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The Therapeutic Goods Act 1989 & the Poisons Standard

The objective of the Therapeutic Goods Act 1989, is 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.

The Therapeutic Goods Act 1989, and Regulations and Orders set 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.

Decisions regarding the classification of drugs and poisons are set out in the Schedules of the Poisons Standard, these are then included in the relevant legislation of the States and Territories.

The Poisons Standard also includes model provisions about containers and labels, a list of products recommended to be exempt from these provisions, and recommendations about other controls on drugs and poisons.