From Monday 30 July 2018, Queensland doctors seeking approval to prescribe medicinal cannabis will do so via the Therapeutic Goods Administration (TGA) online system.
The online system has been introduced to enable the electronic submission of SAS applications and notifications to the TGA. Use of this online system will streamline the application process and allow users to manage the SAS applications and notifications they submit to the TGA. Submission via the TGA's online system will fulfil the requirements for both the TGA and Queensland Health (which were previously 2 separate processes).
Visit the Special Access Scheme Online System page to find out more.
The single-patient prescriber pathway is available for any non-specialist medical practitioner wishing to apply for a medicinal cannabis approval to treat a medical condition.
Specialist medical practitioners who wish to prescribe for a patient with a condition outside of the prescribed patient classes, will also be required to apply for an individual patient approval.
Ensure the pharmacy nominated on your application holds a current Queensland Medicinal Cannabis Dispensing Approval.
Guidance and regulations
- Guidance for the use of medicinal cannabis in Australia, December 2017 is a national guidance document covers the medical conditions, symptoms, and products to be used. The individual documents can be viewed on the TGA's website.
- Clinical guidance for the use of medicinal cannabis products, August 2018 (PDF 564 kB): covers the medical conditions/symptoms and products to be used.
- Standard for security of medicinal cannabis stock, January 2017 (PDF 326 kB) details how to secure and store medicinal cannabis products, under Part 8 of the regulation.
- Public Health (Medicinal Cannabis) Regulation 2017: describes patient-class prescribers, the class of patients to be treated, and the medicinal cannabis products to be prescribed.
- Read more on the Commonwealth's guidance for:
Forms and templates
- Treatment report (PDF 105 kB)
- Notification of medicinal cannabis management plan (PDF 120 kB)
- Application for approval to dispense medicinal cannabis (PDF 287 kB)
- Medicinal cannabis management plan (PDF 133 kB)
Your legal obligations
The authorised single-patient prescriber must:
- comply with any conditions imposed on a TGA approval relating to the medicinal cannabis product(s) being used
- comply with the requirements of the medicinal cannabis approval (including but not limited to):
- not dispense medicinal cannabis for medicinal purposes to any unapproved patient.
- not exceed the approved maximum daily dose in accordance with that specified in the medicinal cannabis approval.
- not vary the approved route of administration.
- not vary the medicinal cannabis product without the relevant approvals.
- do not issue repeat prescriptions
- conduct a medication review prior to initiating medicinal cannabis for therapeutic purposes and in any reassessment of the patient(s) receiving medicinal cannabis.
- retain a copy of all the relevant documented approvals to prescribe medicinal cannabis in the patient's clinical record.
- report any adverse events to the TGA and to the State, as specified in their respective regulations and/or approvals
- include processes to identify any misuse/abuse/diversion by the patient in any reassessment of patient(s) receiving cannabis for medical purposes.
- clinically reassess the patient as to the appropriateness of treatment at least once every 3 months, or more frequently if required.
- advise the patient that if their medicinal cannabis product contains THC then they cannot drive or operate heavy machinery.
- provide a treatment report to the chief executive on request
- if dispensing
- ensure the medicinal cannabis product is stored in accordance with the manufacturers specifications and meets the requirements of the security standard
- prepare a medicinal cannabis management plan under the medicinal cannabis approval
- notify Queensland Health when a medicinal cannabis management plan is made by submitting the notification form
Other conditions may apply, depending on individual cases.
Expert advisory panel
An expert advisory panel may assist the Chief Executive to decide applications made under the single-patient prescriber pathway by providing:
- advice for each individual case under the single patient prescriber pathway
- recommendations about the conditions and symptoms for which an approval may be granted
- the medicinal cannabis products used, including type and form
- recommendations about current or proposed research related to medicinal cannabis.
The panel will be able to advise that all reasonable treatment options for the disorder have been tried before using an unapproved product such as medicinal cannabis. A consumer advocate is included in the membership of the panel.
The panel will only communicate with the applicant i.e. the doctor when more information is required to inform their advice to the Director-General. No direct communication with the patient will be entered into by the panel.