Medicinal cannabis scheme license applications open in Australia

31 October 2016

Businesses in Australia can now apply for a license to cultivate cannabis for medicinal purposes, to manufacture medicinal cannabis products or to conduct medicinal cannabis related research under the Medicinal Cannabis Scheme.

Australia’s Minister for Health, Sussan Ley, said today that the commencement of the Narcotic Drugs Amendment Act 2016 will give patients and doctors access to a safe, reliable and legal source of cannabis for medicinal use.

“It is important that doctors have a wider range of options for treating their patients,” Minister Ley said, adding: “Until now, it has been difficult for patients to access medicinal cannabis products from overseas sources. These new laws change that situation by providing for a domestic supply of medicinal cannabis products that are not readily available for import. However, I want to emphasize that the changes to the Narcotic Drugs Act do not decriminalize cannabis for recreational use.”

The Medicinal Cannabis Scheme is the result of extensive consultation between the federal government and state and territory authorities in the development of regulatory regulations and security protocols for the cultivation, production and manufacture of medicinal cannabis.

The Office of Drug Control, within the Department of Health, regulates the medicinal cannabis framework and those interested in applying for a licence can find detailed information at the Office of Drug Control website.

Background:

Medicinal Cannabis products are therapeutic goods, which means they must be supplied in accordance with the provisions of the Therapeutic Goods Act 1989, either as registered goods, which are assessed for safety, quality and efficacy, or as unregistered goods through either the Special Access Scheme or Authorised Prescriber Schemes. Unregistered medicines are not assessed for efficacy by the Therapeutic Goods Administration (TGA).
Therapeutic goods must also comply with relevant state/territory drug and poisons legislation. States and territories are responsible for the distribution of therapeutic goods through pharmacies and it is expected that, for the most part, medicinal cannabis products will be distributed in accordance with existing legislation. Queensland and Victoria have, however, enacted special legislation dealing with this.
The Commonwealth will be responsible for licensing cultivation of cannabis for medicinal purposes and for manufacturing into medicinal cannabis products. To hold a licence, licensees must pass strict fit and proper persons requirements and other legislative tests relating to security.
Access to medicinal cannabis products will be on prescription from an appropriately qualified medical practitioner is approved by the state/territory to prescribe these products and has the appropriate TGA approvals.

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