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Medicinal cannabis: Information for sponsors and manufacturers
The person or company in Australia who provides the unapproved medicinal cannabis product to the treating medical practitioner or pharmacist is considered the sponsor of that product in Australia. In cases where the medicinal cannabis product is sourced from overseas, the sponsor may also be the importer of the medicine.
General information for sponsors is available through the Role of the sponsor web page.
Product quality standards for medicinal cannabis
Sponsors of medicinal cannabis products must ensure that their products comply with all applicable quality standards. There are various standards that may apply to medicinal cannabis products, including Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017 and Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018.
Manufacturing standards for medicinal cannabis
Under the Therapeutic Goods Act 1989 Australian medicines manufacturers are required to obtain a licence to manufacture medicinal cannabis products (sometimes referred to as GMP licence) unless exempted in Schedule 7 or Schedule 8 of the Therapeutic Goods Regulations 1990. This requirement applies to products that are on the ARTG and unapproved products that may be accessed through the available pathways (Authorised prescriber, special access scheme, clinical trials) for medicinal cannabis products. The applicable standard for medicines manufacture is the Code of GMP. We have published specific guidance on GMP compliance for the manufacture of medicinal cannabis products that applies to unapproved products supplied under 'approved access' provisions.
Products registered on the ARTG
The TGA uses internationally harmonised manufacturing standards to allow manufacturers to operate in an international environment. For medicinal cannabis products intended to be registered on the ARTG that involve an overseas manufacturer, evidence of acceptable GMP in the form of a GMP clearance will be required for each of the overseas manufacturing sites before the goods can be registered. A GMP clearance is only issued if robust evidence is provided to demonstrate that the medicinal cannabis product has been manufactured in accordance with the Code of GMP (or an equivalent manufacturing standard). For more information on how to obtain a GMP clearance please see GMP clearance for overseas manufacturers.
Products not on the ARTG
For medicinal cannabis products intended to be supplied through the available unapproved medicine access pathways that involve an overseas manufacturer, the medicinal cannabis product must be manufactured in accordance with an acceptable manufacturing standard.
TGA provides the following guiding principles to sponsors to assist them in determining what would typically constitute an acceptable manufacturing standard for medicinal products supplied through unapproved access scheme:
- The country in which manufacture of the product occurs has active oversight of medicinal cannabis products and holds them to its own manufacturing standards.
- The product is supplied to patients in the country of its manufacture; and is not manufactured solely for export to other markets.
The countries that demonstrate compliance the above principles currently include Canada, Germany, the Netherlands, Switzerland and Israel.
Sponsors of medicinal cannabis products must ensure compliance with all other applicable manufacturing standards in addition to TGO93 and TGO100.