; and (b) the device is of a kind included in the Register; and (c) the purpose is not a purpose accepted in relation to that inclusion."; "(The advertising must be rebutted.)"; "modalities::argumentation"; 1.0000; . a ; "41MN Criminal offences relating to breaches of conditions"@en; ; "add1bf44ea55abbac2985340efb9c46a191f863b79bee208739663b05d1a5eb5"; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.181". a ; "41MN(1) Criminal offences relating to breaches of conditions"@en; ; "ede1948a5fe57f1ee164857fcdfb8d3d383b6eadfd6b2aa79d57afe549fbe8e3"; ; "A person commits an offence if they include a kind of medical device in the Register and breach a condition related to it."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.181"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "includes"; "Includes a kind of medical device in the Register."; "modalities::logic::deontic"; 1.0000; . . a ; ; "breaches"; "Breach a condition related to the inclusion of the kind of device."; "modalities::logic::deontic"; 1.0000; . . a ; ; "includes"; "Includes a kind of medical device in the Register."; "modalities::dl"; 1.0000; . . a ; ; "resulted-in"; "Resulted in harm or injury to any person."; "modalities::interval_reasoning"; 1.0000; . a ; "41MN(4) Criminal offences relating to breaches of conditions"@en; ; "6d4d12d52e5621572383f4dc6e340efd3859ebfa805cf59391df015458a34dda"; ; "Committing an offence if a medical device is included in the Register and an act or omission breaches a condition of its inclusion."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.181"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Obligation to comply with conditions related to medical devices."; "(a) a kind of medical device is included in the Register in relation to the person;"; "A person commits an offence if..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "ClassInclusion"; "Device inclusion in the Register is a descriptive class."; "(a) a kind of medical device is included in the Register in relation to the person;"; "The condition of inclusion is related to the person."; "modalities::dl"; 1.0000; . . a ; ; "During"; "Act or omission occurs during the period of device inclusion."; "(b) the person does an act or omits to do an act;"; "The act or omission breaches a condition of the inclusion of the kind of device in the Register."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Until"; "Condition of inclusion is breached until the period ends."; "(c) the act or omission breaches a condition of the inclusion of the kind of device in the Register;"; "The person commits an offence if..."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "If"; "Device inclusion is related to the person if certain conditions are met."; "(a) a kind of medical device is included in the Register in relation to the person;"; "A person commits an offence if..."; "modalities::diffusion"; 1.0000; . . a ; ; "Classification"; "Device inclusion is classified as a condition."; "(a) a kind of medical device is included in the Register in relation to the person;"; "The condition of inclusion is related to the person."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "41MN(4A) Criminal offences relating to breaches of conditions"@en; ; "36741c4a1407a0e14d1f8766b853df5ed6d342f2c7adba7791ccb6ee78c2274b"; ; "A person commits an offence if a kind of medical device is included in the Register and does an act or omits to do an act that breaches a condition of the inclusion."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.181"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "hasObligation"; "The state has an obligation to ensure the medical device is included in the Register."; "The person commits an offence if a kind of medical device is included in the Register."; "The state has an obligation to ensure the medical device is included in the Register."; "modalities::logic::deontic"; 1.0000; . . a ; ; "isSubClassOf"; "Medical devices are sub classes of devices that can be included in the Register."; "The person commits an offence if a kind of medical device is included in the Register."; "Medical devices are sub classes of devices that can be included in the Register."; "modalities::dl"; 1.0000; . . a ; ; "during"; "The act or omission must occur during the time the medical device is included in the Register."; "The person commits an offence if a kind of medical device is included in the Register and does an act or omits to do an act."; "The act or omission must occur during the time the medical device is included in the Register."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "until"; "The condition of the inclusion of the medical device in the Register must be breached until the person commits an offence."; "The person commits an offence if a kind of medical device is included in the Register and does an act or omits to do an act."; "The condition of the inclusion of the medical device in the Register must be breached until the person commits an offence."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "hasPermission"; "The state has permission to include a kind of medical device in the Register."; "A person commits an offence if a kind of medical device is included in the Register."; "The state has permission to include a kind of medical device in the Register."; "modalities::logic::deontic"; 1.0000; . . a ; ; "hasRight"; "The person has a right to be included in the Register if a kind of medical device is included."; "A person commits an offence if a kind of medical device is included in the Register and does an act or omits to do an act."; "The person has a right to be included in the Register if a kind of medical device is included."; "modalities::logic::deontic"; 1.0000; . a ; "41MO Criminal offences for misusing medical devices exempted for"@en; ; "063d6e9e5d65f6a9ce6b09e5ee9c4ec1d2d0670ad4fecc6a42c6b86895f41d49"; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.190". a ; "41MO(1) Criminal offences for misusing medical devices exempted for"@en; ; "c1a43d1b4305b7038003ef65e03644f0b0a8b21f796096d171c5327725ee9f5a"; ; "Supplying a medical device without proper authority is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.190"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits supplying a medical device without proper authority."; "(a) the person has been granted an authority under subsection 41HC(1) relating to a specified kind of medical device; and (b) the person supplies a medical device of that kind: ..."; "...the supply is not in accordance with the authority; or the supply is not in accordance with the conditions to which the authority is subject; or the supply is not in accordance with regulations made for the purpose of subsection 41HC(5)."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Classify"; "Classifies medical devices into categories based on their specifications."; "(subsection 41HC(1) relating to a specified kind of medical device)"; "...the person supplies a medical device of that kind: ..."; "modalities::dl"; 0.5000; . . a ; ; "Prohibit"; "Prohibits using a medical device without proper authority."; "(c) either: (i) the use of the device has resulted in, will result in, or is likely to result in, harm or injury to any person; or (ii) the use of the device, if the device were used, would result in, or would be likely to result in, harm or injury to any person."; "...the supply is not in accordance with the authority; or the supply is not in accordance with the conditions to which the authority is subject; or the supply is not in accordance with regulations made for the purpose of subsection 41HC(5)."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Classify"; "Classifies harm or injury into categories based on their severity."; "(the use of the device has resulted in, will result in, or is likely to result in, harm or injury to any person; or the use of the device, if the device were used, would result in, or would be likely to result in, harm or injury to any person.)"; "...the supply is not in accordance with the authority; or the supply is not in accordance with the conditions to which the authority is subject; or the supply is not in accordance with regulations made for the purpose of subsection 41HC(5)."; "modalities::dl"; 0.5000; . . a ; ; "Prohibit"; "Prohibits supplying a medical device without proper conditions."; "(b) the person supplies a medical device of that kind: ... (ii) otherwise than in accordance with any conditions to which the authority is subject; or (iii) otherwise than in accordance with any regulations made for the purpose of subsection 41HC(5)."; "...the supply is not in accordance with the authority; or the supply is not in accordance with the conditions to which the authority is subject; or the supply is not in accordance with regulations made for the purpose of subsection 41HC(5)."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Classify"; "Classifies conditions into categories based on their specifications."; "(any conditions to which the authority is subject)"; "...the supply is not in accordance with the authority; or the supply is not in accordance with the conditions to which the authority is subject; or the supply is not in accordance with regulations made for the purpose of subsection 41HC(5)."; "modalities::dl"; 0.5000; . a ; "41MO(4) Criminal offences for misusing medical devices exempted for"@en; ; "57e47e9ce1960cadc9bf0accdfcc1847835e892b00affc11f6f3ae5384da2133"; ; "Supplying a medical device without authority is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.190"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of supplying a medical device without authority."; "(4) A person commits an offence if..."; "...the person supplies a medical device of that kind: ..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Classify"; "Classification of supplying a medical device without authority as prohibited."; "(4) A person commits an offence if..."; "...the person supplies a medical device of that kind: ..."; "modalities::dl"; 1.0000; . . a ; ; "Prohibit"; "Prohibition of supplying a medical device without authority."; "(4AA) A person commits an offence if..."; "...the person supplies a medical device of that kind: ..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Implication"; "Supplying a medical device without authority implies prohibition."; "(4) A person commits an offence if..."; "...the person supplies a medical device of that kind: ..."; "modalities::linear"; 1.0000; . . a ; ; "Classify"; "Classification of supplying a medical device without authority as prohibited."; "(4AA) A person commits an offence if..."; "...the person supplies a medical device of that kind: ..."; "modalities::dl"; 1.0000; . . a ; ; "Prohibit"; "Prohibition of supplying a medical device without authority."; "(4AB) An offence against subsection (4AA) is an offence of strict liability."; "...the person supplies a medical device of that kind: ..."; "modalities::logic::deontic"; 1.0000; . a ; "41MO(4A) Criminal offences for misusing medical devices exempted for"@en; ; "21b8fea6cbba4689a10e6460ef625d0a83a38d750d99b5d1ebf6422d1b711cc0"; ; "Misusing medical devices is prohibited for specified health practitioners."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.190"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of misuse"; "(4A) A person commits an offence..."; "...the supply is not in accordance with those rules;"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Classify"; "Classification of health practitioners"; "(b) the person is included in a class of health practitioners..."; "...specified in subsection 41HC(6) rules;"; "modalities::dl"; 1.0000; . . a ; ; "Temporal relation"; "Temporal relation between supply and rule"; "(c) the person supplies a medical device of a kind specified in..."; "...the supply is not in accordance with those rules;"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Implication"; "Implication of rule violation on offence"; "(d) any of the following applies:"; "...the person commits an offence if..."; "modalities::argumentation"; 1.0000; . a ; "41MP Criminal offence for failing to notify adverse events etc."@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.194". a ; "41MP(1) Criminal offence for failing to notify adverse events etc."@en; ; "f4cb706f29da6a9b6779f82fcbd40e0b73bf8b15de22fc67800603976e37cd96"; ; "Failing to notify adverse events is a criminal offence. Notify adverse events etc. within specified period."; "Information of a kind mentioned in subsection (2)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.194"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "Prohibition"; "Prohibits failing to notify adverse events."; "modalities::logic::deontic"; 1.0000; . . a ; ; "MUST"; "Must provide information"; "modalities::logic::deontic"; 1.0000; . . a ; ; "IS_A"; "Information of a kind mentioned in subsection (2)"; "modalities::dl"; 1.0000; . a ; "41MP(2) Criminal offence for failing to notify adverse events etc."@en; ; "df810373c6b14d3531ecc357f8b487b89e2819c66024f9cb372ddd6ef69c34d8"; ; "Notify adverse events etc."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.194"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must notify adverse events etc."; "modalities::logic::deontic"; 1.0000; . . a ; ; "IS_A"; "Device malfunction or deterioration"; "(a) information relating to any malfunction or deterioration in the characteristics or performance of the kind of device;"; "modalities::dl"; 1.0000; . a ; "41MP(1) Criminal offence for failing to notify adverse events etc."@en; ; "7a7b2263dc301edc24686f0b491323d9e65e8556fa77e018605ad095ebbe7f59"; ; "Failing to notify adverse events is a criminal offence. Notify adverse events etc. within specified period."; "Information of a kind mentioned in subsection (2)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.194"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "Prohibition"; "Prohibits failing to notify adverse events."; "modalities::logic::deontic"; 1.0000; . . a ; ; "MUST"; "Must provide information"; "modalities::logic::deontic"; 1.0000; . . a ; ; "IS_A"; "Information of a kind mentioned in subsection (2)"; "modalities::dl"; 1.0000; . a ; "41MQ Notification of adverse events etc. where application"@en; ; "93376f2dbbcc61c63c801535701930dcb75f809357e4e8beb1d0a27bc70524ce"; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.198". a ; "41MQ(1) Notification of adverse events etc. where application"@en; ; "e9679e8cb4068e5117ae90d3499c87dd67f42b702846dfd7a5572c1821fa56bc"; ; "Notify applicant of information about withdrawn application."; "Yes"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.198"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must notify applicant."; "modalities::logic::deontic"; 1.0000; . . a ; ; "SUBCLASS OF"; "Notification is a subclass of obligation."; "modalities::dl"; 1.0000; . a ; "41MQ(2) Notification of adverse events etc. where application"@en; ; "8961e012f6bcce31deaaf12b53730c30e4082c9c77f9f240a961ecadc06dc378"; ; "Notice under subsection (1) must be given within 10 working days after an application is withdrawn or lapses."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.198"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must be given within 10 working days"; "(2) Notice under subsection (1)"; "may only be given within 10 working days after an application is withdrawn or lapses."; "modalities::logic::deontic"; 0.5000; . a ; "41MQ(3) Notification of adverse events etc. where application"@en; ; "4342c68fa158050d7961dc07a7fd5c60141782d738bf69d7d3bb64bdb1a9d591"; ; "Failure to comply with notice within 20 working days is an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.198"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "Obligation"; "Obligation to comply with notice."; "Notice given"; "Failure to comply is an offence."; "modalities::logic::deontic"; 1.0000; . a ; "41MQ(4) Notification of adverse events etc. where application"@en; ; "3135d014c47ec912a070a5c43ec54b3bbba6312e51e894a8822fde120a2a9a23"; ; "Giving false information in response to a notice is an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.198"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibition of false information"; "The person gives information in purported compliance with a notice."; "The person commits an offence if the information is false or misleading in a material particular."; "modalities::logic::deontic"; 1.0000; . a ; "41MR Civil penalties for failing to notify adverse effects etc. where"@en; ; "26f7008a3e14c5f1b0690933aaf97973ebb7934e05f46482c7347b1adb2ee083"; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.199". a ; "41MR(1) Civil penalties for failing to notify adverse effects etc. where"@en; ; "d61d313c10cd10817019030e5ef7bf0cdab8fb71ead4b359390c9c6bd60ea6be"; ; "Failure to comply with notice requirements within 20 working days"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.199"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Obligation to comply with notice requirements"; "modalities::logic::deontic"; 1.0000; . a ; "41MR(2) Civil penalties for failing to notify adverse effects etc. where"@en; ; "f0e4189c4837da35723965f1b944b6be67e33a2480b81f1eb6425ad627afa4a4"; ; "False or misleading information in a notice"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.199"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of false or misleading information"; "The person gives information in purported compliance with a notice"; "The person contravenes this subsection"; "modalities::logic::deontic"; 1.0000; . a ; "41N Simplified outline of this Chapter"@en; ; "cad61469cf3cd9b830367dd73078c4b15f4faec68642cc8a9d741531c7580378"; "Importation of vaping goods and manufacture, supply or possession are prohibited in Australia."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.200"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of vaping goods importation and manufacture, supply or possession."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Classify"; "Classification of vaping goods as prohibited."; "modalities::dl"; 1.0000; . a ; "41NA Relationship with other Chapters of this Act"@en; ; "12f314df9f33d98e71c5b2c23998be823a2826643e5eb2154661ce861216e250"; "No limitation on generality of offence provisions or civil penalty provisions between Chapters."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.201"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "!"; "No limitation on generality."; "modalities::logic::deontic"; 1.0000; . a ; "41P Meaning of vaping goods and related terms"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.202". a ; "41P(1) Meaning of vaping goods and related terms"@en; ; "717a17ce0729221428b3d17683ff51b4a3898d8ef23dcd2b69e23510fee629fc"; ; "Defines vaping goods and related terms."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.202"; . a ; ; ; ; ; . a ; "41P(2) Meaning of vaping goods and related terms"@en; ; "ad160889177f901bd9184011a22ea8e4da12e998ffe07aacb519222d954cddbf"; ; "Goods must be presented in a certain way to be considered vaping goods."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.202"; . a ; ; ; ; ; . . a ; ; "="; "Definition of vaping goods"; "Goods are taken to be presented as being a particular kind of goods"; "Goods must be presented in a certain way to be considered vaping goods."; "modalities::dl"; 1.0000; . . a ; ; "="; "Presentation requirements for vaping goods"; "(a) the presentation of goods includes matters in relation to..."; "Goods must meet specific presentation requirements to be considered vaping goods."; "modalities::logic::deontic"; 1.0000; . . a ; ; "="; "Misleading or confusing presentation is prohibited"; "(i) is capable of being misleading or confusing as to the content or proper use or identification of the goods;"; "Goods cannot be presented in a way that is misleading or confusing."; "modalities::logic::deontic"; 1.0000; . . a ; ; "="; "Minister's discretion for determining vaping goods"; "Minister may determine that goods are or are not vaping goods etc."; "The Minister has the authority to determine whether goods are vaping goods or not."; "modalities::logic::deontic"; 1.0000; . . a ; ; "="; "Prohibition on presenting false information"; "(ii) suggests that the goods have ingredients, components or characteristics that they do not have."; "Goods cannot be presented as having ingredients or characteristics they do not actually have."; "modalities::logic::deontic"; 1.0000; . . a ; ; "="; "Right to determine vaping goods"; "(b) goods are taken to be presented as being a particular kind of goods even if..."; "The Minister has the right to determine whether goods are vaping goods or not."; "modalities::logic::deontic"; 1.0000; . a ; "41P(3) Meaning of vaping goods and related terms"@en; ; "2bf494815ec92fd402a9bee16be0c21341c729bb155eb3c4c4f16ae8ae609b5a"; ; "Authority to determine vaping goods classification"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.202"; . a ; ; ; ; ; . . a ; ; "May"; "Granting permission"; "modalities::logic::deontic"; 1.0000; . a ; "41Q Offences and civil penalty provision—importing vaping goods"@en; ; "8b405996892544c4e5929d35ca68d582158dded01ee5c7d0c531c8d2ed6f418c"; , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.204". a ; "41Q(1) Offences and civil penalty provision—importing vaping goods"@en; ; "d526f9ff7a6ddf7f24255598a73e95c8669baaa97f9834273f021fdea71d530e"; ; "Importing vaping goods into Australia is an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.204"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits importing vaping goods into Australia."; "modalities::logic::deontic"; 1.0000; . a ; "41Q(2) Offences and civil penalty provision—importing vaping goods"@en; ; "de689eafec2f1fe061b73f01057383194d9a17a464181f72bad83e075be51c8b"; ; "Importing vaping goods into Australia is an offence of strict liability."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.204"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits importing vaping goods into Australia."; "modalities::logic::deontic"; 1.0000; . a ; "41Q(3) Offences and civil penalty provision—importing vaping goods"@en; ; "1045b4b579daa42ee3006a4636a52c4798d41ee9a18a55d6362b0aa2e81c2633"; ; "Importing vaping goods into Australia is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.204"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits importing vaping goods."; "modalities::logic::deontic"; 1.0000; . a ; "41Q(4) Offences and civil penalty provision—importing vaping goods"@en; ; "32a1bf8ba412d0e353f7caf411284c3dd5e3ef3c54f7e1afb2628f2ee6d883ea"; ; "Importing vaping goods without compliance with subsection (3) is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.204"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of importing vaping goods without compliance."; "Subsection (3) sets conditions for importing vaping goods."; "Importing vaping goods without compliance is prohibited."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlap"; "Temporal overlap between subsection (3) and importation."; "Subsection (3) sets conditions for importation."; "Importation of vaping goods must comply with subsection (3)."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Recurring"; "Recurring trace of compliance with subsection (3)."; "Subsection (3) sets conditions for importation."; "Compliance with subsection (3) must be recurring."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Analyze"; "Analyzing compliance with subsection (3)."; "Subsection (3) sets conditions for importation."; "Compliance with subsection (3) must be analyzed."; "sparql_library::parsers::chk_parser"; 1.0000; . . a ; ; "Validate"; "Validation of compliance with subsection (3)."; "Subsection (3) sets conditions for importation."; "Compliance with subsection (3) must be validated."; "modalities::logic::shacl"; 1.0000; . a ; "41Q(5) Offences and civil penalty provision—importing vaping goods"@en; ; "ff7804e1eec2aa6b8c27ad54cbf802a47f7aecc87ee1760be2a4911e649fa44a"; ; "Exemptions from subsections (1) to (4)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.204"; . a ; ; ; ; ; . a ; "41QA Offences and civil penalty provision—manufacturing vaping"@en; ; "b775ca97317081f36d1a0ea0e8f65625fac7c7fda620f9d15ba77db7fd1da6b3"; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.205". a ; "41QA(1) Offences and civil penalty provision—manufacturing vaping"@en; ; "2be8d5c220667deb601512b1b482cda71679b407bb0dcc84a1e6786ba1095ebc"; ; "Manufacturing vaping goods in Australia is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.205"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits manufacturing vaping goods."; "modalities::logic::deontic"; 1.0000; . a ; "41QA(2) Offences and civil penalty provision—manufacturing vaping"@en; ; "6481547c353c2e4f4649b1d8c62ba6a014526161391ca752fcbfa5f3b4f29f18"; ; "Manufacturing vaping goods is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.205"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits manufacturing vaping goods."; "modalities::logic::deontic"; 1.0000; . a ; "41QA(3) Offences and civil penalty provision—manufacturing vaping"@en; ; "b7301b67639f528d55c26affa2dfd52ef83f14ef987a9e5f862f1a5b3b1ea35e"; ; "Manufacturing vaping goods in Australia is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.205"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits manufacturing vaping goods."; "modalities::logic::deontic"; 1.0000; . a ; "41QA(4) Offences and civil penalty provision—manufacturing vaping"@en; ; "7da3106ad56004305b6d113b26a6f3c6a5ff4f7e1ab8b6f2ab4a61ea0df7e8fd"; ; "Manufacturing vaping goods without compliance with subsection (3) is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.205"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of manufacturing vaping goods without compliance."; "Subsection (3) sets conditions for manufacture."; "Manufacturing without compliance is prohibited."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlap"; "Temporal overlap between manufacture and subsection (3) conditions."; "Manufacture occurs before or concurrently with subsection (3) conditions."; "Manufacture overlaps with subsection (3) conditions."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Recurring"; "Recurring trace of manufacturing vaping goods without compliance."; "Manufacturing vaping goods without compliance is a recurring action."; "Manufacturing vaping goods without compliance has a recurring trace."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Spread"; "Diffusion of non-compliance in manufacturing vaping goods."; "Non-compliance in manufacture spreads to other units of vaping goods."; "Non-compliance in manufacturing vaping goods spreads to other units."; "modalities::diffusion"; 1.0000; . . a ; ; "Analyze"; "Analyzing manufacturing vaping goods for compliance with subsection (3)."; "Manufacturing vaping goods requires analysis for compliance."; "Manufacturing vaping goods must be analyzed for compliance."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "41QB Offences and civil penalty provision—supplying vaping goods"@en; ; "87d390231948a0c49033f78db1046b1c0ea049452008ec1792ea0a263799dcc6"; , , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.206". a ; "41QB(1) Offences and civil penalty provision—supplying vaping goods"@en; ; "ffeefebc19853609449f005428f0dd0abbea1e28b64967b2b326f8a21bdc9991"; ; "Supplying vaping goods in Australia is an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.206"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits supplying vaping goods in Australia."; "modalities::logic::deontic"; 1.0000; . a ; "41QB(2) Offences and civil penalty provision—supplying vaping goods"@en; ; "bc4bb4556243dd3a5a0fe7cf6c2f3bcba9d50774aea8fd636bfd0e7439abc20d"; ; "Supplying vaping goods is an offence of strict liability."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.206"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits supplying vaping goods."; "modalities::logic::deontic"; 1.0000; . a ; "41QB(3) Offences and civil penalty provision—supplying vaping goods"@en; ; "390646aa45178820d4ce6afa3e126c77bb97cd0d0033613eb75310b186bb5faa"; ; "Supplying vaping goods in Australia is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.206"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits supplying vaping goods."; "modalities::logic::deontic"; 1.0000; . a ; "41QB(4) Offences and civil penalty provision—supplying vaping goods"@en; ; "e0817cb2cc040c33c63bbbc79fb79c9c2b5a18cdbea237a7eebbe813c522f6a7"; ; "Supplying vaping goods without compliance with subsection (3) is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.206"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of supplying vaping goods without compliance."; "Subsection (3) sets conditions for supply."; "No supply is allowed."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlap"; "Temporal overlap between supply and prohibition."; "Supplying vaping goods is prohibited after subsection (3) applies."; "Prohibition overlaps with supply."; "modalities::interval_reasoning"; 1.0000; . a ; "41QB(5) Offences and civil penalty provision—supplying vaping goods"@en; ; "e3d9db33033aa560475f4253fc1f2f427c00814af597579a826c1743b776c001"; ; "Exemptions from subsections (1) to (4)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.206"; . a ; ; ; ; ; . a ; "41QB(6) Offences and civil penalty provision—supplying vaping goods"@en; ; "2a82d74807b10840745e3337be654403282da2a52825e80fba16588578860f4a"; ; "Supply of vaping goods without proper exemption is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.206"; . a ; ; ; ; ; . . a ; ; "Prohibit"; "Prohibition"; "modalities::logic::deontic"; 1.0000; . a ; "41QC Offences and civil penalty provision—possessing at least"@en; ; "a085195ac64144deba2ae46a376746eea46dde7ab95499250d752ce535de453c"; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.211". a ; "41QC(1) Offences and civil penalty provision—possessing at least"@en; ; "e6793a3988b2275cba60cfc797ee27ce8fd6c784830177a9279a275e3dfe3b13"; ; "Possessing vaping goods in Australia without permission"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.211"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits possession of vaping goods in Australia"; "(a) the person possesses a quantity of a kind of vaping goods in Australia; and (b) the quantity is at least the commercial quantity, but less than 100 times the commercial quantity of that kind of vaping goods."; "The person commits an offence if..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Classify"; "Classifies possession of vaping goods in Australia as an offence"; "(a) the person possesses a quantity of a kind of vaping goods in Australia; and (b) the quantity is at least the commercial quantity, but less than 100 times the commercial quantity of that kind of vaping goods."; "The person commits an offence if..."; "modalities::dl"; 1.0000; . . a ; ; "Recurring Trace"; "Establishes a recurring trace for possession of vaping goods in Australia"; "(a) the person possesses a quantity of a kind of vaping goods in Australia; and (b) the quantity is at least the commercial quantity, but less than 100 times the commercial quantity of that kind of vaping goods."; "The person commits an offence if..."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Prohibit"; "Imprisonment for 2 years or 1,000 penalty units for possession of vaping goods in Australia"; "Penalty: Imprisonment for 2 years or 1,000 penalty units, or both."; "The person commits an offence if..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Classify"; "Classifies imprisonment for 2 years or 1,000 penalty units as a penalty for possession of vaping goods in Australia"; "Penalty: Imprisonment for 2 years or 1,000 penalty units, or both."; "The person commits an offence if..."; "modalities::dl"; 1.0000; . . a ; ; "Temporal Interval"; "Establishes a temporal interval for imprisonment for possession of vaping goods in Australia"; "Penalty: Imprisonment for 2 years or 1,000 penalty units, or both."; "The person commits an offence if..."; "modalities::interval_reasoning"; 1.0000; . a ; "41QC(2) Offences and civil penalty provision—possessing at least"@en; ; "f0a7520d29fc6be1274c6a95eaa57d05f5089c25008fbc2d4ef9a7c9473ef89a"; ; "Absolute liability applies for possessing at least"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.211"; . a ; ; ; ; "borne by: State"; ; . a ; "41QC(3) Offences and civil penalty provision—possessing at least"@en; ; "cf96091cacd34b8f9d20e30b32d348bac00c4ec8fec45f176b7544d269c4d2dd"; ; "Possessing a quantity of vaping goods without exceeding the commercial quantity is an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.211"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits possessing vaping goods"; "(a) the person possesses a quantity of a kind of vaping goods in Australia;"; "A person commits an offence of strict liability if..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Classify"; "Classifies vaping goods as prohibited"; "(3) A person commits an offence of strict liability if:"; "Penalty: 120 penalty units."; "modalities::dl"; 1.0000; . a ; "41QD Offences and civil penalty provision—possessing less than"@en; ; "b8a8772d2ebb0a01f089ba606f2f270023bad0706812b06b943c151c55fb9350"; "Possessing less than a commercial quantity of vaping goods is an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.215"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits possessing less than a commercial quantity of vaping goods."; "The person is a retailer in relation to retail premises in Australia."; "The person commits an offence if..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlap"; "Overlaps with the definition of a commercial quantity."; "commercial quantity of vaping goods"; "Possessing less than a commercial quantity of vaping goods is an offence."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Recurring"; "Recurring trace for the definition of a commercial quantity."; "commercial quantity of vaping goods"; "Possessing less than a commercial quantity of vaping goods is an offence."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Diffuse"; "Diffuses the definition of a commercial quantity to include retail premises in Australia."; "the person is a retailer in relation to retail premises in Australia."; "The person commits an offence if..."; "modalities::diffusion"; 1.0000; . . a ; ; "Recognize"; "Recognizes the legal concept of possessing less than a commercial quantity of vaping goods as an offence."; "Chapter 4A Vaping goods"; "Offences (1) A person commits an offence if..."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "41QE Exceptions etc. to civil penalty provisions—burden of proof"@en; ; "6c2edca3a526d18e3350cd08aa5cba2e821724d0709ab33f0c2a2f38cfa81fdd"; "Burden of proof for exceptions to civil penalty provisions"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.220"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Obligation on the person to bear evidential burden"; "modalities::logic::deontic"; 1.0000; . a ; "41R Minister may determine that specified vaping goods may be"@en; ; "562b9ab2a5e6dd96a9693eeffc31c484fddb954b15b8cc9826d7e29d2f40cc82"; "The Minister may determine that specified vaping goods may be supplied or possessed in Australia under certain circumstances."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.221"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Permission granted by the Minister."; "modalities::logic::deontic"; 1.0000; . . a ; ; "specified vaping goods"; "Specific goods subject to permission."; "modalities::dl"; 1.0000; . a ; "41RA Minister may determine other indications for which vaping"@en; ; "a9bdc539554b1abf868dc255211eb1bc1015485d0e9f969726951d74b345eff1"; "Minister may determine indications for vaping goods use"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.221"; . a ; ; ; ; ; . . a ; ; "May"; "Permission to vape goods"; "modalities::logic::deontic"; 1.0000; . a ; "41RB Application to Secretary for consent to manufacture, supply"@en; ; "b869976e0d2ce9cee906734fba6320f6bb5c89de188e2a8fdbaae7f7aee121c1"; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.222". a ; "41RB(1) Application to Secretary for consent to manufacture, supply"@en; ; "510f8b4a3f484fab8163df340dd47560150a379de34723189c68e3e883c9ac8a"; ; "Consent required for manufacture, supply or possession of vaping goods."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.222"; . a ; ; ; ; "borne by: NaturalPerson"; ; . . a ; ; "hasPermission"; "Granting permission"; "A person may apply to the Secretary for consent"; "to manufacture, supply or possess vaping goods."; "modalities::logic::deontic"; 1.0000; . . a ; ; "during"; "Temporal scope of application"; "The key applies to a person who may apply to the Secretary for consent during the relevant period"; "to manufacture, supply or possess vaping goods."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "implies"; "Implication of application"; "If a person applies to the Secretary for consent"; "then they may manufacture, supply or possess vaping goods."; "modalities::argumentation"; 1.0000; . a ; "41RB(2) Application to Secretary for consent to manufacture, supply"@en; ; "53d13f0ceddc4f8db4712e2d8bae11593277f9790451f2316915524b856847e2"; ; "Application must be in accordance with a form approved by the Secretary and accompanied by fee (if any)"; "Form, Fee"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.222"; . a ; ; ; ; "borne by: LegalPerson"; ; . . a ; ; "MUST"; "Application must be in accordance with a form approved by the Secretary"; "modalities::logic::deontic"; 1.0000; . a ; "41RB(3) Application to Secretary for consent to manufacture, supply"@en; ; "c3cc1126824974aed077d35a67e4410b5f386ff88234c011d3b6c68e25205d4e"; ; "Secretary may require applicant to provide further information within a reasonable time."; "true"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.222"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MAY"; "Secretary may require applicant to provide further information."; "modalities::logic::deontic"; 1.0000; . a ; "41RB(4) Application to Secretary for consent to manufacture, supply"@en; ; "87904dd2b8eb9e5806edbf2ebf2180fe8b20cb27ed8b7ed781a4d1bec11c2271"; ; "Application for consent may be required or permitted"; "Information in accordance with specified software requirements"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.222"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "May"; "Permission to apply for consent"; "modalities::logic::deontic"; 0.5000; . . a ; ; "Has specified software requirements"; "Requirements for application"; "modalities::dl"; 0.5000; . a ; "41RC Secretary may give consent"@en; ; , , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.222". a ; "41RC(1) Secretary may give consent"@en; ; "c285c353de821d10da6abb4a4228a7df648283501bd3bad80440d69377402791"; ; "Secretary may give consent for manufacture, supply or possession of vaping goods."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.222"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "can"; "Secretary can give consent."; "modalities::logic::deontic"; 1.0000; . a ; "41RC(2) Secretary may give consent"@en; ; "5275cf04203ba8c7c1278b737964ddb7bca74925e8b6c86992ae2d4d940cd0e3"; ; "Secretary may give consent for vaping goods"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.222"; . a ; ; ; ; ; . . a ; ; "may"; "Permission to vape goods"; "modalities::logic::deontic"; 1.0000; . a ; "41RC(2A) Secretary may give consent"@en; ; "bc30c40c19310d0d63e8418d8f3266e35fa7fc9f4c1319cd11ffe977c1232e23"; ; "Secretary must comply with decision-making principles"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.222"; . a ; ; ; ; ; . . a ; ; "MUST"; "Must comply"; "(2A) In making a decision under subsection (1), the Secretary must comply with the decision-making principles (if any) determined under subsection (2B)."; "modalities::logic::deontic"; 1.0000; . . a ; ; "MEETS"; "Decision-making principle is a prerequisite for decision making"; "(2A) In making a decision under subsection (1), the Secretary must comply with the decision-making principles (if any) determined under subsection (2B)."; "modalities::interval_reasoning"; 0.5000; . . a ; ; "MEETS"; "Decision making is contingent on compliance with principle"; "(2A) In making a decision under subsection (1), the Secretary must comply with the decision-making principles (if any) determined under subsection (2B)."; "modalities::temporal_ltl"; 0.5000; . . a ; ; "IS_A"; "Decision making is a subclass of general action"; "(2A) In making a decision under subsection (1), the Secretary must comply with the decision-making principles (if any) determined under subsection (2B)."; "modalities::logic::deontic"; 0.5000; . a ; "41RC(2B) Secretary may give consent"@en; ; "23096ed83a0beb605558bc4a0a077a557867c7c586d6285049f69494bbf2e7f6"; ; "Secretary must comply with decision-making principles"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.222"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must comply"; "(2B) The Minister may, by legislative instrument..."; "The Secretary must comply with the decision-making principles."; "modalities::logic::deontic"; 1.0000; . . a ; ; "CONTAINS"; "Decision-making principles apply to decisions made within this interval"; "(2B) The Minister may, by legislative instrument..."; "The decision-making principles apply to decisions made within the interval of the Minister's power."