a ; "C2025C00525VOL01"; ; "Therapeutic Goods Act 1989"@en; "AU"; "No. 21 of 1990"; "5 September 2025"; ; ; . a ; "5 September 2025"@en; ; "ac58f4b00e4a79b9c0f4fb8614645f192b3df3b7a2965fd86f5422dd18071ee5"; "Compilation information and notes on amendments."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.1"; . a ; ; ; ; . . a ; ; "="; "Identifies the compilation date."; "Compilation date: 05/09/2025"; "The compilation date is 05/09/2025."; "modalities::dl"; 1.0000; . a ; "1 Short title"@en; ; "7be442b62851adeef219c9d693b9584a142701966b7dcd45b8b6cd46e5168d41"; "Citation of the Act"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.17"; . a ; ; ; ; . a ; "2 Commencement"@en; ; "16b31689a5796009e0114137dc64e2f5d5ac545196ee77f04ceb4306cc95c3b1"; "Commencement conditions"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.17"; . a ; ; ; ; . a ; "3 Interpretation"@en; ; , , , , , , , , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.17". a ; "3(1) Interpretation"@en; ; "f01827ecb9c8f5dd9f3b64d1ff91d36608bc3aecd70e7a90dfa5fb89f7bf2701"; ; "Accessory means a thing specifically intended to be used with the device. Defines terms used in the Act State or Territory must issue search warrants. Definition of 'private hospital' Goods that have a tradition of use as foods for humans in the form in which they are presented, or goods covered by a determination under subsection 7AA(1) or (2), must be used, advertised, or presented for supply in the way specified in the determination."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.17"; . a ; ; ; ; ; . . a ; ; "Obligate"; "Accessory means a thing specifically intended to be used with the device."; "modalities::logic::deontic"; 1.0000; . . a ; ; "="; "Classifies 'accessory'"; "Accessory means a thing that the manufacturer of the thing specifically intended to be used together with the device."; "Accessory is an obligation."; "modalities::dl"; 1.0000; . . a ; ; "="; "Classifies terms into categories"; "The term 'customs officer' is defined as an officer of Customs within the meaning of the Customs Act 1901."; "Customs officer means an officer of Customs within the meaning of the Customs Act 1901."; "modalities::dl"; 0.5000; . . a ; ; "="; "Classifies terms into categories"; "The term 'data processing device' is defined as any article or material from which information is capable of being reproduced with or without the aid of any other article or device."; "Data processing device means any article or material (for example, a disc) from which information is capable of being reproduced with or without the aid of any other article or device."; "modalities::dl"; 0.5000; . . a ; ; "="; "Classifies terms into categories"; "The term 'default standard' is defined as any of the following: (a) a standard referred to in paragraph (b) of the definition of standard in this subsection; (b) a standard referred to in paragraph (c) of that definition; (c) a standard referred to in paragraph (d) of that definition."; "Default standard means any of the following: (a) a standard referred to in paragraph (b) of the definition of standard in this subsection; (b) a standard referred to in paragraph (c) of that definition; (c) a standard referred to in paragraph (d) of that definition."; "modalities::dl"; 0.5000; . . a ; ; "="; "Classifies terms into categories"; "The term 'directions for use' is defined as information on: (a) appropriate doses of the goods; and (b) the method of administration or use of the goods; and (c) the frequency and duration of treatment for each indication of the goods; and (d) the use of the goods by persons of particular ages or by persons having particular medical conditions."; "Directions for use, in relation to therapeutic goods, includes information on: (a) appropriate doses of the goods; and (b) the method of administration or use of the goods; and (c) the frequency and duration of treatment for each indication of the goods; and (d) the use of the goods by persons of particular ages or by persons having particular medical conditions."; "modalities::dl"; 0.5000; . . a ; ; "="; "Classifies terms into categories"; "The term 'export only biological' is defined as a biological that is: (a) manufactured in Australia for export only; or (b) imported into Australia for export only."; "Export only biological means a biological that is: (a) manufactured in Australia for export only; or (b) imported into Australia for export only."; "modalities::dl"; 0.5000; . . a ; ; "="; "Classifies terms into categories"; "The term 'export only medicine' is defined as a medicine that: (a) is manufactured in Australia for export only, or imported into Australia for export only; and (b) is listable goods only because it is so manufactured or imported (and not for any other reason)."; "Export only medicine means a medicine that: (a) is manufactured in Australia for export only, or imported into Australia for export only; and (b) is listable goods only because it is so manufactured or imported (and not for any other reason)."; "modalities::dl"; 0.5000; . . a ; ; "MUST"; "Must provide"; "State or Territory must issue search warrants."; "modalities::logic::deontic"; 1.0000; . . a ; ; "label"; "Labeling requirements"; "label, in relation to therapeutic goods, means a display of printed information:"; "modalities::dl"; 1.0000; . . a ; ; "="; "Class hierarchy for therapeutic goods"; "therapeutic goods are goods that are represented in any way to be, or that are, whether because of the way in which the goods are presented or for any other reason, likely to be taken to be..."; "product information, in relation to therapeutic goods, means information relating to the safe and effective use of the goods"; "modalities::dl"; 0.5000; . . a ; ; "="; "Class hierarchy for reportable medical device"; "reportable medical device means a medical device of a kind prescribed by regulations made for the purposes of this definition"; "reportable medicine has the meaning given by section 30EH"; "modalities::dl"; 0.5000; . . a ; ; "="; "Class hierarchy for reportable medicine"; "restricted medicine means: (a) a medicine specified in an instrument under subsection (2A); or (b) a medicine included in a class of medicine specified in an instrument under subsection (2B)"; "reportable medicine has the meaning given by section 30EH"; "modalities::dl"; 0.5000; . . a ; ; "="; "Class hierarchy for therapeutic goods"; "therapeutic goods means goods: (a) that are represented in any way to be, or that are, whether because of the way in which the goods are presented or for any other reason, likely to be taken to be..."; "biologicals, medical devices and goods declared to be therapeutic goods under an order in force under section 7 but do not include..."; "modalities::dl"; 0.5000; . a ; "3(2) Interpretation"@en; ; "1850d309205a511e2bd290a222ad83aa8a24359a60007e63d6b21e1a31d32eda"; ; "Therapeutic goods are taken to be for use in humans if they are not solely for use in animals."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.17"; . a ; ; ; ; ; . . a ; ; "if"; "Conditional obligation"; "(2) For the purposes of this Act, therapeutic goods are taken to be for use in humans if they are not solely for use in animals."; "Therapeutic goods are taken to be for use in humans if they are not solely for use in animals."; "modalities::logic::deontic"; 1.0000; . . a ; ; "during"; "Temporal relation between definitions"; "(2) For the purposes of this Act, therapeutic goods are taken to be for use in humans if they are not solely for use in animals."; "Therapeutic goods are taken to be for use in humans during the period when they are not solely for use in animals."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "during"; "Temporal relation between definitions"; "(2) For the purposes of this Act, therapeutic goods are taken to be for use in humans if they are not solely for use in animals."; "Therapeutic goods are taken to be for use in humans during the period when they are not solely for use in animals."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "if"; "Conditional obligation with diffusion"; "(2) For the purposes of this Act, therapeutic goods are taken to be for use in humans if they are not solely for use in animals."; "Therapeutic goods are taken to be for use in humans if they are not solely for use in animals."; "modalities::diffusion"; 1.0000; . . a ; ; "if"; "Conditional obligation with CogAI"; "(2) For the purposes of this Act, therapeutic goods are taken to be for use in humans if they are not solely for use in animals."; "Therapeutic goods are taken to be for use in humans if they are not solely for use in animals."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "3(2A) Interpretation"@en; ; "dcef1eaca35798482c2f3a3ff76c4e144e2f43b41c45292a45b84c5567e074b3"; ; "Specify medicines for restricted medicine purposes"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.17"; . a ; ; ; ; ; . . a ; ; "May"; "Permission to specify medicines"; "modalities::logic::deontic"; 1.0000; . a ; "3(2B) Interpretation"@en; ; "750ebaff9559b0e7eb87f8ba0926c251b35d450a108d02f212658c9bc814b0e3"; ; "Specify classes of medicine for restricted medicine purposes"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.17"; . a ; ; ; ; ; . . a ; ; "May"; "Permission to specify classes of medicine"; "modalities::logic::deontic"; 1.0000; . a ; "3(4) Interpretation"@en; ; "da2ac2a15c03fc9eaf595c69d7f54ad3af1ee3395823541aa3183582a6f00d39"; ; "Provisions of this Act are in addition to, and not in substitution for, the provisions of any other Act that relate to therapeutic goods."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.17"; . a ; ; ; ; "borne by: State"; ; . a ; "3(5) Interpretation"@en; ; "8f5ef4ffcf78372c7ffab9926afb5106f4af2072d9972353c2b2d2dfc6236662"; ; "Presentation of therapeutic goods is unacceptable if it is capable of being misleading or confusing."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.17"; . a ; ; ; ; ; . . a ; ; "Prohibit"; "Prohibits the presentation of therapeutic goods that is misleading or confusing."; "(5) For the purposes of this Act, the presentation of therapeutic goods is unacceptable if it is capable of being misleading or confusing as to the content or proper use or identification of the goods and"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Classify"; "Classifies presentation of therapeutic goods as unacceptable if it is misleading or confusing."; "(5) For the purposes of this Act, the presentation of therapeutic goods is unacceptable if it is capable of being misleading or confusing as to the content or proper use or identification of the goods and"; "modalities::dl"; 1.0000; . . a ; ; "Temporal Interval"; "Defines a temporal interval for when presentation of therapeutic goods is unacceptable."; "(5) For the purposes of this Act, the presentation of therapeutic goods is unacceptable if it is capable of being misleading or confusing as to the content or proper use or identification of the goods and"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Recurring Trace"; "Defines a recurring trace for when presentation of therapeutic goods is unacceptable."; "(5) For the purposes of this Act, the presentation of therapeutic goods is unacceptable if it is capable of being misleading or confusing as to the content or proper use or identification of the goods and"; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Diffuse"; "Diffuses the prohibition on presentation of therapeutic goods that is misleading or confusing."; "(5) For the purposes of this Act, the presentation of therapeutic goods is unacceptable if it is capable of being misleading or confusing as to the content or proper use or identification of the goods and"; "modalities::diffusion"; 1.0000; . . a ; ; "Recognize"; "Recognizes the presentation of therapeutic goods that is misleading or confusing."; "(5) For the purposes of this Act, the presentation of therapeutic goods is unacceptable if it is capable of being misleading or confusing as to the content or proper use or identification of the goods and"; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "3(5A) Interpretation"@en; ; "94d9ab255ae5ce528a847689c0708d021c095ad5722cdd66b18ad95b4c86ad4d"; ; "Specify advisory statements in relation to medicine"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.17"; . a ; ; ; ; ; . . a ; ; "May"; "Permission to specify advisory statements"; "modalities::logic::deontic"; 1.0000; . a ; "3(5B) Interpretation"@en; ; "a9f4871cbd50c0881fef88a837e22cffac63589fe9d1ef318487ff150c7e6fc9"; ; "Specify different advisory statements for medicines or classes of medicine."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.17"; . a ; ; ; ; ; . . a ; ; "May"; "Permission to specify advisory statements"; "modalities::logic::deontic"; 1.0000; . a ; "3(6) Interpretation"@en; ; "945be2371ee49e84657d83b2b4d293f510054509f82023466561e2a3d00f9e12"; ; "References charges under Therapeutic Goods (Charges) Act 1989."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.17"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "="; "Definition of charge reference"; "Annual charges under Therapeutic Goods (Charges) Act 1989"; "Charge reference defined as such a charge imposed under the Act"; "modalities::logic::deontic"; 1.0000; . a ; "3(7) Interpretation"@en; ; "1506cb92deedf30c0a5143deb9bf5143c6496ae4898956b843354da7dea6d5ba"; ; "References an offence against this Act to related offences under other laws."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.17"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "="; "Classifies the subject of the reference"; "A reference to an offence against this Act includes a reference to..."; "an offence against section 6 of the Crimes Act 1914, or section 11.1, 11.4 or 11.5 of the Criminal Code"; "modalities::dl"; 0.5000; . . a ; ; "="; "Classifies the subject of the reference"; "A reference to an offence against this Act includes a reference to..."; "an offence against section 136.1, 137.1 or 137.2 of the Criminal Code"; "modalities::dl"; 0.5000; . . a ; ; "="; "Classifies the subject of the reference"; "A reference to an offence against this Act includes a reference to..."; "an offence against the regulations"; "modalities::dl"; 0.5000; . a ; "3(7A) Interpretation"@en; ; "dad2a826af5c8026e8470e53d5e0e2cb7b4091c84d99773f2cffbe884f04f139"; ; "Imposes a duty on Commonwealth authorities if corresponding State law confers function or power and gives rise to obligation."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.17"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Imposes"; "States a duty"; "(7A) For the purposes of this Act, a corresponding State law imposes a duty..."; "modalities::logic::deontic"; 1.0000; . a ; "3(8) Interpretation"@en; ; "98247abf26c246b884444c5b0e286260062ae4cc252a403f190c49d8b71a0650"; ; "Clarifies interpretation of registered therapeutic goods and provisional registration."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.17"; . a ; ; ; ; . a ; "3AA Homoeopathic preparations and homoeopathic standards"@en; ; "3383fc12fd184a212b036669080fed02cfce6c85a65900defc3d341e2543595c"; , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.39". a ; "3AA(1) Homoeopathic preparations and homoeopathic standards"@en; ; "2468155ff462464456cf287e87a529abadb4b74097581bf842d27bf0784aea27"; ; "Definition of homoeopathic preparation and standard."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.39"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "="; "Defines a term with a clear obligation."; "(1) For the purposes of this Act, a homoeopathic preparation is a..."; "a homoeopathic standard"; "modalities::logic::deontic"; 1.0000; . . a ; ; "="; "Defines a temporal interval."; "(1) For the purposes of this Act, a homoeopathic preparation is a..."; "a preparation manufactured from a mother substance and in accordance with a manufacturing procedure described in a homoeopathic pharmacopoeia"; "modalities::interval_reasoning"; 0.5000; . . a ; ; "="; "Defines a temporal interval."; "(1) For the purposes of this Act, a homoeopathic preparation is a..."; "a preparation manufactured from a mother substance and in accordance with a manufacturing procedure described in a homoeopathic pharmacopoeia"; "modalities::temporal_ltl"; 0.5000; . . a ; ; "="; "Defines a concept that can be shared."; "(1) For the purposes of this Act, a homoeopathic preparation is a..."; "a preparation manufactured from a mother substance and in accordance with a manufacturing procedure described in a homoeopathic pharmacopoeia"; "modalities::diffusion"; 0.5000; . . a ; ; "="; "Defines a concept that can be processed by AI."; "(1) For the purposes of this Act, a homoeopathic preparation is a..."; "a preparation manufactured from a mother substance and in accordance with a manufacturing procedure described in a homoeopathic pharmacopoeia"; "sparql_library::parsers::chk_parser"; 0.5000; . a ; "3AA(2) Homoeopathic preparations and homoeopathic standards"@en; ; "2b9d0e85e9795e3f27d8f63accc0a2bae97cf91e0b9f1ab249e0afc5e8406a5f"; ; "A homoeopathic standard is constituted by the statements in monographs describing manufacturing procedures."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.39"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "constitutes"; "Establishes a homoeopathic standard"; "(a) and (b)"; "then there is a homoeopathic standard"; "modalities::logic::deontic"; 1.0000; . a ; "3AA(3) Homoeopathic preparations and homoeopathic standards"@en; ; "45cdd88808aaf87e773c2b61bbf8606d68baa57a49ccd04d75705b06b5f9cfbd"; ; "Specify publications and/or parts of publications for homoeopathic pharmacopoeia definition"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.39"; . a ; ; ; ; ; . . a ; ; "May"; "Specify"; "modalities::logic::deontic"; 1.0000; . a ; "3AA(4) Homoeopathic preparations and homoeopathic standards"@en; ; "2014ec9a7bfcb2462e110b40564dbfb491c94ec915f766889e78dde19832e831"; ; "Minister may exempt specified monographs from certain requirements."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.39"; . a ; ; ; ; ; . . a ; ; "May"; "Permission to exempt"; "modalities::logic::deontic"; 1.0000; . a ; "3AA(5) Homoeopathic preparations and homoeopathic standards"@en; ; "761a8e6221f0c333ce2ca7b34fe57eeb0581a8c6b8624b4cf596a6301cc70da0"; ; "The Minister may determine exemptions for specified statements in monographs."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.39"; . a ; ; ; ; ; . . a ; ; "may"; "Permission to exempt"; "modalities::logic::deontic"; 1.0000; . a ; "3AB Anthroposophic preparations and anthroposophic standards"@en; ; "616a5e4d58a92a1643addf2008857abdb58306c5f1b564f2a341b39416332003"; , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.41". a ; "3AB(1) Anthroposophic preparations and anthroposophic standards"@en; ; "7b6040a6c5dba2bb1c82b3197f924094eb594a49c653e6caf75d6aae8c10873a"; ; "Definition of anthroposophic preparation"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.41"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "="; "Definition of term"; "(1) For the purposes of this Act, an anthroposophic preparation is a..."; "anthroposophic standard"; "modalities::logic::deontic"; 1.0000; . . a ; ; "="; "Temporal relation definition"; "(1) For the purposes of this Act, an anthroposophic preparation is a..."; "anthroposophic standard"; "modalities::interval_reasoning"; 1.0000; . a ; "3AB(2) Anthroposophic preparations and anthroposophic standards"@en; ; "5a9112d0b2f7a6654668609dc0008051402f6ddf8efd41215c859b20db44b341"; ; "An anthroposophic standard is constituted by the statements in monographs describing manufacturing procedures."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.41"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "constitutes"; "Anthroposophic standard is constituted by statements in monographs"; "modalities::logic::deontic"; 1.0000; . a ; "3AB(3) Anthroposophic preparations and anthroposophic standards"@en; ; "c8f55ce7f31562fadef757bede35d126cee48cdecb9144d3820112f7583b2c8a"; ; "Specify publications and/or parts of publications for the definition of anthroposophic pharmacopoeia."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.41"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Specify"; "Specify publications and/or parts of publications."; "modalities::logic::deontic"; 1.0000; . a ; "3AB(4) Anthroposophic preparations and anthroposophic standards"@en; ; "0c1c8c1104378d5af8dd0a6af68a57438157bca869326cc6a4400e1033ce064e"; ; "Minister may exempt specified monographs from paragraph (2)(b) purposes."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.41"; . a ; ; ; ; ; . . a ; ; "may"; "Permission to exempt monographs"; "modalities::logic::deontic"; 1.0000; . a ; "3AB(5) Anthroposophic preparations and anthroposophic standards"@en; ; "6052f101770fb2722a70f542e40a860bff0ccafef0f96b61719e2084c2bbb84f"; ; "Minister may exempt specified statements from subsection (2)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.41"; . a ; ; ; ; ; . . a ; ; "may"; "Permission to exempt"; "modalities::logic::deontic"; 0.5000; . a ; "3A Declaration—member of European Community"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.42". a ; "3A(1) Declaration—member of European Community"@en; ; "47395a8dc65c38789bd40e2037d2a2a0e436311ad6f889fac323aed227e049b1"; ; "Declaration of membership in European Community or EFTA"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.42"; . a ; ; ; ; ; . . a ; ; "may"; "Declaration obligation"; "modalities::logic::deontic"; 1.0000; . a ; "3A(2) Declaration—member of European Community"@en; ; "ce8a07762001e7922592074630c962071f4bd9e1a5a1eef85c826579ffda2e73"; ; "Declaration must be published in Gazette or on Department's website."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.42"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must publish declaration"; "modalities::logic::deontic"; 1.0000; . a ; "3B Declaration—country covered by non-EC/EFTA MRA"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.42". a ; "3B(1) Declaration—country covered by non-EC/EFTA MRA"@en; ; "f8c2ec7d62fa2e3ce83fdd9b65d8538fce65f5b85ff17cb2123aabbe543dd042"; ; "Minister may declare a country covered by non-EC/EFTA MRA."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.42"; . a ; ; ; ; "borne by: State"; ; . a ; "3B(2) Declaration—country covered by non-EC/EFTA MRA"@en; ; "7d1abd80b36fc2a7f20ac273a9aa6cdbcf45f178c822e80bc1081e7f18cee3bd"; ; "Declaration must be published in Gazette or on Department's website."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.42"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Declaration is mandatory."; "modalities::logic::deontic"; 1.0000; . a ; "3C Exempting monographs in pharmacopoeias"@en; ; "76e928dcfd1bf39452eac3f6689a84a5d9ec084d04dde922c23dc544cc24e1a2"; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.43". a ; "3C(1) Exempting monographs in pharmacopoeias"@en; ; "b9ae919e1a3a4af94b7e6ee771f5d22d3b5bc57e2701f5beedc7cc7283e47b01"; ; "The Minister may determine exemptions for specified monographs in relation to therapeutic goods."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.43"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "May"; "Permission granted by the Minister."; "modalities::logic::deontic"; 1.0000; . a ; "3C(2) Exempting monographs in pharmacopoeias"@en; ; "36fd97ef13fb0d3e9067ce8b7e1794fc4339503eee8b5ce3db359249b345e987"; ; "Determination of exemptions for therapeutic goods"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.43"; . a ; ; ; ; ; . . a ; ; "may"; "Permission to determine exemptions"; "modalities::logic::deontic"; 1.0000; . a ; "3C(3) Exempting monographs in pharmacopoeias"@en; ; "702308b78f8723eecf04dca3e87d1cff57823311df60208c27656e04ecff70b6"; ; "Exempts monographs in pharmacopoeias from certain legislation"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.43"; . a ; ; ; ; . . a ; ; "Applicable"; "Requires temporal relation between instrument and writing"; "Temporal intervals mentioned"; "Undertaking"; "modalities::interval_reasoning"; 1.0000; . a ; "4 Objects of Act"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.43". a ; "4(1) Objects of Act"@en; ; "8fb5346a1b3cd40e4e1d64f4f29348d2d7cd955b442b6df21d1529f6da805aec"; ; "List therapeutic goods for national system of controls"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.43"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "shall"; "Imposes a duty on the State"; "modalities::logic::deontic"; 1.0000; . a ; "4(1A) Objects of Act"@en; ; "cc38919b75adb824f18af495257f7e66af429c0879d7343a08577a4f5bdf56be"; ; "Manufacturer's intent for medical devices"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.43"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "performance"; "Performance of devices as intended"; "(1A) The reference in paragraph (1)(a)"; "The efficacy of therapeutic goods is a reference to the performance of devices as the manufacturer intended."; "modalities::logic::deontic"; 0.5000; . a ; "4(2) Objects of Act"@en; ; "a50835daff620962963f1f4d961a7587b753102a3288bedcb988f54cc079cf30"; ; "Act does not exclude concurrent operation with other laws."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.43"; . a ; ; ; ; ; . . a ; ; "exclusion"; "Exclusion of concurrent operation"; "(2) This Act is therefore not intended to apply..."; "to the extent that the law is capable of operating concurrently with this Act."; "modalities::logic::deontic"; 1.0000; . . a ; ; "simultaneity"; "Simultaneous operation allowed"; "(2) This Act is therefore not intended to apply..."; "to the extent that the law is capable of operating concurrently with this Act."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "trace"; "Tracing concurrent operation"; "(2) This Act is therefore not intended to apply..."; "to the exclusion of a law of a State, of the Australian Capital Territory or of the Northern Territory."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "diffusion"; "Diffusing concurrent operation"; "(2) This Act is therefore not intended to apply..."; "to the extent that the law is capable of operating concurrently with this Act."; "modalities::diffusion"; 1.0000; . . a ; ; "cognitive framework"; "Cognitive framework for concurrent operation"; "(2) This Act is therefore not intended to apply..."; "to the exclusion of a law of a State, of the Australian Capital Territory or of the Northern Territory."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "5 Act to bind Crown"@en; ; "8468cb9f88c3ac4e007082b53259900c7146fff27b7ba4143822c6f7b069a4a0"; "The Crown is bound by this Act."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.44"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Binding"; "The Crown is obligated to comply with the Act."; "modalities::logic::deontic"; 1.0000; . a ; "5A Application of the Criminal Code—extended geographical"@en; ; "c04b54bc7dade6d16eea6a2d4ae8a04f4c86922cb5b9386d2f9674c96b96e24e"; "Jurisdiction applies to specific offences"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.45"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "applies"; "Jurisdiction is applied"; "Section 15.2 of the Criminal Code"; "to offences against specified subsections"; "modalities::logic::deontic"; 1.0000; . a ; "6 Operation of Act"@en; ; "952e8645f555289bf5258c873872be3a8c92384012e309f79c40542ee5d3de15"; "Applicable to corporations and natural persons/corporations in certain trade/commerce contexts."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.45"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "appliesTo"; "Applicable to corporations and natural persons/corporations."; "(1) This Act (other than Part 4-8A or Part 6-1A)"; "modalities::logic::deontic"; 1.0000; . . a ; ; "appliesTo"; "Applicable to corporations and natural persons/corporations."; "(a) things done by corporations; (b) things done by natural persons or corporations in so far as those things are done:"; "modalities::logic::deontic"; 1.0000; . . a ; ; "appliesTo"; "Applicable to trade/commerce between Australia and a place outside Australia, among the States, between a State and a Territory or between 2 Territories."; "(i) in the course of, or in preparation for, trade or commerce between Australia and a place outside Australia, among the States, between a State and a Territory or between 2 Territories;"; "modalities::logic::deontic"; 1.0000; . a ; "6B Review of certain decisions under State laws"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.50". a ; "6B(1) Review of certain decisions under State laws"@en; ; "718bc1f991af17014aaf3fc89bb49ab2b139d5c057fdb1c85b5ef5a58ddf5ba4"; ; "Application for review of a State decision may be made."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.50"; . a ; ; ; ; ; . a ; "6B(2) Review of certain decisions under State laws"@en; ; "860d4eb148e8b26fe9b92c965f9bb1d645a769e6e3f1924b6262c6ef54df285e"; ; "A decision made by the Secretary is reviewable if it meets certain conditions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.50"; . a ; ; ; ; "borne by: State"; ; . a ; "6B(3) Review of certain decisions under State laws"@en; ; "309f536be3a43d55e5a766e013e8ed4fe252116d00a67b42ca1e75ec777f63bf"; ; "Administrative Review Tribunal Act 2024 has effect as if a corresponding State law were an Act."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.50"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "hasEffectAsIf"; "Legal effect of the Administrative Review Tribunal Act 2024 on State laws."; "State law"; "Administrative Review Tribunal Act 2024 has effect as if a corresponding State law were an Act."; "modalities::logic::deontic"; 1.0000; . . a ; ; "during"; "The Administrative Review Tribunal Act 2024 has effect during the period of a corresponding State law."; "State law"; "Administrative Review Tribunal Act 2024"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "during"; "The Administrative Review Tribunal Act 2024 has effect during the period of a corresponding State law."; "State law"; "Administrative Review Tribunal Act 2024"; "modalities::temporal_ltl"; 1.0000; . . a ; ; "hasEffectAsIf"; "The Administrative Review Tribunal Act 2024 has effect as if a corresponding State law were an Act."; "State law"; "Administrative Review Tribunal Act 2024"; "sparql_library::parsers::chk_parser"; 1.0000; . . a ; ; "hasEffectAsIf"; "The Administrative Review Tribunal Act 2024 has effect as if a corresponding State law were an Act."; "State law"; "Administrative Review Tribunal Act 2024"; "modalities::logic::shacl"; 1.0000; . a ; "6C Fees payable to Commonwealth under State laws"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.51". a ; "6C(1) Fees payable to Commonwealth under State laws"@en; ; "3f6c303772fb336c3c8ce85f73889c8132af069820bd5c6b8317af583fe1aee0"; ; "Fees payable to Commonwealth under State laws"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.51"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Imposes an obligation on States to pay fees to the Commonwealth"; "modalities::logic::deontic"; 1.0000; . a ; "6C(2) Fees payable to Commonwealth under State laws"@en; ; "423a26e76b991ef6deddf868d261030592fb1649e92b8db414a6449db8a0e1b7"; ; "Arrangements for Commonwealth fees under State laws"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.51"; . a ; ; ; ; . a ; "7 Declaration that goods are/are not therapeutic goods"@en; ; , , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.51". a ; "7(1) Declaration that goods are/are not therapeutic goods"@en; ; "4324705dc4e7c5a718d167072d3d60adbb7ef8ee95d157c2f31ac28bf4d6713d"; ; "The Secretary may make an order declaring classes of goods are or are not therapeutic goods. Minister may determine goods are therapeutic for Act purposes"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.51"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "May"; "The Secretary may make an order"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Temporal interval"; "The Secretary may make an order at any time"; "(1) Where the Secretary is satisfied that classes of goods:"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "may"; "Obligation to determine goods"; "modalities::logic::deontic"; 0.5000; . a ; "7(1A) Declaration that goods are/are not therapeutic goods"@en; ; "cdb9890940f4dc43b544369957516ad17c9920ec90a4914b3e81d6e4f57f750a"; ; "Secretary must disregard certain paragraphs when deciding if goods are therapeutic."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.51"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Must Disregard"; "Secretary must disregard certain paragraphs."; "(1A) In deciding..."; "...must disregard paragraphs (e) and (f)"; "modalities::logic::deontic"; 1.0000; . a ; "7(4) Declaration that goods are/are not therapeutic goods"@en; ; "7730eebf64333862e58a47abbe913dedb4d18fa268e00cd1de9fc5c47f70238b"; ; "Goods are not therapeutic goods if declaration applies wholly or partly to goods that would be medical devices."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.51"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Implies"; "Declaration applies implies goods are not therapeutic goods."; "Declaration applies wholly or partly to goods that would be medical devices."; "Goods are not therapeutic goods."; "modalities::logic::deontic"; 1.0000; . . a ; ; "During"; "Declaration applies during use, advertisement, or presentation for supply."; "Declaration applies wholly or partly to goods that would be medical devices."; "Goods are not therapeutic goods during use, advertisement, or presentation for supply."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Recurring"; "Declaration is recurring in its application to goods."; "Declaration applies wholly or partly to goods that would be medical devices."; "Goods are not therapeutic goods due to recurring declaration."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Implication"; "Declaration implies diffusion of goods being non-therapeutic goods."; "Declaration applies wholly or partly to goods that would be medical devices."; "Goods are diffused as non-therapeutic goods."; "modalities::diffusion"; 1.0000; . . a ; ; "Classification"; "Declaration classifies goods using AI."; "Declaration is a declaration that classes of goods are not therapeutic goods."; "Goods are classified as non-therapeutic goods by AI."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "7(1) Declaration that goods are/are not therapeutic goods"@en; ; "fd4a32a34ab6f321a245aa001a105c48c97ea0e716254fc1cdeb5f406d8ebff1"; ; "The Secretary may make an order declaring classes of goods are or are not therapeutic goods. Minister may determine goods are therapeutic for Act purposes"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.51"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "May"; "The Secretary may make an order"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Temporal interval"; "The Secretary may make an order at any time"; "(1) Where the Secretary is satisfied that classes of goods:"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "may"; "Obligation to determine goods"; "modalities::logic::deontic"; 0.5000; . a ; "7(2) Declaration that goods are/are not therapeutic goods"@en; ; "d55875c47c7dfb66a280e6f67a99f8c270f3ea486b7af25b42ef854c74e8bfc0"; ; "Goods are not therapeutic goods under certain conditions. Minister must consider certain matters before making a determination about regulating goods."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.51"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "not"; "Negative assertion of a property"; "(2) (excluded goods)"; "(a) are not therapeutic goods; or (b) when used, advertised, or presented for supply in a particular way, are not therapeutic goods."; "modalities::logic::deontic"; 0.5000; . . a ; ; "before"; "Temporal relationship between conditions"; "(2)"; "when used, advertised, or presented for supply in a particular way"; "modalities::interval_reasoning"; 0.5000; . . a ; ; "MUST"; "Minister must consider certain matters."; "(2) Before making a determination under subsection (1), the Minister:"; "modalities::logic::deontic"; 1.0000; . a ; "7(2) Declaration that goods are/are not therapeutic goods"@en; ; "2fc439d34c27e4c639531f6ed6e4489d5cb149aae973396bb8f7ef9d2e563fb3"; ; "Goods are not therapeutic goods under certain conditions. Minister must consider certain matters before making a determination about regulating goods."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.51"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "not"; "Negative assertion of a property"; "(2) (excluded goods)"; "(a) are not therapeutic goods; or (b) when used, advertised, or presented for supply in a particular way, are not therapeutic goods."; "modalities::logic::deontic"; 0.5000; . . a ; ; "before"; "Temporal relationship between conditions"; "(2)"; "when used, advertised, or presented for supply in a particular way"; "modalities::interval_reasoning"; 0.5000; . . a ; ; "MUST"; "Minister must consider certain matters."; "(2) Before making a determination under subsection (1), the Minister:"; "modalities::logic::deontic"; 1.0000; . a ; "7AA Excluded goods"@en; ; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.52". a ; "7AA(1) Excluded goods"@en; ; "14873a5a6633e32a373575110392d748f1d7eb7f7f55b3953574c6123d640d4a"; ; "The Minister may determine that specified goods are excluded goods."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.52"; . a ; ; ; ; ; . . a ; ; "may"; "Permission to exclude goods"; "modalities::logic::deontic"; 1.0000; . a ; "7AA(2) Excluded goods"@en; ; "7a7c846511c26385796b7c1e46494d7fdb45d5d2a5273181012f29bf1fc3f25e"; ; "Determination of excluded goods"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.52"; . a ; ; ; ; ; . . a ; ; "may"; "Permission to determine excluded goods"; "modalities::logic::deontic"; 1.0000; . a ; "7AA(3) Excluded goods"@en; ; "1e2a3f1ee50aff9948ee58e7b766037eced0ab1f2d821d9928ab897b70098d47"; ; "Minister must consider certain matters before making a determination under this section."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.52"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Minister must consider certain matters."; "(3) Before making a determination under this section, the Minister..."; "modalities::logic::deontic"; 1.0000; . a ; "7AA(4) Excluded goods"@en; ; "b5dcc2727e2b5c9e50188db4654abbd32feeb22b3b25b933e1d0774b24fba80e"; ; "Consideration of relevant matters by the Minister"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.52"; . a ; ; ; ; ; . . a ; ; "may"; "Permission to consider other matters"; "The Minister may have regard to..."; "Consideration of relevant matters by the Minister"; "modalities::logic::deontic"; 1.0000; . . a ; ; "during"; "Temporal relation between consideration and action"; "The Minister may have regard to any other matter he or she considers relevant."; "Consideration of relevant matters by the Minister"; "modalities::interval_reasoning"; 0.5000; . . a ; ; "may"; "Relevance consideration in decision-making"; "The Minister may have regard to any other matter he or she considers relevant."; "Consideration of relevant matters by the Minister"; "modalities::argumentation"; 0.5000; . . a ; ; "may"; "Relevance consideration in decision-making"; "The Minister may have regard to any other matter he or she considers relevant."; "Consideration of relevant matters by the Minister"; "modalities::diffusion"; 0.5000; . . a ; ; "may"; "Relevance consideration in decision-making"; "The Minister may have regard to any other matter he or she considers relevant."; "Consideration of relevant matters by the Minister"; "sparql_library::parsers::chk_parser"; 0.5000; . a ; "7A Authorised persons"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.53". a ; "7A(1) Authorised persons"@en; ; "ab3004bad75e7760ecd72f8356f324b455d3bf2f42508b259ea7ba9d2b53025d"; ; "Authorises Secretary to authorise persons to exercise powers under specified provisions of the Act."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.53"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "authorise"; "Authorisation is granted."; "Secretary may authorise persons to exercise powers under specified provisions of the Act."; "Persons are authorised to exercise powers."; "modalities::logic::deontic"; 1.0000; . . a ; ; "during"; "The authority is granted during the term of the Secretary's office."; "Authority is granted by the Secretary."; "Authority is granted during the term of the Secretary's office."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "entails"; "The authority implies that the person exercising powers has a specified role."; "Person exercising powers has a specified role."; "Authority implies that the person exercising powers has a specified role."; "modalities::argumentation"; 1.0000; . . a ; ; "implies"; "The authority implies that the Secretary's office is responsible for enforcing health matters or law enforcement matters."; "Secretary's office is responsible for enforcing health matters or law enforcement matters."; "Authority implies that the Secretary's office is responsible for enforcing health matters or law enforcement matters."; "modalities::diffusion"; 1.0000; . . a ; ; "implies"; "The authority implies that the person exercising powers has a specified function."; "Person exercising powers has a specified function."; "Authority implies that the person exercising powers has a specified function."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "7A(2) Authorised persons"@en; ; "cc0b5b63c93670398039fcce9d1e5a093611d00cc5c93c393a43a8d866290828"; ; "Authorised person must comply with directions of the Secretary."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.53"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "MUST"; "Must comply"; "Authorised person has power under a provision of this Act."; "Comply with directions of the Secretary."; "modalities::logic::deontic"; 1.0000; . . a ; ; "CONTAINS"; "Temporal relation between directions and actions"; "Directions are given at some point in time."; "Action must occur after directions are given."; "modalities::interval_reasoning"; 1.0000; . a ; "7B Kits"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.54". a ; "7B(1) Kits"@en; ; "12e211e70bf98de0afac83d5d9a89708dfc4d62a1f861c4d92d74cd641d050ae"; ; "A package and its goods constitute a kit if they meet certain conditions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.54"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "must-be"; "Kit definition"; "modalities::logic::deontic"; 0.5000; . a ; "7B(2) Kits"@en; ; "49b98032f4e01978b1c65670c243c3c8d85d5114d13553f0dd0927102755f18a"; ; "Therapeutic goods must be combined before administration or in a particular sequence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.54"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Must"; "Therapeutic goods must be combined before administration or in a particular sequence."; "(2) A package and therapeutic goods in the package together constitute a composite pack if:..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Requires"; "Combining therapeutic goods is necessary before administration."; "it is necessary that the therapeutic goods be combined before administration or that they be administered in a particular sequence."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Requires"; "Combining therapeutic goods must happen before administration."; "it is necessary that the therapeutic goods be combined before administration or that they be administered in a particular sequence."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Requires"; "Combining therapeutic goods must happen in a particular order."; "the package does not contain any medical devices; and"; "modalities::diffusion"; 1.0000; . . a ; ; "Classifies"; "Therapeutic goods are for administration as a single treatment or course of treatment."; "(c) the therapeutic goods are for administration as a single treatment or as a single course of treatment; and"; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "7B(3) Kits"@en; ; "d3df2603ce7c7087f5afd84633445dd30b84efc7756d22a1a34b4cd5650f038e"; ; "A kit constitutes therapeutic goods."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.54"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "is"; "Definition of a kit"; "A kit is defined as..."; "It is declared that..."; "modalities::logic::deontic"; 1.0000; . a ; "7C Secretary may arrange for use of computer programs to make"@en; ; "3183d37be5060278b0f0b2ea1095fea98e027d276f661719821018f5511f4927"; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.55". a ; "7C(1) Secretary may arrange for use of computer programs to make"@en; ; "fba878466a007c7c06cefd3d6dbb98456c09f2a902ea5f994b47a52f8ff7ee0d"; ; "The Secretary may arrange for the use of computer programs under their control."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.55"; . a ; ; ; ; ; . . a ; ; "may"; "Implies permission or obligation"; "modalities::logic::deontic"; 1.0000; . a ; "7C(2) Secretary may arrange for use of computer programs to make"@en; ; "0ca54776f55e6b8faaf5a3d48958a920e1dbdab3bf103ffe3375e7446571db43"; ; "Decision made by computer program is taken to be Secretary's decision."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.55"; . a ; ; ; ; ; . . a ; ; "="; "Decision making"; "Computer program makes a decision"; "Secretary's decision"; "modalities::logic::deontic"; 1.0000; . a ; "7C(3) Secretary may arrange for use of computer programs to make"@en; ; "c2c6eab04637835a93c75f1463eb8a0ec0c3a4bc16bb19ffabe64a9e9637a22a"; ; "Secretary may correct initial decision made by computer program."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.55"; . a ; ; ; ; ; . . a ; ; "MAY"; "May correct initial decision"; "modalities::logic::deontic"; 1.0000; . a ; "7C(4) Secretary may arrange for use of computer programs to make"@en; ; "03659ac93cc30e71042f6c5f2a486b2a35e9520e1882855f0eb6713292133e6c"; ; "Secretary must make substituted decision within 60 days of initial decision."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.55"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide a substituted decision within the specified timeframe."; "modalities::logic::deontic"; 1.0000; . a ; "7D Form for product information for medicine"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.55". a ; "7D(1) Form for product information for medicine"@en; ; "91edc8f13740e3c030223041c0d2518d6a1c4e83ffd694516531dbd52476e2cc"; ; "The Secretary may approve a form for product information in relation to medicine."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.55"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "May"; "The Secretary may approve a form."; "modalities::logic::deontic"; 1.0000; . a ; "7D(2) Form for product information for medicine"@en; ; "56878a263264a37a448d5da4457d78716e9f2e36cf9851978b0e2f8c4aefcb0d"; ; "Secretary may approve different forms for different medicines or classes of medicine."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.55"; . a ; ; ; ; "borne by: State"; ; . a ; "8 Power to obtain information with respect to therapeutic goods"@en; ; , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.55". a ; "8(1) Power to obtain information with respect to therapeutic goods"@en; ; "6d17cd04cdd8f5e892f8c022bd67333cb2301544946adbde7178ab2c3cdf4342"; ; "Request for information about therapeutic goods"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.55"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide information"; "modalities::logic::deontic"; 1.0000; . . a ; ; "WITHIN"; "Within a reasonable period"; "within such reasonable period as is specified in the notice"; "modalities::interval_reasoning"; 1.0000; . a ; "8(1A) Power to obtain information with respect to therapeutic goods"@en; ; "fd3dfc60a96eb831e510f0988bd70096e358016338e16a18d91461c28f6b096c"; ; "Notice may require information to be given in writing or according to specified software requirements."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.55"; . a ; ; ; ; ; . . a ; ; "Permit"; "Permission granted"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Classifies"; "Classification of software requirements"; "(a) in writing; or (b) in accordance with specified software requirements:"; "modalities::dl"; 1.0000; . a ; "8(2) Power to obtain information with respect to therapeutic goods"@en; ; "0dd37f0585aad5323a250bdff55a5202158523b73b0753889d735af5843407ac"; ; "Must comply with notice given under section."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.55"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "MUST"; "Obligation to comply"; "Notice given under section."; "Must comply"; "modalities::logic::deontic"; 1.0000; . a ; "8(3) Power to obtain information with respect to therapeutic goods"@en; ; "89de1c90ed386be3887be1b7edefd187d3717d77b51b45f2d3026b5fc3758291"; ; "A reasonable excuse is a valid reason for not applying subsection (2)."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.55"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "Obligation"; "Obligation to provide a reasonable excuse."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Belief"; "The defendant believes they have a reasonable excuse."; "modalities::epistemic"; 1.0000; . a ; "8(4) Power to obtain information with respect to therapeutic goods"@en; ; "2f4c062b4d9fcbf735959fc2360ecd2f7f01ab3c9ccdd23ad5ec0dada4a827c6"; ; "An offence under subsection (2) is an obligation."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.55"; . a ; ; ; ; ; . . a ; ; "Obligation"; "An obligation"; "modalities::logic::deontic"; 1.0000; . a ; "9 Arrangements with States etc."@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.56". a ; "9(1) Arrangements with States etc."@en; ; "c2624c7bfaa86617f9b2a2a5c3be9f4b7947d4962b2c67c829affa1f5c2c1356"; ; "The Minister may make arrangements with a State for the carrying out of certain functions on behalf of the Commonwealth."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.56"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Permission to make arrangements"; "modalities::logic::deontic"; 1.0000; . . a ; ; "must"; "Obligation to make arrangements"; "modalities::logic::deontic"; 1.0000; . a ; "9(2) Arrangements with States etc."@en; ; "d43d8f7eec65d1874f5957c66c6f95522f56cf7268490c61737f6e1dfdb36f86"; ; "Payment of amounts to a State or Territory for performance of functions under an arrangement."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.56"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Payment obligation"; "modalities::logic::deontic"; 1.0000; . a ; "9A Australian Register of Therapeutic Goods"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.58". a ; "9A(1) Australian Register of Therapeutic Goods"@en; ; "3611fe3d0b7ae6a491c1d4f8fcca69eec0fe05aaa929c045a0b1882fb613694a"; ; "Maintain a register of therapeutic goods."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.58"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Obligation to maintain a register."; "modalities::logic::deontic"; 1.0000; . a ; "9A(2) Australian Register of Therapeutic Goods"@en; ; "c8217ea34a1eee31e0baadbd6fed53e2e347268d7cc5e8465e6eb7b7fb225ab9"; ; "The Register is to be kept in such form as the Secretary determines."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.58"; . a ; ; ; ; . a ; "9A(3) Australian Register of Therapeutic Goods"@en; ; "5b71051ed32004df1a11d6a089c0cd34461efbfa16116f8a988de21e81398973"; ; "Classification of goods in the Australian Register of Therapeutic Goods"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.58"; . a ; ; ; ; . a ; "9C Inspection of entries in Register"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.59". a ; "9C(1) Inspection of entries in Register"@en; ; "5cd00a9ac302b318dde73812828a4943b7d5ec1cfd05112a4dfdd39cebfdc4a2"; ; "Request for copy of entry in Register"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.59"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "hasObligation"; "Therapeutic goods entry request"; "modalities::logic::deontic"; 1.0000; . a ; "9C(2) Inspection of entries in Register"@en; ; "55247de2a616851acdd5f20403b362896de4859ef557c9b936cb6d55659ec690"; ; "Must provide a copy of requested entry from computer database"; "Yes"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.59"; . a ; ; ; ; ; . . a ; ; "MUST"; "Must provide information"; "modalities::logic::deontic"; 1.0000; . a ; "9C(3) Inspection of entries in Register"@en; ; "39ee6041ad21ed00a14d761a141fbe6528c12324252764a431c93b6f726b58c4"; ; "Secretary may provide information in electronic format upon request."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.59"; . a ; ; ; ; ; . a ; "9D Variation of entries in Register"@en; ; , , , , , , , , , , , , , , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.59". a ; "9D(1) Variation of entries in Register"@en; ; "35cfff09f8a83f4cff7ba134984e7614f9175bc1ef15da6b302d04ccb682c309"; ; "Secretary may vary entry in Register under certain conditions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.59"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Permissive obligation"; "modalities::logic::deontic"; 0.5000; . a ; "9D(1A) Variation of entries in Register"@en; ; "983caa18fe2a18004dd611b254056785e7ba943ca6d13b5d8b625c953587c331"; ; "Secretary may vary entry in Register under certain conditions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.59"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "May"; "Permits Secretary to take action."; "modalities::logic::deontic"; 1.0000; . . a ; ; "ClassInclusion"; "Variation of entries in Register is a class inclusion."; "modalities::dl"; 1.0000; . a ; "9D(1B) Variation of entries in Register"@en; ; "6ec60157496fbc8835c6aa5612657dcdac7f6830f9f52dcae0b61fb21bf28f48"; ; "The Secretary may vary the entry in the Register on their own initiative."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.59"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "May"; "Permission to vary the entry in the Register."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Variation of entries"; "Varying the entry in the Register."; "(1B) If..."; "modalities::dl"; 1.0000; . a ; "9D(1C) Variation of entries in Register"@en; ; "85142cccf63885ba5352f3f582139f32a1a19c4606a818191d4c8252a6a97801"; ; "Secretary must give notice and opportunity to submit before making variation."; "written notice, submission"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.59"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Secretary must take submission into account"; "Submission made in accordance with paragraph (b)"; "Decision to make variation"; "modalities::logic::deontic"; 1.0000; . . a ; ; ">="; "Secretary must give notice before making variation"; "Date of proposed variation"; "Notice given at least this far in advance"; "modalities::interval_reasoning"; 1.0000; . a ; "9D(1D) Variation of entries in Register"@en; ; "6032000971de34ad6c8405086321be1ac4a4f5f4552c4b6da0d62f9d01d7fa4f"; ; "Subsections (1A) and (1B) apply despite subsection 16(1)."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.59"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Continuation"; "Continues the obligation despite a condition."; "(1D) Subsections (1A) and (1B)"; "Subsections (1A) and (1B) apply despite subsection 16(1)."; "modalities::logic::deontic"; 0.5000; . . a ; ; "Overriding Condition"; "Overrides the condition."; "(1D)"; "Subsections (1A) and (1B) apply despite subsection 16(1)."; "modalities::logic::deontic"; 0.5000; . . a ; ; "Continuation"; "Continues the linear logic application."; "(1D)"; "Subsections (1A) and (1B) apply despite subsection 16(1)."; "modalities::linear"; 0.5000; . . a ; ; "Negation"; "Negates the condition."; "(1D)"; "Subsections (1A) and (1B) do not apply despite subsection 16(1)."; "modalities::logic::deontic"; 0.5000; . a ; "9D(2) Variation of entries in Register"@en; ; "a3d17269b40dbe63e3bd653cecdaf2709639d6423e1c74626c440b3e9add4fbd"; ; "Variation of entries in Register upon request"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.59"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide variation upon request"; "modalities::logic::deontic"; 1.0000; . . a ; ; "CLASSIFICATION"; "Classification of therapeutic goods"; "modalities::dl"; 1.0000; . a ; "9D(2A) Variation of entries in Register"@en; ; "7e75cdfda3733a253b29509e4289bd40d7ab54229143edd22f2212d511777919"; ; "Subsection (2) of section 16(1) applies despite subsection (2A)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.59"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "applies"; "Subsection (2) applies despite subsection (2A)"; "(2A)"; "(2)"; "modalities::logic::deontic"; 1.0000; . a ; "9D(2C) Variation of entries in Register"@en; ; "57cad66c5a121bdd6d17126d128b102867b3fda0335e6482d08e76b62fb6089b"; ; "Secretary must vary entry in Register upon request."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.59"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide variation upon request."; "(a) the person in relation to whom therapeutic goods are registered or listed has requested the Secretary to vary the entry in the Register that relates to the goods;"; "the Secretary must vary the entry in accordance with the request."; "modalities::logic::deontic"; 1.0000; . . a ; ; "MUST"; "Must satisfy conditions specified in regulations."; "(b) the variation is of a kind specified in the regulations;"; "the conditions (if any) specified in the regulations are satisfied;"; "modalities::logic::deontic"; 1.0000; . . a ; ; "BETWEEN"; "Request must be made within unspecified time frame."; "(a) the person in relation to whom therapeutic goods are registered or listed has requested the Secretary to vary the entry in the Register that relates to the goods;"; "the request was made at some point in time."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "BETWEEN"; "Request must be made within unspecified time frame."; "(a) the person in relation to whom therapeutic goods are registered or listed has requested the Secretary to vary the entry in the Register that relates to the goods;"; "the request was made at some point in time."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "MUST"; "Request must be made by person with registered or listed therapeutic goods."; "(a) the person in relation to whom therapeutic goods are registered or listed has requested the Secretary to vary the entry in the Register that relates to the goods;"; "the request was made by a person who has registered or listed therapeutic goods."; "modalities::logic::deontic"; 1.0000; . a ; "9D(2D) Variation of entries in Register"@en; ; "be85a7a28ac6f6ee5a4d3e7e090bad0f78a939e2a1882e5a8e022338ce29d5e4"; ; "Subsection (2C) applies despite subsection 16(1)."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.59"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Implies"; "Subsection (2C) implies subsection 16(1)."; "(2D)"; "(2C)"; "modalities::logic::deontic"; 0.5000; . a ; "9D(3) Variation of entries in Register"@en; ; "b32b31452e17103c8ea14d4dfa410bf0bd23e58c8a1dc2ba799d6a91b98c5c52"; ; "Secretary may vary entry in Register upon request."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.59"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "May"; "Permits variation of entries in Register."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Variation"; "Specifies conditions for variation of entries in Register."; "(3) If: ...; (3AA) If: ...; (3AC) If: ...;"; "modalities::dl"; 1.0000; . . a ; ; "Must"; "Secretary must vary entry in Register upon request."; "(3AA) If: ...; (3AC) If: ...;"; "modalities::logic::deontic"; 1.0000; . . a ; ; "And"; "Combines conditions for variation of entries in Register."; "(3) If: ... And (3AA) If: ... And (3AC) If: ...;"; "modalities::linear"; 1.0000; . . a ; ; "Satisfies"; "Specifies conditions for variation of entries in Register."; "(c) the Secretary is satisfied that the variation requested does not indicate any reduction in the quality, safety or efficacy of the goods for the purposes for which they are to be used;"; "modalities::dl"; 1.0000; . . a ; ; "Must"; "Secretary must vary entry in Register upon request."; "(3) If: ...; (3AA) If: ...; (3AC) If: ...;"; "modalities::logic::deontic"; 1.0000; . a ; "9D(3A) Variation of entries in Register"@en; ; "2ebc7b3de21f93c195cabfd58b42db0773a777e91c1534d4f59df0d2147cf6b6"; ; "Secretary may vary entry in Register upon request."