The TGA has removed the conformity declaration in an attempt to “reduce (the) regulatory burden on the medicinal cannabis industry.” The tight restrictions on sponsors are one of the many pieces of red tape medical cannabis organisations and brands need to deal with to bring medical cannabis to Australians (though new regulation changes may help with this problem).
Sponsors are people or entities that supply unapproved medical cannabis products that are not included in the Australian Register of Therapeutic Goods (ARTG). Currently, the only approved medical cannabis products in ARTG are Sativex (also known as “nabiximols”) and Epidyolex.
These new changes do not mean that the TGA won’t be watching over sponsors carefully.
The TGA will still require sponsors to report back to it every six months.
If you’d like to learn more about the changes, you can attend the TGA’s webinar on Monday, November 22nd, 2021. It will run from 2 pm – 3 pm AEST (GMT+11:00), and you can register for it here. It will be hosted by Petra Bismire, the Director of the Experimental Products Section for the TGA.