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "IMPLIES"; "Decision-making principles imply certain actions"; "(2B) The Minister may, by legislative instrument..."; "The decision-making principles imply that the Secretary must take certain actions."; "modalities::argumentation"; 1.0000; . . a ; ; "SPREADS_TO"; "Decision-making principles spread to other agents"; "(2B) The Minister may, by legislative instrument..."; "The decision-making principles spread to other agents who must comply with the Secretary's decisions."; "modalities::diffusion"; 1.0000; . . a ; ; "IS_A"; "Decision-making principles are a type of AI algorithm"; "(2B) The Minister may, by legislative instrument..."; "The decision-making principles are a type of AI algorithm that the Secretary must use."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "41RC(2C) Secretary may give consent"@en; ; "6d073cc73c6233749d657e7e239981cca2c8912933a130db8cfa498c09f77008"; ; "Secretary may give consent under certain circumstances."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.222"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Permission to give consent"; "(2C) Without limiting subsection (2B)"; "modalities::logic::deontic"; 0.5000; . a ; "41RC(3) Secretary may give consent"@en; ; "117d66c086662282f9e1ff221fb11511cfed272fbfd811120b1e10ee1c2f91a5"; ; "Secretary must publish decision particulars on website after giving consent"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.222"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide information"; "modalities::logic::deontic"; 1.0000; . a ; "41RD Offences and civil penalty provision—breaching condition of"@en; ; "8a663ace9921b25fcdcfc5fda8b3bc097c7fa8cc9bc6a6d7952e0cd8cb65b208"; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.224". a ; "41RD(1) Offences and civil penalty provision—breaching condition of"@en; ; "601d7105eb4d4e2bc0f01d80f928763031491a6f111ca13f2b54d50a88d27921"; ; "Offence for breaching condition of consent"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.224"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits certain actions"; "(1) A person commits an offence if..."; "...breaches a condition of a consent imposed under subsection 41RC(2); and"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Obligation"; "Imposes obligation to comply with consent conditions"; "(a) the person does an act or omits to do an act; and"; "...breaches a condition of a consent imposed under subsection 41RC(2); and"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Between"; "Defines temporal interval for penalty application"; "(c) the act or omission has resulted in, will result in, or is likely to result in, harm or injury to any person."; "...will result in, or is likely to result in, harm or injury to any person."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Prohibition"; "Prohibits certain actions resulting in harm or injury"; "(c) the act or omission has resulted in, will result in, or is likely to result in, harm or injury to any person."; "...harm or injury to any person."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Obligation"; "Imposes obligation to prevent harm or injury"; "(b) the act or omission breaches a condition of a consent imposed under subsection 41RC(2); and"; "...breaches a condition of a consent imposed under subsection 41RC(2); and"; "modalities::logic::deontic"; 1.0000; . a ; "41RD(2) Offences and civil penalty provision—breaching condition of"@en; ; "6cf46939f87ef605d35f1db799368d032a70bff5d162f597b127c67e72fa39de"; ; "Breach of condition results in an offence and a penalty."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.224"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "breach"; "Breach of obligation"; "(2) A person commits an offence if..."; "Penalty: 500 penalty units."; "modalities::logic::deontic"; 1.0000; . a ; "41RD(3) Offences and civil penalty provision—breaching condition of"@en; ; "4c1ef2b5c2fce45560ef09558eeee63288e3961b5d3112dacd39a1a5a28e63d1"; ; "Offence of strict liability for breaching condition of consent"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.224"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits strict liability for breaching condition of consent"; "(3) A person commits an offence of strict liability if..."; "...Penalty: 100 penalty units."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Obligation"; "Imposes obligation to comply with condition of consent"; "(3) A person commits an offence of strict liability if..."; "...Penalty: 100 penalty units."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Trace"; "Traces breach of condition to strict liability"; "(3) A person commits an offence of strict liability if..."; "...Penalty: 100 penalty units."; "modalities::temporal_ltl"; 1.0000; . a ; "41RD(4) Offences and civil penalty provision—breaching condition of"@en; ; "3d874aeddcc19e2953921de69126b5d2374509620507f2cd4fb1e32bdd7b83bd"; ; "Breaching a condition of consent imposed under subsection 41RC(2) is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.224"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of breaching a condition of consent."; "modalities::logic::deontic"; 1.0000; . a ; "42AA This Part not to apply to advertisements directed at health"@en; ; "d2e243051717584be62f3841e5b73e954635069e92795dcee9988c45e6bafcc4"; , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.226". a ; "42AA(1) This Part not to apply to advertisements directed at health"@en; ; "9854e602d9b391e5223a9a8ab9d3e0724ddc2de91c0230a5617c648d2fe0b528"; ; "Exemptions from advertising restrictions"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.226"; . a ; ; ; ; ; . . a ; ; "="; "Class hierarchy for health professions"; "Registered or licensed to practice in a specific health profession"; "Member of the specified class"; "modalities::dl"; 1.0000; . . a ; ; "<"; "Temporal interval for exemptions"; "Exemptions apply until a certain date"; "No exemption after this date"; "modalities::interval_reasoning"; 1.0000; . a ; "42AA(1A) This Part not to apply to advertisements directed at health"@en; ; "f4ec0a80d2a02ed245a75243b84409c7f67d35f05553e2495927f49ed47cd0a1"; ; "Minister may specify class of persons for purposes of paragraph (1)(d)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.226"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "May"; "Permission to specify class of persons"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Class specification"; "Specify a class of persons for purposes of paragraph (1)(d)"; "modalities::dl"; 1.0000; . a ; "42AA(2) This Part not to apply to advertisements directed at health"@en; ; "4282d97087ad63fd942eff5644755be55020f871a749d1268ee577d3506a8a58"; ; "This Part does not apply to advertisements directed exclusively to members of an Australian branch of one of the bodies prescribed for the purposes of this subsection."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.226"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Exclusion"; "Exclusion from application"; "modalities::logic::deontic"; 1.0000; . a ; "42AA(3) This Part not to apply to advertisements directed at health"@en; ; "f740b3d3ead93bc26972f275a6d2e75232a201d6c7644fdf314e984170c86863"; ; "Person must have qualifications and training for membership of relevant body."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.226"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Must"; "Mandatory qualification requirement."; "Person has qualifications and training."; "Person is a member of the relevant body."; "modalities::logic::deontic"; 1.0000; . a ; "42AA(4) This Part not to apply to advertisements directed at health"@en; ; "1ae04f2309b5e43e9523c8727140f5d91062b2391f5bbe55dfab36f187042c09"; ; "Exemption from Part for certain patient advice"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.226"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "exemption"; "Exempts from Part"; "modalities::logic::deontic"; 1.0000; . a ; "42AB This Part not to apply to advertisements for goods not for"@en; ; "32cbf0a4ae879208b91376bc5c08f0659c26888cd69ad99a9e97342b76591e97"; "This Part does not apply to advertisements in respect of goods that are not for use in humans."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.227"; . a ; ; ; ; ; . a ; "42AC This Part not to apply to advertisements for exported goods"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.227". a ; "42AC(1) This Part not to apply to advertisements for exported goods"@en; ; "642b18ae1c3551a5eb466e513fdf50cc533710e00c4d9d4de6ecacceaa27b861"; ; "This Part applies to advertisements for goods other than therapeutic goods intended exclusively for export."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.227"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Implies"; "If the advertisement is not solely for therapeutic goods intended exclusively for export, then it must comply with this Part."; "Exported goods are subject to this Part."; "The advertisement does not comply with this Part."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlaps"; "The advertisement's applicability to this Part overlaps with the time period during which the exported goods are intended to be used."; "The advertisement is for therapeutic goods intended exclusively for export."; "The advertisement does not comply with this Part."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Repeats"; "The advertisement's applicability to this Part repeats every time the exported goods are intended to be used."; "The advertisement is for therapeutic goods intended exclusively for export."; "The advertisement does not comply with this Part."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Diffuses"; "The advertisement's applicability to this Part diffuses through the time period during which the exported goods are intended to be used."; "The advertisement is for therapeutic goods intended exclusively for export."; "The advertisement does not comply with this Part."; "modalities::diffusion"; 1.0000; . . a ; ; "Recognizes"; "The advertisement's applicability to this Part is recognized by the AI system."; "The advertisement is for therapeutic goods intended exclusively for export."; "The advertisement does not comply with this Part."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "42AC(2) This Part not to apply to advertisements for exported goods"@en; ; "dbba022f7625f8b0e6437f4df8a2e79746c9cf3ef6b0cc6b4d5983549addb4d8"; ; "Sections 42DKB, 42DLA and 42DLC apply to advertisements of that kind."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.227"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "apply"; "Imposes obligation on the state."; "modalities::logic::deontic"; 1.0000; . a ; "42AD This Part not to apply to advertisements or generic"@en; ; "09333731360a486d23542c25a520c9f38f659fc8e4b143442351c796879c7172"; "Exemption from Part for advertisements about vaping goods"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.228"; . a ; ; ; ; ; . . a ; ; "forbid"; "Prohibits application of Part to advertisements about vaping goods"; "modalities::logic::deontic"; 1.0000; . a ; "42B Definitions"@en; ; "cc8765fae30c8cf3afe185762149d91d6ec614f79174c8d15dc2c40ae427cbc7"; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.228". a ; "42B(1) Definitions"@en; ; "f40c48734fe87af270d2c855a1778cd9e2ce670380e8f17717c3097f9ed90816"; ; "The Minister may make a code relating to advertisements about therapeutic goods."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.228"; . a ; ; ; ; ; . a ; "42B(2) Definitions"@en; ; "29cde799d680806158e81d1c5c999ead5e9f91f64166b83c56f574ec7d50921a"; ; "Allows modification of existing instruments or writings in legislative instruments."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.228"; . a ; ; ; ; . a ; "42DA Simplified outline of this Division"@en; ; "a01522bf8aee7f051c46fc990da56ce63c1321667697e60aebe3ca0009211fd0"; "Representations in advertisements about therapeutic goods may be restricted, required or prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.230"; . a ; ; ; ; ; . . a ; ; "Prohibit"; "Prohibits representations in advertisements about therapeutic goods."; "modalities::logic::deontic"; 1.0000; . a ; "42DB Definitions"@en; ; "65e60b1740f4733eb0d638cfbb0a0f0dc6387c781315e0a47680ffe403f8d419"; "Definition of applicant and approval holder."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.230"; . a ; ; ; ; "borne by: State"; ; . a ; "42DD Restricted representations"@en; ; "efadae9ec3a396b744284df92ebfa3215c36885f1556b5ddc2a9acfcc497e8a7"; "Restricted representations in therapeutic goods advertising"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.230"; . a ; ; ; ; ; . . a ; ; "Prohibit"; "Prohibits restricted representations"; "None"; "None"; "modalities::logic::deontic"; 1.0000; . a ; "42DE Applications for approval of use of restricted representation"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.231". a ; "42DE(1) Applications for approval of use of restricted representation"@en; ; "d59e4d4ad5ea46c019aa16e353b1c4a63b6ef328b19ed24823ef381780aa2033"; ; "Application for approval of use of restricted representation must be made to the Secretary."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.231"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "MUST"; "Application is required."; "modalities::logic::deontic"; 1.0000; . a ; "42DE(2) Applications for approval of use of restricted representation"@en; ; "4c5f680f28def8219aa373ddcad69169ba7637529fb6f1c94c0a03bbaabd2e8f"; ; "Application for approval of use of restricted representation may be required or permitted"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.231"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "May"; "Permission to apply for approval"; "modalities::logic::deontic"; 0.5000; . . a ; ; "Classifies"; "Classification of applications based on software requirements"; "modalities::dl"; 0.5000; . a ; "42DF Approval of use of restricted representation"@en; ; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.231". a ; "42DF(1) Approval of use of restricted representation"@en; ; "00db6cd604eb8b968e2ef156cdea4d81b0aae5ec58957544859521f5b9d12d39"; ; "Secretary must approve use of restricted representation if it is accurate and balanced."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.231"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Secretary must approve use of restricted representation."; "(1) If an application for approval of the use of a restricted representation is made, the Secretary must approve the use of the restricted representation if the Secretary is satisfied that:"; "modalities::logic::deontic"; 1.0000; . . a ; ; "MUST"; "Secretary must be satisfied that the representation is accurate and balanced."; "(a) the representation is accurate and balanced;"; "modalities::logic::deontic"; 1.0000; . . a ; ; "MUST"; "Secretary must be satisfied that the representation is not misleading or likely to be misleading."; "(b) the representation is not misleading or likely to be misleading."; "modalities::logic::deontic"; 1.0000; . . a ; ; "BETWEEN"; "Time period for approval of use of restricted representation."; "(1)"; "modalities::interval_reasoning"; 1.0000; . a ; "42DF(2) Approval of use of restricted representation"@en; ; "a413ea21ae5195950a6a07058fe02164554528876bfa9863669576ab26c5d1a9"; ; "Must approve restricted representation use"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.231"; . a ; ; ; ; ; . . a ; ; "MUST"; "Obligation to approve"; "modalities::logic::deontic"; 1.0000; . a ; "42DF(3) Approval of use of restricted representation"@en; ; "094f07df1fd8cea87dc05324b5c3122d1885a2e7dc2ef12036cf6a693b316d78"; ; "Approval may be subject to conditions imposed by the Secretary."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.231"; . a ; ; ; ; ; . . a ; ; "may"; "May impose conditions on approval"; "modalities::logic::deontic"; 1.0000; . a ; "42DF(4) Approval of use of restricted representation"@en; ; "466a0b3ea3095f44f9b14d2222619bbb627e27a1b5f946950ea0167e62c510a1"; ; "Secretary must consider certain factors when deciding to approve or refuse the use of a restricted representation."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.231"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Secretary has an obligation to consider certain factors."; "modalities::logic::deontic"; 1.0000; . a ; "42DG Notice of approval or refusal"@en; ; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.232". a ; "42DG(1) Notice of approval or refusal"@en; ; "39c5662d95b6b285f927b4d77b4544bc83bbb685a5c4e17e15e932b878cb8e11"; ; "Secretary must give written notice to applicant of approval or refusal."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.232"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "MUST"; "Secretary must give written notice."; "modalities::logic::deontic"; 1.0000; . a ; "42DG(2) Notice of approval or refusal"@en; ; "5f5d5cde55811a1646003aa9c1a3a9134f400a6ffd48b47f1006cf1f495666b4"; ; "Failure to provide written notice within 60 days results in approval of use."; "Written notice"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.232"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Obligation to provide written notice"; "modalities::logic::deontic"; 1.0000; . a ; "42DG(3) Notice of approval or refusal"@en; ; "044033893038e5ee144096ed8f19053d666979bb6da2fd954b18662e755e94d8"; ; "Conditions for approval must be set out in the notice."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.232"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide conditions for approval"; "modalities::logic::deontic"; 1.0000; . a ; "42DG(4) Notice of approval or refusal"@en; ; "34a0acbd9e71617f681f94b8793c1d4934df3c4c798bb8c8fedf54d068ad7ae2"; ; "Must provide reasons for refusal and inform applicant of right to review decision."; "Yes"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.232"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide reasons for refusal and inform applicant of right to review decision."; "modalities::logic::deontic"; 1.0000; . a ; "42DH Variation of conditions of approval"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.232". a ; "42DH(1) Variation of conditions of approval"@en; ; "6663b2da573d05c3ad87de437cc81fdddbeb1ec3c1b504002241c3fe5dee698b"; ; "Variation of conditions of approval"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.232"; . a ; ; ; ; ; . . a ; ; "may"; "Permission to vary conditions"; "modalities::logic::deontic"; 1.0000; . a ; "42DH(2) Variation of conditions of approval"@en; ; "d0cb6dc733a79cc56d180b61b7fb4ecc19dedc148b002f0b374c69f4f66a219a"; ; "Secretary must provide reasons and inform approval holder of right to review decision."; "yes"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.232"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Secretary must provide reasons and inform approval holder of right to review decision."; "modalities::logic::deontic"; 1.0000; . a ; "42DI Withdrawal of approval"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.232". a ; "42DI(1) Withdrawal of approval"@en; ; "bf5cd39e69c84254b083f7a77eaab1dfb7cdde16cae87f70029e9d6b4c31b94f"; ; "Withdrawal of approval for restricted representation"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.232"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits withdrawal of approval"; "modalities::logic::deontic"; 1.0000; . a ; "42DI(2) Withdrawal of approval"@en; ; "53dbe2495e4d4bfab67f9622f6974191c3a0c93234163953c2fd5e2026a05336"; ; "Secretary must provide reasons and inform approval holder of right to review decision."; "yes"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.232"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Secretary must provide reasons and inform approval holder of right to review decision."; "modalities::logic::deontic"; 1.0000; . a ; "42DJ Prohibited and required representations"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.233". a ; "42DJ(1) Prohibited and required representations"@en; ; "1a9386a1569967438d215f50c034785e843ed77b22ee0c22634f28152ab1f6c6"; ; "Prohibited representations about therapeutic goods"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.233"; . a ; ; ; ; ; . . a ; ; "forbid"; "Prohibits specified representations"; "(1) For the purposes of this Part, representations..."; "...are prohibited representations about therapeutic goods..."; "modalities::logic::deontic"; 0.5000; . a ; "42DJ(2) Prohibited and required representations"@en; ; "44f8352326cb22fc686d99af86fdcbc5c3ebec420da6c309a921971c1ccedfbf"; ; "Representations about therapeutic goods are required."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.233"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "requires"; "Requires representations."; "modalities::logic::deontic"; 1.0000; . a ; "42DK Permitted use of restricted or prohibited representations"@en; ; "530bc36d49fefe50edc743a78498fe7dfebd3c95c8b14cfc5c7c3cf3b93c21cf"; , , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.234". a ; "42DK(1) Permitted use of restricted or prohibited representations"@en; ; "374a7eb6f5b62b0dd85a601f68a6d2df788807be76ae23a12d67200213e7adcd"; ; "Permits use of restricted representations in advertisements"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.234"; . a ; ; ; ; ; . . a ; ; "permit"; "Grants permission"; "modalities::logic::deontic"; 1.0000; . a ; "42DK(2) Permitted use of restricted or prohibited representations"@en; ; "69427620b35551ca672816dc6b5e99a45a7260a98027c1246d4019ac83fcf358"; ; "Permits use of specified prohibited representations under certain conditions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.234"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Allow"; "Allows the Secretary to permit use of prohibited representations."; "(2) The Secretary may, by writing..."; "...the representations are necessary for the appropriate use of the goods."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Temporal Interval"; "Defines a temporal interval for the permitted use of prohibited representations."; "(2) The Secretary may, by writing..."; "...the representations are necessary for the appropriate use of the goods."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Recurring Trace"; "Defines a recurring trace for the permitted use of prohibited representations."; "(2) The Secretary may, by writing..."; "...the representations are necessary for the appropriate use of the goods."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Diffusion"; "Diffuses the permitted use of restricted or prohibited representations."; "(2) The Secretary may, by writing..."; "...the representations are necessary for the appropriate use of the goods."; "modalities::diffusion"; 1.0000; . . a ; ; "Knowledge Representation"; "Represents knowledge about permitted use of restricted or prohibited representations."; "(2) The Secretary may, by writing..."; "...the representations are necessary for the appropriate use of the goods."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "42DK(3) Permitted use of restricted or prohibited representations"@en; ; "8640a5727f4e78a0b5d9dff04ba3751fa82f26a34b9e00ae1119225089dc117c"; ; "Permits use of prohibited representations in advertisements under certain conditions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.234"; . a ; ; ; ; ; . . a ; ; "Allow"; "Allows the use of prohibited representations in advertisements."; "modalities::logic::deontic"; 1.0000; . a ; "42DK(4) Permitted use of restricted or prohibited representations"@en; ; "c9d5a8b4642eb1277de337925285edd454904502370918aef0959217ead977c3"; ; "Permitted use of restricted or prohibited representations"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.234"; . a ; ; ; ; ; . a ; "42DK(5) Permitted use of restricted or prohibited representations"@en; ; "160b9b81e2cc8d8a2bfded2a6c5a864270996a0c22ef972938d7bab1263edfcf"; ; "Permission under this section is not a legislative instrument."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.234"; . a ; ; ; ; ; . a ; "42DK(6) Permitted use of restricted or prohibited representations"@en; ; "7a43d2566bfdc3021e2b8210f21216fd8e4ca42bc017dc02d33a995d90ee17b1"; ; "Publishing permission on Department's website after giving a permission under this section."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.234"; . a ; ; ; ; "borne by: State"; ; . a ; "42DL Advertising offences—general"@en; ; "67d75f88f57d810867bd4e6480d6442b91cf7557412db022110facdc6443d793"; "Advertising therapeutic goods without permission is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.235"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits advertising therapeutic goods."; "(1) A person commits an offence..."; "...and (b) subsection (5), (6), (7), (8), (9), (10), (11) or (12) applies to the advertisement;"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Classify"; "Classifies advertising as an offence."; "(a) the person: (i) advertises, by any means, therapeutic goods; or (ii) causes the advertising, by any means, of therapeutic goods;"; "...and (b) subsection (5), (6), (7), (8), (9), (10), (11) or (12) applies to the advertisement;"; "modalities::dl"; 1.0000; . . a ; ; "Temporal Interval"; "Defines a temporal interval for the offence."; "(1) A person commits an offence if: (a) the person: (i) advertises, by any means, therapeutic goods; or (ii) causes the advertising, by any means, of therapeutic goods;"; "...and (b) subsection (5), (6), (7), (8), (9), (10), (11) or (12) applies to the advertisement;"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Recurring Trace"; "Defines a recurring trace for the offence."; "(a) the person: (i) advertises, by any means, therapeutic goods; or (ii) causes the advertising, by any means, of therapeutic goods;"; "...and (b) subsection (5), (6), (7), (8), (9), (10), (11) or (12) applies to the advertisement;"; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Diffuse"; "Diffuses the prohibition."; "(a) the person: (i) advertises, by any means, therapeutic goods; or (ii) causes the advertising, by any means, of therapeutic goods;"; "...and (b) subsection (5), (6), (7), (8), (9), (10), (11) or (12) applies to the advertisement;"; "modalities::diffusion"; 1.0000; . . a ; ; "Classify"; "Classifies the advertising as a cognitive task."; "(a) the person: (i) advertises, by any means, therapeutic goods; or (ii) causes the advertising, by any means, of therapeutic goods;"; "...and (b) subsection (5), (6), (7), (8), (9), (10), (11) or (12) applies to the advertisement;"; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "42DM Offences—non-compliance with the Therapeutic Goods"@en; ; "95bbe0b7db7e2452098f9658e3c72bad594c36f3cac2125faa72cf20730625d6"; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.243". a ; "42DM(1) Offences—non-compliance with the Therapeutic Goods"@en; ; "c9b841dca9528a15d33d18267f787261fc54877645ccd15836d67a03afc9ab32"; ; "Advertising therapeutic goods without compliance with the Therapeutic Goods Advertising Code is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.243"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of advertising therapeutic goods without compliance with the Therapeutic Goods Advertising Code."; "(1) A person commits an offence if: (a) the person: (i) advertises, by any means, therapeutic goods; or (ii) causes the advertising, by any means, of therapeutic goods; and"; "Penalty: Imprisonment for 5 years or 4,000 penalty units, or both."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Classify"; "Classification of advertising as therapeutic goods without compliance with the Therapeutic Goods Advertising Code."; "(b) the advertisement does not comply with the Therapeutic Goods Advertising Code; and"; "modalities::dl"; 1.0000; . . a ; ; "Prohibit"; "Prohibition of advertising therapeutic goods without compliance with the Therapeutic Goods Advertising Code."; "(c) either: (i) the use of the goods in reliance on the advertisement has resulted in, will result in, or is likely to result in, harm or injury to any person; or"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibit"; "Prohibition of advertising therapeutic goods without compliance with the Therapeutic Goods Advertising Code."; "(c) either: (ii) the use of the goods in reliance on the advertisement, if the goods were so used, would result in, or would be likely to result in, harm or injury to any person."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Classify"; "Classification of advertising as therapeutic goods without compliance with the Therapeutic Goods Advertising Code."; "Penalty: Imprisonment for 5 years or 4,000 penalty units, or both."; "modalities::dl"; 1.0000; . . a ; ; "Imply"; "Implication of advertising therapeutic goods without compliance with the Therapeutic Goods Advertising Code on imprisonment."; "(c) either: (i) the use of the goods in reliance on the advertisement has resulted in, will result in, or is likely to result in, harm or injury to any person; or"; "modalities::linear"; 1.0000; . a ; "42DM(2) Offences—non-compliance with the Therapeutic Goods"@en; ; "240fd4d68046d94e01e5e428a347e1f7e87e43b537c17a1d9e96722e8d8d6087"; ; "Non-compliance with Therapeutic Goods Advertising Code is an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.243"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits non-compliance with the Therapeutic Goods Advertising Code."; "modalities::logic::deontic"; 1.0000; . . a ; ; "ClassInclusion"; "Defines a class of persons who are subject to this prohibition."; "State"; "NaturalPerson"; "modalities::dl"; 1.0000; . a ; "42DM(3) Offences—non-compliance with the Therapeutic Goods"@en; ; "74e8f4e7da5b288ecb7b4c69111c3d5ebdc9f10a86e804d1559e75dc800e935a"; ; "Non-compliance with therapeutic goods advertising"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.243"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits advertising therapeutic goods"; "(3) A person commits an offence..."; "...if the person advertises, by any means, therapeutic goods;"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Classify"; "Classifies non-compliance as an offence"; "(3) A person commits an offence..."; "...if the person advertises, by any means, therapeutic goods;"; "modalities::dl"; 1.0000; . . a ; ; "Temporal Interval"; "Defines a temporal interval for non-compliance"; "(3) A person commits an offence..."; "...if the person advertises, by any means, therapeutic goods;"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Recurring Trace"; "Defines a recurring trace for non-compliance"; "(3) A person commits an offence..."; "...if the person advertises, by any means, therapeutic goods;"; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Diffuse"; "Diffuses the prohibition to all agents"; "(3) A person commits an offence..."; "...if the person advertises, by any means, therapeutic goods;"; "modalities::diffusion"; 1.0000; . . a ; ; "Recognize"; "Recognizes the prohibition as a rule"; "(3) A person commits an offence..."; "...if the person advertises, by any means, therapeutic goods;"; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "42DN Application of Division"@en; ; "80f849149a80a1a3d429d8961c644afb8d08fc2b8e95d0df447435d9194af0b2"; "Division applies to generic information about goods used in therapeutic goods manufacture or representation."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.246"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "applies"; "Division applies to generic information about goods."; "modalities::logic::deontic"; 1.0000; . a ; "42DO Compliance with the Code"@en; ; "665671b05902ea6b526dd29be6e99c9c30d7935b49be65ae5479bf0051c015ea"; "Generic information must comply with the Therapeutic Goods Advertising Code."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.246"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Generic information must comply with the Therapeutic Goods Advertising Code."; "modalities::logic::deontic"; 1.0000; . a ; "42DP Offences—dissemination of generic information"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.246". a ; "42DP(1) Offences—dissemination of generic information"@en; ; "420e2a081691ad9a60e5ae436af80cc5c61b483df36e2406449c0d02730a671d"; ; "Dissemination of generic information about therapeutic goods to the public or a section of the public is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.246"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Classify"; "Classification of generic information as prohibited"; "modalities::dl"; 1.0000; . a ; "42DP(2) Offences—dissemination of generic information"@en; ; "a3511e83e6f6f76b97a4f2b8c0b8ca71c4dd81659120e596b79eee2c003e2108"; ; "Dissemination of generic information about therapeutic goods is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.246"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits the dissemination of generic information."; "(2) A person commits an offence if: (a) the person disseminates, by any means, generic information about therapeutic goods to the public or a section of the public; and (b) the dissemination of that generic information does not comply with the provisions of the Therapeutic Goods Advertising Code that are prescribed by regulations for the purposes of section 42DO."; "Penalty: 100 penalty units."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Classify"; "Classifies dissemination as an offence."; "(2) A person commits an offence if: (a) the person disseminates, by any means, generic information about therapeutic goods to the public or a section of the public; and (b) the dissemination of that generic information does not comply with the provisions of the Therapeutic Goods Advertising Code that are prescribed by regulations for the purposes of section 42DO."; "modalities::dl"; 1.0000; . . a ; ; "Prohibit"; "Prohibits the dissemination of generic information."; "(2) A person commits an offence if: (a) the person disseminates, by any means, generic information about therapeutic goods to the public or a section of the public; and (b) the dissemination of that generic information does not comply with the provisions of the Therapeutic Goods Advertising Code that are prescribed by regulations for the purposes of section 42DO."; "modalities::logic::deontic"; 1.0000; . a ; "42DP(3) Offences—dissemination of generic information"@en; ; "6399dd55215449c5a9d06b6bb311756ebbb1965b41b9ee0659fbcac6e7efa0c6"; ; "An offence against subsection (2) is an offence of strict liability."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.246"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Imposes a duty on the state."; "(3) An offence against subsection (2) is an offence of strict liability."; "The state must punish offenders."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Implication"; "States that punishment follows from the existence of a strict liability offence."; "(3) An offence against subsection (2) is an offence of strict liability."; "If there is a strict liability offence, then punishment must follow."; "modalities::linear"; 1.0000; . a ; "42DQ Civil penalty for dissemination of generic information"@en; ; "170b1c2011f34e3ca469aa8b6ecae9378aeb43957c254049e797e0642bfbc4a1"; "Dissemination of generic information about therapeutic goods is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.247"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits the dissemination of generic information."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Classify"; "Classifies as a prohibition."; "modalities::dl"; 1.0000; . a ; "42DR Secretary may require information or documents"@en; ; "f60f07a4d550cfae0f22b38e69e609a4d6b1123d9c70bfda65811934d13d8efa"; , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.248". a ; "42DR(1) Secretary may require information or documents"@en; ; "422aefd1c5707d070185758096c38dd6fed5810fa79fba77a9c7f766f3375296"; ; "Secretary may require information or documents from a person responsible for advertising therapeutic goods."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.248"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MAY"; "Implies an obligation."; "modalities::logic::deontic"; 1.0000; . a ; "42DR(2) Secretary may require information or documents"@en; ; "ba6ceff2a69ce79657bbfdc439f7c36e402dadd1ab4c003de4ee62455a35b7fe"; ; "Secretary may require information or documents from a person responsible for disseminating generic information."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.248"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MAY"; "Secretary may require information or documents."; "modalities::logic::deontic"; 1.0000; . a ; "42DR(3) Secretary may require information or documents"@en; ; "076011925dc0569096d572489dad202db09b1606cd604a934d7d6517444b0213"; ; "Must provide information or documents within a specified period and in the form specified by the notice."; "true"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.248"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide information or documents within a specified period and in the form specified by the notice."; "modalities::logic::deontic"; 1.0000; . . a ; ; "within"; "The period within which the person must provide the information or documents is not less than 14 days after the day the notice is given."; "The notice specifies a period."; "The person must provide the information or documents within that period."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "within"; "The period within which the person must provide the information or documents is not less than 14 days after the day the notice is given."; "The notice specifies a period."; "The person must provide the information or documents within that period."; "modalities::temporal_ltl"; 1.0000; . a ; "42DR(4) Secretary may require information or documents"@en; ; "bb9c4c3a54f16340ba9728bff0acc6a832df6e255aaeb07b2653e071a08844b0"; ; "The Secretary may require information or documents in a specified way."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.248"; . a ; ; ; ; ; . a ; "42DR(5) Secretary may require information or documents"@en; ; "1e1835fb6815030084b80c329e5fe549046e14d8b95715c8c0942e3f0c44be72"; ; "Secretary may require information or documents"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.248"; . a ; ; ; ; ; . . a ; ; "requires"; "Requires information or documents from the recipient"; "modalities::logic::deontic"; 1.0000; . . a ; ; "is not"; "Legislative instruments are excluded from the notice"; "(5) A notice under subsection (1) or (2)"; "is a legislative instrument"; "modalities::logic::deontic"; 1.0000; . . a ; ; "may"; "Secretary may require information or documents"; "modalities::logic::deontic"; 1.0000; . a ; "42DS Criminal offences for failing to comply with a notice etc."@en; ; , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.249". a ; "42DS(1) Criminal offences for failing to comply with a notice etc."@en; ; "5f66e2f5ae872c1f570da4b4ce60d6bed4ed52a1010926968f9036f4f115798b"; ; "Failure to comply with a notice results in an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.249"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "obligation"; "Obligation to comply with a notice."; "modalities::logic::deontic"; 1.0000; . a ; "42DS(2) Criminal offences for failing to comply with a notice etc."@en; ; "4962d8df5f7291e64ae70ec789b5465dc92674a942572312ee332e64aa5bc761"; ; "Failure to comply with a notice results in an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.249"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "obligation"; "Obligation to comply with a notice."; "modalities::logic::deontic"; 1.0000; . a ; "42DS(3) Criminal offences for failing to comply with a notice etc."@en; ; "6399dd55215449c5a9d06b6bb311756ebbb1965b41b9ee0659fbcac6e7efa0c6"; ; "Offence of strict liability for failing to comply with a notice"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.249"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Imposes an obligation on the state"; "modalities::logic::deontic"; 1.0000; . a ; "42DS(4) Criminal offences for failing to comply with a notice etc."@en; ; "585509ff84961b491f51844c5f9d88e353b425505de68827dd9cf85377c9bef4"; ; "Failure to comply with a notice results in an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.249"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits failing to comply with a notice."; "modalities::logic::deontic"; 1.0000; . a ; "42DS(5) Criminal offences for failing to comply with a notice etc."