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Medicinal cannabis manufacture
Technical guidance on the interpretation of the PIC/S Guide to GMP
About this guidance
This guidance is for manufacturers of medicinal cannabis products. It outlines and provides information on:
- manufacturing license and certification requirements
- differences between Therapeutic Goods Administration (TGA) and Office of Drug Control (ODC) requirements
- TGA interpretation and expectations for compliance with specific sections of the current PIC/S Guide to Good Manufacturing Practice (GMP) for Medicinal Products (PIC/S Guide to GMP)
This information is provided for guidance only and has been developed on the basis of current knowledge of the subject matter. It should not be relied upon to address every aspect of the relevant legislation.
If you have further questions, or you require further clarification of a particular requirement, you can email your questions to the Manufacturing Quality Branch.
Medicinal cannabis products
In 2016 the Australian Government amended the Narcotic Drugs Act 1967 to allow the cultivation and production of cannabis for medicinal purposes.
The Narcotic Drugs Act 1967 gives effect to the United Nations Single Convention on Narcotic Drugs 1961 (the Single Convention) requirements on cultivation, production of cannabis and the manufacture of narcotic drugs. Existing supply pathways (such as those under the Therapeutic Goods Act 1989) apply to all medicinal cannabis products cultivated or manufactured under the Narcotic Drugs Act 1967.
The Narcotic Drugs Act 1967 defines 'medicinal cannabis product' to mean a product, including but not limited to, a substance, composition, preparation or mixture, that:
- includes, or is from, any part of the cannabis plant; and
- is for use for the purposes of curing, or alleviating the symptoms of, a disease, ailment or injury
The Office of Drug Control (ODC) has more general information regarding medicinal cannabis.
For medicines, biologicals and other therapeutic goods, manufacture includes, but is not limited to, any of the following:
- release for supply
Section 3 of the Therapeutic Goods Act 1989 contains a full definition.
For further information please see Manufacturing medicines.