Medicinal cannabis products by active ingredients

Unapproved medicinal cannabis products by category of active ingredients during the period 1 July to 31 December 2024

The following lists provide the details of unapproved medicinal cannabis products supplied in Australia via the Special Access Scheme and Authorised Prescriber scheme during the period 1 July to 31 December 2024. The lists are based on mandatory sponsor six monthly reporting data submitted to the TGA. Medicinal cannabis products not supplied via the Special Access Scheme or Authorised Prescriber scheme, or reports submitted by sponsors after the required reporting timeframe has ended are not included in this list.

These lists are designed to assist prescribers and pharmacists in prescribing and supplying medicinal cannabis products under the active ingredient categories. These lists should be used where TGA approval has been obtained and the prescriber requires assistance in choosing a product from the correct category, or the pharmacist wishes to ensure that the active ingredient(s) on the prescription matches the category in the TGA approval letter. Inclusion in these lists does not guarantee the product is available. The TGA is unable to provide advice in relation to specific products in these lists and recommends contacting the relevant sponsor.

Category of medicinal cannabis product

Categories of medicinal cannabis product have been determined based on proportion of cannabidiol content compared with the total cannabinoid content of the medicine.

Product Information has been self-declared by sponsors and the TGA cannot guarantee and assumes no legal liability or responsibility for the accuracy, currency, completeness or interpretation of the information. It is an offence to provide false or misleading information to a government agency.

We will be conducting routine compliance assessments as part of ongoing compliance audits.

Category 1: CBD medicinal cannabis product (CBD ≥ 98%)

Products included in Category 1:

• are Schedule 4 Prescription Only medicines as per the Poisons Standard; and
• cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and
• any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and
• the medicine contains no other active ingredients

Category 2: CBD dominant medicinal cannabis product (CBD ≥ 60% and < 98%)

Products included in Category 2:

• are Schedule 8 Controlled Drugs as per the Poisons Standard; and
• cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and
• other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and
• the medicine contains no other active ingredients

Category 3: Balanced medicinal cannabis product (CBD <60% and ≥ 40%)

Products included in Category 3:

• are Schedule 8 Controlled Drugs as per the Poisons Standard; and
• cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and
• other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and
• the medicine contains no other active ingredients

Category 4: THC dominant medicinal cannabis product (THC 60% - 98%)

Products included in Category 4:

• are Schedule 8 Controlled Drugs as per the Poisons Standard; and
• other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise 60% or more and 98% or less of the total cannabinoid content of the medicine; and
• cannabidiol derived from cannabis comprises 2% or more and less than 40% of the total cannabinoid content of the medicine; and
• the medicine contains no other active ingredients

Category 5: THC medicinal cannabis product (THC >98%)

Products included in Category 5:

• are Schedule 8 Controlled Drugs as per the Poisons Standard; and
• cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise more than 98% of the total cannabinoid content of the medicine; and
• cannabidiol comprises less than 2% less of the total cannabinoid content of the medicine; and
• the medicine contains no other active ingredients.