@en; ; "e6384a5b4cea6d71163b4aace529c77bc0621ffe12d307d22b929faa1bae1755"; ; "Failure to comply with a notice results in an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.249"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits failing to comply with a notice."; "modalities::logic::deontic"; 1.0000; . a ; "42DT Civil penalty for giving false or misleading information or"@en; ; "b7224a74a206be0194c5f2e0d92047b2a641d9331e02d371ba0ea189956fba97"; "Giving false or misleading information in compliance with a notice is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.250"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of giving false or misleading information."; "The person is given a notice under section 42DR."; "The person contravenes this section if..."; "modalities::logic::deontic"; 1.0000; . a ; "42DU Self-incrimination"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.250". a ; "42DU(1) Self-incrimination"@en; ; "17f71db0d4d901a9f91e0e2d80c096a5840258443cf881e0991bddebb706b044"; ; "No excuse for refusing to provide information or produce a document under section 42DR."; "True"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.250"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide information or produce a document."; "modalities::logic::deontic"; 1.0000; . a ; "42DU(2) Self-incrimination"@en; ; "46603b2099eeafeeb1cccc5364134e5f76e80e75e640014afe59527436453570"; ; "Protection from self-incrimination in certain cases"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.250"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits admissibility of self-incrimination in certain cases"; "(2) However, in the case of an individual..."; "...the information or producing the document; ... are not admissible in evidence against the individual:"; "modalities::logic::deontic"; 0.5000; . . a ; ; "Permission"; "Permits admissibility in certain cases"; "(2) However, in the case of an individual..."; "...in criminal proceedings, except proceedings for an offence against subsection 42DS(4) or (5); ..."; "modalities::logic::deontic"; 0.5000; . . a ; ; "Right"; "Establishes a right to protection from self-incrimination in certain cases"; "(2) However, in the case of an individual..."; "...the information or producing the document; ... are not admissible in evidence against the individual:"; "modalities::logic::deontic"; 0.5000; . . a ; ; "Obligation"; "Imposes an obligation on the state to protect self-incrimination in certain cases"; "(2) However, in the case of an individual..."; "...the information or producing the document; ... are not admissible in evidence against the individual:"; "modalities::logic::deontic"; 0.5000; . . a ; ; "Permission"; "Permits admissibility in certain cases under specific circumstances"; "(2) However, in the case of an individual..."; "...in civil proceedings, except proceedings under section 42Y for a contravention of section 42DT."; "modalities::logic::deontic"; 0.5000; . . a ; ; "Obligation"; "Imposes an obligation on the state to protect self-incrimination in certain cases under specific circumstances"; "(2) However, in the case of an individual..."; "...in civil proceedings, except proceedings under section 42Y for a contravention of section 42DT."; "modalities::logic::deontic"; 0.5000; . a ; "42DV Directions about advertisements or generic information"@en; ; "f60f07a4d550cfae0f22b38e69e609a4d6b1123d9c70bfda65811934d13d8efa"; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.251". a ; "42DV(1) Directions about advertisements or generic information"@en; ; "f46d1dd0011e195c1af177f0d47d41aeb8eb6a59ca8da801cca1ed01df793e59"; ; "Directs a person to cease advertising or take corrective action."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.251"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Directs a person to cease advertising."; "modalities::logic::deontic"; 1.0000; . a ; "42DV(2) Directions about advertisements or generic information"@en; ; "c2672d1b1ccdc789e88b89859069db7c72ed80bdcfb3cdf5552f1e0d7a024e35"; ; "Directs a person responsible for disseminating generic information to take corrective action."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.251"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Directs a person to withdraw or correct generic information."; "(2) If, in relation to the dissemination of generic information..."; "...the Secretary may, in writing, direct a person..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Influence"; "Affects the dissemination of generic information."; "(2) If, in relation to the dissemination of generic information..."; "...the Secretary may, in writing, direct a person..."; "modalities::diffusion"; 1.0000; . . a ; ; "Analyze"; "Analyzes the impact of generic information on public health."; "(2) If, in relation to the dissemination of generic information..."; "...the Secretary may, in writing, direct a person..."; "sparql_library::parsers::chk_parser"; 1.0000; . . a ; ; "Validate"; "Validates the accuracy of generic information."; "(2) If, in relation to the dissemination of generic information..."; "...the Secretary may, in writing, direct a person..."; "modalities::logic::shacl"; 1.0000; . . a ; ; "Define"; "Defines the scope of prohibited generic information."; "(2) If, in relation to the dissemination of generic information..."; "...the Secretary may, in writing, direct a person..."; "modalities::logic::n3_compiler"; 1.0000; . a ; "42DW Offences—contravening direction under section 42DV"@en; ; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.252". a ; "42DW(1) Offences—contravening direction under section 42DV"@en; ; "8169995f54eb3732a340deea0ffa175396a48b200556197ed933828b5d14d9e1"; ; "Offence for contravening direction under section 42DV"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.252"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of contravening direction"; "(1) A person commits an offence..."; "...the act or omission contravenes the direction..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Temporal relation"; "Temporal relation between contravention and harm"; "(d) either: (i) the use of the goods has resulted in, will result in, or is likely to result in, harm or injury..."; "...the harm or injury has resulted, will result, is likely to result, would result, or would be likely to result..."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Recurring trace"; "Recurring trace of contravention and harm"; "(d) either: (i) the use of the goods has resulted in, will result in, or is likely to result in, harm or injury..."; "...the harm or injury has resulted, will result, is likely to result, would result, or would be likely to result..."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Diffusion"; "Diffusion of contravention and harm"; "(d) either: (i) the use of the goods has resulted in, will result in, or is likely to result in, harm or injury..."; "...the harm or injury has resulted, will result, is likely to result, would result, or would be likely to result..."; "modalities::diffusion"; 1.0000; . . a ; ; "Classification"; "Classification of therapeutic goods"; "(c) the act or omission contravenes the direction or a condition..."; "...the use of the goods has resulted in, will result in, or is likely to result in, harm or injury..."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "42DW(2) Offences—contravening direction under section 42DV"@en; ; "802814fbf47da57ce1f2f70b8ed08cfdd5365908508aa7d2ef91137c67a9e870"; ; "Offence for contravening direction under section 42DV"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.252"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits contravening direction under section 42DV"; "(2) A person commits an offence if..."; "...the act or omission contravenes the direction or a condition of the direction."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Obligation"; "Imposes obligation to comply with direction under section 42DV"; "(2) A person commits an offence if..."; "...the act or omission contravenes the direction or a condition of the direction."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Temporal relation"; "Establishes temporal relation between direction under section 42DV and acts/omissions"; "(2) A person commits an offence if..."; "...the act or omission contravenes the direction or a condition of the direction."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Recurring trace"; "Establishes recurring trace between direction under section 42DV and acts/omissions"; "(2) A person commits an offence if..."; "...the act or omission contravenes the direction or a condition of the direction."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Prohibition"; "Prohibits acts/omissions that contravene direction under section 42DV"; "(b) the person does an act or omits to do an act;"; "...the act or omission contravenes the direction or a condition of the direction."; "modalities::logic::deontic"; 1.0000; . a ; "42DW(3) Offences—contravening direction under section 42DV"@en; ; "b8a92775d91778aca7bf1a7ac10b4506ae03811d43ed78d5592b873b86a5b5f6"; ; "Offence for contravening direction under section 42DV"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.252"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits contravening direction under section 42DV"; "(3) A person commits an offence if..."; "...the act or omission contravenes the direction or a condition of the direction."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Obligation"; "Imposes obligation to comply with direction under section 42DV"; "(a) the Secretary has given a direction to the person under subsection 42DV(1) or (2); and..."; "...the person does an act or omits to do an act."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibition"; "Prohibits omission of act under direction under section 42DV"; "(b) the person does an act or omits to do an act; and..."; "...the act or omission contravenes the direction or a condition of the direction."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Obligation"; "Imposes obligation to comply with conditions of direction under section 42DV"; "(c) the act or omission contravenes the direction or a condition of the direction."; "...the person does an act or omits to do an act."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibition"; "Prohibits failure to comply with conditions of direction under section 42DV"; "(c) the act or omission contravenes the direction or a condition of the direction."; "...the person does an act or omits to do an act."; "modalities::logic::deontic"; 1.0000; . a ; "42DW(4) Offences—contravening direction under section 42DV"@en; ; "436deed04d3f320a344b95ef5058be076990edcd77c14c1020ba45da6185cf7d"; ; "An offence against subsection (3) is an offence of strict liability."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.252"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Imposes a duty on the state."; "modalities::logic::deontic"; 1.0000; . a ; "42DX Civil penalty for contravening direction under section 42DV"@en; ; "1e3f8ee5492976f4ea0bf786553a3cb9ba446803c8c0d1703f06f972fb39986e"; "Contravening direction under section 42DV is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.253"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of contravening direction"; "modalities::logic::deontic"; 1.0000; . a ; "42DY Secretary may issue a public warning notice"@en; ; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.255". a ; "42DY(1) Secretary may issue a public warning notice"@en; ; "d7186cdc48a03de05acd1456dc4b9a4deacd6d00d1741823290ed922e10c4712"; ; "Secretary may issue a public warning notice about therapeutic goods under certain conditions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.255"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Secretary may issue a public warning notice."; "modalities::logic::deontic"; 1.0000; . a ; "42DY(2) Secretary may issue a public warning notice"@en; ; "c9ef81c2b7d857ddbaac25c10e640fdb7da5ec686158275fa14207d84d8da5c8"; ; "Secretary may issue a public warning notice if person fails to comply with substantiation notice."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.255"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits person from failing to comply with substantiation notice."; "(a) the Secretary gives a person a notice (the substantiation notice) under subsection 42DR(1) or (2); and (b) the person fails to comply with the substantiation notice;"; "the Secretary may issue to the public a written notice containing a warning that the person has failed to comply with the substantiation notice, and specifying the matter to which the substantiation notice related."; "modalities::logic::deontic"; 1.0000; . . a ; ; "During"; "Warning notice issued during period of non-compliance."; "(c) the Secretary is satisfied that it is in the public interest to issue a notice under this subsection;"; "the warning notice is issued during the period of non-compliance"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Until"; "Warning notice remains in effect until person complies."; "(c) the Secretary is satisfied that it is in the public interest to issue a notice under this subsection;"; "the warning notice remains in effect until the person complies"; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Spread"; "Warning notice spreads to public."; "(2) If: (a) the Secretary gives a person a notice (the substantiation notice) under subsection 42DR(1) or (2); and (b) the person fails to comply with the substantiation notice;"; "the warning notice spreads to the public"; "modalities::diffusion"; 1.0000; . . a ; ; "Imply"; "Warning notice implies that person has failed to comply."; "(2) If: (a) the Secretary gives a person a notice (the substantiation notice) under subsection 42DR(1) or (2); and (b) the person fails to comply with the substantiation notice;"; "the warning notice implies that the person has failed to comply"; "modalities::argumentation"; 1.0000; . a ; "42DY(3) Secretary may issue a public warning notice"@en; ; "740f18283d983b082a0d365df0febbed0f332219467375706ef817cdd78bfa66"; ; "Secretary must issue a public warning notice"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.255"; . a ; ; ; ; ; . . a ; ; "MUST"; "Must provide a public warning notice"; "modalities::logic::deontic"; 1.0000; . a ; "42DY(4) Secretary may issue a public warning notice"@en; ; "ba45ee4ef87998857fd35214ffaa1c9f2b3f6fa4a3500d68a9b6503c15bd2136"; ; "Secretary must issue a public warning notice."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.255"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide a public warning notice."; "modalities::logic::deontic"; 1.0000; . a ; "42E Offence of dealing with counterfeit therapeutic goods"@en; ; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.270". a ; "42E(1) Offence of dealing with counterfeit therapeutic goods"@en; ; "22404917c70aa2a3648c112d988b287591f171662cec8867b6f2c7951f7f6e40"; ; "Dealing with counterfeit therapeutic goods is an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.270"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits dealing with counterfeit therapeutic goods."; "modalities::logic::deontic"; 1.0000; . a ; "42E(2) Offence of dealing with counterfeit therapeutic goods"@en; ; "2d830f257ef74e04b9a89e868138ae3a80acd29b6f2ebb1cbf92e3a633cfff90"; ; "Dealing with counterfeit therapeutic goods is an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.270"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits dealing with counterfeit therapeutic goods."; "(2) Goods are counterfeit if any of the following contain a false representation..."; "Dealing with counterfeit therapeutic goods is an offence."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlap"; "Overlaps with other provisions related to therapeutic goods."; "(2) Goods are counterfeit if any of the following contain a false representation..."; "This provision overlaps with other provisions related to therapeutic goods."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Recurring"; "Recurring trace for dealing with counterfeit therapeutic goods."; "(2) Goods are counterfeit if any of the following contain a false representation..."; "Dealing with counterfeit therapeutic goods is a recurring trace."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Diffuse"; "Diffuses to other provisions related to therapeutic goods."; "(2) Goods are counterfeit if any of the following contain a false representation..."; "This provision diffuses to other provisions related to therapeutic goods."; "modalities::diffusion"; 1.0000; . . a ; ; "Recognize"; "Recognizes counterfeit therapeutic goods based on representations."; "(2) Goods are counterfeit if any of the following contain a false representation..."; "This provision recognizes counterfeit therapeutic goods based on representations."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "42E(3) Offence of dealing with counterfeit therapeutic goods"@en; ; "38c7cd252153cbf595d66ad21b34fe0b616da4cbab14869ada91d8c3f86ef7fb"; ; "Offence of dealing with counterfeit therapeutic goods"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.270"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits dealing with counterfeit therapeutic goods"; "(3) The matters are as follows:"; "modalities::logic::deontic"; 1.0000; . a ; "42E(5) Offence of dealing with counterfeit therapeutic goods"@en; ; "5012e232e8f9c87f1385ed1a8cd68bcf450beb4a0c6d1d70bcccfab03ebc7001"; ; "Defines term for therapeutic goods in section"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.270"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "defines"; "Defines term"; "modalities::logic::deontic"; 1.0000; . a ; "42EA Civil penalty relating to dealing with counterfeit therapeutic"@en; ; "42a2297340de55f789ad2a3290d7c955bf4f90b5fd9fef4e81f135832377a6fe"; "Dealing with counterfeit therapeutic goods is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.271"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits dealing with counterfeit therapeutic goods."; "modalities::logic::deontic"; 1.0000; . a ; "42EB Relief from liability for certain contraventions relating to"@en; ; "6499fa7239d689d01cd47d203fa3255e748cd868679b9e06b61dadf19ba05f41"; "Excuse from liability for certain contraventions relating to counterfeit therapeutic goods"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.271"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Obligation to excuse liability for certain contraventions"; "The person has a reasonable excuse"; "The person ought fairly be excused for the contravention"; "modalities::logic::deontic"; 0.5000; . . a ; ; "Overlaps"; "Excuse from liability overlaps with other excuses"; "The person has a reasonable excuse"; "The person ought fairly be excused for the contravention"; "modalities::interval_reasoning"; 0.5000; . . a ; ; "Recurrent"; "Excuse from liability is recurrent"; "The person has a reasonable excuse"; "The person ought fairly be excused for the contravention"; "modalities::temporal_ltl"; 0.5000; . a ; "42F Customs treatment of counterfeit therapeutic goods"@en; ; "c05a7a133de5dcfa786ea495d8d6c5ee5f67dd5ad0ee171e7f3892177d3d8896"; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.272". a ; "42F(1) Customs treatment of counterfeit therapeutic goods"@en; ; "a74279125a72eff79698ced84c0fc4da35c826ac9ae699b5122ee2e98fe2eb49"; ; "Customs treatment of counterfeit therapeutic goods"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.272"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "hasEffectAsIf"; "Imposes duty on Secretary to notify Comptroller-General of Customs"; "Secretary wishes the Customs Act 1901 to apply"; "Act has effect as if goods were forfeited to the Crown"; "modalities::logic::deontic"; 1.0000; . . a ; ; "during"; "Customs treatment applies during the period from notification to commencement"; "Secretary notifies Comptroller-General of Customs in writing"; "Customs treatment applies until commencement"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "implies"; "Notification implies application of the Customs Act 1901"; "Secretary notifies Comptroller-General of Customs in writing"; "Customs Act 1901 applies"; "modalities::argumentation"; 1.0000; . . a ; ; "diffuses"; "Notification diffuses to Comptroller-General of Customs"; "Secretary notifies Comptroller-General of Customs in writing"; "Comptroller-General of Customs receives notification"; "modalities::diffusion"; 1.0000; . . a ; ; "recognizes"; "Comptroller-General of Customs recognizes the notification as a directive from Secretary"; "Secretary notifies Comptroller-General of Customs in writing"; "Comptroller-General of Customs acknowledges receipt of notification"; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "42F(2) Customs treatment of counterfeit therapeutic goods"@en; ; "7adef90a479008b23569e0391f890e826228797d4fe10bf64f6c1cee2243697d"; ; "Customs treatment of counterfeit therapeutic goods"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.272"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits export of counterfeit therapeutic goods"; "Section 229 of the Customs Act 1901"; "Customs Act 1901 applies to export"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlap"; "Overlaps with section 229 of the Customs Act 1901"; "Section 42F(2) of the Customs Act 1901"; "Sections overlap in time"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Recurring"; "Recurring trace with section 229 of the Customs Act 1901"; "Section 42F(2) of the Customs Act 1901"; "Trace is recurring"; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Diffuse"; "Diffuses prohibition to export of counterfeit therapeutic goods"; "Section 42F(2) of the Customs Act 1901"; "Prohibition is diffuse"; "modalities::diffusion"; 1.0000; . . a ; ; "Recognize"; "Recognizes prohibition as a rule"; "Section 42F(2) of the Customs Act 1901"; "Prohibition is recognized"; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "42T Notifying of actual or potential tampering"@en; ; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.274". a ; "42T(1) Notifying of actual or potential tampering"@en; ; "6b3d9150b69017dadf15dd571dc82eb2ffd4d6a30613b9f40e1a28f2625ce328"; ; "Notify Secretary of actual or potential tampering within 24 hours."; "Notification to Secretary"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.274"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide notification"; "The person must notify the Secretary."; "modalities::logic::deontic"; 1.0000; . . a ; ; "OBLIGATION"; "Notification is an obligation"; "The person has a duty to notify the Secretary."; "modalities::logic::deontic"; 1.0000; . a ; "42T(2) Notifying of actual or potential tampering"@en; ; "24ae264c26b53b77d6f156a3d57bd3291dcde54233d8f04f0491ebc9bdd56eae"; ; "Failure to notify of actual or potential tampering with therapeutic goods within 24 hours."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.274"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibition of failure to notify"; "Notification is required within 24 hours"; "Failure to comply results in penalty"; "modalities::logic::deontic"; 1.0000; . a ; "42T(3) Notifying of actual or potential tampering"@en; ; "cce4d3b8ddfd23948ec0794e53f4fab9d2c19ee51b3363eeec2b5331f274416e"; ; "Negligence standard for notification of tampering"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.274"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Notification obligation"; "(3) For the purposes of subparagraph (2)(c)(ii)"; "the person is only taken to be negligent..."; "modalities::logic::deontic"; 0.5000; . . a ; ; "Temporal relation"; "Temporal relation between notification and standard of care"; "(a) the person’s acts or omissions involve such a great falling short..."; "...of the standard of care that a reasonable person would exercise in the circumstances;"; "modalities::interval_reasoning"; 0.5000; . . a ; ; "Recurring trace"; "Recurring trace of notification and risk assessment"; "(b) there is such a high risk..."; "...that the acts or omissions merit criminal punishment."; "modalities::temporal_ltl"; 0.5000; . . a ; ; "Risk assessment"; "Risk assessment for tampering notification"; "(b) there is such a high risk..."; "...that the acts or omissions merit criminal punishment."; "modalities::diffusion"; 0.5000; . . a ; ; "Knowledge representation"; "Knowledge representation of negligence standard"; "(a) the person’s acts or omissions involve such a great falling short..."; "...of the standard of care that a reasonable person would exercise in the circumstances;"; "sparql_library::parsers::chk_parser"; 0.5000; . a ; "42T(4) Notifying of actual or potential tampering"@en; ; "0f853c1e609bda064fc90fb8104343e5a45fd6914b6d6bd96474fc2a8bd923bb"; ; "No possession or control required for notification"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.274"; . a ; ; ; ; "borne by: State"; ; . a ; "42U Meaning of actual or potential tampering etc."@en; ; "8470dfd9b0da09e7abd37149dc8cbdbce84400d640904cb3864ac82d07549ec3"; "Tampering with therapeutic goods is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.275"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits tampering with therapeutic goods."; "Therapeutic goods are protected by law."; "Tampering is prohibited."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Classify"; "Classifies therapeutic goods as subject to tampering prohibition."; "Therapeutic goods have a specific meaning in this context."; "Tampering is prohibited for these goods."; "modalities::dl"; 1.0000; . . a ; ; "During"; "Tampering occurs during the manufacturing or distribution of therapeutic goods."; "Therapeutic goods are manufactured or distributed at specific times."; "Tampering occurs during these times."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Until"; "Tampering is prohibited until the therapeutic goods reach a safe state."; "Therapeutic goods must be in a safe state before they can be used."; "Tampering occurs until this safety condition is met."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Through"; "Tampering with therapeutic goods diffuses the risk of harm to others."; "Therapeutic goods can cause harm if tampered with."; "The risk of harm is diffused through tampering."; "modalities::diffusion"; 1.0000; . . a ; ; "By"; "Tampering with therapeutic goods is done by a specific entity or action."; "Therapeutic goods have a specific purpose and are subject to regulation."; "The entity or action responsible for tampering is specified."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "42V Recall of therapeutic goods because of actual or potential"@en; ; "d410c3198e964c544c8e584117f196d490b769c115188ba2b97a283f122e62d2"; , , , , , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.276". a ; "42V(1) Recall of therapeutic goods because of actual or potential"@en; ; "df8dc8357d3eb4138ef50b1634e851e3fc22c600491cc75a0e103b5e121129d9"; ; "Secretary may impose requirements on a person supplying therapeutic goods"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.276"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Imposes obligation"; "modalities::logic::deontic"; 1.0000; . a ; "42V(2) Recall of therapeutic goods because of actual or potential"@en; ; "836ec64714cd89aec5a752e4368b47ee52a9a7f17cee8901a228e3a391d6418f"; ; "Recall of therapeutic goods because of actual or potential tampering"; "specified steps, in the specified manner and within a reasonable period"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.276"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Duty to recall therapeutic goods"; "modalities::logic::deontic"; 1.0000; . . a ; ; "CLASSIFICATION"; "Classification of therapeutic goods based on tampering risk"; "modalities::dl"; 1.0000; . a ; "42V(3) Recall of therapeutic goods because of actual or potential"@en; ; "9e05d4d77d71663afe60b18b929d63ec5ba5936e148a048597211f434aecf8bc"; ; "Therapeutic goods that have been administered to a person cannot be recalled."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.276"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits recall of therapeutic goods administered to a person."; "(3) Requirements referred to in paragraph (2)(a) do not apply..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlaps"; "The recall requirement overlaps with the administration of therapeutic goods."; "(3) Requirements referred to in paragraph (2)(a) do not apply..."; "modalities::interval_reasoning"; 1.0000; . a ; "42V(4) Recall of therapeutic goods because of actual or potential"@en; ; "6e8200d8e1720a619d51ce50525f92e9003185470bf3b861ca0b8d91ca7bf811"; ; "Secretary must publish notice setting out requirements after imposing them."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.276"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Imposes duty on the Secretary."; "The Secretary must publish a notice."; "modalities::logic::deontic"; 1.0000; . a ; "42V(5) Recall of therapeutic goods because of actual or potential"@en; ; "08c99dd8e1647cb2875026db37a8e7bc0f3e2e428d18c71ab700c7a3c0be29aa"; ; "Secretary may impose requirements under this section"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.276"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Imposes obligation on the Secretary"; "modalities::logic::deontic"; 1.0000; . a ; "42V(6) Recall of therapeutic goods because of actual or potential"@en; ; "07cc0436c56b92798e48f64d1b8b47032035611fec896ed88bd0cdee834ed52b"; ; "Failure to comply with a requirement under subsection (1) in relation to a supply of therapeutic goods is an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.276"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "Prohibition"; "Prohibition of non-compliance with a requirement."; "The person fails to comply with a requirement under subsection (1)."; "An offence is committed."; "modalities::logic::deontic"; 0.5000; . a ; "42V(6C) Recall of therapeutic goods because of actual or potential"@en; ; "008d6b3d86ecdca3d07ea3f372d6167f11707debc4595544f9feaf35b5faca5e"; ; "Failure to comply with a requirement in relation to a supply of therapeutic goods is an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.276"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Obligation to comply with a requirement"; "modalities::logic::deontic"; 1.0000; . a ; "42V(6D) Recall of therapeutic goods because of actual or potential"@en; ; "9b4412be441c267120c5c36da424f2e40d626c643d8d1646b270440b65fe4231"; ; "Failure to comply with a requirement under subsection (1) in relation to a supply of therapeutic goods is an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.276"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "obligation"; "Obligation to comply with a requirement."; "modalities::logic::deontic"; 1.0000; . a ; "42V(6E) Recall of therapeutic goods because of actual or potential"@en; ; "6f842f5a76499d093b4a63e9a2e693686e2f6b7f40a316273509861fcbb43ebc"; ; "Offence of strict liability for recall of therapeutic goods"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.276"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits recall of therapeutic goods"; "modalities::logic::deontic"; 1.0000; . a ; "42VA Civil penalty relating to the recall of therapeutic goods"@en; ; "945ecb8c26aa743a479f5b981e0d72e4edbbf2f81f3a1b67330006eeeda86471"; "Failure to comply with a requirement under subsection 42V(1) in relation to a supply of therapeutic goods is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.278"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibition"; "modalities::logic::deontic"; 1.0000; . a ; "42VB Relief from liability for contraventions relating to the recall of"@en; ; "8bfec45cc6a836eb96b9895d577de34cadbedc0a85f61140710f65a1effee643"; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.278". a ; "42VB(1) Relief from liability for contraventions relating to the recall of"@en; ; "ef2d415a7617ab4814d3732793826b839944e3df421e484c9ab04a92b945ea34"; ; "Relief from liability for contraventions relating to the recall of"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.278"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "exemption"; "Exemptions from liability"; "The person has acted honestly and ought fairly to be excused for the contravention."; "Relief from liability is granted."; "modalities::logic::deontic"; 0.5000; . . a ; ; "during"; "Temporal interval during which relief from liability applies"; "The relief from liability applies if the proceedings are brought within a certain timeframe."; "Relief from liability is granted during a specific temporal interval."; "modalities::interval_reasoning"; 0.5000; . . a ; ; "justification"; "Justification for exemption from liability"; "The person's honesty and circumstances of the case justify relief from liability."; "The person's actions are justified by their honesty and circumstances."; "modalities::argumentation"; 0.5000; . . a ; ; "propagation"; "Propagation of exemption from liability"; "Relief from liability is granted to the person if they have acted honestly."; "The exemption from liability propagates to the person."; "modalities::diffusion"; 0.5000; . . a ; ; "recognition"; "Recognition of exemption from liability"; "The Court recognizes the person's honesty and circumstances as justification for relief from liability."; "The Court recognizes the person's exemption from liability."; "sparql_library::parsers::chk_parser"; 0.5000; . a ; "42VB(2) Relief from liability for contraventions relating to the recall of"@en; ; "2e5c7a137962c02aab1ed8ce30f76605eb1a06905804468510701037b1c7cd5a"; ; "Right to apply for relief from liability"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.278"; . a ; ; ; ; "borne by: NaturalPerson"; ; . . a ; ; "May"; "Right to apply"; "modalities::logic::deontic"; 1.0000; . a ; "42VB(3) Relief from liability for contraventions relating to the recall of"@en; ; "5489d4cf7966fdaaeb26e461df070acdbdf741713c806bddd6efa7a92cd38bc8"; ; "Granting relief from liability for contraventions relating to the recall of therapeutic goods."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.278"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Granting obligation"; "modalities::logic::deontic"; 1.0000; . a ; "42VB(4) Relief from liability for contraventions relating to the recall of"@en; ; "c1a6af583d64a91a7811f826e594d75dd38c5d122f950f14b1fd7f986cf0c1ed"; ; "Relief from liability for contraventions relating to the recall of"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.278"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Imposes a duty on the State"; "modalities::logic::deontic"; 1.0000; . . a ; ; "ClassInclusion"; "Defines a subclass of 'contraventions'"; "modalities::dl"; 1.0000; . a ; "42W Supply etc. of therapeutic goods that are subject to recall"@en; ; "10762e1094dbeeaba59c58cec8a91b71b99f2063f7f1f20e5c0e3e635f42b2df"; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.279". a ; "42W(1) Supply etc. of therapeutic goods that are subject to recall"@en; ; "8565cc30b88cafe79344056522c771002f5f2989e7b0fc725bc2f42b97bc0b71"; ; "Supply of therapeutic goods subject to recall is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.279"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits supply of therapeutic goods subject to recall."; "(1) A person commits an offence..."; "...the person supplies therapeutic goods in Australia;"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibit"; "Prohibits supply of therapeutic goods without consent."; "(c) the Secretary has not consented in writing to the supply."; "...the person supplies therapeutic goods in Australia;"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibit"; "Prohibits reckless supply of therapeutic goods subject to recall."; "(ii) the therapeutic goods are of such a kind, or are included in such a batch, and the person is reckless as to that fact;"; "...the person supplies therapeutic goods in Australia;"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Temporal Interval"; "Defines temporal interval for recall requirements."; "(i) the person knows that the therapeutic goods are of a kind, or are included in a batch, in respect of which requirements have been imposed..."; "...requirements have been imposed under section 42V, on that person or another person, to recall therapeutic goods;"; "modalities::interval_reasoning"; 1.0000; . a ; "42W(2) Supply etc. of therapeutic goods that are subject to recall"@en; ; "cbc5f15d7e822c1300c86260329091878991a9e337f353fb2db07f824430fc57"; ; "Exporting therapeutic goods from Australia is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.279"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits exportation of therapeutic goods."; "modalities::logic::deontic"; 1.0000; . a ; "42X Saving of other laws"@en; ; "e447459c61041b466c76aa19bda75607567f8a205b926bcacfb43dd140f1cde6"; "No exclusion or limitation of other laws"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.280"; . a ; ; ; ; ; . . a ; ; "excludes"; "Exclusion clause"; "No exclusion or limitation"; "modalities::logic::deontic"; 1.0000; . a ; "42Y Federal Court may order person to pay pecuniary penalty for"@en; ; "e87c0ec939fd8e6eadbf09bfac450b20b64c5abcbec3a0facadf698d832f455e"; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.281". a ; "42Y(1) Federal Court may order person to pay pecuniary penalty for"@en; ; "c3a60be4f2188e4fddffd3f24178b4e513ef354fa8f05344040a1a8fff80df6e"; ; "Order to pay pecuniary penalty for contravening a civil penalty provision."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.281"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "obligation"; "Obligation to pay pecuniary penalty"; "Contravening a civil penalty provision"; "Pay the Commonwealth a pecuniary penalty"; "modalities::logic::deontic"; 1.0000; . . a ; ; "within-6-years"; "Within 6 years of the wrongdoer's contravention"; "Time period"; "Secretary may apply for an order within this time frame"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "may-apply-on-behalf-of"; "Secretary may apply on behalf of the Commonwealth"; "Commonwealth's interest"; "Secretary has authority to act on behalf of the Commonwealth"; "modalities::argumentation"; 1.0000; . . a ; ; "may-order"; "May order wrongdoer to pay pecuniary penalty"; "Court's power"; "Wrongdoer is subject to the court's order"; "modalities::diffusion"; 1.0000; . a ; "42Y(2) Federal Court may order person to pay pecuniary penalty for"@en; ; "92de092e553ce0b4a769692101e15643f005661248c56649a4bcbf281fff8fec"; ; "Order to pay pecuniary penalty for contravention of civil penalty provision"; "pecuniary penalty amount"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.281"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "obligation"; "Legal obligation to pay pecuniary penalty"; "modalities::logic::deontic"; 1.0000; . a ; "42Y(3) Federal Court may order person to pay pecuniary penalty for"@en; ; "f70a006a55a8414ab6c77a2529fa4b4f1bdecd701f72fe4f90dc76b95c30e06c"; ; "Court must consider certain factors when determining pecuniary penalty."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.281"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Court must consider certain factors."; "(3) In determining the pecuniary penalty, the Court..."; "modalities::logic::deontic"; 1.0000; . a ; "42YA What is a civil penalty provision?"@en; ; "440b0c533d29838f277721fc589819d7169a2f642ccccb75fd7e30736bb8e941"; "Defines civil penalty provision"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.282"; . a ; ; ; ; ; . . a ; ; "is defined as"; "Defines a concept"; "civil penalty provision"; "modalities::logic::deontic"; 1.0000; . a ; "42YC Persons involved in contravening civil penalty provision"@en; ; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.282". a ; "42YC(1) Persons involved in contravening civil penalty provision"@en; ; "f03f82dd55045f406092838667b6592943dc47d17ab449ce392d54b1b6e1febd"; ; "Continuation of obligation despite expired period or passed time. Aiding, abetting, or inducing a contravention of a civil penalty provision is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.282"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "CONTINUES"; "Continuation of obligation despite expired period or passed time."; "(1) If an act or thing is required under a civil penalty provision to be done:"; "modalities::logic::deontic"; 1.0000; . . a ; ; "MEETS"; "Requires a relation between identifiable temporal intervals."; "Conditional commencement is Undertaking, not Prohibition."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "CONTAINS"; "Requires an ordered or recurring trace."; "Do not invent a bearer, holder, condition, cross-reference, premise, or conclusion."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "APPLIES_TO"; "Applicable to obligations."; "(1) If an act or thing is required under a civil penalty provision to be done:"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibit"; "Prohibition"; "(1) A person must not..."; "modalities::logic::deontic"; 1.0000; . a ; "42YC(2) Persons involved in contravening civil penalty provision"@en; ; "859081201637f03f7d227ab33b6dbab0920641757d01d8dba55838e652388db0"; ; "Separate contravention for each day of non-compliance Continuing contraventions of civil penalty provisions are obligations on the person involved."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.282"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits contravention"; "(2) A person who contravenes a civil penalty provision..."; "commits a separate contravention of that provision in respect of each day during which the contravention occurs"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlaps"; "Describes temporal overlap of contraventions"; "(2) A person who contravenes a civil penalty provision..."; "each day during which the contravention occurs (including the day the order under subsection 42Y(2) is made or any later day)"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Repeats"; "Describes recurring nature of contraventions"; "(2) A person who contravenes a civil penalty provision..."; "each day during which the contravention occurs (including the day the order under subsection 42Y(2) is made or any later day)"; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Diffuses"; "Describes diffusion of contraventions over time"; "(2) A person who contravenes a civil penalty provision..."; "each day during which the contravention occurs (including the day the order under subsection 42Y(2) is made or any later day)"; "modalities::diffusion"; 1.0000; . . a ; ; "Recognizes"; "Describes recognition of contraventions by AI system"; "(2) A person who contravenes a civil penalty provision..."; "each day during which the contravention occurs (including the day the order under subsection 42Y(2) is made or any later day)"; "sparql_library::parsers::chk_parser"; 1.0000; . . a ; ; "obligation"; "Obligation"; "The person involved must comply with the civil penalty provision."; "modalities::logic::deontic"; 1.0000; . a ; "42YC(1) Persons involved in contravening civil penalty provision"@en; ; "dac8da6da9cd415391744040ad03ce5ffe6315e03e6120eac9008d6d16c661cd"; ; "Continuation of obligation despite expired period or passed time. Aiding, abetting, or inducing a contravention of a civil penalty provision is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.282"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "CONTINUES"; "Continuation of obligation despite expired period or passed time."; "(1) If an act or thing is required under a civil penalty provision to be done:"; "modalities::logic::deontic"; 1.0000; . . a ; ; "MEETS"; "Requires a relation between identifiable temporal intervals."; "Conditional commencement is Undertaking, not Prohibition."