Australia’s TGA Tinkers With Medical Cannabis

Australia’s Therapeutic Goods Administration (TGA) says changes for ‘unapproved’ medicinal cannabis products will remove some red tape and further improve patient access.

Among the changes to kick in from November 22, medicinal cannabis product sponsors will no longer be required to submit a declaration of compliance with TGO 93 to the TGA. However, the Administration warns random and targeted monitoring and testing will continue to occur.

The TGA will also accept SAS and Authorised Prescriber submissions for medicinal cannabis products by active ingredient, rather than by trade name. Categories have been created based on cannabinoid content ratio, being:

  • Category 1 – CBD ≥98%
  • Category 2 –  CBD ≥60% and <98%
  • Category 3 – CBD <60% and ≥40%
  • Category 4 – THC 60-98%
  • Category 5 – THC >98%

Products in categories 1, 2 and 3 have been included in the Authorised Prescriber ‘Established history of use’ pathway. Approval from a Human Research Ethics Committee or medical specialist college endorsement will no longer be required before submitting an application to the TGA to become an Authorised Prescriber of such products.

“To support health care professionals in prescribing and supplying medicinal cannabis products we will soon publish a list of available medicinal cannabis products and sponsor details under each of these categories,” says the TGA.

Anything cannabis regulation related in Australia can be pretty confusing, so the TGA is holding separate webinars for health care professionals and industry next week on the changes. Further information can be found here.

What’s Happening With Over The Counter Cannabidiol?

Last year, the TGA decided to down-schedule certain CBD (cannabidiol) preparations to Pharmacist Only Medicines (Schedule 3) in Australia. This means purchasing such products won’t require a prescription. Schedule 3 cannabidiol products have been legally accessible since February 1 this year, but there aren’t any yet available.

In order for products to gain Schedule 3 status, there are various hoops to be jumped through; including listing on the Australian Register of Therapeutic Goods (ARTG). None have been as S3, nor were any expected to until late this year at the earliest. But given there are only 6 weeks left in 2021m perhaps over-the-counter Schedule 3 CBD products won’t make an appearance until next year.

There is certainly no shortage of interest from cannabis companies wanting a piece of the action, so it’s more a matter of when this will happen rather than if.

On a related note, in May this year the TGA again warned of the risks in sourcing medical cannabis via illicit channels.

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