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.59"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "May"; "Permits variation of entries in Register."; "modalities::logic::deontic"; 1.0000; . a ; "9D(3B) Variation of entries in Register"@en; ; "b21e1e9da45f15a88d019c656873026c68501ede9c65b35b3758112ea02ddff0"; ; "Secretary must move entry from part of Register for biologicals to applicable part."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.59"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Obligation to move entry"; "modalities::logic::deontic"; 1.0000; . a ; "9D(3C) Variation of entries in Register"@en; ; "0200ff3c57bdf9899fdff339cf2574e201d8017db0935fda2cb585532d4ad480"; ; "Variation of entries in Register upon request"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.59"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must vary entry"; "(a) the person in relation to whom a kind of medical device is included in the Register has requested..."; "...the Secretary must vary the entry in accordance with the request."; "modalities::logic::deontic"; 1.0000; . . a ; ; "MUST"; "Must satisfy conditions"; "(c) the conditions (if any) specified in the regulations are satisfied;"; "...the Secretary must vary the entry in accordance with the request."; "modalities::logic::deontic"; 1.0000; . . a ; ; "SUBCLASS_OF"; "Variation of entries is a subclass of variation upon request"; "(3C) If..."; "...the Secretary must vary the entry in accordance with the request."; "modalities::dl"; 1.0000; . . a ; ; "CONTAINS"; "Variation of entries is contained within variation upon request"; "(3C) If..."; "...the Secretary must vary the entry in accordance with the request."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "MAY"; "May vary entry without conditions"; "(3CB) If...(a) the person in relation to whom a kind of medical device is included in the Register has requested..."; "...the Secretary must vary the entry in accordance with the request."; "modalities::logic::deontic"; 0.5000; . . a ; ; "MUST"; "Must add warning, restriction or precaution"; "(b) the only effect of the variation would be...(ii) to add a warning, restriction or precaution..."; "...the Secretary must vary the entry in accordance with the request."; "modalities::logic::deontic"; 1.0000; . a ; "9D(3D) Variation of entries in Register"@en; ; "c7eda553a0b10dd8f9c80280822007e1c4e2addd1451c921c6265b5a81d68d95"; ; "Secretary may vary entry in Register upon request."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.59"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "May"; "Permits variation of entries in Register."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Variation"; "Allows for variation of entries in Register."; "modalities::dl"; 1.0000; . a ; "9D(4) Variation of entries in Register"@en; ; "c7777b0612bfe49962582486faf9e48f06dfc78b2d893d7b86a58d11aa114da8"; ; "Must move entry from medical devices part to applicable part of Register"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.59"; . a ; ; ; ; . a ; "9D(6) Variation of entries in Register"@en; ; "a8b3f09d9518d7e2889f52f740f6174283ee915d8f98d2e82cb87b5358755563"; ; "Secretary may approve forms and manners for requests under this section."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.59"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "May"; "Permits the Secretary to approve forms and manners."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Within"; "Limits the scope to specific temporal intervals."; "(6) The Secretary may, by writing:"; "modalities::interval_reasoning"; 1.0000; . a ; "9D(7) Variation of entries in Register"@en; ; "78820e3d3a70dc5784d0360e97d151428bf9c084ae08c0fbe6bfe1790a946453"; ; "Request for variation of entries in Register must comply with approved form and contain required information."; "Form, information, application fee, and prescribed documentation"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.59"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Request must comply with approved form"; "modalities::logic::deontic"; 1.0000; . . a ; ; "IS_A"; "Form and information are of a kind determined under subsection (8)"; "modalities::dl"; 1.0000; . a ; "9D(8) Variation of entries in Register"@en; ; "c8acdfa9eebc15a9477630719dd06bd48300858ef11776cca53a6109aa38b695"; ; "The Secretary may determine a kind of information for the purposes of subparagraph (7)(g)(i)."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.59"; . a ; ; ; ; . a ; "9E Publication of list of goods on Register"@en; ; "7f470528acde4bcf8c8e752d1f079acbe43971bd2702ad338c807440f7149bf8"; "The Secretary must publish a list of therapeutic goods on the Register at least once every 12 months."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.65"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "The Secretary must publish a list of therapeutic goods on the Register."; "modalities::logic::deontic"; 1.0000; . a ; "9F Removal of entries from Register"@en; ; , , , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.65". a ; "9F(1) Removal of entries from Register"@en; ; "f20ec0ad3465730dea3a9c906e3c6b86d92e3b76ec72c9b7c3454297c6ac9854"; ; "Prohibition on removal of entries from Register if goods are therapeutic"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.65"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "forbid"; "Prohibits removal of entries from Register"; "(1) This section applies if: (a) there is an entry on the Register in relation to goods; and (b) the Secretary is satisfied that the goods are not therapeutic goods."; "The removal of entries from the Register is prohibited."; "modalities::logic::deontic"; 1.0000; . . a ; ; "during"; "Describes the temporal relationship between the provision and its application"; "(1) This section applies if: (a) there is an entry on the Register in relation to goods; and (b) the Secretary is satisfied that the goods are not therapeutic goods."; "The provision applies during the existence of an entry on the Register related to goods that are not therapeutic goods."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "everywhere"; "Describes the spatial relationship between the provision and its application"; "(a) there is an entry on the Register in relation to goods; and (b) the Secretary is satisfied that the goods are not therapeutic goods."; "The provision applies everywhere where there is an entry on the Register related to goods that are not therapeutic goods."; "modalities::temporal_ltl"; 1.0000; . a ; "9F(2) Removal of entries from Register"@en; ; "e160d9c518b13a788c45335c0363d09a5008c282417fbe88b29050f4bb5a5fe2"; ; "Secretary may remove entry from Register"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.65"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Obligation to remove entry"; "modalities::logic::deontic"; 1.0000; . a ; "9F(3) Removal of entries from Register"@en; ; "327e09ec79bb25bf63354e9999ee0289b257d84869477fc38d7a62fcf9c8a3e1"; ; "Secretary must inform person of proposed removal and invite written submissions."; "written submissions"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.65"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Secretary must inform person of proposed removal."; "modalities::logic::deontic"; 1.0000; . . a ; ; "MAY"; "Person may make written submissions to Secretary."; "modalities::logic::deontic"; 1.0000; . a ; "9F(4) Removal of entries from Register"@en; ; "5293dad18aef60ccfcf180a425ea7b6c3f45f3e6b0f3c50aaa7d6fea34b56e6f"; ; "Secretary must consider submissions before giving notice."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.65"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Must"; "Mandatory action"; "The Secretary must not..."; "...until the Secretary has had regard to..."; "modalities::logic::deontic"; 1.0000; . a ; "9F(5) Removal of entries from Register"@en; ; "d42ef7be6d86528b8640db4091ff3474c857b5d86c78c8578d5e92cd81b913ea"; ; "Notice under subsection (2) is not a legislative instrument."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.65"; . a ; ; ; ; "borne by: State"; ; . a ; "9F(6) Removal of entries from Register"@en; ; "4da4b55b769d42e8d6eb9387bd6510fa1d0ac5e7fbeead75d0f3baaa02b18580"; ; "Removal of entries from Register has effect on specified day"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.65"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "hasEffect"; "Imposes obligation"; "The removal has effect..."; "modalities::logic::deontic"; 1.0000; . a ; "9F(7) Removal of entries from Register"@en; ; "8161738457e3877d2d02251f316a0d1fcc828b9104b3de2d39ffcd6f8f5eefec"; ; "Secretary must publish notice after removing entry from Register."; "Notice setting out particulars of removal"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.65"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Obligation to publish notice"; "modalities::logic::deontic"; 1.0000; . a ; "9G Criminal offences for false statements in requests for variation of"@en; ; "8a2cf7facb7b9373af2789f3f8774361565cd5291d5e460ff55ff32a7154e1b3"; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.66". a ; "9G(1) Criminal offences for false statements in requests for variation of"@en; ; "0f78a194971f9ac7e7a922966282ff3020eeb613ea0b4db3afa40b517adb35e7"; ; "Making false statements in requests for variation of therapeutic goods entries is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.66"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition"; "modalities::logic::deontic"; 1.0000; . a ; "9G(4) Criminal offences for false statements in requests for variation of"@en; ; "2bf760abeb38f2ce7c2a2c987836836979c1848d0fabfbbbfb81f5cee93694d2"; ; "Making false statements in requests for variation of therapeutic goods entries is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.66"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits making false statements in requests for variation of therapeutic goods entries."; "modalities::logic::deontic"; 1.0000; . a ; "9G(5) Criminal offences for false statements in requests for variation of"@en; ; "6302431c0645a2b6a6f111cc023a9da8e26f4d70003dea417bd25f695f6a8592"; ; "Making false statements in requests for variation of therapeutic goods entries is an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.66"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits making false statements in requests for variation of therapeutic goods entries."; "modalities::logic::deontic"; 1.0000; . a ; "9G(6) Criminal offences for false statements in requests for variation of"@en; ; "aa2c5c6c78224eb2b4b4ccc76ad45c9abbf2cf07d58268540d047ab8b3703b0d"; ; "An offence against subsection (5) is an offence of strict liability."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.66"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "is"; "Strict liability"; "(5)"; "(6)"; "modalities::logic::deontic"; 1.0000; . a ; "9H Civil penalty for false statements in requests for variation of"@en; ; "342a544e86298c11472ae3580dd65426662dc1027f0dadf461c1c468bda20af9"; "False statements in requests for variation of entries in Register"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.68"; . a ; ; ; ; ; . . a ; ; "Prohibition"; "Prohibits making false statements"; "modalities::logic::deontic"; 1.0000; . a ; "9J Simplified outline of this Chapter"@en; ; "f5d6023a0da9969ac44554361e9d3c51868f29fffc9f43a94565cfb7ecf7f812"; "Regulations may prohibit imports, exports, manufacture, and supplies of certain goods."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.69"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Regulations prohibit imports, exports, manufacture, and supplies of certain goods."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Temporal Interval"; "Regulations apply to imports, exports, manufacture, and supplies within a specific temporal interval."; "modalities::interval_reasoning"; 1.0000; . a ; "9K Prohibition on import, export, manufacture or supply of"@en; ; "7655ae8d2dfd3a36d7eb99e26bd08b44dd2f31133138e14a9e06673f0467e173"; , , , , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.69". a ; "9K(1) Prohibition on import, export, manufacture or supply of"@en; ; "a7acaba5ee705c954d1cc176766e4324c721bf536ebd49372206c691b4e358d9"; ; "Prohibition on import, export, manufacture or supply of therapeutic goods or vaping goods"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.69"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits the specified actions"; "(1) If therapeutic goods or vaping goods are the subject of an international agreement prescribed for the purposes of this subsection, the regulations may prohibit one or more of the following:"; "modalities::logic::deontic"; 1.0000; . . a ; ; "During"; "Prohibition applies during international agreements"; "If therapeutic goods or vaping goods are the subject of an international agreement prescribed for the purposes of this subsection, the regulations may prohibit one or more of the following:"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Until"; "Prohibition ends when international agreements expire"; "(1) If therapeutic goods or vaping goods are the subject of an international agreement prescribed for the purposes of this subsection, the regulations may prohibit one or more of the following:"; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Prohibit"; "Prohibits the specified actions"; "(b) the export from Australia of the therapeutic goods or vaping goods;"; "modalities::logic::deontic"; 1.0000; . a ; "9K(2) Prohibition on import, export, manufacture or supply of"@en; ; "b07b1180e4d38f1087f4560876d54ba356e1a7804dd2f47985063ac6f6c37140"; ; "Regulations must prohibit or restrict import, export, manufacture and supply of certain goods before an international agreement is made."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.69"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Regulations must prohibit or restrict certain goods."; "International agreement requires parties to take steps to prohibit or restrict import, export, manufacture and supply of certain goods."; "Regulations must prohibit or restrict import, export, manufacture and supply of certain goods."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Temporal Interval"; "Regulations must be made before an international agreement is made."; "Before regulations are made prescribing an international agreement for the purposes of subsection (1), the Minister must be satisfied that the agreement requires parties to the agreement to take steps to prohibit or restrict one or more of the import, export, manufacture and supply of certain goods."; "Regulations must be made before an international agreement is made."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Recurring Trace"; "International agreements require parties to take steps to prohibit or restrict import, export, manufacture and supply of certain goods."; "The Minister must be satisfied that the agreement requires parties to the agreement to take steps to prohibit or restrict one or more of the import, export, manufacture and supply of certain goods."; "International agreements require parties to take steps to prohibit or restrict import, export, manufacture and supply of certain goods."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Diffuse"; "Regulations must diffuse to all parties to the agreement."; "The Minister must be satisfied that the agreement requires parties to the agreement to take steps to prohibit or restrict one or more of the import, export, manufacture and supply of certain goods."; "Regulations must diffuse to all parties to the agreement."; "modalities::diffusion"; 1.0000; . . a ; ; "Implication"; "International agreements imply regulations that prohibit or restrict import, export, manufacture and supply of certain goods."; "The Minister must be satisfied that the agreement requires parties to the agreement to take steps to prohibit or restrict one or more of the import, export, manufacture and supply of certain goods."; "International agreements imply regulations that prohibit or restrict import, export, manufacture and supply of certain goods."; "modalities::argumentation"; 1.0000; . a ; "9K(3) Prohibition on import, export, manufacture or supply of"@en; ; "dd769768394d63c02443553e2558e312353996753c3e9bdae52290112acec0f3"; ; "Regulations may prohibit import, export, manufacture or supply of therapeutic goods or vaping goods containing a specified ingredient or component."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.69"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Regulations prohibit certain actions."; "modalities::logic::deontic"; 1.0000; . a ; "9K(4) Prohibition on import, export, manufacture or supply of"@en; ; "2e86778b334a804e0b9a34226c0aa9b1cee156a55133b857b1811703a4e08956"; ; "Regulations must prohibit or restrict import, export, manufacture and supply of goods containing a specific ingredient or component."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.69"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Regulations must prohibit the specified activity."; "(4) Before regulations are made..."; "...the Minister must be satisfied..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Temporal Interval"; "The regulation must be made before a specific temporal interval."; "(4) Before regulations are made..."; "...the Minister must be satisfied..."; "modalities::interval_reasoning"; 1.0000; . a ; "9K(5) Prohibition on import, export, manufacture or supply of"@en; ; "64d23a5e753ccd7afa4f10349f138612ae966580f0df93dce99197322d0a7a3f"; ; "Absolute or conditionally prescribed prohibition on import, export, manufacture or supply of therapeutic goods or vaping goods."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.69"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Absolute prohibition"; "(5) A prohibition referred to in subsection (1) or (3) may be absolute"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Temporal Interval"; "Temporal interval for prohibition"; "(5) A prohibition referred to in subsection (1) or (3) may be absolute"; "modalities::interval_reasoning"; 1.0000; . a ; "9K(6) Prohibition on import, export, manufacture or supply of"@en; ; "90748b5f61c3cea7534e2e8c8d75ee7240390991609fc7ab3ddd2fcc363596f4"; ; "Regulations containing a prohibition must be published and wait 30 days before implementation."; "(i) the international agreement; (ii) the Minister’s satisfaction; (iii) the proposed prohibition"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.69"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Regulations containing a prohibition"; "(6) Regulations containing a prohibition referred to in subsection (1) or (3)"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Temporal Interval"; "Notice must be published for at least 30 days before implementation"; "(b) a period of 30 days has passed since the notice was published"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Permission"; "Regulations must be published for public review"; "(a) the Minister causes to be published on the Department’s website a notice setting out details of: (i) the international agreement; and (ii) the Minister’s satisfaction"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Obligation"; "Minister must cause publication of notice"; "(a) the Minister causes to be published on the Department’s website a notice setting out details of: (i) the international agreement; and (ii) the Minister’s satisfaction"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibition"; "Regulations containing prohibition must be implemented after publication"; "(b) a period of 30 days has passed since the notice was published"; "modalities::logic::deontic"; 1.0000; . a ; "9K(7) Prohibition on import, export, manufacture or supply of"@en; ; "b2841988c0a3f35a1f6741d1a37750933cc8a45282ea541e4f981447030e2dc9"; ; "Regulations with prohibition must not start before the international agreement enters into force."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.69"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Cannot"; "Regulations with prohibition cannot start before the international agreement enters into force."; "(7) Regulations containing a prohibition referred to in subsection (1) or (3)"; "must not be expressed to commence on a day earlier than the day the international agreement enters into force for Australia."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlaps"; "Regulations with prohibition overlap with the international agreement."; "(7) Regulations containing a prohibition referred to in subsection (1) or (3)"; "the day the international agreement enters into force for Australia."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Until"; "Regulations with prohibition are until the international agreement enters into force."; "(7) Regulations containing a prohibition referred to in subsection (1) or (3)"; "must not be expressed to commence on a day earlier than the day the international agreement enters into force for Australia."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Diffuses"; "Regulations with prohibition diffuse to the international agreement."; "(7) Regulations containing a prohibition referred to in subsection (1) or (3)"; "the day the international agreement enters into force for Australia."; "modalities::diffusion"; 1.0000; . . a ; ; "Infer"; "Regulations with prohibition infer the international agreement."; "(7) Regulations containing a prohibition referred to in subsection (1) or (3)"; "must not be expressed to commence on a day earlier than the day the international agreement enters into force for Australia."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "9K(8) Prohibition on import, export, manufacture or supply of"@en; ; "db29f6246b2ea2103822fbb9d3b5941d6a90f6bd69503813aa7342e156cb5ab8"; ; "Regulations may confer power on Minister or Secretary to make administrative decisions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.69"; . a ; ; ; ; ; . a ; "9L Offence and civil penalty"@en; ; "cd25b8565d4b57e8f856cf50c696d80d49eb0c79087d2888c0de2bddefadce7e"; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.71". a ; "9L(1) Offence and civil penalty"@en; ; "06d52d20d16713928efe4b0944d7486a22ea7c286b6663056a821fa850751a66"; ; "Import, export, manufacture or supply of therapeutic goods or vaping goods is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.71"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits the import, export, manufacture or supply of therapeutic goods or vaping goods."; "modalities::logic::deontic"; 1.0000; . a ; "9L(2) Offence and civil penalty"@en; ; "40867a6982a686e5b8a004ceae81e4a8f9c683856c649f5f7d242fe05da35478"; ; "Prohibition on import, export, manufacture or supply of therapeutic goods or vaping goods—international agreements"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.71"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "="; "Absolute prohibition"; "(i) an absolute prohibition in force for the purposes of subsection 9K(1) or (3);"; "Prohibition on import, export, manufacture or supply of therapeutic goods or vaping goods—international agreements"; "modalities::logic::deontic"; 1.0000; . . a ; ; "="; "Prohibition on import, export, manufacture or supply of therapeutic goods or vaping goods—international agreements"; "(ii) one or more conditions of a prohibition in force for the purposes of subsection 9K(1) or (3)."; "Prohibition on import, export, manufacture or supply of therapeutic goods or vaping goods—international agreements"; "modalities::logic::deontic"; 1.0000; . . a ; ; "="; "Maximum civil penalty: Prohibition on import, export, manufacture or supply of therapeutic goods or vaping goods—international agreements"; "(a) for an individual—300 penalty units; and (b) for a body corporate—3,000 penalty units."; "Prohibition on import, export, manufacture or supply of therapeutic goods or vaping goods—international agreements"; "modalities::logic::deontic"; 1.0000; . . a ; ; "="; "Temporal interval: Maximum civil penalty"; "(a) for an individual—300 penalty units; and (b) for a body corporate—3,000 penalty units."; "Maximum civil penalty: Prohibition on import, export, manufacture or supply of therapeutic goods or vaping goods—international agreements"; "modalities::interval_reasoning"; 1.0000; . a ; "9M Application of Customs Act 1901"@en; ; "973b96a65206bf65b02d38f9d6ac5cb0952713650c14bc704280eb1391e3b022"; "Customs Act 1901 applies to prohibited imports or exports if notified by Secretary."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.73"; . a ; ; ; ; "borne by: State"; ; . a ; "9N Constitutional basis"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.73". a ; "9N(1) Constitutional basis"@en; ; "0a2dfcf17877926e8ad7f65735ed3f9f2b9cc151bb39625dcba3aa487802b5b6"; ; "Relies on Commonwealth's legislative power under paragraph 51(xxix) of the Constitution."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.73"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "ReliesOn"; "Relies on Commonwealth's legislative power"; "(1) This Chapter, and any other provision of this Act to the extent it relates to this Chapter, relies..."; "...to give effect to an international agreement prescribed for the purposes of subsection 9K(1) or (3)."; "modalities::logic::deontic"; 1.0000; . . a ; ; "PrescribedFor"; "Prescribed for the purposes of subsection 9K(1) or (3)"; "...prescribed for the purposes of subsection 9K(1) or (3)."; "...to give effect to an international agreement prescribed for the purposes of subsection 9K(1) or (3)."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "RecurringTrace"; "Recurring trace of subsection 9K(1) or (3)"; "...prescribed for the purposes of subsection 9K(1) or (3)."; "...to give effect to an international agreement prescribed for the purposes of subsection 9K(1) or (3)."; "modalities::temporal_ltl"; 0.5000; . . a ; ; "InternationalAgreement"; "International agreement"; "...prescribed for the purposes of subsection 9K(1) or (3)."; "...to give effect to an international agreement prescribed for the purposes of subsection 9K(1) or (3)."; "modalities::diffusion"; 0.5000; . . a ; ; "SHACL"; "SHACL validation"; "...prescribed for the purposes of subsection 9K(1) or (3)."; "...to give effect to an international agreement prescribed for the purposes of subsection 9K(1) or (3)."; "sparql_library::parsers::chk_parser"; 0.5000; . a ; "9N(2) Constitutional basis"@en; ; "3cf8cd3288d97c3a07989386e89750e4a30998e7a96f14fca24819573468a027"; ; "Does not limit section 6"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.73"; . a ; ; ; ; ; . . a ; ; "does not imply"; "Limits the scope of section 6"; "Section 9N(2)"; "Section 6 is unaffected"; "modalities::logic::deontic"; 1.0000; . . a ; ; "does not prohibit"; "Does not ban conduct related to section 6"; "Section 9N(2) does not limit section 6"; "Conduct related to section 6 is permitted"; "modalities::logic::deontic"; 1.0000; . . a ; ; "does not create right"; "Does not grant a right to conduct related to section 6"; "Section 9N(2) does not limit section 6"; "Conduct related to section 6 is permitted but not a right"; "modalities::logic::deontic"; 1.0000; . a ; "10 Determination of standards"@en; ; , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.74". a ; "10(1) Determination of standards"@en; ; "54824efcd24bfef605ef38a5a09b605cd3c03bf8115e972fb20fbe9e4f9696c0"; ; "The Minister may make an order determining standards for therapeutic goods."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.74"; . a ; ; ; ; ; . . a ; ; "May"; "Permission to determine standards"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Classifies"; "Therapeutic goods or class of therapeutic goods"; "modalities::dl"; 1.0000; . a ; "10(2) Determination of standards"@en; ; "692802e7963ba0c0b726b7f67cff30ee85270dd557407d9e973ddcfc2b99dbcb"; ; "Establishing standards for therapeutic goods may be specified by reference to various factors."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.74"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "requires"; "Requires the specification of standards for therapeutic goods."; "(2) Without limiting the generality of subsection (1), an order establishing a standard for therapeutic goods may..."; "...or (vii) a standard published by Standards Australia; or ..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "is specified by reference to"; "Specifies standards for therapeutic goods by reference to various factors."; "(a) be specified by reference to:..."; "...or (v)"; "modalities::dl"; 1.0000; . . a ; ; "requires"; "Requires the determination of matters relating to standards for therapeutic goods."; "(b) require that a matter relating to the standard be determined in accordance with a particular test;..."; "...or (c)"; "modalities::logic::deontic"; 1.0000; . . a ; ; "requires"; "Requires therapeutic goods or a class of therapeutic goods to be labelled or packaged in a manner specified in the order."; "(c) require that therapeutic goods or a class of therapeutic goods identified in the order be labelled or packaged in a manner, or kept in containers that comply with requirements, specified in the order."; "...or (d)"; "modalities::logic::deontic"; 1.0000; . . a ; ; "within a specified time frame"; "Establishing standards for therapeutic goods may be done within a specified time frame."; "(2) Without limiting the generality of subsection (1), an order establishing a standard for therapeutic goods may..."; "...or (vii)"; "modalities::interval_reasoning"; 0.5000; . . a ; ; "recurring trace"; "Establishing standards for therapeutic goods may be done in a recurring manner."; "(2) Without limiting the generality of subsection (1), an order establishing a standard for therapeutic goods may..."; "...or (viii)"; "modalities::temporal_ltl"; 0.5000; . a ; "10(3) Determination of standards"@en; ; "a7dc813a2e895cf6270489faf0777f5852b49c3e9a8436745c5c0554366a3ed3"; ; "Directs particulars to be set out on a label or package of therapeutic goods"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.74"; . a ; ; ; ; ; . . a ; ; "requires"; "Requires particulars to be set out"; "(3) Without limiting the generality of paragraph (2)(c), the Minister may, in an order establishing a standard..."; "such particulars as are required by the order."; "modalities::logic::deontic"; 1.0000; . . a ; ; "identifies"; "Identifies particulars to be set out"; "(a) therapeutic goods or a class of therapeutic goods identified in the order;"; "or (b) a container or package containing therapeutic goods or a class of therapeutic goods identified in the order;"; "modalities::dl"; 1.0000; . . a ; ; "between"; "Establishes relation between particulars and order"; "(3) Without limiting the generality of paragraph (2)(c), the Minister may, in an order establishing a standard..."; "such particulars as are required by the order."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "implies"; "Implies that particulars must be set out if order is established"; "(3) Without limiting the generality of paragraph (2)(c), the Minister may, in an order establishing a standard..."; "such particulars as are required by the order."; "modalities::argumentation"; 1.0000; . . a ; ; "diffuses"; "Diffuses requirement to set out particulars"; "(3) Without limiting the generality of paragraph (2)(c), the Minister may, in an order establishing a standard..."; "such particulars as are required by the order."; "modalities::diffusion"; 1.0000; . . a ; ; "recognizes"; "Recognizes requirement to set out particulars"; "(3) Without limiting the generality of paragraph (2)(c), the Minister may, in an order establishing a standard..."; "such particulars as are required by the order."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "10(3A) Determination of standards"@en; ; "4a4a57b2be7548a1f29f2fecb9e90f6dd3559b0230804b0da353b757e0f425e5"; ; "Variation or revocation of orders made under subsection (1)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.74"; . a ; ; ; ; ; . . a ; ; "may"; "Permission to vary or revoke orders"; "modalities::logic::deontic"; 0.5000; . a ; "10(4) Determination of standards"@en; ; "52046a47fc4bce7b893fb6f69f731205e0c09189c24efaea579396237c5ac80b"; ; "May incorporate existing provisions from instruments or writings."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.74"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Obligation to incorporate existing provisions"; "modalities::logic::deontic"; 0.5000; . a ; "13 Special provisions relating to Ministerial standards and default"@en; ; "0b21aaddae93d0233f598f4d15c6bdc695206094e89cba27044e721a83c79219"; , , , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.76". a ; "13(1) Special provisions relating to Ministerial standards and default"@en; ; "7082ecac8a155184ba6c9db24920b057b063a33c75887cd3e1a794cd55dc3e60"; ; "Statement in one publication is taken to include another statement."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.76"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "="; "Equivalence of statements"; "Statement in one publication is taken to include another statement."; "Main statement includes other statement."; "modalities::logic::deontic"; 1.0000; . a ; "13(2) Special provisions relating to Ministerial standards and default"@en; ; "3d50d9a0a877b56f848e0c0d0ce5be477bb6d71f44a5f053e0f847f2e041af3a"; ; "Disregard inconsistent requirements for therapeutic goods"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.76"; . a ; ; ; ; ; . . a ; ; "Prohibit"; "Prohibits inconsistent requirements"; "(2) If..."; "...the requirements referred to in paragraph (b) are, so far as they are inconsistent, to be disregarded for the purposes of this Act."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlap"; "Overlaps with inconsistent requirements"; "(2) If..."; "...the requirements referred to in paragraph (b) are, so far as they are inconsistent, to be disregarded for the purposes of this Act."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Overlap"; "Overlaps with inconsistent requirements"; "(2) If..."; "...the requirements referred to in paragraph (b) are, so far as they are inconsistent, to be disregarded for the purposes of this Act."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Overlap"; "Overlaps with inconsistent requirements"; "(2) If..."; "...the requirements referred to in paragraph (b) are, so far as they are inconsistent, to be disregarded for the purposes of this Act."; "modalities::diffusion"; 1.0000; . . a ; ; "Overlap"; "Overlaps with inconsistent requirements"; "(2) If..."; "...the requirements referred to in paragraph (b) are, so far as they are inconsistent, to be disregarded for the purposes of this Act."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "13(3) Special provisions relating to Ministerial standards and default"@en; ; "8fd75bf8793b773bc7f8f17d29d5f63613e01cdae4ebd564216332a966d4c24e"; ; "If two default standards apply to different parts of a class of therapeutic goods, the more restrictive standard applies."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.76"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "implies"; "If A implies B and C, then if A, B."; "(a) a default standard applies to a class of therapeutic goods; (b) another default standard applies to only some of the therapeutic goods within that class; (c) those standards are inconsistent;"; "(3) If: (a) a default standard applies to a class of therapeutic goods; and (b) another default standard applies to only some of the therapeutic goods within that class; and (c) those standards are inconsistent; then the standard referred to in paragraph (a) does not apply in relation to the goods referred to in paragraph (b)."; "modalities::logic::deontic"; 1.0000; . . a ; ; "subClassOf"; "The excerpt defines a subclass relationship between two default standards."; "(a) a default standard applies to a class of therapeutic goods; and (b) another default standard applies to only some of the therapeutic goods within that class;"; "the standard referred to in paragraph (a) does not apply in relation to the goods referred to in paragraph (b)."; "modalities::dl"; 1.0000; . a ; "13(4) Special provisions relating to Ministerial standards and default"@en; ; "1f0db07ac9c9bdea3b0a16f8e700c028091444df12b3601ad52b8d2932553b96"; ; "Therapeutic goods with a mixture of ingredients or component parts do not have to meet the default standard."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.76"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "<"; "Temporal interval for applicability"; "(4) If a default standard is applicable to one or more of the ingredients or one or more of the component parts; and"; "The default standard does not apply if it is not applicable at the time of manufacture."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "<"; "Temporal interval for applicability"; "(4) If a default standard is applicable to one or more of the ingredients or one or more of the component parts; and"; "The default standard does not apply if it is not applicable at the time of manufacture."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "="; "Obligation to meet standard"; "If a default standard is applicable to one or more of the ingredients or one or more of the component parts; and"; "The standard does not apply if it is not applicable at the time of manufacture."; "modalities::logic::deontic"; 1.0000; . . a ; ; "="; "Obligation to meet standard"; "(c) a default standard is applicable to the mixture or combination;"; "The standard does not apply if it is not applicable at the time of manufacture."; "modalities::logic::deontic"; 1.0000; . a ; "13(5) Special provisions relating to Ministerial standards and default"@en; ; "2932628a3a4888bf1f25def413ec60b7ac4aaab51fdb46bc4514e2c91aba6d17"; ; "Minister may determine standard does not apply to therapeutic goods"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.76"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "May"; "Minister has the power to determine a standard does not apply"; "modalities::logic::deontic"; 1.0000; . a ; "13(6) Special provisions relating to Ministerial standards and default"@en; ; "3660d52990970ec297d1549e994043b24ada243c3c47c17f4ff78fca70defa1b"; ; "An order under subsection (5) is not a legislative instrument."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.76"; . a ; ; ; ; ; . . a ; ; "not"; "Negative obligation"; "(6) An order under subsection (5)"; "is not a legislative instrument."; "modalities::logic::deontic"; 1.0000; . a ; "13(7) Special provisions relating to Ministerial standards and default"@en; ; "65ee93d28d0dc45a098a41c28a4a0434d6ea652e82c4139303b25b33e5d2a9b4"; ; "If multiple default standards apply, they are taken not to apply if goods conform with at least one but not all."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.76"; . a ; ; ; ; ; . . a ; ; "¬"; "Negation of obligation"; "modalities::logic::deontic"; 1.0000; . a ; "13A Special provisions relating to homoeopathic standards and"@en; ; "0550e76a3096121d9b65c4ac809b9b3e78d680315a4369bec6571140eb8170cf"; "If a statement in a monograph refers to another statement, the main statement includes the other statement."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.77"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "includes"; "Includes other statement when referring to it"; "Statement A refers to Statement B"; "Statement A includes Statement B"; "modalities::logic::deontic"; 1.0000; . a ; "14 Criminal offences for importing, supplying or exporting goods"@en; ; "146ba93cf47044972733d189ffb9dd50623b84e42edb0be4b1c7ffbf24cfbd6c"; , , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.78". a ; "14(1) Criminal offences for importing, supplying or exporting goods"@en; ; "6db59b3a7787c7b7949e29286cf2adf7cc24287b6440ec45dcad71d894c72dfe"; ; "Importing therapeutic goods without consent is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.78"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits the importation of therapeutic goods without consent."; "modalities::logic::deontic"; 1.0000; . a ; "14(4) Criminal offences for importing, supplying or exporting goods"@en; ; "8105137565b962f08994a05e573000e3da86b8eeb489552872870c352fb4a031"; ; "Importing therapeutic goods without consent is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.78"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits importing therapeutic goods without consent."; "(4) A person commits an offence if: (a) the person imports therapeutic goods into Australia; and (b) the goods are imported without the consent in writing of the Secretary; and (c) the goods do not conform with a standard applicable to the goods (other than by reason of a matter relating to labelling or packaging). Penalty: Imprisonment for 12 months or 1,000 penalty units, or both."; "The person commits an offence if they import therapeutic goods without consent."; "modalities::logic::deontic"; 1.0000; . . a ; ; "During"; "The prohibition applies during the time of importing therapeutic goods."; "(4) A person commits an offence if: (a) the person imports therapeutic goods into Australia; and (b) the goods are imported without the consent in writing of the Secretary; and (c) the goods do not conform with a standard applicable to the goods (other than by reason of a matter relating to labelling or packaging). Penalty: Imprisonment for 12 months or 1,000 penalty units, or both."; "The person commits an offence if they import therapeutic goods during this time."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Recurring"; "The prohibition is recurring and applies to each instance of importing therapeutic goods."; "(4) A person commits an offence if: (a) the person imports therapeutic goods into Australia; and (b) the goods are imported without the consent in writing of the Secretary; and (c) the goods do not conform with a standard applicable to the goods (other than by reason of a matter relating to labelling or packaging). Penalty: Imprisonment for 12 months or 1,000 penalty units, or both."; "The person commits an offence if they import therapeutic goods repeatedly without consent."; "modalities::temporal_ltl"; 1.0000; . a ; "14(4A) Criminal offences for importing, supplying or exporting goods"@en; ; "24deb619fdf5af99d5c530f55e1fbd2ebff255142980fd67d944b62cc3be666d"; ; "Importing therapeutic goods without consent is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.78"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits importing therapeutic goods without consent."; "modalities::logic::deontic"; 1.0000; . a ; "14(4B) Criminal offences for importing, supplying or exporting goods"@en; ; "3cac4e95c9afed2c934d246e7bd817391c105ec5ff2eefa27e5f0138720aaf71"; ; "Criminal offences for importing, supplying or exporting goods"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.78"; . a ; ; ; ; "borne by: State"; ; . a ; "14(5A) Criminal offences for importing, supplying or exporting goods"@en; ; "e24535683a70abf1ec97027ecfd1e44016444a0353f5be48e6d9c48c107ba62d"; ; "Exemptions from subsection (1), (4) or (4A)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.78"; . a ; ; ; ; ; . a ; "14(6) Criminal offences for importing, supplying or exporting goods"@en; ; "c5002421e28cf9197e8ffe7b2a76f65fb42505f27c8584f0721c7f949c2b6b9d"; ; "Importing, supplying or exporting goods without a license is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.78"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits the action."; "modalities::logic::deontic"; 1.0000; . a ; "14A Civil penalties for importing, supplying or exporting goods that"@en; ; "2998c4a796a4431104998f73334e3243a0daebb3d5cab4fa3f1f97dbaa77ea49"; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.83". a ; "14A(1) Civil penalties for importing, supplying or exporting goods that"@en; ; "da1032881be7e0afd95a923b5471ce1ba8f0ab613a906934fc2cdf2b962f2ebe"; ; "Importing therapeutic goods without consent"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.83"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits importing therapeutic goods without consent"; "modalities::logic::deontic"; 1.0000; . a ; "14A(1A) Civil penalties for importing, supplying or exporting goods that"@en; ; "e97730f6f59ca315b8423a45645713caa0dab27becaa4c0fb49115959128016f"; ; "Exempts biological goods from subsection (1) of section 14A(1)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.83"; . a ; ; ; ; "borne by: State"; ; . a ; "14B Application of Customs Act 1901"@en; ; "a8105a855cdd93f0bc5d7aed54867cb9cf8f3dc37367fc417c90ed912dcb1544"; "Customs Act 1901 applies to importation or exportation of goods if notified by Secretary."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.85"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "obliges"; "Customs Act 1901 obliges the Secretary to notify Comptroller-General of Customs."; "Secretary wishes Customs Act 1901 to apply."; "Customs Act 1901 has effect."; "modalities::logic::deontic"; 0.5000; . . a ; ; "during"; "Customs Act 1901 applies during importation or exportation."; "Importation or exportation occurs."; "Customs Act 1901 has effect."; "modalities::interval_reasoning"; 0.5000; . . a ; ; "implies"; "Secretary's notification implies Customs Act 1901 applies."; "Secretary notifies Comptroller-General of Customs."; "Customs Act 1901 has effect."; "modalities::argumentation"; 0.5000; . . a ; ; "diffuses"; "Customs Act 1901 diffuses to goods described as forfeited to the Crown."; "Goods are forfeited to the Crown."; "Goods are subject to Customs Act 1901."; "modalities::diffusion"; 0.5000; . . a ; ; "recognizes"; "Customs Act 1901 recognizes goods described as forfeited to the Crown."; "Goods are forfeited to the Crown."; "Goods are subject to Customs Act 1901."; "sparql_library::parsers::chk_parser"; 0.5000; . a ; "15 Criminal offences relating to breaching a condition of a consent"@en; ; , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.86". a ; "15(1) Criminal offences relating to breaching a condition of a consent"@en; ; "e9f53174d8ad57b088ad813529cbf7682e47916a6aa4cde79536c51b5b4a29a4"; ; "Secretary's consent may be given unconditionally or subject to conditions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.86"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Permission granted by the Secretary."; "modalities::logic::deontic"; 1.0000; . a ; "15(2) Criminal offences relating to breaching a condition of a consent"@en; ; "edf552051b0fdf7d71aa89b27a6ac030d5ee1c44f9c450b3ba8a6bc5a94a384e"; ; "A person commits an offence if they breach a condition of consent."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.86"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Obligation to not breach a condition of consent."; "(2) A person commits an offence if: (a) the person does an act or omits to do an act; (b) the act or omission breaches a condition of a consent; (c) the act or omission has resulted in, will result in, or is likely to result in, harm or injury to any person."; "A person commits an offence if they breach a condition of consent."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibition"; "Prohibition on breaching a condition of consent."; "(2) A person commits an offence if: (a) the person does an act or omits to do an act; (b) the act or omission breaches a condition of a consent; (c) the act or omission has resulted in, will result in, or is likely to result in, harm or injury to any person."; "Breaching a condition of consent is prohibited."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Between"; "Temporal relationship between the act and the harm."; "(2) A person commits an offence if: (a) the person does an act or omits to do an act; (b) the act or omission breaches a condition of a consent; (c) the act or omission has resulted in, will result in, or is likely to result in, harm or injury to any person."; "The act and the harm are temporally related."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Implication"; "Implication of breach on offence commitment."; "(2) A person commits an offence if: (a) the person does an act or omits to do an act; (b) the act or omission breaches a condition of a consent; (c) the act or omission has resulted in, will result in, or is likely to result in, harm or injury to any person."; "If the breach occurs, then the offence is committed."; "modalities::argumentation"; 1.0000; . . a ; ; "Propagation"; "Propagating the effect of the breach."; "(2) A person commits an offence if: (a) the person does an act or omits to do an act; (b) the act or omission breaches a condition of a consent; (c) the act or omission has resulted in, will result in, or is likely to result in, harm or injury to any person."; "The effect of the breach propagates."; "modalities::diffusion"; 1.0000; . a ; "15(5) Criminal offences relating to breaching a condition of a consent"@en; ; "45e75e4326c17e797c9a167b273e0a2edaffbf73f0f6f211ab88d5522ef4547b"; ; "Breach of consent condition results in an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.86"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Obligation to comply with consent conditions."; "(5) A person commits an offence if: (a) the person does an act or omits to do an act; and (b) the act or omission breaches a condition of a consent."; "If an act or omission breaches a consent condition, it is an offence."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Between"; "Temporal interval for breach of consent."; "(5) A person commits an offence if: (a) the person does an act or omits to do an act; and (b) the act or omission breaches a condition of a consent."; "The temporal interval for breach of consent is not specified."; "modalities::interval_reasoning"; 0.5000; . . a ; ; "Until"; "Temporal logic for consent conditions."; "(5) A person commits an offence if: (a) the person does an act or omits to do an act; and (b) the act or omission breaches a condition of a consent."; "The temporal logic for consent conditions is not specified."; "modalities::temporal_ltl"; 0.5000; . . a ; ; "Diffuses"; "Diffusion of obligation to comply with consent conditions."; "(5) A person commits an offence if: (a) the person does an act or omits to do an act; and (b) the act or omission breaches a condition of a consent."; "The diffusion of obligation is not specified."; "modalities::diffusion"; 0.5000; . . a ; ; "Recognizes"; "Cognitive AI application for consent conditions."; "(5) A person commits an offence if: (a) the person does an act or omits to do an act; and (b) the act or omission breaches a condition of a consent."; "The cognitive AI application is not specified."; "sparql_library::parsers::chk_parser"; 0.5000; . a ; "15(6) Criminal offences relating to breaching a condition of a consent"@en; ; "dbe3e761dc82b25eebd0f41013235d7926cf7a520fdd04c03dbd34b6939fb325"; ; "Breach of consent condition results in an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.86"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Obligation to comply with consent conditions."; "(6) A person commits an offence if: (a) the person does an act or omits to do an act; and (b) the act or omission breaches a condition of a consent."; "Penalty: 100 penalty units."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Between"; "Temporal interval for breach of consent."; "(6) A person commits an offence if: (a) the person does an act or omits to do an act; and (b) the act or omission breaches a condition of a consent."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Until"; "Temporal constraint for breach of consent."; "(6) A person commits an offence if: (a) the person does an act or omits to do an act; and (b) the act or omission breaches a condition of a consent."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "If"; "Conditional diffusion for breach of consent."; "(6) A person commits an offence if: (a) the person does an act or omits to do an act; and (b) the act or omission breaches a condition of a consent."; "modalities::diffusion"; 1.0000; . . a ; ; "Knowledge"; "Artificial agent's knowledge for breach of consent."; "(6) A person commits an offence if: (a) the person does an act or omits to do an act; and (b) the act or omission breaches a condition of a consent."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "15(7) Criminal offences relating to breaching a condition of a consent"@en; ; "727895f476d6aed02d887698725dd1d057890ea468669e0028a1994062171172"; ; "An offence against subsection (6) is an offence of strict liability."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.86"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Imposes a duty on the state."; "modalities::logic::deontic"; 1.0000; . a ; "15AA Civil penalty relating to breaching a condition of a consent"@en; ; "403b5a583aea68df9f5daef94dd707ce3350b594a6a1d12ba820d54c616294d0"; "Breach of consent condition results in civil penalty"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.87"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "forbid"; "Prohibits breach of consent condition"; "modalities::logic::deontic"; 1.0000; . a ; "15AB Conditions relating to exceptional release of biologicals"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.87". a ; "15AB(1) Conditions relating to exceptional release of biologicals"@en; ; "f783e0dd36667991e06cd9227a2b734381fd5ea7db420cb7fb6ce8aa30a7d204"; ; "Regulations may prescribe conditions for the supply of a biological after specified circumstances have occurred."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.87"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Regulations may prescribe conditions."; "modalities::logic::deontic"; 1.0000; . a ; "15AB(2) Conditions relating to exceptional release of biologicals"@en; ; "2f10fdee5add1510e2666b5af57b6761ae6cd4445d7cd630d3f5c526bcbf8c9f"; ; "Conditions must apply only to the person supplying biologicals."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.87"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "mustApply"; "Mandatory application of conditions."; "modalities::logic::deontic"; 1.0000; . a ; "15AB(3) Conditions relating to exceptional release of biologicals"@en; ; "3289f94d2efc39766757dcb95689fff0ea08ceaccf81afff9e502962bd7758c4"; ; "Committing an offence for breach of conditions"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.87"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Obligation to comply with conditions"; "(3) A person commits an offence if: (a) the person does an act or omits to do an act;"; "Penalty for contravention of this subsection:60 penalty units."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibition"; "Prohibition on breach of conditions"; "(3) A person commits an offence if: (a) the person does an act or omits to do an act;"; "Penalty for contravention of this subsection:60 penalty units."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Between"; "Temporal relationship between breach and penalty"; "(3) A person commits an offence if: (a) the person does an act or omits to do an act;"; "Penalty for contravention of this subsection:60 penalty units."; "modalities::interval_reasoning"; 0.5000; . . a ; ; "Recurring"; "Recurring trace of breach and penalty"; "(3) A person commits an offence if: (a) the person does an act or omits to do an act;"; "Penalty for contravention of this subsection:60 penalty units."; "modalities::temporal_ltl"; 0.5000; . a ; "15A Part does not apply to a medical device"@en; ; "19af70f5b76fbab4ad94ec5b26b972ed1461e7b81c80bcf1ed0b001995e240ef"; "Part does not apply to medical devices."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.88"; . a ; ; ; ; . a ; "15B Application of this Part to a biological"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.88". a ; "15B(1) Application of this Part to a biological"@en; ; "ceaebbfa15de5ef0c1e21b9a06d3867738b66cfa5a690bf3d85708cf47258d83"; ; "Application of this Part to biologicals on and after commencement."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.88"; . a ; ; ; ; . a ; "15B(2) Application of this Part to a biological"@en; ; "00b2be5e15867c0126189de54add995d634823985495fd252910d2800ab0b5f6"; ; "Continues application of this Part to biological goods after commencement."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.88"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "CONTINUES"; "Continues application of this Part."; "(2) If, immediately before the commencement of this section,"; "this Part continues to apply to the biological on and after that commencement until the time the biological is included in the Register under Part 3-2A."; "modalities::logic::deontic"; 1.0000; . . a ; ; "BEFORE"; "Temporal relationship between commencement and application."; "(2) If, immediately before the commencement of this section,"; "this Part continues to apply to the biological on and after that commencement until the time the biological is included in the Register under Part 3-2A."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "UNTIL"; "Temporal relationship between application and inclusion in Register."; "(2) If, immediately before the commencement of this section,"; "this Part continues to apply to the biological on and after that commencement until the time the biological is included in the Register under Part 3-2A."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "CONTINUES"; "Continued application of this Part."; "(2) If, immediately before the commencement of this section,"; "this Part continues to apply to the biological on and after that commencement until the time the biological is included in the Register under Part 3-2A."; "modalities::diffusion"; 1.0000; . . a ; ; "CLASSIFICATION"; "Classification of biological goods."; "(2) If, immediately before the commencement of this section,"; "the therapeutic goods that are a biological were registered goods or listed goods."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "15B(3) Application of this Part to a biological"@en; ; "730f6b1ece8c1746fc6f32b1978f698f0b7018f4a61a2e21b66bb4f6817197e2"; ; "Continuation of Part application to biological on commencement"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.88"; . a ; ; ; ; . a ; "16 Therapeutic goods and gazetted groups"@en; ; "332e821bf3e340d296550535e75847a6b2321f16e76111ab1ed0f75d5815c2bb"; "Therapeutic goods must be taken to be separate and distinct from other therapeutic goods if they have a different formulation, composition or design specification; or a different strength or size (disregarding pack size); or a different dosage form or model; or a different name;"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.89"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "!"; "Imposes an obligation to classify therapeutic goods based on the specified criteria."; "modalities::logic::deontic"; 1.0000; . a ; "18 Exempt goods"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.91". a ; "18(1) Exempt goods"@en; ; "f1f3a97704900f630fe0291ca069034029de2321979335422aacfe39d055df6c"; ; "Exempts therapeutic goods from operation of this Part"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.91"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "exempt"; "Imposes duty to exempt goods"; "modalities::logic::deontic"; 1.0000; . . a ; ; "subclassOf"; "Classifies goods into subclasses"; "(a) all therapeutic goods, except those included in a class of goods prescribed for the purposes of this paragraph;"; "modalities::dl"; 1.0000; . . a ; ; "subclassOf"; "Classifies goods into subclasses"; "(b) specified therapeutic goods;"; "modalities::dl"; 1.0000; . . a ; ; "subclassOf"; "Classifies goods into subclasses"; "(c) a specified class of therapeutic goods;"; "modalities::dl"; 1.0000; . a ; "18(2) Exempt goods"@en; ; "ccea44de4d3e5717f6b5659b3a70f6aed420bfe899c6c06b16ce5fdf6a32455a"; ; "Exemptions apply only to specified classes of persons."