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Therapeutic Goods Act 1989 sets out the requirements for inclusion of therapeutic goods in the Australian Register of Therapeutic Goods, including advertising, labelling and product appearance. The legislation also sets out the rights of individuals to have a decision that affects them, reviewed.
Therapeutic Goods Act 1989 is designed to provide for the establishment and maintenance of a national system of controls relating to the quality, safety, timely availability and, where necessary, efficacy, of therapeutic goods that are:
- used in Australia, whether produced in Australia or elsewhere; or
- exported from Australia; and
- to provide a framework for the States and Territories to adopt a uniform approach to control the availability and accessibility, and ensure the safe handling, of poisons in Australia.
Chapter 1—Preliminary
Chapter 2—Australian Register of Therapeutic Goods
Chapter 3—Medicines and other therapeutic goods that are not medical devices
Chapter 4—Medical devices
Chapter 5—Advertising, counterfeit therapeutic goods and product tampering
Chapter 5A—Enforcement
Chapter 6—Administration
Chapter 7—Miscellaneous
Chapter 8—Repeal and transitional provisions
