After an unapproved therapeutic good has been supplied, you have specific responsibilities.
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 products.
Monitoring and reporting
Find sponsor obligations for ongoing monitoring and reporting.
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User guideUser guide on the Adverse Event Management System (AEMS) for health professionals.
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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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PageInformation for sponsors conducting market actions for therapeutic goods in Australia.
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PageFind contact details for the state and territory recall coordinators as well as the Australian recall coordinator.
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PageReport counterfeit products, suspicious or illegal activity, or make a complaint about non-compliant advertising.
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FormsUse this form to report a perceived breach of the Therapeutic Goods Act, counterfeit products or questionable practices in relation to therapeutic products.
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PageFind out how to report an adverse event, including side effects from taking medicines and problems with medical devices.
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TransactionUse this portal to report a non-compliant advertisement for a medicine, medical device or any other type of therapeutic good.
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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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PageSummarises the roles and responsibilities of key stakeholders in clinical trial safety reporting of significant safety issues (SSIs) and urgent safety measures (USMs).
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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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PageInformation on the TGA Laboratories testing program for therapeutic goods.
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PageRead about key actions related to regulatory compliance activities related to unlawful import, export, manufacture, supply and advertising of therapeutic goods.
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PageRead about key actions in the 2024-25 financial year related to regulatory compliance activities related to unlawful import, export, manufacture, supply and advertising of therapeutic goods.
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PageRead about key actions in the 2025-26 financial year related to regulatory compliance activities related to unlawful import, export, manufacture, supply and advertising of therapeutic goods.
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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PageThis page contains a list of therapeutic vaping goods, for use in smoking cessation or the management of nicotine dependence, that can be legally supplied in Australia. Healthcare practitioners can use this list when prescribing and supplying unapproved therapeutic vaping goods as they have been notified as complying with applicable standards.
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GuidanceGuidance about how to request reconsideration of 'reviewable' initial decisions by the Minister for Health.
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PageLearn about TGA regulatory compliance, including how compliance is monitored, managed, and enforced to ensure therapeutic goods meet safety, quality, and legal requirements in Australia.
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PageRead about key actions related to regulatory compliance activities related to unlawful import, export, manufacture, supply and advertising of therapeutic goods.
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PageRead about key actions in the 2024-25 financial year related to regulatory compliance activities related to unlawful import, export, manufacture, supply and advertising of therapeutic goods.
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PageRead about key actions in the 2025-26 financial year related to regulatory compliance activities related to unlawful import, export, manufacture, supply and advertising of therapeutic goods.
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PageFind out how we approach and manage compliance with the regulation of vapes in Australia.
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Product types