Legislation
The regulatory framework for therapeutic goods is made up of Acts of Parliament and a series of other subordinate legislative instruments.
The Therapeutic Goods Act 1989, 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 - external site.
If you intend to rely on any legislation referred to on this website, you should access copies of the official versions.
Our instruments are amended from time to time and may occasionally be replaced or new instruments made.
Latest alerts
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The TGA is warning consumers against taking EVE branded products that contain allylisopropylacetylurea (apronal) as they pose a significant health risk and are prohibited from sale, supply or use in Australia.
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The TGA has detected fake semaglutide, also known as Ozempic, being illegally imported into Australia.
Latest articles
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Therapeutic Goods (Technical Master File and Type II Plasma Master File - Application Form) Approval 2026
This instrument is made under subclause 2(3)(a) of Schedule 5A to the Therapeutic Goods Regulations 1990. -
Update to listed medicine ingredients in October 2026
Listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026. -
Consent relating to listed medicines that contain whole live microorganisms as an active ingredient
This consent is given under sections 14 and 14A of the Therapeutic Goods Act 1989.
Latest publications
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We commissioned the Health Design Lab to conduct market research to better understand the individual consumer, pharmacist and prescriber experiences of shortages and discontinuations.
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An overview of the Medicines Repurposing Program's purpose and history.
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Professor McMillan's Final Report on the Review of the Act was tabled in Parliament on Thursday 5 September 2019