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Export of medicines from Australia

24 September 2021
Download Export of medicines from Australia

Description

About this guidance

This guidance is to assist entities and individuals planning to export medicines (including prescription, over-the-counter and complementary medicines) either for commercial supply, or for non-commercial purposes (for example, for a family member or friend).

To export medicines you must meet certain regulatory requirements set out in Australia’s therapeutic goods legislation, in addition to other relevant Commonwealth and state or territory legislation. Criminal and civil penalties may apply if you do not meet these legal requirements.

The guidance replaces all previous guidance about the export of medicines from Australia. We will review and update this guidance in line with future feedback and potential legislative and policy changes in the coming months.

The guidance provides information about:

  • export regulation
  • exporting medicines for commercial supply, including:
    • Export Only medicines
    • exporting medicines that are authorised for sale in Australia
    • export certification for medicines
  • non-commercial export.

Before you export a medicine for any reason, make sure you understand the requirements set out in this guidance.

If you have any feedback or would like more information please contact Exports.

  • About this guidance
  • Export regulation
    • Controlled substances
    • Other legislation applicable to export
  • Exporting medicines for commercial supply
    • ARTG registration or listing is required before export
    • Who can export medicines for commercial supply
  • Export Only medicines
    • Assessment criteria
    • Applying for a new Export Only listing
  • Changing an existing Export Only listing
  • Export of medicines authorised for supply in Australia
    • Any change must be approved before export
    • Changes that result in a separate and distinct good
    • Exporting medicinal cannabis
    • Export of unapproved medicines
  • Export certification for medicines
    • Australia's medicine export certification process
    • Before submitting your certificate application
    • Application process
    • Applications that do not meet requirements
    • Applications put on hold
    • Receiving your certificates
  • Non-commercial export
    • Exporting for personal use, family or friends
    • Exporting medicines for donation

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