Australia – Testing of medicinal cannabis products being supplied via SAS in Australia

Medicinal cannabis products are products intended for therapeutic use that contain or are derived from any part of the Cannabis plant. They generally contain the components cannabidiol (CBD) and/or tetrahydrocannabinol (THC) or their corresponding acids.

Medicinal cannabis products are permitted to be supplied into Australia under the Special Access Scheme (SAS), Authorised Prescriber scheme, and clinical trial schemes. Products supplied under these schemes are required to comply with Therapeutic Goods Order No. 93 (Standard for Medicinal Cannabis) (TGO93). In particular, Section 12(2) specifies the following assay limits:

  • in relation to a medicinal cannabis product in herbal final form – the average content of each active ingredient, together with any corresponding acid, in a representative sample of the product must be not less than 80.0 per cent and not more than 120.0 per cent of the stated content of that active ingredient
  • in relation to a medicinal cannabis product in tablet or capsule form, where that product is not included on the Australian Register of Therapeutic Goods (ARTG) – the average content of each active ingredient, together with any corresponding acid, in a pooled sample of not fewer than 20 tablets or capsules must be not less than 90.0 per cent and not more than 110.0 per cent of the stated content of that active ingredient
  • in relation to a medicinal cannabis product in any other dosage form – the average content of each active ingredient, together with any corresponding acid, in a representative sample of the product must be not less than 90.0 per cent and not more than 110.0 per cent of the stated content of that active ingredient…