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An overview of unapproved therapeutic goods

Information about how we regulate unapproved therapeutic goods and your obligations.

If you're planning to supply an unapproved therapeutic good in Australia, you must understand how we regulate unapproved therapeutic goods and what your obligations are under the supply pathways. 

Before supplying unapproved therapeutic goods, you are responsible for ensuring that an exemption, approval, or authority is in place. 

Being well-prepared helps ensure lawful supply and avoids regulatory delays. 

Start be reviewing your responsibilities and selecting the appropriate supply pathway. 

You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to unapproved therapeutic goods. You may also have to meet obligations that apply to all products.

General information

Learn about how products are regulated.

Definitions and classification

Understand how products are defined and classified.

  • Is my product a therapeutic good?

    Decision tree
    Use this decision tree to work out if the product you want to sell or supply in Australia is a therapeutic good.

  • What are 'therapeutic goods'?

    Page
    Therapeutic goods can comprise a broad range of things, such as bandages, pregnancy testing kits, herbal remedies, tissue grafts and paracetamol.

Ingredients and scheduling

Get information about ingredient approvals and scheduling requirements.

  • Scheduling of medicines & poisons

    Page
    Links to and information on scheduling and the Poisons Standard including public notices, state and territory information, the scheduling advisory committees and proposed committee meeting dates and decision timeframes.

Legislation, Acts and Orders

Review the laws and legal orders that regulate therapeutic goods.

  • 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 (Declared Goods) Order 2019

    Legislation
    This Order clarifies whether specified goods or classes of goods are therapeutic goods according to the terms of the definition of 'therapeutic goods' in the Therapeutic Goods Act 1989.

  • 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).
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