To export therapeutic goods from Australia, you must meet requirements set out in the therapeutic goods legislation, in addition to other Commonwealth and State or Territory legislation. Export regulation supports the development and manufacture of Australian therapeutic goods and ensures that goods leaving Australia meet appropriate safety and quality standards to support public health.
Medicines
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PageTo export medicines from Australia, you must meet requirements set out in the Australian therapeutic goods legislation
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GuidanceThis guidance is to assist entities and individuals planning to export medicines (including prescription, over-the-counter (OTC) and complementary medicines) either for commercial supply, or for non-commercial purposes (for example, for a family member or friend).
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FormsForm to apply to add an export name to a product registered in the ARTG.
Medical devices
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PageTo export medical devices, including in-vitro diagnostic medical devices (IVDs) and Other Therapeutic Goods (OTGs), you must meet requirements set out in the Australian therapeutic goods legislation.
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GuidanceThis guidance is to assist you to apply for a Certificate of Free Sale or an Export Certificate for medical devices, including in-vitro diagnostic medical devices (IVDs) and Other Therapeutic Goods (OTGs).
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FormsApply for a Certificate of Free Sale or an Export Certificate for a medical device.
Human substances
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Reference materialHow to apply for a permit to export human substances under the Customs (Prohibited Exports) Regulations 1958.
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FormsUse these forms to apply for a permit to export human substances from Australia
More information
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PageGuidance material about exporting therapeutic goods from Australia that aligns with current legislation, policy and business operations.
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