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "CONTAINS"; "Requires an ordered or recurring trace."; "Do not invent a bearer, holder, condition, cross-reference, premise, or conclusion."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "APPLIES_TO"; "Applicable to obligations."; "(1) If an act or thing is required under a civil penalty provision to be done:"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibit"; "Prohibition"; "(1) A person must not..."; "modalities::logic::deontic"; 1.0000; . a ; "42YC(2) Persons involved in contravening civil penalty provision"@en; ; "aebe20a21c5acf36ab146a4660752c515af3fd6d0f14c099307ee2f2b751f472"; ; "Separate contravention for each day of non-compliance Continuing contraventions of civil penalty provisions are obligations on the person involved."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.282"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits contravention"; "(2) A person who contravenes a civil penalty provision..."; "commits a separate contravention of that provision in respect of each day during which the contravention occurs"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlaps"; "Describes temporal overlap of contraventions"; "(2) A person who contravenes a civil penalty provision..."; "each day during which the contravention occurs (including the day the order under subsection 42Y(2) is made or any later day)"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Repeats"; "Describes recurring nature of contraventions"; "(2) A person who contravenes a civil penalty provision..."; "each day during which the contravention occurs (including the day the order under subsection 42Y(2) is made or any later day)"; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Diffuses"; "Describes diffusion of contraventions over time"; "(2) A person who contravenes a civil penalty provision..."; "each day during which the contravention occurs (including the day the order under subsection 42Y(2) is made or any later day)"; "modalities::diffusion"; 1.0000; . . a ; ; "Recognizes"; "Describes recognition of contraventions by AI system"; "(2) A person who contravenes a civil penalty provision..."; "each day during which the contravention occurs (including the day the order under subsection 42Y(2) is made or any later day)"; "sparql_library::parsers::chk_parser"; 1.0000; . . a ; ; "obligation"; "Obligation"; "The person involved must comply with the civil penalty provision."; "modalities::logic::deontic"; 1.0000; . a ; "42YD Recovery of a pecuniary penalty"@en; ; "fc3e3971d83224ceca41d33aa68686d555dba3464a86be0416577e3b1f3dcb78"; "The Commonwealth may enforce a pecuniary penalty order as if it were a judgment of the Court."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.283"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MayEnforce"; "The Commonwealth may enforce the order."; "The penalty is payable to the Commonwealth."; "The Commonwealth may enforce the order as if it were a judgment of the Court."; "modalities::logic::deontic"; 0.5000; . a ; "42YE Gathering information for application for pecuniary penalty"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.283". a ; "42YE(1) Gathering information for application for pecuniary penalty"@en; ; "e63782e8b1d5cfd89cf12239e543c1070420c4d5223db3185823d6cd341e6ac9"; ; "Duty to gather information for pecuniary penalty application"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.283"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Duty obligation"; "modalities::logic::deontic"; 1.0000; . a ; "42YE(2) Gathering information for application for pecuniary penalty"@en; ; "5126d0652991cd0dee19fd0d97039b812c6cc7dd083026b3771fb6f36976cb3a"; ; "Secretary may require person to give assistance in connection with application for civil penalty order."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.283"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Obligation to provide assistance"; "modalities::logic::deontic"; 1.0000; . a ; "42YF Civil proceedings after criminal proceedings"@en; ; "1f1163bb26ddf3f3893280cfe76484b828fbc699e9001100ec94501fa4dadb10"; "Federal Court cannot impose pecuniary penalty order on a person convicted of an offence substantially similar to the contravention."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.285"; . a ; ; ; ; ; . . a ; ; "Cannot"; "Prohibition of pecuniary penalty order"; "Federal Court must not make a pecuniary penalty order"; "against a person convicted of an offence substantially similar to the contravention"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Temporal overlap"; "Temporal intervals of conviction and contravention must overlap"; "Conviction of an offence constituting substantially similar conduct to the contravention"; "must be considered when imposing pecuniary penalty order"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Recurring trace"; "Recurring traces of conviction and contravention must be considered"; "Conviction of an offence substantially similar to the contravention"; "must be taken into account when imposing pecuniary penalty order"; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Diffusive effect"; "Diffusive effect of conviction on contravention must be considered"; "Conviction of an offence substantially similar to the contravention"; "must be taken into account when imposing pecuniary penalty order"; "modalities::diffusion"; 1.0000; . . a ; ; "Knowledge-based system"; "Knowledge-based system must consider conviction and contravention"; "Federal Court must not make a pecuniary penalty order against a person convicted of an offence substantially similar to the contravention"; "must be taken into account when imposing pecuniary penalty order"; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "42YG Criminal proceedings during civil proceedings"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.285". a ; "42YG(1) Criminal proceedings during civil proceedings"@en; ; "732c99a75cdb6b11295c4964aa26732fce54a74898c3222ad38b8645fc7869a1"; ; "Stay of pecuniary penalty order proceedings during criminal proceedings for same offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.285"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prevents pecuniary penalty order proceedings during criminal proceedings for same offence."; "(a) criminal proceedings are started or have already been started against the person for an offence; and (b) the offence is constituted by conduct that is substantially the same as the conduct alleged to constitute the contravention."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlaps"; "Defines a temporal overlap between criminal proceedings and pecuniary penalty order proceedings."; "(a) criminal proceedings are started or have already been started against the person for an offence; and (b) the offence is constituted by conduct that is substantially the same as the conduct alleged to constitute the contravention."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Recurrently"; "Defines a recurring relationship between criminal proceedings and pecuniary penalty order proceedings."; "(a) criminal proceedings are started or have already been started against the person for an offence; and (b) the offence is constituted by conduct that is substantially the same as the conduct alleged to constitute the contravention."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Diffuses"; "Diffuses the prohibition of pecuniary penalty order proceedings during criminal proceedings for same offence."; "(a) criminal proceedings are started or have already been started against the person for an offence; and (b) the offence is constituted by conduct that is substantially the same as the conduct alleged to constitute the contravention."; "modalities::diffusion"; 1.0000; . . a ; ; "Recognizes"; "Recognizes the prohibition of pecuniary penalty order proceedings during criminal proceedings for same offence."; "(a) criminal proceedings are started or have already been started against the person for an offence; and (b) the offence is constituted by conduct that is substantially the same as the conduct alleged to constitute the contravention."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "42YG(2) Criminal proceedings during civil proceedings"@en; ; "6809eb957260185e2c23cc179276b59e101819e7def754d87f62d4d229c6871a"; ; "Proceedings for order may be resumed if not convicted."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.285"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "resume"; "Resumption of proceedings"; "(2) The proceedings for the order may be resumed..."; "...the proceedings for the order are dismissed."; "modalities::logic::deontic"; 0.5000; . a ; "42YH Criminal proceedings after civil proceedings"@en; ; "74189f65ca31bb32041099f1e1ccf2239aa77da7b9533bfdb3ba236eb7651070"; "Criminal proceedings cannot start against conduct substantially similar to a civil penalty provision if a pecuniary penalty order has been made."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.285"; . a ; ; ; ; ; . . a ; ; "forbid"; "Prohibits criminal proceedings against similar conduct."; "modalities::logic::deontic"; 1.0000; . a ; "42YI Evidence given in proceedings for civil penalty not admissible"@en; ; "a73ec733acf5bacc42d56d003d9c918a685e31202526fe20eeaa4e96ac0e1ca2"; "Evidence of information given or production of documents by an individual is not admissible in criminal proceedings against the individual."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.285"; . a ; ; ; ; "borne by: State"; ; . a ; "42YJ Simplified outline of this Part"@en; ; "a6bb8b6ed975339a5fd83004ad1c14e3a776f22bf2892a2d91d269b500be4d22"; "Secretary can issue infringement notice for contravention of Act or regulations."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.287"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "can"; "Secretary can issue infringement notice."; "modalities::logic::deontic"; 1.0000; . a ; "42YK When an infringement notice may be given"@en; ; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.287". a ; "42YK(1) When an infringement notice may be given"@en; ; "a709fdede52631216054df095a4655d44d7d4cd352224c5e377df2eeef3dffb3"; ; "Secretary may give infringement notice for alleged contravention."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.287"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Implies obligation."; "modalities::logic::deontic"; 1.0000; . a ; "42YK(2) When an infringement notice may be given"@en; ; "efbfebdeffd3646a8d25c036cd4a5c1fbd9b888f73ec7eda65a983f3abc4eb4a"; ; "Infringement notice must be given within 12 months after contravention."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.287"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Obligation to give infringement notice within 12 months."; "(2) The infringement notice must be given..."; "modalities::logic::deontic"; 1.0000; . a ; "42YK(3) When an infringement notice may be given"@en; ; "ba0f0ec4033417a534a67ae0bc9041b729f19bbbcfa33360f3d6e8b603e22395"; ; "A single infringement notice must relate only to a single contravention of a single provision."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.287"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "necessity"; "Single infringement notice must relate to a single contravention."; "modalities::logic::deontic"; 1.0000; . a ; "42YK(4) When an infringement notice may be given"@en; ; "69fb99c91f59894975fe2d383c1cfe574e2105f3b42f055c62ae6c66446fbe11"; ; "Secretary may give a person an infringement notice relating to multiple contraventions of a single provision if certain conditions are met."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.287"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Secretary may give an infringement notice"; "modalities::logic::deontic"; 1.0000; . a ; "42YL Enforcement of undertakings"@en; ; , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.295". a ; "42YL(1) Enforcement of undertakings"@en; ; "78c0e42099f7170a1f3769cad8f97a9ff71640fb743b17cf8a51f4c29a1196e7"; ; "Secretary may accept written undertaking from person in connection with a matter."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.295"; . a ; ; ; ; . . a ; ; "acceptance"; "Acceptance of undertaking"; "(1) The Secretary may accept a written undertaking..."; "modalities::logic::deontic"; 1.0000; . a ; "42YL(2) Enforcement of undertakings"@en; ; "ecbd0992398e8907cdd8b72a5c4da3ffc7771042dbfb8ae27f35d7e1561b2250"; ; "The person may withdraw or vary the undertaking with consent from the Secretary."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.295"; . a ; ; ; ; "borne by: State"; ; . a ; "42YL(3) Enforcement of undertakings"@en; ; "465301282254efbf35ae32b413253da3902801133c4afcbedc2aceedba1a5afe"; ; "Secretary must publish details of undertaking on the internet."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.295"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must publish details"; "The Secretary must publish..."; "modalities::logic::deontic"; 1.0000; . a ; "42YL(4) Enforcement of undertakings"@en; ; "ea84486e1dfe4a062cd7cd6e19f3659f8a05716264011671bc83e28b434bdedd"; ; "Secretary may apply for order if undertaking is breached"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.295"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "May apply for order"; "modalities::logic::deontic"; 0.5000; . a ; "42YL(5) Enforcement of undertakings"@en; ; "da8a864732f059b045c128da653b95f49fe84883ee6e0a3a165a9fcbec844145"; ; "Court may make orders to enforce breach of undertaking."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.295"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "obligation"; "Enforcement obligation"; "modalities::logic::deontic"; 1.0000; . a ; "42YM Simplified outline of this Part"@en; ; "677142dce40942b1d3619e607b3e7b778bba3426c1b3e578a6db652877ed9f3f"; "Secretary can seek injunctions from Federal Court or Family Court to restrain contravention of Act or regulations."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.296"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "can"; "Possibility of obligation"; "modalities::logic::deontic"; 1.0000; . a ; "42YN Grant of injunctions"@en; ; "2d2c65f99dde74f1ab7c119c57cb3de705b9b8ab95606cbf75f223056d2ecaa7"; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.296". a ; "42YN(1) Grant of injunctions"@en; ; "508b327ec50e7d3e1cbc5ff6daa52071e154beeb6ea9a5ecc2af7681781be4d4"; ; "Grant of injunctions for conduct in contravention of the Act or regulations."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.296"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits conduct in contravention of the Act or regulations."; "modalities::logic::deontic"; 1.0000; . a ; "42YN(2) Grant of injunctions"@en; ; "61643e4f92fa28fe0d9ca9fc0b47d6e3f0c1693430c46e53e4517047cbd7a885"; ; "Grant of injunctions for refusal or failure to comply with the Act"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.296"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "obligation"; "Obligation to comply with the Act"; "(2) If..."; "the Federal Court or Federal Circuit and Family Court of Australia may grant an injunction requiring the person to do that thing."; "modalities::logic::deontic"; 1.0000; . a ; "42YO Interim injunctions"@en; ; "6f4949595625000bdae8f6ffe6c4c76b3a8b946481c3fe5058026fcac4fb69cd"; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.297". a ; "42YO(1) Interim injunctions"@en; ; "42d90cada066216010dfefc4f5fa3f5fb9f1c59879985ab147c004e55934a06f"; ; "Restraining conduct"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.297"; . a ; ; ; ; ; . a ; "42YO(2) Interim injunctions"@en; ; "ee16bb18663138093e40ef6f1928a95f489761209bad0861b11f6a0219291b60"; ; "Cannot require the Secretary to give an undertaking as a condition of granting an interim injunction."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.297"; . a ; ; ; ; ; . . a ; ; "cannot"; "Cannot require the Secretary to give an undertaking as a condition of granting an interim injunction."; "modalities::logic::deontic"; 1.0000; . a ; "42YP Discharging or varying injunctions"@en; ; "148351955c551ac69066da5c39bbc1f85a6a0aa8fb7b60b0dea2e5e4332a105f"; "May discharge or vary an injunction granted by that court under this Part."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.297"; . a ; ; ; ; ; . . a ; ; "may"; "Permits discharge or variation of an injunction"; "modalities::logic::deontic"; 1.0000; . a ; "42YQ Certain limits on granting injunctions not to apply"@en; ; "acf5a9d3496a06038c2adcaa55b9d68e54f378d7a6a084e0481029a33178d9b3"; "Court may grant injunction without considering intent or previous conduct."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.297"; . a ; ; ; ; ; . . a ; ; "Permit"; "Court permits exercise of power to grant injunction."; "modalities::logic::deontic"; 1.0000; . a ; "42YR Other powers of court unaffected"@en; ; "321527a650447a14f5fda26e46a4d01afb7857a21f46d18d23d15b9b178ff866"; "Court's other powers unaffected"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.298"; . a ; ; ; ; ; . a ; "42YS Simplified outline of this Part"@en; ; "aa146065c90516b0b16c6d4daee20e892ccbcc10bac51a372741edf2ce1704fb"; "Secretary may give directions to a person requiring specified actions in relation to goods."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.299"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Secretary may give directions."; "modalities::logic::deontic"; 1.0000; . a ; "42YT Secretary may give directions if this Act or an instrument is"@en; ; "431453420261e6be76470816198413991bfc3f0510f141c6f917be6292954ca3"; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.299". a ; "42YT(1) Secretary may give directions if this Act or an instrument is"@en; ; "4becc095fb4112042c9d3c8cc1abf723719464344fd5a6637cb48cca4cca49da"; ; "Secretary may give directions if this Act or an instrument is not complying with the Act in relation to particular goods."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.299"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Secretary may give directions"; "This section applies if the Secretary believes..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "if the Secretary believes on reasonable grounds that..."; "Conditional commencement"; "it is in the interests of public health or safety to give the person directions under this section."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "is not complying with this Act or an instrument"; "Non-compliance with the Act"; "(a) a person is not complying with this Act or an instrument made under this Act in relation to particular goods;"; "modalities::logic::deontic"; 1.0000; . . a ; ; "is in the interests of public health or safety"; "Public health or safety interest"; "it is in the interests of public health or safety to give the person directions under this section."; "modalities::logic::deontic"; 1.0000; . . a ; ; "to give the person directions"; "Giving directions"; "it is in the interests of public health or safety to give the person directions under this section."; "modalities::logic::deontic"; 1.0000; . a ; "42YT(2) Secretary may give directions if this Act or an instrument is"@en; ; "02bed4be26ea35ecd8bdf82d209fae00fe6c8026de78363de90f2c1270729125"; ; "Secretary may give directions to a person regarding the relabeling, repackaging, or disposal of goods."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.299"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Implies obligation"; "modalities::logic::deontic"; 1.0000; . a ; "43 By whom charges payable"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.301". a ; "43(1) By whom charges payable"@en; ; "37cdc2772810f5ca91fda6bc6d8113b3b8f9f9b1872c524ffdc853c9817027cf"; ; "Annual registration charge payable by person in relation to whom therapeutic goods are registered, listed or included."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.301"; . a ; ; ; ; "borne by: NaturalPerson"; ; . . a ; ; "Obligation"; "Imposes a duty on the person to pay the annual registration charge."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlaps"; "Specifies the temporal interval during which the annual registration charge must be paid."; "Annual"; "modalities::interval_reasoning"; 1.0000; . a ; "43(2) By whom charges payable"@en; ; "34ce0cc9b9f8b32ef4c7e4b0aee2cbfc25cb0486e30090983d22bcd9b948c330"; ; "Annual licensing charge payable by licence holder"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.301"; . a ; ; ; ; ; . . a ; ; "payable by"; "Obligation to pay annual licensing charge"; "holder of the licence"; "annual licensing charge"; "modalities::logic::deontic"; 1.0000; . a ; "43(3) By whom charges payable"@en; ; "c244f40686302b37f238680cc1a935289da74339501c1a02f1cc37becc30245f"; ; "Annual conformity assessment body determination charge payable by Australian corporation"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.301"; . a ; ; ; ; ; . . a ; ; "Obligation"; "Payable obligation"; "modalities::logic::deontic"; 1.0000; . a ; "44 Time for payment of charges"@en; ; "977e3c9571f343d532a7a03ac9b32e1423abf755ab774feecd0a43a7ac706d67"; "Annual registration charge becomes payable on a specific date."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.301"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Imposes an obligation"; "modalities::logic::deontic"; 1.0000; . a ; "44A Exemptions from liability to pay charges"@en; ; , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.302". a ; "44A(1) Exemptions from liability to pay charges"@en; ; "0b4da6d848cc6c33e16c2ef776d27265066b4d03a37a34e667e49c50d4881736"; ; "Exemptions from liability to pay charges"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.302"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "exemption"; "Exempts a person from liability to pay annual registration charge"; "(1) The regulations may make provision for and in relation to:"; "modalities::logic::deontic"; 0.5000; . . a ; ; "requirement"; "Requires payment of charge for current year if application is refused"; "(b) the making of an application for an exemption and requiring payment of that charge for the current year if the application is refused;"; "modalities::logic::deontic"; 0.5000; . . a ; ; "cancellation"; "Cancels exemption and requires payment of charge for current year"; "(c) cancelling an exemption and requiring payment of that charge for the current year."; "modalities::logic::deontic"; 0.5000; . . a ; ; "temporal interval"; "Temporal interval for exemptions"; "if the person’s turnover of the therapeutic goods concerned for the financial year specified in the regulations is of low value;"; "modalities::interval_reasoning"; 0.5000; . . a ; ; "exemption"; "Exempts a person from liability to pay annual listing charge or annual charge for inclusion in the Register"; "(a) exempting a person from liability to pay annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year (the current year) if the person’s turnover of the therapeutic goods concerned for the financial year specified in the regulations is of low value;"; "modalities::logic::deontic"; 0.5000; . a ; "44A(2) Exemptions from liability to pay charges"@en; ; "96646670dc10834f5fe688472ec79a1a3635e9a6955c6cbde41d8d033939442c"; ; "Fee for exemption applications must not amount to taxation."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.302"; . a ; ; ; ; ; . a ; "44A(3) Exemptions from liability to pay charges"@en; ; "efb5ba3b10a6802068182a388246bc2da61c6c053e88a8035a9ab02bc3f8c5aa"; ; "Person must provide statement upon exemption application or grant"; "true"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.302"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide statement"; "modalities::logic::deontic"; 1.0000; . a ; "44A(4) Exemptions from liability to pay charges"@en; ; "be17caf0091f9ab994e806b915c2e3a0734b964bb64c7da70d865a7317e2ffa4"; ; "Regulations may obtain additional information or documents from applicants for exemptions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.302"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Regulations may obtain additional information or documents."; "modalities::logic::deontic"; 0.5000; . a ; "44A(5) Exemptions from liability to pay charges"@en; ; "8cc86816edccc768da2061066831124e166edb01da61cd83ed0df38a19954a05"; ; "Review of exemptions by Administrative Review Tribunal"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.302"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Obligation to review exemptions"; "modalities::logic::deontic"; 1.0000; . a ; "44B Recovery of unpaid charges"@en; ; "31ba6f81b31f77db1c377a455200e1a54ae84bcc24c97f128af4bac6e07bf0c9"; "Recovery of unpaid charges after 28 days"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.304"; . a ; ; ; ; ; . . a ; ; "Obligation"; "Obligation to recover unpaid charges"; "Charge becomes payable after 28 days"; "Recovery of charge due to Commonwealth"; "modalities::logic::deontic"; 1.0000; . a ; "45 Therapeutic Goods Administration Account"@en; ; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.305". a ; "45(1) Therapeutic Goods Administration Account"@en; ; "d42b7f1ad34a46bbe256a3710a8060fe4bee128e364472a10f5f084f61796382"; ; "Continued existence of Therapeutic Goods Administration Account"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.305"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Exists"; "Account exists"; "modalities::logic::deontic"; 1.0000; . a ; "45(2) Therapeutic Goods Administration Account"@en; ; "cc2963ea579c930934ce0e5eacfcfa56e16eac41ff00f97f7ba25982f1dfc037"; ; "The Account is a special account for the purposes of the Public Governance, Performance and Accountability Act 2013."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.305"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "has"; "Account is a special account"; "modalities::logic::deontic"; 1.0000; . a ; "45(3) Therapeutic Goods Administration Account"@en; ; "78bb6f464e2ffd7dec7c5dd15ce9d46d25131edb8c7972463181191ed58478b4"; ; "Amounts must be credited to the Account from various sources."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.305"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "="; "Must provide amounts"; "There must be credited to the Account..."; "Amounts must be provided"; "modalities::logic::deontic"; 1.0000; . a ; "45(4) Therapeutic Goods Administration Account"@en; ; "c205e9546d7f8045fdd97c516dc9ff7c82e11aaed8f3861ad9855d66bdac5ab9"; ; "Payment obligations for therapeutic goods administration account"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.305"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "obligation"; "Payment obligation"; "modalities::logic::deontic"; 1.0000; . a ; "45AA Simplified outline of this Part"@en; ; "81dd8541e3defa2111815a5bc04ef9964adb8fd14f571701872a73de04e224af"; "The Secretary can gather information or documents relevant to a contravention or possible contravention of this Act."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.307"; . a ; ; ; ; "borne by: State"; ; . a ; "45AB Secretary may require information or documents"@en; ; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.308". a ; "45AB(1) Secretary may require information or documents"@en; ; "e7faec5f22b8c5902464066faff5ef4a88e26c71d5ea1dc0d82e9ecc8e65a8b0"; ; "Secretary may require information or documents from a person."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.308"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "requires"; "Requires the person to give information or produce documents."; "modalities::logic::deontic"; 1.0000; . a ; "45AB(2) Secretary may require information or documents"@en; ; "79b5b1a473017d7a4a14df7f8ebae252b6f0742d55d760b906d7a1cac2e5e964"; ; "Secretary must require person to comply within a specified period."; "Notice with a reasonable compliance period"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.308"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Obligation to comply"; "modalities::logic::deontic"; 1.0000; . a ; "45AB(3) Secretary may require information or documents"@en; ; "ee82b967cc5ea312a3d8264d59ee657945a8239c5cb8d0eb4d4b2a33c03229d6"; ; "Secretary must provide notice with specified information"; "true"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.308"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide notice"; "modalities::logic::deontic"; 1.0000; . a ; "45AB(4) Secretary may require information or documents"@en; ; "b26706de6a80064808d323934be14602c6c78eea0c647d7230872072f1978ba1"; ; "Secretary must require information or documents in specified format."; "true"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.308"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide information or documents."; "modalities::logic::deontic"; 1.0000; . . a ; ; "SPECIFIED"; "Information must be provided in specified format."; "modalities::dl"; 1.0000; . a ; "45AC Offences for failing to comply with notice"@en; ; "940fdcc00339432f322307d6ef94b46a5cce68f118ee0c70dd23442725847459"; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.308". a ; "45AC(1) Offences for failing to comply with notice"@en; ; "7cdec73fd34ecceb6e6b5a089c5de07330db1a4a00c4ec89c7dc0bee70aaf955"; ; "Failure to comply with notice results in an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.308"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits failing to comply with notice."; "(1) A person commits an offence if: (a) the person is given a notice under section 45AB; and (b) the person fails to comply with the notice."; "The person commits an offence if they fail to comply with the notice."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlaps"; "Section 45AC(1) overlaps with Chapter 6."; "Compilation date: 05/09/2025 Penalty: 500 penalty units. Strict liability offence"; "The section overlaps with Chapter 6."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Implication"; "Failing to comply with notice implies committing an offence."; "(1) A person commits an offence if: (a) the person is given a notice under section 45AB; and (b) the person fails to comply with the notice."; "If the person fails to comply, they commit an offence."; "modalities::argumentation"; 1.0000; . . a ; ; "Implication"; "Failing to comply with notice implies being subject to penalty units."; "(1) A person commits an offence if: (a) the person is given a notice under section 45AB; and (b) the person fails to comply with the notice."; "If the person fails, they are subject to penalty units."; "modalities::diffusion"; 1.0000; . . a ; ; "Implication"; "Failing to comply with notice implies being subject to a strict liability offence."; "(1) A person commits an offence if: (a) the person is given a notice under section 45AB; and (b) the person fails to comply with the notice."; "If the person fails, they are subject to a strict liability offence."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "45AC(2) Offences for failing to comply with notice"@en; ; "b9d7c94cc55c18d504bcafb102c298da5a43e8e09e055795fe206f49788a45ba"; ; "Failure to comply with notice results in an offence of strict liability."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.308"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "obligation"; "Obligation to comply with notice."; "Given a notice under section 45AB."; "Failure to comply results in an offence of strict liability."; "modalities::logic::deontic"; 1.0000; . a ; "45AC(3) Offences for failing to comply with notice"@en; ; "ee8966ecdba8e7c44ce5610ea99f6146ecfa6853368fe948d84321fcea0a7b8b"; ; "No obligation if person has a reasonable excuse."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.308"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "Excuse"; "Reasonable excuse"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Belief"; "Defendant bears evidential burden"; "modalities::epistemic"; 1.0000; . a ; "45AD Offences and civil penalty for giving false or misleading"@en; ; "f5767a571ed19141fcbf23f1a81e758594ff2b79cb0b2ea8bfcb5cbe9a997e12"; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.309". a ; "45AD(1) Offences and civil penalty for giving false or misleading"@en; ; "943cd4af5ec88267bc4287ac5d028002ca448f7dc6bc0c156c4b069ea215f725"; ; "Giving false or misleading information in response to a notice is an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.309"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of giving false or misleading information."; "The person is given a notice under section 45AB."; "The person commits an offence if the information or document is false or misleading in a material particular."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibit"; "Prohibition of imprisonment for 12 months or 1,000 penalty units."; "Penalty: Imprisonment for 12 months or 1,000 penalty units, or both."; "The provision prohibits imprisonment for 12 months or 1,000 penalty units."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibit"; "Prohibition of liability for an executive officer of a body corporate."; "Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA."; "The provision prohibits liability for an executive officer of a body corporate."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibit"; "Prohibition of strict liability offence."; "Strict liability offence"; "The provision is classified as a strict liability offence."; "modalities::logic::deontic"; 1.0000; . a ; "45AD(2) Offences and civil penalty for giving false or misleading"@en; ; "81c72be235a4438ff767ca427e3f0ced3dcd7b0978c6be76a1b1c26a99dbca3d"; ; "Giving false or misleading information is an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.309"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits giving false or misleading information."; "modalities::logic::deontic"; 1.0000; . a ; "45AE Self-incrimination"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.310". a ; "45AE(1) Self-incrimination"@en; ; "5f343e9f02d35b3913cda461ef0e2d3c651670cdd2d7510eeea33e8180945c9f"; ; "No excuse for self-incrimination"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.310"; . a ; ; ; ; ; . . a ; ; "Obligation"; "Obligation to provide information"; "modalities::logic::deontic"; 1.0000; . a ; "45AE(2) Self-incrimination"@en; ; "69c2b169f04463732ad534fcdb6f4daac5688220e2b7b3e9a49c97ee1c7c33ee"; ; "Protection from self-incrimination in criminal proceedings"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.310"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prevents admissibility of self-incriminating information"; "(2) However: ...; (d) subsection 45AC(1) or (2); or (e) subsection 45AD(1) or (2); or (f) section 137.1 or 137.2 of the Criminal Code"; "... not admissible in evidence against the individual in criminal proceedings other than proceedings for an offence against Administration Chapter 6 Information gathering powers Part 6-1A Obtaining information or documents Division 2 Section 45AE Therapeutic Goods Act 1989"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Permission"; "Allows for exceptions to the prohibition on self-incrimination"; "(f) section 137.1 or 137.2 of the Criminal Code in relation to giving the information or producing the document."; "... proceedings for an offence against Administration Chapter 6 Information gathering powers Part 6-1A Obtaining information or documents Division 2 Section 45AE Therapeutic Goods Act 1989"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlaps"; "Defines the temporal scope of admissible evidence"; "(2) However: ...; (d) subsection 45AC(1) or (2); or (e) subsection 45AD(1) or (2); or (f) section 137.1 or 137.2 of the Criminal Code"; "... criminal proceedings other than proceedings for an offence against Administration Chapter 6 Information gathering powers Part 6-1A Obtaining information or documents Division 2 Section 45AE Therapeutic Goods Act 1989"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Repeats"; "Defines the repetition of admissible evidence"; "(a) the information given or document produced; and (b) the giving of the information or the production of the document;"; "... criminal proceedings other than proceedings for an offence against Administration Chapter 6 Information gathering powers Part 6-1A Obtaining information or documents Division 2 Section 45AE Therapeutic Goods Act 1989"; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Obligation"; "Establishes the duty to protect against self-incrimination"; "(2) However: ...; (d) subsection 45AC(1) or (2); or (e) subsection 45AD(1) or (2); or (f) section 137.1 or 137.2 of the Criminal Code"; "... against the individual in criminal proceedings other than proceedings for an offence against Administration Chapter 6 Information gathering powers Part 6-1A Obtaining information or documents Division 2 Section 45AE Therapeutic Goods Act 1989"; "modalities::logic::deontic"; 1.0000; . a ; "45AE(3) Self-incrimination"@en; ; "7b417cc1d1b4bc644dfa9afbd6631b274f9f46e48c75c699f377bf8c7147f3db"; ; "No claim of privilege against self-exposure to penalty for giving information or producing document under section 45AB."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.310"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits claiming privilege against self-exposure to penalty."; "modalities::logic::deontic"; 1.0000; . a ; "45AF Secretary may inspect and copy documents"@en; ; "e4466d7c0dd1f6bee0077287617c56f72111970f969c7f1dd7afe19705eb3264"; "The Secretary may inspect and copy documents produced under section 45AB."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.312"; . a ; ; ; ; ; . . a ; ; "may"; "The Secretary may inspect and copy documents."; "modalities::logic::deontic"; 1.0000; . a ; "45AG Secretary may retain documents"@en; ; "1cd6a0b735d94b749c9e1aa6e1d422157fb5abf4e47c4b176ff569bd7a97c99e"; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.312". a ; "45AG(1) Secretary may retain documents"@en; ; "eb1d7fc2479c722aec0477047ae2edcd982dab6ec27769765e06358769799d55"; ; "The Secretary may retain documents for as long as necessary."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.312"; . a ; ; ; ; ; . . a ; ; "may"; "Implies an obligation."; "The Secretary must retain documents."; "modalities::logic::deontic"; 1.0000; . a ; "45AG(2) Secretary may retain documents"@en; ; "af7f7e9bfbed93a97669eb7231332cf05a82057bf4a294f5b03531a1b6494c8f"; ; "The Secretary must provide a certified copy of the document as soon as practicable."; "true"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.312"; . a ; ; ; ; ; . . a ; ; "Must"; "The Secretary must provide a certified copy."; "modalities::logic::deontic"; 1.0000; . a ; "45AG(3) Secretary may retain documents"@en; ; "80d9d59a2778a064332ad3fc46e2fc877e01a794c24bccd78e99d9487675d217"; ; "The certified copy must be received in all courts and tribunals as evidence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.312"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "The state has an obligation to provide the certified copy."; "modalities::logic::deontic"; 1.0000; . a ; "45AG(4) Secretary may retain documents"@en; ; "91af642bbede534f44c2a43c053e7c36a71f59dd70c91f53a91c25b266290c61"; ; "Must provide access to document for inspection and copying."; "true"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.312"; . a ; ; ; ; ; . . a ; ; "MUST"; "Obligation to provide access."; "modalities::logic::deontic"; 1.0000; . a ; "45A Definitions"@en; ; "6e89edc95cfd7fdad23a161d98a6056cd34fa9b0b57b55e9f685a34b5dc4b3d4"; "Defines evidential material and occupier for this Part."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.313"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "defines"; "Defines terms used in the provision."; "modalities::logic::deontic"; 1.0000; . . a ; ; "includes"; "Includes definitions for occupier and person assisting."; "modalities::dl"; 1.0000; . a ; "46 Searches to monitor compliance with Act or regulations"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.314". a ; "46(1) Searches to monitor compliance with Act or regulations"@en; ; "296de76ee85cd3c9f25ccb1d612d5a13e60642e90d6d824d346ea8d8d891031b"; ; "Authorized person may enter premises and exercise powers to monitor compliance."