Sponsored import and supply of unregistered medicinal cannabis products – Customs (Prohibited Imports) Regulations 1956

Overview

Medicinal cannabis products are regulated as medicines in Australia. In most cases, medicines supplied in Australia must be included in the Australian Register of Therapeutic Goods (ARTG). However, certain pathways under the Therapeutic Goods Act 1989 allow access to unregistered medicinal cannabis products in specific circumstances. 

Cannabis, cannabis resin, cannabis extracts and cannabinoids are controlled imports and require an Office of Drug Control (ODC) import licence and permit before they can be imported into Australia. 

The Australian Government has supported the importation of medicinal cannabis products to help meet demand while Australia's domestic medicinal cannabis industry develops.

Approved supply pathways

Import permits may be granted for medicinal cannabis products intended for:

• the Special Access Scheme (SAS)
• the Authorised Prescriber pathway
• clinical trials
• animal studies
• laboratory or analytical testing. 

Imported medicinal cannabis products may also be subject to Therapeutic Goods Administration (TGA) standards and manufacturing requirements.

Import requirements

Before applying for an import licence, importers must demonstrate they are authorised to possess and supply medicinal cannabis products within the relevant state or territory. [odc.gov.au]

Applications should include information about:

• the medicinal cannabis products to be imported
• proposed import quantities
• the basis on which demand for the products has been determined
• relevant state or territory licences and approvals.

Importers should also ensure that the overseas exporter has obtained all necessary approvals from the exporting country's regulatory authority before applying for import permission.

Importer responsibilities

Importers may only supply medicinal cannabis products where supply is authorised through approved regulatory pathways. These include:

• Special Access Scheme (SAS)
• Authorised Prescriber approvals
• Clinical Trial Notification (CTN) or Clinical Trial Exemption (CTX) schemes
• approved medical or animal research activities
• approved export arrangements. 

Medicinal cannabis products imported for non-therapeutic purposes may only be supplied for laboratory or analytical testing. 

Storage and record keeping

Importers must store medicinal cannabis products securely and comply with relevant state and territory requirements for controlled medicines. 

Importers must also maintain records of:

• product supply
• stock holdings
• stock destruction
• losses or thefts
• the authority under which products were supplied. 

The ODC may require regular reporting on imported products, including supply and inventory records