If you intend to rely on any legislation referred to on this website, you should access copies of the official versions. These instruments are amended from time to time and may, on occasions, be replaced or new instruments made.
Biologicals
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LegislationThis Instrument specifies whether certain things are or are not biologicals for the purposes of the Therapeutic Goods Act 1989.
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LegislationThis Determination specifies the information that must accompany an application to include a therapeutic good that is a biological in the Australian Register of Therapeutic Goods (ARTG).
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LegislationThis Determination sets out standard conditions for the inclusion of biologicals in the Australian Register of Therapeutic Goods (ARTG).
Blood and tissues
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LegislationThis Determination specifies goods that are excluded from regulation for the purposes of the Therapeutic Goods Act 1989.
Complementary medicines
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LegislationThis Specification provides what information must accompany an application to register complementary medicines on the Australian Register of Therapeutic Goods (ARTG).
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LegislationThis Determination specifies what information must accompany applications to list complementary medicines on the Australian Register of Therapeutic Goods (ARTG).
Conditions of listing
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LegislationThis Determination sets out conditions for listing specified listed medicines on the Australian Register of Therapeutic Goods (ARTG).
Excluded goods
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PageTherapeutic Goods (Excluded Goods) determinations and specifications.
Manufacturing
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PageTherapeutic Goods (Manufacturing Principles) Determination 2024.
Medical Devices
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LegislationThis Specification facilitates the public release of therapeutic goods information that has been provided to the TGA by a sponsor in an Online Notification Form that relates to the transition of a medical device from certain European Directives to the new EU medical devices regulation.
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LegislationThese Rules specify circumstances in which a health practitioner is authorised to supply specified medical devices which are not included in the Australian Register of Therapeutic Goods (ARTG), under the TGA's Special Access Scheme category C pathway.
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LegislationThis Specification specifies kinds of medical devices that cannot be approved for marketing in Australia if they are intended to be used exclusively for one or more specified purposes.
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LegislationTo read the full text, visit the Federal Register of Legislation.
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LegislationThis Instrument amends the Therapeutic Goods (Medical Devices—Specified Articles) Instrument 2020 to specify certain articles and components for use in the manufacture of therapeutic vaping devices or their accessories that are medical devices for the purposes of the Therapeutic Goods Act 1989.
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LegislationThis Instrument specifies certain classes of articles that are considered medical devices for the purposes of the Therapeutic Goods Act 1989.
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LegislationThis Determination specifies the information that must accompany an application to include a medical device in the Australian Register of Therapeutic Goods (ARTG).
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LegislationThis Determination sets out overseas bodies which are overseas regulators of medical devices for the purposes of the Therapeutic Goods Act 1989.
Medicine shortages
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LegislationThis Determination specifies medicines which are reportable medicines for the purposes of the Therapeutic Goods Act 1989.
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LegislationThis Determination sets out the list of reportable medicines which forms the Medicines Watch List under s 30EJ(1) of the Therapeutic Goods Act 1989.
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LegislationSpecifies the foreign countries in which registration or approval for general marketing of specified therapeutic goods in at least one of those countries is a prerequisite for the purposes of subparagraph 19A(1)(b)(i) of the Therapeutic Goods Act 1989
Medicines watch list
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LegislationThis Determination sets out the list of reportable medicines which forms the Medicines Watch List under s 30EJ(1) of the Therapeutic Goods Act 1989.
OTC medicines
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LegislationThis Determination specifies the information that must accompany an application to register an over the counter medicine on the Australian Register of Therapeutic Goods (ARTG).
Overseas regulators
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LegislationThis Determination sets out overseas bodies which are overseas regulators of medical devices for the purposes of the Therapeutic Goods Act 1989.
Permissible indications
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NoticesListed medicines indications and requirements for their use have been updated in the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025.
Permissible ingredients
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LegislationThis Determination sets out a list of ingredients which have been assessed or otherwise considered to be safe for use in medicines that are listed in the Australian Register of Therapeutic Goods (ARTG) (including assessed listed medicines), and associated requirements to be followed when using particular ingredients in such medicines.
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LegislationThis Determination specifies the kind of information that must accompany an application for a recommendation by the Secretary that the Minister vary a section 26BB determination made under the Therapeutic Goods Act 1989.
Prescription medicines
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LegislationThis Determination specifies the information that must accompany an application to register a prescription medicine on the Australian Register of Therapeutic Goods (ARTG).
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LegislationThis Determination specifies the approved format for an application dossier accompanying an application for registration of a prescription medicine on the Australian Register of Therapeutic Goods (ARTG).
Pharmacopoeias
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LegislationThis Determination is made under section 3C of the Therapeutic Goods Act 1989. Its purpose is to exempt certain statements found in specific monographs from the British Pharmacopoeia, the European Pharmacopoeia or the United States Pharmacopoeia-National Formulary, from being treated as legal ‘standards’ for particular therapeutic goods in Australia.
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LegislationThis Determination exempts certain statements in monograph 3053 for Live Biotherapeutic Products for Human Use of both the British Pharmacopoeia (BP) and European Pharmacopoeia (EP) for particular therapeutic goods, under subsection 3C(2) of the Therapeutic Goods Act 1989.
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PagePharmacopoeias provide standards for pharmaceutical substances and medicinal products.
Reportable medicines
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LegislationThis Determination specifies medicines which are reportable medicines for the purposes of the Therapeutic Goods Act 1989.
Specified foreign countries and jurisdictions under subregulation 16DA(3)
Specified foreign countries under section 19A(3)
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LegislationSpecifies the foreign countries in which registration or approval for general marketing of specified therapeutic goods in at least one of those countries is a prerequisite for the purposes of subparagraph 19A(1)(b)(i) of the Therapeutic Goods Act 1989
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