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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.