Access to Medicinal Cannabis in Australia
Currently the only medicinal cannabis product listed on the Australian Register of Therapeutic Goods (ARTG) that therefore does not require TGA approval is Nabiximols, however you may still require state approval for this. If the practitioner wishes to prescribe a medicinal cannabis product other than Nabiximols they will need to apply for authority to prescribe from the TGA as well as their state health department. CBD formulations are scheduled as category 4 and require TGA approval only. THC/CBD formulations are scheduled as category 8 and require both TGA and state health department approval.
In March 2018, the prescribing process in New South Wales was streamlined with a single application process that covers both TGA and state and territory health department. In New South Wales, GPs may also use the hotline for guidance, this hotline aims to assist in determining suitability of cannabis treatment for you patient and can assist in completing the application.
For GPs, specialist endorsement is not essential and the TGA considers each application based on case by case situation. For more information regarding each state, relevant health department should be contacted. In some states you may apply to both the TGA and your state department at the same time, some states also limit the application process to specialists only or for GPs with endorsement from a relevant specialist.
There are two pathways to gaining medicinal cannabis access for practitioners in Australia:
- Special Access Scheme (either category A or B)
- Authorised Prescriber Scheme
NOTE: The TGA also allow access to medicinal cannabis for approved clinical trials.
Special Access Scheme
The Special Access Scheme provides two suitable categories to access medicinal cannabis products in Australia. However, the most common application pathway is category B.
The commonwealth and state and territory departments are working together to streamline access to medicinal cannabis for Australian health practitioners. A single application process was introduced in New South Wales, by which prescribers of medicinal cannabis could provide the relevant information to manage both TGA and state health requirements.
On Monday, 30 July 2018 an online system was introduced to enable the electronic submission of SAS applications. This online system is designed to streamline the process of prescribing medicinal cannabis by simultaneously allowing doctors to submit an application to both the TGA and state health departments. Currently, this system is available for prescribing medical practitioners in New South Wales, Victoria and Queensland. Doctors from these states can register or login to the online application portal by going to the TGA website:
There are four parts to the application.
- The TGA form needs be completed.
- A letter for clinical justification needs to be provided, this will include:
- A history of presenting symptoms
- Other medical history
- Cannabis is not a first line treatment. Therefore, a list of all of the medications that have been trialed needs to be provided as well as the side effects experienced and reasons for trialing cannabis use
- Details of the proposed treatment plan and the strategies for the appropriate management and monitoring.
- GPs will need to provide sufficient current clinical evidence regarding cannabis use for the particular condition being treated.
- An endorsement from a relevant specialist is recommended but not essential. The TGA considers each application based on case by case situation. If no specialist endorsement is available, it is helpful to refer the patient to one and attach this referral letter with the application.
Once you have completed all of these steps, this information needs to be emailed to the following email address: [email protected]. For further information the TGA may be contacted on the following number: (02) 6232 8866. Each state might have different rules so it is important to contact the TGA and your relevant State Health Department to clarify any further queries.
If approved, the TGA will email the approval letter from both the TGA and NSW Health. Both approval letters then need to be emailed to the supplier who will ship the product to the local chemist, and the patient will then receive the medication from that chemist. Patients should be seen before commencing treatment to go through the proposed treatment and answer any questions at the stage. If your application is not approved the TGA will reply with reasons as to why and ask for further information.
Authorised Prescriber (AP)
This pathway is designed for a specialist who wants the authority from the TGA to prescribe for a specific indication to a group of individuals e.g. adult patients with treatment resistant chemotherapy induced nausea and vomiting. It enables the doctor to prescribe to numerous patients without seeking further TGA approval for each patient. This application requires endorsement from a Human Research Ethics Committee (HREC) or specialist college as well as sufficient clinical justification. As an AP the practitioner is allowed to supply the product directly to the specified patients. To be an Authorised Prescriber the medical practitioner must have:
- The training and expertise appropriate for the condition being treated and the proposed use of the product
- The Authorised Prescriber must be able to best determine the needs of the patient
- To monitor the outcome of therapy
You may also require state health department approval depending on your state requirements and the scheduling of the product being prescribed.
Further reading on the AP process from the TGA:
Further information from the TGA:
access medicinal cannabis products
access medicinal cannabis products steps using access schemes
State Health Department Requirements
In most cases both TGA and state health department approval is required before beginning to prescribe a medicinal cannabis product. Each state has their own requirements for medicinal cannabis products and some will only allow for specialists in the relevant field to apply for approval. State and territory requirements also vary depending on the medicinal cannabis product itself. For example, preparations containing 98% cannabidiol (CBD) and no more than 2% of other cannabinoids are classified as ‘Schedule 4’ which do not require state or territory authorisation, with the exception of Queensland and Tasmania. Most other medicinal cannabis products fall under ‘Schedule 8’ which do require state and territory approval.
View each state medicinal cannabis requirements: