'There are currently only two medicinal cannabis products listed as approved medicines on the Australian Register of Therapeutic Goods (ARTG):
To assist health care professionals in identifying and prescribing unapproved medicinal cannabis products not entered on the ARTG, the Therapeutic Goods Administration (TGA) has published a list of available products by category of active ingredient, along with sponsor details.
The Office of Drug Control (ODC) also publishes an updated list of importers and manufacturers of medicinal cannabis products on its website.' (1)
The majority of medicinal cannabis products are unapproved therapeutic goods, which have not been assessed by the Therapeutic Goods Administration (TGA) for safety, quality or effectiveness. There are a number of pathways to enable access to unapproved therapeutic goods, including medicinal cannabis where clinically appropriate.(2)
If an 'unapproved' medical cannabis product is deemed clinically necessary, the TGA will need to be notified or an application submitted before a prescription is provided to the patient.
Special Access Scheme A is a notification pathway and medicines are imported on a patient-by-patient basis via the Office of Drug Control using the licensing and permit application forms.
This pathway is reserved for patients deemed to be seriously ill and death is likely to occur in a matter of months or premature death is reasonably likely to occur in the absence of early treatment.(5)
A completed Category A form must be sent to the TGA within 28 days after the medicine or biological is given to the person.
The Office of Drug Control, Guidance License and Permit Application Forms, Medical Cannabis, https://www.odc.gov.au/licence-and-permit-application-forms-0
Special Access Scheme B is an application pathway where prescribers apply on behalf of a patient to access unapproved medical cannabis products. Prescribers need to provide clinical justification including
There are no restrictions on the medical conditions for which a prescriber may apply via the SAS however the prescriber needs to have knowledge on the condition and the medicinal cannabis product they wish to prescribe. Supporting evidence may be requested by the TGA for some novel indications. In some instances, evidence of specialist support from a practitioner with appropriate expertise may also be requested. (5)
Watch the TGA video for an overview on access to medicinal cannabis products for Healthcare Professionals in Australia.
Frequently Asked Questions About Special Access Scheme https://www.tga.gov.au/special-access-scheme-frequently-asked-questions
Research Articles for Condition Clinical Justifications https://canguide.org.au/mc-research/
Special Access Scheme C
Not available for medical cannabis products
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