Cannabis medicines may contain only delta-9-tetrahydrocannabinol (THC) or cannabidiol (CBD), or a combination of both THC and CBD in different ratios. For information about scheduling of cannabis and tetrahydrocannabinols in the Poisons Standard, refer to the Therapeutic Goods Administration (TGA) webpage.
There are a limited number of cannabis medicines that have been formally assessed for quality, safety and efficacy, either in Australia or by an overseas medicines regulator.
Cannabis medicines registered in Australia
Nabiximols (Sativex®) is registered on the Australian Register of Therapeutic Goods (ARTG) for the treatment of moderate to severe spasticity in multiple sclerosis. It contains a 1:1 ratio of THC:CBD. It is the only cannabis medicine currently registered in Australia and is not available on the Pharmaceutical Benefits Scheme (PBS).
Approval by the Australian Government’s TGA is not required to prescribe Nabiximols (Sativex®), however a NSW Health notification is required for an authority to be issued.
Cannabis medicines registered overseas
Dronabinol is registered in the US by the Food and Drug Administration (FDA) for the treatment of anorexia in patients with AIDS, and for the management of chemotherapy-induced nausea and vomiting where standard anti-nausea treatments have failed. It is a THC only product.
Nabilone is registered in the US by the FDA for the management of chemotherapy-induced nausea and vomiting. It is a THC only product.
The US FDA, on 25 June 2018, approved Epidiolex (cannabidiol) oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy – Lennox-Gastaut syndrome and Dravet syndrome – in patients two years of age and older. It is a CBD only product.
Prescribing and supplying a cannabis medicine
The NSW Cannabis Medicines Advisory Service can provide NSW health professionals with information about cannabis medicines including formulations, dosing, potential drug interactions and cost.
The Australian Government’s Office of Drug Control (ODC) provides a list of Australian manufacturers and importers of unregistered cannabis medicines. Many cannabis medicines have already been imported to Australia and are dispatched from the importer to the pharmacist when a prescription is presented.
Unapproved medicinal cannabis imported into and supplied/manufactured in Australia must conform to Therapeutic Goods Order No. 93 (Standard for Medicinal Cannabis) (TGO 93). TGO 93 is a standard that specifies minimum quality requirements for medicinal cannabis.