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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.