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
-
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.
-
The TGA has detected fake semaglutide, also known as Ozempic, being illegally imported into Australia.
Latest articles
-
TGA statement on sunscreen labelling practices
This statement provides guidance to industry about how the Therapeutic Goods Act 1989 applies in relation to sunscreen labelling. -
The TGA releases compliance principles, reinforcing proactive and risk-based enforcement throughout 2026 and 2027
The TGA Compliance Principles 2026 and 2027 outlines our strategic approach to monitoring and enforcing regulatory compliance for the import, export, manufacture, supply and advertising of therapeutic goods in Australia. -
Therapeutic Goods (Therapeutic Vaping Goods - Supply Information Form) Approval 2025
This instrument is made under Schedule 5A to the Therapeutic Goods Regulations 1990 and Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002.
Latest publications
-
We commissioned the Health Design Lab to conduct market research to better understand the individual consumer, pharmacist and prescriber experiences of shortages and discontinuations.
-
An overview of the Medicines Repurposing Program's purpose and history.
-
Professor McMillan's Final Report on the Review of the Act was tabled in Parliament on Thursday 5 September 2019
Open consultations
-
Consultation: Proposed changes to labelling of medicines supplied in Australia
We are seeking feedback on proposed changes to Australian medicine labelling rules.