Planned consultation to address growing safety concerns of unapproved medicinal cannabis products in Australia

While the consultation is open you can make a submission at our TGA consultation hub. We then review the submissions. After that the submissions and our decision will be available on the same page at the TGA consultation hub.

The Therapeutic Goods Administration (TGA) will be conducting a public consultation to gather information from stakeholders on their knowledge, experiences and observations of the use of unapproved medicinal cannabis products in Australia.

This consultation, which will commence on 11 August 2025, has been prompted by increasing public and professional concern about the safety risks associated with unapproved medicinal cannabis products, particularly those containing higher levels of tetrahydrocannabinol (THC). This concern appears to correlate with the rapid growth in the number and type of these products being used and accessed in Australia by patients. Information received will inform options for regulatory reforms to ensure appropriate regulatory oversight and market controls are in place to provide assurance of the quality and safe use of medicinal cannabis products.

The TGA seeks to understand whether current regulatory arrangements that enable patients to access medical cannabis via the Special Access Scheme (SAS) and Authorised Prescriber (AP) scheme provide adequate oversight for the more than 1000 unapproved products currently supplied in Australia. These schemes were initially designed to provide access to experimental products often used in clinical trials, or for exceptional circumstances at the discretion of the prescribing practitioner.

Access to medicinal cannabis products is governed by complex arrangements. Legal access to medicinal cannabis products is facilitated by the TGA, while prescribing and dispensing is regulated by Ahpra, the Medical Board of Australia, the Pharmacy Board of Australia, and relevant state and territory legislation.

The 3 key issues that have been raised are:

1. whether there is appropriate regulatory oversight of unapproved medicinal cannabis products being accessed via the SAS and AP schemes in Australia
2. the safety risks associated with unapproved medicinal cannabis products, particularly those products containing THC, noting there are large numbers of Australians accessing and using these products
3. the growing number of ‘product-specific’ telehealth and digital services prescribing unapproved medicinal cannabis, or other medicines, through vertically integrated direct-to-consumer business models.

As the regulator of therapeutic goods, the TGA will be consulting on matters relevant to issues 1 and 2 only.

This is a significant regulatory reform consideration, and further consultations may be required to explore detailed and specific regulatory change options.

For enquiries relating to this public consultation, please email MedicinalCannabisReforms@health.gov.au.