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Export of medicines for donation or humanitarian purposes

Therapeutic goods can be exported without being on the Australian Register of Therapeutic Goods (ARTG) if they are intended as donations or humanitarian aid, provided they have been obtained legally and they meet the criteria below.

To qualify for exemption they:

  • must not be for commercial supply;
  • must not contain a controlled substance* under the Customs (Prohibited Exports) Regulations unless an export licence and permit are held; and
  • must not be intended for clinical trials on humans.

*refer to the TGA personal import/export information <http://www.tga.gov.au/impexp/index.htm#prohibited> for examples of controlled substances.

The Australian Pharmaceutical Advisory Committee has produced a publication titled Australian Guidelines for Drug Donations to Developing Countries. You can obtain a copy by calling 02 6289 7753. The document is based on the World Health Organization (WHO) Guidelines for Drug Donations. We strongly suggest intending exporters of medicines for donation read and observe the nine articles of the guidelines.

Note: Donations should not include medicines with an expired 'use by' date. Donating medicines for which Pharmaceutical Benefits were paid is prohibited.