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.91"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "onlyIf"; "Conditional obligation"; "(2) An exemption in terms of paragraph (1)(a)"; "has effect only in relation to such classes of persons as are prescribed for the purposes of this subsection."; "modalities::logic::deontic"; 0.5000; . . a ; ; "during"; "Temporal scope of exemptions"; "(2) An exemption in terms of paragraph (1)(a)"; "relation to such classes of persons as are prescribed for the purposes of this subsection."; "modalities::interval_reasoning"; 0.5000; . . a ; ; "during"; "Temporal scope of exemptions"; "(2) An exemption in terms of paragraph (1)(a)"; "relation to such classes of persons as are prescribed for the purposes of this subsection."; "modalities::temporal_ltl"; 0.5000; . . a ; ; "influence"; "Scope of exemptions"; "(2) An exemption in terms of paragraph (1)(a)"; "relation to such classes of persons as are prescribed for the purposes of this subsection."; "modalities::diffusion"; 0.5000; . . a ; ; "classify"; "Classification of exempt goods"; "(2) An exemption in terms of paragraph (1)(a)"; "relation to such classes of persons as are prescribed for the purposes of this subsection."; "sparql_library::parsers::chk_parser"; 0.5000; . a ; "18(3) Exempt goods"@en; ; "6ee535136cad7fb5c40f8d191714985357ea21ddbe128482ca1206f4a098fd0c"; ; "Revocation of exemption takes effect after 28 days"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.91"; . a ; ; ; ; . . a ; ; "Applicable"; "Defines temporal interval for revocation"; "Revocation takes effect on a specified day"; "After 28 days from the regulations' effective date"; "modalities::interval_reasoning"; 1.0000; . a ; "18A Exemption because of emergency"@en; ; "855832e8c9d7a0db0654b5ff5c17af11d4771b4a7c0464e925ef4d02b8957ce0"; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.91". a ; "18A(1) Exemption because of emergency"@en; ; "c81c2842e24f2928f3352765250aa4233b3d148a051fd55fcab3bebd118600f0"; ; "Exemption from Division 2 operation due to emergency"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.91"; . a ; ; ; ; ; . a ; "18A(1A) Exemption because of emergency"@en; ; "07a26f6deb728139e5c268838e4418ede582d4279165f8b93742e68ff55431a6"; ; "Exemption from goods under subsection (1) based on Minister's satisfaction"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.91"; . a ; ; ; ; ; . . a ; ; "Permit"; "Granting permission"; "(1A) The Minister may exempt goods under subsection (1)"; "modalities::logic::deontic"; 0.5000; . a ; "18A(2) Exemption because of emergency"@en; ; "11bc4262c67a7abab627c65b11af1cb8240f0ca85b44f87eadc124421da02563"; ; "Exemption for stockpiling goods in emergency"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.91"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Creates an obligation for the state to make exemptions"; "modalities::logic::deontic"; 1.0000; . a ; "19 Approvals or authorities for certain uses"@en; ; , , , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.96". a ; "19(1) Approvals or authorities for certain uses"@en; ; "418b7252fa321a961fc1c830f772b554b5cbf8872395358bf998768b77ff1dbc"; ; "Approval for therapeutic goods importation or exportation with conditions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.96"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Grant"; "Approval grant"; "Secretary may grant approval"; "Approval granted"; "modalities::logic::deontic"; 1.0000; . a ; "19(1A) Approvals or authorities for certain uses"@en; ; "fdeda0cb1012356e741509244d21cb2c05e18bcaba6b6fa927f2c5efaa52455b"; ; "Approval conditions are subject to additional regulations."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.96"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "SUBJUNCTIVE"; "Conditional obligation"; "modalities::logic::deontic"; 0.5000; . a ; "19(2) Approvals or authorities for certain uses"@en; ; "0b8e578f3db5a8de62b31c3747a5eeb555da57071d6f3b281f59880be47d7daf"; ; "Application for approval must be made to the Secretary and meet certain requirements."; "Information relating to goods subject to application, evaluation fee"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.96"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Application must be made"; "modalities::logic::deontic"; 1.0000; . a ; "19(3) Approvals or authorities for certain uses"@en; ; "4d7b37901aba5715cfc400b300b48b7c6653e8fbf504a69b5595ff05c350bcf1"; ; "Approval conditions may include charges for therapeutic goods."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.96"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "includes"; "Includes charges in approval conditions."; "modalities::logic::deontic"; 1.0000; . a ; "19(4) Approvals or authorities for certain uses"@en; ; "2444276c81866ecd86b77a89a253735c272a7de395f037589e5c55cbc5e0431a"; ; "Notify applicant of decision on approval within 28 days."; "Reasons for decision (if not granting approval)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.96"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must notify applicant within 28 days."; "modalities::logic::deontic"; 1.0000; . . a ; ; ">="; "Temporal interval for decision notification."; "modalities::interval_reasoning"; 0.5000; . a ; "19(4A) Approvals or authorities for certain uses"@en; ; "a177de48d7bb05c6f28600096f16b73964fc7ac3dd87eaaf6d96583823b8b545"; ; "Conditions for experimental use of therapeutic goods in humans"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.96"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Regulation of experimental use"; "Use by a person for experimental purposes in humans"; "is subject to the conditions specified in the regulations"; "modalities::logic::deontic"; 0.5000; . a ; "19(4B) Approvals or authorities for certain uses"@en; ; "cd149ce253051ebb6df79648b8b080665d31575241ad02e46e5119769459f25d"; ; "Request for variation of therapeutic goods approval"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.96"; . a ; ; ; ; "borne by: State"; ; . a ; "19A Approvals where unavailability etc. of therapeutic goods"@en; ; "c08d18d286923cefe07aafbd020c063b168a8af45954d7225017ab722404396e"; "Secretary may grant approval for importation or supply of therapeutic goods under certain conditions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.101"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "grant"; "Secretary grants approval"; "(1) The Secretary may, by notice in writing..."; "...the goods that are the subject of the application are registered or approved for general marketing..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "during"; "Approval is granted during a specific period"; "(1) The Secretary may, by notice in writing..."; "...the goods that are the subject of the application are registered or approved for general marketing in at least one foreign country specified by the Secretary in a determination under subsection (3);..."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "everywhere"; "Approval applies to all therapeutic goods"; "(1) The Secretary may, by notice in writing..."; "...the goods that are the subject of the application are registered or approved for general marketing in at least one foreign country specified by the Secretary in a determination under subsection (3);..."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "if-then"; "Approval is conditional on certain conditions being met"; "(a) registered goods that could act as a substitute for the goods..."; "...the Secretary is satisfied that: (i) the goods that are the subject of the application are registered or approved for general marketing in at least one foreign country specified by the Secretary in a determination under subsection (3); or..."; "modalities::diffusion"; 1.0000; . . a ; ; "if-then"; "Approval is conditional on preliminary assessment of registration application"; "(b) either: (i) the goods that are the subject of the application are registered or approved for general marketing in at least one foreign country specified by the Secretary in a determination under subsection (3); or..."; "...an application under section 23 has been made for registration of the goods and the application has passed preliminary assessment;..."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "19B Criminal offences relating to registration or listing etc. of"@en; ; "6850b34595c7a4d6d003c209d3752a27321057f49c1488728829f39ad45044a8"; "Offences relating to importing, exporting, manufacturing or supplying goods for use in humans"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.105"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits importing, exporting, manufacturing or supplying goods for use in humans"; "modalities::logic::deontic"; 1.0000; . a ; "19C Notice required to adduce evidence in support of exception"@en; ; "77146b6ede20dfed3c542c124cb75182179bf06dcb289624c7d97eac832e7e37"; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.109". a ; "19C(1) Notice required to adduce evidence in support of exception"@en; ; "4180d440edbd45c3262d8e19038554bc4d417754b5a341c6e2fc8e504082ef06"; ; "Defendant must be informed of requirements and given a copy of the section."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.109"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Defendant must be informed."; "modalities::logic::deontic"; 1.0000; . a ; "19C(2) Notice required to adduce evidence in support of exception"@en; ; "2fb5cdbb61f9ca020106a6a2397abe081a92e8e8a25dcb5dc0e23a20f570769e"; ; "No evidence in support of exception can be adduced without notice."; "Notice of particulars of the exception"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.109"; . a ; ; ; ; ; . . a ; ; "Prohibit"; "Prohibition"; "modalities::logic::deontic"; 1.0000; . a ; "19D Civil penalties relating to registration or listing etc. of imported,"@en; ; "59dab709ccb4e7fa63b38d836473d44d9caed4b97b62abf5b77fbc560f14b7d9"; "Importing, exporting, manufacturing or supplying therapeutic goods for use in humans is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.111"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of importing, exporting, manufacturing or supplying therapeutic goods for use in humans."; "modalities::logic::deontic"; 1.0000; . a ; "20 Criminal offences relating to notifying the Secretary and to"@en; ; "e85aa15a1d9a68ba4e48d2e1d94c83fec7cb2f92ec2cb8bdcdedd6821d6c9770"; , , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.114". a ; "20(1B) Criminal offences relating to notifying the Secretary and to"@en; ; "394de7b75dbb4ab307e3656a4f9fe8961e04f95d6396b3d76453698101245ad8"; ; "Importing, exporting, manufacturing, or supplying therapeutic goods without proper notification is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.114"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "Prohibit"; "Prohibition of actions"; "The person has not properly notified..."; "An offence is committed."; "modalities::logic::deontic"; 1.0000; . a ; "20(1C) Criminal offences relating to notifying the Secretary and to"@en; ; "2cc560039442327b97230baf25cfa97b64f4a0a793ac94735660b2d0a6e71d87"; ; "Manufacturer and premises must be notified to the Secretary."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.114"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide notification"; "Notification is required"; "Manufacturer and premises must be notified"; "modalities::logic::deontic"; 1.0000; . a ; "20(2A) Criminal offences relating to notifying the Secretary and to"@en; ; "41a35cb1369c61a41878ff59b79e8d2d1625130314effd8dbba8066893e511cb"; ; "Importation of therapeutic goods into Australia without exemption breaches a condition."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.114"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits importation of therapeutic goods without exemption."; "(2A) A person commits an offence..."; "...breaches a condition of the exemption."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlap"; "Identifies overlap between exemption conditions and importation."; "(2A) A person commits an offence..."; "...if the importation breaches a condition of the exemption."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Recurring"; "Identifies recurring breach of exemption conditions."; "(2A) A person commits an offence..."; "...if the goods are exempt under section 18A; and..."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Diffuse"; "Diffuses breach of exemption conditions."; "(2A) A person commits an offence..."; "...breaches a condition of the exemption."; "modalities::diffusion"; 1.0000; . . a ; ; "Analyze"; "Analyzes importation of therapeutic goods without exemption."; "(2A) A person commits an offence..."; "...if the goods are exempt under section 18A; and..."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "20(2B) Criminal offences relating to notifying the Secretary and to"@en; ; "06c2dde25a0e5b60ef8b0edea23d964be73ec2915121b83191402e72d78a55fc"; ; "Prohibition on strict liability for notifying the Secretary"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.114"; . a ; ; ; ; ; . . a ; ; "forbid"; "Prohibits strict liability"; "modalities::logic::deontic"; 1.0000; . a ; "20(2C) Criminal offences relating to notifying the Secretary and to"@en; ; "c4e02d263c7e4448227aaca4673c59435d2f0ad502c42258889e6b3be9ec92a6"; ; "Importation of therapeutic goods exempt under section 18A breaches a condition, committing an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.114"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits importation of therapeutic goods exempt under section 18A."; "(2C) A person commits an offence if: (a) the person imports therapeutic goods into Australia; and (b) the goods are exempt under section 18A; and (c) the importation breaches a condition of the exemption."; "Penalty: 60 penalty units."; "modalities::logic::deontic"; 1.0000; . . a ; ; "During"; "Importation occurs during the period when therapeutic goods are exempt."; "(a) The person imports therapeutic goods into Australia; and (b) the goods are exempt under section 18A; and (c) the importation breaches a condition of the exemption."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Recurring"; "Importation is a recurring action that breaches a condition."; "(a) The person imports therapeutic goods into Australia; and (b) the goods are exempt under section 18A; and (c) the importation breaches a condition of the exemption."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Spreads"; "Importation spreads to other actions that breach a condition."; "(a) The person imports therapeutic goods into Australia; and (b) the goods are exempt under section 18A; and (c) the importation breaches a condition of the exemption."; "modalities::diffusion"; 1.0000; . . a ; ; "Implicates"; "Importation implies that therapeutic goods are not exempt."; "(a) The person imports therapeutic goods into Australia; and (b) the goods are exempt under section 18A; and (c) the importation breaches a condition of the exemption."; "modalities::argumentation"; 1.0000; . a ; "20(2D) Criminal offences relating to notifying the Secretary and to"@en; ; "424ce4198ecfe8e2b9899030254aa8c31f45ef861c75b66ca3521f684be522d9"; ; "Offence of strict liability for notifying the Secretary and to"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.114"; . a ; ; ; ; ; . . a ; ; "Prohibit"; "Prohibits an offence under subsection (2C)"; "An offence under subsection (2C) is an offence of strict liability."; "modalities::logic::deontic"; 1.0000; . a ; "20A Civil penalty relating to the importation, exportation,"@en; ; "ecf0722fc03846acb3de4646f504b1ec898509d4ee2f5f32d638badf7515224c"; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.116". a ; "20A(1) Civil penalty relating to the importation, exportation,"@en; ; "2f05e789932ca7d0915d53f2e2fd4447137431616a5040d13b97259676fb91fb"; ; "Importation, exportation, manufacture, or supply of therapeutic goods without proper notification."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.116"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition"; "Importation, exportation, manufacture, or supply of therapeutic goods without proper notification."; "modalities::logic::deontic"; 1.0000; . a ; "20A(2) Civil penalty relating to the importation, exportation,"@en; ; "d1307bd01e6066d904a59bb2fff2e3062280512ba57781437d1c6e60fa12c8e7"; ; "Manufacturer and premises must be notified to the Secretary."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.116"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must notify the Secretary."; "modalities::logic::deontic"; 1.0000; . a ; "21 Offence relating to wholesale supply"@en; ; "391f25ba88de1d2d063a88a388d620f5e82b39f41093ee3b129290f5b63c787a"; "Supplying therapeutic goods without proper authorization is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.117"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits supplying therapeutic goods without proper authorization."; "modalities::logic::deontic"; 1.0000; . a ; "21A General criminal offences relating to this Part"@en; ; "3761e724949345bd4afb4fd92f44ec3fcb1847967ffca46dc3929cafdd314a2f"; "Making false or misleading statements in certification is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.117"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits making false or misleading statements in certification."; "The statement is made in or in connection with a certification."; "The person commits an offence if..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlap"; "The use of the medicine has resulted in, will result in, or is likely to result in harm or injury."; "(i) the use of the medicine has resulted in, will result in, or is likely to result in, harm or injury to any person;"; "...or (ii)"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Recurring"; "The use of the medicine would result in, or would be likely to result in, harm or injury."; "(ii) the use of the medicine, if the medicine were used, would result in, or would be likely to result in, harm or injury to any person."; "...or (ii)"; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Prohibit"; "The use of the medicine has resulted in, will result in, or is likely to result in harm or injury."; "(i) the use of the medicine has resulted in, will result in, or is likely to result in, harm or injury to any person;"; "...or (ii)"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibit"; "The use of the medicine would result in, or would be likely to result in, harm or injury."; "(ii) the use of the medicine, if the medicine were used, would result in, or would be likely to result in, harm or injury to any person."; "...or (ii)"; "modalities::logic::deontic"; 1.0000; . a ; "21B General civil penalties relating to this Part"@en; ; "e1d360b5c055794f8a5d4e6715fac0309559f3686cfb9507387e6bd5d2560737"; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.125". a ; "21B(1) General civil penalties relating to this Part"@en; ; "5654818f433c59f7fba0e5366d700314120c685e9a70ae8110cef3116d9b3efd"; ; "False statement in certification is prohibited"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.125"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of false statements"; "modalities::logic::deontic"; 1.0000; . a ; "21B(2) General civil penalties relating to this Part"@en; ; "732dd41ef3110f51ce07e89c4f1fa569244b4eb5d1c55fe1b612f88f9afc2170"; ; "Falsely representing therapeutic goods is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.125"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of falsely representing therapeutic goods."; "modalities::logic::deontic"; 1.0000; . a ; "21B(3) General civil penalties relating to this Part"@en; ; "5ae534a444e1562b7e341cf81cea721083655f755b11516b1b9c53643b0b7f91"; ; "Representing false information about therapeutic goods is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.125"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of representing false information about therapeutic goods."; "Representing false information is generally prohibited."; "This subsection prohibits representing false information about therapeutic goods."; "modalities::logic::deontic"; 1.0000; . a ; "22 General offences relating to this Part"@en; ; , , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.126". a ; "22(1) General offences relating to this Part"@en; ; "54d5b430fdb6c3b945f0ff94fd083c3ba094f4b3e461c5651e3e41e8a3f87562"; ; "Do not misrepresent therapeutic goods registration numbers."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.126"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "Prohibit"; "Prohibition of false representation"; "Registration number misrepresentation"; "No registration number may be misrepresented."; "modalities::logic::deontic"; 1.0000; . a ; "22(2) General offences relating to this Part"@en; ; "dbcd5760e78b3c3a7190f3dbcee8df4ec25ebdf312e54152201f302c48c76995"; ; "Advertising therapeutic goods for an unaccepted indication without harm risk"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.126"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of advertising therapeutic goods for an unaccepted indication without harm risk"; "(a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion;"; "The person commits an offence if..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Classify"; "Classification of therapeutic goods based on indications"; "(a) the use of the goods for the advertised indication has resulted in, will result in, or is likely to result in, harm or injury to any person; or (ii) the use of the goods for the advertised indication, if the goods were so used, would result in, or would be likely to result in, harm or injury to any person."; "The therapeutic goods are included in the Register;"; "modalities::dl"; 1.0000; . . a ; ; "Trace"; "Temporal tracing of advertising and harm risk"; "(a) the person, by any means, advertises therapeutic goods for an indication; (b) the therapeutic goods are included in the Register; (c) the indication is not an indication accepted in relation to that inclusion;"; "The use of the goods for the advertised indication has resulted in, will result in, or is likely to result in, harm or injury to any person;"; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Prohibit"; "Prohibition of advertising therapeutic goods for an unaccepted indication without harm risk"; "(a) the use of the goods for the advertised indication has resulted in, will result in, or is likely to result in, harm or injury to any person; or (ii) the use of the goods for the advertised indication, if the goods were so used, would result in, or would be likely to result in, harm or injury to any person."; "The therapeutic goods are included in the Register;"; "modalities::logic::deontic"; 1.0000; . a ; "22(3) General offences relating to this Part"@en; ; "ffa113ba0089f551015b8288bca27c98c78fb43fc47bc4159150aa74f8f8b534"; ; "Advertising therapeutic goods for an unaccepted indication is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.126"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of advertising therapeutic goods for an unaccepted indication."; "(3) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion."; "(3) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Classify"; "Classification of advertising as a general offence relating to this Part."; "(3) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion."; "(3) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion."; "modalities::dl"; 1.0000; . . a ; ; "Temporal Interval"; "Temporal interval of prohibited advertising."; "(3) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion."; "(3) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Recurring Trace"; "Recurring trace of prohibited advertising."; "(3) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion."; "(3) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Spread"; "Spread of prohibited advertising."; "(3) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion."; "(3) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion."; "modalities::diffusion"; 1.0000; . . a ; ; "Knowledge Representation"; "Knowledge representation of prohibited advertising."; "(3) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion."; "(3) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "22(5) General offences relating to this Part"@en; ; "c35dcb58492b8de241e7c81065177917123b379b0406afa519eeb4c7c4cdf5b1"; ; "Advertising therapeutic goods for an unaccepted indication is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.126"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of advertising therapeutic goods for an unaccepted indication."; "(5) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion."; "(Penalty: 100 penalty units.)"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Classify"; "Classification of therapeutic goods into the Register."; "(5) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion."; "modalities::dl"; 1.0000; . . a ; ; "Temporal Interval"; "Temporal interval for advertising therapeutic goods."; "(5) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Recurring Trace"; "Recurring trace of advertising therapeutic goods for unaccepted indications."; "(5) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Diffusion"; "Diffusion of advertising therapeutic goods for unaccepted indications."; "(5) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion."; "modalities::diffusion"; 1.0000; . . a ; ; "Classification"; "Classification of therapeutic goods into the Register."; "(5) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "22(5A) General offences relating to this Part"@en; ; "e09c665a178aca4b049ce40bda0aa53930d46c5574c03e3eb64db2a017233315"; ; "An offence against subsection (5) is an obligation."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.126"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "is"; "Definition of Obligation"; "(5A) An offence against subsection (5)"; "An offence against subsection (5) is an obligation."; "modalities::logic::deontic"; 1.0000; . a ; "22(6) General offences relating to this Part"@en; ; "d257c190edbdc2f77cd7a39630dd351fd63b47ea722e6d21eef4efc528fccd1e"; ; "Committing an offence requires doing or omitting an act."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.126"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits committing an offence."; "Doing or omitting an act."; "Committing an offence."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlaps"; "The act or omission must overlap with the provision's scope."; "Doing or omitting an act."; "Act or omission overlaps with the provision's scope."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Recurring"; "The act or omission must be recurring."; "Committing an offence requires doing or omitting an act."; "Act or omission is recurring."; "modalities::temporal_ltl"; 1.0000; . a ; "22AA Civil penalty for breaching conditions"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.130". a ; "22AA(1) Civil penalty for breaching conditions"@en; ; "68247ae45874e7a0674f2963b2d4aaa990e9665a2d6ec0a18871ba9adfb33325"; ; "Civil penalty for breaching conditions"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.130"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits breach of conditions"; "(1) A person contravenes this subsection..."; "...breaches a condition of the exemption."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlap"; "Identifies overlapping conditions and exemptions"; "(b) the goods are exempt under section 18A;"; "...and (c) the act or omission breaches a condition of the exemption."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Imply"; "Implies breach of conditions from exemptions"; "(b) the goods are exempt under section 18A;"; "...and (c) the act or omission breaches a condition of the exemption."; "modalities::argumentation"; 1.0000; . . a ; ; "Spread"; "Spreads breach of conditions to exemptions"; "(a) the person does an act or omits to do an act in relation to..."; "...and (c) the act or omission breaches a condition of the exemption."; "modalities::diffusion"; 1.0000; . . a ; ; "Analyze"; "Analyzes breach of conditions from exemptions"; "(a) the person does an act or omits to do an act in relation to..."; "...and (c) the act or omission breaches a condition of the exemption."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "22AA(2) Civil penalty for breaching conditions"@en; ; "a1535276d08396c59681d0e10995ffb98b3ddf0c7b54d483a553e2df14e1abe6"; ; "Civil penalty for breaching conditions"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.130"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of breach"; "(2) A person contravenes this subsection if..."; "modalities::logic::deontic"; 1.0000; . a ; "22A Criminal offences for false statements in applications for"@en; ; "29c9c30e0604515ced98b3d14fd88751a8f8e4b9bc69d483a67a257c14ab79fb"; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.131". a ; "22A(1) Criminal offences for false statements in applications for"@en; ; "662884e28ecce9081f048e40281cd39c73ba0665ebcc627ad28e1bba309cf43e"; ; "Making false statements in applications for registration of therapeutic goods is a criminal offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.131"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits making false statements in applications for registration of therapeutic goods."; "modalities::logic::deontic"; 1.0000; . a ; "22A(4) Criminal offences for false statements in applications for"@en; ; "082f04dd0b6ef2215af9bc84d5f568991c60b5d61ca2d8520a28a159714a9555"; ; "Making false statements in applications for registration of therapeutic goods is a criminal offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.131"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits making false statements in applications for registration of therapeutic goods."; "modalities::logic::deontic"; 1.0000; . a ; "22A(5) Criminal offences for false statements in applications for"@en; ; "992bedebf57a8075066fb0135c2c5b6d2166a2389f5bf0211c1f3d8656fa3a9c"; ; "Making false statements in applications for registration of therapeutic goods is an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.131"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits making false statements in applications for registration of therapeutic goods."; "modalities::logic::deontic"; 1.0000; . a ; "22B Civil penalty for false statements in applications for registration"@en; ; "1a762350399cc1c40c28a02315063a9ed2fe57a68b0824e2c1261159b1befd30"; "False statements in applications for registration are prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.132"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of false statements"; "modalities::logic::deontic"; 1.0000; . a ; "22C Applications for provisional determination"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.133". a ; "22C(1) Applications for provisional determination"@en; ; "4dda2e01c7e735393bea367da3573dc5dc0526ee053c1e541e2629a199dc2d11"; ; "Application for provisional determination of a medicine"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.133"; . a ; ; ; ; "borne by: NaturalPerson"; ; . . a ; ; "May"; "Permission to apply for provisional determination"; "modalities::logic::deontic"; 1.0000; . . a ; ; "HasPart"; "Relates to a medicine of a kind prescribed by the regulations"; "modalities::dl"; 1.0000; . a ; "22C(2) Applications for provisional determination"@en; ; "9c707f812b209b7cf457b62d7bed9e72c93f7bedde417e1dad6d9fdeef90999b"; ; "Application requirements for provisional determination"; "Information, application fee, and required documents"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.133"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Application must be made in accordance with a form approved by the Secretary"; "modalities::logic::deontic"; 1.0000; . a ; "22C(3) Applications for provisional determination"@en; ; "87da6b39abfca9e679160251c950ccb8b15aae35223b5de559d2df144a8efa33"; ; "Application for provisional determination may be required or permitted"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.133"; . a ; ; ; ; "borne by: State"; ; . a ; "22D Provisional determinations"@en; ; "87f857880be4cab55d90a591fec34adfd14e773dfaf78197a4393079675dbd1c"; "Secretary must decide on provisional determination"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.133"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must decide"; "modalities::logic::deontic"; 1.0000; . a ; "22E Period during which provisional determination is in force"@en; ; , , , , , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.134". a ; "22E(1) Period during which provisional determination is in force"@en; ; "affeeff2c4ee29d130531cbc207a9402886e3efacbecb702896a42bdb21640df"; ; "Provisional determination period"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.134"; . a ; ; ; ; . a ; "22E(2) Period during which provisional determination is in force"@en; ; "ce929780af9e9bf0e53882c2f822223230f644b899fd4c2f839c18d6c00a73a4"; ; "Defines initial period for provisional determination"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.134"; . a ; ; ; ; . a ; "22E(3) Period during which provisional determination is in force"@en; ; "3c6bbedecdd3447ef33f2be6151b74c5e23feb2e6ef4aa2001c6b02c7391ed1e"; ; "Application for extension of initial period"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.134"; . a ; ; ; ; "borne by: State"; ; . a ; "22E(4) Period during which provisional determination is in force"@en; ; "12b161e48b41a98012d242e0dd18254e485050fc7c2a5f89ede0216ac6bfaeb3"; ; "Application requirements for provisional determination"; "Application must be in a form approved by the Secretary, accompanied by the prescribed application fee, and made at least 28 days before the determination would otherwise cease to be in force."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.134"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Application must meet certain requirements"; "The application must be in a form approved by the Secretary, accompanied by the prescribed application fee, and made at least 28 days before the determination would otherwise cease to be in force."; "modalities::logic::deontic"; 1.0000; . . a ; ; "BETWEEN"; "Application must be made within a certain time frame"; "(4) The application must: (a) be in a form approved, in writing, by the Secretary; and (b) be made at least 28 days before the determination would otherwise cease to be in force; and (c) be accompanied by the prescribed application fee."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "BETWEEN"; "Application must be made within a certain time frame"; "(4) The application must: (a) be in a form approved, in writing, by the Secretary; and (b) be made at least 28 days before the determination would otherwise cease to be in force; and (c) be accompanied by the prescribed application fee."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "MUST"; "Application must meet certain requirements"; "(4) The application must: (a) be in a form approved, in writing, by the Secretary; and (b) be made at least 28 days before the determination would otherwise cease to be in force; and (c) be accompanied by the prescribed application fee."; "modalities::logic::deontic"; 1.0000; . a ; "22E(5) Period during which provisional determination is in force"@en; ; "ca5dcb8e0d429a42c7934d32375851bd9bbea7e5ebe940e3cb6b3f8cfe84f028"; ; "Secretary must decide to extend or refuse initial period"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.134"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must decide"; "modalities::logic::deontic"; 1.0000; . a ; "22E(6) Period during which provisional determination is in force"@en; ; "ef6b322e66683f73924ac0e2bc293e5fdbdd1c21753ce3ea514c481eeb35f336"; ; "Secretary may extend provisional determination period"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.134"; . a ; ; ; ; . a ; "22E(7) Period during which provisional determination is in force"@en; ; "4b39dba13b3eaf23a89b13ba1464d4193489158b52342185068fe247c4414af8"; ; "Provide written notice of decision and reasons for refusal"; "yes"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.134"; . a ; ; ; ; ; . . a ; ; "MUST"; "Obligation to provide notice"; "modalities::logic::deontic"; 1.0000; . a ; "22E(8) Period during which provisional determination is in force"@en; ; "97c8ccbdda1df675ef8bd42aebb8672a2c3679eec4cf43ac95fd715162f95313"; ; "Limitation on extension of provisional determination"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.134"; . a ; ; ; ; ; . . a ; ; "NOT"; "Prohibition on multiple extensions"; "(8) Only one extension may be given."; "modalities::logic::deontic"; 1.0000; . a ; "22E(9) Period during which provisional determination is in force"@en; ; "95b48c87e78c0ae0de468d5923bda9e164e0eaa888b2655c58c57c60120349d1"; ; "Provisional determination remains in force until application for provisional registration is made."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.134"; . a ; ; ; ; . a ; "22F Revocation of provisional determination"@en; ; "6e75ab479905bdbba7c1e57d0311cfe9c0adf3a3549977464ca792bb1bc13261"; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.136". a ; "22F(1) Revocation of provisional determination"@en; ; "c3b7ea528766e0821229958c2cf1d38d8b708e206b8ab94e364d749725fc17d5"; ; "Secretary may revoke provisional determination under certain conditions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.136"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "May revoke"; "modalities::logic::deontic"; 0.5000; . a ; "22F(2) Revocation of provisional determination"@en; ; "a4ab95190e8d5ff118255f57b6eb037858ddf791bcb3093e9304c4cb63e11422"; ; "Secretary must revoke provisional determination upon request."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.136"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide revocation notice"; "modalities::logic::deontic"; 1.0000; . a ; "22F(3) Revocation of provisional determination"@en; ; "6095127f050bb015300261ecf66d7e52f36db9a6dfe01734cae98fcb1d137eaf"; ; "Secretary must give written notice of revocation and set out reasons for revocation."; "written notice, reasons for revocation"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.136"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Secretary must perform action"; "modalities::logic::deontic"; 1.0000; . a ; "22F(4) Revocation of provisional determination"@en; ; "dc91b0f05e016673379c8d9c81d7e78899ac2988f4c99c5b96784cfeb60a8495"; ; "Revocation of provisional determination takes effect on the day notice is given."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.136"; . a ; ; ; ; . . a ; ; "Applicable"; "Defines temporal interval for revocation"; "day on which the Secretary gives notice"; "revocation takes effect"; "modalities::interval_reasoning"; 1.0000; . a ; "22G Scientific advice about aspects of quality, safety or efficacy of"@en; ; "afd816f87ccc696c3c4988fa0d05b4e252baa3d8553d2eb28dbc025d5dd95af9"; , , , , , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.138". a ; "22G(1) Scientific advice about aspects of quality, safety or efficacy of"@en; ; "a1a105729d985285f9cbc7d58614901743ba1d8e2abc83703567692dab733afc"; ; "Request for scientific advice on medicine registration"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.138"; . a ; ; ; ; "borne by: NaturalPerson"; ; . a ; "22G(2) Scientific advice about aspects of quality, safety or efficacy of"@en; ; "71f84d30a406b36156816a50aab1879bf5a771a54880484aa492e2c826c8a0ea"; ; "Each request must relate only to one aspect of the quality of the medicine."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.138"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Obligation to provide information"; "modalities::logic::deontic"; 1.0000; . a ; "22G(3) Scientific advice about aspects of quality, safety or efficacy of"@en; ; "e58faf240cb32f14cdb7698290a3ac8aacc1dba17ebfdd7ccd1a310a21b8bc9e"; ; "Request for scientific advice on medicine safety"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.138"; . a ; ; ; ; "borne by: NaturalPerson"; ; . a ; "22G(4) Scientific advice about aspects of quality, safety or efficacy of"@en; ; "83523cde186747144d290f2f30bd275bbc2022b9a1f77919610b86d042584783"; ; "Each request must relate only to one aspect of the safety of the medicine."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.138"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must relate only to one aspect"; "(4) Each request under subsection (3)"; "relate only to one aspect of the safety of the medicine."; "modalities::logic::deontic"; 1.0000; . . a ; ; "CONTAINS"; "Temporal interval for requests"; "(4) Each request under subsection (3)"; "relate only to one aspect of the safety of the medicine."; "modalities::interval_reasoning"; 1.0000; . a ; "22G(5) Scientific advice about aspects of quality, safety or efficacy of"@en; ; "bce34df4beb3e28ba1371beaf9c6105bf711c811446adbbe44c4b58838547165"; ; "Request for scientific advice on efficacy of medicine"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.138"; . a ; ; ; ; ; . a ; "22G(6) Scientific advice about aspects of quality, safety or efficacy of"@en; ; "466daec0fa29be269fb72a9f5a1b00bea9925ae3764dab2f441f98b68d3b98bb"; ; "Each request must relate only to one aspect of the efficacy of the medicine."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.138"; . a ; ; ; ; ; . . a ; ; "MUST"; "Must relate only to one aspect"; "modalities::logic::deontic"; 1.0000; . a ; "22G(7) Scientific advice about aspects of quality, safety or efficacy of"@en; ; "bd19c8840e08f2c8f1af0bb37cb1c1248628be60723330353160c6c68ca72aa0"; ; "Secretary must provide scientific advice in response to a request."; "true"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.138"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide"; "modalities::logic::deontic"; 1.0000; . a ; "22G(8) Scientific advice about aspects of quality, safety or efficacy of"@en; ; "db64be2ec6c5d53a6ef27be46264f411cdacf5cf95066766e37980917ec05cb3"; ; "Request must be made in accordance with a form approved by the Secretary and accompanied by the prescribed fee."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.138"; . a ; ; ; ; "borne by: LegalPerson"; ; . . a ; ; "MUST"; "Request must be made in accordance with a form approved by the Secretary."; "modalities::logic::deontic"; 1.0000; . a ; "22G(9) Scientific advice about aspects of quality, safety or efficacy of"@en; ; "062617911cbf7c95db18ffa777342e5a7c8216bf9553bf512d857dc3af2fb6e0"; ; "Request for information or document may be required or permitted"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.138"; . a ; ; ; ; "borne by: State"; ; . a ; "23 Applications generally"@en; ; "4f955fa3c7f22b223a79bdb3ba521358595094ca89f65b56b08ab9b16a1a1d1b"; "A person may make an application to the Secretary for registration or listing of therapeutic goods."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.140"; . a ; ; ; ; "borne by: NaturalPerson"; ; . . a ; ; "May"; "Permission to make an application"; "modalities::logic::deontic"; 1.0000; . a ; "23AA Applications for provisional registration of medicine"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.140". a ; "23AA(1) Applications for provisional registration of medicine"@en; ; "42792cb26f1d5310ba0ae38be4928487747a40aeafd7e7610f6e4697afb78c88"; ; "Application for provisional registration of medicine is taken to be an application for provisional registration if certain conditions are met."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.140"; . a ; ; ; ; "borne by: State"; ; . . a ; ; ">"; "Conditional obligation"; "Application made under section 23 for registration of medicine"; "Provisional determination under section 22D is in force"; "modalities::logic::deontic"; 1.0000; . a ; "23AA(2) Applications for provisional registration of medicine"@en; ; "c098c6f9015f9e24b099736913b5ab7e5703ef9bc9e2bc0499e0c2f2518ac41b"; ; "Application for provisional registration of new medicine must be made before end of provisional registration period."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.140"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Application for provisional registration of new medicine must be made before end of provisional registration period."; "modalities::logic::deontic"; 1.0000; . a ; "23A Classes of therapeutic goods"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.141". a ; "23A(1) Classes of therapeutic goods"@en; ; "4290e768cb89c6f3368142c7ebbedc4de9a52b29f7d4c6101291122206f62510"; ; "The Secretary may specify different classes of therapeutic goods."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.141"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "May"; "Permits the Secretary to take action."; "modalities::logic::deontic"; 1.0000; . a ; "23A(2) Classes of therapeutic goods"@en; ; "92cbcde2bcea90e50109c19d0e70dbc7de3b940367d14687de4e1098a48418c4"; ; "Specifies classes of therapeutic goods by reference to certain matters."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.141"; . a ; ; ; ; . a ; "23B Requirements relating to applications for registration of"@en; ; "f7974b3170ae19f70aa86c6f735ac1423d5e09a3482dcd31a792b5bd0ad3229d"; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.141". a ; "23B(1) Requirements relating to applications for registration of"@en; ; "8added4c93d31143b91d0609033975740caf58f4ff3161ea4a4ef8ccba22f106"; ; "Secretary must carry out assessment of requirements met in relation to application."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.141"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must carry out assessment"; "modalities::logic::deontic"; 1.0000; . a ; "23B(2) Requirements relating to applications for registration of"@en; ; "a6c54513db3ad429f47018e9afa6ba4efd0fea68c8af347aab2660327db39069"; ; "Application must be made in a specific manner"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.141"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must be made in accordance with the approved form"; "modalities::logic::deontic"; 1.0000; . . a ; ; "IS"; "Application must be made in a manner that is approved by the Secretary"; "modalities::dl"; 1.0000; . a ; "23C Requirements relating to applications for listing of therapeutic"@en; ; "6cbcba44011f176dc0c6a57bda4e764b1df7b821038bfa37bbba63d9e1603dd9"; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.144". a ; "23C(1) Requirements relating to applications for listing of therapeutic"@en; ; "b5fc69726bca042e3a2b94d11247026b151677e880c34963cb8573d9d012fee2"; ; "Application requirement for listing of therapeutic goods under section 26 or 26A."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.144"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Application requirement"; "modalities::logic::deontic"; 1.0000; . a ; "23C(2) Requirements relating to applications for listing of therapeutic"@en; ; "6f4e6b6a0e110c11650053374d4c34403c4842a6ca20d297562c7da1af2b791c"; ; "Application must comply with requirements to be listed."; "Information, application fee, and samples (if required)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.144"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "MUST"; "Application must comply with requirements."; "modalities::logic::deontic"; 1.0000; . a ; "23C(3) Requirements relating to applications for listing of therapeutic"@en; ; "82e864f2842157e8494809278fcd23f48d8d88f14221cf111bd7bf76ca8d1db6"; ; "Secretary may determine forms of information for application purposes."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.144"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "May impose obligation on the Secretary."; "modalities::logic::deontic"; 1.0000; . a ; "24 Applications for registration"@en; ; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.146". a ; "24(1) Applications for registration"@en; ; "10ecacdc7e418ce44ea412d07190077cbba0d5da5321f0540a57d10e276cd213"; ; "Application for registration of therapeutic goods under section 23 is required if certain conditions are met."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.146"; . a ; ; ; ; "borne by: LegalPerson"; ; . . a ; ; "requires"; "Application for registration is required"; "(a) an application is made for the registration of therapeutic goods under section 23; and (b) the goods are goods that are required to be registered; and (c) the application has passed preliminary assessment."; "modalities::logic::deontic"; 1.0000; . a ; "24(1A) Applications for registration"@en; ; "971553f423bfcf98dde61294ecbf4d903af1b6df7b029363826b84f2f71f8862"; ; "Applicant must pay evaluation fee"; "evaluation fee amount"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.146"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Duty to pay evaluation fee"; "modalities::logic::deontic"; 1.0000; . a ; "24(2) Applications for registration"@en; ; "d2966e67656883a64279bc5ef7ad530015eb760ff07bbf8c85500d060c96906b"; ; "Application for registration lapses if fee remains unpaid or application contains inaccurate information."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.146"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Application lapse due to non-payment or inaccuracy."; "(2) An application for registration of therapeutic goods lapses if..."; "...the amount became due and payable;"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlap"; "Temporal overlap between application lapse and fee payment deadline."; "(2) An application for registration of therapeutic goods lapses if..."; "...the day on which the amount became due and payable;"; "modalities::interval_reasoning"; 1.0000; . a ; "24(3) Applications for registration"@en; ; "494eb062214fcc052f393d4f3e64b7a1da9022983fe2ab21ced2e5fd7a9a572b"; ; "Defines individual patient data in relation to therapeutic goods."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.146"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "="; "Classifies individuals into categories"; "Demographic, biochemical and haematological information"; "Individual patient data"; "modalities::dl"; 1.0000; . . a ; ; "during"; "Describes temporal relationship between administration of goods and collection of data"; "Before, during and after the administration of the goods"; "Clinical trials"; "modalities::interval_reasoning"; 1.0000; . a ; "24A When evaluation fee due for payment"@en; ; "5d41302046d2bfaeaf44faf648e24df6fb80b3609d14f35c4a682b5eedf22970"; "Evaluation fee due on notification of amount"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.147"; . a ; ; ; ; "borne by: NaturalPerson"; ; . . a ; ; "due"; "Obligation to pay evaluation fee"; "Section 24A"; "Evaluation fee is due"; "modalities::logic::deontic"; 1.0000; . a ; "24B Payment of evaluation fee by instalments"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.147". a ; "24B(1) Payment of evaluation fee by instalments"@en; ; "3ff021854052314d2c78c33224804bd5a95fbca00826dfd624103a5824025f2e"; ; "Payment of evaluation fee by instalments"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.147"; . a ; ; ; ; . a ; "24B(2) Payment of evaluation fee by instalments"@en; ; "a5c45b8502bc913b48db234371b20106053773ca8b0946330636de263ed7c1a6"; ; "Payment of evaluation fee by instalments is not allowed if part of an instalment is unpaid."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.147"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "forbid"; "Prohibition"; "modalities::logic::deontic"; 1.0000; . . a ; ; "¬(A ∧ B)"; "Payment of evaluation fee by instalments is not allowed if part of an instalment is unpaid."; "(2) Regulations made for the purposes of subsection (1) may provide that a person is not allowed to pay an evaluation fee under section 24 by instalments..."; "modalities::linear"; 1.0000; . . a ; ; "¬(A ∧ B)"; "Payment of evaluation fee by instalments is not allowed if part of an instalment is unpaid."; "(2) Regulations made for the purposes of subsection (1) may provide that a person is not allowed to pay an evaluation fee under section 24 by instalments..."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "forbid"; "Payment of evaluation fee by instalments is not allowed if part of an instalment is unpaid."; "(2) Regulations made for the purposes of subsection (1) may provide that a person is not allowed to pay an evaluation fee under section 24 by instalments..."; "modalities::logic::deontic"; 1.0000; . a ; "24B(3) Payment of evaluation fee by instalments"@en; ; "839e5e1c70551a66043469b8456639715beffad0fa9e8be7a933dc8a9ed61c2b"; ; "Payment of evaluation fee by instalments is obligatory."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.147"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "obligation"; "Obligation"; "modalities::logic::deontic"; 1.0000; . a ; "24C Recovery of evaluation fee"@en; ; "fba16f99658a71db745e501a7b23381ce395fe98522fff70bf077e79f6030772"; "Recovery of evaluation fee is an obligation for the Commonwealth."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.147"; . a ; ; ; ; ; . . a ; ; "Obligation"; "Recovery of evaluation fee is an obligation."; "modalities::logic::deontic"; 1.0000; . a ; "24D Refund of evaluation fee where evaluation not completed within"@en; ; "94b0ba2c6c13c6b14bde96e2e5e97185fabb752195134d21bd27ba5aa69e166a"; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.148". a ; "24D(1) Refund of evaluation fee where evaluation not completed within"@en; ; "95cfa43c47d084701d28652008ad57d5378b002f363c79c04e405829cb04eb7d"; ; "This section applies to an application under section 23 in relation to therapeutic goods for the evaluation of which a period is prescribed under paragraph 63(2)(da)."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.148"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "applies"; "Section applies to an application under section 23"; "modalities::logic::deontic"; 1.0000; . a ; "24D(2) Refund of evaluation fee where evaluation not completed within"@en; ; "5147612c8740267eb21450819f4011215e386e6ab11273dadcd0fbcbc1c70648"; ; "Refund of evaluation fee if not completed within period"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.148"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Obligation to refund evaluation fee"; "(2) If..."; "25% of the evaluation fee must be refunded"; "modalities::logic::deontic"; 1.0000; . . a ; ; ">="; "Evaluation period is a temporal interval"; "but not within the period referred to in subsection (1)"; "25% of the evaluation fee must be refunded"; "modalities::interval_reasoning"; 1.0000; . a ; "24D(3) Refund of evaluation fee where evaluation not completed within"@en; ; "24f07e24a4cb3612037cc43e78d4a9273426742a4a55df84962d96208ea96d15"; ; "Notification of decision constitutes completion of evaluation."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.148"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligate"; "Notification of decision constitutes completion of evaluation."; "modalities::logic::deontic"; 1.0000; . a ; "24E Deemed refusal of application"@en; ; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.148". a ; "24E(1) Deemed refusal of application"@en; ; "7b74f3a4359e7edc46c5f6e3d9d5e24044d4e8db0e2c168a0c9b3342627f8adb"; ; "Deemed refusal of application"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.148"; . a ; ; ; ; "borne by: State"; ; . a ; "24E(2) Deemed refusal of application"@en; ; "7982b950bc59e92bafa420f3da92d0b12f8ec4a1575aefa9b0c90c2dd535dc9d"; ; "Applicant may give notice to treat application as refused if evaluation not completed"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.148"; . a ; ; ; ; ; . . a ; ; "May"; "Applicant may give notice to treat application as refused"; "modalities::logic::deontic"; 1.0000; . a ; "24E(3) Deemed refusal of application"@en; ; "e40c2499dea7ec1bcbc5ba602e3825b3015dabd80002dc59b55c2eed361c701e"; ; "Notice may be given at any time before evaluation is completed."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.148"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Permission to give notice at any time"; "modalities::logic::deontic"; 1.0000; . a ; "24E(4) Deemed refusal of application"@en; ; "4b5fa4a40f2f3ccb0d4ea9106b99d35608c7cfd2e677414343f75e8cec84f29e"; ; "Deemed refusal of application"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.148"; . a ; ; ; ; ; . a ; "25 Evaluation of therapeutic goods"@en; ; "20c3419d869a5e99429a6f76dde03bc8beb01c71c6ee4018189f44a0c5894d12"; "The Secretary must evaluate therapeutic goods for registration having regard to the quality, safety and efficacy of the goods."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.149"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "The Secretary must evaluate therapeutic goods for registration."; "modalities::logic::deontic"; 1.0000; . a ; "25AA Approved product information for medicine"@en; ; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.155". a ; "25AA(1) Approved product information for medicine"@en; ; "6217d2f4ee109a8e598cc5b8c958538a06d58af1397d084a712e2af173bb5e03"; ; "The Secretary must approve product information for therapeutic goods if certain conditions are met."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.155"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "The Secretary has a duty to approve product information."; "modalities::logic::deontic"; 1.0000; . a ; "25AA(1A) Approved product information for medicine"@en; ; "7bc01a0f2127b6482167ca2e450bdf3a7aea953b08e8ec65355aa798f5708858"; ; "Secretary must approve product information reflecting basis for registration."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.155"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Must"; "Mandatory approval requirement."; "modalities::logic::deontic"; 1.0000; . a ; "25AA(1B) Approved product information for medicine"@en; ; "95359503a63fbbe32182c682d6dcb104b635a7f58d3969943207ed0fbc3c93eb"; ; "Require person to provide product information for restricted medicine."; "Yes"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.155"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide product information."; "modalities::logic::deontic"; 1.0000; . a ; "25AA(1C) Approved product information for medicine"@en; ; "fda5cb4deeade7e8d990a8377df5e7c8bed8c39057f3407219fab5f50082121b"; ; "Secretary must approve product information if person complies with subsection (1B)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.155"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Obligation to approve product information"; "modalities::logic::deontic"; 1.0000; . a ; "25AB Registration of therapeutic goods etc."@en; ; , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.158". a ; "25AB(2) Registration of therapeutic goods etc."@en; ; "ec25583240eb7e3b0beabe5d66938d812cd43234cb3a9b0d30a1bf9b0806a443"; ; "Secretary must notify applicant within 28 days of decision to register therapeutic goods."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.158"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must notify applicant within 28 days."; "modalities::logic::deontic"; 1.0000; . a ; "25AB(3) Registration of therapeutic goods etc."@en; ; "292bccc54f2e81f998f6d13cbf9beea6c6611335e635e05dfe521c749b2c275b"; ; "The notice must set out certain information about the decision to register goods."; "(a) and (b)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.158"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "The notice must contain certain information."; "(a) and (b)"; "modalities::logic::deontic"; 1.0000; . a ; "25AB(4) Registration of therapeutic goods etc."@en; ; "0067ef10fc13f30c1d483d857a96a5f5dd6adff2563f9efd794136c1e2d27603"; ; "Secretary must include goods in Register and give applicant a certificate of registration."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.158"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Secretary must perform action."; "modalities::logic::deontic"; 1.0000; . a ; "25AB(5) Registration of therapeutic goods etc."