Who is medicinal cannabis appropriate for?
Most medicinal cannabis products in Australia are not TGA listed or registered. They can only be accessed through special access pathways for unapproved medicines. Therefore, medicinal cannabis products are only for those patients who have exhausted all other evidence-based treatment options (i.e. approved medicines) for their condition and there is evidence to support the safety and effectiveness of medicinal cannabis in that individual. This decision can only be made by a registered medical practitioner who must apply to the TGA for approval before prescribing medicinal cannabis.1
How do patients obtain medicinal cannabis?
Medicinal cannabis can be prescribed by a registered medical practitioner (GP or specialist depending on the state/territory) following a thorough consultation to determine if treatment is appropriate for the individual’s circumstances.If the doctor decides that therapy is clinically appropriate for the individual – and all other treatment options have been exhausted – then the doctor will apply to the TGA, and if needed the local health authority, for approval to prescibe.1
Some patients may be able to access medicinal cannabis through clinical trials that are being conducted.
How long does TGA approval take?
If all required information has been submitted and the evidence supports the clinical appropriateness of medicinal cannabis in that individual, the TGA approval process may be complete within 1–2 business days.2
How much does medicinal cannabis cost?
Medicinal cannabis is not funded under the Pharmaceutical Benefits Scheme (PBS), so patients will need to cover the full cost of the product. This will vary depending on the product they are prescribed.1
What quality control measures are in place for medicinal cannabis?
Most medicinal cannabis products in Australia are unlisted or unregistered – this means that they have not been assessed by the TGA.3
The TGA has mandated quality standards for all medicinal cannabis products available in Australia. This includes a requirement that such products are manufactured in a way that is compliant with an international code known as the Good Manufacturing Practice (GMP) which ensures that therapeutic goods are of high quality.3 Healthcare professionals can also request additional information, such as Phase 1 clinical research results for safety and tolerability, to help determine the safety of the medicine.
Can you drive if you use medicinal cannabis?
Patients using any medicinal cannabis products should seek their doctor’s advice before driving or operating machinery. Patients are advised to refer to the Patient Product Information sheet of the product they are using for further information.1
In Australia it is illegal to drive with THC present in your saliva, blood or urine. Some medicinal cannabis products contain THC. Due to current laws, detection of THC in bodily fluids, regardless of its amount, is a criminal offense. Cannabis products with low levels of THC can also lead to failure of drug tests.
Where can I find more information about medicinal cannabis?
If you wish to learn more about medicinal cannabis for yourself or a loved one you may find our information summary of use. You should also speak to your doctor for clinical advice relevant to your needs.
For healthcare professionals, please visit the TGA website and your relevant state health authority: