After an unapproved medicinal cannabis product has been supplied, you have specific responsibilities.
You must:
- maintain accurate records
- monitor product use
- report supply data every 6-months
- report adverse events.
We oversee these activities to ensure that unapproved medicinal cannabis products have been supplied appropriately.
Understanding and fulfilling your obligations is crucial for maintaining compliance.
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.
Monitoring and reporting
Find sponsor obligations for ongoing monitoring and reporting.
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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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FormsThis form is for sponsors to report Significant Safety Issues (SSIs) and Urgent Safety Measures (USMs) to the TGA.
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PageAs the sponsor of a medicine or a medical device in Australia, you have a responsibility to report adverse events.
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User guideA step-by-step guide to completing the form
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FormsSponsors must report every six months in relation to unapproved therapeutic goods supplied under the SAS and Authorised Prescriber (AP) schemes.
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PageWe have published a method used for the analysis of medicinal cannabis products.
Compliance
Learn how we ensure compliance, including post-market reviews.
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PageKnow the ways we respond to breaches such as warnings, fines and legal action.
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PageFind out how we approach and manage compliance with therapeutic goods regulation in Australia.
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PageLearn about GCP inspections of clinical trial sites of investigational biologicals, medicines and medical devices.
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PageRead about our new priority areas for compliance activities relating to the import, advertising and supply requirements of the Therapeutic Goods Act 1989 from 2023 to 2025.
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PageInformation about therapeutic goods cancelled at the request of the sponsor.
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PageInformation about how the TGA uses and calculates the value of infringement notices
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GuidanceGuidance for making an offer of enforceable undertaking to us.
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GuidanceGuidance about how to request reconsideration of 'reviewable' initial decisions by the Minister for Health.
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Product types