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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Update to listed medicine ingredients in September 2024
Find out how listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 3) which commenced on 27 September 2024. -
Therapeutic Goods (Clinical Trial Notification Form) Approval 2024
This instrument is made under the Therapeutic Goods Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002. -
New quality standards for MDMA and psilocybine
Two new quality standards, one for MDMA and another for psilocybine, have been published.
Latest publications
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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
Latest guidance
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Guidance on the quality and labelling requirements of Therapeutic Goods Legislation Amendment (Standard for Therapeutic Vaping Goods) (TGO 110) Instrument 2024.
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This guidance helps sponsors and manufacturers of ‘unapproved’ therapeutic vapes understand quality and safety requirements, under the Therapeutic Goods (Medical Device Standard —Therapeutic Vaping Devices) Amendment Order 2024.
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Guidance to assist Australian corporations seeking to apply for an Australian conformity assessment body (CAB) determination for medical devices (including IVDs) by the TGA.