28 August 2017

There has been some media reporting that alleges the Office of Drug Control is blocking the import of medicinal cannabis products for use in the Special Access Scheme Category A.

This is incorrect

Doctors wishing to prescribe unregistered medicinal cannabis products under SAS Cat A can do so. The prescribing doctor, or the dispensing pharmacist, will need to hold an import licence under Regulation 5 of the Customs (Prohibited Imports) Regulations 1956 and seek import permission from ODC.

ODC gives one day priority processing time to all SAS Cat A import applications it receives.

Details on how to apply are here: Import and export.

There are also relevant state and territory requirements that doctors must comply with.

Since SAS Cat A became a pathway for access to medicinal cannabis products in June 2017, the Therapeutic Goods Administration has only received four notifications under the Scheme.

ODC has only received one import application, which was processed and approved within the above timeframe.

Practitioners considering prescribing an unregistered medicinal cannabis product for a patient that fits the Category A definition should be aware that they can use the other access pathway, the Special Access Scheme Category B.

Practitioners should also be aware that:

  • The Narcotic Drugs Act 1967 prevents supply of domestically manufactured, unregistered medicinal cannabis products through SAS Cat A. This product, when it becomes available, can only be used for clinical trials, or through SAS Cat B or the Authorised Prescriber Scheme or when compounded in a public hospital pharmacy.
  • The product imported under the amended import policy announced in February 2017 cannot be used under SAS Cat A. The import permissions are conditioned in accordance with the Narcotic Drugs Act.

The Office of Drug Control is obligated to follow the existing legislation. In particular, under the Customs (Prohibited Imports) Regulations, it must verify, prior to import, that the end use will be legal. This means sighting the SAS Cat A notification prior to permitting import.

Any questions about importing unregistered medicinal cannabis products under SAS Cat A, see ODC's website or contact us at dcs@health.gov.au.