In the coming months, the TGA will expand the number of quality audits of medicinal cannabis products imported or supplied under the Special Access Scheme (SAS) and other unapproved product access pathways.
Most medicinal cannabis products being supplied in Australia are ‘unapproved’, that is, they are not included in the Australian Register of Therapeutic Goods (ARTG), but they must still comply with relevant quality standards.
Currently, the TGA is approving more than 3,000 SAS applications for medicinal cannabis each month. Unlike other products accessed through the SAS, unapproved medicinal cannabis products are usually not approved or registered overseas.
It is important that consumers have confidence in the quality of medicinal cannabis products. Therefore, a larger number of these medicinal cannabis products will be tested for compliance with the Therapeutic Goods Order No. 93 (Standard for Medicinal Cannabis) (TGO 93). This includes laboratory testing to check that the medicines are consistent with the statements made in their TGO 93 declaration about cannabinoid content. Importers and suppliers of medicinal cannabis products are legally responsible for declaring and ensuring conformity with TGO 93.
While manufacturers of imported unapproved medicines are not required to undergo GMP inspections or clearances unless further steps of manufacture occur in Australia, importers or suppliers of products that do not comply with applicable standards, such as TGO 93, may be subject to a range of regulatory compliance actions, including civil and criminal penalties.
Importers and suppliers of these products must also comply with the Therapeutic Goods Advertising Code. All material with information about the goods, including the label, must therefore be truthful, balanced and not misleading, and otherwise promote safe and proper use.