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Medicinal cannabis: Information for sponsors and manufacturers

16 November 2021

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.

For information on how to apply for an entry on the Australian Register of Therapeutic Goods (ARTG), please refer to the Industry section of our website.

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. TGO 93 sets out requirements which together comprise the 'minimum quality standard' for all medicinal cannabis imported into and supplied or manufactured in Australia.

Sponsors are legally responsible for ensuring that their products comply with the TGO 93, and all other relevant orders. Any breach is subject to a range of regulatory compliance actions, including civil and criminal penalties under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act).

As of 22 November 2021, sponsors of unapproved medicinal cannabis products are no longer required to submit a declaration of conformity with the TGO 93. This change aims to reduce regulatory burden on the medicinal cannabis industry. Increased compliance measures will be imposed including enforcement of sponsors via the six monthly reporting requirements.

We will also continue to conduct TGO93 compliance audits, including random and targeted tested for compliance with TGO 93, including consistency with claims of the stated content of active ingredients, and presence of toxins and impurities in finished products.

Guidance to comply with standards for medicinal cannabis

Reporting requirements

Sponsor reporting obligations under the Therapeutic Goods Regulations 1990 (reg 47B)

Sponsors are reminded that they must report to the TGA every six months in relation to unapproved therapeutic goods supplied under the SAS, AP and clinical trials schemes.

Regulation 47B of the Therapeutic Goods Regulations 1990 outlines the requirement for the sponsor (importer) to submit six-monthly supply reports to the TGA listing the product (brand name) details and quantities supplied in Australia in the relevant period. Reporting periods are 1 January - 30 June (inclusive) and 1 July - 31 December (inclusive). Reports must be submitted within 1 month of the end of the relevant reporting period.

Sponsor six monthly reporting data is used to publish medicinal cannabis product details by active ingredient category. This aims to support health care professionals in prescribing and supplying medicinal cannabis products.

Reports must be provided by email to eps@health.gov.au.

Reporting side effects

We strongly encourage sponsors to report any suspected side effects related to medicinal cannabis products.

The TGA has an important role in monitoring the safety of 'unapproved' products. Reporting side effects and problems helps us to understand the safety of a product. We investigate significant safety concerns as part of ensuring product safety in the Australian community.

There are multiple ways in which adverse events and defects can be reported to the TGA (see Reporting mechanisms).

Manufacturing standards for medicinal cannabis

Australian Manufacturers

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.

Overseas manufacturers

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.

Additional information and resources