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Legislation and legislative instruments

Find information about legislation, acts and regulations, legislative instruments and other legislative information.

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

Acts and regulations

  • Therapeutic Goods Act 1989

    Legislation
    The Therapeutic Goods Act 1989 provides for the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia.

  • Therapeutic Goods Regulations 1990

    Legislation
    These regulations provide requirements relating to the manufacturing, supply and advertising of therapeutic goods in Australia. These regulations also set out a number of important elements of the therapeutic goods regulatory scheme in Australia, including for instance specifying fees for applying for marketing approval for a therapeutic good or for a manufacturing licence, and setting out exemptions from the requirement for therapeutic goods other than medical devices to be included in the Australian Register of Therapeutic Goods (ARTG).

Legislative amendments

Legislative instruments

  • Instruments

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    Access copies of official Instruments that we refer to on this website.

  • Pharmacopoeias

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    Pharmacopoeias provide standards for pharmaceutical substances and medicinal products.

  • Product Information

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    A new form for providing Product Information (PI) has been published following recent amendments to the Act.

  • Specifications

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    Specifies kinds of therapeutic goods information relating to the importation and exportation of therapeutic goods.

  • Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021

    Legislation
    This Instrument contains the Therapeutic Goods Advertising Code. The Code specifies a range of requirements to protect the Australian public from the personal and public health risks associated with unethical, inaccurate or misleading advertising practices relating to the advertising of therapeutic goods.

  • Therapeutic Goods Groups Orders

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    Group orders document the differences that result in goods being considered separate and distinct from other goods.

  • Therapeutic goods orders

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    Therapeutic goods must comply with various standards, which determine the consistency of product quality, including label quality. Many of these standards are international standards. However, sometimes it is necessary to specify an Australian standard, either for a particular type of therapeutic good or to specify particular labelling, packaging or other requirements. In these situations a Therapeutic Goods Order (TGO) is published.

Other legislative information

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