Information on using cannabis for medicinal and research purposes, including regulations, approvals, and requirements under Australia’s therapeutic framework.
Download Using cannabis for medicinal cannabis research and medical research
This policy has been developed to provide advice on the use of cannabis cultivated and produced under the Narcotic Drugs Act 1967 (the Act) for research purposes.
Cannabis produced under both cannabis research licences and medicinal cannabis licences can be used for research, but in simple terms:
Activities authorised under a cannabis research licence are outlined in section 9D of the Act, with additional discussion on what research cannabis produced under such licences can be used for under section 9H.
Separately, activities authorised under a medicinal cannabis licence are outlined in section 8E of the Act, with additional discussion on supplying cannabis produced under such a licence for manufacturer and research in relation to medicinal cannabis products further laid out under section 10J.
Importantly, the relationship between a medicinal cannabis licence and a manufacture licence is the aspect of the regulatory framework that allows for human therapeutic supply and subsequently precludes the use of cannabis produced under a cannabis research licence to be used in human clinical trials.
These different aspects of the regulatory framework has led to some confusion over what cannabis cultivated and produced under a cannabis research licence can be used for, what cannabis produced under a medicinal cannabis licence can be used for, and what research means in this context.
The following table outlines where cannabis produced under the various licences can be used for research.
It is important to remember that the only pure research that can be undertaken by a cannabis licence holder is by a cannabis research licence holder for horticultural and infrastructure research. All other research relating to medicinal cannabis requires the further involvement of a manufacture licence holder under the Act.
| Research activity | Cannabis research licence | Medicinal cannabis licence |
|---|---|---|
| strain development | Yes | No |
| growing conditions | Yes | No |
| Harvest, destruction, and drying processes | Yes | No |
| Physicochemical analysis1 | Yes | Yes |
| pre-clinical pharmacological research2 | Yes | Yes |
| Toxicology (in-vitro studies)2 | Yes | Yes |
| in-vivo studies (animal models)2 | Yes | Yes |
| product development (in-vitro /physicochemical)2 | Yes | Yes |
| stability assessment2 | Yes | Yes |
| Clinical trials2 | No | Yes |
Footnotes:
