Legislation and 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

Acts and 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 amendments

• Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023
• Therapeutic Goods Amendment (2022 Measures No. 1) Act 2023 (March 2023)

Legislative instruments

• Declared goods orders
• Excluded goods orders, determinations and specifications
• Instruments
• Manufacturing principles and guidelines
• Medical device notices and standards orders
• Notices
• Pharmacopoeias
• Prescribe an unapproved therapeutic good (health practitioners)
• Product Information
• Specifications
• Therapeutic Goods advertising code
• Therapeutic Goods determinations
• Therapeutic Goods Groups Orders
• Therapeutic Goods Orders
• Therapeutic Goods (Single Therapeutic Goods) Order No 1 of 1991
• Therapeutic Goods (TGA Assessed Claim) Authorisation 2020

Other legislative information

• Compliance with ministerial and default standards
• The Poisons Standard (the SUSMP)