Medicinal cannabis: Information for importers, exporters and manufacturers

This page provides an overview of what businesses involved in the importation, manufacture or supply of medicinal cannabis need to know about the regulation of medicinal cannabis.

This page includes information that is relevant to medicinal cannabis substances, including those that are intended for vaping, and including capsules, cartridges, pods and disposable vapes that contain medicinal cannabis substances that are intended for vaping.

Devices used to vape cannabis are subject to different requirements. See Medicinal cannabis vaping devices: Information for importers, exporters and manufacturers.

Supplying therapeutic goods in Australia

Inclusion on the Australian Register of Therapeutic Goods (ARTG)

Generally, it is unlawful for a sponsor to import, manufacture or supply a therapeutic good that is not included on the ARTG in Australia. The sponsor is the person who manufactures, imports or arranges for the manufacture or import of the goods. Sponsors are responsible for applying for the inclusion of therapeutics goods in the ARTG. Therapeutic goods included in the ARTG can be lawfully supplied in Australia by the sponsor. In the absence of inclusion in the ARTG, therapeutic goods must be subject to an exemption, approval or authority to be imported into, manufactured or supplied in Australia.

Registering prescription medicines on the ARTG

See our Prescription medicines hub for more information on registering prescription medicines on the ARTG.

Unapproved therapeutic goods

The Special Access Scheme (SAS) and Authorised Prescriber (AP) schemes provide approvals and authorities to specific registered health practitioners for the supply of 'unapproved' therapeutic goods to patients under their direct care.

Sponsors of unapproved therapeutic goods are responsible for ensuring that an exemption, approval, or authority is in place before supplying unapproved therapeutic goods.

Quality standards for medicinal cannabis

Sponsors of therapeutic goods that contain, or are manufactured from, any part of the cannabis plant, are legally responsible for ensuring that those goods 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) that comprise the 'minimum quality standard' for medicinal cannabis manufactured in, imported into, and supplied in Australia.

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

Read Complying with the quality requirements for medicinal cannabis for guidance on how to comply with TGO 93. TGO 93 does not apply to therapeutic goods that are or contain synthetic cannabis. However, other pharmaceutical standards apply to those goods.

The TGA conducts random and targeted TGO 93 compliance audits. These audits can include assessing accuracy of active ingredient content claims and identifying the presence of toxins and impurities in finished products.

Import licences and permits

Importers of medicinal cannabis products must hold an import licence and permit from the Office of Drug Control (ODC): Importing medicinal cannabis products into Australia - external site.

Importation requirements under the Therapeutic Goods Act

Apart from an import licence and permit being required under the Customs (Prohibited Imports) Regulations 1956, the importation of unapproved medicinal cannabis must comply with the Therapeutic Goods Act 1989.

An exemption to the requirement for registration on the ARTG allows sponsors to import medicinal cannabis, other than synthetic cannabis for vaping, to enable it to be supplied under the SAS and AP pathways. Goods that are imported under this exemption must be stored in a warehouse or properly secured area under the importer’s direct control until the goods are approved for supply to a patient under the SAS or AP schemes.

Reporting requirements

Sponsors of therapeutic goods supplied under the SAS and AP schemes must provide six-monthly reports to the TGA.

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

The TGA uses sponsor six-monthly reporting data to publish details of medicinal cannabis by active ingredient category.

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.

Please refer to the step-by-step guide for help completing the Sponsor six monthly reporting form.

Email your report to medicinal.cannabis@health.gov.au.

Reporting side effects

Sponsors are encouraged to report any side effects (adverse events) from therapeutic goods that are, or contain, medicinal cannabis.

The TGA has an important role in monitoring the safety of therapeutic goods, including 'unapproved' goods. Reporting side effects and problems helps us to understand the safety of a product. The TGA investigates 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 requirements for medicinal cannabis

Australian manufacturers must operate in compliance with the Australian Code of Good Manufacturing Practice (GMP) for medicines, and be licensed by the TGA to manufacture medicinal cannabis in Australia.

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

Unregistered medicinal cannabis products derived from the cannabis plant can be manufactured in Australia by a licensed manufacturer but must be stored in a warehouse or properly secured area under the sponsor’s direct control until the goods are approved for supply to a patient under the SAS or AP schemes.

Labelling requirements

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

Labels should clearly differentiate between medicinal cannabis 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 – i.e. more information is required for active ingredients that are not present as isolates.

Medicinal cannabis must also have child-resistant packaging to address risks 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 to consumers is illegal.

The Act prohibits public advertising of a substance, or a therapeutic good containing a substance, included in Schedule 4 or Schedule 8 to the Poisons Standard.

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

Advertising of vaping goods is prohibited unless authorised by the TGA, see Vapes: advertising and promotion.

Further help

• You should seek the services of a regulatory affairs consultant for specific advice and assistance on product development and regulatory requirements.
• Enquiries related to cultivation, production, manufacture, or the import or export of drugs should be directed to the Office of Drug Control - external site.
• SME Assist is a dedicated service that the TGA offers to help small to medium enterprises (SMEs), start-ups, and researchers developing new medicines and medical devices to understand their regulatory and legislative obligations.

Additional information and resources

• Medicinal cannabis reforms: Frequently asked questions
• Reminder: supply and advertising controls on medicinal cannabis
• Supply and wholesaling of medicinal cannabis products (MCP)
• Conforming with TGO93
• Access to medicinal cannabis: Frequently asked questions
• Medicinal cannabis reforms: Frequently asked questions
• Regulation basics
• Office of Drug Control - external site