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Supply a therapeutic good

Information on how to add a medicine or medical device to the ARTG and how to legally supply different types of therapeutic goods in Australia.

Before a therapeutic good can be supplied to the Australian market, a company (referred to as the ‘sponsor' or ‘applicant') must obtain pre-market approval from the Therapeutic Goods Administration (TGA). In most cases this involves entry of the product in the Australian Register of Therapeutic Goods (ARTG).

The TGA must be satisfied that the product meets requisite standards of quality, safety and efficacy and/or performance before approval can be given. For higher risk therapeutic goods, this usually requires a rigorous scientific evaluation of data submitted by the product sponsor and uses expertise from several scientific fields.

The TGA's pre-market evaluation activities are supported by post-market monitoring and enforcement of standards, and by licensing of Australian manufacturers and verifying overseas manufacturers' compliance with the same standards as their Australian counterparts.

For more detailed information about supplying a therapeutic good and how to get started, go to Overview of supplying therapeutic goods in Australia.

You may also be interested in our SME Assist service.

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