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.
Overview
Stakeholders have raised concerns about the safety risks associated with the use of certain unapproved medicinal cannabis products. Further, questions are being raised about the appropriateness of the current regulatory oversight of these products being accessed through the TGA’s Special Access Scheme (SAS) and Authorised Prescriber (AP) scheme.
Review of the safety and regulatory oversight of unapproved medicinal cannabis products
The TGA supports the call for a review of the safety and regulatory framework for medicinal cannabis products. As such, we are seeking stakeholder input on their experiences, observations and knowledge of the use of unapproved medicinal cannabis products to inform our considerations for future regulatory reform. Submissions must be received by 11:59pm on 7 October 2025.
Submissions should be provided through the consultation hub.
Consultation document
Consultation: Reviewing the safety and regulatory oversight of unapproved medicinal cannabis products is available on the consultation hub.
We aim to provide documents in an accessible format. If you're having problems using this document, please contact medicinalcannabisreforms@health.gov.au.
Contents
- Information about this consultation
- Purpose and Scope
- Consultation Process
- How to provide feedback
- Background
- Current concerns with unapproved medicinal cannabis products
- Emerging safety concerns with medicinal cannabis products
- Risks with certain dosage forms
- Risks with high concentrations of medicinal cannabis components
- We are seeking your input to inform future regulatory reform