Australia’s Therapeutic Goods Administration (TGA) has released a public consultation paper, through which it will gather feedback on experiences, observations and knowledge of the use of unapproved medicinal cannabis products.
Last week we reported the TGA would be launching a public consultation after increasing concerns in the healthcare and general community about the risks associated with such products.
The consultation paper was launched this week, focusing on whether there is sufficient regulatory oversight of unapproved medicinal cannabis products accessed legally through Australia’s Special Access Scheme (SAS) and Authorised Prescriber (AP) scheme, and their safety risks — particularly with high potency THC products.
“The TGA is not intending to remove access to medicinal cannabis products,” says the consultation paper. “Rather, we aim to ensure that products being supplied are of appropriate quality, there is confidence in the level of safety, efficacy and performance, and further evidence is being generated to support legitimate use as a therapeutic good.”
Feedback from the consultation will inform options for future amendments to a regulatory framework, but further consultation with stakeholders will be undertaken for any proposed reforms before they are implemented.
The Australian Medical Association (AMA) has welcomed the consultation.
“Clearly, the health landscape has changed dramatically in Australia, so it is vital we look at our regulatory settings and find out what needs to be done to address any gaps, including in the medicinal cannabis space,” said AMA President Dr Danielle McMullen.
The AMA is also concerned about unapproved medicinal cannabis products being prescribed at ‘alarming rates’ through direct-to-consumer telehealth models.
“Telehealth is an important mechanism to improve access to health services — but these direct-to-consumer, single-issue models lack clear referral pathways or a feedback loop to GPs and as the TGA has acknowledged, this requires much broader consideration by government,” said Dr. McMullen.
Telehealth’s impact isn’t covered in the TGA consultation as that is beyond the Administration’s scope.
Feedback can be provided using the online submission form here, and is due by 5pm on Tuesday 7 October 2025. Note that submissions will be published on the TGA’s website unless marked confidential.
