After MDMA and psilocybine has been supplied, you have specific responsibilities.
You must:
- maintain accurate records
- monitor product use
- report supply data every six months
- report adverse events.
We oversee these activities to ensure that unapproved therapeutic goods are 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 unapproved therapeutic goods and all products.
Monitoring and reporting
Find sponsor obligations for ongoing monitoring and reporting.
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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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LegislationThe TGO 112 Order 2024 sets forth the quality standards for MDMA (3,4-methylenedioxymethamphetamine) products, which must comply with specific requirements to ensure safety and efficacy.
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LegislationThe Therapeutic Goods (Standard for Psilocybine) (TGO 113) Order 2024 establishes new quality standards for psilocybine products in Australia.
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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GuidanceGuidance on how to comply with the quality standards for MDMA (TGO 112) and psilocybine (TGO 113).
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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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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