@en; ; "05af4b5e647941efa1fb795999f12f0f1d566e635ae548fc6b1d7bb1e453b7a6"; ; "Secretary must register therapeutic goods without inquiry into correctness of certificate or notice."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.158"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Secretary must register therapeutic goods."; "modalities::logic::deontic"; 1.0000; . a ; "25AB(6) Registration of therapeutic goods etc."@en; ; "3b080a46097b485b8df65f1f2dfd6a9aaee0bf621bc71ee7766af04a4c3e389a"; ; "Commencement of therapeutic goods registration"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.158"; . a ; ; ; ; . . a ; ; "begins"; "Indicates the start of a process"; "(6) The registration of therapeutic goods commences on the day specified in the certificate of registration."; "The registration of therapeutic goods begins on the specified day."; "modalities::logic::deontic"; 1.0000; . . a ; ; "during"; "Indicates a temporal relationship between two events"; "(6) The registration of therapeutic goods commences on the day specified in the certificate of registration."; "The registration occurs during the specified day."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "then"; "Indicates a causal relationship between two events"; "(6) The registration of therapeutic goods commences on the day specified in the certificate of registration."; "The registration then occurs on the specified day."; "modalities::linear"; 1.0000; . . a ; ; "through"; "Indicates a means of transmission or application"; "(6) The registration of therapeutic goods commences on the day specified in the certificate of registration."; "The registration is transmitted through the specified day."; "modalities::diffusion"; 1.0000; . . a ; ; "by"; "Indicates a means of processing or application"; "(6) The registration of therapeutic goods commences on the day specified in the certificate of registration."; "The registration is processed by the specified day."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "25AC Notice of decision not to register therapeutic goods"@en; ; "4e912b5f5cb0d5f08ec2b8eceb6af21d16ad74e7d70585e9b4e75db392838891"; "Secretary must notify applicant of decision within 28 days."; "Reasons for the decision"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.159"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Secretary must notify applicant"; "modalities::logic::deontic"; 1.0000; . a ; "25A When the Secretary must not use protected information"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.159". a ; "25A(1) When the Secretary must not use protected information"@en; ; "bf6f9de40221e0563f4ca7f7376725c0321a64b4e754d6bc026a1342e72b19ee"; ; "Prohibition on using protected information when evaluating therapeutic goods for registration"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.159"; . a ; ; ; ; ; . . a ; ; "prohibition"; "Prohibition on using protected information"; "(1) When evaluating therapeutic goods for registration, the Secretary must not use information about other therapeutic goods that is protected information."; "modalities::logic::deontic"; 1.0000; . . a ; ; "duty"; "Duty to refrain from using protected information"; "(1) When evaluating therapeutic goods for registration, the Secretary must not use information about other therapeutic goods that is protected information."; "modalities::logic::deontic"; 1.0000; . a ; "25A(2) When the Secretary must not use protected information"@en; ; "36dba8202ce7dde4df81709557e366180f8ab28e7ae9771ca5daf5ffd43a9888"; ; "The Secretary must not use protected information."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.159"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of using protected information."; "(2) Information is protected information if..."; "...the Secretary must not use protected information."; "modalities::logic::deontic"; 1.0000; . a ; "26 Listing of therapeutic goods"@en; ; "44c0529b7264dced4a0ece3601f18204662a12e4409cf6c5f0ffe7966ed228e2"; "Listing of therapeutic goods"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.160"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligate"; "Listing of therapeutic goods"; "modalities::logic::deontic"; 1.0000; . . a ; ; ">="; "Temporal interval"; "modalities::interval_reasoning"; 1.0000; . a ; "26A Listing of certain medicines"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.164". a ; "26A(1) Listing of certain medicines"@en; ; "e81659a540d8704c660672ae1267969a8e6fe990e8e2bbc175a279f242cc063e"; ; "The Secretary must list a medicine if certain conditions are met."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.164"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "The Secretary must list the medicine."; "modalities::logic::deontic"; 1.0000; . a ; "26A(1A) Listing of certain medicines"@en; ; "9ff40943e2a0b5a4d6b49fc6f4076251ffb3bcd6f77f9fdad7bd77e2476e6620"; ; "Secretary must list medicine under subsection (1) without inquiring into the correctness of the certificate or notice."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.164"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Duty to list medicine"; "modalities::logic::deontic"; 1.0000; . a ; "26A(2) Listing of certain medicines"@en; ; "9c1fedd11d1abcd16718e171e420984dd6eb27bbcc389bee81caf6bb81161adf"; ; "Certify that medicine meets certain requirements."; "Certification of eligibility, safety, and presentation."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.164"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Obligation to certify"; "modalities::logic::deontic"; 1.0000; . a ; "26AB Application for listing of certain medicines following efficacy"@en; ; "50d1c4821a4146f9310da915d494bfd8462576196622274227ede249165f5053"; "Application for listing of certain medicines following efficacy"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.169"; . a ; ; ; ; "borne by: State"; ; . a ; "26AC Evaluation fees for listing of medicine under section 26AE"@en; ; , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.173". a ; "26AC(1) Evaluation fees for listing of medicine under section 26AE"@en; ; "c181b04960a50b57f2c454e94403406233eeb7d1d7ce6b9379377cc703b15d18"; ; "Application must pass preliminary assessment to be eligible for listing under section 26AE."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.173"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Application must pass preliminary assessment."; "Section 23 application"; "Eligible for listing under section 26AE."; "modalities::logic::deontic"; 1.0000; . . a ; ; "⇒"; "Preliminary assessment is a necessary condition for listing under section 26AE."; "Section 23 application"; "Eligible for listing under section 26AE."; "modalities::linear"; 1.0000; . . a ; ; "BETWEEN"; "Preliminary assessment must occur before listing under section 26AE."; "Section 23 application"; "Eligible for listing under section 26AE."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "IS_A"; "Preliminary assessment is a type of evaluation required for listing under section 26AE."; "Section 23 application"; "Eligible for listing under section 26AE."; "sparql_library::parsers::chk_parser"; 1.0000; . . a ; ; "IS_A"; "Preliminary assessment is a schema required for listing under section 26AE."; "Section 23 application"; "Eligible for listing under section 26AE."; "modalities::logic::shacl"; 1.0000; . a ; "26AC(2) Evaluation fees for listing of medicine under section 26AE"@en; ; "916ff028b072f3ab1a45a59e9888e6782d61e03ea3da501b3a80b44ed002845b"; ; "Payable evaluation fee for listing of medicine under section 26AE"; "Evaluation fee"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.173"; . a ; ; ; ; ; . . a ; ; "Obligation"; "Payable obligation"; "Pay evaluation fee"; "modalities::logic::deontic"; 1.0000; . a ; "26AC(3) Evaluation fees for listing of medicine under section 26AE"@en; ; "13af40081538133bbea3700fe7abfc64c0763839b100a23411b3b3d3c419fc9f"; ; "Secretary must notify applicant of evaluation fee amount."; "Evaluation fee amount"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.173"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide notification"; "modalities::logic::deontic"; 1.0000; . a ; "26AC(4) Evaluation fees for listing of medicine under section 26AE"@en; ; "6e22db43b6d5bd8f4cca91af9ae2cdd09989370eb4ef58fc22e2aff6150873ec"; ; "Evaluation fee payable by applicant on notification of evaluation fee amount"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.173"; . a ; ; ; ; ; . . a ; ; "due"; "Due payment obligation"; "(4) The evaluation fee payable by an applicant:"; "modalities::logic::deontic"; 1.0000; . . a ; ; "recoverable"; "Recoverable debt due to Commonwealth"; "(b) may be recovered by the Commonwealth as a debt due to the Commonwealth."; "modalities::logic::deontic"; 1.0000; . a ; "26AC(5) Evaluation fees for listing of medicine under section 26AE"@en; ; "1d01f11d5556c8a7d7b129bb4dbce2c96fc117499c1977db49193d905b960050"; ; "Pay evaluation fee before listing medicine under section 26AE"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.173"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must pay evaluation fee"; "modalities::logic::deontic"; 1.0000; . a ; "26AD Lapsing and deemed refusal of applications for listing of"@en; ; "68f39f5b384d9e42a9e3cb3607877a04c5a02447c47a83d8f1956cb38f3ba234"; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.174". a ; "26AD(1) Lapsing and deemed refusal of applications for listing of"@en; ; "2f48ee7c329bb51cdd1133b86228ee5acca88aee897c51817b7a0b59b3cf72e0"; ; "Application lapses if evaluation fee remains unpaid or application contains inaccurate information."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.174"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Forbid"; "Application lapses if evaluation fee remains unpaid or application contains inaccurate information."; "modalities::logic::deontic"; 1.0000; . a ; "26AD(2) Lapsing and deemed refusal of applications for listing of"@en; ; "1465f4763738f52663786d329b843c55880f4d2a367b5953af304d465390f57c"; ; "Applicant may give notice to treat application as refused if evaluation not completed within prescribed period."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.174"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Obligation to complete evaluation within prescribed period."; "(2) If..."; "the applicant may give the Secretary written notice..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Temporal Interval"; "Prescribed period within which evaluation must be completed."; "(a) regulations made for the purposes of paragraph 63(2)(daaaa)..."; "...the applicant may give the Secretary written notice..."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Recurring Trace"; "Evaluation must be completed within prescribed period."; "(b) at the end of that period, the evaluation has not been completed;"; "...the applicant may give the Secretary written notice..."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Knowledge Representation"; "Classification and evaluation process."; "(2) If..."; "...the applicant wishes to treat the application as having been refused."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "26AD(3) Lapsing and deemed refusal of applications for listing of"@en; ; "f6935edd328a78ea5580293618e2d1cf082e2be98d62e6e5126d9a47add65522"; ; "Notice may be given at any time before evaluation is completed."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.174"; . a ; ; ; ; ; . a ; "26AD(4) Lapsing and deemed refusal of applications for listing of"@en; ; "d6c60b67c7ca0387b59b91f297b815ad1334a0a74ded09b97115d5a5ebad5263"; ; "Refusal of listing of medicine without notice"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.174"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits listing of medicine"; "(4) If a notice has been given"; "modalities::logic::deontic"; 1.0000; . a ; "26AE Evaluation and listing of certain medicines"@en; ; "163e44b102626149bbbfb058eee4fcfa7748b40949629e0a1a4ff058f3bb548b"; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.175". a ; "26AE(1) Evaluation and listing of certain medicines"@en; ; "9b69e3def574e8f5c29ce54751d651e6f2612a0034eda1269ef7cb0028f356f1"; ; "The Secretary must evaluate a medicine if an application has passed preliminary assessment."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.175"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "The Secretary must evaluate the medicine."; "(a) an application is made under section 23 for the listing of a medicine in relation to a person under this section; and (b) the application has passed preliminary assessment;"; "the Secretary must evaluate the medicine having regard to..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "MUST NOT"; "The Secretary must not use restricted information when evaluating the medicine."; "Note: The Secretary must not use restricted information when evaluating the medicine for listing: see section 26AF;"; "the Secretary must not use restricted information when evaluating the medicine for listing:"; "modalities::logic::deontic"; 1.0000; . a ; "26AE(2) Evaluation and listing of certain medicines"@en; ; "40ab2f3548db614f935a5dfd982f4aef037e638a26f61ca94c89f7ea6524dd1a"; ; "Evaluation must be completed within a prescribed period."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.175"; . a ; ; ; ; ; . . a ; ; "MUST"; "Obligation to complete evaluation"; "modalities::logic::deontic"; 1.0000; . a ; "26AE(3) Evaluation and listing of certain medicines"@en; ; "f28faf5bb7ab09fd3a30c3a441182bc6cb7f981f893590a039e154124a85f148"; ; "Secretary must decide whether to list a medicine after evaluation."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.175"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Duty obligation"; "modalities::logic::deontic"; 1.0000; . a ; "26AF When the Secretary must not use restricted information in"@en; ; "43ce1ef0621d8809a8ecb431e9fa340a57a6cb806b8cb042cc97695bdd5a0706"; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.177". a ; "26AF(1) When the Secretary must not use restricted information in"@en; ; "e7f720c8a8d60d6b73ef9ca7f7b452a6db512553edc7cc455076b0251a8ac7b1"; ; "Must not use restricted information in evaluating a medicine under section 26AE."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.177"; . a ; ; ; ; ; . . a ; ; "MustNotUse"; "Prohibition on using restricted information"; "Application for listing a medicine under section 26AE"; "Evaluating the medicine under section 26AE"; "modalities::logic::deontic"; 1.0000; . . a ; ; "MustNotUse"; "Prohibition on using restricted information in evaluating a medicine under section 26AE"; "Section 23 application for listing a medicine under section 26AE"; "Evaluating the medicine under section 26AE"; "modalities::logic::deontic"; 1.0000; . . a ; ; "During"; "Use of restricted information during evaluation of a medicine under section 26AE"; "Section 23 application for listing a medicine under section 26AE"; "Evaluating the medicine under section 26AE"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Until"; "Prohibition on using restricted information until evaluation of a medicine under section 26AE is complete"; "Section 23 application for listing a medicine under section 26AE"; "Evaluating the medicine under section 26AE"; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Through"; "Use of restricted information through evaluation of a medicine under section 26AE"; "Section 23 application for listing a medicine under section 26AE"; "Evaluating the medicine under section 26AE"; "modalities::diffusion"; 1.0000; . a ; "26AF(2) When the Secretary must not use restricted information in"@en; ; "dbb6878db05404f908585085eea8323583b86aeb5a17c9906e0188639571b4a6"; ; "The Secretary must not use restricted information in certain circumstances."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.177"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of using restricted information"; "The Secretary must not use..."; "...in certain circumstances."; "modalities::logic::deontic"; 1.0000; . a ; "26B Certificates required in relation to patents"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.179". a ; "26B(1A) Certificates required in relation to patents"@en; ; "ed55e9d6a79bca6142602eabd59f29f105e4645adcdfb40631e9c8b228bfa42e"; ; "Applicant must provide evidence or information submitted by another person."; "true"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.179"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "MUST"; "Must provide evidence or information."; "modalities::logic::deontic"; 1.0000; . a ; "26B(1) Certificates required in relation to patents"@en; ; "071618007d9b8ebfa61f8300f2734914f1920b3ff24afe5803bc941043342ffd"; ; "Applicant must provide a certificate stating their intentions regarding patent infringement."; "true"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.179"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "Obligation"; "Applicant has an obligation to provide a certificate."; "modalities::logic::deontic"; 1.0000; . a ; "26B(2) Certificates required in relation to patents"@en; ; "4455acf9b7cc062b151d65536562f766bf2d2696559a2ac8e18fc150f50ececd"; ; "Giving a false or misleading certificate is an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.179"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits giving a false or misleading certificate."; "The person gives a certificate required under subsection (1)."; "The person commits an offence if the certificate is false or misleading in a material particular."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Obligation"; "Requires giving a true and accurate certificate."; "A person commits an offence if: (a) the person gives a certificate required under subsection (1);"; "The person must give a true and accurate certificate."; "modalities::logic::deontic"; 1.0000; . a ; "26BA Approved form for notices"@en; ; "107fe1080d93d8dcb19b8cbd489e47095a2c992666a2796b36e35ec7004a1e6e"; "Permits notice to be given in accordance with specified software requirements."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.180"; . a ; ; ; ; ; . . a ; ; "hasClass"; "Defines a class for notices"; "modalities::dl"; 1.0000; . . a ; ; "requires"; "Requires notice to be given in accordance with specified software requirements"; "modalities::logic::deontic"; 1.0000; . a ; "26BB Permissible ingredients"@en; ; , , , , , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.180". a ; "26BB(1) Permissible ingredients"@en; ; "ba7878164f2bb10c2137ff23c805d417a5530147eac4af48d6a0c0aec38c7f82"; ; "The Minister may make a determination specifying ingredients for medicine."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.180"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "May"; "Permission to specify ingredients"; "modalities::logic::deontic"; 1.0000; . a ; "26BB(2) Permissible ingredients"@en; ; "8665877e41f5718d6e1d1fd747f4b4d2fbd3bae58eb640c860cf226496fcbc6b"; ; "Permits particular ingredients not being contained in particular medicine."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.180"; . a ; ; ; ; ; . a ; "26BB(2A) Permissible ingredients"@en; ; "7521c10892f3eda896cba3e154b1b789dff2de2a0238e3e87ef96cccc92d212f"; ; "Permits specific circumstances for a particular ingredient in medicine."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.180"; . a ; ; ; ; ; . . a ; ; "Permit"; "Allows specified conditions."; "(2A) The requirements referred to in paragraph (1)(b)"; "may relate to a particular ingredient being contained in particular medicine only in the circumstances specified in the determination in relation to the ingredient."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Temporal Interval"; "Defines temporal scope."; "(2A) The requirements referred to in paragraph (1)(b)"; "The requirements relate to a particular ingredient being contained in particular medicine only in the circumstances specified in the determination in relation to the ingredient at some point in time."; "modalities::interval_reasoning"; 0.5000; . . a ; ; "Temporal Trace"; "Defines temporal relationship."; "(2A) The requirements referred to in paragraph (1)(b)"; "The requirements relate to a particular ingredient being contained in particular medicine only in the circumstances specified in the determination in relation to the ingredient over some period of time."; "modalities::temporal_ltl"; 0.5000; . . a ; ; "Spread"; "Describes information spread."; "(2A) The requirements referred to in paragraph (1)(b)"; "The requirements relate to a particular ingredient being contained in particular medicine only in the circumstances specified in the determination in relation to the ingredient over some period of time."; "modalities::diffusion"; 0.5000; . . a ; ; "Knowledge Representation"; "Describes knowledge representation."; "(2A) The requirements referred to in paragraph (1)(b)"; "The requirements relate to a particular ingredient being contained in particular medicine only in the circumstances specified in the determination in relation to the ingredient."; "sparql_library::parsers::chk_parser"; 0.5000; . a ; "26BB(3) Permissible ingredients"@en; ; "82770451d008d3e4c99d12ae829f37cff24889c0fed3cf28fdc7f6e115925c98"; ; "Permitted concentrations or amounts of ingredients"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.180"; . a ; ; ; ; ; . a ; "26BB(4) Permissible ingredients"@en; ; "0c0f873f053d93d59b3548a490b51855491ffe4c035fcd61335842393bac9306"; ; "Permits certain subsections not to limit paragraph (1)(b)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.180"; . a ; ; ; ; ; . a ; "26BB(5) Permissible ingredients"@en; ; "19884e377c89833f95c869e92e9dc112940c4d1ba6f1aac5d6c8a8cd18d0a041"; ; "Determination may make different provision for different classes of medicine."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.180"; . a ; ; ; ; ; . a ; "26BB(6) Permissible ingredients"@en; ; "3fa0ee0c720e8758aa40b7ec16366baaf6f2b348d97eace792a19025a9717e06"; ; "The Minister may make a determination specifying ingredients and requirements."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.180"; . a ; ; ; ; ; . . a ; ; "May"; "Permission to determine ingredients and requirements."; "modalities::logic::deontic"; 1.0000; . a ; "26BB(7) Permissible ingredients"@en; ; "7859e7bceecb6375c80ad8aaf63a4cd1dd9f520f4aad3f84e405e9135efe5917"; ; "Different classes of medicine may be treated differently under a determination."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.180"; . a ; ; ; ; ; . a ; "26BB(8) Permissible ingredients"@en; ; "4dd6abff750264d632080eddaa6c5475d4fb2271f02d2090219e8b3b51544bb2"; ; "Allows provision in relation to a matter by applying, adopting or incorporating any matter contained in an instrument or other writing."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.180"; . a ; ; ; ; ; . a ; "26BC Variation of determination under section 26BB—Minister’s"@en; ; "aa223413af93e4bd5dd2e0f8bfd83361070a7b4940487ea33cded984058a88c9"; "Minister may vary a determination under section 26BB."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.181"; . a ; ; ; ; ; . . a ; ; "may"; "Expresses permission or obligation."; "modalities::logic::deontic"; 1.0000; . a ; "26BD Requirements relating to an application for variation of a"@en; ; "826752f897ea707fdb0078f8a1e2183d31cbfd89102d983eacf57c0aeadd17f7"; , , , , , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.182". a ; "26BD(1) Requirements relating to an application for variation of a"@en; ; "4e5ebf4e4e4aca5852ae141ee97a6099b1f93d56ba0c1fb577a2a4ddd65c752d"; ; "A person may make an application to the Secretary for a recommendation by the Secretary that the Minister vary a section 26BB determination."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.182"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "May"; "Permission to make an application"; "modalities::logic::deontic"; 1.0000; . a ; "26BD(2) Requirements relating to an application for variation of a"@en; ; "4865dd3262bdc814229929d9b3aa6d6ffce445db5e998d0b98a740555dbf58e9"; ; "Secretary must carry out assessment of requirements met in relation to application."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.182"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must carry out assessment"; "modalities::logic::deontic"; 1.0000; . a ; "26BD(3) Requirements relating to an application for variation of a"@en; ; "0b3f93b32a4e8b70cb85387c9cb421eddaa7c9c5f01fd828b433fbae4df6d62c"; ; "Application requirements for variation of a"; "information determined under subsection (8) and in a form determined under subsection (9)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.182"; . a ; ; ; ; "borne by: LegalPerson"; ; . . a ; ; "MUST"; "Application must meet certain requirements"; "modalities::logic::deontic"; 1.0000; . a ; "26BD(4) Requirements relating to an application for variation of a"@en; ; "dd9e85813a1135c98b20a4dd3133f1139f0213616a37164dda5d35ef4577567f"; ; "The Secretary must be satisfied that the requirements have been met."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.182"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Satisfies"; "The Secretary must be satisfied."; "(a) has carried out an assessment, under subsection (2), in relation to the application;"; "is satisfied that the requirements set out in subsection (3) have been met in relation to the application."; "modalities::logic::deontic"; 1.0000; . . a ; ; "During"; "The assessment must occur during a specific time period."; "(a) has carried out an assessment, under subsection (2), in relation to the application;"; "The assessment occurs during this time period."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Until"; "The requirements must be met until a specific point in time."; "(b) is satisfied that the requirements set out in subsection (3) have been met in relation to the application;"; "The requirements are met until this point in time."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "If-Then"; "There is a conditional relationship between the assessment and the satisfaction of the requirements."; "(a) has carried out an assessment, under subsection (2), in relation to the application;"; "The assessment implies that the requirements are met."; "modalities::diffusion"; 1.0000; . . a ; ; "Implication"; "There is a logical implication between the assessment and the satisfaction of the requirements."; "(a) has carried out an assessment, under subsection (2), in relation to the application;"; "The assessment implies that the requirements are met."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "26BD(5) Requirements relating to an application for variation of a"@en; ; "99b6420ae381d337f0cec7f9a615034a6a7da0d49ef5bba366c5df3d05a284f7"; ; "Secretary must give written notice to applicant stating application has passed preliminary assessment."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.182"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide written notice"; "modalities::logic::deontic"; 1.0000; . a ; "26BD(6) Requirements relating to an application for variation of a"@en; ; "4af6faddd57aa78b39caea73786da008c49bf5ffaa54393fc7e99ac75bbd5e1f"; ; "Refuse application if not passed preliminary assessment."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.182"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition"; "Application not passed preliminary assessment."; "Refuse application."; "modalities::logic::deontic"; 1.0000; . a ; "26BD(7) Requirements relating to an application for variation of a"@en; ; "75a11d8a79a2046b5b20f3257cf5a647f5c3879beafc817725217589c37e01d7"; ; "Specify software requirements for an application or information"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.182"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "requires"; "Requires specified software requirements"; "(7) An approval of a form mentioned in paragraph (3)(a)"; "may require or permit an application or information to be given in accordance with specified software requirements"; "modalities::dl"; 0.5000; . a ; "26BD(8) Requirements relating to an application for variation of a"@en; ; "203c97d1ed94269c5f3ff77b062e0ad8fc31958c0029b0819328247ba2d7c696"; ; "The Secretary may determine a kind of information for the purposes of subparagraph (3)(e)(i)."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.182"; . a ; ; ; ; "borne by: State"; ; . a ; "26BD(9) Requirements relating to an application for variation of a"@en; ; "ac3e3500ed495d6adcf72e74f38f7a60de5690ffeb14ebf85d01088b6565ee37"; ; "Application lapse due to inaccurate or misleading information"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.182"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of application lapse due to inaccurate or misleading information"; "(9) The Secretary may, by legislative instrument, determine a form of information for the purposes of subparagraph (3)(e)(ii)."; "If an application made under subsection 26BD(1) has passed preliminary assessment, the application lapses if: (a) the application contains information that is inaccurate or misleading in a material particular; or (b) information given to the Secretary by, or on behalf of, the applicant in connection with the application is inaccurate or misleading in a material particular; or (c) the evaluation fee prescribed for the purposes of paragraph 26BE(3)(b) has not been paid before the end of the period worked out in accordance with the regulations."; "modalities::logic::deontic"; 1.0000; . a ; "26BE Evaluation of whether to make recommendation for variation"@en; ; "4be8d46dc3eea9a5b5b56bbde3f96fdb7a4c62395b4739bc204ea641a27e685e"; "Evaluation of whether to make recommendation for variation of a section 26BB determination"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.183"; . a ; ; ; ; . . a ; ; "Applicable"; "Classifies the legal effect as Undertaking"; "No obligation, prohibition, permission, or right explicitly stated"; "Undertaking"; "modalities::logic::deontic"; 1.0000; . a ; "26BF Permissible indications"@en; ; , , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.186". a ; "26BF(1) Permissible indications"@en; ; "7eff2b77f392683d67fc42274a51be6d338b76471e590121f0f0c2d3573782a4"; ; "The Minister may make a determination in relation to indications."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.186"; . a ; ; ; ; ; . . a ; ; "may"; "Permission to make a determination"; "modalities::logic::deontic"; 1.0000; . a ; "26BF(2) Permissible indications"@en; ; "9c2e6715f958e751000f9ebe6f459a5525c44b6c49a03c73db2e96a5849dcc66"; ; "The Minister may consider therapeutic uses of a substance when making a determination."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.186"; . a ; ; ; ; ; . a ; "26BF(3) Permissible indications"@en; ; "327dd4082c69aff601db35b25cc8ca4c1e0cd37105d2db593fa78663cdaacd6f"; ; "The Minister may have regard in deciding whether to make a determination under subsection (1) in relation to a particular indication."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.186"; . a ; ; ; ; "borne by: State"; ; . a ; "26BF(4) Permissible indications"@en; ; "c7779374c793053dbffa3d62f0f8ea4ab7b43519194b92a777d6f4cda3312988"; ; "Permits use of particular indications in specified circumstances or under certain conditions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.186"; . a ; ; ; ; ; . . a ; ; "permittedBy"; "Specifies the permitted use of particular indications."; "modalities::logic::deontic"; 1.0000; . . a ; ; "during"; "Describes the temporal relationship between the use of indications and specified circumstances or conditions."; "modalities::interval_reasoning"; 1.0000; . a ; "26BF(5) Permissible indications"@en; ; "633729ca32b6b1bf9b86a2a76d6dfa2ae7de9b53fb8c054f35ae2e8ff62242a7"; ; "Permits different classes of medicines to have varying determinations."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.186"; . a ; ; ; ; ; . a ; "26BF(6) Permissible indications"@en; ; "d19355e47e9764bec9ee3e6e7aa48788613f60a8905b0e811e1e0fd852061fad"; ; "Allows for incorporation of existing instruments or writings with modifications."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.186"; . a ; ; ; ; ; . . a ; ; "permitted"; "Permits modification of incorporated matter"; "modalities::logic::deontic"; 1.0000; . a ; "26BG Limitations on determination under section 26BF"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.187". a ; "26BG(1) Limitations on determination under section 26BF"@en; ; "cf8a7a4a80269ac1742af096ad71343c0543721a6e38ed5195de68ade5419462"; ; "Minister may make a determination specifying indications that must not be covered by a determination under section 26BF(1)(a)."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.187"; . a ; ; ; ; . a ; "26BG(2) Limitations on determination under section 26BF"@en; ; "358a95c4c8f2b513d6037e4ba8c5ebc57dc1e0a807a182ad7f9c52f9603e370c"; ; "The determination may specify an indication either generally or in relation to specified circumstances."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.187"; . a ; ; ; ; "borne by: State"; ; . a ; "26BG(3) Limitations on determination under section 26BF"@en; ; "0c947be8ae6ab2447fe1e4fb5c80854f82cf4d310cdac2cf53a38f316135f6ae"; ; "Minister may vary or revoke determination under subsection (1)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.187"; . a ; ; ; ; . . a ; ; "May"; "Permission to vary or revoke"; "modalities::logic::deontic"; 1.0000; . a ; "26BH Variation of determination under section 26BF—Minister’s"@en; ; "ae6d1a8efc50b19ca236485d16087bfb9ab4aa67faea141c63a0aa0ca4bf5abb"; "Minister may vary determination under section 26BF on own initiative."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.187"; . a ; ; ; ; ; . . a ; ; "may"; "Expresses permission or obligation."; "modalities::logic::deontic"; 1.0000; . a ; "26BJ Variation of determination under section 26BF—application"@en; ; "083a12edc12ec8f343425200158471c55facfef6bea0775f80f1422db91eb7c3"; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.188". a ; "26BJ(1) Variation of determination under section 26BF—application"@en; ; "e6c5ce48a6ed40e23edb2993d189961dd03583ffebb15835d5a48a533f11803f"; ; "A person may apply for a recommendation to vary a determination under section 26BF."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.188"; . a ; ; ; ; "borne by: Agent"; ; . a ; "26BJ(2) Variation of determination under section 26BF—application"@en; ; "5fb9645a59ea8dbb365dcb95ab1c84ebda22167cd4ae10e048ddada157e9ff57"; ; "Application requirements for variation of determination under section 26BF"; "Form, application fee (if any), recommendation sought"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.188"; . 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 ; "26BJ(3) Variation of determination under section 26BF—application"@en; ; "32e582816daf7b7eec9abd7f4e546ad7156c991113057ddaf9a387ef7f5630ce"; ; "Cannot make an application for a recommendation that would affect certain types of indications."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.188"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition on making an application for a recommendation that would affect certain types of indications."; "(3) A person cannot make an application under subsection (1)"; "for the effect of which would be for the determination to cover any of the following:"; "modalities::logic::deontic"; 1.0000; . a ; "26C Certificates required in relation to patent infringement"@en; ; "f99c1f9de7186d02a99b51c9f669796df1494134a4005827ae9ab9c68b6630f6"; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.191". a ; "26C(1) Certificates required in relation to patent infringement"@en; ; "4df6de79faf9f73f8dd5ba0ad8c86c72b9d3847150376d0c0e88924e0c1b81e5"; ; "Certificate required for therapeutic goods patent infringement proceedings"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.191"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "requires"; "Requires certificate for patent infringement proceedings"; "(1) This section applies if: (a) a person gives a certificate required under subsection 26B(1) in relation to therapeutic goods; and (b) another person (the second person) intends to commence proceedings under the Patents Act 1990 against the person referred to in paragraph (1)(a) for infringement of a patent that has been granted in relation to the therapeutic goods (the proceedings)."; "(1) This section applies if: (a) a person gives a certificate required under subsection 26B(1) in relation to therapeutic goods; and (b) another person (the second person) intends to commence proceedings under the Patents Act 1990 against the person referred to in paragraph (1)(a) for infringement of a patent that has been granted in relation to the therapeutic goods (the proceedings)."; "modalities::logic::deontic"; 1.0000; . a ; "26C(2) Certificates required in relation to patent infringement"@en; ; "0718d97cd83999db20929ad35f3c1720ec8e0eb7f3be6dca718b5c25f19a3191"; ; "Second person must provide certificate before commencement of proceedings."; "true"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.191"; . a ; ; ; ; "borne by: NaturalPerson"; ; . . a ; ; "MUST"; "Must provide certificate"; "modalities::logic::deontic"; 1.0000; . a ; "26C(3) Certificates required in relation to patent infringement"@en; ; "a8efc7800acff85e6e8526ecc0471e74ac6a5beae8db86b39daded0aef1be30f"; ; "Certificate must be signed in good faith, with reasonable prospects of success, and without unreasonable delay."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.191"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Obligation to sign certificate in good faith, with reasonable prospects of success, and without unreasonable delay."; "modalities::logic::deontic"; 1.0000; . a ; "26C(4) Certificates required in relation to patent infringement"@en; ; "3fdd302be19ff048790ef4e14bde03c71525035c2b60ae2298589306dc58f287"; ; "Second person must have reasonable grounds for proceedings to have a chance of success"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.191"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Second person must have reasonable grounds"; "Reasonable prospects of success"; "Second person has a duty to investigate"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Possibility"; "Second person must know the circumstances"; "Circumstances known to the second person"; "Second person has knowledge of circumstances"; "modalities::epistemic"; 1.0000; . a ; "26D Requirements for interlocutory injunction"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.193". a ; "26D(1) Requirements for interlocutory injunction"@en; ; "ca9f7c82eda87c0bfbe75e90bdcc67c4a61fc47e4c961938bbac033642df912f"; ; "Notice to patentee required before applying for interlocutory injunction."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.193"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Requires"; "Notice is a requirement."; "Application for interlocutory injunction."; "Patentee must be notified."; "modalities::logic::deontic"; 1.0000; . a ; "26D(2) Requirements for interlocutory injunction"@en; ; "d1ab0007d75009ce24c298cb4ab482344771156203706773bc0fd2934fb3ce7e"; ; "No application for interlocutory relief can be instituted without prior notification to the Attorney-General."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.193"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of instituting an application without prior notification."; "The patentee must notify the Attorney-General before applying for interlocutory relief."; "No application can be instituted without prior notification."; "modalities::logic::deontic"; 1.0000; . a ; "27 Registration or listing number"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.195". a ; "27(1) Registration or listing number"@en; ; "db768849f074aa0a2828d48279455d60839b46e4a9c8fd2ccf08837ce1a1b2a7"; ; "Secretary must assign a unique registration or listing number to therapeutic goods included in the Register."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.195"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Duty obligation"; "modalities::logic::deontic"; 1.0000; . . a ; ; "CLASSIFICATION"; "Classification of therapeutic goods"; "modalities::dl"; 1.0000; . a ; "27(2) Registration or listing number"@en; ; "f91e1a408a10181c956fc5c519a6556ad0dffd7b29f009cce56db015bc7b6ec4"; ; "Secretary must assign a unique registration or listing number to grouped therapeutic goods."; "Registration or listing number"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.195"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Duty obligation"; "modalities::logic::deontic"; 1.0000; . . a ; ; "CLASSIFICATION"; "Classification of grouped therapeutic goods"; "modalities::dl"; 1.0000; . a ; "28 Conditions of registration or listing"@en; ; "66608fdbbc94f9ee48ed49abe82a4da01de111b29cc23d64e6ddab2fa3a13d47"; "Conditions for registration or listing of therapeutic goods"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.195"; . a ; ; ; ; . a ; "28A Certification of manufacturing steps outside Australia following"@en; ; "fd495c787aca056546d56e043ceeb42ae077d3498c3eca4ed8cb4cac45ee5589"; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.201". a ; "28A(1) Certification of manufacturing steps outside Australia following"@en; ; "0f921068e0c20fc906333d62e7d3474808ccf870ee565c97887cefc0453c0e66"; ; "Certification required for manufacture of medicine outside Australia"; "Step in manufacture of medicine to be carried out outside Australia"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.201"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Obligation to provide certification"; "modalities::logic::deontic"; 1.0000; . a ; "28A(2) Certification of manufacturing steps outside Australia following"@en; ; "c40ca69ba68dc6d1acb628395d5b4a6c34c19231ff493bebb89e7487c8768289"; ; "Secretary must give written notice of certification."; "written notice"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.201"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide written notice."; "The Secretary must give the person written notice of the certification."; "modalities::logic::deontic"; 1.0000; . a ; "28A(3) Certification of manufacturing steps outside Australia following"@en; ; "fd3e9539d9da12836ef942494f0b87df0739534b2f39123d784dec1c86f1db43"; ; "Certification requirement for manufacturing steps outside Australia"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.201"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Certification is required"; "modalities::logic::deontic"; 1.0000; . a ; "29 Duration of registration or listing"@en; ; , , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.202". a ; "29(1) Duration of registration or listing"@en; ; "8287395b6a5825496bceb82e8d2b62ad7a0e897875f0b14ff2e18f1473cc11bf"; ; "Goods remain in the Register until registration or listing is cancelled."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.202"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "holds"; "Holds true"; "modalities::logic::deontic"; 1.0000; . a ; "29(2) Duration of registration or listing"@en; ; "bf10e9e5a0ae6265b6df1f851103b819014fde4c19142e23630452a02112435c"; ; "Medicine provisional registration period"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.202"; . a ; ; ; ; . a ; "29(3) Duration of registration or listing"@en; ; "b35f241a759e4f4093406d84cc6b3a78fa51e60f6eaca234489d1da9eb441745"; ; "Defines provisional registration period for medicines"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.202"; . a ; ; ; ; . a ; "29(3A) Duration of registration or listing"@en; ; "92beafd442b62c52a761527ff9bd7f5ded74102583818ae92c2e83e582c74ad4"; ; "Defines provisional registration period for a new medicine"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.202"; . a ; ; ; ; . . a ; ; "⊆"; "Defines a temporal interval for the provisional registration period"; "(3A) Subject to this section, the provisional registration period..."; "The original period"; "modalities::interval_reasoning"; 1.0000; . a ; "29(4) Duration of registration or listing"@en; ; "fcff9bd55c8a4a785bc69f0bebfbcddf437b89af3bd3b41d85d9bba9c51fea23"; ; "Application for extension of provisional registration period"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.202"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MAY"; "May apply"; "modalities::logic::deontic"; 1.0000; . a ; "29(5) Duration of registration or listing"@en; ; "0b6eb52cddbaae195bd9e85bce5904e07721897b98080eac127e0e9a329530f0"; ; "Application must be in a specific form and contain required information."; "The application must be in a form approved by the Secretary and contain all required information."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.202"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Application must meet specific requirements."; "modalities::logic::deontic"; 1.0000; . a ; "29A Criminal offence for failing to notify adverse effects etc. of"@en; ; "089857f9c407941715faed7f7321a5534f6f825b0d2c074d86e62ffe95071d76"; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.206". a ; "29A(1) Criminal offence for failing to notify adverse effects etc. of"@en; ; "93646423d42b264996701ca0cc9181a2d819065ab88639e5d0e66cca40e9c0ec"; ; "Notify adverse effects of therapeutic goods to the Secretary."; "Information of a kind mentioned in subsection (2)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.206"; . a ; ; ; ; "borne by: NaturalPerson"; ; . . a ; ; "MUST"; "Obligation to notify"; "modalities::logic::deontic"; 1.0000; . a ; "29A(2) Criminal offence for failing to notify adverse effects etc. of"@en; ; "abc9f684f0006313e6699e947e5181a291c583244611539e91c9278e1b3e311b"; ; "Failing to notify adverse effects of goods may be a criminal offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.206"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition"; "modalities::logic::deontic"; 1.0000; . a ; "29AA Civil penalty for failing to notify adverse effects etc. of goods"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.207". a ; "29AA(1) Civil penalty for failing to notify adverse effects etc. of goods"@en; ; "570100f7ee8bc5d4a57af0690f857b3da7e3cf809012340739fc96154eb748c7"; ; "Failure to notify adverse effects of goods is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.207"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition"; "modalities::logic::deontic"; 1.0000; . a ; "29AA(2) Civil penalty for failing to notify adverse effects etc. of goods"@en; ; "52f2e2963cbf20d8ec7488cb535eda2b21a878c6eebfb017b0bd5a6c83d32631"; ; "Failing to notify adverse effects of goods is a civil penalty."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.207"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits failing to notify adverse effects of goods."; "The person under this Act must provide information about adverse effects."; "Failing to do so is a civil penalty."; "modalities::logic::deontic"; 1.0000; . a ; "29B Notification of adverse effects etc. where application withdrawn"@en; ; "2710565d187731f292c10ed89d60ea440515d5e3bd308eced61cf8ab126a2d78"; "Secretary must give applicant written notice requiring action upon withdrawal or lapse of application."; "written notice"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.207"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide written notice"; "modalities::logic::deontic"; 1.0000; . a ; "29C Civil penalties for failing to notify adverse effects etc. where"@en; ; "26f7008a3e14c5f1b0690933aaf97973ebb7934e05f46482c7347b1adb2ee083"; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.208". a ; "29C(1) Civil penalties for failing to notify adverse effects etc. where"@en; ; "5d2f03421854eb95932bca8b8a9745ad59d5b3584592c17b495b8748d0f99504"; ; "Failure to comply with notice requirements within 30 days"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.208"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of non-compliance"; "modalities::logic::deontic"; 1.0000; . a ; "29C(2) Civil penalties for failing to notify adverse effects etc. where"@en; ; "f6ef292cd31616c8905449b6efe4ea4289f5e9675cc4bed307eebbd347926ff5"; ; "False or misleading information in purported compliance with a notice"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.208"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "Prohibit"; "Prohibition of false or misleading information"; "Subsection 29B(1) notice"; "Contravention of subsection (2)"; "modalities::logic::deontic"; 1.0000; . a ; "29D Suspension of registration or listing"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.209". a ; "29D(1) Suspension of registration or listing"@en; ; "7b74bacb80fba500bae21a8cc90a5ef8ad69d5186155d06bac11b95d9f749e8d"; ; "Suspension of registration or listing of therapeutic goods"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.209"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition on therapeutic goods registration or listing"; "(1) The Secretary may, by written notice..."; "modalities::logic::deontic"; 1.0000; . a ; "29D(2) Suspension of registration or listing"@en; ; "46cbd9488123908351a439511c1a95545723d5fca818cb88c11365866e5c0168"; ; "Secretary must inform person of proposed suspension and set out reasons."; "written notice, reasons for suspension"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.209"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Duty to inform and provide reasons"; "modalities::logic::deontic"; 1.0000; . a ; "29E When suspension takes effect etc."@en; ; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.210". a ; "29E(1) When suspension takes effect etc."@en; ; "cba423e600d82e1f45b03d58012f254bff011358071708dde38319ee51448ec1"; ; "Suspension takes effect on specified day under certain conditions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.210"; . a ; ; ; ; "borne by: State"; ; . a ; "29E(2) When suspension takes effect etc."@en; ; "83d06539aa0a3c49b1f560b99af37efce17469cedc280413553841a535e98474"; ; "Suspension duration"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.210"; . a ; ; ; ; . a ; "29E(3) When suspension takes effect etc."@en; ; "c9dbaddeef8d6eb7a6e1a20e9488e5a857b99a4b0ca63e010f2e2b699c2c3262"; ; "Secretary may extend period specified in notice under subsection 29D(4) by a further specified period not exceeding 6 months."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.210"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "May"; "Permission to extend period"; "modalities::logic::deontic"; 1.0000; . a ; "29E(4) When suspension takes effect etc."@en; ; "d91547cb39b8cbb3d58b5a732d2affffb9f911813a926990a52ac66e539d57e6"; ; "Publish notice of extension particulars"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.210"; . a ; ; ; ; . a ; "29F Revocation of suspension"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.211". a ; "29F(1) Revocation of suspension"@en; ; "625a62824dfbab0eba69eed7192c2630727b6b1fec410aadcfd690313d091aa1"; ; "Secretary must revoke suspension upon certain conditions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.211"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Obligation to revoke suspension"; "(1) The Secretary must..."; "...revocation of suspension under section 29D"; "modalities::logic::deontic"; 1.0000; . a ; "29F(2) Revocation of suspension"@en; ; "4d6e54f170f95c6da10d96f9de6fc1bae0d626ab2fef65424b69122ad6ea278d"; ; "Secretary's power to revoke suspension may be exercised"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.211"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Permission granted by Secretary"; "modalities::logic::deontic"; 1.0000; . a ; "29F(3) Revocation of suspension"@en; ; "9dd33d88f45a6cb8d03d1adc13b339fdc9babc9b6f33b2e6507a32f794529e00"; ; "Publish notice of revocation within a specified timeframe."; "Notice setting out particulars of the revocation"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.211"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Duty to publish notice"; "The Secretary must cause to be published..."; "modalities::logic::deontic"; 1.0000; . a ; "29G Effect of suspension"@en; ; "19687dbf3cf6f1062248d965b09d18c5d743e786c2bff4af60c96a3328943ff2"; "Therapeutic goods not included in Register during suspension."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.212"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits dealing with suspended goods."; "modalities::logic::deontic"; 1.0000; . a ; "30 Cancellation of registration or listing"@en; ; "4e72502e6fb9343ecefe28b8caf513a45b082c92ff54bc6b276ea90bdb69186d"; "Cancellation of registration or listing of therapeutic goods under certain conditions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.212"; . a ; ; ; ; "borne by: State"; ; . . a ; ; ">"; "Risk assessment for cancellation"; "it appears to the Secretary that failure to cancel the registration or listing would create an imminent risk of death..."; "the person requests in writing the cancellation of the registration or listing"; "modalities::logic::deontic"; 1.0000; . . a ; ; "<"; "Timeframe for record availability"; "if the person was requested under that paragraph to make the record in question available at or before a requested time—before the end of the period of 24 hours after that time;"; "within 24 hours after the request was made"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "="; "Certification requirements for medicines"; "in the case of a medicine listed under section 26A, it appears to the Secretary that any of the certifications under paragraph 26A(2)(a), (ca), (cb), (e), (fba), (fd), (fe) or (g) are incorrect or..."; "the requirements under subsection 26A(3) or (4A) are not fulfilled"; "modalities::logic::deontic"; 1.0000; . . a ; ; "="; "Advertising regulations"; "there is a breach, involving the goods, of an applicable provision of the Therapeutic Goods Advertising Code or any other requirement relating to advertising applicable under"; "the Secretary is satisfied that the contravention is significant"; "modalities::logic::deontic"; 1.0000; . a ; "30A Revocation of cancellation of registration or listing upon"@en; ; "1f58b9145b24d108d7ac38887338b3ea3229833b9c1e418250343f907bfd1047"; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.218". a ; "30A(1) Revocation of cancellation of registration or listing upon"@en; ; "9415c9481d005faa05b017cb71ee6c4770af06641187d127ed223dd41881753a"; ; "Secretary may revoke cancellation upon request and payment of fee."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.218"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "May"; "Permits Secretary to revoke cancellation."; "modalities::logic::deontic"; 1.0000; . a ; "30A(2) Revocation of cancellation of registration or listing upon"@en; ; "50d87d298ae1a68ff51ca0ac5bcb60d83c6b4f5f49779a13a62cfec134a353b1"; ; "Cancellation is taken never to have occurred upon revocation."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.218"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Implies"; "If cancellation is revoked, then it is never taken to have occurred."; "Cancellation is revoked."; "Cancellation is taken never to have occurred."; "modalities::logic::deontic"; 1.0000; . a ; "30AA Revocation of cancellation of registration or listing—payment"@en; ; "0e6b489dd51eb00a9693aac35d8d430ea01aacd680fdec31cb9aa822bacb1ce7"; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.218". a ; "30AA(1) Revocation of cancellation of registration or listing—payment"@en; ; "aa30612e6b2aa57ffa3636fc3d692223d32d80ada135b2cf4f4f142b8398397e"; ; "Secretary may revoke cancellation of registration or listing under certain conditions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.218"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Permission to revoke cancellation"; "modalities::logic::deontic"; 1.0000; . a ; "30AA(2) Revocation of cancellation of registration or listing—payment"@en; ; "b1611a3c24d0d13560943610afc0164bb00527499bc6d6823ba3d4c9f02febaa"; ; "If cancellation is revoked, it is taken never to have occurred."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.218"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Implies"; "If A, then B."; "Cancellation is revoked."; "It is taken never to have occurred."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlaps"; "Temporal interval overlap."; "Cancellation is revoked."; "It is taken never to have occurred."; "modalities::interval_reasoning"; 1.0000; . a ; "30B Publication of cancellation of registration or listing"@en; ; "da3c41bf8618cf831752cc7369f69e9a7718aa59c156fc5d028d8208542e4530"; "Secretary must publish notice after cancellation of registration or listing."; "Notice setting out particulars of the cancellation."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.219"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Obligation to publish notice."; "modalities::logic::deontic"; 1.0000; . a ; "30C Consultation with Gene Technology Regulator"@en; ; , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.219". a ; "30C(1) Consultation with Gene Technology Regulator"@en; ; "ebad6a12a5cc3d786c241e27c5a98f5a8722450c5783e072f06905566dfe9b39"; ; "Application for listing or registration of a therapeutic good must pass preliminary assessment."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.219"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Therapeutic good must meet conditions."; "(1) This section applies to an application for listing or registration of a therapeutic good under section 23 if:"; "modalities::logic::deontic"; 1.0000; . a ; "30C(2) Consultation with Gene Technology Regulator"@en; ; "72f4b66640772a86767f0b5d10f6a70d034e87a7de72257b9ecf0218ca53659e"; ; "Secretary must give written notice to Gene Technology Regulator about application."; "Advice on application"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.219"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide notice"; "modalities::logic::deontic"; 1.0000; . a ; "30C(3) Consultation with Gene Technology Regulator"@en; ; "3d5d299bf76932c099e508d0af6ee43fab79648ef5191cf7bc1c4b603ebec156"; ; "The Gene Technology Regulator must provide written advice to the Secretary about a gene technology application."; "Yes"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.219"; . a ; ; ; ; ; . . a ; ; "MUST"; "The Gene Technology Regulator must provide written advice."; "modalities::logic::deontic"; 1.0000; . a ; "30C(4) Consultation with Gene Technology Regulator"@en; ; "00b1b875e100436c290e3e2970316321c0a13934db4ea38ff0fbcf8885da1a15"; ; "Consultation with Gene Technology Regulator within specified period."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.219"; . a ; ; ; ; ; . . a ; ; "MUST"; "Must provide consultation"; "The advice is to be given within the period specified in the notice."; "Obligation to consult"; "modalities::logic::deontic"; 1.0000; . . a ; ; "CONTAINS"; "Temporal interval for consultation"; "The advice is to be given within the period specified in the notice."; "Period defined as containing the time of consultation"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "IMPLIES"; "Implication from consultation requirement"; "The advice is to be given within the period specified in the notice."; "If advice is given, then it must be within a period"; "modalities::argumentation"; 1.0000; . . a ; ; "IS_A"; "Definition of consultation as giving advice"; "The advice is to be given within the period specified in the notice."; "Consultation defined as giving advice"; "modalities::diffusion"; 1.0000; . . a ; ; "IS_A"; "Definition of consultation as a cognitive process"; "The advice is to be given within the period specified in the notice."; "Consultation defined as a cognitive process"; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "30C(5) Consultation with Gene Technology Regulator"@en; ; "5f40412a2d7255cdc752c18f3acd09164aeec6439f54ee3a019896d4338fb35a"; ; "No notification required for therapeutic goods belonging to a class with an active advice from the Gene Technology Regulator."