The Regulation Amendment

The Poisons and Therapeutic Goods Amendment (Cannabis Medicines) Regulation 2019 commenced on 30 September 2019.

From 30 September 2019 an application to NSW Health for a Schedule 8 cannabis medicine is required where it is for:

  • prescribing or supplying to a drug dependent person*, or
  • prescribing or supplying for a clinical trial (if it is an unregistered cannabis medicine), or
  • prescribing or supplying to treat a child (aged under 16 years).

* A drug dependent person means a person who has acquired, as a result of repeated administration of any of the following drugs an overpowering desire for the continued administration of a drug of addiction (Schedule 8), or a prohibited drug within the meaning of the Drug Misuse and Trafficking Act 1985 (including but not limited to heroin, methylamphetamine or cocaine). A person treated under the Opioid Treatment Program is a drug dependent person.

NSW Authorities issued before 30 September 2019 are valid until they expire (unless they are cancelled).

Prescriptions for Schedule 8 cannabis medicines issued from 30 September 2019 do not require a NSW Authority number.

The changes described above do not affect the requirement for a Commonwealth approval to prescribe an unregistered cannabis medicine.

Details of the new requirements and how to apply to prescribe or supply a Schedule 8 cannabis medicine in NSW are available.

From 30 September 2019 there are also changes to requirements for prescribing and supplying unregistered Schedule 8 medicines other than cannabis medicines, and compounded Schedule 8 medicines.

Cannabis medicines

Cannabis medicines are products used for therapeutic purposes which are either derived from the cannabis plant, or synthetically made substances that have similar effects to the substances found in the cannabis plant called cannabinoids. There are estimated to be 104 unique, naturally occurring cannabinoids but the two that have been most extensively studied are tetrahydrocannabinol and cannabidiol. Research is being conducted on the potential uses of other cannabinoids.

Therapeutic goods, such as medicines, must be entered in the Australian Register of Therapeutic Goods (ARTG) before they can be lawfully supplied in or exported from Australia, unless exempt from being entered in the ARTG, or otherwise approved for use by the Therapeutic Goods Administration (TGA).

Most cannabis medicines available in Australia are unregistered.

Epidyolex® (cannabidiol) and Sativex® (nabiximols) are the only cannabis medicines currently registered in Australia on the Australian Register of Therapeutic Goods (ARTG). Epidyolex® is approved for adjunctive therapy of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS) for patients 2 years of age and older. Sativex® is approved for the treatment, for symptom improvement in patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy.

Other cannabis medicines that have been registered by regulators outside of Australia, but are not registered in Australia, include:

  • Marinol® (dronabinol) 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 anti-nausea treatments have failed.
  • Cesamet® (nabilone) synthetically manufactured, and registered in the US by the FDA for the management of chemotherapy-induced nausea and vomiting.

Current as at: Tuesday 30 March 2021
Contact page owner: Pharmaceutical Services