After your prescription medicine is on the market, you have ongoing responsibilities to ensure it remains safe and compliant.
You must:
pay regulatory charges
manage your product’s registration
tell us about any changes through variations
monitor safety and report any adverse event or other safety issues promptly
tell us if your product is going to be in shortage or is being discontinued.
While your prescription medicine is active on the Australian Register of Therapeutic Goods (ARTG), you must continuously monitor for safety and regulatory compliance. We can work with you to address safety concerns and protect public health.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to prescription 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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PageInformation about what to include in the Product Information (PI) and Consumer Medicine Information (CMI) for products included in the Black Triangle Scheme.
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PageInformation about influenza reference reagents for testing influenza vaccines and how to order them.
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PageYou need to notify us if your reportable medicine is in shortage or is being discontinued.
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PageInformation on reporting adverse drug reactions, adverse events and significant safety issues for medicines and biologicals.
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PageInformation for sponsors conducting market actions for therapeutic goods in Australia.
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GuidanceGuidance for the deletion of commercially confidential and personal information in an Australian Public Assessment Report (AusPAR).
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GuidanceGuidance for sponsors of antibiotics on collecting and providing pre- and post-market information about antibiotic resistance.
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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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PageSponsors have ongoing responsibilities when a prescription medicine is registered in the Australian Register of Therapeutic Goods (ARTG).
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.