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.219"; . a ; ; ; ; ; . . a ; ; "exemption"; "Exemption from notification"; "Advice from the Gene Technology Regulator is in force"; "No notification required"; "modalities::logic::deontic"; 1.0000; . . a ; ; "subclassOf"; "Therapeutic goods belonging to a class with an active advice"; "Class of therapeutic goods"; "Subclass of goods subject to exemption"; "modalities::dl"; 1.0000; . a ; "30D Secretary may seek advice about classes of GM products or"@en; ; "07160fce713519494f31c57c608d3f2ff3f06e3142cabdc1488cb0a3b72e5d52"; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.220". a ; "30D(1) Secretary may seek advice about classes of GM products or"@en; ; "a7c4a188b8b20aee2456a64d4ada4f5ef001bb855227829c8a4bff6468d77441"; ; "The Secretary may request advice from the Gene Technology Regulator."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.220"; . a ; ; ; ; ; . . a ; ; "MAY"; "The Secretary may request advice."; "modalities::logic::deontic"; 1.0000; . . a ; ; "CLASSIFICATION"; "Classes of GM products specified in the request."; "modalities::dl"; 1.0000; . a ; "30D(2) Secretary may seek advice about classes of GM products or"@en; ; "4e51265a78ab04cf4897d038214b8031a92317bf59ed9b320dea0926eea7ef14"; ; "Request for advice must specify matters to which the advice is to relate."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.220"; . a ; ; ; ; ; . . a ; ; "MUST"; "Specify matters for advice"; "modalities::logic::deontic"; 1.0000; . a ; "30D(3) Secretary may seek advice about classes of GM products or"@en; ; "97b1b5fb649ef20fc4b0e5063ef3b7785799626f322d932d1e0d1119efefc4e4"; ; "Secretary must seek advice from Gene Technology Regulator on specified matters."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.220"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide written advice"; "Secretary requests advice"; "Gene Technology Regulator must provide written advice"; "modalities::logic::deontic"; 1.0000; . a ; "30D(4) Secretary may seek advice about classes of GM products or"@en; ; "2fe027cec6dac4534a3352fab9e417bee5b6d8e2f9cbbef87e72de4a0e43dafd"; ; "Advice from the Gene Technology Regulator remains in force until withdrawn."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.220"; . a ; ; ; ; ; . . a ; ; "holds"; "Holds advice from the Gene Technology Regulator."; "The Gene Technology Regulator gives advice to the Secretary."; "The advice remains in force until it is withdrawn by the Gene Technology Regulator."; "modalities::logic::deontic"; 1.0000; . . a ; ; "during"; "Advice from the Gene Technology Regulator lasts during its validity."; "The Gene Technology Regulator gives advice to the Secretary."; "The advice remains in force until it is withdrawn by the Gene Technology Regulator."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "until"; "Advice from the Gene Technology Regulator ends when it is withdrawn."; "The Gene Technology Regulator gives advice to the Secretary."; "The advice remains in force until it is withdrawn by the Gene Technology Regulator."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "diffuses"; "Advice from the Gene Technology Regulator diffuses to the Secretary."; "The Gene Technology Regulator gives advice to the Secretary."; "The advice remains in force until it is withdrawn by the Gene Technology Regulator."; "modalities::diffusion"; 1.0000; . . a ; ; "cognizes"; "The Secretary cognizes the advice from the Gene Technology Regulator."; "The Gene Technology Regulator gives advice to the Secretary."; "The advice remains in force until it is withdrawn by the Gene Technology Regulator."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "30E Secretary to take advice into account"@en; ; "67fbe04aaecb63a7368b814ab4868ec8f0e93a1c24186726976d9aa9da80a685"; "Secretary must take advice from Gene Technology Regulator into account when making decisions on applications."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.220"; . a ; ; ; ; ; . . a ; ; "MUST"; "Must take advice into account"; "modalities::logic::deontic"; 1.0000; . a ; "30EA Public notification, and recall, of therapeutic goods"@en; ; "4a6afbc25782c17398578517ec52cd4708bf096662781acd0e79f5e34d20e5af"; "The Secretary may impose requirements on a person if certain circumstances occur."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.222"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Imposition of obligations"; "modalities::logic::deontic"; 1.0000; . a ; "30EB Publication of requirements"@en; ; "6a70553c8ba374b646e76201e821ab7a6738d0f477c89994bc75deb29fdccf39"; "Secretary must publish notice after imposing requirement."; "Notice setting out particulars of the requirement"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.225"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Obligation to publish notice"; "modalities::logic::deontic"; 1.0000; . a ; "30EC Criminal offences for non-compliance with requirements"@en; ; "aa9e8da167b724dedc1ceb78d37a2628eb968d9e15a7b83639367e504584667f"; "Non-compliance with requirements is a criminal offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.225"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits non-compliance with requirements."; "modalities::logic::deontic"; 1.0000; . a ; "30ED Powers of suspension and cancellation unaffected"@en; ; "ace2650e20504c390da801ccbb21fc5276a82d4d80ae1d3df7af9379452c8f36"; "Imposition of requirement under section 30EA does not affect suspension or cancellation power."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.226"; . a ; ; ; ; "borne by: State"; ; . a ; "30EE Saving of other laws"@en; ; "d60e452d40d4d8c4426e32e3f836a586f2a94e7ff1468a6edf7dd0a4fff87758"; "No exclusion or limitation of other laws"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.227"; . a ; ; ; ; . a ; "30EF Reporting medicine shortages"@en; ; , , , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.228". a ; "30EF(1) Reporting medicine shortages"@en; ; "95b8ebe35e4c3a8234bb3382362faba4062f8690716f99ada4e8c9e90b7b91c7"; ; "Notify shortage of reportable medicine within 2 working days or 10 working days."; "True"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.228"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "MUST"; "Must notify shortage within specified timeframe."; "modalities::logic::deontic"; 1.0000; . . a ; ; "OUGHT"; "Ought to reasonably know of shortage before notification."; "modalities::epistemic"; 1.0000; . . a ; ; "BUT"; "Notification within timeframe is but not required."; "modalities::temporal_ltl"; 1.0000; . a ; "30EF(2) Reporting medicine shortages"@en; ; "84e50dfdc8a41df32e280e548f7857692dee6891ba1c14bde4a57327ddc91ad4"; ; "Reporting medicine shortages when included in an instrument under section 30EJ has a critical impact."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.228"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Reporting medicine shortages when included in an instrument under section 30EJ is obligatory."; "modalities::logic::deontic"; 1.0000; . a ; "30EF(3) Reporting medicine shortages"@en; ; "7ac0ba3169eb2c95069a0f5e26e8acb21180f253e2e88711070cce6d3b07a992"; ; "Reporting medicine shortages when there is a critical impact on health or functioning."; "Notification requirements"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.228"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Reporting medicine shortages is a duty."; "Notification requirements must be provided."; "modalities::logic::deontic"; 1.0000; . a ; "30EF(4) Reporting medicine shortages"@en; ; "6768b9138dc76e3662afbba407f7e5c9fdcfefd8eeb623392a966f3ba2ec9567"; ; "Notification requirements for medicine shortages"; "Specific period of shortage, approved form, and required information"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.228"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Notification requirements are mandatory"; "modalities::logic::deontic"; 1.0000; . a ; "30EF(5) Reporting medicine shortages"@en; ; "b8c5f3469c62488d5780db16e22ef8bacfcec121411b26a021cd3d8170126b9f"; ; "Specify software requirements for reporting medicine shortages"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.228"; . a ; ; ; ; ; . . a ; ; "hasClass"; "Classifies the provision as a descriptive clause"; "modalities::dl"; 1.0000; . . a ; ; "during"; "Describes the temporal relationship between software requirements and reporting medicine shortages"; "modalities::interval_reasoning"; 1.0000; . a ; "30EF(6) Reporting medicine shortages"@en; ; "4f8907e2f2adadcaf6ae9fd8ec831e5902ba6b417846ebbccb3a77a6976a31c5"; ; "Reporting medicine shortages is prohibited for individuals and bodies corporate."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.228"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "Prohibit"; "Prohibition of reporting medicine shortages"; "(6) A person contravenes this subsection..."; "...the person contravenes the requirement."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Temporal Interval"; "Temporal interval of reporting medicine shortages"; "(6) A person contravenes this subsection..."; "...if the person is subject to a requirement under subsection (1);"; "modalities::interval_reasoning"; 0.5000; . . a ; ; "Recurring Trace"; "Recurring trace of reporting medicine shortages"; "(6) A person contravenes this subsection..."; "...and the person contravenes the requirement."; "modalities::temporal_ltl"; 0.5000; . . a ; ; "Information Diffusion"; "Information diffusion of reporting medicine shortages"; "(6) A person contravenes this subsection..."; "...Maximum civil penalty:"; "modalities::diffusion"; 0.5000; . . a ; ; "Knowledge Representation"; "Knowledge representation of reporting medicine shortages"; "(a) for an individual—100 penalty units;"; "...and (b) for a body corporate—1,000 penalty units."; "sparql_library::parsers::chk_parser"; 0.5000; . a ; "30EF(7) Reporting medicine shortages"@en; ; "84dca6a9dc05ab382ffc6ec10369fe89824c2a24b938d13d0c3a92edc35d59aa"; ; "Exemption from reporting medicine shortages under certain conditions"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.228"; . a ; ; ; ; "borne by: State"; ; . a ; "1 March 2024 and end on 31 March 2024 (see section 30EIA)."@en; ; "7da61ec8257aaa582608977966ad0c9149e0140aa5adedaf3fbf582576aee212"; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.230". a ; "1(1) March 2024 and end on 31 March 2024 (see section 30EIA)."@en; ; "40d2d33a7e6be84a207c948218e1594bf2413d7bb115f1a84c7a0417ae293294"; ; "Notify Secretary of change to medicine shortage period within specified timeframe."; "Change in medicine shortage period"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.230"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "MUST"; "Obligation to notify"; "modalities::logic::deontic"; 1.0000; . . a ; ; "KNOWS"; "Knowledge of change in shortage period"; "modalities::epistemic"; 1.0000; . . a ; ; "BUT"; "Temporal relation between notification and change"; "modalities::temporal_ltl"; 1.0000; . a ; "1(2) March 2024 and end on 31 March 2024 (see section 30EIA)."@en; ; "c35d734da0032e3da13b1979a37b90c823c76a0658b6f49ccdb40027387708b7"; ; "Notify Secretary of shortage resolution within 2 working days or 10 working days."; "Notification requirements"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.230"; . a ; ; ; ; "borne by: NaturalPerson"; ; . . a ; ; "MUST"; "Must notify within specified timeframe."; "modalities::logic::deontic"; 1.0000; . . a ; ; "OUGHT"; "Should reasonably know of shortage end date."; "modalities::epistemic"; 1.0000; . a ; "1(3) March 2024 and end on 31 March 2024 (see section 30EIA)."@en; ; "f2ed0c809243e4194ba323e83bef5b14136131c501cec07d519da68ae98c99d9"; ; "Notification requirements for shortage of medicine in Australia."; "period of shortage, day period ended"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.230"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Notification requirements"; "modalities::logic::deontic"; 1.0000; . a ; "30EG Reporting discontinuation of supply of medicine"@en; ; , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.232". a ; "30EG(1) Reporting discontinuation of supply of medicine"@en; ; "bf74c473feacd22cde9142e2446695cf2b6ce677c8affac5d107f50f4f9e0916"; ; "Notify Secretary of discontinuation decision at least 6 months before proposed date."; "Notification"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.232"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Obligation to notify"; "The person must notify the Secretary."; "modalities::logic::deontic"; 1.0000; . a ; "30EG(2) Reporting discontinuation of supply of medicine"@en; ; "f2326cf88c21d968142d34ffded3a31569e9fea2b00a43551edca39d0294adb5"; ; "Reporting required when discontinuation of supply of medicine is made under section 30EJ"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.232"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Reporting obligation"; "modalities::logic::deontic"; 1.0000; . a ; "30EG(3) Reporting discontinuation of supply of medicine"@en; ; "99725bfdf337ec6cead73e3b28093e14583c283b10758142733fd7f450956830"; ; "Notify discontinuation of medicine supply if critical impact on health or functioning"; "Notification requirements"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.232"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Obligation to notify"; "Notification requirements"; "modalities::logic::deontic"; 1.0000; . a ; "30EG(4) Reporting discontinuation of supply of medicine"@en; ; "3acffbbc2ebffe89830e45850da3bb277456d4896f09d66e34114f0bce09598b"; ; "Notification must be in a specified form and contain required information."; "true"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.232"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Notification must be in a specified form."; "modalities::logic::deontic"; 1.0000; . a ; "30EG(5) Reporting discontinuation of supply of medicine"@en; ; "bae4623a085cbac5127c1e9c7709ff9582d0e50d4443beccaa7c29426095a2b5"; ; "Specify software requirements for information transmission"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.232"; . a ; ; ; ; ; . . a ; ; "hasClass"; "Classifies the provision as a descriptive clause"; "modalities::dl"; 1.0000; . . a ; ; "during"; "Identifies the temporal relation of software requirements"; "modalities::interval_reasoning"; 1.0000; . a ; "30EH What is a reportable medicine?"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.234". a ; "30EH(1) What is a reportable medicine?"@en; ; "99ee0448839d858230ff9f8ae3c57bc17d3196970b88c8dca4062939bc3927d9"; ; "Defines reportable medicine under the Act."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.234"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "is"; "Identifies a reportable medicine."; "(1) For the purposes of this Act, registered goods are a reportable medicine if:"; "modalities::logic::deontic"; 1.0000; . . a ; ; "and"; "Combines conditions for a reportable medicine."; "(a) the goods are medicine; and (b) either: (i) the medicine contains one or more substances included in Schedule 4 or 8 to the current Poisons Standard;"; "modalities::linear"; 1.0000; . . a ; ; "contains"; "Includes temporal intervals for substance inclusion."; "(i) the medicine contains one or more substances included in Schedule 4 or 8 to the current Poisons Standard;"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "or"; "Combines conditions for a reportable medicine using LTL."; "(b) either: (i) the medicine contains one or more substances included in Schedule 4 or 8 to the current Poisons Standard;"; "modalities::temporal_ltl"; 1.0000; . a ; "30EH(2) What is a reportable medicine?"@en; ; "1ab08086a83a617121c624f1422aea9258dd94b2da663a9800d03a9f62f47128"; ; "The Minister may determine medicine for the purposes of subparagraph (1)(b)(ii)."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.234"; . a ; ; ; ; ; . a ; "30EH(3) What is a reportable medicine?"@en; ; "c8fb71c934cc946f15f71ce26a2c1a1dd862f9657e32864fde8e983b0c948c72"; ; "The Minister must determine a medicine if it is critical to patient health and notification of shortage would be in public health interests."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.234"; . a ; ; ; ; ; . . a ; ; "MUST"; "The Minister must determine a medicine."; "modalities::logic::deontic"; 1.0000; . . a ; ; "SUFFICIENT"; "Notification of shortage would be in public health interests."; "modalities::epistemic"; 1.0000; . a ; "30EI When is there a medicine shortage?"@en; ; "5d36f41962dbdf774fea3bb2f538fed7976bd88299fde489f7247769747f6162"; "Defines when there is a medicine shortage in Australia."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.235"; . a ; ; ; ; . a ; "30EJ Medicines Watch List"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.235". a ; "30EJ(1) Medicines Watch List"@en; ; "6c6b540490e1b6eb6544ed6f2ea5a70fc7cbb9ddc12ce92c27010a7657b9b25a"; ; "Minister may determine medicine for purposes of subsections 30EF(2) and 30EG(2)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.235"; . a ; ; ; ; . . a ; ; "May"; "Expresses permission or obligation"; "modalities::logic::deontic"; 1.0000; . a ; "30EJ(2) Medicines Watch List"@en; ; "169175bcb72b0ca425464212e44bdb364db8109345991e9e872bb814425a026e"; ; "The Minister must not determine a medicine unless certain conditions are met."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.235"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits the Minister from determining a medicine without satisfying certain conditions."; "(2) The Minister must not determine a medicine..."; "...unless the Minister is satisfied that any shortage of the medicine..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Obligation"; "Imposes an obligation on the Minister to satisfy certain conditions before determining a medicine."; "(2) The Minister must not determine a medicine..."; "...unless the Minister is satisfied that any shortage of the medicine..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "TemporalOverlap"; "Defines a temporal overlap between the conditions and the determination of a medicine."; "(2) The Minister must not determine a medicine unless..."; "...the Minister is satisfied that any shortage of the medicine..."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "TemporalRelevance"; "Defines a temporal relevance between the conditions and the determination of a medicine."; "(2) The Minister must not determine a medicine unless..."; "...the Minister is satisfied that any shortage of the medicine..."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "InformationFlow"; "Defines an information flow between the conditions and the determination of a medicine."; "(2) The Minister must not determine a medicine unless..."; "...the Minister is satisfied that any shortage of the medicine..."; "modalities::diffusion"; 1.0000; . a ; "30EK Minister may declare a serious scarcity of medicine"@en; ; , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.236". a ; "30EK(1) Minister may declare a serious scarcity of medicine"@en; ; "4ec81030918796be37dfed2396affbdb96f07956004e877d1543c8161dbe195d"; ; "Minister may declare a serious scarcity of medicine and specify substitution rules."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.236"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Permit"; "Permission to dispense substitutable medicine."; "(a) declare that there is a serious scarcity of specified medicine"; "(b) specify the medicine (the substitutable medicine)"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Permit"; "Pharmacists permitted to dispense substitutable medicine under specified circumstances."; "(b) specify the circumstances in which that substitution is permitted."; "Substitution permitted under specified circumstances."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibit"; "No prohibition on declaring scarcity or specifying substitution rules."; "(a) declare that there is a serious scarcity of specified medicine"; "No prohibition."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlaps"; "Temporal overlap between declaration and substitution rules."; "The Minister may, by legislative instrument:"; "The declaration and substitution rules overlap in time."; "modalities::interval_reasoning"; 1.0000; . a ; "30EK(2) Minister may declare a serious scarcity of medicine"@en; ; "82f6cab193e4fa5ca0fc106f936ebcca71ce553ac4b44d8d5787f3061fa7b03e"; ; "The Minister may declare a serious scarcity of medicine under certain conditions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.236"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "The Minister may declare a serious scarcity of medicine."; "modalities::logic::deontic"; 1.0000; . . a ; ; "is"; "The supply of the scarce medicine in Australia is not currently meeting the demand for that medicine for all of the patients in Australia who take that medicine."; "modalities::dl"; 1.0000; . a ; "30EK(3) Minister may declare a serious scarcity of medicine"@en; ; "353db3cf2dfc558c32066008a7118345b92bbc01dcc9222a78ac2531db96c63d"; ; "Minister must declare a serious scarcity of medicine if certain conditions are met."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.236"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Minister must declare a serious scarcity of medicine"; "modalities::logic::deontic"; 1.0000; . a ; "30EK(4) Minister may declare a serious scarcity of medicine"@en; ; "ee65e7460a69cf871e4254de4ffae69ac73382ad0ab003c397a74c0b5237352e"; ; "Minister must declare a serious scarcity of medicine under certain circumstances."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.236"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Minister must declare a serious scarcity of medicine."; "modalities::logic::deontic"; 1.0000; . . a ; ; "CLASSIFICATION"; "Classification of persons for whom the substitutable medicine is suitable or not suitable."; "(a) the class of persons for whom the substitutable medicine is suitable; or (b) the class of persons for whom the substitutable medicine is not suitable."; "modalities::dl"; 1.0000; . . a ; ; "CONTAINS"; "Temporal interval for declaration."; "(4)"; "modalities::interval_reasoning"; 1.0000; . a ; "30EK(5) Minister may declare a serious scarcity of medicine"@en; ; "03c7a4fbec5a96cb32536c7060d85a52b116d1ecd0ef680d99131211dc80f760"; ; "Instrument remains in force for a specified period unless revoked."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.236"; . a ; ; ; ; . a ; "30EL Substitution of prescription medicine by pharmacists"@en; ; "c1d84a9818ab11e0b4164982262f55745a49c3189648d669af73769211591214"; "Pharmacist may dispense scarce medicine in substitution for another"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.237"; . a ; ; ; ; ; . . a ; ; "may"; "Permission to dispense"; "modalities::logic::deontic"; 1.0000; . a ; "30F Criminal offences for goods exempt under section 18A not"@en; ; "12d2b2e35f3f849925d69a8145ed8cc043746662e2c469a65057c21a308818c6"; , , , , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.238". a ; "30F(1) Criminal offences for goods exempt under section 18A not"@en; ; "684290c8df2613239f3f4e9bbc08d67e3cd3adb7530f8d6ed68b460cb78fc14d"; ; "Supplying goods of a particular kind that do not conform to a standard or are not fit for their intended purposes is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.238"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of supplying goods that do not conform to a standard or are not fit for their intended purposes."; "(a) therapeutic goods of a particular kind are exempt under section 18A; and (b) a person supplies a batch of goods of that kind; and (c) the Secretary is satisfied that the goods included in that batch: ..."; "...is prohibited."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlap"; "Temporal overlap between the supply of goods and the Secretary's satisfaction that the goods included in that batch do not conform to a standard or are not fit for their intended purposes."; "(c) the Secretary is satisfied that the goods included in that batch: ..."; "...overlap with the supply of goods."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Recurring"; "Recurring trace of supplying goods that do not conform to a standard or are not fit for their intended purposes."; "(a) therapeutic goods of a particular kind are exempt under section 18A; and (b) a person supplies a batch of goods of that kind; and (c) the Secretary is satisfied that the goods included in that batch: ..."; "...are recurring traces of supplying goods that do not conform to a standard or are not fit for their intended purposes."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Diffuse"; "Diffusion of the prohibition on supplying goods that do not conform to a standard or are not fit for their intended purposes."; "(a) therapeutic goods of a particular kind are exempt under section 18A; and (b) a person supplies a batch of goods of that kind; and (c) the Secretary is satisfied that the goods included in that batch: ..."; "...diffuse to all persons."; "modalities::diffusion"; 1.0000; . . a ; ; "Classify"; "Classification of goods as not conforming to a standard or being unfit for their intended purposes using artificial intelligence."; "(i) do not conform to a standard applicable to goods of that kind; or (ii) are otherwise not fit to be used for their intended purposes."; "...are classified as not conforming to a standard or being unfit for their intended purposes."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "30F(2) Criminal offences for goods exempt under section 18A not"@en; ; "9f35d6f2d147971a01ec064964497ca0a7efcc26818342c7c0149bc8322652ff"; ; "Require person to take steps to recall goods"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.238"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "require"; "Imposes a duty on the state"; "The person must take steps to recall the goods"; "modalities::logic::deontic"; 1.0000; . a ; "30F(3) Criminal offences for goods exempt under section 18A not"@en; ; "ac38ab52705ca8a59d3c56c85e414815518c888c35280f432819bc27670b3e89"; ; "Specify steps for recall of goods"; "Steps to be taken, manner of taking, reasonable period"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.238"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Specify steps for recall of goods"; "modalities::logic::deontic"; 1.0000; . . a ; ; "CONTAINS"; "Temporal interval for recall"; "(a) the steps to be taken, (b) the manner in which the steps are to be taken, (c) a reasonable period within which the steps are to be taken"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "CONTAINS"; "Temporal interval for recall"; "(a) the steps to be taken, (b) the manner in which the steps are to be taken, (c) a reasonable period within which the steps are to be taken"; "modalities::temporal_ltl"; 1.0000; . . a ; ; "CONTAINS"; "Diffusion of recall requirements"; "(a) the steps to be taken, (b) the manner in which the steps are to be taken, (c) a reasonable period within which the steps are to be taken"; "modalities::diffusion"; 1.0000; . . a ; ; "CONTAINS"; "Artificial intelligence application for recall requirements"; "(a) the steps to be taken, (b) the manner in which the steps are to be taken, (c) a reasonable period within which the steps are to be taken"; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "30F(4) Criminal offences for goods exempt under section 18A not"@en; ; "4f3df3e367af89fa108808bc58b426a849df68dbbe2aa0ed9001e9f611955ac1"; ; "Publish notice in Gazette or Department's website"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.238"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must publish notice"; "modalities::logic::deontic"; 1.0000; . a ; "30F(4A) Criminal offences for goods exempt under section 18A not"@en; ; "7ebd8475f22eec6693df87720bc9abe216cfe210b3f07867ef38be915a8f5704"; ; "A written notice given to a person by the Secretary under this section is not a legislative instrument."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.238"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits notices from being considered legislative instruments."; "None"; "None"; "modalities::logic::deontic"; 1.0000; . a ; "30F(4B) Criminal offences for goods exempt under section 18A not"@en; ; "0adfcc10519709f44bf4af8223516387f5bf4613d270c5d6ec9bbf75c440dbcd"; ; "Failure to comply with a notice results in harm or injury."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.238"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits non-compliance with a notice."; "The Secretary gives a notice to the person under subsection (2); and"; "the person fails to comply with that requirement; and"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlaps"; "The provision applies to temporal intervals where harm or injury occurs."; "the harm or injury has resulted, will result, is likely to result, would result, or would be likely to result, because the person failed to comply with that requirement."; "because the person failed to comply with that requirement."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Repeats"; "The provision is repeated for each occurrence of harm or injury."; "the use of the goods has resulted in, will result in, or is likely to result in, harm or injury to any person; or"; "or would be likely to result in, harm or injury to any person;"; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Obligation"; "Imposes an obligation on the person to comply with the notice."; "A person commits an offence if:"; "the person fails to comply with that requirement; and"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibition"; "Prohibits non-compliance with the notice."; "A person commits an offence if:"; "the person fails to comply with that requirement; and"; "modalities::logic::deontic"; 1.0000; . a ; "30F(5) Criminal offences for goods exempt under section 18A not"@en; ; "9bf6e1ccd78a5af70f2576d50ed44578a9bb4897064514de4329a5064f740990"; ; "Failure to comply with notice requirement is an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.238"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Obligation to comply with notice requirement."; "The Secretary gives a notice to the person under subsection (2); and"; "the person fails to comply with that requirement."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlaps"; "Compliance with notice requirement overlaps with the offence of failing to comply."; "The person commits an offence if: (a) the Secretary gives a notice to the person under subsection (2); and (b) the notice specifies a particular requirement mentioned in subsection (3); and"; "the person fails to comply with that requirement."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Recurrently"; "Compliance with notice requirement is recurrently related to the offence of failing to comply."; "The person commits an offence if: (a) the Secretary gives a notice to the person under subsection (2); and (b) the notice specifies a particular requirement mentioned in subsection (3); and"; "the person fails to comply with that requirement."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Obligation"; "Obligation to pay penalty for failing to comply with notice requirement."; "Penalty: Imprisonment for 12 months or 1,000 penalty units, or both."; "the person fails to comply with that requirement."; "modalities::logic::deontic"; 1.0000; . a ; "30F(6) Criminal offences for goods exempt under section 18A not"@en; ; "d99e1b7faf79f004b1adceba6aa6811994012fa3e8735c0cfbb34b9760458495"; ; "A person commits an offence if the Secretary gives a notice to the person under subsection (2)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.238"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "hasObligation"; "Has obligation"; "The Secretary gives a notice to the person under subsection (2)"; "A person commits an offence"; "modalities::logic::deontic"; 1.0000; . . a ; ; "overlaps"; "Overlaps with"; "Chapter 3 Medicines and other therapeutic goods that are not medical devices"; "Section 30F(6)"; "modalities::interval_reasoning"; 1.0000; . a ; "30FA Civil penalty for goods exempt under section 18A not"@en; ; "77b8fdca45d638bf5b177ade91d457a92ac3577489fc403845880bebdf100cd4"; "Civil penalty for non-compliance with standards"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.240"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits non-compliance"; "Notice specifies requirement"; "Non-compliance is prohibited"; "modalities::logic::deontic"; 1.0000; . a ; "30G Disposal of unused goods exempt under section 18A"@en; ; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.240". a ; "30G(1) Disposal of unused goods exempt under section 18A"@en; ; "6e2e8dfa43d1530ceee8e7978c257e33f22517102893b68af9405cf278cbba50"; ; "Therapeutic goods must be used before an exemption ceases to have effect."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.240"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Therapeutic goods must be used before an exemption ceases to have effect."; "modalities::logic::deontic"; 1.0000; . a ; "30G(2) Disposal of unused goods exempt under section 18A"@en; ; "08ce4156279bb1eda5c3a02a8ff3e5b56c6a38660ac584a1925924d7ba22c197"; ; "The Secretary must arrange for disposal of unused goods."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.240"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Obligation to arrange for disposal"; "modalities::logic::deontic"; 1.0000; . a ; "30G(3) Disposal of unused goods exempt under section 18A"@en; ; "a1e0e95f92fb5549863b8b26ca8a4510fedcdb25bb8c23418f213928778bfeca"; ; "Methods for disposal of goods"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.240"; . a ; ; ; ; . a ; "30G(4) Disposal of unused goods exempt under section 18A"@en; ; "a623d3286b059b1169be944b65c7d87f1f83791abbd1270b6c325a9ae82f1759"; ; "No benefit can be conferred on a person other than the owner of goods"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.240"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Cannot"; "No benefit can be conferred"; "modalities::logic::deontic"; 1.0000; . a ; "30H Record for goods exempt under section 18A"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.241". a ; "30H(1) Record for goods exempt under section 18A"@en; ; "27130c3bc7c38cc95d5d24eddad3b11b0e85cb6db8df657450766e6d53a31556"; ; "Keeping a record of therapeutic goods exempt under section 18A is required."; "Record keeping"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.241"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Requires"; "The exemption requires record keeping."; "modalities::logic::deontic"; 1.0000; . a ; "30H(2) Record for goods exempt under section 18A"@en; ; "c9073f5b3de1691ba95af8e23d995cdd8ae82be111e22e0298152fe06cb21679"; ; "Strict liability applies to paragraph (1)(b)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.241"; . a ; ; ; ; ; . . a ; ; "applies"; "Strict liability obligation"; "(2) Strict liability applies to paragraph (1)(b)"; "modalities::logic::deontic"; 0.5000; . a ; "30H(3) Record for goods exempt under section 18A"@en; ; "bf53a44a3a35158ffc86b6e6c89d9b65271a7e82c0bde7dcf45418b160ec90c4"; ; "Keeping a record about therapeutic goods exempt under section 18A is required."; "Record keeping"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.241"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Obligation to keep a record"; "modalities::logic::deontic"; 1.0000; . a ; "31 Secretary may require information or documents"@en; ; "877d7890c288f39381029382e437b17a4a8c948b846d530428db4b883869487b"; "The Secretary may require information or documents from a person."; "Yes"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.242"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MAY"; "The Secretary may require information or documents."; "modalities::logic::deontic"; 1.0000; . a ; "31A Secretary may require information etc. about goods exempt"@en; ; "e301885500dfdc53b65c9cbb5f7acd042e0e1b4a1d7440aef269bc1e24ef05db"; "Secretary may require sponsor to provide specified information about exempt goods for experimental purposes in humans."; "Yes"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.249"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MAY"; "Secretary may require information"; "modalities::logic::deontic"; 1.0000; . a ; "31AA Secretary may require information etc. about goods exempt"@en; ; "c6f998e68ddcbd55bff9d37cc2c21469aa6b9847c82f2c01efd57fcb40f3166f"; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.251". a ; "31AA(1) Secretary may require information etc. about goods exempt"@en; ; "2a88bb72301aeb106835c45bb9e9b857eda54b409eba5955273f301b737f470c"; ; "Secretary may require information about goods exempt"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.251"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "requires"; "Requires information"; "modalities::logic::deontic"; 1.0000; . . a ; ; "between"; "Between a condition and a person"; "(1) This section applies to a person who is required to comply with a condition of an exemption of therapeutic goods under section 18A."; "modalities::interval_reasoning"; 0.5000; . . a ; ; "may lead to"; "May lead to further action"; "modalities::argumentation"; 0.5000; . a ; "31AA(2) Secretary may require information etc. about goods exempt"@en; ; "36b1ad9b8454af6fe1c2721492cf409028277938fbc51a7a0e80738cb8286ac5"; ; "The Secretary may require information from a person about goods exempt."; "true"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.251"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MAY"; "The Secretary may require information."; "modalities::logic::deontic"; 1.0000; . a ; "31AA(3) Secretary may require information etc. about goods exempt"@en; ; "3cd028cc3fd5851f396c2f973817d7f67d4fdcff127b2b498288fa5ebd28643d"; ; "Secretary must require information within a specified period."; "Information about goods exempt"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.251"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide information"; "modalities::logic::deontic"; 1.0000; . a ; "31AA(4) Secretary may require information etc. about goods exempt"@en; ; "45c5d705dc7db097b5af7baa1404fcfef943b583f2a458671dd111da3090167b"; ; "Secretary must require information about goods exempt"; "Information"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.251"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Obligation to provide information"; "modalities::logic::deontic"; 1.0000; . . a ; ; "hasPart"; "Classifies goods exempt"; "modalities::dl"; 1.0000; . a ; "31B Secretary may require information relating to approvals and"@en; ; "bef4ff44bc88275ff356fff89618a6d74be64a80d041fd0f95d83862153f4ad7"; "Secretary may require information from a person granted an approval under subsection 19(1)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.251"; . a ; ; ; ; "borne by: State"; ; . a ; "31BA Secretary may require information about therapeutic goods"@en; ; "04847e4713245e7bf2b31e2862d72f050a9af1ed10d7fc52de020585a81c0145"; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.254". a ; "31BA(1) Secretary may require information about therapeutic goods"@en; ; "ecea591eb90562e28916ecc1892fd15733206cc349ce01e41443d8f03393a448"; ; "The Secretary may require information about therapeutic goods from a person granted an approval."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.254"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MAY"; "The Secretary may require information."; "modalities::logic::deontic"; 1.0000; . a ; "31BA(2) Secretary may require information about therapeutic goods"@en; ; "ccefbed566d95dc3ff072f312dff877c801468012ecba837bb05cdde4b2488ec"; ; "Must provide information within a specified period and in the form specified by the notice."; "true"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.254"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide information within a specified period and in the form specified by the notice."; "modalities::logic::deontic"; 1.0000; . a ; "31BA(3) Secretary may require information about therapeutic goods"@en; ; "999e17e97c5dea127f3240fd393f3fe0ec24fd37d2d7e946d2d6490a19414b48"; ; "Secretary may require information about therapeutic goods in specified ways."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.254"; . a ; ; ; ; "borne by: State"; ; . a ; "31C Criminal offences for failing to give information or documents"@en; ; "a79e4cc5ec0d8659396307f90adb4e677b5b3cf6d2130ca8cdc48ad1956fe850"; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.254". a ; "31C(1) Criminal offences for failing to give information or documents"@en; ; "95110c5aa0b88732c842cfd2be5e2368692158d7dd9dd8ce98c1743897268a7f"; ; "Failure to comply with a notice results in an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.254"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "obligation"; "Obligation to comply with a notice."; "modalities::logic::deontic"; 1.0000; . a ; "31C(2) Criminal offences for failing to give information or documents"@en; ; "1d41c1bb964d36ce3c30a7c01ca5d4af0cb52a022fcf85506e60f5b1dbb3c34d"; ; "Failure to comply with a notice results in an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.254"; . a ; ; ; ; "borne by: NaturalPerson"; ; . . a ; ; "Prohibition"; "Prohibits failing to comply with a notice."; "(2) A person commits an offence if..."; "...Penalty: 100 penalty units."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlaps"; "Indicates that failing to comply with a notice overlaps with committing an offence."; "(2) A person commits an offence if..."; "...Penalty: 100 penalty units."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Repeats"; "Indicates that failing to comply with a notice repeats the action of committing an offence."; "(2) A person commits an offence if..."; "...Penalty: 100 penalty units."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Diffuses"; "Diffuses the information that failing to comply with a notice results in an offence."; "(2) A person commits an offence if..."; "...Penalty: 100 penalty units."; "modalities::diffusion"; 1.0000; . . a ; ; "Recognizes"; "Recognizes the pattern of failing to comply with a notice resulting in an offence."; "(2) A person commits an offence if..."; "...Penalty: 100 penalty units."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "31C(3) Criminal offences for failing to give information or documents"@en; ; "6399dd55215449c5a9d06b6bb311756ebbb1965b41b9ee0659fbcac6e7efa0c6"; ; "Duty to provide information or documents"; "true"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.254"; . a ; ; ; ; "borne by: NaturalPerson"; ; . . a ; ; "obligation"; "Obligation to provide information or documents"; "modalities::logic::deontic"; 1.0000; . a ; "31D False or misleading information"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.255". a ; "31D(1) False or misleading information"@en; ; "8cbd54068536a9b02bfae57ab442d07a7ae0837f774ddcda0e4a0ca5d623fa87"; ; "Giving false or misleading information in compliance with a notice is an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.255"; . a ; ; ; ; "borne by: NaturalPerson"; ; . . a ; ; "Prohibition"; "Prohibits giving false or misleading information in compliance with a notice."; "The person gives information to the Secretary in compliance or purported compliance with the notice."; "The person commits an offence if they do so knowing that the information is false or misleading."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Obligation"; "Imposes a duty on the person to not give false or misleading information in compliance with a notice."; "The person does so knowing that the information is false or misleading."; "The person commits an offence if they do so."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibition"; "Prohibits giving false or misleading information in purported compliance with a notice."; "The person gives information to the Secretary in purported compliance with the notice."; "The person commits an offence if they do so knowing that the information is false or misleading."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Obligation"; "Imposes a duty on the person to not give false or misleading information in purported compliance with a notice."; "The person gives information to the Secretary in purported compliance with the notice."; "The person commits an offence if they do so knowing that the information is false or misleading."; "modalities::logic::deontic"; 1.0000; . a ; "31D(1A) False or misleading information"@en; ; "24067eb6b5d79f1a00096ce5ca92b5bdcbcd9832967eb89031b06ebde06e15cc"; ; "Giving false or misleading information after receiving a notice is an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.255"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits giving false or misleading information after receiving a notice."; "The person gives information to the Secretary in compliance or purported compliance with the notice."; "The person commits an offence if the information is false or misleading."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Obligation"; "Imposes an obligation on the person to give accurate information after receiving a notice."; "The person is required to give information in compliance with the notice."; "modalities::logic::deontic"; 1.0000; . . a ; ; "TemporalInterval"; "Specifies the temporal interval for giving false or misleading information as after receiving a notice."; "The person gives information to the Secretary in compliance or purported compliance with the notice."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Prohibition"; "Prohibits omitting any matter or thing without which the information is misleading."; "The information omits any matter or thing without which it is misleading."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Obligation"; "Imposes an obligation on the person to provide accurate information that includes all necessary matters and things."; "The information must include all matter and thing without which it is misleading."; "modalities::logic::deontic"; 1.0000; . a ; "31E False or misleading documents"@en; ; , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.256". a ; "31E(1) False or misleading documents"@en; ; "c95b51d234355cf6fd8c9ed88c8c7f046a1d317fe6943fad96fafee86187e23b"; ; "Producing false or misleading documents is an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.256"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits producing false or misleading documents."; "The document is produced in compliance or purported compliance with a notice given under section 31A, 31AA, 31B or 31BA."; "The person commits an offence if the document is produced knowing that it is false or misleading."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Temporal Interval"; "Defines a temporal interval for producing documents."; "(1) A person commits an offence if: (a) the person produces a document to the Secretary; and (b) the person does so knowing that the document is false or misleading; and (c) the document is produced in compliance or purported compliance with a notice given under section 31A, 31AA, 31B or 31BA."; "The temporal interval for producing documents starts at (1)"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Recurring Trace"; "Defines a recurring trace of document production."; "(1) A person commits an offence if: (a) the person produces a document to the Secretary; and (b) the person does so knowing that the document is false or misleading; and (c) the document is produced in compliance or purported compliance with a notice given under section 31A, 31AA, 31B or 31BA."; "The recurring trace of document production starts at (1)"; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Diffuse"; "Diffuses the prohibition to all agents."; "(1) A person commits an offence if: (a) the person produces a document to the Secretary; and (b) the person does so knowing that the document is false or misleading; and (c) the document is produced in compliance or purported compliance with a notice given under section 31A, 31AA, 31B or 31BA."; "The prohibition diffuses to all agents who produce documents."; "modalities::diffusion"; 1.0000; . . a ; ; "Classify"; "Classifies the document as true or false/misleading using AI."; "(1) A person commits an offence if: (a) the person produces a document to the Secretary; and (b) the person does so knowing that the document is false or misleading; and (c) the document is produced in compliance or purported compliance with a notice given under section 31A, 31AA, 31B or 31BA."; "The document is classified as true or false/misleading using AI."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "31E(1A) False or misleading documents"@en; ; "6fa37081d617a2cbb57faf543ad7f53e2aed31a85e0cb1f63957878620214fe3"; ; "Producing false or misleading documents in compliance with a notice is an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.256"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits producing false or misleading documents in compliance with a notice."; "modalities::logic::deontic"; 1.0000; . a ; "31E(1B) False or misleading documents"@en; ; "0e0cdce4f49bcdede84da2c8cb10ce3f352a4869982d14472853df3c1e9c44ee"; ; "Offence of strict liability for false or misleading documents"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.256"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits offence of strict liability"; "modalities::logic::deontic"; 1.0000; . a ; "31E(2) False or misleading documents"@en; ; "2c3d92b51b834d223d710dc2f8cb28326eb41d64fcde25fc0028c501ecee9d98"; ; "Defendant bears evidential burden in relation to the matter."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.256"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "obligation"; "Defendant bears evidential burden."; "modalities::logic::deontic"; 1.0000; . . a ; ; "evidential burden"; "Defendant has a duty to provide evidence."; "modalities::epistemic"; 1.0000; . a ; "31E(3) False or misleading documents"@en; ; "e9336a74b01a2846118c1e33ea5bf36b037f1e7cc68e8ca2d19d0bae7640dffc"; ; "Exemption from subsection (1) or (1A) for documents accompanied by a written statement"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.256"; . a ; ; ; ; ; . a ; "31F Self-incrimination"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.257". a ; "31F(1) Self-incrimination"@en; ; "3ca17c1aeb0c96e40f199c8a0a5a55ba354878370dda88ab4f2005975b5e759f"; ; "No excuse for giving information under certain notices"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.257"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Obligation to provide information"; "modalities::logic::deontic"; 1.0000; . a ; "31F(2) Self-incrimination"@en; ; "a5170f520055e58779cda61ab645c5d031f60c1f785bceb15f1f6d1987278dbc"; ; "Protection against self-incrimination in certain cases"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.257"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits admissibility of self-incrimination evidence in certain cases"; "None"; "None"; "modalities::logic::deontic"; 1.0000; . a ; "32 What this Part is about"@en; ; "d9a8a890a88c4335375c74126e592e00162f9ef87ec76e1c65f8a053958d2965"; "Regulates biologicals by providing a process for inclusion in the Register and enforcement through criminal offences and civil penalties."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.259"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "regulates"; "Establishes a regulatory framework for biologicals."; "modalities::logic::deontic"; 1.0000; . . a ; ; "provides"; "Establishes administrative processes for regulating biologicals."; "modalities::linear"; 1.0000; . a ; "32A Meaning of biological"@en; ; "688e347afe658c99d9c5d23183a0f1bd1dc0fe12bcbdceacc38180dda8ad2b58"; "Defines what constitutes a biological."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.259"; . a ; ; ; ; ; . a ; "32AA Biological classes"@en; ; "e24bc7f4db33f66737936ceb7363370b3bdde49ff986958622f13b846cfcb56a"; "Regulations may prescribe different classes of biologicals."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.260"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "mayPrescribe"; "May prescribe different classes of biologicals."; "modalities::logic::deontic"; 1.0000; . . a ; ; "classify"; "Classify biologicals into different classes."; "modalities::dl"; 1.0000; . a ; "32AB When biologicals are separate and distinct from other"@en; ; "999e230b8a5219a386be04788b21dc41b76be03fa3db0662e21d85b66b4f80fc"; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.260". a ; "32AB(1) When biologicals are separate and distinct from other"@en; ; "dbbc85cba0a091bb5625a683b02d981a6248ab1a5a3afeff7adc108ccf610d34"; ; "Regulations may prescribe circumstances for separate and distinct biologicals."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.260"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "mayPrescribe"; "Regulations may prescribe circumstances."; "modalities::logic::deontic"; 1.0000; . . a ; ; "classify"; "Classify biologicals by specified class."; "modalities::dl"; 1.0000; . a ; "32AB(2) When biologicals are separate and distinct from other"@en; ; "63a462d5bb4ff2836c2e8eaf8561d71bd4113089cadb5e3dea1e8a9e017d7c35"; ; "Different provision for different classes of biologicals"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.260"; . a ; ; ; ; "borne by: State"; ; . a ; "32B What this Division is about"@en; ; "80b0d0676bfee26056dd3ed5682eb90172a72b0377a09f89fdc83fa37e80de5e"; "Defines criminal offences and civil penalties relating to biologicals."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.262"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "is"; "Identifies the subject of the obligation."; "State"; "modalities::logic::deontic"; 1.0000; . a ; "32BA Criminal offences for importing a biological"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.262". a ; "32BA(1) Criminal offences for importing a biological"@en; ; "792913e2e247ca1544884ddb576f19a480297b1fd960a111ee98ac14d30f9bc3"; ; "Importing a biological for use in humans is prohibited unless certain exemptions apply."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.262"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition"; "modalities::logic::deontic"; 1.0000; . a ; "32BA(4) Criminal offences for importing a biological"@en; ; "75e3ae16b65bc4be99c0bfe5a38edb2a77af9a56f383e1cf324483c156e628e3"; ; "Importing a biological for use in humans is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.262"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits the importation of a biological for use in humans."; "modalities::logic::deontic"; 1.0000; . a ; "32BA(4A) Criminal offences for importing a biological"@en; ; "7c3b346f39b4c32183e5432c92496807dcc4f187df7b72a3a9e198edd7b7d07c"; ; "Importing a biological for use in humans without registration is an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.262"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits importing a biological for use in humans without registration."; "(4A) A person commits an offence if: (a) the person imports into Australia a biological for use in humans; and (b) none of the following subparagraphs applies:"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Temporal Interval"; "Defines the temporal interval during which importing a biological for use in humans without registration is an offence."; "(4A) A person commits an offence if: (a) the person imports into Australia a biological for use in humans; and (b) none of the following subparagraphs applies:"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Recurring Trace"; "Defines a recurring trace of importing a biological for use in humans without registration as an offence."; "(4A) A person commits an offence if: (a) the person imports into Australia a biological for use in humans; and (b) none of the following subparagraphs applies:"; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Knowledge Representation"; "Represents importing a biological for use in humans without registration as an offence using knowledge representation."; "(4A) A person commits an offence if: (a) the person imports into Australia a biological for use in humans; and (b) none of the following subparagraphs applies:"; "sparql_library::parsers::chk_parser"; 1.0000; . . a ; ; "Schema Definition"; "Defines a schema definition for importing a biological for use in humans without registration as an offence."; "(4A) A person commits an offence if: (a) the person imports into Australia a biological for use in humans; and (b) none of the following subparagraphs applies:"; "modalities::logic::shacl"; 1.0000; . a ; "32BB Criminal offences for exporting a biological"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.265". a ; "32BB(1) Criminal offences for exporting a biological"@en; ; "0a7daf3409b0e6b2288a3ab4647159ebb3596e2e12fa3fadcfa8cf8e8560a081"; ; "Exporting a biological for use in humans is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.265"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits the export of a biological for use in humans."; "modalities::logic::deontic"; 1.0000; . a ; "32BB(4) Criminal offences for exporting a biological"@en; ; "c70b93dd58444bebdddf2f4d6be0e391c76e7affac958fcaac505848b55542b0"; ; "Exporting a biological for use in humans is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.265"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits exporting a biological for use in humans."; "(4) A person commits an offence if: (a) the person exports from Australia a biological for use in humans; and (b) none of the following subparagraphs applies:"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibit"; "Prohibits exporting a biological for use in humans."; "(4) A person commits an offence if: (a) the person exports from Australia a biological for use in humans; and (b) none of the following subparagraphs applies:"; "modalities::linear"; 1.0000; . a ; "32BC Criminal offences for manufacturing a biological"@en; ; "fae1f67ea011d907dd77b46b41db5e86fa815e6a2125ca9947534c13ae77466c"; "Manufacturing a biological without proper authorization is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.267"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits the manufacture of biologicals without authorization."; "modalities::logic::deontic"; 1.0000; . a ; "32BD Criminal offences for supplying a biological"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.270". a ; "32BD(1) Criminal offences for supplying a biological"@en; ; "8bbbd90ec595085a508f5546c78a6c034cfc06ba6766f62bf0d133fd16153e8e"; ; "Supplying a biological for use in humans is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.270"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits supplying a biological for use in humans."; "modalities::logic::deontic"; 1.0000; . a ; "32BD(4) Criminal offences for supplying a biological"@en; ; "de13f9ca81eba433192e7a927047958e7fbf31bab0e2b4aaaaffe226567dc11a"; ; "Supplying a biological for use in humans is an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.270"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits supplying a biological for use in humans."; "(4) A person commits an offence if..."; "The supply of a biological for use in humans is prohibited."; "modalities::logic::deontic"; 1.0000; . a ; "32BD(4A) Criminal offences for supplying a biological"@en; ; "ed3f858ccff6ab4d9e70c3a2422d0668db91b2f473004b0af7e92724ef3604a4"; ; "Supplying a biological for use in humans is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.270"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits supplying a biological for use in humans."; "(4A) A person commits an offence if: (a) the person supplies in Australia a biological for use in humans;"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Trace"; "Traces supplying a biological for use in humans to an offence."; "(4A) A person commits an offence if: (a) the person supplies in Australia a biological for use in humans;"; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Between"; "Places supplying a biological for use in humans between committing an offence."; "(4A) A person commits an offence if: (a) the person supplies in Australia a biological for use in humans;"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Diffuse"; "Diffuses the prohibition of supplying a biological for use in humans."; "(4A) A person commits an offence if: (a) the person supplies in Australia a biological for use in humans;"; "modalities::diffusion"; 1.0000; . a ; "32BE Notice required to adduce evidence in support of exception to"@en; ; "3b1136af07e5f03743ec4abe274eef1fe23ae5890e24a975247fc98d3bba8c9d"; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.273". a ; "32BE(1) Notice required to adduce evidence in support of exception to"@en; ; "4561beb3cff2e2ea0ab7dcdb8ffac4b184554075661bcdd00c8fd92694a3fa2f"; ; "Defendant must be informed of requirements and given a copy of the section."