As posted on Linked In
Indicated Legal has made a detailed submission to the TGA’s consultation on the regulation of unapproved medicinal cannabis products.
Drawing on our experience working with clients across the medicinal cannabis sector, we propose a new national framework with three core priorities:
1. A dedicated ARTG registration pathway tailored to the complexity of cannabis medicines.
2. Robust enforcement of TGO 93 and GMP standards.
3. A clear focus on prescriber education and real-world evidence to support safe and effective use.
We also raise concerns about batch consistency limits for minor cannabinoids and SAS-B approvals for vape batteries.
We do not support broad restrictions on access through the SAS-B and AP schemes without a clear, accessible pathway to maintain patient continuity of care.
It was a pleasure to work with Daniel Rathner on this submission.
We welcome continued engagement with regulators and stakeholders to help shape the future of medicinal cannabis in Australia.
