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 state approval may be required. 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 and some state health departments may require a notification as well. CBD formulations containing equal or more than 98% of CBD are scheduled as category 4 and require TGA approval only.
CBD formulations containing < than 98% of CBD are scheduled as category 8. THC/CBD formulations are scheduled as category 8 and require both TGA and state health department approval in some states. Since October 2019 NSW health department doesn’t require notification unless patients are identified as:
For GPs, specialist endorsement is useful but 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:
NOTE: The TGA also allow access to medicinal cannabis for approved clinical trials.
The Special Access Scheme provides two suitable categories A and B 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.
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 most states and territories (except for Tasmania) can be applied to simultaneously via this online system. Doctors from these states can register or login to the online application portal by going to the TGA website.TGA SAS Online Portal
There no paper forms and applications are online only. The medical practitioner needs to register first. Once this is done, the doctor will be able to login and follow the simple steps to apply. With regards to cannabis dosing, TGA requires that a maximum daily dose is specified. Regarding clinical justification, applying practitioner needs to state the medical condition for which cannabis is sought and list all the conventional drugs that have been ineffective or caused adverse effects as this is the eligibility criteria. Currently, cannabis is not a first line treatment and can only be prescribed if other conventional medicines fail.
Practitioners may need to provide sufficient current clinical evidence regarding cannabis use for the particular condition being treated. An endorsement from a relevant specialist is useful but not essential. The TGA considers each application based on case by case situation. If no specialist endorsement is available, it might be helpful to refer the patient to one and attach this referral letter with the application. It is always recommended to discuss patient’s case with the relevant specialist and other doctors involved in patient’s care as a part of good clinical practice.
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 the relevant State Health Department to clarify any further queries.
If approved, the TGA will email the approval letter to the applying doctor. Following that, patient will come for a follow up consultation, during which he/she will be provided with the written instructions regarding dosing and will be issued with the approval letter and hand written script. Both will need to be taken to the pharmacy, and the patient will then receive the medication from that pharmacy. If the application is not approved, the TGA will reply with reasons as to why and ask for further information.
This pathway is designed for a medical practitioner 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:
You may also require state health department approval depending on your state requirements and the scheduling of the product being prescribed. Currently, since October 2019, this is not required in NSW.
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
In some 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 Tasmania. Most other medicinal cannabis products fall under ‘Schedule 8’ which may require state and territory approval. As mentioned already, in NSW since October 2019 state department notification is not required unless patients are identified as
View each state medicinal cannabis requirements:
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