Quick links for medical practitioners
Medical practitioners seeking to prescribe an unapproved Schedule 8 medicinal cannabis product can now apply for both Therapeutic Goods Administration (TGA) Special Access Scheme approval and a Victorian Schedule 8 treatment permit using the TGA's single online application.
To apply for the necessary regulatory approvals, click on the button below that best describes the medicinal cannabis product you intend to prescribe.
Visit the TGA website if you intend to prescribe an unapproved Schedule 8 medicinal cannabis product
Use the DHHS online form if you intend to prescribe a registered Schedule 8 medicinal cannabis product,
such as nabiximols (Sativex)
Authorised prescribers: Medical practitioners who have been granted approval as an Authorised Prescriber and intend to prescribe a Schedule 8 medicinal cannabis product can apply for a Schedule 8 treatment permit.
Schedule 4 medicinal cannabis products: A Victorian permit is not required to prescribe a Schedule 4 product. However, TGA Special Access Scheme approval may still be required.
Further information about the regulatory approvals necessary to prescribe medicinal cannabis in Victoria is provided below.
Schedule 8 Treatment Permits
Based on the Australian Standard for the Uniform Scheduling of Medicines and Poisons, medicinal cannabis products are classified as either Schedule 8 or Schedule 4. If the medicinal cannabis product a medical practitioner intends to prescribe is classified as a Schedule 8 poison, they will need to apply for a treatment permit from the Victorian Department of Health & Human Services, unless an exemption applies (e.g. treatment of a hospital inpatient).
No Victorian permit is required if the product is a Schedule 4 poison.
All applicants must satisfy the requirements of the Drugs, Poisons and Controlled Substances Act 1981 and the Drugs, Poisons and Controlled Substances Regulations 2017 to ensure that treatment is appropriate and coordinated between practitioners.
Most medicinal cannabis products have not been assessed for safety and efficacy by the Therapeutic Goods Administration (TGA) and are not approved goods on the Australian Register of Therapeutic Goods (ARTG).
Treatment permits to prescribe an unapproved medicinal cannabis product will generally only be approved where the applicant has obtained TGA approval to prescribe that product to the patient under either the Special Access Scheme Category B (SAS B) or Authorised Prescriber (AP) Scheme.
When making an application for a Schedule 8 treatment permit practitioners may be asked to provide information such as evidence of TGA approval to prescribe.
Medical practitioners seeking to prescribe an unapproved Schedule 8 medicinal cannabis product can now apply for both TGA SAS B approval and a Victorian Schedule 8 treatment permit using the TGA’s single online application.
In relation to patients that fall within the definition of a Special Access Scheme Category A (SAS A) patient in Regulation 12A of the Therapeutic Goods Regulations 1990 (Cth), permits to prescribe an unapproved medicinal cannabis product will generally only be approved where the applicant is a relevant specialist or provides a letter of support from a relevant specialist. Applicants may also be required to provide a copy of the 'Category A form Special Access Scheme' that the medical practitioner has, or will, send to the TGA, and/or sign a declaration, and/or provide detailed information in relation to the unapproved product they wish to prescribe including any evidence of safety and efficacy.
It is important to note that pending the availability of locally manufactured medicinal cannabis products -- all medicinal cannabis products must be imported in accordance with licences and permits from the federal Office of Drug Control. The Office of Drug Control has permitted the bulk import of some products by authorised importers. Details of those importers and products is available on the Office of Drug Control website. Access to those imported products is only available in accordance with a SAS B or AP approval.
Medical practitioners intending to prescribe imported medicinal cannabis products under SAS A will need to hold an import licence from the Office of Drug Control and apply for separate import permission for each patient. More information about medicinal cannabis products and SAS A is available on the Office of Drug Control website.
For further information on Commonwealth access schemes and requirements please see the TGA website.
Products registered on the Australian Register of Therapeutic Goods
For medicinal cannabis products that are registered on the ARTG, where the proposed use is outside the recommended indication, or there is limited evidence for the proposed treatment, a letter of support from a relevant specialist may be required before a treatment permit will be approved. You may also be asked to sign a declaration.
Please visit the smart forms for drugs and poisons section for the online application form for a permit to treat a patient with a Schedule 8 medicinal cannabis product.