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Complementary medicines for export
ARGCM Part A: General guidance on complementary medicine regulation in Australia
Refer to Exporting medicines from Australia for commercial supply for information relating to the export of medicines from Australia.
Generally, any complementary medicine exported for commercial purposes is either:
- intended for supply in Australia as well as overseas; or
- intended exclusively for export.
Complementary medicines intended for supply in Australia as well as overseas
Complementary medicines that are:
- registered or listed (under the provisions of section 26A of the act); or
- exempt from the requirement to be on the ARTG; and
- are supplied in Australia
can automatically be exported by the sponsor or their agent, providing other applicable export legislation is complied with, for example: State poisons legislation, legislation covering trademarks, patents, wildlife protection, customs and quarantine.
Complementary medicines intended exclusively for export
Medicines solely for the purpose of export are required to be listed (not registered) on the ARTG before export is commenced. These products can be listed under section 26 of the Act (referred to as Export-only products) or under section 26A of the Act (referred to as Solely for Export products). Both type of products are exclusively for export purpose and cannot be supplied within Australia including Duty Free outlets.
Sponsors of medicines intended exclusively for export are required to submit an application using the Export Electronic Lodgement (EEL) System which is part of the TGA Business Services.