TGA Enforces New Standards for Medicinal Cannabis Quality, Packaging, and Labelling

Commencing July 1, 2023, the Therapeutic Goods Administration (TGA) has instituted transformative alterations to the requirements governing the quality, packaging, and labelling of medicinal cannabis products in Australia. These comprehensive changes represent a significant shift, as they extend the application of Australian Good Manufacturing Practice (GMP) standards to imported medicinal cannabis, a change from the previous focus on domestically manufactured products.

The key modifications encompass enhancements in manufacturing quality, child-resistant packaging, labelling standards, and microbiological attributes.

A groundbreaking adjustment is the insistence that every batch of imported medicinal cannabis products adhere to an array of GMP standards equivalent to those accredited by the national authority in the country of origin. Notably, Delta 9 has consistently adhered to Australian GMP requirements and urges healthcare providers to pose the following questions to manufacturers:

• Do their products comply with the newly implemented standards?
• Where do they conduct manufacturing and packaging processes for their final products, and what necessitates this location?
• What is the stability profile of their product?

Furthermore, the TGA mandates new labelling and packaging requirements. Child-resistant packaging is now obligatory for all products, with the exception of flower-based products. Labelling will be standardised and will include essential information such as the product name, product sponsor, active ingredients, concentrations, batch numbers, and expiry dates.

Healthcare prescribers should anticipate adjustments in product labelling, especially within the Delta 9 Classic product range, to provide enhanced clarity regarding the product's composition.

The TGA has also issued a guidance note outlining the compliance requirements for TGO93, incorporating the amendments made in 2022. These changes signify a significant step towards ensuring the safety and transparency of medicinal cannabis products within the Australian market.