Medicinal cannabis products (S4 and S8)

Both the Commonwealth government and the States and Territories regulate the use of medicinal cannabis. Most medicinal cannabis products are not registered by the Therapeutic Goods Administration (TGA) for supply in Australia. This means that prescribers who wish to prescribe medicinal cannabis require approval from the Commonwealth. This approval is obtained through either the Special Access Scheme – B (SAS-B) or Authorised Prescriber (AP) pathways before medicinal cannabis products can be prescribed and supplied.

Approval to prescribe through SAS-B and AP pathway are not transferable to another prescriber.

Medicinal cannabis products containing THC

Medicinal cannabis products containing tetrahydrocannabinol (THC) are Schedule 8 (S8) medicines, also known as controlled drugs. These products are limited to human use only.

S8 medicinal cannabis products include all formulations of:

cannabis
dronabinol
nabilone
nabiximols
tetrahydrocannabinols (THC) and
any other synthetically or botanically derived cannabinoids included in S8.

Medicinal products only containing CBD

Products only containing cannabidiol (CBD, the non-psychoactive cannabinoid) are Schedule 4 (S4) medicines, also known as prescription only medicines.

The Poisons Standard (external site) allows “cannabidiol only” medicinal cannabis products to also contain very low levels of THC or other cannabinoids naturally found in cannabis – up to 2 per cent of the total cannabinoid content.

Part 4 of the Monitored Medicines Prescribing Code (the Code) outlines the prescribing conditions and requirements for Schedule 8 medicinal cannabis products in WA, including the requirements to obtain written authorisation from the CEO before prescribing medicinal cannabis

Information about the role of the Commonwealth Government in providing access to medicinal cannabis is available from the Therapeutic Goods Administration (TGA, external site).

Applying for authorisation

Approval from the TGA

Except where the product is listed on the ARTG (Australian Register of Therapeutic Goods), all prescribers must be approved to prescribe medicinal cannabis through a TGA process.

Information on the TGA processes is available from Medicinal cannabis: Information for health professionals | Therapeutic Goods Administration (external site)

Authorisation to prescribe from the CEO of the Department of Health

Whether a TGA Authorised Prescriber or a prescriber applying through the TGA portal, prescribers need to obtain a patient-specific authorisation from the CEO before prescribing an S8 Medicinal Cannabis Products in the following situations:

the patient is under 18 years of age
the patient is drug dependent, oversupplied or has a history of substance use disorder for a drug of addiction in the past 5 years
the patient has a history of psychosis or other psychiatric comorbidity
the dose prescribed is greater than 40mg THC per day across all oral products and 300mg THC per day across all inhaled / vaporised products.

Application can be made:

through the TGA SAS dashboard (external site) by checking the box related to the requirement for state or territory health department applications. OR
where approval from the TGA already exists as an Authorised Prescriber complete the Application for authorisation cannabis based products form (PDF 765KB).

TGA SAS B application required

TGA SAS B application not required

General conditions for the prescribing of S8 medicinal cannabis products

Prescribers should be aware of their patient’s current prescriptions and other prescribers who may be supplying medicinal cannabis both within a clinic and from other clinics. To mitigate the risk of oversupply, prior to prescribing a S8 Medicinal Cannabis Product, the prescriber should use ScriptCheckWA to assess the prescribing history for their patient and to ensure there is no current active prescription or outstanding repeat(s).

Prescriptions for S8 medicinal cannabis products must be written for a specific product. Category authorisations are issued by both the TGA and the CEO of Health; however, prescribing by broad category is not permitted under Regulation 10 (external site). Where multiple products are prescribed, prescribers must be aware of the total dose of THC and ensure directions and / or repeat intervals support patients accessing the intended dose.

Due to the lack of bioequivalence data and the variable nature of plant-based products, substitution of products by pharmacists is not appropriate. In circumstances such as unavailability of stock, the pharmacist should contact the prescriber for approval before altering what is dispensed. Prescribers will need to supply a new prescription for the alternative product.

Compounding of any product should be limited to situations where a commercially available product is not available. Given the broad range of cannabis-based products available through the TGA scheme, compounding is generally not appropriate for cannabis-based products.

Due to the unapproved nature of medicinal cannabis products and limited information about safety and efficacy, the prescriber is strongly advised to obtain informed patient consent prior to treatment with these products, and to ensure appropriate levels of monitoring are in place. This should include advice on the risk of impaired attention and concentration impacting on the ability to drive or to operate machinery.

Medicinal cannabis products in S8 are limited to use in humans. Veterinary use is not permitted other than for S4 cannabidiol only products.

Calculating the total THC dose

Importation from overseas by health practitioners

More information

Medicines and Poisons Regulation Branch
Mailing address: PO Box 8172, Perth Business Centre, WA 6849
Phone: 9222 4424 (Monitored Medicines Prescriber Advisory Line)
Email: MPRB@health.wa.gov.au