An Australian review of regulatory processes for the manufacturing, labelling and packaging of medical cannabis products recently kicked off.
The Therapeutic Goods Administration (TGA) is carrying out the review on behalf of the Department of Health. Potential reforms include:
- Making Good Manufacturing Practice (GMP) requirements for imported medicinal cannabis products the same as those for products manufactured in Australia.
- Improving labelling requirements for imported medicinal cannabis.
- Providing clarity in relation to the sourcing and regulation of active materials.
- Requiring child-resistant closures for products.
- Reviewing compounding exemptions for medicinal cannabis products. While not defined in therapeutic goods legislation, compounding is taken to mean preparation, mixing, assembling, altering, packaging and labelling of a medicine for a prescription. This can also include manipulating a product in a way not in accordance with the instructions of the manufacturer.
To manufacture medicinal cannabis in Australia, the following are required:
- Licences and associated permits from the Office of Drug Control (ODC).
- A GMP licence under Part 3-3 of the Therapeutic Goods Act.
- Relevant state or territory government licences or approvals.
Currently, all medicinal cannabis products imported into Australia under the various “unapproved” pathways (i.e. products not listed on the Australian Register of Therapeutic Goods) don’t need to demonstrate equivalent GMP; however, they do need to conform to TGO 93, a standard specifying minimum quality requirements for medicinal cannabis products.
For overseas manufacturers of products listed on the ARTG, GMP clearance and certification is already required.
While the proposed reforms don’t imply there are concerns with the general quality of medicinal cannabis products, this is about helping to ensure such a situation doesn’t happen.
“The overall objective is to provide greater assurance for medical practitioners and patients regarding the quality and safety of medicinal cannabis products that are imported and supplied in Australia,” says the Department of Health.
The review announcement follows a recent final decision by the TGA to make some forms of CBD available over the counter without a prescription in Australia.