Legislation

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 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

Other legislative information

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