Product
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).
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
In Australia, two cannabis medicines have been registered on the Australian Register of Therapeutic Goods (ARTG):
- Sativex® (nabiximols), which contains a 1:1 ratio of THC:CBD, for the treatment of moderate to severe spasticity in multiple sclerosis.
- Epidyolex®, which is a CBD only product, for the management of Dravet and Lennox-Gastaut syndromes.
Although approval by the Australian Government’s TGA is not required to prescribe Sativex® (nabiximols) or Epidyolex®, a NSW Health authority must be obtained to prescribe Schedule 8 cannabis medicines to certain patient groups. Further details can be found on the Pharmaceutical Services website.
Cannabis medicines registered overseas
Marinol® and Syndros (dronabinol) is registered in the US by the Food and Drug Administration (FDA) for the treatment of anorexia in patients with AIDS and management of chemotherapy-induced nausea and vomiting where standard anti-nausea treatments have failed. It is a synthetically manufactured, THC only product.
Cesamet® (nabilone) is registered in the US by the FDA for the management of chemotherapy-induced nausea and vomiting. It is synthetically manufactured and a THC only product.
Epidiolex® (cannabidiol) is plant-derived, and registered in the US by the FDA and in the United Kingdom by the European Medicines Agency for the management of Dravet and Lennox-Gastaut syndromes, as well as Tuberous Sclerosis Complex. It is a CBD only product.
Prescribing and supplying a cannabis medicine
The NSW Cannabis Medicines Advisory Service can provide NSW health professionals with free, evidence-based 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 cannabis medicines.