The Therapeutic Goods Act, Regulations and Orders set out the requirements for inclusion of therapeutic goods in the Australian Register of Therapeutic Goods, including advertising, labelling, product appearance and appeal guidelines.
Some provisions such as the scheduling of substances and the safe storage of therapeutic goods, are covered by the relevant State or Territory legislation.
Australian legislation in full text is available from the Attorney General's Federal Register of Legislation.
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.
About legislation
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PageLegal requirements for the import, export, manufacture and supply of therapeutic goods in Australia.
Acts and regulations
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LegislationThe Therapeutic Goods Act 1989 provides for the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia.
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LegislationThese regulations provide requirements relating to the manufacturing, supply and advertising of therapeutic goods in Australia. These regulations also set out a number of important elements of the therapeutic goods regulatory scheme in Australia, including for instance specifying fees for applying for marketing approval for a therapeutic good or for a manufacturing licence, and setting out exemptions from the requirement for therapeutic goods other than medical devices to be included in the Australian Register of Therapeutic Goods (ARTG).
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LegislationTo read the full text, visit the Federal Register of Legislation.
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LegislationTo read the full text, visit the Federal Register of Legislation.
Legislative amendments
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PageThe Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 was approved by the Executive Council on 23 November and was registered on the Federal Register of Legislation on 27 November 2023.
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PageThe Therapeutic Goods Amendment (2022 Measures No. 1) Act 2023 (the Amendment Act) was passed by both Houses of Parliament on 9 March 2023
Legislative instruments
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PageTherapeutic Goods (Excluded Goods) determinations and specifications.
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PageTherapeutic Goods (Manufacturing Principles) Determination 2024.
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PageIf you intend to rely on any legislation referred to on this website, you should access copies of the official versions
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PagePharmacopoeias provide standards for pharmaceutical substances and medicinal products.
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PageYou can access unapproved therapeutic goods in certain circumstances. Find out who can apply, what you can access and what to do before you apply.
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PageA new form for providing Product Information (PI) has been published following recent amendments to the Act.
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PageSpecifies kinds of therapeutic goods information relating to the importation and exportation of therapeutic goods.
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LegislationThis Instrument contains the Therapeutic Goods Advertising Code. The Code specifies a range of requirements to protect the Australian public from the personal and public health risks associated with unethical, inaccurate or misleading advertising practices relating to the advertising of therapeutic goods.
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PageGroup orders document the differences that result in goods being considered separate and distinct from other goods.
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PageTherapeutic goods must comply with various standards, which determine the consistency of product quality, including label quality. Many of these standards are international standards. However, sometimes it is necessary to specify an Australian standard, either for a particular type of therapeutic good or to specify particular labelling, packaging or other requirements. In these situations a Therapeutic Goods Order (TGO) is published.
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Regulatory decision noticesThis Order revokes Therapeutic Goods (Groups) Order No. 1 of 1991.
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PageThis instrument is made for the purposes of paragraphs 42DL(9)(b) and 42DLB(6)(b) of the Therapeutic Goods Act 1989.
Other legislative information
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GuidanceGuidance for industry organisations applying to add a medicine to the Australian Register of Therapeutic Goods (ARTG).
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PageThe Poisons Standard consists of decisions regarding the classification of medicines and poisons into Schedules for inclusion in the relevant legislation of the States and Territories.
Product types
- Biologicals
- Faecal microbiota transplant products
- Human cell and tissue products
- Medical devices
- Implantable devices
- In vitro diagnostic devices
- Personal protective equipment
- Software and artificial intelligence
- System and procedure packs
- Medicines
- Assessed listed medicines
- Listed medicines
- Over-the-counter medicines
- Prescription medicines
- Registered complementary medicines
- Therapeutic sunscreens
- Other therapeutic goods
- Disinfectants and sterilants
- Tampons and menstrual cups
- Unapproved therapeutic goods
- MDMA and psilocybine
- Medicinal cannabis
- Boundary and combination products
Topics