Regulatory Framework

The regulatory framework for the supply and access of medicinal cannabis in Australia is a complex and rapidly changing area.

Legislation to enable the cultivation of cannabis for medicinal and related research purposes in Australia was passed by Parliament on 29 February 2016. The amendments relating to licensing came into effect on 30 October 2016.

A detailed regulatory framework has been put in place to enable applications for licences and permits for the cultivation, production and manufacture of medicinal cannabis products.

Cannabis grown for medicinal purposes, as well as the resulting product, is subject to stringent security and quality control measures. There are currently three types of licences relating to the supply of medicinal cannabis products available relating to cultivation, research and manufacturing.

The TGA states that medicinal cannabis is a controlled substance that is regulated to prevent diversion and illicit use. For this reason, demand and supply are linked in the regulatory process. For permits to be issued to Australian manufacturers, there needs to be communication between health professionals obtaining access for patients and medicinal cannabis manufacturers.

Therapeutics Goods Administration (TGA)

Access to Medicinal Cannabis Products 

Guidance for the use of medicinal cannabis in Australia

Medicinal Cannabis Guidance Documents

Australia Overview

The treatment of multiple sclerosis in Australia

The treatment of palliative care patients in Australia

The treatment of epilepsy in paediatric and young adult patients in Australia

For the prevention or management of nausea and vomiting in Australia

The treatment of chronic non-cancer pain in Australia

The Office of Drug Control (ODC)

ODC – Medicinal Cannabis

Legislative Framework

Narcotics Drugs Amendment Bill 2016

Therapeutic Goods Order No. 93 (The Standard for Medicinal Cannabis) – TGO 93

Poisons Standard June 2019