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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 Department's ComLaw website (incorporating the Federal Register of Legislative Instruments (FRLI)). For details on how to obtain hardcopies of the Acts and Regulations see the Government Publications Register.

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 & regulations

• Therapeutic Goods Act 1989
• Therapeutic Goods Regulations 1990
• Therapeutic Goods (Medical Devices) Regulations 2002
• Therapeutic Goods (Charges) Act 1989
• Therapeutic Goods (Charges) Regulations 1990

Legislative instruments

• Excluded goods orders
• Groups orders
• Listing notices
• Manufacturing principles & guidelines
• Medical devices notices & standards orders
• Orders that goods are therapeutic goods
• Pharmacopoeias
• Product information
• Section 23 instruments
• Single therapeutic goods orders
• Therapeutic goods advertising code
• Therapeutic goods determinations
• Therapeutic goods information specifications
• Therapeutic goods orders

Other legislative information

• Compliance with ministerial and default standards
• The Therapeutic Goods Act 1989 & the Poisons Standard