Medicinal Cannabis - Information for Sponsor & Manufacturers in Australia

Australian Government: Department of Health and Aged Care, Therapeutic Goods Administration. 22 November 2022. View the Article here.

Information for sponsors and manufacturers about product quality, manufacturing standards, and reporting requirements for the supply of medicinal cannabis products.

The person or company in Australia who provides a medicinal cannabis product to the treating medical practitioner or pharmacist is considered the 'sponsor' of that product. In cases where the medicinal cannabis product is sourced from overseas, the importer may also be the sponsor of the medicine.

Supplying therapeutic goods in Australia

Include the product in the Australian Register of Therapeutic Goods (ARTG) for long term supply.

Sponsors are responsible for applying to the TGA to have their therapeutic good included in the ARTG.

Therapeutic goods must be in the ARTG before they can be lawfully supplied in, imported into, or exported from Australia (unless exempt from being entered in the ARTG, or otherwise authorised by the TGA).

Generally, it is unlawful for a sponsor to supply a therapeutic good that is not included in the ARTG. However, the Special Access Scheme (SAS) and Authorised Prescriber (AP) scheme can enable specific registered health practitioners to import and/or supply an 'unapproved' therapeutic good for a patient under their direct care.

The sponsor for an unapproved good is responsible for ensuring that an exemption, approval or authorisation under one of the SAS pathways or AP scheme is in place prior to the release of a therapeutic good.

Quality Standards for Medicinal Cannabis

Sponsors of medicinal cannabis products are legally responsible for ensuring that their products comply with the Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017- external site and all other relevant orders. TGO 93 sets out requirements, including microbiological requirements, which together comprise the 'minimum quality standard' for all medicinal cannabis imported into and supplied or manufactured in Australia.

Not meeting with these standards can result in civil and criminal penalties under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act).

Read Conforming with Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017 for guidance on how to comply with TGO 93.

Recent Changes

From 22 November 2021, sponsors of unapproved medicinal cannabis products:

• no longer need to submit a declaration of conformity with the TGO 93. This change aims to reduce regulatory burden on the medicinal cannabis industry.

We will continue to conduct random and targeted TGO93 compliance audits. This includes consistency with active ingredient content claims and presence of toxins and impurities in finished products.

Reporting Requirements

It is a legal requirement for sponsors of therapeutic goods supplied under the Special Access Scheme (SAS) and Authorised Prescriber (AP) scheme to provide six monthly reports to the TGA.

Regulation 47B of the Therapeutic Goods Regulations 1990 outlines the requirement for the sponsor to submit six-monthly supply reports to the TGA listing the product (brand name) details and quantities supplied in Australia in the relevant period.

We use sponsor six monthly reporting data to publish medicinal cannabis product details by active ingredient category. This aims to support health care professionals.

Reporting periods are:

• 1 January - 30 June (inclusive)

• 1 July - 31 December (inclusive).

Reports must be submitted within 1 month of the end of the relevant reporting period.

PDF and Word versions of the Sponsor 6 monthly reporting form.

Refer to the step-by-step guide for help completing the form.

Reporting Side Effects

We strongly encourage sponsors to report any side effects (adverse events) from medicinal cannabis products.

The TGA has an important role in monitoring the safety of therapeutic goods, including '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 community.

There are multiple ways to report adverse events and defects- external site.

Manufacturing Standards for Medicinal Cannabis

New requirements from 1 July 2023

New requirements will apply to medicinal cannabis products available for supply in Australia from 1 July 2023.

Australian manufacturers must operate in compliance with the Australian code of Good Manufacturing Practice (GMP) for medicines and be licensed by the TGA.

Overseas manufacturing of medicinal cannabis must occur on sites that comply with one of the Good Manufacturing Practice (GMP) standards and the Australian sponsor (the importer) of the medicinal cannabis product must hold evidence of GMP compliance in accordance with section 13 of the TGO 93- external site.

Labelling Requirements

TGO 93- external site sets out the labelling requirements for medicinal cannabis products. Section 15 outlines what must be included on the label to ensure the safe use of the medicinal cannabis product.

Labels should clearly differentiate between medicinal cannabis products that are based on plant material, broad spectrum extracts, full spectrum extracts and isolates (of the active ingredient). Different information is required in each case - more information is required for active ingredients that are not present as isolates.

Products must also have child-resistant packaging when there is a high risk associated with accidental ingestion.

Labelling requirements aim to help prescribers and consumers identify the goods and know how to use and store them safely.

Advertising

Advertising medicinal cannabis products to consumers is illegal.

The Act prohibits advertising to the general public for a substance or a therapeutic good containing a substance included in Schedule 4 or Schedule 8 of the Poisons Standard. Schedule 3 CBD products also cannot be advertised to consumers as they are not included in Appendix H of the Poisons Standard.

Under the Act, it is also illegal to promote medicines to consumers if they are not in the ARTG. This requirement also prohibits the advertising of most medicinal cannabis products to consumers.

For more information refer to Advertising guidance for businesses involved with medicinal cannabis products.