After your therapeutic sunscreen is on the market, you must meet ongoing regulatory responsibilities.
You must:
- manage your product’s inclusion in the Australian Register of Therapeutic Goods (ARTG)
- keep your product’s details up to date
- notify us of any changes through variation processes
- pay regulatory charges
- monitor product safety
- report any issues or adverse events.
Meeting these post-market obligations helps ensure your therapeutic sunscreen remains safe, effective, and compliant with Australian regulatory requirements.
We monitor medicines on the market and work with you to address safety concerns. Our monitoring and compliance activities protect consumers and maintain product integrity.
You can find consumer information and the latest sunscreen news and alerts on our sunscreens page.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to therapeutic sunscreens. You may also have to meet obligations that apply to all medicines and all products.
Monitoring and reporting
Find sponsor obligations for ongoing monitoring and reporting.
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PageLearn about your on-going responsibilities once your non-prescription medicine is on the Australian Register of Therapeutic Goods.
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FormsUse this form to report defects that you think have arisen during manufacture, storage or handling of a medicine or vaccine.
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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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PageVary your Australian Register of Therapeutic Goods (ARTG) entry for your non-prescription medicine
Compliance
Learn how we ensure compliance, including post-market reviews.
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PageFind out about our compliance review activities for listed medicines and how to avoid common compliance issues.
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GuidanceGuidance explaining the post-market surveillance of listed medicines and how we undertake compliance reviews.