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.314"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "can"; "Authorization to enter premises"; "(1) Subject to subsections (2) and (3), an authorised person may..."; "...an authorised person may, for the purpose of finding out whether this Act or the regulations have been complied with:"; "modalities::logic::deontic"; 1.0000; . . a ; ; "may"; "Exercise powers to monitor compliance"; "(a) enter any premises; and (b) exercise the powers set out in subsection 48(1) and section 48BA."; "...and exercise the powers set out in subsection 48(1) and section 48BA."; "modalities::logic::deontic"; 1.0000; . . a ; ; "during"; "Temporal relation: Authorized person monitors compliance during specific time period"; "(1) Subject to subsections (2) and (3), an authorised person may..."; "...for the purpose of finding out whether this Act or the regulations have been complied with:"; "modalities::interval_reasoning"; 0.5000; . . a ; ; "until"; "Temporal relation: Authorized person monitors compliance until specific time period ends"; "(1) Subject to subsections (2) and (3), an authorised person may..."; "...for the purpose of finding out whether this Act or the regulations have been complied with:"; "modalities::temporal_ltl"; 0.5000; . . a ; ; "through"; "Spread of information: Authorized person monitors compliance through specific means"; "(a) enter any premises; and (b) exercise the powers set out in subsection 48(1) and section 48BA."; "...and exercise the powers set out in subsection 48(1) and section 48BA."; "modalities::diffusion"; 0.5000; . a ; "46(2) Searches to monitor compliance with Act or regulations"@en; ; "549ae85686d67ad80f9fe572f24731e3505918f64a3b313f1b759329014eb5c7"; ; "Authorized person cannot enter premises without consent or warrant."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.314"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "cannot"; "Prohibition of entry"; "Authorized person must not enter premises."; "No entry without consent or warrant."; "modalities::logic::deontic"; 1.0000; . . a ; ; "during"; "Entry requires warrant issued under section 49"; "The entry is made under a warrant issued under section 49."; "Entry requires warrant issued under section 49."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "mustNot"; "Prohibition of unauthorized entry"; "The authorised person must not enter the premises."; "No unauthorized entry allowed."; "modalities::logic::deontic"; 1.0000; . a ; "46(3) Searches to monitor compliance with Act or regulations"@en; ; "c6ed3c03f94ad096da34632b0ba7395dea3ec2bef71aacd3224baac3ce70db3f"; ; "Authorized person cannot exercise powers under subsection (1) if occupier requests identity card inspection."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.314"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibition of exercising powers under subsection (1)"; "Authorized person has required identity card inspection"; "Exercise of powers under subsection (1) is prohibited"; "modalities::logic::deontic"; 0.5000; . . a ; ; "Permission"; "Occupier's request for identity card inspection is a permission"; "Occupier requests identity card inspection"; "Identity card inspection is permitted"; "modalities::logic::deontic"; 0.5000; . a ; "46A Searches of certain premises to monitor compliance with Act"@en; ; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.314". a ; "46A(1) Searches of certain premises to monitor compliance with Act"@en; ; "0fb103d415f006eccadb007e4ba610d4b6e97db2b8f167c9e500aafa0e3e384e"; ; "Authorized person may enter premises to monitor compliance with Act."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.314"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "can"; "Authorized person can enter premises."; "modalities::logic::deontic"; 1.0000; . a ; "46A(2) Searches of certain premises to monitor compliance with Act"@en; ; "384eb7dc9e03419850e904e1685ca6c8b7d529bca68834327f242ddabd3dc9c7"; ; "No unauthorized entry into residential premises without consent or commercial use."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.314"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of unauthorized entry into residential premises."; "(2) An authorised person must not, under subsection (1), enter premises that are a residence unless: (a) the occupier of the premises has consented to the entry; or (b) the premises are used for commercial purposes in relation to therapeutic goods or vaping goods, in addition to residential purposes."; "(2) An authorised person must not enter premises that are a residence unless: (a) the occupier of the premises has consented to the entry; or (b) the premises are used for commercial purposes in relation to therapeutic goods or vaping goods, in addition to residential purposes."; "modalities::logic::deontic"; 1.0000; . a ; "46A(3) Searches of certain premises to monitor compliance with Act"@en; ; "c6ed3c03f94ad096da34632b0ba7395dea3ec2bef71aacd3224baac3ce70db3f"; ; "Authorized person cannot exercise powers under subsection (1) if occupier requires identity card inspection."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.314"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibition of exercising powers under subsection (1)"; "(a) the occupier of the premises has required the authorised person to produce his or her identity card for inspection by the occupier;"; "An authorised person is not entitled to exercise any powers under subsection (1) in relation to premises"; "modalities::logic::deontic"; 0.5000; . . a ; ; "Prohibition"; "Prohibition of failing to comply with occupier's requirement"; "(b) the authorised person fails to comply with the requirement."; "An authorised person is not entitled to exercise any powers under subsection (1) in relation to premises"; "modalities::logic::deontic"; 0.5000; . . a ; ; "Implication"; "Occupier's requirement implies authorized person cannot exercise powers under subsection (1)"; "(a) the occupier of the premises has required the authorised person to produce his or her identity card for inspection by the occupier;"; "An authorised person is not entitled to exercise any powers under subsection (1) in relation to premises"; "modalities::linear"; 0.5000; . . a ; ; "Prohibition"; "Prohibition of exercising powers under subsection (1)"; "(3) An authorised person is not entitled to exercise any powers under subsection (1) in relation to premises if:"; "An authorised person is not entitled to exercise any powers under subsection (1) in relation to premises"; "modalities::logic::deontic"; 0.5000; . a ; "46A(4) Searches of certain premises to monitor compliance with Act"@en; ; "fb428561fb7ebcb09220ec54b9d5b2c78e5079f375229ab36b243b43ebe762cd"; ; "Searches of certain premises to monitor compliance with Act"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.314"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "requires"; "Requires compliance"; "(iaa) who is required to comply with a condition of an exemption..."; "must comply"; "modalities::logic::deontic"; 1.0000; . . a ; ; "during"; "Searches during compliance period"; "This section applies to: (a) premises of a person:"; "searches occur during compliance"; "modalities::interval_reasoning"; 1.0000; . a ; "46B Searches and seizures on public health grounds"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.316". a ; "46B(1) Searches and seizures on public health grounds"@en; ; "fc412e1cb101ad8fb7127c207ffa64e5e4a2f78036e41e833d7d62c65d3dd14b"; ; "Prohibition on entering premises without reasonable grounds and in the interests of public health."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.316"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition on entering premises."; "(a) there may be on any premises a particular thing in respect of which this Act or the regulations have not been complied"; "The authorised person may not enter the premises."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Temporal Interval"; "Temporal interval for exercising powers under this section."; "(c) search the premises for the thing;"; "The authorised person may enter the premises within a reasonable time frame to search for the item."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Recurring Trace"; "Recurring trace of searches and seizures on public health grounds."; "(d) if the authorised person finds the thing on the premises—seize it;"; "The authorised person may seize the item repeatedly within a reasonable time frame."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Obligation"; "Obligation to exercise powers under this section in certain circumstances."; "(b) it is necessary in the interests of public health to exercise powers under this section in order to avoid an imminent risk of death, serious illness or serious injury;"; "The authorised person has an obligation to exercise their powers if there is a risk to public health."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Inference"; "Inference from the text that the authorised person may enter premises and seize items under certain circumstances."; "(a) there may be on any premises a particular thing in respect of which this Act or the regulations have not been complied (b) it is necessary in the interests of public health to exercise powers under this section in order to avoid an imminent risk of death, serious illness or serious injury;"; "The authorised person may enter premises and seize items if there is a risk to public health."; "modalities::argumentation"; 1.0000; . a ; "46B(2) Searches and seizures on public health grounds"@en; ; "b93def83a19431a61d68cf2dfb4e1adeb4fd3c5337537f238ca4dec482d9591a"; ; "Authorized person cannot exercise powers under subsection (1) in relation to premises if occupier requires identity card inspection."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.316"; . a ; ; ; ; "borne by: State"; ; . a ; "47 Searches and seizures related to offences and civil penalty"@en; ; "59216e616e82741c8a6f6cd8707084e74bd8aacfdfd30fa506e233e17992700f"; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.317". a ; "47(1) Searches and seizures related to offences and civil penalty"@en; ; "d52c8d5df4fd283df0a85e29663c3f7baba41647a63c5b28e4bb5a7a1a5abcd3"; ; "Authorized person may enter premises and seize evidential material if reasonable grounds exist."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.317"; . a ; ; ; ; ; . . a ; ; "Prohibit"; "Prohibits entering premises without reasonable grounds."; "(a) enter the premises;"; "May not enter premises without reasonable grounds."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlap"; "Overlaps with time intervals for entering premises."; "(1) Subject to subsections (2) and (3), if an authorised person has reasonable grounds for suspecting that there may be evidential material in respect of an offence against this Act, in respect of a contravention of a civil penalty provision or in respect of both on any premises"; "Overlaps with time intervals for entering premises."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Recurring"; "Recurring trace for authorized person's actions."; "(a) enter the premises; and (b) exercise the powers set out in subsection (4), subsection 48(1) and section 48C;"; "Recurring trace for authorized person's actions."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Diffuse"; "Diffuses information about reasonable grounds to others."; "(a) enter the premises; and (b) exercise the powers set out in subsection (4), subsection 48(1) and section 48C;"; "Diffuses information about reasonable grounds to others."; "modalities::diffusion"; 1.0000; . . a ; ; "Imply"; "Implies that authorized person has authority to enter premises."; "(a) enter the premises; and (b) exercise the powers set out in subsection (4), subsection 48(1) and section 48C;"; "Authorized person implies they have authority to enter premises."; "modalities::argumentation"; 1.0000; . a ; "47(2) Searches and seizures related to offences and civil penalty"@en; ; "3381605f6f9f783c497f4765c34d0232bc3ddd811f70475ad07db706bf4a767f"; ; "Authorized person must not enter premises without consent or warrant."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.317"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Must Not"; "Prohibition of entry"; "Authorized person must not enter premises."; "modalities::logic::deontic"; 1.0000; . a ; "48 General powers of authorised persons in relation to premises"@en; ; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.318". a ; "48(1) General powers of authorised persons in relation to premises"@en; ; "e5fb23c28eaef89f5b2f8da04efbf4e9a98ab7954aa5bcf85104aac218bb08d8"; ; "Authorised persons have powers to search, inspect, and require information from premises."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.318"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "hasPower"; "Has power to search"; "Authorised person has authority to enter premises."; "Can search premises"; "modalities::logic::deontic"; 1.0000; . . a ; ; "canRequire"; "Can require occupier to answer questions"; "Authorised person has power to enter premises."; "Can require occupier to answer questions"; "modalities::logic::deontic"; 1.0000; . . a ; ; "implies"; "Requires occupier to produce documents"; "Occupier is required to provide information."; "Must produce documents"; "modalities::linear"; 1.0000; . . a ; ; "canInspect"; "Can inspect books and records"; "Authorised person has power to enter premises."; "Can inspect books and records"; "modalities::logic::deontic"; 1.0000; . . a ; ; "during"; "Can take equipment onto premises during entry"; "Entry is a specific time period."; "Must be taken onto premises during entry"; "modalities::interval_reasoning"; 1.0000; . a ; "48(3) General powers of authorised persons in relation to premises"@en; ; "352463fa4b38e746779b618b394bfd782860ae0c76ce8d3da278e4d625f0bb19"; ; "Must comply with a requirement under paragraph (1)(e)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.318"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "Must"; "Mandatory compliance"; "(3) A person must not refuse or fail to comply..."; "A person must comply with a requirement under paragraph (1)(e)"; "modalities::logic::deontic"; 0.5000; . . a ; ; "Prohibition"; "Refusal or failure to comply is prohibited"; "(3) A person must not refuse or fail to comply..."; "A person must not refuse or fail to comply with a requirement under paragraph (1)(e)"; "modalities::logic::deontic"; 0.5000; . . a ; ; "Obligation"; "Compliance is an obligation"; "(3) A person must not refuse or fail to comply..."; "A person has an obligation to comply with a requirement under paragraph (1)(e)"; "modalities::logic::deontic"; 0.5000; . a ; "48(3A) General powers of authorised persons in relation to premises"@en; ; "9cab5da41854e8c96f1e9590ffb592653533e648a04c78f26c58b9e34085519a"; ; "Defendant bears evidential burden in relation to reasonable excuse."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.318"; . a ; ; ; ; "borne by: NaturalPerson"; ; . . a ; ; "Obligation"; "Defendant bears evidential burden."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Burden of Proof"; "Defendant must provide evidence for reasonable excuse."; "modalities::epistemic"; 1.0000; . a ; "48(4) General powers of authorised persons in relation to premises"@en; ; "9a7d8e1b6077a96f083baf25f10f6c88dcf15b1421e163315f0b51920b6492b5"; ; "Excuse for refusing or failing to answer a question or produce a document that may incriminate the person."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.318"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Excuse"; "Excuse for refusing or failing to answer a question or produce a document."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Knowledge"; "Person has knowledge that answering the question or producing the document may incriminate them."; "modalities::epistemic"; 1.0000; . . a ; ; "Temporal Interval"; "Excuse applies to a specific temporal interval."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Reasoning"; "Excuse is based on reasoning about the person's situation."; "modalities::argumentation"; 1.0000; . . a ; ; "Temporal Relationship"; "Excuse applies to a specific temporal relationship between events."; "modalities::interval_reasoning"; 1.0000; . a ; "48A Details of warrant to be given to occupier etc."@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.320". a ; "48A(1) Details of warrant to be given to occupier etc."@en; ; "0398ca9e4e1031b9411b6bc5b86a574dfc900c6a029d7f75b7595295228d4c6d"; ; "Must provide a copy of the warrant to the occupier or apparent representative."; "true"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.320"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST PROVIDE"; "Must provide a copy of the warrant."; "modalities::logic::deontic"; 1.0000; . a ; "48A(2) Details of warrant to be given to occupier etc."@en; ; "b64bab1a1a937da4e595bfa08c0d8b34ddebef3d0ccf22dba2b69fe1b5670788"; ; "Authorised person must identify themselves to the occupier."; "Identification"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.320"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "MUST"; "Must provide identification"; "The authorised person must identify themselves."; "modalities::logic::deontic"; 1.0000; . a ; "48A(3) Details of warrant to be given to occupier etc."@en; ; "3e97e2aeffe4e72cbd6014d1d440828dfb804ba600dbc3ed83d2bb4032c09790"; ; "No signature of issuing officer is required on warrant copy."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.320"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "No signature requirement"; "modalities::logic::deontic"; 1.0000; . a ; "48AA Completing execution of warrant under section 50 after"@en; ; "d31bc8566ab5f8ae4de1231f3efb187cf89246a2e342b0003696854e4eb4e58f"; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.321". a ; "48AA(1) Completing execution of warrant under section 50 after"@en; ; "cde609c124fb0010fd57d264e8529f5efa970bce37fc6443db3610e6df885586"; ; "Authorized persons must cease execution and leave premises."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.321"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Must"; "Mandatory obligation"; "(1) This section applies..."; "Authorized persons must cease execution and leave premises."; "modalities::logic::deontic"; 1.0000; . a ; "48AA(2) Completing execution of warrant under section 50 after"@en; ; "e220b667c3134c8b8bdfeb3bc48969c23e28814cfd63d69881b98951305b17c5"; ; "Authorized persons and assistants may complete warrant execution under certain conditions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.321"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Permit"; "Permission granted"; "(2) One or more of the authorised persons..."; "modalities::logic::deontic"; 0.5000; . . a ; ; "Overlap"; "Temporal overlap between absence and emergency situation"; "(i) for not more than 1 hour;"; "modalities::interval_reasoning"; 0.5000; . . a ; ; "Recurrent"; "Recurring trace of authorized persons' absence"; "(ii) if there is an emergency situation, for not more than 12 hours or such longer period as allowed by an issuing officer under subsection (5);"; "modalities::temporal_ltl"; 0.5000; . . a ; ; "Diffuse"; "Diffusion of authorized persons' absence to emergency situation"; "(iii) for a longer period if the occupier of the premises consents in writing."; "modalities::diffusion"; 0.5000; . . a ; ; "Recognize"; "Recognition of occupier's written consent"; "the occupier of the premises consents in writing."; "sparql_library::parsers::chk_parser"; 0.5000; . a ; "48AA(3) Completing execution of warrant under section 50 after"@en; ; "d4bdadadd0d514cd7e36943f6e5f401086bf421b24ce941a52c2476caf62b287"; ; "Authorized person may apply for extension of warrant execution period under emergency situation."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.321"; . a ; ; ; ; "borne by: LegalPerson"; ; . . a ; ; "May"; "Permission to apply for extension"; "Authorized person may apply"; "for an extension of the warrant execution period"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlaps"; "Extension request overlaps with warrant execution period"; "there is an emergency situation; and"; "the authorized person or person assisting the authorized person will not be able to return to the premises within that period."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Until"; "Extension request until warrant execution period ends"; "there is an emergency situation; and"; "the authorized person or person assisting the authorized person will not be able to return to the premises within that period."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Diffuses"; "Extension request diffuses into warrant execution process"; "there is an emergency situation; and"; "the authorized person or person assisting the authorized person will not be able to return to the premises within that period."; "modalities::diffusion"; 1.0000; . . a ; ; "Recognizes"; "CogAI recognizes extension request as warrant execution process part"; "The authorized person or person assisting the authorized person believes on reasonable grounds that..."; "the authorized person or person assisting the authorized person will not be able to return to the premises within that period."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "48B Announcement before entry"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.322". a ; "48B(1) Announcement before entry"@en; ; "fd87d3229350ddb105971b08452fe018baa9911417e00f2fe06fe6fcd3e3a50f"; ; "Announcement before entry into premises under warrant."; "Yes"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.322"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "Must"; "Obligation to announce and allow entry."; "modalities::logic::deontic"; 1.0000; . a ; "48B(2) Announcement before entry"@en; ; "390caaf066e32ec371b6e34057e667bac9ca7eca44cabf70a8fd323797aff418"; ; "Authorized person not required to comply with subsection (1) if believes immediate entry is necessary for safety or warrant execution."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.322"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "Belief"; "Belief on reasonable grounds necessary for exemption"; "Authorized person believes immediate entry is necessary"; "modalities::epistemic"; 0.5000; . a ; "48BA Use of electronic equipment at premises for monitoring"@en; ; "e47a5c7f3bee6f3ecfbd1f3b5fdf3235f2cbdf0d4130cc4d48c45bc564e6e42d"; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.322". a ; "48BA(1) Use of electronic equipment at premises for monitoring"@en; ; "690490d7dadbbe72cee7587d0959721656eec6230feb6a7e639d75b1934e6440"; ; "Authorized person may operate electronic equipment to monitor premises."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.322"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "May"; "Authorized operation"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Access"; "Information accessibility"; "modalities::epistemic"; 1.0000; . . a ; ; "Recurring"; "Monitoring for compliance"; "modalities::temporal_ltl"; 1.0000; . a ; "48BA(2) Use of electronic equipment at premises for monitoring"@en; ; "835b0ca18797492ea14538afbb9bf6a880f3b21b74cc492aee03f9c0644a0a8c"; ; "Authorized person may operate electronic equipment to gather information."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.322"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "May"; "Authorization to perform action."; "modalities::logic::deontic"; 1.0000; . a ; "48BA(3) Use of electronic equipment at premises for monitoring"@en; ; "493fd43c4c669069e1bbd7bb208467b83def5e36c344ce950b4cabe366493c1b"; ; "Authorized person may operate electronic equipment under certain conditions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.322"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "May"; "Permission to operate equipment"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Believes"; "Authorized person must believe conditions are met"; "modalities::logic::deontic"; 1.0000; . a ; "48BA(4) Use of electronic equipment at premises for monitoring"@en; ; "cf0350f3377522cd41f68915763a94541605abe32356cbb9396fb94d1c2d3f48"; ; "Authorized person has obligation to secure electronic equipment."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.322"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "Obligation"; "Obligation to secure equipment."; "(4) If the authorised person believes..."; "he or she may do whatever is necessary..."; "modalities::logic::deontic"; 1.0000; . a ; "48C Use of electronic equipment at premises relating to offences and"@en; ; "dc07ea3217d3017a552a23d64ad08a8930c65d8314c9822a3574e50990b5efe8"; , , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.324". a ; "48C(1) Use of electronic equipment at premises relating to offences and"@en; ; "11da5c2359caa1f0eed68cc46f7efeab7443606e0785537ecc55c16cc4e6e70b"; ; "Authorized person may operate electronic equipment to access evidential material."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.324"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "May"; "Permission granted by the State."; "modalities::logic::deontic"; 1.0000; . a ; "48C(2) Use of electronic equipment at premises relating to offences and"@en; ; "3fae9e29f6104f6d71515c266846f86b21c6998dbc10e6d119bec737fc7f5fa8"; ; "Authorized person may seize equipment or operate electronic equipment to access evidential material."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.324"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "May"; "Authorized person has permission to seize equipment or operate electronic equipment."; "Authorized person is authorized to access evidential material."; "Seize equipment or operate electronic equipment."; "modalities::logic::deontic"; 1.0000; . a ; "48C(2A) Use of electronic equipment at premises relating to offences and"@en; ; "60a56e7472114b413dc0673bc6ad1bbe1e8d5754a61a3a18b90f8ce5d0f0d220"; ; "Authorized person may operate electronic equipment under certain conditions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.324"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "May"; "Permission to operate electronic equipment"; "modalities::logic::deontic"; 0.5000; . . a ; ; "Overlaps"; "Temporal overlap between authorized operation and potential damage"; "(2A) An authorised person may operate electronic equipment as mentioned in subsection (1) or (2)"; "modalities::interval_reasoning"; 0.5000; . . a ; ; "Until"; "Temporal relationship between authorized operation and potential damage"; "(2A) An authorised person may operate electronic equipment as mentioned in subsection (1) or (2)"; "modalities::temporal_ltl"; 0.5000; . . a ; ; "Diffuses"; "Spread of authorized operation to other conditions"; "(2A) An authorised person may operate electronic equipment as mentioned in subsection (1) or (2)"; "modalities::diffusion"; 0.5000; . . a ; ; "Incorporates"; "Integration of authorized operation with other conditions"; "(2A) An authorised person may operate electronic equipment as mentioned in subsection (1) or (2)"; "sparql_library::parsers::chk_parser"; 0.5000; . a ; "48C(3) Use of electronic equipment at premises relating to offences and"@en; ; "1d70c2adbe7015dd3f6e7de177de88a835fb410571398673f03b6a089fb0f66e"; ; "Seizure of equipment under certain conditions"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.324"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits seizure without specified conditions"; "(3) An authorised person may seize equipment..."; "modalities::logic::deontic"; 1.0000; . a ; "48C(4) Use of electronic equipment at premises relating to offences and"@en; ; "752409f0bfc34fddb81506cee9e8803349c9680e9a7cc0c46570c64284085f8d"; ; "Authorized person may take necessary actions to secure electronic equipment."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.324"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "may"; "Authorization to act."; "(4) If the authorised person believes..."; "He or she may do whatever is necessary..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "during"; "Temporal relation: authorized action during premises visit."; "(4) If the authorised person believes..."; "He or she may do whatever is necessary..."; "modalities::interval_reasoning"; 1.0000; . a ; "48C(5) Use of electronic equipment at premises relating to offences and"@en; ; "6dd33c510693289ec984adac1db5b7ff0ee52f8ad89154bcd70ae1abe391706c"; ; "Authorised person must give notice to occupier of premises before securing equipment."; "Notice"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.324"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Obligation to provide notice"; "The authorised person must give notice..."; "modalities::logic::deontic"; 1.0000; . a ; "48D Compensation for damage to electronic equipment"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.326". a ; "48D(1) Compensation for damage to electronic equipment"@en; ; "c7f6ee29779d85c35d93fa955662cf860274336a898ea3a6af05d599b08a4d08"; ; "Compensation for damage to electronic equipment if caused by insufficient care."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.326"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "obligation"; "Obligation to compensate for damage."; "(1) If..."; "...compensation for the damage is payable."; "modalities::logic::deontic"; 1.0000; . a ; "48D(2) Compensation for damage to electronic equipment"@en; ; "936d6c6cc10c36ec40bbe38f5d18b671cf985076f531a1d6e17469b8ee81f006"; ; "Compensation is payable out of money appropriated by the Parliament for the purpose."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.326"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Imposes a duty on the State to provide compensation."; "modalities::logic::deontic"; 1.0000; . a ; "48D(3) Compensation for damage to electronic equipment"@en; ; "07285c55838625e1b42c8cf82ca617a278754a10968f319e06b6f8ef0e0243e6"; ; "Occupier must provide warning or guidance about equipment operation."; "warning or guidance"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.326"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "OBLIG"; "Mandatory duty"; "modalities::logic::deontic"; 1.0000; . a ; "48E Copies of seized things to be provided"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.327". a ; "48E(1) Copies of seized things to be provided"@en; ; "cedaf440f50176fcec43e6b42575b6c5e20664fa7c4306ed59239610e23f19ef"; ; "Must provide a copy of seized documents or information to the occupier upon request."; "true"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.327"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST PROVIDE"; "Must provide a copy of seized documents or information."; "modalities::logic::deontic"; 1.0000; . a ; "48E(2) Copies of seized things to be provided"@en; ; "eeaef3fe95072cc8c4e5ed1892d726564f740d160a16f48bee9dc1f7ed3536dc"; ; "Possession of seized things may constitute an offence against a law or civil penalty provision."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.327"; . a ; ; ; ; ; . . a ; ; "Prohibition"; "Prohibits possession of seized things"; "modalities::logic::deontic"; 1.0000; . a ; "48F Occupier entitled to be present during search"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.327". a ; "48F(1) Occupier entitled to be present during search"@en; ; "f11176fbc262d3f1085b7b0cc6a9959d353a6be20f0d8f3a61207bad72473628"; ; "Occupier entitled to be present during search"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.327"; . a ; ; ; ; ; . . a ; ; "hasRight"; "Occupier has right"; "modalities::logic::deontic"; 1.0000; . a ; "48F(2) Occupier entitled to be present during search"@en; ; "ec5660e4419d2bab94cb534b8fc39661b6e2b508486baea04645d113f3598dcc"; ; "Right to observe search ceases if person impedes search."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.327"; . a ; ; ; ; ; . . a ; ; "Cease"; "Obligation to observe ceases"; "Person impedes search"; "Right to observe ceases"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlaps"; "Right to observe ceases during overlap with impediment"; "Search and impediment are temporal intervals"; "Cease right to observe during overlap"; "modalities::interval_reasoning"; 1.0000; . a ; "48F(3) Occupier entitled to be present during search"@en; ; "3ef1aefe8157efdd0ea9c7cbe20c98e540be927db9b1f90b45137c5f796f9d76"; ; "Right to be present during search"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.327"; . a ; ; ; ; ; . a ; "48FA Responsibility to provide facilities and assistance"@en; ; "906394d2a872a4f98b677661830e7b84bfaae53d8644f8796960580ca6aac293"; "Occupier must provide facilities and assistance for warrant execution."; "yes"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.327"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide facilities and assistance."; "modalities::logic::deontic"; 1.0000; . a ; "48G Receipts for things seized under warrant"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.328". a ; "48G(1) Receipts for things seized under warrant"@en; ; "a82f447ed87e65ce11d17875b636f8410b400415093c01cd0cc122dd0c066d8a"; ; "Authorised person must provide a receipt for seized thing."; "Yes"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.328"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "MUST"; "Must provide a receipt."; "modalities::logic::deontic"; 1.0000; . a ; "48G(2) Receipts for things seized under warrant"@en; ; "4db106c9953a77eedad4f540d815ec254884e8fab22ce48794504fe6caac2a31"; ; "Things seized or moved may be covered in one receipt."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.328"; . a ; ; ; ; ; . a ; "48H Retention of seized things"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.328". a ; "48H(1) Retention of seized things"@en; ; "b1fd9329aea0e6374457a5520a72dd1a9e57b5a716d29cd2291fce89ba31d15d"; ; "Must return seized thing if reason for seizure no longer exists or period ends"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.328"; . a ; ; ; ; ; . . a ; ; "MUST"; "Obligation to return seized thing"; "Reason for seizure no longer exists or period ends"; "Must return seized thing"; "modalities::logic::deontic"; 1.0000; . . a ; ; "BETWEEN"; "Seizure period is an interval that must be considered when determining return of seized thing"; "Period of 120 days after seizure ends"; "Seizure period is an interval that must be considered when determining return of seized thing"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "BETWEEN"; "Seizure period is a trace that must be considered when determining return of seized thing"; "Period of 120 days after seizure ends"; "Seizure period is a trace that must be considered when determining return of seized thing"; "modalities::temporal_ltl"; 1.0000; . . a ; ; "IF"; "Return of seized thing depends on reason for seizure no longer existing or period ending"; "Reason for seizure no longer exists or period ends"; "Return of seized thing depends on reason for seizure no longer existing or period ending"; "modalities::diffusion"; 1.0000; . . a ; ; "IF"; "Authorised person must return seized thing if condition is met"; "Reason for seizure no longer exists or period ends"; "Authorised person must return seized thing if condition is met"; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "48H(2) Retention of seized things"@en; ; "5a2e5a793ce063adb2ba630fd8c1b930a8880a3249e2c8702b6d3fdafeffe6a9"; ; "Return seized things after 120 days unless proceedings are ongoing or authorized by law."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.328"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Duty to return seized things"; "Authorized person must take reasonable steps to return thing"; "Thing must be returned unless proceedings are ongoing or authorized by law."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Temporal interval"; "120-day temporal interval for return"; "End of 120 days specified in subsection (1)"; "Thing must be returned within 120 days unless proceedings are ongoing or authorized by law."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Recurring trace"; "Recurring requirement to return seized things"; "Proceedings in respect of which thing may afford evidence were instituted before end of 120 days"; "Thing must be returned unless proceedings are ongoing or authorized by law."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Propagation"; "Propagation of retention requirements"; "Authorized person may retain thing because of order under section 48J"; "Thing must be returned unless proceedings are ongoing or authorized by law."; "modalities::diffusion"; 1.0000; . . a ; ; "Knowledge representation"; "Knowledge representation of seized things"; "Thing is classified as a seized thing"; "Thing is subject to retention requirements"; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "48H(3) Retention of seized things"@en; ; "4f203aa9caea4ec17dcc3578d88b45836575bee78a430eedf53e75a5838e7eea"; ; "The thing may be returned under subsection (2) either unconditionally or on such terms and conditions as the Secretary sees fit."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.328"; . a ; ; ; ; ; . a ; "48J Issuing officer may permit a thing to be retained"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.329". a ; "48J(1) Issuing officer may permit a thing to be retained"@en; ; "d058b2a4cb52888e320c26c4dc28095dbce3ff8ea289fcf9f2e9ea5a8eb27074"; ; "Issuing officer may permit a thing to be retained for a further period under certain conditions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.329"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "Permit"; "Granting permission"; "Issuing officer may permit a thing to be retained"; "Thing may be retained for a further period"; "modalities::logic::deontic"; 1.0000; . a ; "48J(2) Issuing officer may permit a thing to be retained"@en; ; "fcfb9103cd38c950c8fe9e173203d968ec8173d56742dab5cd05a4157e74e0e4"; ; "Issuing officer may permit an authorised person to retain a thing for a specified period."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.329"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Permit"; "Permission granted by the issuing officer."; "Issuing officer may permit an authorised person to retain a thing."; "Authorised person may retain the thing for a specified period."; "modalities::logic::deontic"; 1.0000; . a ; "48J(3) Issuing officer may permit a thing to be retained"@en; ; "9a3da35284e1de37f6bced6fc0af9cf0242fd7286293df5ec3b4ec081ff6cda0"; ; "Issuing officer may permit a thing to be retained"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.329"; . a ; ; ; ; "borne by: State"; ; . a ; "49 Monitoring warrants"@en; ; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.330". a ; "49(1) Monitoring warrants"@en; ; "259dcb65833e21ebef90a01e3bad4c26e479a8547a1868a32feba54c906c65c6"; ; "Authorized person may apply for a warrant under this section."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.330"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "May"; "Permission to apply for a warrant"; "modalities::logic::deontic"; 1.0000; . a ; "49(2) Monitoring warrants"@en; ; "f12fe322385c2674d86cb6796136cd563cefff1466e2ff309c8e3f42d826f1e2"; ; "Issuing officer must issue warrant if satisfied by oath that access is necessary."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.330"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Issuing officer must issue warrant."; "modalities::logic::deontic"; 1.0000; . . a ; ; "REASONABLY NECESSARY"; "Information on oath is sufficient for issuing officer to make decision."; "modalities::epistemic"; 1.0000; . a ; "49(3) Monitoring warrants"@en; ; "c263d42fb402c3841e33eb8fe5df87f8c0ce4af29db90b714bb0c1f69e0e860f"; ; "Issuing officer must provide additional information before issuing warrant."; "Further information (if any) as the issuing officer requires concerning the grounds on which the issue of the warrant is being sought."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.330"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Must"; "The issuing officer must provide additional information."; "modalities::logic::deontic"; 1.0000; . a ; "49(4) Monitoring warrants"@en; ; "9581a525a2a40a18925eea6d49f48e1498241d84ebd43612b47b0e36c3170a06"; ; "Warrant must authorise entry and exercise powers under specified conditions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.330"; . a ; ; ; ; ; . . a ; ; "Prohibit"; "Prohibits warrant from authorising entry without specified conditions."; "(4) The warrant must: (a) authorise one or more authorised persons..."; "...and exercise the powers set out in subsection 48(1)..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Within"; "Warrant's effect is limited to a specified time period."; "(4) The warrant must: (c) specify the day (not more than 6 months after the issue of the warrant) on which the warrant ceases to have effect..."; "...on which the warrant ceases to have effect;"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Until"; "Warrant's authority is limited to a specified time period."; "(4) The warrant must: (c) specify the day (not more than 6 months after the issue of the warrant) on which the warrant ceases to have effect..."; "...on which the warrant ceases to have effect;"; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Authorise"; "Warrant authorises entry and exercise of powers under specified conditions."; "(4) The warrant must: (a) authorise one or more authorised persons..."; "...with such assistance and by such force as is necessary and reasonable...;"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Imply"; "Warrant implies specified conditions for entry."; "(4) The warrant must: (a) authorise one or more authorised persons..."; "...with such assistance and by such force as is necessary and reasonable...;"; "modalities::argumentation"; 1.0000; . a ; "50 Offence and civil penalty provision related warrants"@en; ; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.331". a ; "50(1) Offence and civil penalty provision related warrants"@en; ; "259dcb65833e21ebef90a01e3bad4c26e479a8547a1868a32feba54c906c65c6"; ; "Authorized person may apply for warrant under this section."