Medicinal cannabis is subject to the Therapeutic Goods Act 1989 as well as the Narcotic Drugs Act 1967, which are administered by the Australian Government Department of Health (through the Therapeutic Goods Administration and Office of Drug Control respectively). State and Territory health departments also have requirements regarding how controlled substances, including medicinal cannabis, may be authorised for use in their jurisdictions.
If you want to become involved in the manufacture of medicinal cannabis, you should ensure that you have the relevant:
- approvals
- licences or GMP certification or clearance
- permits under each of the relevant legislative frameworks.
This includes relevant state or territory government licences or approvals.
You must consider:
- a manufacturing licence under the Therapeutic Goods Act 1989 (if the manufacturer resides in Australia) or GMP certification or clearance (if the manufacturer resides overseas)
- a manufacturing and cultivation licence and associated permits under the Narcotic Drugs Act 1967.
- relevant state or territory government licences or approvals.
Guidance and resources
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GuidanceGuidance on specific criteria and paperwork required for submission to the TGA to ensure conformance with TGO 93.