Medicinal Cannabis & TGA: What You Need to Know
Get insights into medicinal cannabis regulations by the TGA. Understand the Special Access Scheme and the responsibilities of prescribers in Australia.
Most medicinal cannabis products are unapproved therapeutic goods, which means they have not been assessed by the TGA for safety, quality or effectiveness.
The TGA administers the Therapeutic Goods Act 1989 (the Act), which establishes the regulatory framework for all medicines in Australia.
The TGA has a responsibility to encourage the use of medicines that are included in the Australian Register of Therapeutic Goods (ARTG), as these products have been evaluated to ensure they meet strict standards of safety, quality and effectiveness.
The Act provides a number of mechanisms, including the Special Access Scheme (SAS) and Authorised Prescriber (AP) pathway, to enable access to 'unapproved' therapeutic goods, such as medicinal cannabis.
It is expected that registered health practitioners (prescribers) will have considered clinically appropriate treatment options that are included in the ARTG before applying to access an unapproved medicinal cannabis product under the SAS or AP pathway.
It is important to note that the TGA does not vouch for the quality, safety and effectiveness of unapproved products accessed through the SAS and the prescriber and patient (via informed consent) accept responsibility for any adverse consequences of the treatment.
It is the responsibility of the prescriber making the application to specify for which indication they are intending to use the unapproved medicinal cannabis product. SAS Category B and AP applications are individually considered by the TGA based on the information provided with the application.
This dashboard displays all Special Access Scheme Category B (SAS B) applications received for medicinal cannabis products by the TGA. The SAS B pathway allows healthcare practitioners to access therapeutic goods that are not included in the Australian Register of Therapeutic Goods (ARTG) for a single patient where the SAS Category A or SAS Category C pathways are not applicable.
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