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.331"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "May"; "Permission to apply for warrant"; "modalities::logic::deontic"; 1.0000; . a ; "50(2) Offence and civil penalty provision related warrants"@en; ; "9723387d1ebfcfb9168f73c58dd4b7dae106a60f31f90145e9004f8015238643"; ; "Issuing officer may issue warrant if satisfied of reasonable grounds for suspecting evidential material within 72 hours."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.331"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "May"; "Permission to issue warrant"; "Issuing officer has reasonable grounds for suspecting evidential material"; "Warrant may be issued"; "modalities::logic::deontic"; 1.0000; . a ; "50(3) Offence and civil penalty provision related warrants"@en; ; "c263d42fb402c3841e33eb8fe5df87f8c0ce4af29db90b714bb0c1f69e0e860f"; ; "Issuing officer must provide further information before issuing warrant."; "Further information"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.331"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Must"; "Issuing officer must provide further information."; "modalities::logic::deontic"; 1.0000; . a ; "50(4) Offence and civil penalty provision related warrants"@en; ; "7376613b572136a9e0da603fca35d6bdacaef874504fc04a3fc5c24727b55e9c"; ; "Warrant requirements for entry and seizure of evidential material"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.331"; . a ; ; ; ; ; . . a ; ; "Prohibit"; "Prohibits warrant issuance without specified conditions"; "(4) The warrant must..."; "...authorise the persons so named..."; "modalities::logic::deontic"; 1.0000; . a ; "51 Offence and civil penalty provision related warrants by telephone"@en; ; "28e632296013d70d98788a8b93408094234dff4791336ad558f6e6ea077a1c5b"; "Authorized person may apply for warrant by telephone in urgent cases."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.331"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "May"; "Permission to apply for warrant"; "modalities::logic::deontic"; 0.5000; . a ; "51A Inspections for purposes of Mutual Recognition Convention"@en; ; "8515f4b2230d33a1525abb2e0b996ff3d9850f9563b795b3445c2c00aa73c4c9"; "Request for inspection under Mutual Recognition Convention"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.333"; . a ; ; ; ; "borne by: State"; ; . a ; "51B Offences relating to warrants"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.334". a ; "51B(1) Offences relating to warrants"@en; ; "0fe372e0a860c18d42a8408f361d09eb6e1d790973a6f53bcbff29d66fc60fe9"; ; "Making false statements in a warrant application is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.334"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "Prohibit"; "Prohibition of false statements"; "False statement in warrant application"; "Prohibited"; "modalities::logic::deontic"; 1.0000; . a ; "51B(2) Offences relating to warrants"@en; ; "6e7aa047bf885eef9b8ce531d980e8d36696a6724c6eb7239a69868ba3f91101"; ; "Prohibits false statements about warrants"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.334"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "forbid"; "Prohibition"; "modalities::logic::deontic"; 1.0000; . a ; "51C Issuing officers—personal capacity"@en; ; "a3d9ce38f203e8b183955c1df3c707be225fa24ea2ebd96628bb6f45dc1fcae0"; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.334". a ; "51C(1) Issuing officers—personal capacity"@en; ; "62ce064368e32ebe21e3d63516466f4b0088975606e6925dd7c06d56949cb4df"; ; "Issuing officers must act in a personal capacity when exercising powers under this Part."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.334"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Must"; "Mandatory action"; "Issuing officers must act in a personal capacity."; "Obligation to act in a personal capacity"; "modalities::logic::deontic"; 1.0000; . . a ; ; "MustNot"; "No court or judicial authority can override this obligation"; "Powers need not be accepted"; "No court or judicial authority can override the issuing officer's personal capacity"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Must"; "The issuing officer must act in a personal capacity when exercising powers under this Part"; "(1) A power conferred on an issuing officer by this Part is conferred on the issuing officer: (a) in a personal capacity; and"; "The issuing officer must act in a personal capacity when exercising powers under this Part"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Must"; "No court or judicial authority can override the issuing officer's personal capacity"; "(b) not as a court, or as a member or an officer of a court."; "No court or judicial authority can override the issuing officer's personal capacity"; "modalities::logic::deontic"; 1.0000; . a ; "51C(2) Issuing officers—personal capacity"@en; ; "fa147534ec38bc4881faba10a6bf5a1af17e727e3e2fecf7f7b80f9b40a00dfd"; ; "Issuing officer must accept power conferred."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.334"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "MUST"; "Must provide"; "The issuing officer need not accept the power conferred."; "The issuing officer MUST accept the power conferred."; "modalities::logic::deontic"; 1.0000; . a ; "51C(3) Issuing officers—personal capacity"@en; ; "16bdc5055770683902d20ce00e92af00b2f54ed4e63d1557886180d8e48b372b"; ; "Issuing officers have protection and immunity in their personal capacity."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.334"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "has"; "Protection and immunity"; "Issuing officer exercising power"; "Same protection and immunity as court or officer"; "modalities::logic::deontic"; 1.0000; . a ; "52 Identity cards"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.335". a ; "52(1) Identity cards"@en; ; "bc5ca877ed0a635bb16c069a9d0a27f9280d05bee921c8eb4ee5ba37aabc4c54"; ; "The Secretary must ensure that each authorised person is issued with an identity card."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.335"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "The Secretary must ensure that each authorised person is issued with an identity card."; "modalities::logic::deontic"; 1.0000; . a ; "52(3) Identity cards"@en; ; "1f7051111b44fa768ef86fc5a1b02061faaa78257d659aca12875e20eeb473b4"; ; "Return identity card after ceasing to be authorised person."; "Identity card"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.335"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Obligation"; "Return identity card."; "modalities::logic::deontic"; 1.0000; . . a ; ; "CONTAINS"; "Temporal interval for returning identity card"; "modalities::interval_reasoning"; 0.5000; . . a ; ; "IMPLIES"; "Consequence of ceasing to be authorised person"; "Return identity card."; "modalities::argumentation"; 1.0000; . a ; "52(4) Identity cards"@en; ; "ff143790560f5f230f5538d7369630e04e0553c3bf50bb5ad3454f316630a4f6"; ; "An offence under subsection (3) is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.335"; . a ; ; ; ; ; . . a ; ; "Prohibit"; "Prohibits an offence under subsection (3)"; "(4) An offence under subsection (3) is an offence of strict liability."; "modalities::logic::deontic"; 1.0000; . a ; "52AA Overview"@en; ; "c9a15ab67ef9d6e197068006d1a55acffe6e3b242e8aa8af0053598495ca16aa"; "Restrictions on supply of scheduled substances for public health and safety"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.340"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Imposes an obligation on the state to restrict supply"; "modalities::logic::deontic"; 1.0000; . a ; "52A Definitions"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.340". a ; "52A(1) Definitions"@en; ; "e2ed59c0bc756cc5435c555b7e6997ed087b4cc59195a6cc77a9606848cf59e3"; ; "Defines terms for the current Poisons Standard and substance scheduling."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.340"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligate"; "Defines terms for the current Poisons Standard and substance scheduling."; "modalities::logic::deontic"; 0.5000; . . a ; ; "="; "Classifies substances into schedules."; "substance means an ingredient, compound, material or preparation..."; "scheduling in relation to a substance means determining the schedule or schedules..."; "modalities::dl"; 0.5000; . . a ; ; "="; "Defines the first Poisons Standard as the latest edition at commencement."; "first Poisons Standard means the latest edition at the commencement of this Part of the document known as the Standard for..."; "the first Poisons Standard is the latest edition at the commencement of this Part of the document known as the Standard for..."; "modalities::dl"; 0.5000; . . a ; ; "="; "Defines substance as an ingredient, compound, material or preparation that may cause death, illness or injury."; "substance means: (a) an ingredient, compound, material or preparation which, or the use of which, may cause death, illness or injury to persons or animals;"; "the substance is an ingredient, compound, material or preparation that may cause death, illness or injury."; "modalities::dl"; 0.5000; . . a ; ; "="; "Defines the current Poisons Standard as the document last prepared under paragraph 52D(2)(b)."; "(1) In this Part, unless the contrary intention appears: current Poisons Standard means: (a) if no document has been prepared under paragraph 52D(2)(b)—the first Poisons Standard; or (b) otherwise—the document last prepared under that paragraph..."; "the current Poisons Standard is the document last prepared under paragraph 52D(2)(b)."; "modalities::dl"; 0.5000; . . a ; ; "="; "Defines scheduling as determining the schedule or schedules to the current Poisons Standard."; "scheduling, in relation to a substance, means determining the schedule or schedules to the current Poisons Standard in which the name or a description of the substance is to be included."; "scheduling in relation to a substance means determining the schedule or schedules to the current Poisons Standard."; "modalities::dl"; 0.5000; . . a ; ; "="; "Defines substance as an ingredient, compound, material or preparation specified under subsection (2)."; "substance means: (b) an ingredient, compound, material or preparation specified under subsection (2);"; "the substance is an ingredient, compound, material or preparation specified under subsection (2)."; "modalities::dl"; 0.5000; . a ; "52A(2) Definitions"@en; ; "6f14d7e5463215b42a24d5d28045a6762e1f1b5ec2b850aab05d901aa2fbdad4"; ; "Secretary may specify ingredients for purposes of definition"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.340"; . a ; ; ; ; . a ; "52B Advisory Committee on Medicines Scheduling"@en; ; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.341". a ; "52B(1) Advisory Committee on Medicines Scheduling"@en; ; "31e3ae5a8dd99096b9e76118c730218bbfa2bfef2a0c7fb1ed15c336f640ff02"; ; "Establishment of Advisory Committee on Medicines Scheduling"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.341"; . a ; ; ; ; . a ; "52B(2) Advisory Committee on Medicines Scheduling"@en; ; "927664ea70662d41ffc536c3851fa5442d1070a4def2b43b51a86a54293bdaa4"; ; "Committee constitution and meeting requirements"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.341"; . a ; ; ; ; . a ; "52B(3) Advisory Committee on Medicines Scheduling"@en; ; "2fa1bf462837c67a561c19974ebcb26fdf8e598971ddb48f6d1945a000a82692"; ; "Each State and the Commonwealth can nominate a member of the Advisory Committee on Medicines Scheduling."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.341"; . a ; ; ; ; ; . . a ; ; "entitlement"; "Entitlement to nominate a member of the Advisory Committee on Medicines Scheduling."; "The Commonwealth, each State, the Australian Capital Territory and the Northern Territory are each entitled..."; "Each State and the Commonwealth can nominate a member of the Advisory Committee on Medicines Scheduling."; "modalities::logic::deontic"; 1.0000; . . a ; ; "between"; "There is an interval between the nomination and the appointment of a member of the Advisory Committee on Medicines Scheduling."; "(3) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory are each entitled..."; "The nomination and appointment of a member of the Advisory Committee on Medicines Scheduling occur between these entities."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "between"; "There is an interval between the nomination and the appointment of a member of the Advisory Committee on Medicines Scheduling."; "(3) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory are each entitled..."; "The nomination and appointment of a member of the Advisory Committee on Medicines Scheduling occur between these entities."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "diffusion"; "The information about the nomination of a member of the Advisory Committee on Medicines Scheduling is diffused to the relevant parties."; "(3) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory are each entitled..."; "The information about the nomination of a member of the Advisory Committee on Medicines Scheduling is diffused to the relevant parties."; "modalities::diffusion"; 1.0000; . . a ; ; "nominating"; "A State or the Commonwealth can nominate a member of the Advisory Committee on Medicines Scheduling."; "(3) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory are each entitled..."; "A State or the Commonwealth can nominate a member of the Advisory Committee on Medicines Scheduling."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "52B(4) Advisory Committee on Medicines Scheduling"@en; ; "aa87c7ac9a4f2c39c6186d5f069de526bc9eda7f4675a1270f0c0f8663a71e84"; ; "Makes recommendations to the Secretary on therapeutic goods classification and scheduling."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.341"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "Obligation"; "Makes recommendations"; "modalities::logic::deontic"; 0.5000; . a ; "52C Advisory Committee on Chemicals Scheduling"@en; ; , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.342". a ; "52C(1) Advisory Committee on Chemicals Scheduling"@en; ; "6b4c76a07cb56eff808bc14d981b7ee3cac549787a4aba727c9b87f0e9528296"; ; "Establishment of Advisory Committee on Chemicals Scheduling"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.342"; . a ; ; ; ; . . a ; ; "establishes"; "Establishes the Advisory Committee on Chemicals Scheduling"; "modalities::logic::deontic"; 1.0000; . a ; "52C(2) Advisory Committee on Chemicals Scheduling"@en; ; "927664ea70662d41ffc536c3851fa5442d1070a4def2b43b51a86a54293bdaa4"; ; "Committee constitution and meeting requirements"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.342"; . a ; ; ; ; . a ; "52C(3) Advisory Committee on Chemicals Scheduling"@en; ; "2fa1bf462837c67a561c19974ebcb26fdf8e598971ddb48f6d1945a000a82692"; ; "Each State and the Commonwealth can nominate a member to the Advisory Committee on Chemicals Scheduling."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.342"; . a ; ; ; ; ; . . a ; ; "entitlement"; "Entitlement to nominate a member"; "modalities::logic::deontic"; 1.0000; . a ; "52C(4) Advisory Committee on Chemicals Scheduling"@en; ; "dfb7f9a1141e6371df732284d097073046d67f7749e25412dd88831b8691169b"; ; "The Committee must make recommendations to the Secretary on certain matters."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.342"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "MUST"; "The Committee must make recommendations."; "modalities::logic::deontic"; 1.0000; . a ; "52C(5) Advisory Committee on Chemicals Scheduling"@en; ; "d0bb4dd0c533b156eee821c1c4f0f0d13c44f6b410cf99ab76701551ebe13560"; ; "Exempts therapeutic goods from certain provisions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.342"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "exemption"; "Exempts substances from certain provisions."; "(5) Paragraphs (4)(a) and (d)"; "do not apply in relation to substances..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "includes"; "Therapeutic goods include certain substances."; "(5) Paragraphs (4)(a) and (d)"; "...are included in, therapeutic goods."; "modalities::interval_reasoning"; 1.0000; . a ; "52CA Joint meetings"@en; ; "d3114025bbcbcf7c49c0aadbd6abfb4beea9d698eb2b19b799b9fd68da0724da"; "May hold joint meetings"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.343"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Obligation to hold joint meetings"; "modalities::logic::deontic"; 1.0000; . a ; "52D Poisons Standard"@en; ; , , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.343". a ; "52D(1) Poisons Standard"@en; ; "98f1ad41d75bf0927ac833e19880043ccddad4ba84c56acf619309ea2814cc29"; ; "Commences with a prepared Poisons Standard"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.343"; . a ; ; ; ; . . a ; ; "begins"; "Establishes the commencement of a standard"; "(1) On the commencement of this Part..."; "the first Poisons Standard is taken to have been prepared and made available"; "modalities::logic::deontic"; 1.0000; . . a ; ; "begins-at"; "Describes a temporal relationship between events"; "(1) On the commencement of this Part..."; "the first Poisons Standard is taken to have been prepared and made available at the commencement of this Part"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "asserts"; "Describes a fact about the standard's preparation using AI"; "(1) On the commencement of this Part..."; "the first Poisons Standard is taken to have been prepared and made available by the then National Drugs and Poisons Schedule Committee"; "sparql_library::parsers::chk_parser"; 1.0000; . . a ; ; "asserts"; "Describes a fact about the standard's preparation using N3 logic"; "(1) On the commencement of this Part..."; "the first Poisons Standard is taken to have been prepared and made available by the then National Drugs and Poisons Schedule Committee"; "modalities::logic::n3_compiler"; 1.0000; . . a ; ; "asserts"; "Describes a fact about the standard's preparation using SHACL"; "(1) On the commencement of this Part..."; "the first Poisons Standard is taken to have been prepared and made available by the then National Drugs and Poisons Schedule Committee"; "modalities::logic::shacl"; 1.0000; . a ; "52D(2) Poisons Standard"@en; ; "bc819fc539fad70f1eeda1b80c2a5eb085d48704842a841483cd508ba91b7793"; ; "Secretary may amend or prepare a new Poisons Standard."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.343"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Permission to amend the standard."; "modalities::logic::deontic"; 1.0000; . a ; "52D(3) Poisons Standard"@en; ; "c64f185b60cc1086ce193584d215d0a3df24a7774d49f8792ebb8789557b65da"; ; "Power to exercise under subsection (2)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.343"; . a ; ; ; ; ; . . a ; ; "Permit"; "Grant of permission"; "(3) The Secretary may exercise a power..."; "modalities::logic::deontic"; 1.0000; . a ; "52D(4A) Poisons Standard"@en; ; "f7bd95a99f6f34d086cabc71ab140fc6dbbd936fbbb8aa88bca2659fccf3b835"; ; "Instrument made under paragraph (2)(a) or (b) is a legislative instrument."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.343"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "is"; "Instrument is a legislative instrument."; "modalities::logic::deontic"; 1.0000; . a ; "52D(4B) Poisons Standard"@en; ; "8cfcb722de9b3356b537cfc747c70a2466e075f1d0ea855654590583ade337e1"; ; "Allows for incorporation of existing provisions from other instruments or writings."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.343"; . a ; ; ; ; . a ; "52D(5) Poisons Standard"@en; ; "639e389af3170e5bc1ddc611865a7f0ca9c176b70db0c71ac103c668cdd20a03"; ; "Definition of 'Administration' in relation to the current Poisons Standard"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.343"; . a ; ; ; ; . a ; "52E Secretary to take certain matters into account in exercising"@en; ; "0e25d57dbe558245aead9ac9aa0089a2d18634aa26fa0dd81efbff7c4622d971"; , , , , , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.344". a ; "52E(1) Secretary to take certain matters into account in exercising"@en; ; "92908ce64a49b90b21e81fdc2d0092b553b84fa44a3bef47e43715dc4c6b6d3d"; ; "Secretary must consider certain matters when exercising power. Allow person to apply for amendment of current Poisons Standard."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.344"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must consider all relevant factors."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Permit"; "Grant permission to apply for amendment."; "modalities::logic::deontic"; 1.0000; . a ; "52E(2) Secretary to take certain matters into account in exercising"@en; ; "a325ddf6748881193ebf7a96606e226ea43e8432f4475d29bccfab32ae2e9a10"; ; "Application requirements Secretary must comply with guidelines from the Australian Health Ministers’ Advisory Council and the National Coordinating Committee on Therapeutic Goods."; "Application form, amendment sought, office of Department, application fee"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.344"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide required information"; "None"; "None"; "modalities::logic::deontic"; 1.0000; . . a ; ; "MUST"; "Obligation to comply with guidelines"; "The Secretary has a power under subsection 52D(2)"; "The Secretary must comply with the guidelines"; "modalities::logic::deontic"; 1.0000; . . a ; ; ">="; "Guidelines are notified to the Secretary for at least one year before this section comes into effect"; "The subcommittee of the Council known as the National Coordinating Committee on Therapeutic Goods is notified to the Secretary"; "The guidelines were notified to the Secretary for at least one year before this section came into effect"; "modalities::interval_reasoning"; 1.0000; . . a ; ; ">="; "Guidelines are applicable to all powers under subsection 52D(2)"; "The Secretary has a power under subsection 52D(2)"; "All powers under subsection 52D(2) must comply with the guidelines"; "modalities::temporal_ltl"; 1.0000; . . a ; ; "IS_A"; "Guidelines are a type of guideline that can be shared and applied by others"; "The Australian Health Ministers’ Advisory Council has guidelines"; "The subcommittee of the Council known as the National Coordinating Committee on Therapeutic Goods is a type of guideline that can be shared and applied by others"; "modalities::diffusion"; 1.0000; . . a ; ; "IS_A"; "Guidelines are a type of knowledge that can be used to make decisions"; "The Secretary has a power under subsection 52D(2)"; "The guidelines are a type of knowledge that can be used to make decisions"; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "52E(3) Secretary to take certain matters into account in exercising"@en; ; "21bf574860497753cb271e98ef817a7014f878c99ea867f44cbdfb09d61d9a5f"; ; "Must consider recommendations or advice from Advisory Committees Secretary must require person to provide further information within a reasonable time."; "true"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.344"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Obligation to consider recommendations"; "modalities::logic::deontic"; 1.0000; . a ; "52E(4) Secretary to take certain matters into account in exercising"@en; ; "d558cba65a58eac4c2e407c7279c75742bcacc9427869b7855d5f2d5d11a35d8"; ; "Application may be required or permitted for specified software requirements Secretary may seek advice from committees or persons when exercising power."; "Information"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.344"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "May"; "Permission to provide information"; "modalities::logic::deontic"; 0.5000; . . a ; ; "For"; "Application for specified software requirements"; "modalities::dl"; 0.5000; . . a ; ; "Overlaps"; "Temporal overlap with exercising power."; "(4) In exercising a power under subsection 52D(2), the Secretary may seek advice from either or both of the following:"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Repeats"; "Repeating pattern of seeking advice."; "(4) In exercising a power under subsection 52D(2), the Secretary may seek advice from either or both of the following:"; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Diffuses"; "Diffusing information to committees and persons."; "(4) In exercising a power under subsection 52D(2), the Secretary may seek advice from either or both of the following:"; "modalities::diffusion"; 1.0000; . . a ; ; "Incorporates"; "Incorporating committees and persons into decision-making."; "(4) In exercising a power under subsection 52D(2), the Secretary may seek advice from either or both of the following:"; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "52E(5) Secretary to take certain matters into account in exercising"@en; ; "12d6ffd021fb2097cf87a48602615f0e768a23e16139f20e32667474bfc1ea26"; ; "Secretary must consider additional information when exercising power"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.344"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must consider additional information"; "(5) Subsections (2) to (4) do not limit the information the Secretary may consider in exercising a power under subsection 52D(2)."; "modalities::logic::deontic"; 1.0000; . . a ; ; "CONTAINS"; "Temporal interval of consideration"; "(5) Subsections (2) to (4) do not limit the information the Secretary may consider in exercising a power under subsection 52D(2)."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "CONTAINS"; "Temporal interval of consideration"; "(5) Subsections (2) to (4) do not limit the information the Secretary may consider in exercising a power under subsection 52D(2)."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "CONTAINS"; "Temporal interval of consideration"; "(5) Subsections (2) to (4) do not limit the information the Secretary may consider in exercising a power under subsection 52D(2)."; "modalities::diffusion"; 1.0000; . . a ; ; "CONTAINS"; "Temporal interval of consideration"; "(5) Subsections (2) to (4) do not limit the information the Secretary may consider in exercising a power under subsection 52D(2)."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "52E(1) Secretary to take certain matters into account in exercising"@en; ; "e653a468812039f15affadbe89154a2386d982b1b453a270122a140bbfb8fd33"; ; "Secretary must consider certain matters when exercising power. Allow person to apply for amendment of current Poisons Standard."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.344"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must consider all relevant factors."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Permit"; "Grant permission to apply for amendment."; "modalities::logic::deontic"; 1.0000; . a ; "52E(2) Secretary to take certain matters into account in exercising"@en; ; "7a5db6bbb89398c1da761dd76460729e86fa4532b1d7070d40a878d8373ad63c"; ; "Application requirements Secretary must comply with guidelines from the Australian Health Ministers’ Advisory Council and the National Coordinating Committee on Therapeutic Goods."; "Application form, amendment sought, office of Department, application fee"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.344"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide required information"; "None"; "None"; "modalities::logic::deontic"; 1.0000; . . a ; ; "MUST"; "Obligation to comply with guidelines"; "The Secretary has a power under subsection 52D(2)"; "The Secretary must comply with the guidelines"; "modalities::logic::deontic"; 1.0000; . . a ; ; ">="; "Guidelines are notified to the Secretary for at least one year before this section comes into effect"; "The subcommittee of the Council known as the National Coordinating Committee on Therapeutic Goods is notified to the Secretary"; "The guidelines were notified to the Secretary for at least one year before this section came into effect"; "modalities::interval_reasoning"; 1.0000; . . a ; ; ">="; "Guidelines are applicable to all powers under subsection 52D(2)"; "The Secretary has a power under subsection 52D(2)"; "All powers under subsection 52D(2) must comply with the guidelines"; "modalities::temporal_ltl"; 1.0000; . . a ; ; "IS_A"; "Guidelines are a type of guideline that can be shared and applied by others"; "The Australian Health Ministers’ Advisory Council has guidelines"; "The subcommittee of the Council known as the National Coordinating Committee on Therapeutic Goods is a type of guideline that can be shared and applied by others"; "modalities::diffusion"; 1.0000; . . a ; ; "IS_A"; "Guidelines are a type of knowledge that can be used to make decisions"; "The Secretary has a power under subsection 52D(2)"; "The guidelines are a type of knowledge that can be used to make decisions"; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "52E(3) Secretary to take certain matters into account in exercising"@en; ; "47c4db6deb539834c792f6f1a9154898b8f69b331d84d712467a012293234ea8"; ; "Must consider recommendations or advice from Advisory Committees Secretary must require person to provide further information within a reasonable time."; "true"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.344"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Obligation to consider recommendations"; "modalities::logic::deontic"; 1.0000; . a ; "52E(4) Secretary to take certain matters into account in exercising"@en; ; "6edb8f78a3eec2803d548bdc449346b35f8fdde4b3ed6a3d9ead06243ed77be6"; ; "Application may be required or permitted for specified software requirements Secretary may seek advice from committees or persons when exercising power."; "Information"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.344"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "May"; "Permission to provide information"; "modalities::logic::deontic"; 0.5000; . . a ; ; "For"; "Application for specified software requirements"; "modalities::dl"; 0.5000; . . a ; ; "Overlaps"; "Temporal overlap with exercising power."; "(4) In exercising a power under subsection 52D(2), the Secretary may seek advice from either or both of the following:"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Repeats"; "Repeating pattern of seeking advice."; "(4) In exercising a power under subsection 52D(2), the Secretary may seek advice from either or both of the following:"; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Diffuses"; "Diffusing information to committees and persons."; "(4) In exercising a power under subsection 52D(2), the Secretary may seek advice from either or both of the following:"; "modalities::diffusion"; 1.0000; . . a ; ; "Incorporates"; "Incorporating committees and persons into decision-making."; "(4) In exercising a power under subsection 52D(2), the Secretary may seek advice from either or both of the following:"; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "52F Incorporation of current Poisons Standard"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.346". a ; "52F(1) Incorporation of current Poisons Standard"@en; ; "aeb97bcaa47f5ebc8e3680425f1fc9b79973a201d2c63d20fa88f118fff3ddd4"; ; "Legislative instrument may incorporate current Poisons Standard."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.346"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "incorporate"; "Incorporation of matter from current Poisons Standard."; "modalities::logic::deontic"; 1.0000; . a ; "52F(2) Incorporation of current Poisons Standard"@en; ; "e39f0ce23d71584732f97b5a258cbce8118c65125ee7f09e58c450a3f1531b88"; ; "An instrument under this Act may incorporate the current Poisons Standard with modifications."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.346"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "incorporate"; "Incorporation of current Poisons Standard"; "modalities::logic::deontic"; 1.0000; . a ; "52G Exemptions, approvals and authorities to be consistent with"@en; ; "0760a1e4dcde6c61e27d91a23e3517ee2a6580ca968b9d337f38fc4214a687f2"; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.347". a ; "52G(1) Exemptions, approvals and authorities to be consistent with"@en; ; "8b34fa02008be6305e2beb8703a9b2648660c9220bade4df4471eb7f5658fa17"; ; "Absolute prohibitions apply to therapeutic goods or vaping goods."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.347"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "="; "Absolute prohibition"; "subsection 9K(1) or (3)"; "thing referred to in subsection (3) of this section"; "modalities::logic::deontic"; 1.0000; . a ; "52G(2) Exemptions, approvals and authorities to be consistent with"@en; ; "baad14767a6eded1b4cd252ab72b5e0564ed82588d3fe3bd3c13f0230337850b"; ; "Exemptions and approvals must be consistent with prohibitions"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.347"; . a ; ; ; ; ; . . a ; ; "Consistency"; "Consistency requirement"; "Exemptions and approvals must be consistent with prohibitions"; "modalities::logic::deontic"; 1.0000; . a ; "52G(3) Exemptions, approvals and authorities to be consistent with"@en; ; "baa17e994e49ad04d7332d95f74b79493092c8ece2abaf8f08f5ac9125ef1e10"; ; "List of exemptions, approvals and authorities to be consistent with"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.347"; . a ; ; ; ; ; . . a ; ; "inclusion"; "List of exemptions, approvals and authorities"; "modalities::logic::deontic"; 1.0000; . a ; "53 Retention of material on withdrawal of application"@en; ; "f3883da62b564cb998ecafe6e27cced3096316e96001ac17fd401e9443b7dcde"; "Department may retain application and material upon withdrawal."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.348"; . a ; ; ; ; ; . . a ; ; "Prohibit"; "Prohibits Department from releasing application and material."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Classify"; "Classifies retained application and material as confidential."; "modalities::dl"; 1.0000; . a ; "53A Alternative verdicts for various offences"@en; ; "54edf86a4220d83589940a2b6661176385eb9686511ee547f5c839f9f329c62d"; "If a jury acquits a person of an offence against a provision listed in column 2 of an item in the following table, but is satisfied beyond reasonable doubt of facts that prove that the person is guilty of the offence listed in column 3 of that item, the jury may convict the person of the offence listed in column 3 of that item."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.348"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "The provision imposes an obligation on the State to convict a person of an offence if certain conditions are met."; "If a jury acquits a person of an offence against a provision listed in column 2..."; "...the jury may convict the person of the offence listed in column 3 of that item:"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlaps"; "The provision specifies a temporal overlap between two events."; "If a prosecution is for an offence against..."; "...the jury may instead convict the person of an offence against..."; "modalities::interval_reasoning"; 0.5000; . . a ; ; "Repeats"; "The provision specifies a recurring pattern."; "If a prosecution is for an offence against..."; "...the jury may instead convict the person of an offence against..."; "modalities::temporal_ltl"; 0.5000; . . a ; ; "Implication"; "The provision implies a causal relationship between two events."; "If a jury acquits a person of an offence against a provision listed in column 2..."; "...the jury may convict the person of the offence listed in column 3 of that item:"; "modalities::argumentation"; 0.5000; . . a ; ; "Diffuses"; "The provision diffuses information from one event to another."; "If a prosecution is for an offence against..."; "...the jury may instead convict the person of an offence against..."; "modalities::diffusion"; 0.5000; . a ; "54 Offences and forfeiture"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.351". a ; "54(3) Offences and forfeiture"@en; ; "b4d20fb3979fffa9c593a6f547a01886430c38fae5425b12736b6ec7f8315889"; ; "Forfeiture of goods in relation to therapeutic or vaping products"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.351"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits the possession of goods"; "(3) If a court orders that the goods be forfeited"; "The goods must be forfeited to the Commonwealth"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlap"; "Goods must overlap with therapeutic or vaping products"; "(3) If a court orders that the goods be forfeited in relation to any therapeutic goods or vaping goods"; "The goods overlap with therapeutic or vaping products"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Recurring"; "Goods must be forfeited repeatedly"; "(3) If a court orders that the goods be forfeited in relation to any therapeutic goods or vaping goods"; "The goods are forfeited repeatedly"; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Diffuse"; "Forfeiture must diffuse to all goods"; "(3) If a court orders that the goods be forfeited in relation to any therapeutic goods or vaping goods"; "The forfeiture diffuses to all goods"; "modalities::diffusion"; 1.0000; . . a ; ; "Recognize"; "Forfeiture must recognize as a threat"; "(3) If a court orders that the goods be forfeited in relation to any therapeutic goods or vaping goods"; "The forfeiture recognizes as a threat"; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "54(4) Offences and forfeiture"@en; ; "d612d6d7b67625ace66a2836714ee2e7a3e6ff58d30a96425534697bd186f735"; ; "Notice of forfeiture must be published in Gazette or website."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.351"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits publication of notice without Secretary's action."; "modalities::logic::deontic"; 1.0000; . a ; "54(5) Offences and forfeiture"@en; ; "1ef1fdfd689ec48b7d8c5d6f19dae8d04b2c93115dff01974ac2209120b2ecdd"; ; "Goods forfeited under an order must be disposed of in a manner specified by the Secretary."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.351"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits disposal of goods in a manner other than specified by the Secretary."; "modalities::logic::deontic"; 1.0000; . a ; "54AA Offences for contravening conditions or requirements"@en; ; "ed88344744c9d99d8157b18ec5a8ffe20ee1e4e2902e52c0efc97fff4d1744e3"; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.352". a ; "54AA(1) Offences for contravening conditions or requirements"@en; ; "979340a964565da202a512e9fc17b3f1c887b28f6cd92b69b068d495a4861da0"; ; "Breach of licence or permission conditions results in an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.352"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits conduct"; "(a) a person holds a licence or a permission to import or export therapeutic goods; and (b) the person engages in conduct; and (c) the conduct breaches a condition or a requirement to which the licence or permission is subject under the regulations;"; "the person commits an offence punishable on conviction by a fine of no more than the number of penalty units specified in whichever of subsection (2) or (3) applies."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibition"; "Prohibits breach of conditions or requirements"; "(c) the conduct breaches a condition or a requirement to which the licence or permission is subject under the regulations;"; "the person commits an offence."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlaps"; "Describes temporal overlap between licence/permission and conduct"; "(1) If: (a) a person holds a licence or a permission to import or export therapeutic goods; and (b) the person engages in conduct;"; "the conduct occurs during the period of the licence or permission."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Until"; "Describes temporal relationship between licence/permission and conduct"; "(1) If: (a) a person holds a licence or a permission to import or export therapeutic goods; and (b) the person engages in conduct;"; "the conduct ends before the period of the licence or permission."; "modalities::temporal_ltl"; 1.0000; . a ; "54AA(1A) Offences for contravening conditions or requirements"@en; ; "4ebb61080b88abfaf5a0acc701c0c1517ad2a9b6b06280b72d4dae959bd165f2"; ; "Engaging in conduct means doing an act or omitting to perform an act."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.352"; . a ; ; ; ; "borne by: LegalPerson"; ; . . a ; ; "is"; "Definition of conduct"; "engaging in conduct means doing an act or omitting to perform an act."; "modalities::logic::deontic"; 1.0000; . . a ; ; "subClassOf"; "Classification of conduct"; "modalities::dl"; 1.0000; . a ; "54AA(2) Offences for contravening conditions or requirements"@en; ; "e4e91572021a7e8259ff26b0bfe226bfff93bbb5cebd17a55ff2ade3a90d6f00"; ; "Increased penalty for contravention of certain conditions or requirements"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.352"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Increase"; "Increases the penalty for contravention"; "(2) If..."; "240 penalty units"; "modalities::logic::deontic"; 1.0000; . a ; "54AA(3) Offences for contravening conditions or requirements"@en; ; "d31b1f0501c7445e5f596e18dc87f2296ff47c6e948c891b1e07ed347db22b8f"; ; "Penalty for contravention of conditions or requirements"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.352"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "="; "Imposes a penalty"; "Subsection (2) does not apply"; "50 penalty units"; "modalities::logic::deontic"; 1.0000; . a ; "54AB Criminal offence for damaging etc. documents"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.353". a ; "54AB(1) Criminal offence for damaging etc. documents"@en; ; "01407f9663132bb3e8c2dd830c54a42d8f4e641ecb4ce93988e54041bf331e56"; ; "Damaging or destroying documents for purposes of this Act is a criminal offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.353"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits damaging or destroying documents."; "(1) A person commits an offence..."; "Penalty: 7 years imprisonment or 2,000 penalty units, or both."