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. These instruments are amended from time to time and may, on occasions, be replaced or new instruments made.
- About the Australian therapeutic goods legislation
The Therapeutic Goods Act 1989 sets out the legal requirements for the import, export, manufacture and supply of therapeutic goods in Australia
Other legislative information
- Counterfeit semaglutide vialsThe TGA has detected fake semaglutide, also known as Ozempic, being illegally imported into Australia.
- Therapeutic Goods (Adverse Event Management System - Sponsors) (Arrangement for Computer Programs) Instrument 2023Arrangement under subsection 7C(1) of the Therapeutic Goods Act 1989
- Instrument of arrangement: Use of computer program to make decisions, July 2018Arrangement under subsection 7C(1) of the Therapeutic Goods Act 1989
- Update to listed medicine ingredients in May 2023Listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2023.
- Tabling of Report on the Review into the 2016 Medicinal Cannabis amendments to the Narcotic Drugs Act 1967Professor McMillan's Final Report on the Review of the Act was tabled in Parliament on Thursday 5 September 2019