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Legislation & legislative instruments
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
- 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 - Regulatory change: How the TGA legislation and guidelines are amended
Provides an overview of how the TG Act, the regulations and legislative instruments are amended and an idea of the timeframes
Acts & regulations
- Therapeutic Goods Act 1989
- Therapeutic Goods Regulations 1990
- Therapeutic Goods (Medical Devices) Regulations 2002
- Therapeutic Goods (Charges) Act 1989
- Therapeutic Goods (Charges) Regulations 2018
Legislative instruments
- Authorisations
- Excluded goods orders, determinations and specifications
- Groups orders
- Instruments
- Listing notices
- Manufacturing principles & guidelines
- Medical devices notices & standards orders
- Orders that goods are therapeutic goods
- Pharmacopoeias
- Product information
- Single therapeutic goods orders
- Special access scheme rules
- Specifications
- Therapeutic goods advertising code
- Therapeutic goods determinations
- Therapeutic goods orders