The Therapeutic Goods Administration (TGA) have made some significant changes to the application process and access framework for unapproved medical cannabis products as of November 22, 2021.
The changes have been made to reduce the administrative burden for prescribers and pharmacists, with the goal to improve the pathways to medical cannabis for eligible patients.
These changes include:
- Allowing the submission of TGA applications by active cannabinoid ingredient, which is organised by five categories, instead of the product’s trade name
- Inclusion of certain cannabis medicines in the Authorised Prescriber Established History of Use pathway
- Medicinal cannabis sponsors will no longer need to submit a declaration of compliance with the quality standard (Therapeutic Goods Order, TGO 93) to the TGA.
Let’s take an in-depth look at these changes below.
Medicinal Cannabis Products by Active Ingredients
As of November 22, 2021, Authorised Prescriber and Special Access Scheme (SAS) submissions for unapproved medical cannabis medicines can be made by active ingredient under a category based on cannabinoid content, instead of by its trade name.
Where clinically necessary, the prescriber should include the product’s details, including the product’s trade name and specific active ingredient content in the prescription.
The TGA has provided the following five active ingredient categories for medical cannabis products. Below is an overview of these categories.
For each patient application, doctors are required to enter the category as well as the dosage form to prescribe products from any brand with the same formulation.
To see which is the most suitable category for your patient, we’ve put together some more information and examples of each category below.
TGA Categories Explained
Category 1 | CBD >98% (S4)
- CBD percentage is 98% or more
- Other cannabinoids make up 2% or less
Example: 100mg/ml. CBD = 100%
Category 2 | CBD >60% – <98% (S8)
- CBD percentage sits between 60% and 98%
- Other cannabinoids make up the remaining % (e.g. THC, CBG, CBN etc.)
Example: 1:25 formulation in a 30ml bottle = 780mg total (30mg THC : 750mg CBD). CBD = 96%. THC = 3.8%
Category 3 | CBD <60% – >40% (S8)
- CBD percentage sits between 40% and 60%
- Other cannabinoids can make up remaining % (e.g. THC, CBG, CBN etc.)
Example: 10:10 formulation in a 30ml bottle is 600mg total (300mg THC : 300mg CBD). CBD = 0%. THC = 50%
Category 4 | THC 60-98% (S8)
- CBD Percentage sits between 2% and 40%
- Percentage of other cannabinoids is between 60% to 98%
Example (oil): 20:1 formulation in a 30ml bottle is 630mg total (600mg THC : 30mg CBD). CBD = 4.7%. THC = 95%
Example (flower): 20% THC, 1% CBD (should not be less than 1% on the label for this category) in a 10g jar is 2100mg (2000mg THC : 100mg CBD). CBD = 4.7%. THC = 95%
Category 5 | THC >98% (S8)
- CBD percentage is below 2%
- Percentage of other cannabinoids is more than 98%
Example (oil) = 25:0 formulation in a 30ml bottle is 750 (750mg THC : 0mg CBD). CBD = 0%. THC = 100%
Example (flower): 20% THC (many will state on the label <1%) in a 10g jar is 2000mg total (2000mg THC : 0mg CBD). CBD = 0%. THC = 100%
In the event of a product shortage or discontinuation, this new pathway allows healthcare practitioners more flexibility when substituting brands and products.
Prescribers of medicinal cannabis can now issue a new prescription for a different product or brand within each category without the need for a new TGA approval for that product. To view how these changes will affect current prescribing, click here.
A note for pharmacists
Although Authorised Prescriber and SAS submissions for medical cannabis products can now be made by active ingredient category, it does not mean that pharmacists are able to substitute between any product included in that product category.
If patients would like to try a different brand or product form, they are still required to go back to their GP to get a new script.
Publication of medicinal cannabis products by category of active ingredient
To support healthcare professionals in supplying and prescribing medical cannabis products using the new active ingredient categories, the TGA has published a list of available medical cannabis products under each active ingredient category.
Sponsor details have also been included to facilitate patient access.
View the TGA’s list of available medical cannabis products to see which products fall under each active ingredient category and find the most suitable product for your patient.
Authorised Prescriber Established History of Use pathway (no ethics committee approval required)
Another significant update is the inclusion of specific medical cannabis products in the Authorised Prescriber ‘Established history of use’ pathway. This is for category 1, 2 and 3 medicinal cannabis products for the treatment of refractory chronic pain in adults, and for category 1 and 2 medicinal cannabis products for the treatment of refractory anxiety in adults.
When using this pathway as a healthcare professional, approval from a specialist college endorsement or a Human Research Ethics Committee (HREC) member is not required before applying to register as an Authorised Prescriber of these products.
Authorised Prescribers can prescribe the unapproved products to patients under their direct care without the need for separate approvals for individual patients. They must also report the number of patients they have treated every six months.
Use of the medicine must be reported twice yearly, covering each period between January 1 to June 30 and July 1 to December 31.
Medical cannabis sponsors will no longer need to submit a declaration of compliance
Medical cannabis product sponsors are no longer required to submit a declaration of compliance in accordance with the quality standard (Therapeutic Goods Order, TGO 93) to the TGA.
However, it is important to note that the TGA does conduct random and targeted monitoring and laboratory testing of medical cannabis products to check for compliance.
Sponsors of medical cannabis products will continue to be legally responsible for ensuring that their product(s) comply with the TGO 93 quality order and all other orders relevant to them.
Breaches of these orders are subject to compliance actions, which include criminal and civil penalties. Sponsors will also continue to be legally responsible to submit six-monthly reports on unapproved product usage.