The Therapeutic Goods Administration (TGA) has released details of the much-anticipated changes to medicinal cannabis quality, packaging and labelling requirements which will go into effect on July 1, 2023.
Cannabiz exclusively revealed the TGA was considering reforming import quality standards in October 2020. Throughout the consultation period, issues were raised around an uneven playing field, where locally made medicinal cannabis products were required to conform to stricter quality standards than imported products.
While all products supplied in Australia must adhere to Therapeutic Goods Order 93 (TGO93), only local products were also required to be manufactured in facilities certified for compliance with Good Manufacturing Practice (GMP).
The newly announced changes incorporate GMP requirements into TGO93. Specifically, that every batch of imported products must be manufactured in facilities that meet one of a number of ‘equivalent’ GMP codes accredited by the national authority at the country of origin.
These countries include all EU member states; the UK; the US; Israel; Canada; and South Africa. This is in addition to countries which already have a mutual GMP recognition agreement in place with Australia, such as Switzerland and New Zealand, and manufacturers in other countries which have independently sought and received Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP accreditation.
Products from Canadian manufacturers that only have Good Production Practice certification, and are not certified as GMP by Health Canada or an EU member state, will no longer be permitted.
Australian sponsors of imported products will be legally responsible for ensuring their products meet these new quality standards, and will need to provide and keep evidence of this compliance for at least until the end of the shelf-life of the batch of product. The TGA will conduct random and targeted investigations to ensure sponsors are meeting their obligations.
New requirements for labelling and packaging will also go into effect from July 1, 2023. These include child-resistant packaging for all products, except flower. Cannabiz understands this is because flower products do not pose a serious risk to children if accidentally ingested.
Product labelling will be standardised to include both the name of the product and product sponsor, as well as active ingredients, concentrations, batch numbers and expiry dates. Flower products will have to specify the minimum weight per unit, and extracted products will need to specify the minimum amount of cannabis from which the product is derived.
The TGA will be holding an webinar on April 6 to explain the changes in detail, and provide information on the transition period and how importers and sponsors can comply with the new requirements.
UPDATE (March 31). The TGA has issued a guidance note on conforming with TGO93, including the 2022 amendments.