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.273"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Defendant must be informed."; "modalities::logic::deontic"; 1.0000; . a ; "32BE(2) Notice required to adduce evidence in support of exception to"@en; ; "068a90c5aa14cbfe6f2a4b7240d73f881042f23bd47c1428f94e8d12d353649b"; ; "No evidence can be adduced without notice of particulars of the exception."; "Notice of particulars of the exception"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.273"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "Prohibit"; "Prohibition"; "modalities::logic::deontic"; 1.0000; . a ; "32BE(3) Notice required to adduce evidence in support of exception to"@en; ; "0c456728e444ce6f5ecf6164c4d8b4189bec728333dd3f165447764ca9f8517f"; ; "Defendant cannot call another person to give evidence without leave of the court."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.273"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "Prohibit"; "Prohibition on calling another person to give evidence."; "(3) A defendant must not, without leave of the court..."; "...call any other person to give evidence in support of the exception unless..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Classify"; "Classification of individuals based on notice and address information."; "(a) the notice under subsection (2) includes the name and address of the person or..."; "...the court is satisfied that the defendant before giving the notice took, and after giving the notice continued to take, all reasonable steps to ascertain the name or address;"; "modalities::dl"; 1.0000; . . a ; ; "Temporal relation"; "Temporal relation between notice and address information."; "(b) if the name or the address is not included in the notice—the court is satisfied that..."; "...the defendant before giving the notice took, and after giving the notice continued to take, all reasonable steps to ascertain the name or address;"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Recurring trace"; "Recurring trace of defendant's actions."; "...the court is satisfied that the defendant before giving the notice took, and after giving the notice continued to take, all reasonable steps..."; "...the name or address; and"; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Information dissemination"; "Dissemination of information about defendant's actions."; "...the court is satisfied that the defendant before giving the notice took, and after giving the notice continued to take, all reasonable steps..."; "...to ascertain the name or address;"; "modalities::diffusion"; 1.0000; . . a ; ; "Knowledge representation"; "Knowledge representation of defendant's actions."; "(a) the notice under subsection (2) includes the name and address of the person or..."; "...the court is satisfied that the defendant before giving the notice took, and after giving the notice continued to take, all reasonable steps to ascertain the name or address;"; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "32BF Civil penalties for importing, exporting, manufacturing or"@en; ; "0677747650a09431b56b23a3cfcf39c06feec3ef42ac2c67dd31bc9f3ca5873c"; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.275". a ; "32BF(1) Civil penalties for importing, exporting, manufacturing or"@en; ; "7c5a4b9b281aab1b1b5fa77fccc9b4ce05e29e45641bd93c1faf84d92571c9d9"; ; "Importing, exporting, manufacturing biologicals for use in humans without approval is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.275"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of importing, exporting, manufacturing biologicals for use in humans."; "modalities::logic::deontic"; 1.0000; . a ; "32BF(2) Civil penalties for importing, exporting, manufacturing or"@en; ; "b05e5e684e4d48ae020182b20a2e512fec863e36612d58bcaf0ab561111529f1"; ; "Exporting biologicals for human use without registration is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.275"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of exporting biologicals for human use without registration."; "(2) A person contravenes this subsection if: (a) the person exports from Australia a biological for use in humans; and (b) none of the following subparagraphs applies:"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Temporal Interval"; "Temporal interval between export and registration."; "(2) A person contravenes this subsection if: (a) the person exports from Australia a biological for use in humans; and (b) none of the following subparagraphs applies:"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Recurring Trace"; "Recurring trace of unregistered exports."; "(2) A person contravenes this subsection if: (a) the person exports from Australia a biological for use in humans; and (b) none of the following subparagraphs applies:"; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Diffusion"; "Diffusion of prohibited knowledge."; "(2) A person contravenes this subsection if: (a) the person exports from Australia a biological for use in humans; and (b) none of the following subparagraphs applies:"; "modalities::diffusion"; 1.0000; . . a ; ; "Knowledge Graph"; "Knowledge graph representation of prohibited knowledge."; "(2) A person contravenes this subsection if: (a) the person exports from Australia a biological for use in humans; and (b) none of the following subparagraphs applies:"; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "32BG Criminal offences and civil penalty relating to a failure to"@en; ; "dd0fec9e174dd72cf2617f620da7b466f0c8086f4c0d38048ed657f6b0617646"; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.279". a ; "32BG(1) Criminal offences and civil penalty relating to a failure to"@en; ; "cdd10a4b6c6b569aff8fbb260d98283c39b68ee1d324485dbf49111bd8fce541"; ; "Importing, exporting, manufacturing, or supplying a biological for use in humans without proper notification is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.279"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition"; "modalities::logic::deontic"; 1.0000; . a ; "32BG(1A) Criminal offences and civil penalty relating to a failure to"@en; ; "25c3681cc8d63c95009d6e5acce789eb9e40d95e253fac00dc0c91be046ef64c"; ; "Importing or exporting biologicals for use in humans is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.279"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits the action."; "modalities::logic::deontic"; 1.0000; . a ; "32BH Criminal offence relating to wholesale supply"@en; ; "229ac0ee4086a71c767aa2db7da313557c305a292ced5d9370a1b3f5b9aff0a2"; "Supplying biologicals for use in humans without proper exemption or approval is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.281"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits supplying biologicals for use in humans without proper exemption or approval."; "modalities::logic::deontic"; 1.0000; . a ; "32BI Criminal offence for using a biological not included in the"@en; ; "bb7234ec12451361e6f35bcbe76de58e4350657fe60d1b96ace0947f59194083"; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.282". a ; "32BI(1) Criminal offence for using a biological not included in the"@en; ; "e9f99ef5c8e0821147a4dbc1e4d3b7b7f99cad157f27fca22180683c49526601"; ; "Using a biological without proper authorization is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.282"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition"; "modalities::logic::deontic"; 1.0000; . a ; "32BI(4) Criminal offence for using a biological not included in the"@en; ; "24fae3178dc16ea3016c6f1e30101477f32e3e8b7040cd239b9f7100d294deb7"; ; "Using a biological not included in the Register for certain purposes is an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.282"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition"; "The biological is used in the treatment of another person or solely for experimental purposes in humans."; "An offence has been committed."; "modalities::logic::deontic"; 1.0000; . a ; "32BJ General criminal offences relating to this Part"@en; ; "35b6bde922634858a35a80861a3ae5396245e7b18e562eff950c3ffcef6d7b4e"; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.284". a ; "32BJ(1) General criminal offences relating to this Part"@en; ; "2d43b0126a6339b64168b11efb8960639cec616cbf1a5f792098a389c0441d51"; ; "Setting out false biological numbers on containers or labels is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.284"; . a ; ; ; ; ; . . a ; ; "Prohibit"; "Prohibition of false biological numbers"; "modalities::logic::deontic"; 1.0000; . a ; "32BJ(2) General criminal offences relating to this Part"@en; ; "02785f0cbc8942d64ddff8b6912a6c073c758f4336d86bd1af9feacb7f29d8cc"; ; "Defines what constitutes a number for the purposes of subsection (1)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.284"; . a ; ; ; ; "borne by: State"; ; . a ; "32BJ(2A) General criminal offences relating to this Part"@en; ; "db99284500a8ae665df24129e2c0b062ce26441fc4dbd22fff1171fa4baf1489"; ; "Advertising a biological for an indication that is not accepted in relation to its inclusion in the Register is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.284"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of advertising a biological for an indication that is not accepted in relation to its inclusion in the Register."; "(2A) A person commits an offence if: (a) the person, by any means, advertises a biological for an indication; and (b) the biological is included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion; and"; "Penalty: Imprisonment for 5 years or 4,000 penalty units, or both."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Classify"; "Classification of the advertisement as a prohibited act."; "(2A) A person commits an offence if: (a) the person, by any means, advertises a biological for an indication; and (b) the biological is included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion; and"; "(d) either: (i) the use of the biological for the advertised indication has resulted in, will result in, or is likely to result in, harm or injury to any person; or (ii) the use of the biological for the advertised indication, if the biological were so used, would result in, or would be likely to result in, harm or injury to any person."; "modalities::dl"; 1.0000; . a ; "32BJ(2B) General criminal offences relating to this Part"@en; ; "57aff9b490de1351e8d2d84ece74d5f207da48b05ce14bac99489aa611a9c75e"; ; "Advertising a biological for an indication without proper inclusion in the Register is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.284"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of advertising a biological for an indication without proper inclusion in the Register."; "(2B) A person commits an offence if: (a) the person, by any means, advertises a biological for an indication; and (b) the biological is included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion."; "(2B) A person commits an offence if: (a) the person, by any means, advertises a biological for an indication; and (b) the biological is included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion."; "modalities::logic::deontic"; 1.0000; . a ; "32BK Civil penalty for making misrepresentations about biologicals"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.286". a ; "32BK(1) Civil penalty for making misrepresentations about biologicals"@en; ; "e2540a4f20ec9e4332ab4f0dd4a35ee5afd712b91ddc904a454340576faaca0e"; ; "Making false or misleading representations about biologicals is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.286"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits making false or misleading representations about biologicals."; "(a) the person makes a representation of a kind referred to in subsection (2); and (b) the representation is false or misleading."; "(1) A person contravenes this section if:..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Temporal Interval"; "Defines a temporal interval for the prohibition."; "(1) A person contravenes this section if:"; "...and (b) for an individual—5,000 penalty units; and"; "modalities::interval_reasoning"; 0.5000; . . a ; ; "Temporal Interval"; "Defines a temporal interval for the prohibition."; "(1) A person contravenes this section if:"; "...and (b) for a body corporate—50,000 penalty units."; "modalities::temporal_ltl"; 0.5000; . a ; "32BK(2) Civil penalty for making misrepresentations about biologicals"@en; ; "06cd48fdb1ff12f5e99fc5f9cb34bcc7125ea6329ee289bc64eb65a9cedf7dcc"; ; "Making misrepresentations about biologicals is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.286"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of making misrepresentations about biologicals."; "Subsection (1) applies to the following representations:"; "modalities::logic::deontic"; 1.0000; . a ; "32BL Civil penalty for advertising biological for an indication"@en; ; "3f0e9dca5ed0e450272c4a41587cee91108d4449fdc09162998d0291c7947e38"; "Advertising biological for an indication without proper registration is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.287"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits advertising biological for an indication without proper registration."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Classify"; "Classifies advertisements as prohibited if they include unregistered biologicals."; "modalities::dl"; 1.0000; . a ; "32C What this Division is about"@en; ; "c38bc359a91a2207e4a55da9309d6818217b55e4c65f0ef58a706fed4adb366f"; "Exemptions of biologicals under regulations, emergencies, special and experimental uses, and substitutes unavailable."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.288"; . a ; ; ; ; . a ; "32CA Exempt biologicals"@en; ; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.288". a ; "32CA(1) Exempt biologicals"@en; ; "db9728862b6e72db922a14db963a70c825f350f38cadc4460643730e2fc05dd2"; ; "Exempts specified persons from Division 4 operation in relation to specified biologicals."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.288"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "exemption"; "Exempts"; "modalities::logic::deontic"; 1.0000; . a ; "32CA(2) Exempt biologicals"@en; ; "b0b15accc1ac77e0103634de3f6f0996f11acdae25fd87d75268c3e925b817f4"; ; "Exempt biologicals from Division 4 operation."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.288"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "exemption"; "Regulations may exempt specified biologicals."; "modalities::logic::deontic"; 1.0000; . a ; "32CA(3) Exempt biologicals"@en; ; "7004e0a402d1dc126e0632c590e6cac5f00016297805b7289d36824db7da25f2"; ; "Exemptions may be subject to conditions prescribed in regulations."; "sec-32CP", "sec-32CQ"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.288"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Permission to exempt biologicals with conditions."; "modalities::logic::deontic"; 1.0000; . a ; "32CA(5) Exempt biologicals"@en; ; "2ca56c6529b8857c8521bb0ef230cb25379c9023e083819165ea2a7fde94ab34"; ; "Revocation of exemption takes effect after specified day"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.288"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "takesEffect"; "Obligation to revoke exemption on specified day"; "(5) If the regulations revoke an exemption, the revocation takes effect..."; "...than 28 days after the day on which the regulations revoking the exemption take effect."; "modalities::logic::deontic"; 1.0000; . . a ; ; "meetsBefore"; "Temporal relationship between revocation and commencement of revocation"; "(5) If the regulations revoke an exemption, the revocation takes effect..."; "...than 28 days after the day on which the regulations revoking the exemption take effect."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "holdsForAll"; "Temporal relationship between revocation and commencement of revocation"; "(5) If the regulations revoke an exemption, the revocation takes effect..."; "...than 28 days after the day on which the regulations revoking the exemption take effect."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "diffusesTo"; "Revocation of exemption diffuses to affected parties"; "(5) If the regulations revoke an exemption, the revocation takes effect..."; "...than 28 days after the day on which the regulations revoking the exemption take effect."; "modalities::diffusion"; 1.0000; . . a ; ; "recognizes"; "Revocation of exemption recognized by regulatory agency"; "(5) If the regulations revoke an exemption, the revocation takes effect..."; "...than 28 days after the day on which the regulations revoking the exemption take effect."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "32CB Minister may make exemptions"@en; ; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.289". a ; "32CB(1) Minister may make exemptions"@en; ; "3ddd512dd92caa45a244cff3b3718ed2673b78865b2036a98ec39057762193e8"; ; "Minister may exempt specified biologicals from Division 4 operation."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.289"; . a ; ; ; ; ; . . a ; ; "may"; "Permission to exempt"; "modalities::logic::deontic"; 1.0000; . a ; "32CB(1A) Minister may make exemptions"@en; ; "fc5de5e42117aadbd69848069a4b5d9b3d6d2a5644eb3c1a7a7d76d1acbadecf"; ; "Minister must make exemption under certain conditions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.289"; . a ; ; ; ; ; . . a ; ; "MUST"; "Obligation to make exemption"; "Minister is satisfied of the matter in subsection (2) or (2A)"; "Exemption must be made"; "modalities::logic::deontic"; 0.5000; . a ; "32CB(2) Minister may make exemptions"@en; ; "b05959bf8079b221dc670546ec6ce03432a39d57646c600eddb0ccbefca70def"; ; "Minister may make exemptions in national interest."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.289"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Permission to make exemptions."; "modalities::logic::deontic"; 1.0000; . a ; "32CB(2A) Minister may make exemptions"@en; ; "ff8a0ded51bb92009ddf22609c12fad77d7071c77e323f785ecd3e09ff211fd8"; ; "Minister may make exemptions under certain conditions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.289"; . a ; ; ; ; "borne by: State"; ; . a ; "32CC Conditions of exemptions"@en; ; "c7b1c460731585fbba3a42855f586235f97ca637206d026d81d8378972880350"; "Conditions for exemptions under section 32CB"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.290"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Conditions for exemptions"; "modalities::logic::deontic"; 1.0000; . . a ; ; "ClassHierarchy"; "Exemptions under section 32CB are subject to conditions"; "modalities::dl"; 1.0000; . a ; "32CD Variation or revocation of exemption"@en; ; "c2f34d233068d447bce67a922c935760ef233255887c06da805ed973ebd562ed"; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.291". a ; "32CD(1) Variation or revocation of exemption"@en; ; "a808afa79dd17f48b8286d2e12544726b8e037bfc3723762ddbcda78855e47a0"; ; "Variation of exemption by Minister"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.291"; . a ; ; ; ; ; . . a ; ; "may"; "Granting permission"; "modalities::logic::deontic"; 1.0000; . a ; "32CD(2) Variation or revocation of exemption"@en; ; "7135b280090a1ee49d6ee39b85effc23406959dd475285f0213043fe8a7ee440"; ; "Revocation of exemption by Minister"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.291"; . a ; ; ; ; ; . . a ; ; "may"; "Permission to revoke exemption"; "modalities::logic::deontic"; 1.0000; . a ; "32CD(3) Variation or revocation of exemption"@en; ; "b82d77970e909892b6afd3bffa069f89cbbe11fc192556d2e30e16f90e1824ff"; ; "The Minister may vary or revoke the conditions of an exemption made under section 32CB."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.291"; . a ; ; ; ; ; . . a ; ; "may"; "Expresses permission or obligation."; "modalities::logic::deontic"; 1.0000; . a ; "32CE Informing persons of exemption etc."@en; ; "9baa2ceddbda14d2cba328934dbb3080aff62d164434e59b6e7b9e7ef4ccdb34"; "Must inform persons of exemption under section 32CB"; "copy of exemption and variation/revocation"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.292"; . a ; ; ; ; ; . . a ; ; "MUST"; "Obligation to inform"; "modalities::logic::deontic"; 1.0000; . a ; "32CF Notification and tabling"@en; ; "7d31b83313991d4c969b95ff28385ff891514dbe7a93c93c5db8145ad031420f"; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.292". a ; "32CF(1) Notification and tabling"@en; ; "ce6a18dbebdfe47b38ce43f46ae91dff34bf01ff26f24ea293802a44f4ca525b"; ; "Publish notice in Gazette within 7 days after exemption, variation or revocation is made."; "Notice setting out particulars of exemption, variation or revocation"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.292"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must publish notice in Gazette within 7 days"; "modalities::logic::deontic"; 1.0000; . a ; "32CF(2) Notification and tabling"@en; ; "f9881921d65ac7ae6a48921cd2c372fca1a183a6d66b823e903500383e73e720"; ; "Notification and tabling of exemptions, variations, or revocations made under section 32CB."; "document setting out particulars"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.292"; . a ; ; ; ; ; . . a ; ; "MUST"; "Obligation to notify and table"; "modalities::logic::deontic"; 1.0000; . a ; "32CG Disposal of unused biologicals"@en; ; "eb2a5e9863ba36f144ee4e3841286108c8fb08381bee777ce9c72a03e14257a4"; "This section applies to a biological if an exemption under section 32CB ceases to have effect."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.293"; . a ; ; ; ; ; . a ; "32CJ Criminal offences and civil penalty for biologicals not"@en; ; "12d2b2e35f3f849925d69a8145ed8cc043746662e2c469a65057c21a308818c6"; , , , , , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.294". a ; "32CJ(1) Criminal offences and civil penalty for biologicals not"@en; ; "d255966b5d50b94d0dcc3f4c82d24d87cebeca7a2162f2bfda0875c3a2e0915f"; ; "Supplying non-conforming biologicals is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.294"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition"; "(a) a biological is exempt under section 32CB; and (b) a person supplies a batch of the biologicals;"; "Supplying non-conforming biologicals is prohibited."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Imply"; "Implication from exemption and supply"; "(a) a biological is exempt under section 32CB; and (b) a person supplies a batch of the biologicals;"; "Supplying non-conforming biologicals implies violation of exemption."; "modalities::linear"; 1.0000; . . a ; ; "Within"; "Temporal interval within supply period"; "(c) the Secretary is satisfied that the biologicals included in that batch: (i) do not conform to a standard applicable to the biologicals; or (ii) are otherwise not fit to be used for their intended purposes."; "Supply period includes non-conforming biologicals."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Imply"; "Implication from supply and non-compliance"; "(c) the Secretary is satisfied that the biologicals included in that batch: (i) do not conform to a standard applicable to the biologicals; or (ii) are otherwise not fit to be used for their intended purposes."; "Non-compliance implies supply."; "modalities::diffusion"; 1.0000; . a ; "32CJ(2) Criminal offences and civil penalty for biologicals not"@en; ; "c8b634d4ccd6b2a089a260e79adfce6e33899c4e378d8bfc263bbfd860b2b8aa"; ; "Require person to take steps to recall biologicals"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.294"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "require"; "Imposes a duty on the state"; "modalities::logic::deontic"; 1.0000; . a ; "32CJ(3) Criminal offences and civil penalty for biologicals not"@en; ; "c9f828f3465dc1f8ac5c62c88f09d045c31c2d08e44cb0bf9a53a3e3913ed25f"; ; "Requirements for recalling biologicals"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.294"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "requires"; "Requires steps to be taken"; "(3) The notice may specify one or more of the following requirements:"; "modalities::logic::deontic"; 1.0000; . . a ; ; "within"; "Steps must be taken within a reasonable period"; "c) a reasonable period within which the steps are to be taken."; "modalities::interval_reasoning"; 1.0000; . a ; "32CJ(4) Criminal offences and civil penalty for biologicals not"@en; ; "e50cf2ee04df7e945ee6224562b56c62abef9854ac8568bedd7ccdfc55391374"; ; "Publish notice in Gazette or Department's website"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.294"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must publish notice"; "modalities::logic::deontic"; 1.0000; . a ; "32CJ(5) Criminal offences and civil penalty for biologicals not"@en; ; "236643b62b82e86b3a70c2140edffdf78cd39d6079dc9c193e868b7894443351"; ; "Notice given under subsection (2) is not a legislative instrument."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.294"; . a ; ; ; ; ; . . a ; ; "Prohibition"; "Prohibits notice given under subsection (2) from being a legislative instrument."; "modalities::logic::deontic"; 1.0000; . a ; "32CJ(6) Criminal offences and civil penalty for biologicals not"@en; ; "78ab3acffacaca9381df72ef1e04017c8bcc0f3ab56d64213beb686bf8eb2153"; ; "Failure to comply with notice requirement results in harm or injury."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.294"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibition of non-compliance with notice requirement."; "The person fails to comply with the specified requirement."; "Harm or injury results."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Obligation"; "Notice requirement is a duty."; "The Secretary gives a notice to the person under subsection (2)."; "Compliance with notice requirement is required."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlaps"; "Temporal overlap between notice and harm/injury."; "The use of any of the biologicals has resulted in, will result in, or is likely to result in, harm or injury to any person."; "Notice requirement overlaps with potential harm/injury."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Prohibition"; "Non-compliance with notice requirement is prohibited."; "(c) the person fails to comply with that requirement; and"; "Harm or injury results from non-compliance."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Obligation"; "Compliance with notice requirement is a duty."; "(a) the Secretary gives a notice to the person under subsection (2); and"; "Compliance with notice requirement is required."; "modalities::logic::deontic"; 1.0000; . a ; "32CJ(7) Criminal offences and civil penalty for biologicals not"@en; ; "d97606b3646e0c55b11f306658674f3ce38bb019beaa2267212f86b749c46fc1"; ; "Failure to comply with notice requirement is an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.294"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Obligation to comply with notice requirement."; "(7) A person commits an offence if: (a) the Secretary gives a notice to the person under subsection (2); and (b) the notice specifies a particular requirement mentioned in subsection (3); and (c) the person fails to comply with that requirement."; "Penalty: Imprisonment for 12 months or 1,000 penalty units, or both."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlaps"; "The provision has an overlapping temporal interval."; "(7) A person commits an offence if: (a) the Secretary gives a notice to the person under subsection (2); and (b) the notice specifies a particular requirement mentioned in subsection (3); and (c) the person fails to comply with that requirement."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Recurrently"; "The provision has a recurring trace."; "(7) A person commits an offence if: (a) the Secretary gives a notice to the person under subsection (2); and (b) the notice specifies a particular requirement mentioned in subsection (3); and (c) the person fails to comply with that requirement."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Implication"; "The provision implies a consequence if the person fails to comply."; "(7) A person commits an offence if: (a) the Secretary gives a notice to the person under subsection (2); and (b) the notice specifies a particular requirement mentioned in subsection (3); and (c) the person fails to comply with that requirement."; "Penalty: Imprisonment for 12 months or 1,000 penalty units, or both."; "modalities::argumentation"; 1.0000; . a ; "32CJ(9) Criminal offences and civil penalty for biologicals not"@en; ; "d2e7ccd79a198b12bcc0a6c0d9e3a20b45a8cc09fc3e0d67681a19bc819f8a7d"; ; "Failure to comply with notice requirement is an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.294"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "obligation"; "Obligation to comply with notice requirement."; "(a) the Secretary gives a notice to the person under subsection (2); and (b) the notice specifies a particular requirement mentioned in subsection (3); and (c) the person fails to comply with that requirement."; "The person commits an offence if..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "prohibition"; "Prohibition on non-compliance with notice requirement."; "(9) A person commits an offence if: (a) the Secretary gives a notice to the person under subsection (2); and (b) the notice specifies a particular requirement mentioned in subsection (3); and (c) the person fails to comply with that requirement."; "Penalty: 100 penalty units."; "modalities::logic::deontic"; 1.0000; . . a ; ; "implies"; "Implies penalty for non-compliance."; "(9) A person commits an offence if: (a) the Secretary gives a notice to the person under subsection (2); and (b) the notice specifies a particular requirement mentioned in subsection (3); and (c) the person fails to comply with that requirement."; "Penalty: 100 penalty units."; "modalities::linear"; 1.0000; . . a ; ; "right"; "Right to receive notice from Secretary."; "(9) A person commits an offence if: (a) the Secretary gives a notice to the person under subsection (2); and (b) the notice specifies a particular requirement mentioned in subsection (3); and (c) the person fails to comply with that requirement."; "The person has a right to receive notice from the Secretary."; "modalities::logic::deontic"; 1.0000; . a ; "32CJ(10) Criminal offences and civil penalty for biologicals not"@en; ; "6d4597e8e796e3547be52a0119b80a81c0a8dcfdf06fbfa58269f392da9ff357"; ; "An offence against subsection (9) is an offence of strict liability."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.294"; . a ; ; ; ; ; . . a ; ; "is"; "Strict liability"; "(9)"; "(10)"; "modalities::logic::deontic"; 1.0000; . a ; "32CK Approvals for importing, exporting or supplying a biological"@en; ; "920370b334e486f0d3932b0a2f4f556fab654a43d9faa04f448fc4e998d0d339"; , , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.296". a ; "32CK(1) Approvals for importing, exporting or supplying a biological"@en; ; "5e0cc969ca7a56fe8e77b34630c98c3d70f3f2d16bd9a3235f1d8fe10c35a79d"; ; "Approval for importing, exporting or supplying a biological"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.296"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "grant"; "Granting approval"; "(1) The Secretary may, by notice in writing..."; "...a person for one or more of the following:"; "modalities::logic::deontic"; 0.5000; . . a ; ; "during"; "Temporal relation for approval"; "(1)(e) for use solely for experimental purposes in humans."; "...for variation of an approval..."; "modalities::interval_reasoning"; 0.5000; . . a ; ; "until"; "Conditional commencement"; "For variation of an approval..."; "...see subsection (9A)."; "modalities::temporal_ltl"; 0.5000; . . a ; ; "forbid"; "Prohibition on experimental use"; "(e) for use solely for experimental purposes in humans."; "...or for use in the treatment of another person;"; "modalities::logic::deontic"; 0.5000; . . a ; ; "forbid"; "Prohibition on unauthorized use"; "(d) for use in the treatment of another person."; "...or for use solely for experimental purposes in humans."; "modalities::logic::deontic"; 0.5000; . a ; "32CK(1A) Approvals for importing, exporting or supplying a biological"@en; ; "8c229996e0fe7498af430b67cef2bc380e7c5735ae00e76470e4d78f04c6a06c"; ; "Approval for use of a biological must be granted only to a health practitioner."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.296"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits granting approval unless the person is a health practitioner."; "(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."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Restrict"; "Restricts the approval to only those who are 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."; "modalities::logic::deontic"; 0.5000; . . a ; ; "Temporal Restriction"; "Restricts the approval to only those who are health practitioners at the time of granting."; "(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."; "modalities::interval_reasoning"; 0.5000; . . a ; ; "Enforce"; "Ensures that only health practitioners are granted approval."; "(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."; "modalities::logic::deontic"; 0.5000; . . a ; ; "Justify"; "Justifies the restriction on approval to only those who are 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."; "modalities::logic::deontic"; 0.5000; . a ; "32CK(2) Approvals for importing, exporting or supplying a biological"@en; ; "ed431cd6aa277fa4e94694fa1abcffc211c5f1b94285e2ddf0bceafc4cf26552"; ; "Exemption from subsection 32CA(1) for biologicals in the Register or under subsection 32CA(2)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.296"; . a ; ; ; ; ; . a ; "32CK(3) Approvals for importing, exporting or supplying a biological"@en; ; "6e176c2ed174eea921ab27fcb626351a859de766379b9c72e1453eaa3d9a738a"; ; "Application for approval must be made to the Secretary and accompanied by required information."; "Information relating to the biological subject of the application"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.296"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Application must be made"; "modalities::logic::deontic"; 1.0000; . a ; "32CK(4) Approvals for importing, exporting or supplying a biological"@en; ; "22046edada565bfb92398c70e6dc34ea332e3586881e3dac883d7e20ab1d1a73"; ; "Application for approval must be made to the Secretary and meet certain requirements."; "Information relating to the biological subject of the application, prescribed evaluation fee"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.296"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Application must be made"; "modalities::logic::deontic"; 1.0000; . a ; "32CK(5) Approvals for importing, exporting or supplying a biological"@en; ; "1f01bb9a50b4abd4ae6370b9c2e964457ea7a388cba31f44448dc0ce383de087"; ; "Secretary must notify applicant of decision on application as soon as practicable."; "Reasons for decision if not granting approval"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.296"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Secretary must notify applicant"; "modalities::logic::deontic"; 1.0000; . a ; "32CL Conditions of use of biological for experimental purposes in"@en; ; "7e701d11574a534623c3bd1f6c743bdb945e3a815eb9934ef8470707c3a2f145"; "Use of biological for experimental purposes in humans subject to conditions specified in regulations."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.299"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Imposes a duty on the experimenter."; "The use by a person (the experimenter) for experimental purposes in humans of a biological..."; "is subject to the conditions specified in the regulations."; "modalities::logic::deontic"; 0.5000; . . a ; ; "Overlaps"; "Describes the temporal relationship between the regulation and its application."; "The use by a person (the experimenter) for experimental purposes..."; "occurs during the period specified in the regulations."; "modalities::interval_reasoning"; 0.5000; . . a ; ; "Implication"; "Describes the relationship between the regulation and its consequences."; "The use by a person (the experimenter) for experimental purposes..."; "must comply with the conditions specified in the regulations."; "modalities::argumentation"; 0.5000; . . a ; ; "Propagation"; "Describes the spread of information about the regulation."; "The use by a person (the experimenter) for experimental purposes..."; "is disseminated through the regulations."; "modalities::diffusion"; 0.5000; . . a ; ; "Inference"; "Describes the process of reasoning about the regulation."; "The use by a person (the experimenter) for experimental purposes..."; "can be inferred from the regulations."; "sparql_library::parsers::chk_parser"; 0.5000; . a ; "32CM Authorities for health practitioners"@en; ; , , , , , , , , , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.300". a ; "32CM(1) Authorities for health practitioners"@en; ; "2ebb04903485bb08c5b51c3121e90c32cbe4497f08f911ccec9070e58a7bfcb5"; ; "The Secretary may authorise a medical practitioner to supply biologicals."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.300"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "authorise"; "Authorisation is an obligation."; "modalities::logic::deontic"; 1.0000; . a ; "32CM(1A) Authorities for health practitioners"@en; ; "08807ce063a19d294a3e8ec5c4286cac61c2b55d571ffb679a457b7ada675751"; ; "Application for authority must be in approved form"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.300"; . a ; ; ; ; ; . . a ; ; "MUST"; "Must provide approved application form"; "modalities::logic::deontic"; 1.0000; . a ; "32CM(2) Authorities for health practitioners"@en; ; "bb3578d9ca0d71cea2c6fab3d924bf3110c723d2490b46fa2d16c6a19f03d746"; ; "The Secretary may give an authority under subsection (1) subject to conditions."; "sec-32cp", "sec-32cq"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.300"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Authority may be given subject to conditions."; "modalities::logic::deontic"; 0.5000; . a ; "32CM(3) Authorities for health practitioners"@en; ; "95ca73c03a373e1fa34e1934febb8c07716d9d3c521f5c01b187a079608d7b43"; ; "Secretary may impose conditions on an authority"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.300"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Imposes obligation"; "modalities::logic::deontic"; 1.0000; . a ; "32CM(4) Authorities for health practitioners"@en; ; "b6e70e5ca9265ef50145bf766b83db88f392181cb25baadcf9aa6544b0d11b9b"; ; "Authority for medical practitioners to supply specified biologicals."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.300"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may only be given"; "Authority restriction"; "(4) An authority under subsection (1)"; "to a medical practitioner"; "modalities::logic::deontic"; 1.0000; . . a ; ; "includes"; "Class of medical practitioners"; "(a) who is included in a class of medical practitioners prescribed by the regulations"; "for the purposes of this paragraph"; "modalities::dl"; 1.0000; . . a ; ; "has approval"; "Approval requirement for supply"; "(b) who has the approval of an ethics committee to supply the specified biological"; "modalities::logic::deontic"; 1.0000; . . a ; ; "prescribed by"; "Temporal interval relation"; "for the purposes of this subsection"; "modalities::interval_reasoning"; 1.0000; . a ; "32CM(5) Authorities for health practitioners"@en; ; "0410059304f5f30c95956712a465cad332945b73d82e8f778d078b997a87fe23"; ; "Authority for health practitioners limited to prescribed classes of recipients."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.300"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "only"; "Limited authority"; "(5) An authority under subsection (1)"; "may only be given in relation to a class or classes of recipients prescribed by the regulations"; "modalities::logic::deontic"; 1.0000; . a ; "32CM(6) Authorities for health practitioners"@en; ; "9579659c8525d9cea0b9831f88fcda3e30fce38225012d45c3f23141d6f5e02f"; ; "Regulations may prescribe circumstances for supplying biologicals under authority."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.300"; . a ; ; ; ; "borne by: State"; ; . a ; "32CM(7) Authorities for health practitioners"@en; ; "9c072b796ea59494b11ce727710328635f1c5db95b75700f4db17dd2121a1046"; ; "An authority under subsection (1) is not a legislative instrument."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.300"; . a ; ; ; ; "borne by: State"; ; . a ; "32CM(7A) Authorities for health practitioners"@en; ; "72fbee116e9bcf24c7ddfea9fd972b87404fc52111ca4aa9d8b9c2ddef45e7a5"; ; "The Minister may make rules authorising health practitioners to supply biologicals."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.300"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "May"; "Permission to supply biologicals"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Class inclusion"; "Rules specify class of health practitioners and recipients"; "modalities::dl"; 1.0000; . a ; "32CM(7B) Authorities for health practitioners"@en; ; "5bf3e89932880e5235525b23527e7e83a18538df47d215d5a7796ba43d44e333"; ; "Comply with regulations when making rules under subsection (7A)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.300"; . a ; ; ; ; ; . . a ; ; "Must"; "Minister must comply with regulations"; "(7B) In making rules under subsection (7A), the Minister..."; "modalities::logic::deontic"; 1.0000; . a ; "32CM(7C) Authorities for health practitioners"@en; ; "626e2da458734e9a587fa1a333a8ce482c07cf5cb3b0aa159a37d759f07bc9ff"; ; "Notify supply to Secretary within 28 days after supply."; "true"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.300"; . a ; ; ; ; ; . . a ; ; "MUST"; "Must provide notification."; "modalities::logic::deontic"; 1.0000; . a ; "32CM(7D) Authorities for health practitioners"@en; ; "9b42e934c94e11a48a8ef0759413c3c09246e8376bb66e9467e07c5be3b0970f"; ; "Notification requirements for health practitioners"; "Information as prescribed by regulations"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.300"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide information"; "modalities::logic::deontic"; 1.0000; . a ; "32CM(7E) Authorities for health practitioners"@en; ; "13b4eb4ec7297e75f064b8a2b5422a5f90ec01ed1880a070f751a6b812940a52"; ; "Approval of a form may require or permit information to be given in accordance with specified software requirements."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.300"; . a ; ; ; ; ; . a ; "32CN Criminal offences relating to the giving of an authority to a"@en; ; "73c01c8f80eb06d9ed352e080ae678a2a850abaa2b279eb92f5cd3e14cbf2fa5"; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.302". a ; "32CN(1) Criminal offences relating to the giving of an authority to a"@en; ; "ac365f50da309abc6c9d0052f2f1357375363bb4b2c5abef4d4171bb640a41ca"; ; "Supplying a biological without proper authority is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.302"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits supplying a biological without proper authority."; "(a) the Secretary has authorised, under subsection 32CM(1), the person to supply a biological; and (b) the person supplies the biological;"; "The supply is not in accordance with the authority."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibit"; "Prohibits supplying a biological that would result in harm or injury to any person."; "(d) either: (i) the use of the biological has resulted in, will result in, or is likely to result in, harm or injury to any person; or (ii) the use of the biological, if the biological were used, would result in, or would be likely to result in, harm or injury to any person;"; "The supply is not in accordance with the authority."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Implication"; "If supplying a biological without proper authority would result in harm or injury, then it is prohibited."; "(d) either: (i) the use of the biological has resulted in, will result in, or is likely to result in, harm or injury to any person; or (ii) the use of the biological, if the biological were used, would result in, or would be likely to result in, harm or injury to any person;"; "The supply is prohibited."; "modalities::linear"; 1.0000; . . a ; ; "Prohibit"; "Prohibits supplying a biological that would not result in harm or injury to any person."; "(e) the harm or injury has resulted, will result, is likely to result, would result, or would be likely to result, because: (i) the supply is not in accordance with the authority; or (ii) the supply is not in accordance with regulations made for the purpose of subsection 32CM(6)."; "The supply is not in accordance with the authority."; "modalities::logic::deontic"; 1.0000; . a ; "32CN(4) Criminal offences relating to the giving of an authority to a"@en; ; "d8693c508ed83619a658d9a72823e3924846794dac950c5891a95e95b59e7a29"; ; "Supplying a biological without proper authority is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.302"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits supplying a biological without proper authority."; "(4) A person commits an offence if..."; "...the supply is not in accordance with the authority;"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Recurring Trace"; "Requires recurring trace of supplying a biological."; "(4) A person commits an offence if..."; "...the supply is not in accordance with the authority;"; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Prohibit"; "Prohibits supplying a biological without proper authority."; "(4) A person commits an offence if..."; "...the supply is not in accordance with the regulations;"; "modalities::logic::deontic"; 1.0000; . a ; "32CN(4A) Criminal offences relating to the giving of an authority to a"@en; ; "ebfadb98d821e301989e579a6841f062804b3dad877bf932b809869290444005"; ; "Supplying a biological without authorization is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.302"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits supplying a biological."; "(4A) A person commits an offence if..."; "...and (b) the person supplies the biological;"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Temporal Interval"; "Defines temporal interval for supply of a biological."; "(4A) A person commits an offence if..."; "...and (b) the person supplies the biological;"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Temporal Trace"; "Defines temporal trace for supply of a biological."; "(4A) A person commits an offence if..."; "...and (c) either of the following applies:"; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Diffuse"; "Diffuses prohibition to related provisions."; "(4A) A person commits an offence if..."; "...and (b) the person supplies the biological;"; "modalities::diffusion"; 1.0000; . . a ; ; "Recognize"; "Recognizes prohibition in supply of a biological."; "(4A) A person commits an offence if..."; "...and (c) either of the following applies:"; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "32CO Approvals where substitutes for biologicals are unavailable"@en; ; "6e8d2a37f80b515f57a83b73ef7002f557cbb6ced79347bb2b91cfa76fdb5541"; "Secretary may grant approval for importation of specified biologicals"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.305"; . a ; ; ; ; "borne by: State"; ; . a ; "32CP Offences for breaching a condition of an exemption, approval"@en; ; "c64a21d0a209fed309ed557e74d2de66b7cf3f8fe947b6404e9fee17796b4c70"; "Offence for breaching a condition of an exemption, approval"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.309"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits breaching a condition of an exemption, approval"; "The person does an act or omits to do an act"; "The person commits an offence"; "modalities::logic::deontic"; 1.0000; . a ; "32CQ Civil penalty for breaching a condition of an exemption,"@en; ; "ea9efe8d6f0548fb8b1ca5664514395015c34dd9ce1b68313dbc4de1b98ebdca"; "Civil penalty for breaching a condition of an exemption"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.311"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits breach of conditions"; "Section 32CQ"; "Civil penalty for breaching a condition of an exemption"; "modalities::logic::deontic"; 1.0000; . a ; "32D Simplified outline of this Division"@en; ; "d6a66d4dcf8daac16316f4b3f2d7dd481383e31e46cee7a83282f1f0036a2df9"; "Application requirements for inclusion in the Register"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.313"; . a ; ; ; ; "borne by: State"; ; . a ; "32DA Application for inclusion in the Register"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.313". a ; "32DA(1) Application for inclusion in the Register"@en; ; "2a935e6f709080b451ceea6e635220ff5b841846815173b7365fa48856fb0d73"; ; "Application for inclusion in the Register"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.313"; . a ; ; ; ; "borne by: NaturalPerson"; ; . a ; "32DA(2) Application for inclusion in the Register"@en; ; "ed470fc6b7d907740b8a04ebfda4134351ff148f8fd004d2e30d2a1a19104954"; ; "Application must be made in accordance with a form approved by the Secretary and accompanied by a statement certifying matters."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.313"; . a ; ; ; ; "borne by: NaturalPerson"; ; . . a ; ; "MUST"; "Application must be made in accordance with a form approved by the Secretary."; "modalities::logic::deontic"; 1.0000; . a ; "32DB Inclusion of Class 1 biological in the Register"@en; ; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.315". a ; "32DB(1) Inclusion of Class 1 biological in the Register"@en; ; "0cd60607d68faddb66ddcdf5a1b6cfea2d5bfd576862d0791d49994252e19d5e"; ; "Secretary must include biological in Register if application is made."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.315"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must include biological"; "Application made for inclusion"; "Biological included in Register"; "modalities::logic::deontic"; 1.0000; . a ; "32DB(2) Inclusion of Class 1 biological in the Register"@en; ; "aed08050be459a84549eba417bf185a03131b7ec10a31974aa21a76145b33350"; ; "Secretary must assign a unique number to the biological if included in the Register."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.315"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Duty obligation"; "modalities::logic::deontic"; 1.0000; . . a ; ; "CLASSIFICATION"; "Classification of biological in Register"; "modalities::dl"; 1.0000; . a ; "32DB(3) Inclusion of Class 1 biological in the Register"@en; ; "70481819b3d475e5d1242f973adf65b6da177f0b12aadfff4187e1106c5797eb"; ; "Secretary must provide certificate upon inclusion in Register"; "Certificate of inclusion"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.315"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide certificate"; "The Secretary must give to the applicant a certificate of the inclusion of the biological in the Register."; "modalities::logic::deontic"; 1.0000; . a ; "32DB(4) Inclusion of Class 1 biological in the Register"@en; ; "75f5e41b9253d96e0c996bc8f7f6379601dd1d665f03d1d81df9618afe79d631"; ; "Specify biological number and commencement day for inclusion in Register"; "Yes"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.315"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Specify biological number and commencement day"; "modalities::logic::deontic"; 1.0000; . a ; "32DC Refusal to include Class 1 biological in the Register"@en; ; "030bfa7139c3b798884a92dcea25d6734d666111cce8c356ec4cedb8421e4ee0"; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.316". a ; "32DC(1) Refusal to include Class 1 biological in the Register"@en; ; "bc0add9eb99e3c70b9fcb7b17999e504392eb6bb880c8776a1bee8e2d1ca099d"; ; "Application for inclusion of export only biological in the Register"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.316"; . a ; ; ; ; "borne by: State"; ; . a ; "32DC(2) Refusal to include Class 1 biological in the Register"@en; ; "726a97035710c322a4d4ee310ec178a35b24edb51b574fed18dd63e8a06b80b9"; ; "Application must be made in accordance with a form approved by the Secretary and accompanied by a statement certifying certain matters."; "Form, statement, and fee"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.316"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Application must be made in accordance with a form approved by the Secretary."; "modalities::logic::deontic"; 1.0000; . a ; "32DC(3) Refusal to include Class 1 biological in the Register"@en; ; "19552b88733597f6894101a641fc94a2883f8200c93f2f7ee08b93ecc8dbc720"; ; "Application may be required for approval of a form"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.316"; . a ; ; ; ; ; . a ; "32DC(4) Refusal to include Class 1 biological in the Register"@en; ; "65c9a987f7d93bd581dbd19411998ac53ecaede6219856118dc653b555ebd2d0"; ; "Certification requirements for export only biologicals"; "Certification of safety, presentation, and compliance with standards"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.316"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "MUST"; "Certification is required"; "modalities::logic::deontic"; 1.0000; . a ; "32DD Application for inclusion in the Register"@en; ; "33ae6aa64cb0e566f9ce2df3ad9c925412693d3b7d0618cb8c424ad6e4fd59a5"; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.321". a ; "32DD(1) Application for inclusion in the Register"@en; ; "c788cc7249a642b49014f9e427b583593e95e1785477f72f86b3884c709ca074"; ; "Secretary must carry out assessment of application requirements"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.321"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must perform assessment"; "modalities::logic::deontic"; 1.0000; . a ; "32DD(2) Application for inclusion in the Register"@en; ; "bde4e7b5ebeaec82471fbf3706906bb6c2d4be3a703c5159b7c25d46c075e3d2"; ; "Application requirements for inclusion in the Register"; "Information of a kind determined under subsection (9) and in a form determined under subsection (10)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.321"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligate"; "Application requirements for inclusion in the Register"; "Information of a kind determined under subsection (9) and in a form determined under subsection (10)"; "modalities::logic::deontic"; 1.0000; . . a ; ; "hasClass"; "Application must be made in accordance with the approved form"; "modalities::dl"; 1.0000; . . a ; ; "hasValue"; "Prescribed application fee must be paid"; "modalities::dl"; 1.0000; . . a ; ; ">="; "Application must be delivered to an office of the Department within a reasonable time frame"; "modalities::interval_reasoning"; 1.0000; . a ; "32DE Evaluation of biologicals"@en; ; , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.324". a ; "32DE(1) Evaluation of biologicals"@en; ; "4ee5ea41fc4a799f9008e7866dd1c3b9bc8c49d5d62a882753dcdda545903451"; ; "The Secretary must evaluate a biological for inclusion in the Register, considering various factors. The regulations may empower the Secretary to make biologicals (priority applicant) determinations."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.324"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "The Secretary must evaluate a biological."; "modalities::logic::deontic"; 1.0000; . a ; "32DE(2) Evaluation of biologicals"@en; ; "99e9c1954ec4e359da5ad661d9bd2d853844a6415cebfc5cd163feb8f3427396"; ; "Determination of priority applicant for section 32DD applications Corresponding application of subsections for paragraph (1)(g)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.324"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "has"; "Priority applicant designation"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Obligate"; "Corresponding application of subsections for paragraph (1)(g)"; "modalities::logic::deontic"; 0.5000; . a ; "32DE(1) Evaluation of biologicals"@en; ; "1bc29360409d475956fbd13f3f46d1f292d95a9e629cf34fe13ed51fa2d0e850"; ; "The Secretary must evaluate a biological for inclusion in the Register, considering various factors. The regulations may empower the Secretary to make biologicals (priority applicant) determinations."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.324"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "The Secretary must evaluate a biological."; "modalities::logic::deontic"; 1.0000; . a ; "32DE(2) Evaluation of biologicals"@en; ; "d2c4d83022b84dde69fd5ceff6a4fb34781fab8b9882e60fe8c56e88f357cbdc"; ; "Determination of priority applicant for section 32DD applications Corresponding application of subsections for paragraph (1)(g)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.324"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "has"; "Priority applicant designation"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Obligate"; "Corresponding application of subsections for paragraph (1)(g)"; "modalities::logic::deontic"; 0.5000; . a ; "32DE(3) Evaluation of biologicals"@en; ; "4bf75d3653197b779b9a5539c3b4561e103a0096760081a530defb8ca3dc2842"; ; "Regulations for applications of biologicals"; "information that must accompany an application"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.324"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST PROVIDE"; "Regulations require information to be provided"; "modalities::logic::deontic"; 0.5000; . a ; "32DF Inclusion of biological in the Register"@en; ; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.327". a ; "32DF(1) Inclusion of biological in the Register"@en; ; "3e05419e98737dcc73b529db10cdb53fa0e5d7d8f5af1c7f2a5d91266d8d1ec7"; ; "Secretary must include biological in Register if certain conditions met."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.327"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide"; "(1) If..."; "the Secretary must include the biological in the Register."; "modalities::logic::deontic"; 1.0000; . . a ; ; ">="; "Evaluation must occur before inclusion"; "(b) the Secretary decides that it is appropriate to include the biological in the Register after an evaluation under section 32DE;"; "the evaluation must occur before inclusion."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "<="; "Evaluation fee must be paid before inclusion"; "(c) no part of an evaluation fee under section 32DI that is due and payable by the person remains unpaid;"; "the evaluation fee must be paid before inclusion."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "MUST"; "No exceptions allowed"; "(1) If..."; "no exceptions are allowed."; "modalities::logic::deontic"; 1.0000; . a ; "32DF(2) Inclusion of biological in the Register"@en; ; "aed08050be459a84549eba417bf185a03131b7ec10a31974aa21a76145b33350"; ; "Secretary must assign a unique number to the biological if included in the Register."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.327"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Duty obligation"; "modalities::logic::deontic"; 1.0000; . . a ; ; "CLASSIFICATION"; "Classification of biological in the Register"; "modalities::dl"; 1.0000; . a ; "32DF(3) Inclusion of biological in the Register"@en; ; "70481819b3d475e5d1242f973adf65b6da177f0b12aadfff4187e1106c5797eb"; ; "Secretary must provide certificate upon inclusion in Register"; "Certificate of inclusion"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.327"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide certificate"; "The Secretary must give to the applicant a certificate of the inclusion of the biological in the Register."; "modalities::logic::deontic"; 1.0000; . a ; "32DF(4) Inclusion of biological in the Register"@en; ; "75f5e41b9253d96e0c996bc8f7f6379601dd1d665f03d1d81df9618afe79d631"; ; "Specifies requirements for a certificate's content regarding biological inclusion in the Register."