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Export of medicines

25 September 2021

Medicines must generally be registered or listed in the Australian Register of Therapeutic Goods (ARTG) before you can legally export them, unless the goods are the subject of an exemption, exclusion, approval or authority.

Medicines authorised for supply in Australia will already be in the ARTG and are permitted for export, provided you are either:

  • the person in relation to whom the medicine is included in the ARTG

OR

  • an agent authorised to act on behalf of the person in relation to whom the medicine is included in the ARTG.

For more information, refer to Export of medicines from Australia guidance.

Export Only medicines

The purpose of an Export Only medicine listing is to ensure that all products exported from Australia comply with standards that are similar to the standards applied to products supplied in Australia.

Export Only medicines must be listed in the ARTG (under section 26 of the Therapeutic Goods Act 1989) and cannot be supplied in Australia, including Australian duty free outlets.

For more information, refer to Export of medicines from Australia guidance.

Export certification for medicines

To facilitate export, the TGA issues export certification for medicines that are registered or listed in the ARTG under section 58 of the Therapeutic Goods Act 1989.

If certification is required by the importing country, the TGA can issue a Certificate of Pharmaceutical Product (CPP) or a Certificate of Listed Product (CLP).

For more information, refer to Export of medicines from Australia guidance.