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Consultation: Potential reforms to medicinal cannabis manufacturing, labelling and packing requirement

18 December 2020

This consultation closed on 29 January 2021.

The TGA administers the Therapeutic Goods Act 1989. The Therapeutic Goods Act establishes a national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods in Australia. The general rule is that therapeutic goods must be included in the Australian Register of Therapeutic Goods (ARTG) or otherwise subject to an exemption, approval or authority before those goods may be lawfully supplied in, imported into, or exported from Australia.

The TGA is looking at potential reforms principally intended to enhance the quality and safety of medicinal cannabis products by introducing equivalent GMP requirements for imported medicinal cannabis products to those that are domestically manufactured, introducing labelling requirements for imported medicinal cannabis, clarifying certain matters in the applicable standard, and requiring child-resistant closures to be used on products. Also the potential reforms would include removing extemporaneously compounding exemptions for medicinal cannabis products.

The objective would be 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, and further clarifications regarding active ingredients, labelling and packaging matters. in the interest of quality and public safety.

We invite you to review the consultation paper and provide a response using the response template, accessible through our Consultation Hub.