Medical cannabis quality crack-down
The Therapeutic Goods Administration (TGA) has announced it will be ramping up the number of quality audits it conducts on imported medical cannabis products. This will include analytical testing to assess compliance with TGO93, the quality standard for cannabis products.
TGO93 requires products to have acceptable levels of pesticides, heavy metals and contaminants. It also requires active ingredients to be no more than +/- 10% of the stated label content for formulated products and +/- 20% for herbal products.
FreshLeaf understands that until recently, the TGA has been conducting relatively few of these quality audits. This means the government has been largely relying on importers to act in good faith and ensure their products are compliant.
All importers are required to sign a declaration of TGO93 conformity, but are not technically required to do additional batch testing or on-shore analytical verification.
It is likely that many importers have simply been relying on their manufacturer or up-stream supplier to maintain quality conformity. But the legal responsibility for ensuring compliance sits with the importer who signs the declaration. So it’s the importers who will face potential civil or criminal penalties if their products are found to be in breach.
Registered importers have received letters from the TGA advising them of the upcoming ‘targeted audits’ and that, if their products are selected for review, they can expect further correspondence later in March requesting product documentation and samples for assessment.
If the products are found to be non-compliant, the most likely initial outcome would be that the offending importer is issued a formal warning and is instructed to become compliant.
Enforcement actions could escalate to product cancellations, removing non-compliant products from the Australian market entirely. If the products tested are found to be unsafe, a recall may be issued.
Depending on the severity and nature of the breach, the cooperation of the offending entity, and whether there are repeated breaches, the TGA can take actions up to and including criminal charges.
How many of the 100-odd imported products will be selected for review is unknown. Anecdotally, it seems likely that at least some of the products selected will fall short of the quality requirements.
FreshLeaf Analytics, a division of Southern Cannabis Holdings, is the leading supplier of data about the medicinal cannabis industry in Australia. We have access to medicinal cannabis product, pricing and clinical data sets from some of Australia’s leading healthcare companies and organizations including healthcare clinics, pharmacies, product suppliers and the TGA. The FreshLeaf Analytics team provides custom research, analysis and consulting services in the Medicinal Cannabis market in Australia. The FreshLeaf Analytics team can be contacted on +61 2 8203 8741 or [email protected]