Information about medicinal cannabis for prescribers in Tasmania

Regulation of medicinal cannabis products follows the same regulatory process as for all other medicines and includes both Commonwealth and State legislation and frameworks.

• Medicinal cannabis products are scheduled in the Commonwealth Poisons Standard.
• Applicable controls depending on the product schedule are applied in Tasmania under the Poisons Act 1971 and Poisons Regulations 2018.
• Most medicines prescribed in Australia have been approved by the Therapeutic Goods Administration (TGA) for inclusion on the Australian Register of Therapeutic Goods (ARTG). 
• Medicines are only included on the ARTG when the TGA is satisfied with the medicine’s evidence of quality, safety and efficacy.  
• Medicines that the TGA has either not assessed, or that have insufficient evidence of quality, safety and efficacy are known as ‘unregistered’ medicines.

In Tasmania, as a registered medical practitioner you can prescribe an unregistered medicinal cannabis product to a patient if you:

• believe it is clinically appropriate
• have obtained all required Commonwealth approvals and State authorisations
• are present and practicing in Tasmania when issuing the prescription for Schedule 8 products.

Visit the following websites for more information:

• Commonwealth Office of Drug Control (ODC)
• Commonwealth Therapeutic Goods Administration (TGA)
• TGA Special Access Scheme and Authorised Prescriber online application

What approvals are required?

Prescribing medicinal cannabis follows the same regulatory process as for all other medicines.

• If a Schedule 4 or Schedule 8 medicinal cannabis product is not registered in the ARTG it cannot legally be supplied in Australia, unless approval has been gained under either the Special Access Scheme (SAS) or Authorised Prescriber (AP) Scheme as administered by the TGA.
• An authorisation under Section 59E of the Tasmanian Poisons Act 1971 is required prior to issuing a prescription for a Schedule 8 medicinal cannabis product. Section 59E authorisation is required for each individual patient.
• No authorisation under the Poisons Act 1971 is required to prescribe a Schedule 4 medicinal cannabis product.

Product type	Commonwealth approval (SAS or AP scheme)	Tasmanian authorisation for each individual patient (Section 59E of the Poisons Act 1971)
Unregistered Schedule 8 medicinal cannabis product (not registered on ARTG)	Required	Required
Registered Schedule 8 medicinal cannabis product	Not required	Required
Unregistered Schedule 4 medicinal cannabis product (not registered on ARTG)	Required	Not required
Registered Schedule 4 medicinal cannabis product	Not required	Not required

Application process

• You can apply for both Tasmanian and TGA approvals for unregistered medicinal cannabis products (Schedule 8 products) concurrently through this online application form.
• Decisions are advised by email within two business days if all required information has been provided.
• Where a TGA registered Schedule 8 medicinal cannabis product exists, you can apply for authorisation to prescribe directly to the Tasmanian Department of Health using an approved Section 59E application form.
• Before applying, you must identify the medicinal cannabis product chosen for the clinical condition.

What medical conditions are eligible?

There is no list of eligible medical conditions. Prior to making an application, you are responsible for:

• reviewing the clinical evidence for medicinal cannabis
• making an informed risk-benefit assessment with respect to your patient’s individual clinical circumstances.

Prescriptions for unregistered medicinal cannabis products

• Once you have the required Commonwealth SAS or AP approval and Tasmanian authorisation (for Schedule 8 products), you may issue a prescription for the unregistered medicinal cannabis product.
• The prescription must comply with the Poisons Act 1971 and Poisons Regulations 2018 which will have different requirements depending on the schedule of the product.
• The prescription may be legally dispensed at any pharmacy in Tasmania.
• You must supply the pharmacy with a copy of the TGA approval so the wholesaler can release the product.

What medicinal cannabis products are available in Australia?

• Information on medicines and products in the ARTG are available from the TGA website.
• Most medicinal cannabis products available in Australia are unregistered.
• Unregistered medicinal cannabis must comply with the TGA Standard for Medicinal Cannabis (TGO 93) to be supplied in Australia. This standard is about minimum manufacturing quality requirements and is not about clinical effectiveness or risk of adverse events.
• The Commonwealth Office of Drug Control (ODC) licenses businesses that import medicinal cannabis products and Australian based manufacturers.
• You can obtain information about available products, formulations, strengths and dosing directly from manufacturers and importers.
• You can access a list of licensed suppliers on the ODC website.

What is the cost of medicinal cannabis products?

• Unregistered medicinal cannabis products are not subsidised by the Commonwealth Pharmaceutical Benefits Scheme (PBS).
• The patient is responsible for funding the cost of treatment.
• The cost will vary depending on the prescribed product and regimen.
• Costs are set by manufacturers and importers. Please contact suppliers directly for price information.
• If you are a specialist medical practitioner within the Tasmanian Health Service, you may utilise existing application pathways for subsidised medicines access to high-cost and highly specialised medicines.

Importation by health practitioners

• You can import medicinal cannabis products from overseas for the treatment of individual patients.
• You must still obtain TGA approvals and Department of Health (Tasmania) authorisations.
• Importation must also be approved by the ODC. Please see the ODC website for more information.

Medicinal cannabis and driving

• Medicinal cannabis can cause impairment and affect fitness to drive.
• It is recommended that patients do not drive whilst being treated with medicinal cannabis.
• A person who drives a vehicle while under the influence of a drug to the extent that the person is incapable of having proper control of the vehicle is guilty of an offence (even if the drug is prescribed).
• THC is the main psychoactive substance in cannabis and is present in some medicinal cannabis products.
• Driving with any detectable amount of THC in your system is an offence in Tasmania, unless the product was obtained and administered in accordance with the Poisons Act 1971.

Clinical evidence resources for prescribers

• High-quality peer-reviewed scientific literature supporting the use of medicinal cannabis to treat a range of conditions is limited.
• The role of medicinal cannabis will become clearer as additional research is published and the evidence base expands.
• The TGA has developed a series of clinical guidance documents to assist doctors and patients to understand the evidence for the potential uses of medicinal cannabis. These guidance documents have been based on evidence reviews conducted by the National Drug and Alcohol Research Centre (NDARC) and can be accessed via the TGA website.

Professional organisation statements

• Faculty of Pain Medicine, Australia New Zealand College of Anaesthetists: PM10, 2019, Statement on “Medicinal Cannabis” with particular reference to its use in the management of patients with chronic non-cancer pain
• The Royal Australian & New Zealand College of Psychiatrists: Clinical Memorandum: Therapeutic use of medicinal cannabis products, January 2021
• Royal Australian College of General Practitioners: Use of medicinal cannabis products Position statement – 2019 update

Clinical evidence resources for your patients

Visit the TGA website to access patient information documents for potential uses of medicinal cannabis:

You can also direct your patients to the NPS Medicine Wise website for information about medicinal cannabis.

Training and education

Accredited continual professional development courses for registered health professionals about medicinal cannabis may be available through education providers including major health professional representative organisations.