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.327"; . a ; ; ; ; . a ; "32DG Refusal to include biological in the Register"@en; ; "35d6590932023d91330c68b047f37499e2bf4593bab974bf4dbfaf5806d3373d"; "Secretary must provide notice after refusing application to include biological in the Register."; "Notice of refusal and reasons for refusal"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.328"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Must"; "Secretary must provide notice"; "modalities::logic::deontic"; 1.0000; . a ; "32DH Lapsing of application"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.328". a ; "32DH(1) Lapsing of application"@en; ; "21734f645e98b0804e0e0348aa6cb0d634e2519147b432f72d6a23a34173fa86"; ; "Application lapse due to unpaid fee, false information, or non-compliance with patient data requirements."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.328"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of application lapse due to unpaid fee."; "Unpaid fee"; "Application lapse."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibit"; "Prohibition of application lapse due to false information."; "False information"; "Application lapse."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibit"; "Prohibition of application lapse due to non-compliance with patient data requirements."; "Non-compliance with patient data requirements"; "Application lapse."; "modalities::logic::deontic"; 1.0000; . a ; "32DH(2) Lapsing of application"@en; ; "a43ad6992fe4cc3dd6e55a6a25052952eb6a696ff2f6bda506851e5a5c545b93"; ; "Defines patient data in relation to a biological."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.328"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "="; "Identifies specific information types"; "patient data, in relation to a biological"; "information derived from clinical trials"; "modalities::dl"; 1.0000; . . a ; ; "during"; "Describes temporal relationship"; "before, during and after"; "clinical trials"; "modalities::interval_reasoning"; 1.0000; . a ; "32DI Evaluation fee"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.329". a ; "32DI(1) Evaluation fee"@en; ; "e0018270574c19239785c7fbfeee5a3aaba6aac71fe1bc7312c82b14017d9133"; ; "Pay evaluation fee for biological inclusion in Register"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.329"; . a ; ; ; ; ; . . a ; ; "Obligation"; "Duty to pay evaluation fee"; "modalities::logic::deontic"; 1.0000; . a ; "32DI(2) Evaluation fee"@en; ; "afa4101debfec40f8f26adaa4642f7c90183727c9cc9e8d40484a1d4ba7f9c25"; ; "The Secretary must notify the applicant in writing of the evaluation fee."; "yes"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.329"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "The Secretary must notify the applicant in writing of the evaluation fee."; "modalities::logic::deontic"; 1.0000; . a ; "32DJ When evaluation fee due for payment"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.329". a ; "32DJ(1) When evaluation fee due for payment"@en; ; "1120492f9496e87c45d6a6cabf1b373d23f28c6467d23b573f2fc7bdf9b3120c"; ; "Evaluation fee due on notification of amount"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.329"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "due"; "Obligation to pay evaluation fee"; "(1) Subject to sections 32DK and 32DM, an evaluation fee payable by an applicant is due and payable on the day on which the applicant is notified of the amount of the evaluation fee."; "modalities::logic::deontic"; 1.0000; . . a ; ; "on"; "Temporal relation between notification and payment"; "(1) Subject to sections 32DK and 32DM, an evaluation fee payable by an applicant is due and payable on the day on which the applicant is notified of the amount of the evaluation fee."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "on"; "Temporal trace between notification and payment"; "(1) Subject to sections 32DK and 32DM, an evaluation fee payable by an applicant is due and payable on the day on which the applicant is notified of the amount of the evaluation fee."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "on"; "Spread of obligation to pay evaluation fee"; "(1) Subject to sections 32DK and 32DM, an evaluation fee payable by an applicant is due and payable on the day on which the applicant is notified of the amount of the evaluation fee."; "modalities::diffusion"; 1.0000; . a ; "32DJ(2) When evaluation fee due for payment"@en; ; "0cc8694786fc1b02c8150cd49896bd52e4b6040881ee57fdf51d5d1f5e042449"; ; "Evaluation fee must be paid in the manner prescribed by regulations."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.329"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Obligation to pay evaluation fee"; "modalities::logic::deontic"; 1.0000; . a ; "32DK Payment of evaluation fee by instalments"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.329". a ; "32DK(1) Payment of evaluation fee by instalments"@en; ; "f81f85ab9e8ee0e7303e5b8e6817715ee7e4fb0b4cdd0aea1c19bd2820dfbd4d"; ; "Payment of evaluation fee by instalments is obligatory."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.329"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Payment of evaluation fee by instalments is obligatory."; "modalities::logic::deontic"; 1.0000; . a ; "32DK(2) Payment of evaluation fee by instalments"@en; ; "900dedc4f8227348093cd3474005c7e84ecee1256e67a428392d5e0d18a61db9"; ; "Payment of evaluation fee by instalments is not allowed if any part of an instalment was unpaid immediately after it became due for payment."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.329"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits payment of evaluation fee by instalments if any part was unpaid immediately after it became due."; "(2) Regulations may provide that a person is not allowed to pay an evaluation fee by instalments..."; "...if any part of an instalment of that or any other evaluation fee payable by the person was unpaid immediately after the time when it became due for payment."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlaps"; "Payment of evaluation fee by instalments overlaps with the condition that any part of an instalment was unpaid immediately after it became due."; "(2) Regulations may provide that a person is not allowed to pay an evaluation fee by instalments..."; "...if any part of an instalment of that or any other evaluation fee payable by the person was unpaid immediately after the time when it became due for payment."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Contains"; "Payment of evaluation fee by instalments contains the condition that any part of an instalment was unpaid immediately after it became due."; "(2) Regulations may provide that a person is not allowed to pay an evaluation fee by instalments..."; "...if any part of an instalment of that or any other evaluation fee payable by the person was unpaid immediately after the time when it became due for payment."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Diffuses"; "Payment of evaluation fee by instalments diffuses to all persons who are not allowed to pay an evaluation fee by instalments if any part was unpaid immediately after it became due."; "(2) Regulations may provide that a person is not allowed to pay an evaluation fee by instalments..."; "...if any part of an instalment of that or any other evaluation fee payable by the person was unpaid immediately after the time when it became due for payment."; "modalities::diffusion"; 1.0000; . . a ; ; "Recognizes"; "Payment of evaluation fee by instalments is recognized as a prohibited action if any part was unpaid immediately after it became due."; "(2) Regulations may provide that a person is not allowed to pay an evaluation fee by instalments..."; "...if any part of an instalment of that or any other evaluation fee payable by the person was unpaid immediately after the time when it became due for payment."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "32DK(3) Payment of evaluation fee by instalments"@en; ; "256c422ca8d35e3f5d3c14fe4842f835d07799df690a0160457a57caca8cee70"; ; "Payment of evaluation fee by instalments"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.329"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must pay evaluation fee"; "modalities::logic::deontic"; 1.0000; . a ; "32DL Recovery of evaluation fee"@en; ; "12b041b79bd55dfe569f500412a8f8fcb6fd50ac36630d59e1e0ad7b369fd486"; "The Commonwealth may recover an evaluation fee as a debt."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.330"; . a ; ; ; ; ; . . a ; ; "may"; "Implies obligation"; "modalities::logic::deontic"; 1.0000; . a ; "32DM Reduction of evaluation fee where evaluation not completed"@en; ; "96c601b27894655e1c8e45a83ce1461ee33eb8540bf3dc01ec901a777733e9ba"; , , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.330". a ; "32DM(1) Reduction of evaluation fee where evaluation not completed"@en; ; "df27b2d0d8a2e5be5d89680e0fe31979edc7b340f43141ebef3a21d0c12dc03e"; ; "No payment of more than 3/4 evaluation fee before completion if a period is prescribed for completing the evaluation."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.330"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Imposes an obligation on the state."; "modalities::logic::deontic"; 1.0000; . a ; "32DM(2) Reduction of evaluation fee where evaluation not completed"@en; ; "2e33b8338063be603cd123109ced2e6550788de196c748b20fe796bcf92179f7"; ; "Secretary must notify applicant of evaluation completion date"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.330"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Obligation to notify"; "modalities::logic::deontic"; 1.0000; . a ; "32DM(3) Reduction of evaluation fee where evaluation not completed"@en; ; "607b83da3744add83581b1875dcd57d58262e4714cbc97da3ce67c5c019c9d89"; ; "Reduction of evaluation fee if evaluation not completed within period"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.330"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "if"; "Conditional obligation"; "(evaluation not completed within period)"; "(evaluation fee is reduced)"; "modalities::logic::deontic"; 1.0000; . a ; "32DM(4) Reduction of evaluation fee where evaluation not completed"@en; ; "538eb0ce1ba29a88261e889469b6aa62b01a38a18b70cfed6123c781c05c491a"; ; "Payment of unpaid evaluation fee upon completion of evaluation."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.330"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Imposes a duty on the state."; "modalities::logic::deontic"; 1.0000; . a ; "32DM(5) Reduction of evaluation fee where evaluation not completed"@en; ; "24b601ca5d1956414b630885c30c09a3ecdd222182668435f3e95d01aae60134"; ; "Evaluation fee reduction where report is given to applicant or committee."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.330"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Duty to pay full evaluation fee if applicant withdraws after report is given."; "(5) For the purposes of this section, if a copy of the evaluation report..."; "then the evaluation is taken to be completed immediately before the first copy or summary is so given."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlaps"; "Evaluation fee reduction applies when report is given within a specified period."; "(5) For the purposes of this section, if a copy of the evaluation report..."; "then the evaluation is taken to be completed immediately before the first copy or summary is so given."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Until"; "Evaluation fee reduction applies until report is given to applicant or committee."; "(5) For the purposes of this section, if a copy of the evaluation report..."; "then the evaluation is taken to be completed immediately before the first copy or summary is so given."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Diffuses"; "Report being given to applicant or committee diffuses the obligation to pay full evaluation fee."; "(5) For the purposes of this section, if a copy of the evaluation report..."; "then the evaluation is taken to be completed immediately before the first copy or summary is so given."; "modalities::diffusion"; 1.0000; . . a ; ; "Implication"; "Withdrawal after report being given implies obligation to pay full evaluation fee."; "(5) For the purposes of this section, if a copy of the evaluation report..."; "then the evaluation is taken to be completed immediately before the first copy or summary is so given."; "modalities::argumentation"; 1.0000; . a ; "32DM(6) Reduction of evaluation fee where evaluation not completed"@en; ; "4ccfe30a0aaa914bfdcd080309140d4ac02b4f0d5907986d36cfce1c46d2048d"; ; "Notification under subsection (2) is not a legislative instrument."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.330"; . a ; ; ; ; "borne by: State"; ; . a ; "32DN Transitional provisions for existing biologicals"@en; ; "63bdba36929143db55d07872f5c19c018addd7c331ddd71bd69e4763933339a9"; "Secretary must cancel inclusion of goods in part and include biological in Register under Part"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.331"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Secretary must perform action"; "modalities::logic::deontic"; 1.0000; . a ; "32DO Criminal offences for false statements in applications for"@en; ; "76894ee034b29d5f53608365656279a356af0f53ab78b8501ea4da7ea00c8034"; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.334". a ; "32DO(1) Criminal offences for false statements in applications for"@en; ; "5c316cfe4548b797e61b6a6bd98656e70dd6b1c0211b2b1248d7befb3a85f129"; ; "Making false statements in applications for biological inclusion is a criminal offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.334"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits making false statements in applications for biological inclusion."; "The statement is made in, or in connection with, an application for inclusion of a biological in the Register."; "A person commits an offence if..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibit"; "Prohibits harm or injury to any person resulting from the use of the biological."; "(i) the use of the biological has resulted in, will result in, or is likely to result in, harm or injury to any person;"; "or (ii) the use of the biological, if the biological were used, would result in, or would be likely to result in, harm or injury to any person."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Imply"; "Implies that the provision is related to harm or injury."; "(i) the use of the biological has resulted in, will result in, or is likely to result in, harm or injury to any person;"; "or (ii) the use of the biological, if the biological were used, would result in, or would be likely to result in, harm or injury to any person."; "modalities::linear"; 1.0000; . . a ; ; "Prohibit"; "Prohibits making false statements in applications for biological inclusion."; "(a) the person makes a statement;"; "and (b) the statement is made in, or in connection with, an application for inclusion of a biological in the Register."; "modalities::logic::deontic"; 1.0000; . a ; "32DO(4) Criminal offences for false statements in applications for"@en; ; "abd03b6bef0384250a00315152f44b464c65d81267309c327bc131579675cfba"; ; "Making false statements in applications for inclusion of biologicals in the Register is an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.334"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of false statements"; "modalities::logic::deontic"; 1.0000; . a ; "32DO(5) Criminal offences for false statements in applications for"@en; ; "2a7e830472a7cb8df801467a1ec8b2cfb10c6634fbbe645f2eb9274c3b649237"; ; "Making false statements in applications for inclusion of a biological in the Register is an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.334"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits making false statements in applications."; "modalities::logic::deontic"; 1.0000; . a ; "32DO(6) Criminal offences for false statements in applications for"@en; ; "c385da7f11ff5e7f14e072e858989feb81f5b1c13125da3beda70e38518df21e"; ; "An offence against subsection (5) is an offence of strict liability."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.334"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Imposes a duty on the state."; "modalities::logic::deontic"; 1.0000; . a ; "32DP Civil penalty for false statements in applications for including"@en; ; "b48caf5e8f12bcfef45d2983b175ffba1bba31d96c654fa06b18c89ab8610697"; "False statements in applications for inclusion of biologicals in the Register"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.335"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition on false statements"; "modalities::logic::deontic"; 1.0000; . a ; "32DQ Criminal offence and civil penalty for failing to notify adverse"@en; ; "df485be7af1475b18b8908e5d1492812ab83aa3d0c56e543cade0fff9e83ba1e"; "Failure to notify adverse effects of a biological included in the Register is an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.335"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Obligation to notify adverse effects of a biological included in the Register."; "modalities::logic::deontic"; 1.0000; . a ; "32DR Criminal offences and civil penalties for failing to notify"@en; ; "0b09453967a471070eda69bc1f6ccc39569366942a29a8fc9da335c9d8834c44"; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.337". a ; "32DR(1) Criminal offences and civil penalties for failing to notify"@en; ; "cb367538ff1b72f75dae54f1f629fe812935b989af68bf86168b2a6c0025c862"; ; "Notify the Secretary of known information within 14 days after application withdrawal or lapse."; "Yes"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.337"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must notify the Secretary."; "modalities::logic::deontic"; 1.0000; . a ; "32DR(2) Criminal offences and civil penalties for failing to notify"@en; ; "75e78fdbe2f2bf101f8c3428f2cf4923be4c3cf7f08d3e5b94b2664b0e694517"; ; "Failing to notify of certain information may result in criminal offences or civil penalties."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.337"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of failing to notify"; "Notification is required"; "Failing to notify is prohibited"; "modalities::logic::deontic"; 1.0000; . a ; "32DR(3) Criminal offences and civil penalties for failing to notify"@en; ; "297ab860e3a368cd97201d81e906f6d8660efd6b3f6528361e1fa6083216b8bb"; ; "Failure to comply with notice within 30 days results in imprisonment or penalty units."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.337"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "obligation"; "Obligation to comply with notice."; "Secretary gives notice."; "Failure to comply results in penalty."; "modalities::logic::deontic"; 1.0000; . a ; "32DS Consultation with Gene Technology Regulator"@en; ; , , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.339". a ; "32DS(1) Consultation with Gene Technology Regulator"@en; ; "f387d14888fbef829a846a503f263e392d71b3b563832942ec94d309433d79b6"; ; "Application for inclusion of a biological in the Register must consult with the Gene Technology Regulator."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.339"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Application must comply with consultation requirement."; "The application for inclusion of a biological in the Register..."; "...must consult with the Gene Technology Regulator."; "modalities::logic::deontic"; 1.0000; . . a ; ; ">="; "Consultation must occur before the application is processed."; "The application for inclusion of a biological in the Register..."; "...must consult with the Gene Technology Regulator."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "IMPLIES"; "Consultation implies that the application is not exempt from regulation."; "The application for inclusion of a biological in the Register..."; "...must consult with the Gene Technology Regulator."; "modalities::argumentation"; 1.0000; . . a ; ; "IS_A"; "Consultation is a necessary step for the regulation of genetic modification."; "The application for inclusion of a biological in the Register..."; "...must consult with the Gene Technology Regulator."; "modalities::diffusion"; 1.0000; . . a ; ; "IS_A"; "Consultation is an artificial intelligence-powered regulation mechanism."; "The application for inclusion of a biological in the Register..."; "...must consult with the Gene Technology Regulator."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "32DS(2) Consultation with Gene Technology Regulator"@en; ; "72f4b66640772a86767f0b5d10f6a70d034e87a7de72257b9ecf0218ca53659e"; ; "The Secretary must give written notice to the Gene Technology Regulator."; "Yes"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.339"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "The Secretary must give written notice."; "modalities::logic::deontic"; 1.0000; . a ; "32DS(3) Consultation with Gene Technology Regulator"@en; ; "3d5d299bf76932c099e508d0af6ee43fab79648ef5191cf7bc1c4b603ebec156"; ; "The Gene Technology Regulator must provide written advice to the Secretary about a gene technology application."; "Yes"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.339"; . a ; ; ; ; ; . . a ; ; "MUST"; "The Gene Technology Regulator must provide written advice."; "modalities::logic::deontic"; 1.0000; . a ; "32DS(4) Consultation with Gene Technology Regulator"@en; ; "00b1b875e100436c290e3e2970316321c0a13934db4ea38ff0fbcf8885da1a15"; ; "Consultation with Gene Technology Regulator within specified period."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.339"; . a ; ; ; ; ; . . a ; ; "MUST"; "Must provide consultation"; "The advice is to be given within the period specified in the notice."; "Consultation with Gene Technology Regulator within specified period."; "modalities::logic::deontic"; 1.0000; . a ; "32DS(5) Consultation with Gene Technology Regulator"@en; ; "9ab5b6d3d6a1a80352b64b13ee57680a39735774676b084e0b3e9ee3cdde29a5"; ; "No notification required for applications within a class of biologicals subject to Gene Technology Regulator advice."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.339"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Exemption"; "No notification required for applications within a class of biologicals subject to Gene Technology Regulator advice."; "(5) If an advice from the Gene Technology Regulator is in force under section 32DT in relation to a class of biologicals, the Secretary is not required to notify the Gene Technology Regulator under this section in relation to an application for inclusion in the Register of a biological belonging to that class."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Class Inclusion"; "The Secretary is not required to notify the Gene Technology Regulator under this section in relation to an application for inclusion in the Register of a biological belonging to that class."; "(5) If an advice from the Gene Technology Regulator is in force under section 32DT in relation to a class of biologicals, the Secretary is not required to notify the Gene Technology Regulator under this section in relation to an application for inclusion in the Register of a biological belonging to that class."; "modalities::dl"; 1.0000; . . a ; ; "Temporal Exemption"; "The exemption applies only within the scope of Gene Technology Regulator advice under section 32DT."; "(5) If an advice from the Gene Technology Regulator is in force under section 32DT in relation to a class of biologicals, the Secretary is not required to notify the Gene Technology Regulator under this section in relation to an application for inclusion in the Register of a biological belonging to that class."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Temporal Exemption"; "The exemption applies only within the scope of Gene Technology Regulator advice under section 32DT."; "(5) If an advice from the Gene Technology Regulator is in force under section 32DT in relation to a class of biologicals, the Secretary is not required to notify the Gene Technology Regulator under this section in relation to an application for inclusion in the Register of a biological belonging to that class."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Information Dissemination"; "The exemption applies only within the scope of Gene Technology Regulator advice under section 32DT."; "(5) If an advice from the Gene Technology Regulator is in force under section 32DT in relation to a class of biologicals, the Secretary is not required to notify the Gene Technology Regulator under this section in relation to an application for inclusion in the Register of a biological belonging to that class."; "modalities::diffusion"; 1.0000; . . a ; ; "Knowledge Representation"; "The exemption applies only within the scope of Gene Technology Regulator advice under section 32DT."; "(5) If an advice from the Gene Technology Regulator is in force under section 32DT in relation to a class of biologicals, the Secretary is not required to notify the Gene Technology Regulator under this section in relation to an application for inclusion in the Register of a biological belonging to that class."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "32DS(6) Consultation with Gene Technology Regulator"@en; ; "f16a590d4fbc3da687afd54d8da954039fe5daa94f2328a3b86ce03614eec63b"; ; "Notice under subsection (2) is not a legislative instrument."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.339"; . a ; ; ; ; ; . a ; "32DT Secretary may seek advice about classes of GM products or"@en; ; "8b9f3a54fe96d74cd996e8477e33a6ea12d240d714f3bdf2cd697b3e7d18ab19"; "The Secretary may request advice from the Gene Technology Regulator about specific GM products or organisms."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.339"; . a ; ; ; ; ; . a ; "32DU Secretary to take advice into account"@en; ; "1197cb1929b5c8073f900c10e133b790e91c1ee4285eeaeae25a7eccd5e314bc"; "Secretary must take advice into account when making a decision on an application."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.340"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Secretary must take advice into account."; "The Secretary receives advice from the Gene Technology Regulator."; "The Secretary must ensure that the advice is taken into account in making a decision on the application."; "modalities::logic::deontic"; 1.0000; . . a ; ; "MUST"; "Secretary informs the Gene Technology Regulator of the decision on the application."; "The Secretary must inform the Gene Technology Regulator of the decision on the application."; "The Secretary must inform the Gene Technology Regulator of the decision on the application."; "modalities::logic::deontic"; 1.0000; . a ; "32E What this Division is about"@en; ; "55c7893eefc5e4d3c641701e1c1f27f33d7a6e5f1d2c7bd23186a7663cda6f9f"; "Exemptions from automatic conditions for inclusions of biologicals in the Register"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.341"; . a ; ; ; ; . a ; "32EA Conditions applying automatically"@en; ; "9a37c6652c9fa43f76135a5e1330bf7596828e100acc1afd10924f9758c91fdc"; "Allow entry and inspection of premises for authorized persons."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.341"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Allow"; "Grant permission for entry and inspection."; "The person in relation to whom the biological is included in the Register..."; "...to allow an authorised person to enter, inspect, and examine."; "modalities::logic::deontic"; 1.0000; . . a ; ; "During"; "Entry is allowed during reasonable hours."; "at any reasonable time"; "...to enter, inspect, and examine at any reasonable time."; "modalities::interval_reasoning"; 1.0000; . a ; "32EB Certification of manufacturing steps outside Australia"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.345". a ; "32EB(1) Certification of manufacturing steps outside Australia"@en; ; "6a544b077b0642b6bbe0f5f0922c82bf6721cc2ab660c508e7f4104d1e2bbd04"; ; "Application for certification of manufacturing steps outside Australia"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.345"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "obligation"; "Obligation to apply for certification"; "modalities::logic::deontic"; 1.0000; . a ; "32EB(2) Certification of manufacturing steps outside Australia"@en; ; "c40ca69ba68dc6d1acb628395d5b4a6c34c19231ff493bebb89e7487c8768289"; ; "Secretary must certify manufacturing procedures upon request."; "written notice"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.345"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide written notice"; "The Secretary must give the person written notice of the certification."; "modalities::logic::deontic"; 1.0000; . . a ; ; "BETWEEN"; "Certification is within a specific time frame"; "(2) If an application is made to the Secretary under this section, the Secretary may, by writing, certify that the manufacturing and quality control procedures used in that step are acceptable."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "BETWEEN"; "Certification is within a specific time frame"; "(2) If an application is made to the Secretary under this section, the Secretary may, by writing, certify that the manufacturing and quality control procedures used in that step are acceptable."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "IS_A"; "Certification is a form of diffusion"; "(2) If an application is made to the Secretary under this section, the Secretary may, by writing, certify that the manufacturing and quality control procedures used in that step are acceptable."; "modalities::diffusion"; 1.0000; . . a ; ; "IS_A"; "Certification is a form of artificial intelligence"; "(2) If an application is made to the Secretary under this section, the Secretary may, by writing, certify that the manufacturing and quality control procedures used in that step are acceptable."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "32EB(3) Certification of manufacturing steps outside Australia"@en; ; "8cb955a1a6cd49d7d0286a80cedabe527c61578e40b8c2c44a51ca0d6816352f"; ; "Applying subsections for certification decision"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.345"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "apply"; "Applying relevant rules"; "Subsections apply for certification decision"; "Decision made under subsections"; "modalities::logic::deontic"; 1.0000; . a ; "32EC Imposition of conditions by legislative instrument"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.345". a ; "32EC(1) Imposition of conditions by legislative instrument"@en; ; "095fc5d3954f931f447ef18dfc29bdde641e3127078abcb074a3bdd4ea2ee2aa"; ; "Conditions for inclusion of a biological in the Register"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.345"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "imposes"; "Imposes conditions on inclusion of a biological in the Register"; "(1) The inclusion of a biological in the Register is subject to the conditions set out in a determination under subsection (2)."; "modalities::logic::deontic"; 1.0000; . . a ; ; "during"; "Conditions apply during the process of inclusion"; "(1) The inclusion of a biological in the Register is subject to the conditions set out in a determination under subsection (2)."; "modalities::interval_reasoning"; 0.5000; . . a ; ; "during"; "Conditions apply during the process of inclusion"; "(1) The inclusion of a biological in the Register is subject to the conditions set out in a determination under subsection (2)."; "modalities::temporal_ltl"; 0.5000; . . a ; ; "appliesTo"; "Applies to the process of inclusion"; "(1) The inclusion of a biological in the Register is subject to the conditions set out in a determination under subsection (2)."; "modalities::diffusion"; 0.5000; . . a ; ; "appliesTo"; "Applies to the process of inclusion"; "(1) The inclusion of a biological in the Register is subject to the conditions set out in a determination under subsection (2)."; "sparql_library::parsers::chk_parser"; 0.5000; . a ; "32EC(2) Imposition of conditions by legislative instrument"@en; ; "b5c3bce67e48221bdab79e01ffe56e87b2445380655aee821082ec24a53be544"; ; "Minister may impose conditions on the manufacture, custody, use, supply, disposal or destruction of a biological."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.345"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Imposition of conditions"; "modalities::logic::deontic"; 1.0000; . . a ; ; "between"; "Temporal intervals for conditions"; "(2) The Minister may, by legislative instrument, make a determination setting out conditions for the purposes of subsection (1);"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "for all"; "Temporal scope of conditions"; "(2) The Minister may, by legislative instrument, make a determination setting out conditions for the purposes of subsection (1);"; "modalities::temporal_ltl"; 1.0000; . . a ; ; "must be met"; "Conditions for the biological"; "(a) the manufacture of the biological; or (b) the custody, use, supply, disposal or destruction of the biological;"; "modalities::logic::deontic"; 1.0000; . . a ; ; "must be met"; "Reporting requirements for the biological"; "(ca) reporting requirements relating to the biological;"; "modalities::logic::deontic"; 1.0000; . a ; "32EC(3) Imposition of conditions by legislative instrument"@en; ; "cd58bb3bdc13d9d1de75a21101598577b73da47ceaf17de393a506887cd7f9f2"; ; "Different conditions may be specified for different classes of biologicals."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.345"; . a ; ; ; ; "borne by: State"; ; . a ; "32ED Imposition of conditions at time biological included in the"@en; ; "bb7234ec12451361e6f35bcbe76de58e4350657fe60d1b96ace0947f59194083"; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.346". a ; "32ED(1) Imposition of conditions at time biological included in the"@en; ; "120197c6fb4635544726606aa001608922f893bb3f86d968571bca61abe61049"; ; "Secretary may impose conditions on inclusion of biological in Register"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.346"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Imposes obligation"; "modalities::logic::deontic"; 1.0000; . . a ; ; "includes"; "Includes biological in Register"; "modalities::dl"; 1.0000; . a ; "32ED(2) Imposition of conditions at time biological included in the"@en; ; "aa9e9e5083928beca4beead99c50e3f05db93cce8047b6c6e76bac9f994d71cf"; ; "A notice under subsection (1) is not a legislative instrument."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.346"; . a ; ; ; ; ; . . a ; ; "not"; "Negative obligation"; "A notice under subsection (1) is a legislative instrument."; "A notice under subsection (1) is not a legislative instrument."; "modalities::logic::deontic"; 0.5000; . a ; "32EE Imposition or variation or removal of conditions after"@en; ; "192f53ccf8e81fc2ddf34ea930612e71df94f2fc6a74286380042ff20c268714"; , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.346". a ; "32EE(1) Imposition or variation or removal of conditions after"@en; ; "5ff133b09281fbfe91327b6f5ded4f8992e0cd55d3fb626946d4eece03a587ce"; ; "Secretary may impose new conditions on biological inclusion"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.346"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Imposes obligation"; "modalities::logic::deontic"; 1.0000; . a ; "32EE(2) Imposition or variation or removal of conditions after"@en; ; "a5a6ce2eadcd3e61ec692bb4b6ed4527096f63e6a35fdf3eea34bc88e8b1925d"; ; "Request must be accompanied by prescribed fee."; "fee"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.346"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Obligation to provide fee"; "fee must be provided"; "modalities::logic::deontic"; 1.0000; . a ; "32EE(3) Imposition or variation or removal of conditions after"@en; ; "91cbf126ac4c0e4989cfef61aa763d5d524182628560f11ba746d6b71c19fa3b"; ; "Conditions for imposition or variation of conditions after notice is given to the person."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.346"; . a ; ; ; ; . . a ; ; "takes effect"; "Imposition or variation takes effect on specified day."; "(3) The imposition or variation or removal of a condition under subsection (1) takes effect:"; "modalities::logic::deontic"; 1.0000; . . a ; ; "within interval"; "Notice specifies start date for imposition or variation."; "(aa) in the case of an imposition or variation requested by the person, and to which paragraph (a) does not apply—on the day specified in the notice, which must be at least 28 days after the notice is given to the person;"; "modalities::interval_reasoning"; 1.0000; . . a ; ; "recurring trace"; "Notice specifies recurring pattern for imposition or variation."; "(ab) in the case of a removal to which paragraph (a) does not apply—on the day specified in the notice, which must be at least 28 days after the notice is given to the person, unless the person has agreed to an earlier day;"; "modalities::temporal_ltl"; 1.0000; . . a ; ; "must provide"; "Person must agree to earlier start date for imposition or variation."; "unless the person has agreed to an earlier day;"; "modalities::logic::deontic"; 1.0000; . a ; "32EE(3A) Imposition or variation or removal of conditions after"@en; ; "b3e7aec7d80b3b465518a1c49459c596ab5eb3c6fea84242c2190afcecb73f4c"; ; "The earlier day must not be earlier than the day the notice is given to the person."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.346"; . a ; ; ; ; "borne by: State"; ; . . a ; ; ">="; "Temporal constraint"; "The earlier day must not be earlier than the given day."; "The notice must be given on or after the given day."; "modalities::logic::deontic"; 1.0000; . . a ; ; "="; "Temporal relation"; "The earlier day is a temporal interval before the given day."; "The notice must be given on or after the day before the given day."; "modalities::interval_reasoning"; 1.0000; . a ; "32EE(4) Imposition or variation or removal of conditions after"@en; ; "0931782cccff8e870982346a7802e881886319db33b6f9d0f235a8445e82b99e"; ; "Legislative instrument notice is not a legislative instrument."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.346"; . a ; ; ; ; ; . . a ; ; "Prohibition"; "Prohibits notices from being legislative instruments."; "modalities::logic::deontic"; 1.0000; . a ; "32EF Criminal offences for breach of condition"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.347". a ; "32EF(1) Criminal offences for breach of condition"@en; ; "df2dbde40d25ef264b7fa56ea092c432ad1a6c234511ddfb65ab4be89d644e25"; ; "Breach of condition results in harm or injury to any person."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.347"; . a ; ; ; ; ; . . a ; ; "Prohibition"; "Prohibits breach of condition."; "(1) A person commits an offence if: (a) a biological is included in the Register in relation to the person; and (b) the person does an act or omits to do an act; and (c) the act or omission breaches a condition of the inclusion of the biological in the Register; and (d) the act or omission has resulted in, will result in, or is likely to result in, harm or injury to any person."; "(Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.)"; "modalities::logic::deontic"; 1.0000; . a ; "32EF(4) Criminal offences for breach of condition"@en; ; "e7d1c45bd6ae131d2b2c6d1f6f5f0348ef943e62bbadfec0a8a412755dc447e5"; ; "Breach of condition results in criminal offence"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.347"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Obligation to comply with conditions"; "(a) a biological is included in the Register in relation to the person; and (b) the person does an act or omits to do an act;"; "The person commits an offence if..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibition"; "Prohibition on breach of conditions"; "(c) the act or omission breaches a condition of the inclusion of the biological in the Register."; "Penalty: Imprisonment for 12 months or 1,000 penalty units, or both."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Between"; "Temporal interval for breach of conditions"; "(c) the act or omission breaches a condition of the inclusion of the biological in the Register."; "The person commits an offence if..."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Until"; "Temporal constraint on breach of conditions"; "(c) the act or omission breaches a condition of the inclusion of the biological in the Register."; "The person commits an offence if..."; "modalities::temporal_ltl"; 1.0000; . a ; "32EF(5) Criminal offences for breach of condition"@en; ; "d15f98236552d89268460bca51b98a23109290bf5608869c6666368de6dcdf45"; ; "Breach of condition results in criminal offence"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.347"; . a ; ; ; ; ; . . a ; ; "Prohibition"; "Prohibits breach of condition"; "modalities::logic::deontic"; 1.0000; . a ; "32EG Civil penalty for breach of condition"@en; ; "7fa8daa875f693606dac1f66e80cc1c841475b7bfa27a433726c47ffd1113418"; "Civil penalty for breach of condition"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.348"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits breach of condition"; "A person contravenes this section if..."; "...breaches a condition of the inclusion of the biological in the Register."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibit"; "Prohibits breach of condition for individuals and bodies corporate"; "Maximum civil penalty: (a) for an individual—5,000 penalty units; and (b) for a body corporate—50,000 penalty units."; "...for an individual—5,000 penalty units; and (b) for a body corporate—50,000 penalty units."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Imply"; "Implicates breach of condition on inclusion in Register"; "(a) a biological is included in the Register in relation to the person; and (b) the person does an act or omits to do an act;"; "...breaches a condition..."; "modalities::linear"; 1.0000; . . a ; ; "Within"; "Indicates temporal interval for breach of condition"; "(a) a biological is included in the Register in relation to the person; and (b) the person does an act or omits to do an act;"; "...breaches a condition..."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Prohibit"; "Prohibits breach of condition for individuals and bodies corporate"; "(a) for an individual—5,000 penalty units; (b) for a body corporate—50,000 penalty units."; "...for an individual—5,000 penalty units; and (b) for a body corporate—50,000 penalty units."; "modalities::logic::deontic"; 1.0000; . a ; "32F What this Division is about"@en; ; "ac0dda23769b7df38fc8a7abc292acafcf3a25565272f95283c498928b6c5df2"; "The Secretary may suspend biologicals from the Register in certain circumstances."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.349"; . a ; ; ; ; "borne by: State"; ; . a ; "32FA Suspension of biological from the Register"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.349". a ; "32FA(1) Suspension of biological from the Register"@en; ; "1027dca81d738088861b624c86143b20172a910d8a7d8c8e1b428f1cd02e1eea"; ; "Suspension of biological from the Register is allowed under certain conditions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.349"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits suspension of biological from the Register."; "(1) The Secretary may, by written notice given to a person in relation to whom a biological is included in the Register..."; "modalities::logic::deontic"; 1.0000; . a ; "32FA(2) Suspension of biological from the Register"@en; ; "c31aa5b44e3464818b578e7e643b4317217f87e58bf99287da9303b230594298"; ; "Secretary must suspend biological from Register before cancelling entry under section 32GC"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.349"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Duty to suspend biological from Register"; "modalities::logic::deontic"; 1.0000; . a ; "32FB When suspension takes effect etc."@en; ; , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.350". a ; "32FB(1) When suspension takes effect etc."@en; ; "a90b40959a4ff8a7d408b129a20babf0dfe424ab622da3da26d8998054f4538d"; ; "Suspension of therapeutic goods takes effect under certain conditions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.350"; . a ; ; ; ; ; . a ; "32FB(2) When suspension takes effect etc."@en; ; "267166a6bb7d152e252abd18346157d2d8c973960ba8eac30c665ddca84e2c89"; ; "Suspension duration"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.350"; . a ; ; ; ; . a ; "32FB(3) When suspension takes effect etc."@en; ; "092f1d6f85a4ec4e43cda04bfef82820c935dbaeb09ef6ae4fdb954d3d765f25"; ; "Secretary may extend period specified under subsection 32FA(4) by a further specified period not exceeding 6 months."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.350"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "May"; "Permission to extend period"; "modalities::logic::deontic"; 1.0000; . a ; "32FB(4) When suspension takes effect etc."@en; ; "b27c4e7bd78f2371fa366001f60f75e5c1fd8dfb8ad7bbea84d606cb3337a2d2"; ; "Publish notice of extension particulars"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.350"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must publish notice"; "modalities::logic::deontic"; 1.0000; . a ; "32FB(5) When suspension takes effect etc."@en; ; "56037ee4b951a607910640ec197dbec5ccb71dc71a9b13532f28d1649ac6d345"; ; "Notice under subsection (3) is not a legislative instrument."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.350"; . a ; ; ; ; "borne by: State"; ; . a ; "32FC Revocation of suspension"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.351". a ; "32FC(1) Revocation of suspension"@en; ; "204713cdecd1e823eeb33858d50d881492193f47e8bb977f926cf082f8796dc5"; ; "Secretary must revoke suspension under certain conditions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.351"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Must"; "Secretary must revoke suspension"; "Ground on which biological was suspended no longer applies"; "Revocation required"; "modalities::logic::deontic"; 1.0000; . a ; "32FC(2) Revocation of suspension"@en; ; "384bbaeef74d5dc7c38d97bb1a3e131fe1ba990d28daaef3fc5a1f3b2b47d7e1"; ; "Exercise of power by Secretary"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.351"; . a ; ; ; ; "borne by: State"; ; . a ; "32FD Effect of suspension"@en; ; "a2d5f0c0c50f79eef3d0f6d304c15f2ca9053c4a1b87a067a6ce345c54b24253"; "Dealing in a biological not included in the Register may be a criminal offence or contravene a civil penalty provision."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.352"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits dealing in a biological not included in the Register."; "modalities::logic::deontic"; 1.0000; . a ; "32G What this Division is about"@en; ; "f249cc31560c19b037e8ffe51e95fc561d461a5d73ccbf715839d13240457a1f"; "Secretary may cancel inclusions of biologicals in the Register under certain circumstances."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.353"; . a ; ; ; ; . a ; "32GA Immediate cancellation of biological from the Register in"@en; ; "746132fb58f62e028c03dfb237f56d3b7522c6cbb47312b62ea238b212de1be6"; "Cancellation of biological entry from Register under specified circumstances."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.353"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition on biological entry"; "The Secretary may cancel the entry of a biological from the Register."; "The entry must be cancelled."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Temporal Interval"; "Temporal interval for cancellation"; "The cancellation is effective immediately."; "The cancellation is effective from the date of notice."; "modalities::interval_reasoning"; 1.0000; . a ; "32GB Immediate cancellation of biological from the Register after"@en; ; "c23ccface09347eb1f7020aadef0ed419d583a0626704f21b4060a169fbc1586"; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.355". a ; "32GB(1) Immediate cancellation of biological from the Register after"@en; ; "bddd4caf49460b3a1fe83ce8f784fe4b2693d20faea0a6261024a02a0c44a9b1"; ; "The Secretary may cancel a biological entry from the Register if the person fails to comply with a notice."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.355"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "obligation"; "The Secretary has an obligation to cancel the biological entry."; "modalities::logic::deontic"; 1.0000; . a ; "32GB(2) Immediate cancellation of biological from the Register after"@en; ; "9e5c1f325f13d686bc3c64dc55fdab3f1fcefc998c2d1df33bc9d9d86ef4f6d8"; ; "Secretary must provide notice to person before cancelling biological entry from Register."; "Notice under section 32JA"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.355"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Secretary must provide notice"; "modalities::logic::deontic"; 1.0000; . a ; "32GC Cancellation of biological from the Register after notice of"@en; ; "0e0f66cdcf3e53140072d4eb880d4b5a77b303a15de0e787b1995b0aebfb740f"; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.356". a ; "32GC(1) Cancellation of biological from the Register after notice of"@en; ; "27cd471a8ef8458364f3b58e9f0966a34967b1f88a69e01cf4ec9df73d4e2b90"; ; "Cancellation of biological from the Register after notice of unacceptable quality, safety or efficacy."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.356"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition"; "The Secretary may cancel the entry of the biological from the Register."; "The person must not include the biological in the Register."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibit"; "Prohibition of advertising"; "The person contravenes subsection 32DQ(1) or (2) in relation to the biological."; "The person must not advertise the biological."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibit"; "Prohibition of advertising by related body corporate"; "If the person is a body corporate, a related body corporate contravenes a direction or condition given to the related body corporate under subsection 42DV(1) in relation to the advertising of the biological."; "The related body corporate must not advertise the biological."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibit"; "Prohibition of non-compliance with Therapeutic Goods Advertising Code"; "Either of the following has not been complied with in relation to the biological: an applicable provision of the Therapeutic Goods Advertising Code; any other requirement relating to advertising applicable under Part 5-1 or under the regulations."; "The person must comply with the Therapeutic Goods Advertising Code."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibit"; "Prohibition of non-compliance with regulatory requirements"; "The person contravenes subsection 32DQ(1) or (2) in relation to the biological."; "The person must comply with regulatory requirements."; "modalities::logic::deontic"; 1.0000; . a ; "32GC(2) Cancellation of biological from the Register after notice of"@en; ; "328985119a7fcda959f3ba4bfe4a2e74d9e88f4297a6317a8bda16cabf1599e4"; ; "Secretary must inform person of proposed cancellation and invite written submissions."; "written notice, written submissions"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.356"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Secretary must inform person of proposed cancellation."; "modalities::logic::deontic"; 1.0000; . . a ; ; "OBLIGES"; "Secretary is obligated to inform person of proposed cancellation."; "modalities::epistemic"; 1.0000; . . a ; ; "CONTAINS"; "Cancellation must be made within a specified period after notice."; "28 days after day notice is given."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "REQUIRES"; "Person must provide written submissions in response to notice."; "modalities::argumentation"; 1.0000; . . a ; ; "DURING"; "Cancellation period is specified as a duration after notice."; "28 days after day notice is given."; "modalities::interval_reasoning"; 1.0000; . a ; "32GC(3) Cancellation of biological from the Register after notice of"@en; ; "725f05f931ef82d37eb6dff6dcbcefcb6622f9c06135470fa63571733416a4f3"; ; "Secretary must consider submissions before making a decision on cancellation."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.356"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must consider submissions"; "modalities::logic::deontic"; 1.0000; . a ; "32GC(4) Cancellation of biological from the Register after notice of"@en; ; "0931782cccff8e870982346a7802e881886319db33b6f9d0f235a8445e82b99e"; ; "A notice under subsection (1) must not be a legislative instrument."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.356"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MustNot"; "Prohibition of notice being a legislative instrument."; "modalities::logic::deontic"; 1.0000; . a ; "32GD Revocation of cancellation of biological upon request"@en; ; "e7590ed4953ed0a9be12e0af8b07efd787cdc4b79c8b4f1e37e8c583ba32a5df"; "Request for revocation of cancellation of biological upon request"; "Application fee"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.357"; . a ; ; ; ; "borne by: State"; ; . a ; "32GE Publication of cancellation of entry from Register"@en; ; "bb3dee238e862e9591907502045fe8abe26e8332e4af67384d0018b09c2c591d"; "Publish notice of cancellation from Register"; "Notice with particulars of cancellation"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.358"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Publish notice"; "modalities::logic::deontic"; 1.0000; . a ; "32GF Date of effect of cancellation of entries from Register"@en; ; "f3c1b824fa0e5215268d6e9df4c4ec3fcfb803aac1b834e88b7fc9d2d1c5134d"; "Date of effect of cancellation of entries from Register"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.359"; . a ; ; ; ; . a ; "32H What this Division is about"@en; ; "0bc42af7187106f0ddfe272cc39ce589044d2d16a8819adcbbfad95bd7216088"; "The Secretary may require a person to recall biologicals or inform the public about non-compliant biologicals."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.360"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "require"; "Imposes a duty on the Secretary to require recall or notification."; "modalities::logic::deontic"; 1.0000; . a ; "32HA Public notification, and recall, of biologicals"@en; ; "b8704ece98d6847693b714453eb76eadcc8f17405d135858207e62dc7fca44f1"; "The Secretary may impose requirements on a person supplying a biological if certain circumstances occur."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.360"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Imposition of requirements is an obligation."; "modalities::logic::deontic"; 1.0000; . a ; "32HB Publication of requirements"@en; ; "131f1f748ac79b2a1a4c8c5097ce6ccd49674fc4a3fc4ab5719bf8fa5416ab08"; "Secretary must publish notice after imposing requirement."; "Notice setting out particulars of the requirement"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.364"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Obligation to publish notice"; "modalities::logic::deontic"; 1.0000; . a ; "32HC Criminal offences for non-compliance with requirements"@en; ; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.364". a ; "32HC(1) Criminal offences for non-compliance with requirements"@en; ; "142a5b4d275f2c214421434ecc494d4d566ce50c84eda65b012fdbe44a06aa89"; ; "Non-compliance with requirements is a criminal offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.364"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits non-compliance with requirements."; "modalities::logic::deontic"; 1.0000; . a ; "32HC(4) Criminal offences for non-compliance with requirements"@en; ; "229487f58195951d90ed41d51336d2c97f7cad67c576d72e87f9ab2473a2c3e1"; ; "Non-compliance with section 32HA requirements is an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.364"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "is"; "Definition of obligation"; "The person commits an offence."; "modalities::logic::deontic"; 1.0000; . a ; "32HC(5) Criminal offences for non-compliance with requirements"@en; ; "c3b6793ae0c5f7575a0eb95afd1d0deb92515aca8d6a4c6f7a31b66e75be7164"; ; "Offence for non-compliance with requirements"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.364"; . a ; ; ; ; ; . . a ; ; "Prohibition"; "Prohibits non-compliance with requirements"; "modalities::logic::deontic"; 1.0000; . a ; "32HC(6) Criminal offences for non-compliance with requirements"@en; ; "c385da7f11ff5e7f14e072e858989feb81f5b1c13125da3beda70e38518df21e"; ; "Offence of strict liability for non-compliance with requirements"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.364"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "is"; "Definition of strict liability"; "(6) An offence against subsection (5)"; "An offence of strict liability"; "modalities::logic::deontic"; 1.0000; . a ; "32HD Civil penalty for non-compliance with requirements"@en; ; "0afe274f1b9cb51789e56ca199fa8691156b60af901ec51c0d420ad1ece62701"; "Civil penalty for non-compliance with requirements"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.365"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits civil penalty for non-compliance"; "modalities::logic::deontic"; 1.0000; . a ; "32HE Powers of suspension and cancellation unaffected"@en; ; "670f28f015de613c6cb7f719e5306c6ddf7e39dd2dc0770ad3382f8acbcb0adf"; "Powers of suspension and cancellation unaffected"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.365"; . a ; ; ; ; . a ; "32HF Saving of other laws"@en; ; "d60e452d40d4d8c4426e32e3f836a586f2a94e7ff1468a6edf7dd0a4fff87758"; "No exclusion or limitation of other laws"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.365"; . a ; ; ; ; ; . . a ; ; "prohibition"; "Prohibiting exclusion"; "modalities::logic::deontic"; 1.0000; . a ; "32J What this Division is about"@en; ; "a4b8b329d56528433ed5a3b2f123d18a50c9b3e1c1762789996b5547bdb92100"; "The Secretary may seek information or documents from applicants, biologicals included in the Register, and suppliers of exempted biologicals."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.366"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "The Secretary may seek information or documents."; "modalities::logic::deontic"; 1.0000; . . a ; ; "must provide"; "There are penalties for failing to comply with a notice."; "modalities::epistemic"; 1.0000; . . a ; ; "for"; "The Secretary may seek information or documents from applicants, biologicals included in the Register, and suppliers of exempted biologicals."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "for"; "There are criminal offences for failing to comply with a notice and civil penalties for giving false or misleading information or documents."; "modalities::argumentation"; 1.0000; . a ; "32JA Secretary may require information or documents"@en; ; "950f43f5b377e730c40bc5ad3ffedcf87d834eff985bf7155fa3bdd8b3202857"; "The Secretary may require information or documents from a person."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.366"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MAY"; "May require"; "modalities::logic::deontic"; 1.0000; . a ; "32JB Criminal offences for failing to comply with a notice etc."@en; ; , , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.368". a ; "32JB(1) Criminal offences for failing to comply with a notice etc."@en; ; "834aad409511818db7b636c62aa1cdc7d69501fdd8d481fe2aafcbd603c8ba35"; ; "Failure to comply with a notice results in an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.368"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits failing to comply with a notice."; "modalities::logic::deontic"; 1.0000; . a ; "32JB(1A) Criminal offences for failing to comply with a notice etc."