After your therapeutic vape product has been supplied, you have specific responsibilities, such as:
- maintain accurate records
- monitor product use, and
- 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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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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PageAs the sponsor of a medicine or a medical device in Australia, you have a responsibility to report adverse events.
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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.
Compliance
Learn how we ensure compliance, including post-market reviews.
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PageLearn about GCP inspections of clinical trial sites of investigational biologicals, medicines and medical devices.
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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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PageFind out more about the restrictions around advertising and promotion that apply to vapes.
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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