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Temporal overlap"; "Documents must be created, retained or issued within the same temporal interval as this Act."; "(b) the document is created, retained or issued for the purposes..."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Recurring trace"; "Documents must be part of a recurring trace that includes this Act."; "(b) the document is created, retained or issued for the purposes..."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Diffuse"; "This Act must diffuse to all documents created, retained or issued within its temporal interval."; "(b) the document is created, retained or issued for the purposes..."; "modalities::diffusion"; 1.0000; . . a ; ; "Classify"; "This Act must be classified as a legal provision."; "Note:"; "For the liability of an executive officer of a body corporate, see sections 54B and 54BA."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "54AB(2) Criminal offence for damaging etc. documents"@en; ; "c9073f5b3de1691ba95af8e23d995cdd8ae82be111e22e0298152fe06cb21679"; ; "Strict liability applies for damaging documents"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.353"; . a ; ; ; ; ; . . a ; ; "applies"; "Strict liability obligation"; "modalities::logic::deontic"; 1.0000; . a ; "54AC Civil penalty for damaging etc. documents"@en; ; "bb10afc0ad7127b9095a9eefec4f94004850847515cca73cbe5fb076f9c352c4"; "Damaging, destroying, altering, concealing or falsifying documents for purposes of the Act."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.353"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits damaging, destroying, altering, concealing or falsifying documents."; "None"; "None"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlap"; "Documents must be created, retained or issued within a specific time frame."; "None"; "Document is created, retained or issued for the purposes of this Act."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Recurring"; "Documents must be regularly updated or reviewed."; "None"; "Document is created, retained or issued for the purposes of this Act."; "modalities::temporal_ltl"; 1.0000; . a ; "54A Time for bringing prosecutions"@en; ; "5b54f99cfc86c1753e0a2f1a5848c870012ddc8e33b4437722c0edacecf05f30"; "Prosecution can be commenced within 3 years after commission of the offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.353"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "can"; "Ability to commence prosecution within specified timeframe."; "modalities::logic::deontic"; 1.0000; . a ; "54B Personal liability of an executive officer of a body corporate—"@en; ; "0feae16d55365acf07fe9f909834361ba6ee606854746539230bdc84a6a24cee"; , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.354". a ; "54B(1) Personal liability of an executive officer of a body corporate—"@en; ; "dff6da4339e5f46de43bae2aff3c0790202b3180537b02fce03b1ece113b3064"; ; "Executive officer commits an offence if they knew and failed to prevent the commission of an offence against the Act."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.354"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "obligation"; "Executive officer has a duty to prevent commission of offence."; "Knew and failed to act."; "Offence committed."; "modalities::logic::deontic"; 1.0000; . . a ; ; "knowledge"; "Executive officer must know the offence will be committed."; "Knew the offence would be committed."; "Offence committed."; "modalities::epistemic"; 1.0000; . . a ; ; "interval"; "Offence occurred within a specific time interval."; "Failed to take reasonable steps."; "Offence committed."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "class"; "Executive officer is part of a class with a specific description."; "An executive officer of a body corporate."; "Offence committed."; "modalities::dl"; 1.0000; . a ; "54B(2) Personal liability of an executive officer of a body corporate—"@en; ; "c982497a7430d06e5217d1b39e0558b2eeb8dfb9cc00cb6fe651fdd4402b6df6"; ; "Maximum penalty for an offence against subsection (1)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.354"; . a ; ; ; ; "borne by: State"; ; . a ; "54B(3) Personal liability of an executive officer of a body corporate—"@en; ; "65211f4be3e156a861f091cb405c0115c99660caf892bfc69f5a90753f0a30af"; ; "Executive officer must take reasonable steps to prevent contravention of civil penalty provision."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.354"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "obligation"; "Executive officer has an obligation to prevent contravention."; "The executive officer knew the contravention would occur."; "The executive officer must take reasonable steps to prevent the contravention."; "modalities::logic::deontic"; 1.0000; . . a ; ; "obligation"; "Executive officer has an obligation to prevent contravention."; "The executive officer was in a position to influence the conduct of the body corporate."; "The executive officer must take reasonable steps to prevent the contravention."; "modalities::logic::deontic"; 1.0000; . . a ; ; "obligation"; "Executive officer has an obligation to prevent contravention."; "The executive officer failed to take all reasonable steps to prevent the contravention."; "The executive officer must take reasonable steps to prevent the contravention."; "modalities::logic::deontic"; 1.0000; . a ; "54B(4) Personal liability of an executive officer of a body corporate—"@en; ; "399b01805777936f112869e5e668d18dcd28395f3dd020b8c6b9c89285b604b9"; ; "Maximum civil penalty for contravention of subsection (3)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.354"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "hasObligation"; "Imposes obligation on the state"; "modalities::logic::deontic"; 1.0000; . a ; "54B(5) Personal liability of an executive officer of a body corporate—"@en; ; "f3f328e39cf84ba61546b161cdd2d47fd18f87d617ba9b14fccb8fb101b5cef8"; ; "Defines executive officer of a body corporate"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.354"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "is defined as"; "Defines term"; "executive officer of a body corporate"; "modalities::logic::deontic"; 1.0000; . . a ; ; "has class"; "Class hierarchy"; "body corporate"; "modalities::dl"; 1.0000; . a ; "54BA Personal liability of an executive officer of a body corporate—"@en; ; "a3d055a1bb2a7ccfe0a4d4e56773d99f42ceb19b1989edf5662dcde664365ea7"; "Personal liability of an executive officer of a body corporate—"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.355"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "coveredBy"; "Personal liability covered by this section"; "modalities::logic::deontic"; 1.0000; . a ; "11 Section 11"@en; ; "f1aab5c7e7bd038629f266bf4900c9e5a57a06a51269faa29cfb5a2d66752b4a"; "Corporate officers may be personally liable for certain offences."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.355"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Corporate officers have an obligation to comply with certain regulations."; "modalities::logic::deontic"; 1.0000; . a ; "54C Establishing whether an executive officer took reasonable steps"@en; ; "53df1947c8d1e25dbc5068e17cfb3734e168c6aa6095c6d250117e5303a33198"; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.358". a ; "54C(1) Establishing whether an executive officer took reasonable steps"@en; ; "5842ec336a8eb582ab1f278d454481fa9e6d5d7d38e2bd8949b2df832893269f"; ; "Executive officer must take reasonable steps to prevent commission of offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.358"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Executive officer has an obligation to take reasonable steps."; "The executive officer is responsible for preventing the commission of the offence."; "The officer must take all reasonable steps to prevent the commission of the offence."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlaps"; "The officer's awareness of the body's commission of an offence is relevant to determining their obligations."; "The officer became aware that the body was committing an offence against this Act or the regulations."; "The officer's awareness of the body's commission of an offence overlaps with their obligation to prevent the commission of the offence."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Obligation"; "The officer has an obligation to take action when they become aware that the body is committing an offence."; "When the officer became aware that the body was committing an offence against this Act or the regulations, they had an obligation to take action."; "The officer must take action when they become aware that the body is committing an offence."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Obligation"; "The officer has an obligation to ensure that employees, agents, and contractors have a reasonable knowledge and understanding of the requirements."; "The officer is responsible for ensuring that employees, agents, and contractors have a reasonable knowledge and understanding of the requirements."; "The officer must ensure that employees, agents, and contractors have a reasonable knowledge and understanding of the requirements."; "modalities::logic::deontic"; 1.0000; . a ; "54C(2) Establishing whether an executive officer took reasonable steps"@en; ; "4e0727bb6aab2e0a505bbf99c062f65c0b97c3402d446782870fa4293d5bcff1"; ; "Does not limit the generality of section 54B by implication."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.358"; . a ; ; ; ; "borne by: State"; ; . a ; "54C(3) Establishing whether an executive officer took reasonable steps"@en; ; "a13750efb9f07fab797f1d9e87cfff22f0c0cfbd641ab6b25f1f1b3f3b7b9dd6"; ; "Executive officer must take reasonable steps"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.358"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "MUST"; "Must provide reasonable steps"; "modalities::logic::deontic"; 1.0000; . a ; "55 Conduct by directors, employees and agents"@en; ; , , , , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.358". a ; "55(1) Conduct by directors, employees and agents"@en; ; "64af537c1d1e7bf31e26f3f3244bc9aff7ed89522d13f968636d04b29b085e86"; ; "Establishing state of mind of a body corporate in relation to conduct"; "Director, employee or agent's actual or apparent authority and state of mind"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.358"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "hasAuthority"; "Establishing authority"; "modalities::logic::deontic"; 1.0000; . a ; "55(2) Conduct by directors, employees and agents"@en; ; "5168f66658d99db1ba2601e79f742cc64abe0eb7c7dbc5d00d04e2f2ae880535"; ; "Body corporate must take reasonable precautions to avoid conduct by directors, employees and agents."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.358"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "obligation"; "Obligation to take precautions"; "Body corporate has authority"; "Must take precautions"; "modalities::logic::deontic"; 1.0000; . a ; "55(3) Conduct by directors, employees and agents"@en; ; "b44e50bb588ebcec505d42da564b6419976b9302b8f6315da8db557940cf8ce3"; ; "Establishing state of mind for employees or agents"; "state of mind"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.358"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "hasAuthority"; "Authority relation"; "actual or apparent authority"; "state of mind"; "modalities::logic::deontic"; 1.0000; . a ; "55(4) Conduct by directors, employees and agents"@en; ; "bb2235be6dda6e76680cfd3045b1e68ca3175d0ea1db23e85c1965cf90f03328"; ; "Employer liable for conduct of employee/agent within scope of authority"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.358"; . a ; ; ; ; ; . . a ; ; "Liability"; "Employer liable for conduct"; "Employee/agent within scope of authority"; "Employer must provide liability"; "modalities::logic::deontic"; 1.0000; . a ; "55(5) Conduct by directors, employees and agents"@en; ; "6fe882b570b32f6c05fd121a4ae143bb84077188002292139eb050dce5fd2d7b"; ; "No imprisonment for certain offences if convicted by a non-corporate person"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.358"; . a ; ; ; ; "borne by: NaturalPerson"; ; . . a ; ; "Implies"; "No imprisonment implies obligation to refrain from punishment"; "(5) Where: ... the person is not liable to be punished by imprisonment for that offence."; "If a person would not have been convicted of the offence if subsections (3) and (4) had not been enacted, then they are not liable to be punished by imprisonment for that offence."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Permits"; "Imprisonment permits other forms of punishment"; "(5) Where: ... the person is not liable to be punished by imprisonment for that offence."; "If a person would not have been convicted of the offence if subsections (3) and (4) had not been enacted, then they are permitted to receive other forms of punishment"; "modalities::logic::deontic"; 1.0000; . . a ; ; "And"; "No imprisonment implies obligation to refrain from punishment and permits other forms of punishment"; "(5) Where: ... the person is not liable to be punished by imprisonment for that offence."; "If a person would not have been convicted of the offence if subsections (3) and (4) had not been enacted, then they are permitted to receive other forms of punishment"; "modalities::linear"; 1.0000; . . a ; ; "Justifies"; "Obligation to refrain from punishment justifies no imprisonment"; "(5) Where: ... the person is not liable to be punished by imprisonment for that offence."; "If a person would not have been convicted of the offence if subsections (3) and (4) had not been enacted, then they are justified in refraining from punishment"; "modalities::logic::deontic"; 1.0000; . a ; "55(6) Conduct by directors, employees and agents"@en; ; "1315e6721d4b51124c656bce1be24f8086c4f37b4a4a0b06d6ed6f97a99d13e4"; ; "Directors, employees and agents must have certain knowledge or reasons for their intentions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.358"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "hasKnowledge"; "Directors, employees and agents must have certain knowledge."; "The person has a certain state of mind."; "The person must have that knowledge."; "modalities::logic::deontic"; 1.0000; . . a ; ; "hasReasons"; "Directors, employees and agents must have certain reasons for their intentions."; "The person has a certain intention or purpose."; "The person must have those reasons."; "modalities::logic::deontic"; 1.0000; . . a ; ; "hasProperty"; "Directors, employees and agents must have certain knowledge or reasons."; "The person has a certain state of mind."; "The person has that knowledge or reason."; "modalities::dl"; 1.0000; . . a ; ; "during"; "Directors, employees and agents must have certain knowledge or reasons during their actions."; "The person performs an action."; "The person has that knowledge or reason during the action."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "mustJustify"; "Directors, employees and agents must justify their intentions with certain reasons."; "The person has an intention."; "The person must justify that intention with those reasons."; "modalities::argumentation"; 1.0000; . . a ; ; "mustInform"; "Directors, employees and agents must inform others of their knowledge or reasons."; "The person has certain knowledge or reasons."; "The person must inform others of that knowledge or reason."; "modalities::diffusion"; 1.0000; . a ; "55(7) Conduct by directors, employees and agents"@en; ; "5ea19562c2955142a5b4c15c86cfb32f83097eca13fc4c41962cf730c53f4910"; ; "Directors, employees and agents of a body corporate are subject to this section."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.358"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "includes"; "Inclusion in the reference list"; "A director of a body corporate is included in this section."; "The reference to a director includes a reference to a constituent member of a body corporate."; "modalities::logic::deontic"; 0.5000; . . a ; ; "subclassOf"; "Classification of the constituent member"; "A constituent member is a type of body corporate."; "The constituent member is classified as a body corporate."; "modalities::dl"; 0.5000; . a ; "55(8) Conduct by directors, employees and agents"@en; ; "784c369f04cb9ef0e05bd0c7aaeb3c6faca611ba3028eb8188be051098c811a4"; ; "Directors, employees and agents must engage in conduct."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.358"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide obligation"; "modalities::logic::deontic"; 1.0000; . . a ; ; "CLASSIFICATION"; "Classification of conduct"; "modalities::dl"; 1.0000; . a ; "56 Judicial notice"@en; ; "c4800eab611dc70219fe20473c0fa652d4850a2b3d70bb15eac29d26a6cfa013"; "Courts must take judicial notice of certain pharmacopeias."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.360"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Court obligation"; "Courts are required to take judicial notice."; "Courts must take judicial notice."; "modalities::logic::deontic"; 1.0000; . a ; "56A Certificates to provide evidence of certain matters"@en; ; "de793b2b3a4b2ad5c7790fb02c97319f4311bef0579c71c7ad1f3eb59e2ed91e"; "The Secretary or authorized person must certify certain matters in writing."; "Certificates to provide evidence of certain matters"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.360"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "The Secretary or authorized person must certify certain matters in writing."; "modalities::logic::deontic"; 1.0000; . . a ; ; "IS_A"; "Certificates to provide evidence of certain matters"; "modalities::dl"; 1.0000; . a ; "57 Delegation"@en; ; , , , , , , , , , , , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.364". a ; "57(1) Delegation"@en; ; "7d5a9fd0c956efd7d08b28cedc15410d2cb1636d04290831f3688dd3c1ba7973"; ; "Delegation of powers and functions"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.364"; . a ; ; ; ; . a ; "57(1A) Delegation"@en; ; "ea47560aee51095dbd39d88b66658ac4324a13ef7f155e6bb3ceb45fee8c134e"; ; "Delegate powers and functions to an officer of a Department, unit or authority with related functions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.364"; . a ; ; ; ; ; . . a ; ; "Permit"; "Permission to delegate powers and functions."; "modalities::logic::deontic"; 1.0000; . a ; "57(2) Delegation"@en; ; "4a5dd28e2e5fcac2aae9459756af00e2fd4e93533bedc8dce0bf41c41c709a3d"; ; "Delegation of powers to registered medical or dental practitioners or pharmacists."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.364"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "canDelegate"; "Authorization of power delegation"; "(2) The powers of the Secretary under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d)"; "may be delegated under subsection (1)"; "modalities::logic::deontic"; 1.0000; . . a ; ; "during"; "Temporal relationship of delegation"; "(2) The powers of the Secretary under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d)"; "may be delegated during subsection (1)"; "modalities::interval_reasoning"; 0.5000; . . a ; ; "during"; "Temporal relationship of delegation"; "(2) The powers of the Secretary under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d)"; "may be delegated during subsection (1)"; "modalities::temporal_ltl"; 0.5000; . . a ; ; "mustBeRegistered"; "Registration requirement for delegation"; "(2) The powers of the Secretary under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d)"; "who is registered, or eligible for registration, in a State or internal Territory"; "modalities::logic::deontic"; 1.0000; . . a ; ; "mustBeEligibleForRegistration"; "Eligibility requirement for delegation"; "(2) The powers of the Secretary under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d)"; "or eligible for registration, in a State or internal Territory"; "modalities::logic::deontic"; 0.5000; . a ; "57(3) Delegation"@en; ; "24160bd133701d3c7ee9b5ecff86e6e53e6b1807382bdd963f523aead20b6e78"; ; "Delegation of powers by Secretary to registered medical or dental practitioner"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.364"; . a ; ; ; ; . a ; "57(4) Delegation"@en; ; "d98b15dd8fb83caac1a8624ba46484b2d0b49edc0b8f1dde3dfd30828092b298"; ; "Delegate must follow directions from Secretary, officer, or person referred to in paragraph (1)(c)."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.364"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "obligation"; "Delegate has an obligation to follow directions."; "modalities::logic::deontic"; 1.0000; . a ; "57(5) Delegation"@en; ; "df7336e313cc9b63916b010f73ff6d0dbf49af5da7b1578591ee5b504a7b332c"; ; "Regulations may make provision for delegates, approvals, and conditions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.364"; . a ; ; ; ; "borne by: State"; ; . a ; "57(5A) Delegation"@en; ; "6655cb3aeabb2a44496efa4e81765f7a2172c6c7289587b6338b542937aee635"; ; "Delegation of powers to registered medical or dental practitioners or pharmacists."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.364"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Permit"; "Delegation of powers to registered medical or dental practitioners or pharmacists."; "modalities::logic::deontic"; 1.0000; . a ; "57(6) Delegation"@en; ; "fc2eed2ec9b8f2751243e6bbc6ebc917b7b9b937bf5df2127adab80ecb7928c0"; ; "Delegation of powers is restricted to registered medical practitioners."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.364"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "canDelegate"; "Authorization for delegation"; "The powers of the Secretary under subsection 32CM(1) or 41HC(1)"; "may be delegated to a registered medical practitioner"; "modalities::logic::deontic"; 1.0000; . . a ; ; "during"; "Temporal restriction on delegation"; "The powers of the Secretary under subsection 32CM(1) or 41HC(1)"; "may only be delegated during the registration period"; "modalities::interval_reasoning"; 0.5000; . . a ; ; "everywhere"; "Universal applicability of delegation restriction"; "The powers of the Secretary under subsection 32CM(1) or 41HC(1)"; "are restricted to registered medical practitioners everywhere"; "modalities::temporal_ltl"; 0.5000; . . a ; ; "isAuthorizedTo"; "Authorization for delegation by AI system"; "The person referred to in paragraph (1)(a) or (c)"; "is authorized to delegate powers as a registered medical practitioner"; "sparql_library::parsers::chk_parser"; 0.5000; . . a ; ; "hasShape"; "Validation of delegation restriction"; "The person referred to in paragraph (1)(a) or (c)"; "must be validated as a registered medical practitioner"; "modalities::logic::shacl"; 0.5000; . a ; "57(7) Delegation"@en; ; "4e454a6be4cdce324d35bb68c9738de4d58a64997fa80f0404894910eff40404"; ; "Regulations may prescribe circumstances for delegate authorities."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.364"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "mayPrescribe"; "May prescribe"; "modalities::logic::deontic"; 1.0000; . a ; "57(8) Delegation"@en; ; "3685f2afdfb798445ca5cb5d09e98d38686585f55281180e7084a52a9c8720aa"; ; "Powers of Secretary can be delegated to a specific person."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.364"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "can"; "Delegation is permitted."; "modalities::logic::deontic"; 1.0000; . a ; "57(9) Delegation"@en; ; "0f929f5ec13e96828454b8340f5151517e5325e9b41e36d224ce994973ed65c2"; ; "Powers of Secretary under section 41HD may be delegated to a person holding the prescribed duties."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.364"; . a ; ; ; ; . a ; "57(10) Delegation"@en; ; "5e8c848fb79601b4574db4e64db39976664e9c7abf38011017dcd493fca99211"; ; "Delegation of power to certain individuals or positions within the Department."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.364"; . a ; ; ; ; ; . . a ; ; ">="; "Temporal interval"; "(10) The power of the Minister under subsection 18A(1) or 41P(3) may be delegated only to..."; "...on or after a specified date;"; "modalities::interval_reasoning"; 0.5000; . . a ; ; "<="; "Temporal interval"; "(10AA) The power of the Minister under subsection 30EK(1) may be delegated only to..."; "...before a specified date;"; "modalities::temporal_ltl"; 0.5000; . . a ; ; "="; "Permission"; "The power of the Minister under subsection 18A(1) or 41P(3) may be delegated only to..."; "...a specified individual or position;"; "modalities::logic::deontic"; 1.0000; . a ; "57(10A) Delegation"@en; ; "312661f44f1c494159265039aa8c672cc5b9d0ff8a488e9806ff0fd803d8dc2f"; ; "Delegation of power to the Minister under subsection 32CB(1)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.364"; . a ; ; ; ; "borne by: State"; ; . a ; "57(11) Delegation"@en; ; "a62d340868c024869b38cb76ff49a667bae546bc027ef2c545716b79d5ab1e5f"; ; "Delegation of power to specific individuals or positions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.364"; . a ; ; ; ; ; . a ; "57(12) Delegation"@en; ; "6857992b20ecccccd8b6883d6ef3f80147e9c492d85970bf43adee0abc978e2a"; ; "Delegate must comply with directions of the person who delegated."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.364"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must comply"; "modalities::logic::deontic"; 1.0000; . a ; "58 Export certifications"@en; ; , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.367". a ; "58(1) Export certifications"@en; ; "cb5cffe10020adda30bcf077c6db503b9d0091d12e28d3615967d4b111c164e1"; ; "The Secretary may issue export certification for goods for therapeutic use in humans."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.367"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "May"; "Permission to issue export certification"; "modalities::logic::deontic"; 1.0000; . a ; "58(2) Export certifications"@en; ; "32077c0af2b4c132a6ecc610033b919f49b1d0e77f8cff0a71d9cf793f467830"; ; "No export certifications for therapeutic use in humans."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.367"; . a ; ; ; ; ; . . a ; ; "not"; "Negative obligation"; "No export certifications"; "modalities::logic::deontic"; 1.0000; . a ; "58(2A) Export certifications"@en; ; "2b25472d4316ba91c2f6994ac2543ddf276973bad5497bc7a5a265bd98bd75ab"; ; "Secretary may issue export certification for vaping goods not covered by subsection (1)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.367"; . a ; ; ; ; "borne by: State"; ; . a ; "58(2B) Export certifications"@en; ; "70b11da2f27766f22e3b39ac2875b71c0dd5201c1f89c624a61a8d59f9238e13"; ; "No export certification for vaping goods under subsection (2A) may be issued."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.367"; . a ; ; ; ; ; . . a ; ; "Prohibit"; "Prohibition of export certification"; "(2B) A State or Territory must not issue..."; "...export certification for vaping goods under subsection (2A)."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Temporal Restriction"; "Restriction on export certification timing"; "(2B) A State or Territory must not issue..."; "...export certification for vaping goods under subsection (2A)."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Temporal Restriction"; "Restriction on export certification timing"; "(2B) A State or Territory must not issue..."; "...export certification for vaping goods under subsection (2A)."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Propagation"; "Propagating prohibition of export certification"; "(2B) A State or Territory must not issue..."; "...export certification for vaping goods under subsection (2A)."; "modalities::diffusion"; 1.0000; . . a ; ; "Knowledge Representation"; "Representation of prohibition in knowledge base"; "(2B) A State or Territory must not issue..."; "...export certification for vaping goods under subsection (2A)."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "58(3) Export certifications"@en; ; "287d5c644caa158347161cc54c5ddc9d4f8bcbab674ae3628462fb2a796a7762"; ; "Fee for certification application and inspection"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.367"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Payment of fee is obligatory"; "modalities::logic::deontic"; 1.0000; . a ; "59 Fees"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.368". a ; "59(1) Fees"@en; ; "6d70df9a062c1c1fa45cc132f38fef49f9aa0a5718dacdbe055b66a5cb196067"; ; "No fees payable before July 1990"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.368"; . a ; ; ; ; ; . . a ; ; "forbid"; "Prohibits paying fees before July 1990"; "No event occurring before July 1990"; "No fees payable"; "modalities::logic::deontic"; 1.0000; . a ; "59(2) Fees"@en; ; "1baa73c415311070c47495ec06e9b88ef56d107011c0e18179ea99ef5bade970"; ; "Fees must not amount to taxation."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.368"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MustNot"; "Prohibition on taxing fees"; "modalities::logic::deontic"; 1.0000; . a ; "60 Review of decisions"@en; ; "4a47d81bbcbfe5270c94b80c8cb991dfab670ee5ade11c0fc8af53ad09234f65"; "Refusal to grant consent or impose conditions on a grant of consent under section 14 or 14A."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.368"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of refusal to grant consent or impose conditions."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Classify"; "Classification of decisions under Part 3-2 (registration and listing of therapeutic goods)."; "modalities::dl"; 1.0000; . a ; "60A New information on review—discretion to remit"@en; ; , , , , , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.374". a ; "60A(1) New information on review—discretion to remit"@en; ; "37c625c5f9a3bbdeeffa3a414ade262175edad236c053db2b3269dcbcfcfdb9c"; ; "Secretary or delegate has discretion to remit a decision."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.374"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "hasDiscretion"; "Secretary or delegate has discretion to remit a decision."; "modalities::logic::deontic"; 1.0000; . . a ; ; "withinTemporalInterval"; "Decision must be made within a specific temporal interval."; "modalities::interval_reasoning"; 0.5000; . a ; "60A(2) New information on review—discretion to remit"@en; ; "2109460986072fd8387f0229b969edbfb1de88c740f113edfc38617588e4046e"; ; "Minister must reconsider decision or remit to delegate upon new information."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.374"; . a ; ; ; ; ; . . a ; ; "MUST"; "Minister has obligation to reconsider decision."; "Appellant requests reconsideration."; "Minister must reconsider decision."; "modalities::logic::deontic"; 1.0000; . a ; "60A(3) New information on review—discretion to remit"@en; ; "24ca841f8e97f8709f0d76287a01a87eb6c9f5128c98433127aab40376056694"; ; "Tribunal may remit matter to delegate for fresh decision if it thinks fit."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.374"; . a ; ; ; ; ; . . a ; ; "may"; "Tribunal has discretion to remit matter."; "modalities::logic::deontic"; 0.5000; . a ; "60A(4) New information on review—discretion to remit"@en; ; "1f98abad1a8748f375a324a72f174b98e1570fc5e7bf9c6932ea4ed244a937e6"; ; "Tribunal must not remit the matter under subsection (3) if all of initial new information is information that the Minister took into account."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.374"; . a ; ; ; ; ; . . a ; ; "MustNot"; "Tribunal must not remit the matter."; "Appellant lodges initial new information."; "Tribunal cannot remit the matter."; "modalities::logic::deontic"; 0.5000; . . a ; ; "Overlaps"; "Initial new information overlaps with the Minister's decision on reconsideration."; "Appellant lodges initial new information."; "Tribunal's discretion to remit is limited by this overlap."; "modalities::interval_reasoning"; 0.5000; . . a ; ; "Repeats"; "The Minister's decision on reconsideration repeats the initial new information."; "Minister took initial new information into account."; "Tribunal's discretion to remit is limited by this repetition."; "modalities::temporal_ltl"; 0.5000; . a ; "60A(5) New information on review—discretion to remit"@en; ; "154dad67d61e08fea5643f23324efebc1c6678ab7a8aa8287493d535a94d0ee9"; ; "Tribunal must consider initial new information that indicates unacceptable quality, safety or efficacy of therapeutic goods."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.374"; . a ; ; ; ; ; . . a ; ; "MUST"; "Tribunal must consider initial new information"; "Subsection (3)"; "Initial new information considered"; "modalities::logic::deontic"; 1.0000; . . a ; ; ">="; "Tribunal must consider initial new information within a certain timeframe"; "Subsection (3)"; "Initial new information considered within timeframe"; "modalities::interval_reasoning"; 1.0000; . a ; "60A(6) New information on review—discretion to remit"@en; ; "218688f846807fb19e08426edf3d27f38cf6bab2f3e9106f1f261775304612ff"; ; "Authorised delegate must make a decision under section 25 taking into account new information."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.374"; . a ; ; ; ; ; . . a ; ; "MUST"; "Must provide a decision under section 25."; "(6) If..."; "the authorised delegate must make a decision under section 25..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "BETWEEN"; "The decision must be made within a specific timeframe."; "(6) If..."; "the authorised delegate must make a decision under section 25... within the timeframe specified by the provision."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "IMPLIES"; "The provision implies that the Minister or Tribunal has discretion to remit the matter."; "(6) If..."; "the Minister or Tribunal has discretion to remit the matter."; "modalities::argumentation"; 1.0000; . . a ; ; "NOT"; "The provision is not a prohibition on making a new application for registration."; "(6) If..."; "the provision does not prohibit making a new application for registration."; "modalities::dialectical"; 1.0000; . . a ; ; "AND"; "The provision requires the authorised delegate to make a decision under section 25 and include the biological in the Register."; "(6) If..."; "the authorised delegate must make a decision under section 25 and include the biological in the Register."; "modalities::linear"; 1.0000; . a ; "60A(6A) New information on review—discretion to remit"@en; ; "d86245ee5eb12dc4b56afa8aea8e0305cb51fbac0faed8e490c720d9027db4f3"; ; "The authorised delegate must make a decision under section 41EC, taking into account the initial new information or later new information."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.374"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "The authorised delegate must make a decision."; "modalities::logic::deontic"; 1.0000; . a ; "60A(7) New information on review—discretion to remit"@en; ; "f8dd0edfebf4432c0f1d75e038ac3a42439b5dca34f50c1bb4d8be12feddb8a3"; ; "Delegates' decisions are treated as decisions under Part 3-2, 3-2A or 4-4 for subsequent applications."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.374"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Treatment"; "Treated as decisions under Part 3-2, 3-2A or 4-4"; "(7) To remove any doubt..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Temporal relation"; "Relates to temporal intervals under Part 3-2, 3-2A or 4-4"; "(7) To remove any doubt..."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Recurring trace"; "Involves recurring traces under Part 3-2, 3-2A or 4-4"; "(7) To remove any doubt..."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Knowledge representation"; "Involves knowledge representation under Part 3-2, 3-2A or 4-4"; "(7) To remove any doubt..."; "sparql_library::parsers::chk_parser"; 1.0000; . . a ; ; "Schema validation"; "Validates schema under Part 3-2, 3-2A or 4-4"; "(7) To remove any doubt..."; "modalities::logic::shacl"; 1.0000; . a ; "60A(8) New information on review—discretion to remit"@en; ; "6d03ed07cd7b49ecbde9a6764bf00666f56d57ebc614c4b8fe44e5bfe24caaaa"; ; "Defines authorized delegate and conditions for new information."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.374"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "exercising a power to decide"; "Exercise of power"; "(a) exercising a power to decide"; "modalities::logic::deontic"; 1.0000; . . a ; ; "includes"; "Includes relevant information"; "(a) was in existence at the time the decision referred to in subsection (1) was made; and"; "modalities::dl"; 1.0000; . a ; "61 Release of information"@en; ; , , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.377". a ; "61(1) Release of information"@en; ; "998bb6bee35cb2e99b705b746a88b050a46b33bacd2cf9dbbcbc734546816f3e"; ; "Definition of therapeutic goods information and vaping goods information."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.377"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "definition"; "Defines terms for the purpose of this section."; "modalities::dl"; 1.0000; . a ; "61(2) Release of information"@en; ; "921fb311c11dd7500bee37650426b0a96bccb2bd398687deaa68c9efca17debc"; ; "Release of information to World Health Organisation"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.377"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Permit"; "Permission granted by the State"; "The Secretary may release information"; "Information can be released to WHO"; "modalities::logic::deontic"; 1.0000; . a ; "61(3) Release of information"@en; ; "4acd189e12683d4c0558e36b06f9d4c61698150c8ec8c5615efec9c485179bb5"; ; "Release of information to authorities for therapeutic goods functions"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.377"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Permit"; "Permission granted"; "modalities::logic::deontic"; 1.0000; . a ; "61(3A) Release of information"@en; ; "e4420e5470de0eb58b80a0f5f2e8a450be8e0ffa8b33bb81702d3b551e990841"; ; "Release of information to certain authorities and bodies."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.377"; . a ; ; ; ; ; . . a ; ; "Permit"; "Permission granted."; "modalities::logic::deontic"; 1.0000; . a ; "61(4) Release of information"@en; ; "52229e3fadd05ca6a4a4298bbab777f060fcc757477cbfb384c4d05c5cb408b4"; ; "Release of information to national regulatory authorities of other countries."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.377"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Permit"; "Allows release of information to national regulatory authorities."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Temporal Interval"; "Defines the temporal scope of the permission."; "(4) The Secretary may release to a national regulatory authority..."; "...of therapeutic goods and their compliance with the manufacturing principles;"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Spread"; "Describes how the permission is disseminated."; "(4) The Secretary may release to a national regulatory authority..."; "...of therapeutic goods and their compliance with the manufacturing principles;"; "modalities::diffusion"; 1.0000; . . a ; ; "Reasoning"; "Describes how the permission is applied."; "(4) The Secretary may release to a national regulatory authority..."; "...of therapeutic goods and their compliance with the manufacturing principles;"; "sparql_library::parsers::chk_parser"; 1.0000; . . a ; ; "Validate"; "Describes the validation rules for the permission."; "(4) The Secretary may release to a national regulatory authority..."; "...of therapeutic goods and their compliance with the manufacturing principles;"; "modalities::logic::shacl"; 1.0000; . a ; "61(4A) Release of information"@en; ; "9ebfe4d8064ae8003d55d789fa7e104170b1a465ee272c077a9ad3026edbacf2"; ; "Release of information to authorities and international organisations"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.377"; . a ; ; ; ; ; . . a ; ; "Permit"; "Permission granted by the Secretary"; "(4A) The Secretary may release..."; "...therapeutic goods information relating to one or more of the following:"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Temporal overlap"; "Temporal overlap between release and therapeutic goods information"; "(4A) The Secretary may release..."; "...contraventions, or possible contraventions, of Part 5-2 or"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Implication"; "Implication of release on therapeutic goods information"; "(4A) The Secretary may release..."; "...action taken by the Secretary under Part 5-3;"; "modalities::argumentation"; 1.0000; . . a ; ; "Propagation"; "Propagation of release to action taken by the Secretary"; "(4A) The Secretary may release..."; "...action taken by the Secretary under section 30EA (about notification and recall of therapeutic goods);"; "modalities::diffusion"; 1.0000; . . a ; ; "Inference"; "Inference of release on action taken by the Secretary"; "(4A) The Secretary may release..."; "...action taken by the Secretary under section 32HA (about notification and recall of biologicals);"; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "61A Immunity from civil actions"@en; ; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.385". a ; "61A(1) Immunity from civil actions"@en; ; "4926f889f969b3fb1954bdec92d7ab50aa05fc23f7deacab40d1eba93cd9f8d0"; ; "No civil action against Commonwealth or protected person for loss/damage/injury caused by their actions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.385"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Imposes duty on Commonwealth and protected persons."; "modalities::logic::deontic"; 1.0000; . a ; "61A(2) Immunity from civil actions"@en; ; "9d0398ed0a860603ef8d58f9e2bf684f7952faa955c8ffef26ed4bf9137a76bb"; ; "Immunity from civil actions in bad faith"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.385"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "exemption"; "Exempts acts in bad faith from civil actions"; "(2) Subsection (1) does not apply to an act or omission in bad faith."; "Subsection (1) does not apply to an act or omission in bad faith."; "modalities::logic::deontic"; 0.5000; . . a ; ; "permission"; "Permits acts in bad faith without civil liability"; "(2) Subsection (1) does not apply to an act or omission in bad faith."; "Acts in bad faith are permitted without civil liability"; "modalities::logic::deontic"; 0.5000; . . a ; ; "exclusion"; "Excludes acts in bad faith from general applicability of subsection (1)"; "(2) Subsection (1) does not apply to an act or omission in bad faith."; "Subsection (1) is excluded for acts in bad faith"; "modalities::linear"; 0.5000; . . a ; ; "during"; "Acts in bad faith occur during the period of exemption"; "(2) Subsection (1) does not apply to an act or omission in bad faith."; "The period of exemption includes acts in bad faith"; "modalities::interval_reasoning"; 0.5000; . . a ; ; "inference"; "Inferential relationship between exemption and bad faith"; "(2) Subsection (1) does not apply to an act or omission in bad faith."; "Exemption implies bad faith"; "sparql_library::parsers::chk_parser"; 0.5000; . a ; "61A(3) Immunity from civil actions"@en; ; "6eca28ddf118bd8a48d3fa4fedd3e34b77696b63d43983d61955f916841ac908"; ; "A reference to a failure to make a decision includes a reference to anything omitted to be done."