Generally, medicines prescribed in Australia must be assessed by the Australian Government’s Therapeutic Goods Administration (TGA) for quality, safety and efficacy, and registered on the Australian Register of Therapeutic Goods (ARTG). They must be legally produced, meaning the product will be either supplied by wholesale and/or imported from a legal supply source overseas according to the Customs (Prohibited Imports) Regulations 1956, or, in due course, lawfully produced and manufactured in Australia under the amended Narcotic Drugs Act 1967.
Formally registered cannabis medicines
There are four cannabis medicines that have been formally assessed for quality, safety and efficacy, either in Australia or by an overseas medicines regulator. These include the following:
- Sativex® (nabiximols) is registered in Australia by the TGA on the ARTG for the treatment of moderate to severe spasticity associated with multiple sclerosis. It is the only cannabis medicine currently registered in Australia on the ARTG.
- Marinol® (dronabinol) is synthetically manufactured and 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 antinausea treatments have failed.
- Cesamet® (nabilone) is synthetically manufactured and registered in the US by the FDA for the management of chemotherapyinduced nausea and vomiting.
- Epidiolex® (cannabidiol) is plant-derived, and registered in the US by the FDA for the management of Dravet and Lennox-Gastaut syndromes.
Applications to prescribe are not limited to the small number of medicines that have been formally registered here or overseas. Potential access and importation of these products (if necessary) can be discussed with your doctor.