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Medicinal cannabis manufacture

Technical guidance on the interpretation of the PIC/S Guide to GMP

10 December 2019

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Import requirements

Where a product is imported, it must meet the TGA GMP requirements as well as the ODC requirements, unless exempt.

ODC requirements

Medicinal cannabis and medicinal cannabis products are regulated for import under the Customs (Prohibited Export) Regulations 1956.

These regulations are administered by ODC, more information can be found on the ODC import and export page.

TGA requirements

Information on TGA requirements regarding import can be found on the TGA website:

Importing considerations

Imported unapproved medicinal cannabis products for use through one of the access pathways schemes like SAS require an import licence and permit from the ODC.

Overseas manufacturers can obtain GMP certification following a successful on-site inspection by the TGA or via the compliance verification pathway, if applicable. See GMP clearance and certification for overseas manufacturers.

Declaration of intent to supply is requested as part of the process for certification of overseas manufacturers at the application review stage as per the Australian manufacturing licences and overseas GMP certification guidance.

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