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.385"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "includes"; "Inclusion relation for obligations"; "(x) includes (y) if and only if x is an obligation that requires y."; "(3) A reference in subsection (1) to anything omitted to be done includes a reference to a failure to make a decision."; "modalities::logic::deontic"; 1.0000; . . a ; ; "includes"; "Inclusion relation for descriptions"; "(x) includes (y) if and only if x is a description that contains y."; "(3) A reference in subsection (1) to anything omitted to be done includes a reference to a failure to make a decision."; "modalities::dl"; 1.0000; . . a ; ; "includes"; "Inclusion relation for linear logic"; "(x) includes (y) if and only if x is a linear logic statement that implies y."; "(3) A reference in subsection (1) to anything omitted to be done includes a reference to a failure to make a decision."; "modalities::linear"; 1.0000; . . a ; ; "requires"; "Requirement relation for obligations"; "(x) requires (y) if and only if x is an obligation that necessitates y."; "(3) A reference in subsection (1) to anything omitted to be done includes a reference to a failure to make a decision."; "modalities::logic::deontic"; 1.0000; . . a ; ; "contains"; "Containment relation for descriptions"; "(x) contains (y) if and only if x is a description that encompasses y."; "(3) A reference in subsection (1) to anything omitted to be done includes a reference to a failure to make a decision."; "modalities::dl"; 1.0000; . . a ; ; "during"; "Temporal relation for Allen intervals"; "(x) during (y) if and only if x starts before y ends."; "(3) A reference in subsection (1) to anything omitted to be done includes a reference to a failure to make a decision."; "modalities::interval_reasoning"; 0.5000; . a ; "61A(4) Immunity from civil actions"@en; ; "b28154014219d630aeb9f0dcac09c59bfc9255da7f269fea3dad6c50756eaf1c"; ; "Protected persons are defined for immunity from civil actions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.385"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Imposes a duty on the State."; "modalities::logic::deontic"; 1.0000; . . a ; ; "ClassInclusion"; "Defines a class of protected persons."; "(a) the Minister;"; "protected person means any of the following:"; "modalities::dl"; 1.0000; . a ; "62 Protection from criminal responsibility"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.386". a ; "62(1) Protection from criminal responsibility"@en; ; "47194556e944c516c4d693705832a838f2b6dfcf01f0ef3bee565f8b3f87da06"; ; "Protected person not criminally responsible for obtaining or possessing goods to comply with laws."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.386"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Obligation to comply with laws"; "Protected person obtains goods for compliance"; "Not criminally responsible"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlaps"; "Temporal overlap: Protected person's actions overlap with law compliance"; "Protected person obtains goods for compliance"; "Not criminally responsible"; "modalities::interval_reasoning"; 1.0000; . a ; "62(2) Protection from criminal responsibility"@en; ; "ac9a7045cef3fca0b7eecb1381eba72a107ed09b7ad19ef6f2e16b40f58c6ab9"; ; "Protected person not criminally responsible for offense related to conveyance of goods"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.386"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Protected person not criminally responsible for offense related to conveyance of goods"; "(2) If a protected person, in connection with finding out whether this Act or the regulations have been complied with..."; "The other person is not criminally responsible for an offence against a law of the Commonwealth, or a State law..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlaps"; "Conveyance of goods overlaps with finding out compliance"; "(2) If a protected person, in connection with finding out whether this Act or the regulations have been complied with..."; "The conveyance of goods overlaps with finding out compliance"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Repeats"; "Conveyance of goods repeats in connection with finding out compliance"; "(2) If a protected person, in connection with finding out whether this Act or the regulations have been complied with..."; "The conveyance of goods repeats in connection with finding out compliance"; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Diffuses"; "Conveyance of goods diffuses to other persons"; "(a) the possession of the goods by the other person, to the extent the possession is in connection with that conveyance of the goods"; "The conveyance of goods diffuses to other persons"; "modalities::diffusion"; 1.0000; . . a ; ; "Inferential"; "Protected person not criminally responsible for offense related to conveyance of goods"; "(2) If a protected person, in connection with finding out whether this Act or the regulations have been complied with..."; "The other person is not criminally responsible for an offence against a law of the Commonwealth, or a State law..."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "62(3) Protection from criminal responsibility"@en; ; "71f0047157d0f05fd1995e9b69f01ee4f67e48afa0ce89ef5260bba7ebd71802"; ; "Definition of protected person"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.386"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "ClassInclusion"; "Identifies a class hierarchy"; "(a) an APS employee in the Department"; "(b) a person of a kind prescribed by the regulations"; "modalities::dl"; 0.5000; . . a ; ; "Overlaps"; "Temporal overlap between two events"; "In this section:"; "protected person means any of the following:"; "modalities::interval_reasoning"; 0.5000; . . a ; ; "Definition"; "Defines a term with a specific meaning"; "(3) In this section:"; "protected person means any of the following:"; "modalities::logic::deontic"; 0.5000; . . a ; ; "TemporalConnective"; "Expresses temporal relationships between events"; "In this section:"; "protected person means any of the following:"; "modalities::temporal_ltl"; 0.5000; . a ; "63 Regulations"@en; ; , , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.386". a ; "63(1) Regulations"@en; ; "718d8ea3d20405acf408b7d01c030bafdd739974a853fd2df826cc9397ba6b3f"; ; "Governor-General may make regulations not inconsistent with the Act."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.386"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Regulations are permitted."; "modalities::logic::deontic"; 1.0000; . a ; "63(2) Regulations"@en; ; "971614cd42bbf60e7371148d77a0181f86d75426ec38cfbb2b9b951dbf889437"; ; "Regulations for therapeutic goods and vaping goods"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.386"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide regulations"; "modalities::logic::deontic"; 1.0000; . . a ; ; "CLASSIFICATION"; "Classify therapeutic goods and vaping goods"; "modalities::dl"; 1.0000; . a ; "63(3) Regulations"@en; ; "4f39e9ba585448cee707893c6484b65366333b2e99e86d7041991c3df9ffa6d2"; ; "Regulations may prescribe different fees under this Act."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.386"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Prescribes obligations"; "modalities::logic::deontic"; 1.0000; . . a ; ; "classify"; "Classify goods into classes"; "(i) different classes of goods"; "modalities::dl"; 1.0000; . a ; "63(3A) Regulations"@en; ; "10e652f390d6bc4398075e331f8cf992415a125de573c023f23903a87f64e35f"; ; "Licence or permission to import/export therapeutic goods may be granted."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.386"; . a ; ; ; ; ; . . a ; ; "Grant"; "Permission to import/export therapeutic goods."; "modalities::logic::deontic"; 1.0000; . a ; "63(4) Regulations"@en; ; "ed51b78bd78fabaaba38f9c4eea6a86d46d2401316e24251ed71d6f317bda886"; ; "Regulations may incorporate existing instruments or writings."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.386"; . a ; ; ; ; . a ; "63(5) Regulations"@en; ; "3490d0dc93e2c48d53032dc271a279b521e00bb7d200cbbaf702e27043306e8f"; ; "Regulations may be made before commencement."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.386"; . a ; ; ; ; ; . a ; "66 Transitional arrangements for goods required to be registered or"@en; ; "56547a7cc8bbf46bb4aa2f18a097fee842ce6e94ca4c7f5cda6df35c4f5825c9"; , , , , , , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.390". a ; "66(1) Transitional arrangements for goods required to be registered or"@en; ; "53c9af9e9a72fa3981d101d87397877fc31e41cebd3c4268083ceb4a6664c562"; ; "Therapeutic goods supplying person must comply with transitional arrangements."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.390"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Therapeutic goods supplying person must comply with transitional arrangements."; "modalities::logic::deontic"; 1.0000; . a ; "66(2) Transitional arrangements for goods required to be registered or"@en; ; "ddca6907a37ab8564d878ad42f8602e082f4c2033dfd836227cf7c198b995b6e"; ; "Exemptions from subsection 20(1) and (2) for certain individuals"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.390"; . a ; ; ; ; "borne by: State"; ; . a ; "66(3) Transitional arrangements for goods required to be registered or"@en; ; "87d4d28af6657e71e41b3762ffda9c37d75a671972bbc878029668f7edb75a01"; ; "Therapeutic goods registration application within 3 months after commencement."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.390"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Therapeutic goods registration application within 3 months after commencement."; "modalities::logic::deontic"; 1.0000; . a ; "66(3A) Transitional arrangements for goods required to be registered or"@en; ; "cc900127271b884ad8560ab6602a37a7aa8e7f983663f4939e08d3998695006c"; ; "Notice must be given to person in relation to whom goods are registered."; "Written notice"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.390"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Notice must be given"; "modalities::logic::deontic"; 1.0000; . a ; "66(4) Transitional arrangements for goods required to be registered or"@en; ; "8fee253a710602cf49e77b7a17cc3ef206d0dfdcd839911b4d6b0dab0c68eef1"; ; "No application fee for registration or listing of goods."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.390"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "!"; "No fee for evaluation of goods"; "modalities::logic::deontic"; 1.0000; . a ; "66(4A) Transitional arrangements for goods required to be registered or"@en; ; "a83342b417c93b94a4679b8fcec0267e5d9a519f0d8822abfd5bc9ee8f79d95a"; ; "Transitional arrangements for goods required to be registered or"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.390"; . a ; ; ; ; . a ; "66(4B) Transitional arrangements for goods required to be registered or"@en; ; "a853016961d6852efc6a6f597a7ba46c15cc85220711dbafce77f7475ff9e2cf"; ; "Secretary may give written notice to person listed goods"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.390"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Implies obligation"; "modalities::logic::deontic"; 0.5000; . a ; "66(4C) Transitional arrangements for goods required to be registered or"@en; ; "75520faafe07ff84b1aba16c467c8ffb37dcc6ec6fbeac7c8aa635d1760e66c9"; ; "If notice is given under subsection (4B), section 26 applies as if the person in relation to whom the goods are listed were an applicant for the listing of the goods."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.390"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "if-then"; "Conditional obligation"; "Notice is given under subsection (4B)"; "Section 26 applies"; "modalities::logic::deontic"; 1.0000; . a ; "66(5) Transitional arrangements for goods required to be registered or"@en; ; "a61163ad065da808b32700788acc0390d6decf6c0d3e01edf699b4b2a956e15f"; ; "Exemption from Section 21 for goods during transitional period"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.390"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "exemption"; "Exempts goods from Section 21 during transitional period"; "modalities::logic::deontic"; 1.0000; . a ; "66(6) Transitional arrangements for goods required to be registered or"@en; ; "dfe2cef4144e62d12e2390015d8f9196825bbfad17e5ec8411815f65b0b475bb"; ; "No liability attaches to Commonwealth, Secretary, or delegate for losses caused by therapeutic goods."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.390"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Implies"; "No liability implies loss or damage"; "Loss or damage occurs"; "No liability attaches"; "modalities::logic::deontic"; 1.0000; . . a ; ; "SubClassOf"; "Therapeutic goods are a subclass of goods subject to this section"; "This section applies to therapeutic goods"; "Loss or damage is covered by this section"; "modalities::dl"; 1.0000; . . a ; ; "Implies"; "No liability implies lack of responsibility"; "Lack of liability implies no responsibility"; "The Commonwealth, Secretary, or delegate is not responsible for losses"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Until"; "Liability attaches until loss or damage is covered by this section"; "Loss or damage occurs before this section applies"; "No liability attaches until this section applies"; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Implies"; "This section implies a duty to provide compensation for losses caused by therapeutic goods"; "Losses are caused by therapeutic goods subject to this section"; "The Commonwealth, Secretary, or delegate must provide compensation"; "modalities::logic::deontic"; 0.5000; . a ; "67 Transitional provision for therapeutic goods for export only"@en; ; "2e3de76f5908db2170ad3e585ad6d5eb47b79a8afdb9a8405458cd8ad7277a88"; "Therapeutic goods manufactured in Australia solely for export from Australia are exempt from Section 20 during the first 6 months after commencement."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.392"; . a ; ; ; ; . a ; "68 Transitional arrangements for Part 3-3"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.392". a ; "68(1) Transitional arrangements for Part 3-3"@en; ; "5e6881f1ec5bb0385fb1d6f34a1953a71487f96e5f85755e355923192e1b3689"; ; "Applicability of transitional arrangements for Part 3-3"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.392"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "applies"; "Transitional arrangement applies to a step in the manufacture of therapeutic goods"; "(1) This section applies..."; "...to a person in relation to premises in Australia if..."; "modalities::logic::deontic"; 0.5000; . a ; "68(2) Transitional arrangements for Part 3-3"@en; ; "67f74215afdd954587bfa8be94c591c3af1017c0a948d2ef4e9655fe541001f3"; ; "No prosecution for 4 months after commencement"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.392"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Obligation to not prosecute"; "(2) Where..."; "subsection 35(1) does not apply"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlaps"; "Temporal overlap of 4 months"; "(a) this section applies to a step in the manufacture..."; "subsection 35(1) does not apply"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Diffuses"; "Diffusion of obligation to not prosecute"; "(2) Where..."; "subsection 35(1) does not apply"; "modalities::diffusion"; 1.0000; . a ; "68(3) Transitional arrangements for Part 3-3"@en; ; "fea248bbec2428e8a1439ad38c893c3e8e4e4d0e34494feac0e8e9ca6d83b928"; ; "Application for licence must be made within 4 months after commencement."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.392"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Application for licence must be made within 4 months after commencement."; "modalities::logic::deontic"; 1.0000; . a ; "69 Continuation of standards and requirements"@en; ; "bb9419c96a803f074fd7fddce5972f7bce38b676ad3d088cab55b23f1fd62113"; "Continues standards and requirements from Therapeutic Goods Act 1966."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.393"; . a ; ; ; ; . . a ; ; "CONTINUE"; "Continues existing standards and requirements."; "modalities::logic::deontic"; 1.0000; . . a ; ; "SUBCLASS_OF"; "Continues standards and requirements from Therapeutic Goods Act 1966."; "modalities::dl"; 1.0000; . a ; "17 Jan 1990"@en; ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.397"; . a ; ; ; ; . a ; "15 Feb 1991 (s 2)"@en; ; "9c4cdffd45adf47d02b457d6486a8747c70186c98919d3da6b2862a458b94c23"; "Community Services and Health Legislation Amendment Act (No. 2) 141, 1990"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.397"; . a ; ; ; ; . a ; "28 Dec"@en; ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.397"; . a ; ; ; ; . a ; "26 June"@en; ; "0f7dfa3d546e2b794d031e391cd6648445358063fdbf66a612e6fea9fc9c94f6"; "Conditional commencement of the Therapeutic Goods Amendment Act 1991"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.397"; . a ; ; ; ; . a ; "24 Dec"@en; ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.397"; . a ; ; ; ; . a ; "24 Dec 1991 (s 2)"@en; ; "f115f068f39426bd9691592e03211c993fd548ce11beacc6d7687292bfda7395"; "References s 4(2), 10(2) and 13(2)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.397"; . a ; ; ; ; ; . a ; "30 June"@en; ; "53a1fbe1b34bf800947ed0ff4aa2ee42dcb39786ea2365d08e5f77cda8e32319"; "Conditional commencement of Health and Community Services Legislation Amendment Act (No. 2)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.397"; . a ; ; ; ; . . a ; ; "Applicable"; "Requires relation between identifiable temporal intervals for conditional commencement"; "s 82–88: 30 Jun 1992 (s (1)) s 83(2)"; "modalities::interval_reasoning"; 0.5000; . . a ; ; "Applicable"; "Requires ordered or recurring trace for conditional commencement"; "s 82–88: 30 Jun 1992 (s (1)) s 83(2)"; "modalities::temporal_ltl"; 0.5000; . . a ; ; "Applicable"; "Classifies the legal effect as Undertaking"; "No explicit duty, ban conduct, grant permission, or create a right"; "Undertaking"; "modalities::logic::deontic"; 1.0000; . a ; "25 Nov"@en; ; "81c3a1fab1ea45eb7211f7da4f877c46557e124c8c06305c9dd1a56933556f88"; "Customs, Excise and Bounty Legislation Amendment Act 1995"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.397"; . a ; ; ; ; . a ; "1 July 1995"@en; ; "5a078cb643de24c95d4bf8d859e084db57c540ea3924499494bf453f47d66e0e"; "Conditional commencement of Therapeutic Goods Amendment Act 1996"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.397"; . a ; ; ; ; . a ; "11 June"@en; ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.397"; . a ; ; ; ; . a ; "11 June 1996 (s 2)"@en; ; "5ce4a6a9f2b57dd2ba739aaabbe9e2349e0244ba212a2a6956e3aa0f60dec94f"; "Legislation history for Therapeutic Goods Act 1989"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.397"; . a ; ; ; ; . . a ; ; "Applicable"; "Defines compilation date"; "Compilation date is defined as the date of publication"; "2025-09-05"; "modalities::logic::n3_compiler"; 1.0000; . a ; "7 July 1997"@en; ; "c362835f09a01307303a31902bcc46dccfe922b4155c54cb15f12036d4371d85"; "Amendment of schedule"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.398"; . a ; ; ; ; . a ; "29 Mar"@en; ; "0263c61c2df3adb172d8fbff62ac1b149c15b78834ebe9b99639be2ca752efa4"; "Audit (Transitional and Miscellaneous) Amendment Act 1997"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.398"; . a ; ; ; ; . a ; "24 Oct"@en; ; "1a50fb5c97583f17648870f22eac907d25334021d1f880480b4ac573252dc08f"; "Commences on 1 January 1998"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.398"; . a ; ; ; ; . a ; "17 Apr"@en; ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.398"; . a ; ; ; ; . a ; "17 Apr 1998 (s 2)"@en; ; "dd68fc51537b22dd390fde6b2c71dc51f3721ab33ea2415ef82e9a1f0a4b1566"; "Conditional commencement of Therapeutic Goods Legislation Amendment Act 1999"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.398"; . a ; ; ; ; . a ; "29 Mar"@en; ; "b764d1ba08181c17a19374547a251c5b44f5559daa1c61c6885e83ff4f4f68eb"; "Amendment Act 1999"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.398"; . a ; ; ; ; . a ; "11 Nov"@en; ; "4a695abf2298384bcead27bddecc0af60840bf60d16fcb5a9a984c1d6412975d"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.398"; . a ; ; ; ; . a ; "5 Dec 1999 (gaz 1999,"@en; ; "45857c72ce5906cf92c73b0cc69bf5d11b1d6450e97fbed02a30ab442c87128c"; "No S584"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.398"; . a ; ; ; ; ; . a ; "31 Mar"@en; ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.398"; . a ; ; ; ; . a ; "31 Mar 2000 (s 2)"@en; ; "1c52bf9b9ff911129b83839e19a87a3d2b3ebfd7ad956cb977c82b572d3fdcf6"; "Therapeutic Goods Amendment Act (No. 2) - March 2000"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.398"; . a ; ; ; ; . a ; "30 May"@en; ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.398"; . a ; ; ; ; ; . a ; "30 May 2000 (s 2)"@en; ; "37cfa3a5c416190985934de91bcdb27a615f3656c001143980c7d5a1bd8e7a3c"; "Amendment Act (No. 3)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.398"; . a ; ; ; ; . a ; "12 Sept"@en; ; "344eb579a28dc7f2644bcf36af39cdd5b5e240defe7ccb8f5e24bdb8afda885c"; "Remains in force until further notice"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.398"; . a ; ; ; ; . a ; "21 Dec"@en; ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.399"; . a ; ; ; ; . a ; "22 June 2001 (s 2)"@en; ; "ef8c2ad2bb4325d93c2feb2447f2147b72d4d536c700ad20168e7ff46447f846"; "Conditional commencement of the Therapeutic Goods Amendment Act 2001"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.399"; . a ; ; ; ; . a ; "22 Mar"@en; ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.399"; . a ; ; ; ; . a ; "22 Sept 2001"@en; ; "5353b9d4778b7803abecbe6dde005812b7ead3fbf193871c4c6add16f3853dd8"; "Amendment Act 2001"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.399"; . a ; ; ; ; . a ; "10 July"@en; ; "2f1855871bc8f1a4de499bf9959925c49c3b580e49913d30bc3820fca86667dc"; "July section"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.399"; . a ; ; ; ; ; . a ; "17 Sept"@en; ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.399"; . a ; ; ; ; . a ; "17 Sept 2001 (s 2)"@en; ; "41f00e82be48397d1b347509465461e4a9ba6135d9b57d9516b03ec0a33e64cf"; "Amendment Act (No. 1)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.399"; . a ; ; ; ; . a ; "4 Apr 2002"@en; ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.399"; . a ; ; ; ; . a ; "4 Apr 2002 (s 2)"@en; ; "f58051aec453a2ccc11fd56a619bb6308783adb5921c9b550fb4cf073f964a55"; "Conditional commencement of the Act"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.399"; . a ; ; ; ; . a ; "4 Apr 2002"@en; ; "b2834cfedb570caf72d1a7a25ea945ec31bee06b7a4e74c0a59d9e8cfbcd7a91"; "Schedule amendments"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.399"; . a ; ; ; ; . a ; "3 July 2002"@en; ; "1688c977dd4f73c5f8fb447c53c2e659168f8518ae5faf917ab306e49d7eb137"; "Therapeutic Goods Amendment Act (No. 1) 2006"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.399"; . a ; ; ; ; . a ; "3 May 2006"@en; ; "94993cbb1a085d43618dc2492cc79691a25ef041b61f029f8b8a75fc1935775b"; "Conditional commencement of Therapeutic Goods Amendment Act 2007"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.399"; . a ; ; ; ; . a ; "14 Sept"@en; ; "23a2de87a9848775c41f2e75ca27aa60cc9907506ebea8e294253614405bfd04"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.399"; . a ; ; ; ; . a ; "3 July 2002"@en; ; "e90696b376feb616ba7445e9ee4cdea11621a342d58ebaff0d1084a8d3cb3e87"; "Commencement dates for certain provisions of the Therapeutic Goods Amendment Act (No. 1)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.400"; . a ; ; ; ; . a ; "27 May"@en; ; "05d0895732544998989fe7ba6011761df7ac2971679b60e404ec3b7e46bea657"; "Conditional commencement of certain provisions"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.400"; . a ; ; ; ; ; . a ; "27 May 2003 (s 2(1)"@en; ; "2e51cb6253d1a5ecdc59ccf5c7396652be02d092dc02de9aaa4a5b3b741a1f16"; "US Free Trade Agreement Implementation Act"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.400"; . a ; ; ; ; ; . . a ; ; "MUST"; "Must implement US Free Trade Agreement"; "modalities::logic::deontic"; 1.0000; . a ; "16 Aug"@en; ; "226d6cd50cff0588de2ae67286b52c66864a8a16c5eccee1cd9b88ac3ae0331a"; "Conditional commencement of Sch 7 (item 7)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.400"; . a ; ; ; ; . a ; "22 Feb"@en; ; "0fef335bab5d94afb50141b22503c37e3c88ecdca0a3a91992745955beeca07c"; "Conditional commencement of Therapeutic Goods Amendment Act (No. 2)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.400"; . a ; ; ; ; . a ; "1 Mar 2006"@en; ; "fd44a63585ecfe7c6290a8c7a255e8167a704fab57dd6a36a8fe72a44c380753"; "Remainder: 1 Mar 2006"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.400"; . a ; ; ; ; ; . . a ; ; "Obligation"; "Obligation"; "modalities::logic::deontic"; 1.0000; . a ; "3 Mar 2006"@en; ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.401"; . a ; ; ; ; . a ; "3 Mar 2006 (s 2)"@en; ; "59a02ddf67b93ad359adf5ca8118ce0d9943a24b8d4a1c0d440b505ad0b6b8df"; "Therapeutic Goods Amendment Act (No. 1)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.401"; . a ; ; ; ; . a ; "3 May 2006"@en; ; "6f60ea84a45482ebf7b27cb0a3fb77e4f87075755c8458e2a6f052f4d4e2fb4f"; "Amendment of therapeutic goods schedule"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.401"; . a ; ; ; ; . a ; "14 Sept"@en; ; "f9af6d3222fa85b3b32ecbcfa0adf60c5724b127fe9daaa6a8123cc20f317541"; "Conditional commencement of National Health and Medical Research Council Amendment Act 50, 2006"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.401"; . a ; ; ; ; . a ; "9 June 2006"@en; ; "1d335fc1c1a910abb0bbf16da00982730be862ebd1a6176fe0765fd8a9a85f85"; "Commencement of Sch 1"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.401"; . a ; ; ; ; . a ; "5 Sept 2006"@en; ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.401"; . a ; ; ; ; . a ; "5 Sept 2006 (s 2)"@en; ; "cc11b74f9873a988107c9e6c617076bf928406ae50eddc5021c1aa15d8fd4db7"; "Therapeutic Goods Amendment Act 2007"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.401"; . a ; ; ; ; . a ; "14 Sept"@en; ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.401"; . a ; ; ; ; . a ; "3 Oct 2007 (s 2)"@en; ; "9c6c9d26ca3d78dfc25244b7284c315ac59ffb1bca027fc31d8d6c5fcaa3b4e0"; "Conditional commencement of the Therapeutic Goods Amendment (Poisons Standard) Act 2008"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.401"; . a ; ; ; ; . . a ; ; "Applicable"; "Requires temporal relation between commencement and amendment"; "Conditional commencement"; "Undertaking"; "modalities::interval_reasoning"; 1.0000; . a ; "20 Mar"@en; ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.401"; . a ; ; ; ; . a ; "20 Mar 2008 (s 2)"@en; ; "09e15d4272dc4975a43d44a3918461adaece5bfa7f91cc42d8723f823fb01d89"; "Statute Law Revision Act 2008"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.401"; . a ; ; ; ; . a ; "3 July 2008"@en; ; "55e750f6151b8c05516aa0470e5ff08e141971aec988e7735ed3f2eefcaa9e8b"; "Therapeutic Goods Legislation Amendment (Annual Charges) Act 2008"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.401"; . a ; ; ; ; . a ; "3 Oct 2008"@en; ; "9970a2a8c3cff6585a938dfbae98f5006fed4abba67d8d0d6d320dacb8efdeed"; "Commencement of Sch 1 (items 1–3)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.401"; . a ; ; ; ; . a ; "17 June"@en; ; "88a017a323faff502154de519ac5f2d168daa69d20fecdcc24aaa3e3264c6c50"; "References Schedule 1, 2 and 5–7."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.402"; . a ; ; ; ; . a ; "18 June 2009 (s 2(1)"@en; ; "8fe257670881554c92e02de328f2e58c229a4b48b254ff396343a899b7f5b4ee"; "June 2009 (s 2(1))"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.402"; . a ; ; ; ; ; . a ; "27 Aug"@en; ; "744f0b904875d558961b963c1c7784d00d2550c4ccd8d754c934b2149e56da7f"; "Sch 1, 3, 6 and Sch 7 (items 1–28): 28 Aug 2009"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.402"; . a ; ; ; ; ; . . a ; ; "Obligation"; "Imposes an obligation"; "modalities::logic::deontic"; 1.0000; . a ; "29 Sept"@en; ; "5f76c0a3c5bfc30c02c8516728cf838109acb1bfec864ce9d8806f18ae5ad050"; "Schedule 1 and items 2–7 of Schedule 2 commence on 30 September 2009; Schedule 3 items 8–10 commence on 29 March 2010."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.402"; . a ; ; ; ; . . a ; ; "Applicable"; "Defines commencement dates for schedules"; "Sch 1: 1 July 2010 (s 2(1) item 2)"; "30 Sept 2009 and 29 Mar 2010"; "modalities::interval_reasoning"; 0.5000; . . a ; ; "Applicable"; "Defines commencement dates for schedules"; "Sch 1: 1 July 2010 (s 2(1) item 13)"; "30 Sept 2009 and 29 Mar 2010"; "modalities::temporal_ltl"; 0.5000; . . a ; ; "Applicable"; "Classifies commencement dates as undertakings"; "Sch 1: 1 July 2010 (s 2(1) item 2)"; "30 Sept 2009 and 29 Mar 2010"; "modalities::logic::deontic"; 0.5000; . . a ; ; "Applicable"; "Classifies commencement dates as undertakings"; "Sch 1: 1 July 2010 (s 2(1) item 13)"; "30 Sept 2009 and 29 Mar 2010"; "modalities::logic::deontic"; 0.5000; . a ; "1 Mar 2010"@en; ; "150a70c78e888c5f96ee6713175421f31ee34b6c537a0a7499e960001167f119"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.403"; . a ; ; ; ; . a ; "1 Mar 2010(s 2(1)"@en; ; "2137d58c2055e87d7a19dbca3717d75e41150b62f61b1831837761beca2ed70e"; "Therapeutic Goods Amendment (2009 Measures No. 3) Act"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.403"; . a ; ; ; ; . a ; "31 May"@en; ; "741088c4227a30e3df5c187b16727cad4c014a4bacbd255afaad3ee453ad9ac6"; "Schedule 1 commencement date"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.403"; . a ; ; ; ; ; . a ; "15 Dec"@en; ; "2e69ce6c6e405c1062d237c62f46a844d0463867a101a3799b207f03048c8dd0"; "Schedule and commencement dates"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.403"; . a ; ; ; ; . a ; "31 May 2011 (s 2(1)"@en; ; "b134bca1dfe1a72594fc21689d678194c2634011948ceaf322724a5fc5c22a01"; "Reference to Statute Law Revision Act 2011"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.403"; . a ; ; ; ; . a ; "22 Mar"@en; ; "f4ca0c28543a1172ee2c236abd82c1178bbcd7dbab4a787fa4082a04b0408889"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.403"; . a ; ; ; ; . a ; "19 Apr 2011 (s 2(1)"@en; ; "47da2a36358ce4c9ce2484de10d24d83d6e87a30a00f5325f393dc87a6a86b49"; "Acts Interpretation Amendment Act 2011"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.403"; . a ; ; ; ; ; . a ; "27 June"@en; ; "778f389d3f40238654bba5ea17d3420103104964be82a155b1d762fae4f5906f"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.403"; . a ; ; ; ; . a ; "27 Dec 2011"@en; ; "1472eaad7a7a19022c9593bc9a90b6ca408d01931324f902941e01db9bce60d5"; "Therapeutic Goods Amendment (2011 Measures No. 1) Act"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.403"; . a ; ; ; ; . a ; "25 July"@en; ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.403"; . a ; ; ; ; . a ; "26 July 2011 (s 2)"@en; ; "381653bb241c4bb17cee7b34ca537c385afef0929a80b2606fe51d7f69f174e1"; "Legislation history"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.403"; . a ; ; ; ; . a ; "22 Sept"@en; ; "61bc5a615180e1268a070237f14ae8532ea8389bb7a723220bce51b3265f13a6"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.404"; . a ; ; ; ; . a ; "22 Sept 2012"@en; ; "b738660ee8c3fc7756ebf2acd8192856b30d3cef665e43a5e5c849a5377b70a6"; "Personal Liability for Corporate Fault Reform Act 2012"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.404"; . a ; ; ; ; ; . a ; "10 Dec"@en; ; "716280d294f17c54cfc58d4733d2fbde4fcc18e20a4eefb912f781c008826a88"; "Commencement of Sch 5 and Sch 7"; ; 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0.5000; . . a ; ; "Applicable"; "Provides information about amendments"; "Sch 5 (item 98) and Sch 6 (items 15–19): 12 Mar 2014 (s 2(1) items 3, 19)"; "Sch 6 (item 1): 12 Dec 2012 (s 2(1) item 16)"; "modalities::epistemic"; 0.5000; . . a ; ; "Applicable"; "None applicable"; "Sch 5 (item 98) and Sch 6 (items 15–19): 12 Mar 2014 (s 2(1) items 3, 19)"; "Sch 6 (item 1): 12 Dec 2012 (s 2(1) item 16)"; "modalities::paraconsistent"; 0.5000; . a ; "28 Feb"@en; ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.404"; . a ; ; ; ; . a ; "28 Feb 2014"@en; ; "8ed12b1855934827cfc150bab07ffe249d2ecead94e2ecdef857bd056b7a80f7"; "List of schedules and items for the Statute Law Revision Act (No. 1) 2014"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.404"; . a ; ; ; ; . a ; "27 May"@en; ; "6cf4fa9313594d50dcee631a7f94cbb49aba93152ee66a31ad3412e234bb68ca"; "May"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.404"; . a ; ; ; ; ; . a ; "24 June 2014"@en; ; "2d2874f9bf18b97c25012af488a2636806085286308a6f47aeab080674f2dfb0"; "Legislation history"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.404"; . a ; ; ; ; . a ; "30 June"@en; ; "d0dba89cc78eb82d5cab336835970860e79fa2adc1aa5ad1a8e611d36143eeaf"; "Amendment of Schedule 14 by Public Governance and Resources Legislation Amendment Act (No. 1) 2015"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.405"; . a ; ; ; ; . a ; "13 Apr"@en; ; "98b72dbeb476fb32107a2bae25e29fa6d391f1e5214baaa2573051bdf52467f3"; "References Schedule 2 (item 7) and Schedule 7"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.405"; . a ; ; ; ; . a ; "14 Apr 2015 (s 2)"@en; ; "bdd8316f695a83454d5dc0aed8b1c31944f0835bf7056efbf40e778a9ec0f390"; "Amendment of Schedule 7 by Acts and Instruments (Framework Reform) (Consequential Provisions) Act 126, 2015"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.405"; . a ; ; ; ; . a ; "10 Sept"@en; ; "50622982752161d0db92e96efd55237ba10163a3854e65284fa320ec29bef920"; "Consequential Provisions"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.405"; . a ; ; ; ; ; . a ; "10 Sept"@en; ; "cfd558da173d18e06d6bdb542e825cd9aaf97735d764808148e1355902716fb7"; "Statute Law Revision Act (No. 1) 2015"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.405"; . a ; ; ; ; . a ; "25 Feb"@en; ; "8b46cf4f901a3e395a81d220dafc99a64d4accd923252253d046b35aea34706e"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.405"; . a ; ; ; ; . a ; "25 Mar 2015 (s 2(1)"@en; ; "c760be9ff2c55e8f9786139657a44472525ee01f0de18a4190e7e71b7fe883df"; "Endnote 3—Legislation history"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.405"; . a ; ; ; ; ; . a ; "20 May"@en; ; "64a72754973a7ae2d91d316dc01432da18fc8b3d9d147a9810069048a0a6a04d"; "Mandatory amendment of Australian Border Force Amendment (Protected Information) Act 2017"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.406"; . a ; ; ; ; ; . . a ; ; "MUST AMEND"; "Mandatory amendment"; "modalities::logic::deontic"; 1.0000; . a ; "30 Oct"@en; ; "afc0c816c6bb280d0681c222c471a4266740685047f4d3ff2c3d55f1fae078bd"; "Prohibition on certain acts"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.406"; . a ; ; ; ; ; . . a ; ; "forbid"; "Prohibits the specified act"; "modalities::logic::deontic"; 1.0000; . a ; "10 Sept"@en; ; "0bbe29eae64e4fcc40f2133bf3b6e7e1ed11ca5be43391b868a79a8b5b641202"; "Statute Law Revision Act (No. 1) 2016"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.406"; . a ; ; ; ; . a ; "11 Feb"@en; ; "88eecf8216e921a4784250862fdb9de31aec3b8e8e0990c416785b035aae9e92"; "Narcotic Drugs Amendment Act 2016"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.406"; . a ; ; ; ; ; . a ; "29 Feb"@en; ; "15b902885feb528abb6399a9d10628b8639a08851450fc7aade22ca9d47b1413"; "Conditional commencement of Narcotic Drugs Legislation Amendment Act 2016"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.406"; . a ; ; ; ; . a ; "23 Nov"@en; ; "b66b061937a9ededc9c9043c655a536e3b0a4daa4fc224a0f707ed03e128788d"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.406"; . a ; ; ; ; . a ; "23 Nov 2016 (s 2(1)"@en; ; "02d96bea6d96f1a8fdf39369e0e795a5dba362a10ce5928d5d82fa7415084fcb"; "Therapeutic Goods Amendment (2016 Measures No. 1) Act"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.406"; . a ; ; ; ; ; . a ; "19 June"@en; ; "a2bf4e4d704230db0bdbf0c76e7a31b8ecf1a98670a4b0835471889220632f25"; "Conditional commencement of certain schedules"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.406"; . a ; ; ; ; . a ; "20 June 2017 (s 2(1)"@en; ; "7d60ba60a69a2a4ebcf0a5bb2d6d3412d7b363c14694359e55e6f4685b4eef06"; "List of items included in certain schedules"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.406"; . a ; ; ; ; ; . a ; "5 Mar 2018"@en; ; "8f13c30d4ecaff0487397aa63c0f6a5ff972237fdd77dfeaeae8b7494f85fd76"; "Conditional commencement of certain sections"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.407"; . a ; ; ; ; . a ; "1 July 2020 (s 2(1)"@en; ; "055b90c380dc9008d220c71363fe46a2cc4f8796c6e81c56b2c368a0fd72182e"; "Therapeutic Goods Amendment (2018 Measures No. 1) Act"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.407"; . a ; ; ; ; . a ; "21 Sept"@en; ; "889dc4a059e78b1be82807f9e5428f5de5b8aeb4cf6d00dd39224cb85f5a9c66"; "Schedule definitions and commencement dates"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.407"; . a ; ; ; ; . a ; "12 Dec"@en; ; "e2deb2017d3899302b03401bb4cf698ce57504285bd95c46cf811677324e9fdb"; "Conditional commencement of the Therapeutic Goods Amendment (2020 Measures No. 1) Act"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.407"; . a ; ; ; ; . a ; "25 June"@en; ; "6b1f58c8c4c221013d6ead880bb51fc616830cda10ecd4a6e70e58c854fddc85"; "Sch 1 (items 1–18): 25 Aug 2020 (s 2(1) item 2)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.407"; . a ; ; ; ; . a ; "15 Dec"@en; ; "57c067d5e440b34720104399d25263a1b1e77f2e0f99958b734cf6b1d78c1a67"; "Sch 1 (items 57–73): 16 Dec 2020 (s 2(1) item 2)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.407"; . a ; ; ; ; ; . a ; "19 Feb"@en; ; "bbb257a5d6616dc5b2c3f9bdc6107a1c41d9ef1984407e456062f50ae2ce4616"; "Conditional commencement"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.408"; . a ; ; ; ; . a ; "1 Mar 2021"@en; ; "6ce838907b72c4ec2166ac68b8643ac32aedcc8dc4be6a7e9ca0eed5d9f219a5"; "Therapeutic Goods Amendment (2022 Measures No. 1) Act 2023 commencement and application details."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.408"; . a ; ; ; ; . a ; "21 Mar"@en; ; "044c857923b90408c5e09a109ee296eaff16ca25d487727095d920c1a706dbf7"; "Schedule 1: 21 March 2025 (s2(1) item 2)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.408"; . a ; ; ; ; ; . a ; "31 May"@en; ; "c8e0d345d0561b2a5c7eb339506e5af2bf1445afd1abb9dd85e78d811f5bb221"; "Granting permission for therapeutic goods and other legislation amendment"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.409"; . a ; ; ; ; ; . . a ; ; "PERM"; "Permission granted"; "modalities::logic::deontic"; 1.0000; . a ; "27 June"@en; ; "10b25dcf26309635709802e588ae130dfd131d5190961c7afb5fbe3af9a8398e"; "Conditional commencement of certain sections"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.409"; . a ; ; ; ; . . a ; ; "Applicable"; "Defines temporal intervals for commencement"; "1 July 2024 (s2(1) items 2-2C)"; "commences on July 1, 2024"; "modalities::temporal_ltl"; 0.5000; . a ; "4 Sept"@en; ; "bed59666f88c19adbb137c7808358762b224a3af16eca1904a5cdb824cf0764d"; "Amendment history for Therapeutic Goods Act 1989"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.409"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "affectedBy"; "Provision affected"; "modalities::logic::deontic"; 1.0000; .