@en; ; "2cb61cef44f2feec7a5162ffaacd0a1b61bfed3032ae9af83f4ab66923913940"; ; "Defendant bears evidential burden for reasonable excuse"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.368"; . a ; ; ; ; "borne by: NaturalPerson"; ; . . a ; ; "Obligation"; "Defendant has an obligation to provide a reasonable excuse"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Burden of Proof"; "Defendant bears the burden of proof for their excuse"; "modalities::epistemic"; 1.0000; . a ; "32JB(1B) Criminal offences for failing to comply with a notice etc."@en; ; "610d949501cee19d59d9673b7b20aaec8a1ced323afb537483e32cbc644ea722"; ; "Failure to comply with a notice results in an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.368"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits failing to comply with a notice."; "(a) the person is given a notice under section 32JA; and (b) the person is covered by paragraph 32JA(1)(b) or (c); and (c) the person fails to comply with the notice."; "Penalty: 100 penalty units."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Obligation"; "Imposes an obligation to comply with a notice."; "(c) the person fails to comply with the notice."; "Penalty: 100 penalty units."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlaps"; "Defines the temporal interval during which the obligation to comply applies."; "modalities::interval_reasoning"; 0.5000; . a ; "32JB(1C) Criminal offences for failing to comply with a notice etc."@en; ; "87bd57090867c0a019d17047639634d39580d81b441962e88fb655ec9def4b9d"; ; "Offence of strict liability for failing to comply with a notice."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.368"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Imposes an obligation on the state."; "modalities::logic::deontic"; 1.0000; . a ; "32JB(1D) Criminal offences for failing to comply with a notice etc."@en; ; "7485e0ee217f5a0694c170cc1ebf34b763480f3d34b972a1a9c605cedc525cf0"; ; "Defendant bears evidential burden for reasonable excuse"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.368"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "has"; "Bearing of evidential burden"; "modalities::logic::deontic"; 1.0000; . . a ; ; "justification"; "Reasonable excuse justification"; "modalities::epistemic"; 1.0000; . a ; "32JB(2) Criminal offences for failing to comply with a notice etc."@en; ; "9a368a19045f6eb2d5e072218149b9dc2d347e69c9ce808f278e71f34f650a03"; ; "Failure to comply with a notice results in an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.368"; . a ; ; ; ; ; . . a ; ; "Prohibition"; "Prohibits failing to comply with a notice."; "modalities::logic::deontic"; 1.0000; . a ; "32JC Civil penalty for giving false or misleading information or"@en; ; "7fe630bd5d110b2510f427c893db8f5f8276c70b90d083460f0deb05a112cb65"; "Giving false or misleading information in compliance with a notice is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.370"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of giving false or misleading information."; "The person is given a notice under section 32JA."; "The person contravenes this section if..."; "modalities::logic::deontic"; 1.0000; . a ; "32JD Self-incrimination"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.371". a ; "32JD(1) Self-incrimination"@en; ; "c23e01f6202e12db94e967ba2c599cc5521c24bac1af8b5bc7ff705261c50c71"; ; "No excuse for self-incrimination"; "Information or document"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.371"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide information or document"; "modalities::logic::deontic"; 1.0000; . a ; "32JD(2) Self-incrimination"@en; ; "e45e91c9c5d468cc6a3b43573c85d0b4a5a80870845f23f21c5415557ea9d6d9"; ; "Exemptions from self-incrimination in certain cases"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.371"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Exemptions from self-incrimination"; "modalities::logic::deontic"; 1.0000; . a ; "32JE Secretary may require information etc. about biologicals"@en; ; "9c4bcc3c6143357646c6d62fe8052ce1e7559b8b8f0e9e01db059e337b02690e"; "Secretary may require information about biologicals from exempt persons."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.371"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Implies an obligation."; "modalities::logic::deontic"; 0.5000; . a ; "32JF Secretary may require information etc. about biologicals"@en; ; "951edf9d3466603b4bbc319403325ec19bcd4ce43be4fededd8adf6fbcd9114e"; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.373". a ; "32JF(1) Secretary may require information etc. about biologicals"@en; ; "2bd9c5c95f4e1aa3209d5b20c20f1705b0e508c1c64519d67c9ada84ebb0e3e5"; ; "Secretary may require information about biologicals"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.373"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "requires"; "Requires information from a person"; "modalities::logic::deontic"; 1.0000; . a ; "32JF(2) Secretary may require information etc. about biologicals"@en; ; "cba4779bd457384b251ed47cdfc3dd47cd59c7f51595933bf7484a6708408913"; ; "The Secretary may require information or documents from a person."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.373"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Implies an obligation."; "modalities::logic::deontic"; 1.0000; . a ; "32JF(3) Secretary may require information etc. about biologicals"@en; ; "bf46f61c9d8b1916d13b5ace9c6406ba4df80a3b00fd70ad1b3ca70d1bc67ba2"; ; "Must provide information within a specified period and in a specified form."; "true"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.373"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST PROVIDE"; "Must provide information within a specified period and in a specified form."; "modalities::logic::deontic"; 1.0000; . a ; "32JF(4) Secretary may require information etc. about biologicals"@en; ; "18ca6b122c71e30b4094c7b46b2a3453441b59a1b0e35b59076fdc572147bc70"; ; "The form may require or permit the information to be given, or the documents to be produced, in accordance with specified software requirements."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.373"; . a ; ; ; ; "borne by: State"; ; . a ; "32JG Secretary may require information etc. about biologicals"@en; ; "035dc4c95da45dab66b56525f7b2329edbd7c535e729b26a31efb045e9f1dc84"; , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.374". a ; "32JG(1) Secretary may require information etc. about biologicals"@en; ; "74d7127dc2b6a0df299f251e6173b9bf3134209b98fc4feccc5d155dd5e2f956"; ; "The Secretary may require information from a person granted an approval under subsection 32CK(1) in relation to a biological."; "specified information or documents relating to the supply, handling, monitoring of the supply, and results of the supply of the biological"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.374"; . a ; ; ; ; "borne by: State"; ; . a ; "32JG(2) Secretary may require information etc. about biologicals"@en; ; "e17853c491ba004ddb7ab409a450904d262a32bcc2889b8398d5da4d4ac0dfe4"; ; "The Secretary may require information etc. about biologicals."; "specified information or documents relating to the use of the biological"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.374"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MAY"; "The Secretary may require information etc."; "modalities::logic::deontic"; 1.0000; . a ; "32JG(3) Secretary may require information etc. about biologicals"@en; ; "865eb9a8a536603ed962b86ff3d6713cd6f1bc146aa69edd1533e0cd62761b1a"; ; "The Secretary may require specified information or documents from a person granted an authority under subsection 32CM(1) in relation to a biological."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.374"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MAY"; "The Secretary may require specified information or documents."; "modalities::logic::deontic"; 1.0000; . a ; "32JG(3A) Secretary may require information etc. about biologicals"@en; ; "daf8784c70415796d96fcfc2d54c2d57c5432fd98b900485d64958cb10a91a79"; ; "Secretary may require specified information or documents from a person authorized to supply a biological."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.374"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MAY"; "Implies an obligation."; "modalities::logic::deontic"; 1.0000; . a ; "32JG(4) Secretary may require information etc. about biologicals"@en; ; "d96684780b351f277267e40151005b6127b6b6feaa4ed15373d62beff9e55e6e"; ; "Must provide information or documents within a specified period and in a specified form."; "true"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.374"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "MUST"; "Must provide information or documents within a specified period and in a specified form."; "modalities::logic::deontic"; 1.0000; . a ; "32JH Secretary may require information etc. about biologicals"@en; ; "6fab7489960b7192508ea09834f88c92a26f20fa6d5632b23e19de699909004e"; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.376". a ; "32JH(1) Secretary may require information etc. about biologicals"@en; ; "cb020c8217eafdb02f15265a4d14bb8c4e3dd116c3f033428dffcee435025f0a"; ; "The Secretary may require information about a biological."; "(a) the supply of the biological; (b) the handling of the biological; (c) the monitoring of the supply of the biological; (d) the results of the supply of the biological; (e) any other matter prescribed by the regulations for the purposes of this paragraph in relation to a biological of that kind."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.376"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MAY"; "The Secretary may require information."; "modalities::logic::deontic"; 1.0000; . a ; "32JH(2) Secretary may require information etc. about biologicals"@en; ; "eca9aa41925f7d9df5ae799e1abeef637d6b3eb6402ce884374238203d61342f"; ; "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.376"; . 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 ; "32JH(3) Secretary may require information etc. about biologicals"@en; ; "999e17e97c5dea127f3240fd393f3fe0ec24fd37d2d7e946d2d6490a19414b48"; ; "The form may require or permit the information to be given, or the documents to be produced in accordance with specified software requirements."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.376"; . a ; ; ; ; "borne by: State"; ; . a ; "32JI Criminal offences for failing to comply with a notice etc."@en; ; , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.377". a ; "32JI(1) Criminal offences for failing to comply with a notice etc."@en; ; "185ac3a82132bbc2293d8905c1beda94f248fbbeb4c7fd10833fff0acb6d953c"; ; "Failure to comply with a notice results in an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.377"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits failing to comply with a notice."; "(a) the person is given a notice under section 32JE, 32JF, 32JG or 32JH; and (b) the person fails to comply with the notice."; "Penalty: 500 penalty units."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlaps"; "Defines a temporal interval during which failing to comply with a notice results in an offence."; "(a) the person is given a notice under section 32JE, 32JF, 32JG or 32JH; and (b) the person fails to comply with the notice."; "...and penalty: 500 penalty units."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Recurrently"; "Defines a recurring obligation to comply with notices."; "(a) the person is given a notice under section 32JE, 32JF, 32JG or 32JH; and (b) the person fails to comply with the notice."; "...and penalty: 500 penalty units."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Obligation"; "Imposes an obligation on persons to comply with notices."; "(a) the person is given a notice under section 32JE, 32JF, 32JG or 32JH; and (b) the person fails to comply with the notice."; "...and penalty: 500 penalty units."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Implication"; "Justifies the imposition of a penalty for failing to comply with notices."; "(a) the person is given a notice under section 32JE, 32JF, 32JG or 32JH; and (b) the person fails to comply with the notice."; "...and penalty: 500 penalty units."; "modalities::argumentation"; 1.0000; . a ; "32JI(1A) Criminal offences for failing to comply with a notice etc."@en; ; "e85ba99d9ef15022ed2ba3dc569edc8d681d88740be85b181c3c121abf452ba3"; ; "Failure to comply with a notice results in an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.377"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits failing to comply with a notice."; "(a) the person is given a notice under section 32JE, 32JF, 32JG or 32JH; and (b) the person fails to comply with the notice."; "Penalty: 100 penalty units."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Overlaps"; "Notices issued under sections 32JE, 32JF, 32JG or 32JH overlap with the offence."; "(1A) A person commits an offence if: (a) the person is given a notice under section 32JE, 32JF, 32JG or 32JH; and"; "modalities::interval_reasoning"; 0.5000; . . a ; ; "Repeats"; "Notice must be repeated for each failure to comply."; "(1A) A person commits an offence if: (a) the person is given a notice under section 32JE, 32JF, 32JG or 32JH; and"; "modalities::temporal_ltl"; 0.5000; . . a ; ; "Obligation"; "Imposes an obligation to comply with the notice."; "(1A) A person commits an offence if: (a) the person is given a notice under section 32JE, 32JF, 32JG or 32JH; and"; "modalities::logic::deontic"; 0.5000; . . a ; ; "Prohibition"; "Prohibits failure to comply with the notice."; "(1A) A person commits an offence if: (a) the person is given a notice under section 32JE, 32JF, 32JG or 32JH; and"; "modalities::logic::deontic"; 0.5000; . a ; "32JI(1B) Criminal offences for failing to comply with a notice etc."@en; ; "0e0cdce4f49bcdede84da2c8cb10ce3f352a4869982d14472853df3c1e9c44ee"; ; "Offence of strict liability for failing to comply with a notice"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.377"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits an offence of strict liability"; "(1B) An offence against subsection (1A)"; "An offence of strict liability"; "modalities::logic::deontic"; 1.0000; . a ; "32JI(2) Criminal offences for failing to comply with a notice etc."@en; ; "a2c8711943ee9f6cacad211b7224d6047adaafeab3d1df75a58f105cb84af182"; ; "Failing to comply with a notice results in an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.377"; . a ; ; ; ; ; . . a ; ; "Prohibition"; "Prohibits failing to comply with a notice."; "modalities::logic::deontic"; 1.0000; . a ; "32JI(3) Criminal offences for failing to comply with a notice etc."@en; ; "b12846970c34a3d1360202f8dcd64a0e8fb411e932564440c7ac73823a87fe67"; ; "Offence for failing to comply with a notice"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.377"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits failure to comply with a notice"; "modalities::logic::deontic"; 1.0000; . a ; "32JJ Civil penalty for giving false or misleading information or"@en; ; "4fb152d0f61815fed84acf184caa1c9b05ddfc83a1798985bc019c1bf439bddd"; "Giving false or misleading information in compliance with a notice is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.378"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits giving false or misleading information in compliance with a notice."; "modalities::logic::deontic"; 1.0000; . a ; "32JK Self-incrimination"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.378". a ; "32JK(1) Self-incrimination"@en; ; "c0137937764612eb65b2162dc614b9d948ba242c6145c598acbbe3b796fb7ce7"; ; "No excuse for self-incrimination"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.378"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Obligation to provide information"; "modalities::logic::deontic"; 1.0000; . a ; "32JK(2) Self-incrimination"@en; ; "c90302cc6bdad7bdb74b2882b4f4cb9f67fa280648908d982dabd2d26ccb1331"; ; "Exemptions from self-incrimination in certain circumstances"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.378"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Exemptions from self-incrimination"; "None"; "None"; "modalities::logic::deontic"; 1.0000; . a ; "32JL Secretary may inspect and copy documents"@en; ; "725ea2ad7cb0c0c5c8009d8159826a6af422ecee8b5c94f3ce18dfdcdfed21a4"; "Inspect and copy documents produced under certain sections."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.379"; . a ; ; ; ; ; . . a ; ; "can"; "Permits inspection and copying."; "modalities::logic::deontic"; 0.5000; . a ; "32JM Secretary may retain documents"@en; ; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.379". a ; "32JM(1) Secretary may retain documents"@en; ; "4f6a24541790728efb9dfccfb99ab443171e619f7a163ac16edebf83437b5d62"; ; "The Secretary may retain documents for a reasonable period."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.379"; . a ; ; ; ; ; . . a ; ; "may"; "Permission to retain documents"; "modalities::logic::deontic"; 0.5000; . . a ; ; "during"; "Temporal relation to document retention"; "modalities::interval_reasoning"; 0.5000; . a ; "32JM(2) Secretary may retain documents"@en; ; "39b840de0aebe6d9fbfe33d0f47cc203c4c340e15b499956df9f62d8bf008099"; ; "Secretary must provide a copy of the document upon request."; "true"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.379"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Secretary has an obligation to provide a copy of the document."; "modalities::logic::deontic"; 1.0000; . a ; "32JM(3) Secretary may retain documents"@en; ; "80d9d59a2778a064332ad3fc46e2fc877e01a794c24bccd78e99d9487675d217"; ; "The certified copy must be received as evidence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.379"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Obligation to receive certified copy"; "modalities::logic::deontic"; 1.0000; . a ; "32JM(4) Secretary may retain documents"@en; ; "65c05402790361096b09ba5075c5d77f23b1f7d378696fbdfa09353c6c41b3ef"; ; "Must provide access to documents for inspection and copying."; "Yes"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.379"; . a ; ; ; ; ; . . a ; ; "MUST"; "Obligation to provide access"; "modalities::logic::deontic"; 1.0000; . a ; "33A Part does not apply to a medical device"@en; ; "19af70f5b76fbab4ad94ec5b26b972ed1461e7b81c80bcf1ed0b001995e240ef"; "Part does not apply to medical devices."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.380"; . a ; ; ; ; . a ; "33B Application of this Part to biologicals"@en; ; "4186ce48132d2af1439d776bca7f86d2455abe4512c2ce182d37313f35f93545"; "This Part does not apply to a Class 1 biological."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.380"; . a ; ; ; ; ; . a ; "34 Exempt goods and exempt persons"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.380". a ; "34(1) Exempt goods and exempt persons"@en; ; "786a06541bb52f02f105a18a1e3a0b4aa1783901f8318311bf68cd213a5a7f4d"; ; "Therapeutic goods may be exempt from the operation of this Part."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.380"; . a ; ; ; ; "borne by: State"; ; . a ; "34(2) Exempt goods and exempt persons"@en; ; "9ab9fb76f2cf483d964d7f0656328c852c65650e0813ebfd22c73f60633dc8dd"; ; "Exempts a person from the operation of this Part in relation to the manufacture or a step in the manufacture of therapeutic goods."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.380"; . a ; ; ; ; ; . a ; "34(3) Exempt goods and exempt persons"@en; ; "e1f5ef79b2831a36434bc9810b239259a7db61409570f48c7cc993da91208010"; ; "Revocation of exemption takes effect after 28 days"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.380"; . a ; ; ; ; . a ; "35 Criminal offences relating to manufacturing therapeutic goods"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.380". a ; "35(1) Criminal offences relating to manufacturing therapeutic goods"@en; ; "b1de34011cad22794f135fc6399b702d41f6209f1af6b75ef056cd88dba8045e"; ; "Manufacturing therapeutic goods without proper authorization is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.380"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits the manufacture of therapeutic goods without proper authorization."; "modalities::logic::deontic"; 1.0000; . a ; "35(4) Criminal offences relating to manufacturing therapeutic goods"@en; ; "2eedcd7b145ded277170dd0edcfb7b550e7a046b97421d7edc657e7ceeb92000"; ; "Manufacturing therapeutic goods without proper license"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.380"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits manufacturing therapeutic goods without license"; "(a) the person, at premises in Australia, carries out a step in the manufacture of therapeutic goods..."; "...and none of the following applies: (i) the goods are exempt goods;"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibit"; "Prohibits manufacturing therapeutic goods without proper license"; "(b) the goods are for supply for use in humans;"; "...and none of the following applies: (i) the goods are exempt goods;"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibit"; "Prohibits manufacturing therapeutic goods without proper license"; "(c) none of the following applies:"; "...and none of the following applies: (i) the goods are exempt goods;"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibit"; "Prohibits manufacturing therapeutic goods without proper license"; "(iii) the person is the holder of a licence that is in force that authorises the carrying out of that step in relation to the goods at those premises."; "...and none of the following applies: (i) the goods are exempt goods;"; "modalities::logic::deontic"; 1.0000; . a ; "35A Civil penalties relating to manufacturing therapeutic goods"@en; ; "a6516c6e428c0e28849bb916246584c3e7cfe60c5adadb39a9dba91976623015"; "Carrying out steps in manufacturing therapeutic goods at Australian premises is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.383"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of manufacturing therapeutic goods at Australian premises."; "modalities::logic::deontic"; 1.0000; . a ; "35B Criminal offences relating to breaching a condition of a licence"@en; ; , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.384". a ; "35B(1) Criminal offences relating to breaching a condition of a licence"@en; ; "a0866b55206427146969c1ca4cfaef2310b0ee1235e944b4a4b670e808d96406"; ; "A person commits an offence if they hold a licence and breach a condition of the licence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.384"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "has"; "Licence is a necessary condition for committing an offence."; "The person holds a licence."; "The person commits an offence."; "modalities::logic::deontic"; 1.0000; . . a ; ; "has"; "Breach of the licence's condition is a necessary condition for committing an offence."; "The act or omission has resulted in, will result in, or is likely to result in harm or injury to any person."; "The person commits an offence."; "modalities::logic::deontic"; 1.0000; . . a ; ; "has"; "Imprisonment for 5 years or 4,000 penalty units is a possible consequence of committing an offence."; "A person commits an offence if: (a) the person holds a licence; and (b) the person does an act or omits to do an act; and (c) the act or omission breaches a condition of the licence; and (d) the act or omission has resulted in, will result in, or is likely to result in harm or injury to any person."; "The penalty for committing an offence is imprisonment for 5 years or 4,000 penalty units."; "modalities::logic::deontic"; 1.0000; . . a ; ; "has"; "A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead."; "A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A."; "The court has discretion to acquit or convict a person of an offence."; "modalities::logic::deontic"; 1.0000; . a ; "35B(4) Criminal offences relating to breaching a condition of a licence"@en; ; "15f35ff81eb6354aee60ddf3261c9599a2a2d07b21338f162d852f7e34368830"; ; "Breach of licence condition is an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.384"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "is"; "Licence breach is a duty."; "modalities::logic::deontic"; 1.0000; . a ; "35B(5) Criminal offences relating to breaching a condition of a licence"@en; ; "ff44ee5f30ea16bf3d52007a11ae5e0c5b8054fcbcb05394469c0b715439aedf"; ; "Breach of licence condition is an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.384"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "is"; "Licence breach is a duty."; "(5) A person commits an offence if: (a) the person holds a licence; and (b) the person does an act or omits to do an act; and (c) the act or omission breaches a condition of the licence."; "The person is obligated to comply with the licence conditions."; "modalities::logic::deontic"; 1.0000; . . a ; ; "=>"; "Licence breach implies obligation to comply."; "(5) A person commits an offence if: (a) the person holds a licence; and (b) the person does an act or omits to do an act; and (c) the act or omission breaches a condition of the licence."; "The person is obligated to comply with the licence conditions."; "modalities::linear"; 1.0000; . . a ; ; "during"; "Licence breach occurs during licence period."; "(5) A person commits an offence if: (a) the person holds a licence; and (b) the person does an act or omits to do an act; and (c) the act or omission breaches a condition of the licence."; "The licence breach occurs during the licence period."; "modalities::interval_reasoning"; 1.0000; . a ; "35B(6) Criminal offences relating to breaching a condition of a licence"@en; ; "c385da7f11ff5e7f14e072e858989feb81f5b1c13125da3beda70e38518df21e"; ; "An offence against subsection (5) is an offence of strict liability."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.384"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Imposes a duty on the state."; "modalities::logic::deontic"; 1.0000; . a ; "35C Civil penalty relating to breaching a condition of a licence"@en; ; "671e5d890c39839dbd99093eb324ea5ebca9dae4d723ac6e4c9f63cc6d7c7bfb"; "Breach of licence condition results in civil penalty"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.385"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "forbid"; "Prohibits breaching a licence condition"; "modalities::logic::deontic"; 1.0000; . a ; "36 Manufacturing principles"@en; ; "72cf1a68212b3c8fd3686d80789139dee349192aa9ba572146cea7da9d7ff879"; "The Minister may determine written principles for the manufacture of therapeutic goods."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.385"; . a ; ; ; ; ; . . a ; ; "may"; "Permission to determine principles"; "modalities::logic::deontic"; 1.0000; . a ; "37 Application for licence"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.386". a ; "37(1) Application for licence"@en; ; "823f4f6b0f643d1bcfe08c522bd12ef4ba714c764eb10b82f774902e8051f288"; ; "Application for licence must be made in accordance with a form approved by the Secretary."; "a form approved by the Secretary, identification of therapeutic goods or classes of therapeutic goods, manufacturing sites, steps in manufacture, and control measures"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.386"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "MUST"; "Application must be made in accordance with a form approved by the Secretary."; "modalities::logic::deontic"; 1.0000; . a ; "37(1A) Application for licence"@en; ; "016a603df80d896b076ce6511461926e36d66ad645de63df75237a37039c746f"; ; "Application must relate to one manufacturing site only."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.386"; . a ; ; ; ; "borne by: LegalPerson"; ; . . a ; ; "Obligate"; "Application must relate to one manufacturing site only."; "modalities::logic::deontic"; 1.0000; . . a ; ; "during"; "Temporal relation between manufacturing sites"; "modalities::interval_reasoning"; 1.0000; . a ; "37(1B) Application for licence"@en; ; "05346525101c5634d6cd94847acc9cbfdb381de12153f5717d2c5c790bcac7a9"; ; "Applicant may identify multiple manufacturing sites in application."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.386"; . a ; ; ; ; "borne by: State"; ; . a ; "38 Grant of licence"@en; ; "a59be4096747b5017b36442b420d51e6c633d29fc64950d2817c749b3604bcfe"; "Grant of licence for manufacturing therapeutic goods"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.388"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligate"; "Grant of licence for manufacturing therapeutic goods"; "modalities::logic::deontic"; 1.0000; . a ; "38A Guidelines for multi-site licences"@en; ; "e400ba6304d4a70588635168adb1ab7598bffca80dbc120fe43d7f9fce1134f0"; "The Secretary must make guidelines for multi-site licences."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.391"; . a ; ; ; ; . a ; "38B Splitting multi-site licences"@en; ; "5369fcecd8ee3b9d96311368fb5dddfe92ac96ddc86096dd9040eccea6e64e2b"; "This section applies if a licence (the old licence):"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.391"; . a ; ; ; ; ; . a ; "39 Term of licence"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.394". a ; "39(1) Term of licence"@en; ; "2d4f6788c93008a0616fe5e8e8fae7a8912126f8587b0a2c421738cf9c9e15e2"; ; "Licence commencement and duration"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.394"; . a ; ; ; ; . . a ; ; "Applicable"; "Defines temporal interval for licence commencement"; "Commencement day is specified"; "Licence commences on specified day"; "modalities::interval_reasoning"; 1.0000; . a ; "39(2) Term of licence"@en; ; "e88995f51c5daf9ef2c10254f3e07fec174d40e020b80e6949ec8da16c7f4244"; ; "Licence ceases to be in force if goods cease to be exempt under section 18A."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.394"; . a ; ; ; ; ; . . a ; ; "cease"; "Ceases to be in force"; "(2) If the licence covers therapeutic goods that are exempt under section 18A; and those goods cease to be exempt under that section before the licence is revoked;"; "the licence ceases to be in force in relation to those goods when those goods cease to be exempt under that section."; "modalities::logic::deontic"; 1.0000; . . a ; ; "during"; "Temporal relation between exemption and licence revocation"; "(b) those goods cease to be exempt under that section before the licence is revoked;"; "when those goods cease to be exempt under that section."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "during"; "Temporal relation between exemption and licence revocation"; "(b) those goods cease to be exempt under that section before the licence is revoked;"; "when those goods cease to be exempt under that section."; "modalities::temporal_ltl"; 1.0000; . a ; "39(3) Term of licence"@en; ; "41f378cf70f82afbc42eae902f636bae38c0898972f0b3da17b6f39b8412b177"; ; "Licence ceases in force if biological ceases to be exempt under section 32CB."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.394"; . a ; ; ; ; ; . . a ; ; "CEASES"; "Ceases in force"; "(a) the licence covers a biological that is exempt under section 32CB; and (b) the biological ceases to be exempt under that section before the licence is revoked;"; "the licence ceases to be in force in relation to the biological when the biological ceases to be exempt under that section."; "modalities::logic::deontic"; 1.0000; . . a ; ; "MEETS"; "Biological ceases to be exempt under section 32CB before licence is revoked"; "(b) the biological ceases to be exempt under that section before the licence is revoked;"; "modalities::interval_reasoning"; 0.8000; . . a ; ; "MEETS"; "Biological ceases to be exempt under section 32CB at some point in time"; "(b) the biological ceases to be exempt under that section before the licence is revoked;"; "modalities::temporal_ltl"; 0.8000; . . a ; ; "MEETS"; "Licence ceases in force when biological ceases to be exempt under section 32CB"; "(a) the licence covers a biological that is exempt under section 32CB; and (b) the biological ceases to be exempt under that section before the licence is revoked;"; "modalities::diffusion"; 0.8000; . . a ; ; "MEETS"; "Licence ceases in force when biological ceases to be exempt under section 32CB"; "(a) the licence covers a biological that is exempt under section 32CB; and (b) the biological ceases to be exempt under that section before the licence is revoked;"; "sparql_library::parsers::chk_parser"; 0.8000; . a ; "40 Conditions of licences"@en; ; , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.394". a ; "40(1) Conditions of licences"@en; ; "bce90fa1856c50d45b98e0d7fc2792ab10fdeead0db86b4ee9b831954df28db4"; ; "Conditions for granting a licence"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.394"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "shall"; "Imposes an obligation on the State"; "modalities::logic::deontic"; 1.0000; . a ; "40(2) Conditions of licences"@en; ; "ed9e6a9364bc4439a62594c58cb050f71dd622e9e95956e8f336e1d0aee8829a"; ; "Secretary may impose new conditions on a licence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.394"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "may"; "Imposes obligation"; "modalities::logic::deontic"; 1.0000; . a ; "40(3) Conditions of licences"@en; ; "76fd027f3c8145fe227cea6a3e17dbdac713cb3a92e126229b8ae8f03f8f7e4d"; ; "Conditions for imposing, varying or removing conditions on licences."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.394"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Imposition of obligations."; "modalities::logic::deontic"; 1.0000; . a ; "40(3A) Conditions of licences"@en; ; "e9297eb92871c46d7b5997d4608a86576567b30fa9749516395fb4a7c6673573"; ; "The earlier day must not be earlier than the day the notice is given to the person."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.394"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Necessity"; "The earlier day must be on or after the notice day."; "(3A) For the purposes of paragraph (3)(b), the earlier day must not be earther than the day the notice is given to the person."; "(3A) For the purposes of paragraph (3)(b), the earlier day must be on or after the notice day."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Meets"; "The earlier day meets the notice day."; "(3A) For the purposes of paragraph (3)(b), the earlier day must not be earther than the day the notice is given to the person."; "(3A) For the purposes of paragraph (3)(b), the earlier day meets the notice day."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "Meets"; "The earlier day meets the notice day."; "(3A) For the purposes of paragraph (3)(b), the earlier day must not be earther than the day the notice is given to the person."; "(3A) For the purposes of paragraph (3)(b), the earlier day meets the notice day."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "Meets"; "The earlier day meets the notice day."; "(3A) For the purposes of paragraph (3)(b), the earlier day must not be earther than the day the notice is given to the person."; "(3A) For the purposes of paragraph (3)(b), the earlier day meets the notice day."; "modalities::diffusion"; 1.0000; . . a ; ; "Meets"; "The earlier day meets the notice day."; "(3A) For the purposes of paragraph (3)(b), the earlier day must not be earther than the day the notice is given to the person."; "(3A) For the purposes of paragraph (3)(b), the earlier day meets the notice day."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "40(4) Conditions of licences"@en; ; "42ef28113032f666f0038448350849101b897571dcf66524a16c62cee5d36acd"; ; "Ensure goods conform to standards and follow manufacturing principles."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.394"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "must"; "Ensure compliance with standards and principles."; "The holder of the licence must ensure that..."; "...the goods conform to any standard applicable to the goods; and the holder of the licence observes the manufacturing principles in carrying out any steps in the manufacture of the goods under the licence."; "modalities::logic::deontic"; 1.0000; . . a ; ; "during"; "Manufacturing principles apply during the manufacture of goods."; "The holder of the licence observes the manufacturing principles in carrying out any steps in the manufacture of the goods under the licence;"; "...the goods conform to any standard applicable to the goods; and..."; "modalities::interval_reasoning"; 1.0000; . . a ; ; "until"; "Manufacturing principles apply until the circumstances prescribed by the regulations have occurred."; "The holder of the licence observes the manufacturing principles in carrying out any steps in the manufacture of the goods under the licence;"; "...the goods are a biological and are for supply after the circumstances prescribed by the regulations..."; "modalities::temporal_ltl"; 1.0000; . . a ; ; "if"; "Manufacturing principles apply if certain conditions are met."; "The holder of the licence will: (a) ensure that:..."; "...the goods conform to any standard applicable to the goods; and..."; "modalities::diffusion"; 1.0000; . . a ; ; "has"; "Goods have a certain property if they conform to standards."; "(i) the goods conform to any standard applicable to the goods;"; "...the goods are a biological and are for supply after the circumstances prescribed by the regulations..."; "sparql_library::parsers::chk_parser"; 1.0000; . a ; "40A Variation of manufacturing site authorisations—Secretary’s"@en; ; "772cef773de65c05e8af2d38d0f6ff0d833e257ee5dd5d0377e439cbc856c9f0"; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.397". a ; "40A(1) Variation of manufacturing site authorisations—Secretary’s"@en; ; "b430ea172eaaeeceee938df8bfd0ad160a5176cae5e33acfecd69175bca45c1d"; ; "The Secretary may vary a manufacturing site authorisation on their own initiative."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.397"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "May"; "The Secretary has the power to vary a manufacturing site authorisation."; "modalities::logic::deontic"; 1.0000; . a ; "40A(2) Variation of manufacturing site authorisations—Secretary’s"@en; ; "28501499e725b83d0c0781e8a473b6af811f5d6adbbd9bfc4c211b32d75b4d04"; ; "Variation of manufacturing site authorisations—Secretary’s"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.397"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "takes effect"; "Effectiveness of variation"; "(2) A variation under subsection (1)"; "Chapter 3 Medicines and other therapeutic goods that are not medical devices"; "modalities::logic::deontic"; 0.5000; . . a ; ; "begins at"; "Temporal relationship of variation effectiveness"; "(2) A variation under subsection (1)"; "Chapter 3 Medicines and other therapeutic goods that are not medical devices"; "modalities::interval_reasoning"; 0.5000; . . a ; ; "is a trace of"; "Recurring relationship of variation effectiveness"; "(2) A variation under subsection (1)"; "Chapter 3 Medicines and other therapeutic goods that are not medical devices"; "modalities::temporal_ltl"; 0.5000; . . a ; ; "diffuses to"; "Spread of variation effectiveness"; "(2) A variation under subsection (1)"; "Chapter 3 Medicines and other therapeutic goods that are not medical devices"; "modalities::diffusion"; 0.5000; . . a ; ; "is a capability of"; "Artificial intelligence application for variation effectiveness"; "(2) A variation under subsection (1)"; "Chapter 3 Medicines and other therapeutic goods that are not medical devices"; "sparql_library::parsers::chk_parser"; 0.5000; . a ; "40B Variation of licences—application by licence holder"@en; ; "23631f5b408e0ffe207e9d7d35b987d75af7fcaa23985e24c729e62b43b1aec9"; , , , , , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.398". a ; "40B(1) Variation of licences—application by licence holder"@en; ; "873f1327535160237468c62c43837f8983a4632fc26c255cbe57b149229c7d32"; ; "Licence holder may apply for variation of licence to cover additional manufacturing sites."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.398"; . a ; ; ; ; ; . . a ; ; "May"; "Permission granted by the holder."; "modalities::logic::deontic"; 1.0000; . a ; "40B(2) Variation of licences—application by licence holder"@en; ; "faa1a26da7eb49ec0db13d71d4d9f80f27f94a11a3993f901a1e019c3804e7c1"; ; "Application requirements for variation of licences"; "information relating to manufacturing steps, quality control measures, and personnel"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.398"; . a ; ; ; ; ; . . a ; ; "MUST"; "Application must be made in accordance with a form approved by the Secretary"; "modalities::logic::deontic"; 1.0000; . a ; "40B(3) Variation of licences—application by licence holder"@en; ; "e7712ac023a994b706e250c553d86608eb5531268109ba62cde98d6ce020d7ab"; ; "Variation of licences—application by licence holder"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.398"; . a ; ; ; ; "borne by: State"; ; . a ; "40B(4) Variation of licences—application by licence holder"@en; ; "b2326fd704e1f95cfebdca810bf196177fe62d7548945f5ff45c348d0471df8f"; ; "The Secretary must vary the licence to authorise the holder of the licence to carry out specified steps in the manufacture of specified therapeutic goods at that manufacturing site."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.398"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "The Secretary must vary the licence."; "modalities::logic::deontic"; 1.0000; . . a ; ; "AT A SPECIFIED MANUFACTURING SITE"; "The variation is specified for each manufacturing site."; "modalities::interval_reasoning"; 1.0000; . a ; "40B(5) Variation of licences—application by licence holder"@en; ; "afe440d48bb49c15f08205465ab4c80277d0ccdefa5d869501128dc2b178e984"; ; "Variation of manufacturing site authorisations takes effect on the day notice is given to the holder."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.398"; . a ; ; ; ; . a ; "40B(6) Variation of licences—application by licence holder"@en; ; "4c26da67d5139314367ed4a64774cb67de5864acb5579d9e73f899cab4b54c6e"; ; "Holder of a licence may apply for variation of manufacturing site authorisation."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.398"; . a ; ; ; ; ; . . a ; ; "May"; "Permission to apply for variation"; "modalities::logic::deontic"; 1.0000; . a ; "40B(7) Variation of licences—application by licence holder"@en; ; "5d7a365a6b97644a4d1c8c3e4c821040ec1216decebf484535a660d3dddf4a8c"; ; "Application for variation of licence must be made in accordance with a form approved by the Secretary."; "Form, application fee"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.398"; . 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 ; "40B(8) Variation of licences—application by licence holder"@en; ; "699014c0bd3df205b9cf2a07d90402955b12cd0cc189ca0b182a1817f7de60d6"; ; "Secretary may vary manufacturing site authorisation upon application and payment of inspection fees."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.398"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "May"; "Permits variation of manufacturing site authorisation."; "modalities::logic::deontic"; 1.0000; . a ; "40B(9) Variation of licences—application by licence holder"@en; ; "983e7d9928431ae3c9422c83e47eb4b86d19ab75ad442a9f77801e2994f2ec64"; ; "Variation of licences—application by licence holder"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.398"; . a ; ; ; ; ; . . a ; ; "takes effect"; "Effectiveness of variation"; "(9) A variation under subsection (8) takes effect on the day on which the notice is given to the holder."; "The variation takes effect on the specified day."; "modalities::logic::deontic"; 0.5000; . . a ; ; "specifies temporal interval"; "Temporal specification of variation"; "(9) A variation under subsection (8) takes effect on the day on which the notice is given to the holder."; "The variation's effectiveness is tied to a specific date."; "modalities::interval_reasoning"; 0.5000; . . a ; ; "specifies trace"; "Tracing variation application"; "(9) A variation under subsection (8) takes effect on the day on which the notice is given to the holder."; "The variation's application can be traced back to its notification date."; "modalities::temporal_ltl"; 0.5000; . . a ; ; "applies to licence holder"; "Application of variation obligation"; "(9) A variation under subsection (8) takes effect on the day on which the notice is given to the holder."; "The licence holder must comply with the variation's terms."; "modalities::logic::deontic"; 0.5000; . . a ; ; "specifies variation type"; "Variation type specification"; "(9) A variation under subsection (8) takes effect on the day on which the notice is given to the holder."; "The variation's application is subject to specific rules."; "modalities::logic::deontic"; 0.5000; . a ; "41 Revocation and suspension of licences"@en; ; "f6fbda13eb4b0aa914a819e81dadaddea46f623e8f2b38a0025ed1e084bef85d"; "Revocation or suspension of a licence for specified reasons"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.401"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibits revocation or suspension of a licence for specified reasons"; "(1) Subject to subsection (2), the Secretary may, by notice in writing..."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibit"; "Prohibits breach of a condition of a manufacturing licence"; "(viii) breached a condition of a manufacturing licence;"; "modalities::logic::deontic"; 1.0000; . a ; "41AA Spent convictions scheme"@en; ; "26a042a4750a2b1bf06d170e8a3c7ea9fa8618b617f178ccd724915efff5183c"; "Relieves persons from the requirement to disclose spent convictions and require persons aware of such convictions to disregard them."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.404"; . a ; ; ; ; . a ; "41AB Secretary may require information or documents"@en; ; "0ca2016bc197b39b16f90526eac02e1923fc9e38107c7fe8a65be79ed4588ddd"; "The Secretary may require a person to provide information or documents."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.404"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MAY"; "The Secretary may require the person to provide information or documents."; "modalities::logic::deontic"; 1.0000; . a ; "41AC Criminal offence for contravening a requirement in a notice"@en; ; "ef30cf0b81e2401c874c7ab17c67d338f6b72782dd25e9f6da05399b8de4cf2c"; "Failure to comply with a notice results in an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.406"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "obligation"; "Obligation to comply with a notice."; "Given a notice under section 41AB, the person must do an act."; "Failure to do so results in an offence."; "modalities::logic::deontic"; 1.0000; . a ; "41AD False or misleading information—offence"@en; ; , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.406". a ; "41AD(1) False or misleading information—offence"@en; ; "68fb03c08ec4388464058e1e49f6cd31708b56694ee5fbde63e61ed967f6e7fb"; ; "Providing false or misleading information to the Secretary is an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.406"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of providing false or misleading information."; "The person gives information to the Secretary in compliance, or purported compliance, with the notice."; "Providing false or misleading information is an offence."; "modalities::logic::deontic"; 1.0000; . a ; "41AD(2) False or misleading information—offence"@en; ; "00463da5e36b809eefe73703a5d76091f56af79e3a0b85b6081466cb894b9799"; ; "Defendant bears evidential burden in relation to the matter."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.406"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Defendant bears evidential burden."; "modalities::logic::deontic"; 1.0000; . a ; "41AD(3) False or misleading information—offence"@en; ; "1a5be959c6c9488e39376b2fca0368adff330d7c123f7c13fd0ea6fbbfb951e4"; ; "Defendant bears evidential burden in relation to matter in subsection (3)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.406"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "Obligation"; "Defendant bears evidential burden"; "modalities::logic::deontic"; 1.0000; . a ; "41AE False or misleading documents—offence"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.407". a ; "41AE(1) False or misleading documents—offence"@en; ; "edb41603b3fd0906de1fb04f347ac3b95445dc5becc7e21f67301fd8d8a5b023"; ; "Producing false or misleading documents is an offence."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.407"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits producing false or misleading documents."; "(1) A person commits an offence if..."; "...the document is produced in compliance, or purported compliance, with a notice given under section 41AB."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Obligation"; "Imposes an obligation to not produce false or misleading documents."; "(1) A person commits an offence if..."; "...the document is produced in compliance, or purported compliance, with a notice given under section 41AB."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibition"; "Prohibits knowing that the document is false or misleading."; "(a) the person produces a document to the Secretary; and"; "...the person does so knowing that the document is false or misleading;"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibition"; "Prohibits producing in compliance with a notice given under section 41AB."; "(c) the document is produced in compliance, or purported compliance, with a notice given under section 41AB."; "...the document is produced in compliance, or purported compliance, with a notice given under section 41AB."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibition"; "Imposes an obligation to not produce false or misleading documents."; "(b) the person does so knowing that the document is false or misleading;"; "...the document is produced in compliance, or purported compliance, with a notice given under section 41AB."; "modalities::logic::deontic"; 1.0000; . a ; "41AE(2) False or misleading documents—offence"@en; ; "11f701f33a6e0c4b2334d197a377629f94ed394eed38a98d95411fcc6227ab09"; ; "Defendant bears evidential burden in relation to the matter."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.407"; . a ; ; ; ; "borne by: Agent"; ; . . a ; ; "obligation"; "Defendant bears evidential burden."; "modalities::logic::deontic"; 1.0000; . . a ; ; "evidential burden"; "Defendant must provide evidence."; "modalities::epistemic"; 1.0000; . a ; "41AF False or misleading information or documents—civil penalty"@en; ; , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.408". a ; "41AF(1) False or misleading information or documents—civil penalty"@en; ; "e162c3b8ffa8130cdaa8f8e4d9e6fcfa989bec4ac616c178da9c83db44db9b28"; ; "Giving false or misleading information in compliance with a notice is prohibited."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.408"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibit"; "Prohibition of false or misleading information"; "Notice under section 41AB"; "Civil penalty for contravention"; "modalities::logic::deontic"; 1.0000; . a ; "41AF(2) False or misleading information or documents—civil penalty"@en; ; "e0ea8e1628c670cb2195f568025d16ae6aba0b036b13f64c061e8e4251979fb0"; ; "Exemption from subsection (1) for documents accompanied by a written statement"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.408"; . a ; ; ; ; ; . a ; "41AG Self-incrimination"@en; ; , , , , ; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.409". a ; "41AG(1) Self-incrimination"@en; ; "cbef972a1e2aa68b325447ce3fdda8df3a2ea2ecff8ca74d2cdd4239c0175b67"; ; "Regulations may make provision for the transfer of licences. No excuse for giving information or producing a document under a section 41AB notice"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.409"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide information or document"; "modalities::logic::deontic"; 1.0000; . a ; "41AG(2) Self-incrimination"@en; ; "dd1eb486ffe39512fe187787171a926ba6d016768f564bf75a7961b51c02b891"; ; "Self-incrimination protection for individuals in criminal proceedings. Regulations may make provision for and in relation to the making of an application, payment of a fee, assessment of an application, conditions of a licence upon transfer, and review of decisions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.409"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits admissibility of self-incrimination evidence in criminal proceedings."; "(2) However, in the case of an individual:"; "is not admissible in evidence in: (d) criminal proceedings against the individual, except proceedings under, or arising out of, section 41AD or 41AE;"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibition"; "Prohibits admissibility of self-incrimination evidence in pecuniary penalty order proceedings."; "(e) proceedings for a pecuniary penalty order against the individual for a contravention of a civil penalty provision."; "is not admissible in evidence in: (e) proceedings for a pecuniary penalty order against the individual for a contravention of a civil penalty provision."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Permission"; "Permits admissibility of self-incrimination evidence in certain proceedings."; "(d) criminal proceedings against the individual, except proceedings under, or arising out of, section 41AD or 41AE;"; "is admissible in evidence in: (d) criminal proceedings against the individual, except proceedings under, or arising out of, section 41AD or 41AE;"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Permission"; "Permits admissibility of self-incrimination evidence in certain proceedings."; "(e) proceedings for a pecuniary penalty order against the individual for a contravention of a civil penalty provision."; "is admissible in evidence in: (e) proceedings for a pecuniary penalty order against the individual for a contravention of a civil penalty provision;"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Right"; "Establishes right to self-incrimination protection."; "(2) However, in the case of an individual:"; "the information given or the document produced; or the giving of the information or the production of the document; or any information, document or thing obtained as a direct or indirect consequence of giving the information or producing the document; is not admissible in evidence in: (d) criminal proceedings against the individual, except proceedings under, or arising out of, section 41AD or 41AE;"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Undertaking"; "Establishes undertaking to protect self-incrimination."; "(2) However, in the case of an individual:"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Permit"; "Regulations may make provision for and in relation to the making of an application, payment of a fee, assessment of an application, conditions of a licence upon transfer, and review of decisions."; "modalities::logic::deontic"; 1.0000; . . a ; ; "during"; "Temporal interval"; "modalities::interval_reasoning"; 1.0000; . a ; "41AG(1) Self-incrimination"@en; ; "86ba820229c358c5e336e42a26817a09128e60d398c5ebef22bcc484fc9404fb"; ; "Regulations may make provision for the transfer of licences. No excuse for giving information or producing a document under a section 41AB notice"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.409"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Must provide information or document"; "modalities::logic::deontic"; 1.0000; . a ; "41AG(2) Self-incrimination"@en; ; "dad8d7fe1a31736697720a3c28cfaa6ef9b187bb6b8408eef6b34f944c0c3a1f"; ; "Self-incrimination protection for individuals in criminal proceedings. Regulations may make provision for and in relation to the making of an application, payment of a fee, assessment of an application, conditions of a licence upon transfer, and review of decisions."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.409"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Prohibition"; "Prohibits admissibility of self-incrimination evidence in criminal proceedings."; "(2) However, in the case of an individual:"; "is not admissible in evidence in: (d) criminal proceedings against the individual, except proceedings under, or arising out of, section 41AD or 41AE;"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Prohibition"; "Prohibits admissibility of self-incrimination evidence in pecuniary penalty order proceedings."; "(e) proceedings for a pecuniary penalty order against the individual for a contravention of a civil penalty provision."; "is not admissible in evidence in: (e) proceedings for a pecuniary penalty order against the individual for a contravention of a civil penalty provision."; "modalities::logic::deontic"; 1.0000; . . a ; ; "Permission"; "Permits admissibility of self-incrimination evidence in certain proceedings."; "(d) criminal proceedings against the individual, except proceedings under, or arising out of, section 41AD or 41AE;"; "is admissible in evidence in: (d) criminal proceedings against the individual, except proceedings under, or arising out of, section 41AD or 41AE;"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Permission"; "Permits admissibility of self-incrimination evidence in certain proceedings."; "(e) proceedings for a pecuniary penalty order against the individual for a contravention of a civil penalty provision."; "is admissible in evidence in: (e) proceedings for a pecuniary penalty order against the individual for a contravention of a civil penalty provision;"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Right"; "Establishes right to self-incrimination protection."; "(2) However, in the case of an individual:"; "the information given or the document produced; or the giving of the information or the production of the document; or any information, document or thing obtained as a direct or indirect consequence of giving the information or producing the document; is not admissible in evidence in: (d) criminal proceedings against the individual, except proceedings under, or arising out of, section 41AD or 41AE;"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Undertaking"; "Establishes undertaking to protect self-incrimination."; "(2) However, in the case of an individual:"; "modalities::logic::deontic"; 1.0000; . . a ; ; "Permit"; "Regulations may make provision for and in relation to the making of an application, payment of a fee, assessment of an application, conditions of a licence upon transfer, and review of decisions."; "modalities::logic::deontic"; 1.0000; . . a ; ; "during"; "Temporal interval"; "modalities::interval_reasoning"; 1.0000; . a ; "41AG(3) Self-incrimination"@en; ; "bfd25a533a72a1956b04bf71c90e85bb613debf83c81b1ea2c5e0c52b11def21"; ; "No self-incrimination for subsection (1) beyond what is limited by subsection (2)"; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.409"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "Obligation"; "Imposes obligation on the state"; "Subsection (2) does not limit subsection (1)"; "State must not incriminate under subsection (1)"; "modalities::logic::deontic"; 0.5000; . . a ; ; "Permission"; "Permits self-incrimination under subsection (1)"; "Subsection (2) does not limit subsection (1)"; "State may incriminate under subsection (1)"; "modalities::logic::deontic"; 0.5000; . . a ; ; "Obligation"; "Imposes obligation on the state to limit self-incrimination under subsection (1)"; "Subsection (2) does not limit subsection (1)"; "State must limit self-incrimination under subsection (1)"; "modalities::logic::deontic"; 0.5000; . a ; "41A Publication of list of manufacturers etc."@en; ; "75e00883133ed60b78187fdbe07620aef47d843d4b735ef804a87ffa57ef1c5d"; "The Secretary must publish a list of licensed persons and goods."; ; "2"; ; ; "therapeutic-goods-act-1989.pdf, p.410"; . a ; ; ; ; "borne by: State"; ; . . a ; ; "MUST"; "Obligation to publish"; "modalities::logic::deontic"; 1.0000; .