Most medicinal cannabis products in Australia are unapproved therapeutic goods, meaning they are not included in the Australian Register of Therapeutic Goods (ARTG) and have not been assessed by us for safety, quality or effectiveness.
Registered medical practitioners and nurse practitioners may apply to access unapproved medicinal cannabis products under specific pathways if all other clinically appropriate treatment options on the ARTG have been considered.
These pathways support access for individual patients or groups under specific conditions and include the:
- Special Access Scheme (SAS),
- Authorised Prescriber (AP) Scheme
- Clinical Trial (CT) Schemes
Any medicinal cannabis products that are registered in the ARTG can be lawfully supplied in Australia by a sponsor.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to unapproved therapeutic goods. You may also have to meet obligations that apply to all products.
Special Access Scheme
Learn about and apply for the Special Access Scheme.
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PageQuestions and answers for consumer, medical practitioners, sponsors and manufacturers
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ServiceYou can apply to access unapproved therapeutic goods for individual patients through the Special Access Scheme (SAS).
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PageThis page provides prescribers with information on how to access an unapproved medicinal cannabis product using the SAS or Authorised Prescriber pathways and the reporting required.
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PageThis infographic provides an overview of consumer access to medicinal cannabis in Australia. Access can only be arranged through an Australian registered health practitioner.
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PageInformation about access pathways for medicinal cannabis and usage data.
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PageThese dashboards display all Special Access Scheme Category A (SAS A) notifications received and Special Access Scheme Category B (SAS B) applications approved for medicinal cannabis products.
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PageFind out more information on the medicinal cannabis vaping devices that are approved in Australia.
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PageUse the SAS and AP Online System to apply to access unapproved therapeutic goods through the Special Access Scheme or Authorised Prescriber scheme.
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GuidanceThis guidance is to assist health practitioners understand their requirements when prescribing ‘unapproved’ therapeutic goods for an individual patient using the Special Access Scheme (SAS).
Authorised Prescriber Scheme
Learn how prescribers can apply to the Authorised Prescriber Scheme.
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PageQuestions and answers for consumer, medical practitioners, sponsors and manufacturers
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ServiceAs a medical practitioner, you can apply to access an unapproved therapeutic good for a class of patients with the same condition.
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PageThis page provides prescribers with information on how to access an unapproved medicinal cannabis product using the SAS or Authorised Prescriber pathways and the reporting required.
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User guideThe Special Access Scheme (SAS) & Authorised Prescriber (AP) Online System (SAS & AP online system) is the preferred method of submission for AP applications.
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GuidanceGuidance for medical practitioners, Human Research Ethics Committees, specialist colleges and sponsors of 'unapproved' therapeutic goods.
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PageThis infographic provides an overview of consumer access to medicinal cannabis in Australia. Access can only be arranged through an Australian registered health practitioner.
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PageInformation about access pathways for medicinal cannabis and usage data.
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PageDashboard displaying all Authorised Prescriber applications for medicinal cannabis products approved by the TGA.
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PageFind out more information on the medicinal cannabis vaping devices that are approved in Australia.
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User guideA step-by-step guide to completing the form
Clinical trial schemes
Find how to access unapproved goods through clinical trials.
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PageFind out how we regulate clinical trials in Australia and ensure compliance with Good Clinical Practice.