Source: Australian Department of Health
Most medicinal cannabis products manufactured in Australia are currently unapproved medicines, supplied to patients through either the Special Access Scheme (SAS), Authorised Prescriber Scheme (APS), or used in clinical trials .
Manufacturers of medicinal cannabis products, including dosage forms, should ensure their TGA Licence to Manufacture Therapeutic Goods includes the authorisation/s to manufacture medicinal cannabis products. Manufacturers should note that existing TGA licenses with authorisations with the Product Category of ‘Registered Therapeutic Good’ do not authorise the manufacture of medicinal cannabis products for supply as unapproved medicines, supplied under the SAS, APS & clinical trial frameworks.
Unapproved medicines, being made available to patients through the Special Access Scheme (SAS) or Authorised Prescriber Scheme should only be manufactured at a site whose licence includes the relevant dosage form/s (e.g. oil, tincture; Herb, dried), manufacturing steps (e.g. finished product manufacture, full product manufacture – excluding testing), and the product category of ‘Not Applicable’ (used for unapproved medicines). The licence should also contain a condition statement further explaining the product category e.g. ‘Medicines manufacture in the product category “Not Applicable” is restricted to therapeutic goods that are intended for export or exempt from registration and listing on the ARTG under the provisions of Section 18(1) or Section 19(1)(a) of the Therapeutics Goods Act 1989.’, or similar.
Manufacturers of medicinal products used in clinical trials should hold a licence that includes manufacturing authorisations for each dosage form with the product category ‘Therapeutic Good for Clinical Trials’.
Australian manufacturers who wish to produce medicinal cannabis products but do not hold a licence to manufacture medicinal products with the appropriate manufacturing authorisations should apply for a licence variation, prior to undertaking any manufacture of a medicinal cannabis product.
The TGA’s guidance for medicinal cannabis manufacture will be reviewed in the near future to reflect the licencing requirements and any changes that might be introduced with the adoption of version 14 of the PICS Guide to GMP.