After your OTC medicine is on the market, you have ongoing responsibilities to ensure it remains safe and compliant with all applicable regulatory requirements.
You must:
- manage your product’s registration
- tell us if there are any changes to your product by applying for a change
- pay ongoing regulatory charges
- monitor safety
- report any issues promptly.
We may also act if we receive adverse event reports or consumer complaints.
You are responsible for maintaining compliance and responding to safety concerns to help ensure your medicine remains safe for the Australian market.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to OTC medicines. 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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PageVary your Australian Register of Therapeutic Goods (ARTG) entry for your non-prescription medicine
Product types