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AU: MMJ issues and regulations

Authors: Josh Hunt & Callum Twigger

Through the Narcotic Drugs Amendment Act 2016 (Cth) and its amendments to the Narcotic Drugs Act 1967 (Cth) (NDA), the Australian Government commenced the legalisation of medicinal cannabis products in Australia under federal law in 2016. The Commonwealth Parliament’s legislation is in line with a trend towards medicinal legalisation across the developed world in recognition of a growing medical consensus concerning the therapeutic role that “cannabinoids” (chemical compounds derived from plants of the genus cannabis) can play in treating disease and illness.

The production, refinement and sale of medicinal cannabis (which is typically low in the psychoactive compound tetrahydrocannabinol, otherwise known as THC) is a high-growth industry and a lucrative emerging market. Nonetheless, the authorisation process under the NDA to lawfully manufacture a medicinal cannabis product remains complex. Medicinal cannabis in Australia is regulated under a mixture of changing international, federal and state laws. Unless manufactured or sold in accordance with the NDA or state licensing regimes, cannabis remains an illegal drug in Australia.

This article provides a general introduction to the Australian medicinal cannabis product licensing and permit application regime. In particular, it considers the basic elements of an application under the NDA for a licence to produce or manufacture medicinal cannabis products. We also consider some of the issues associated with regulatory environment for medicinal cannabis in Australia.

Australia’s medicinal cannabis industry continues to flourish. Between November 2016 and 15 January 2019, the Office of Drug Control (ODC) has granted a total of 26 medicinal cannabis (cultivation and production) and 20 manufacturing licences.

Read more at cannabislaw.report

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