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After your human cell and tissue product is on the market, you have ongoing responsibilities to meet regulatory requirements.
You must:
manage your product’s registration in the Australian Register of Therapeutic Goods
pay regulatory charges
notify us of any changes or variations to your registered product
monitor safety
Report product issues
support post-market surveillance.
We oversee these activities to ensure products remain safe and effective.
Understanding your responsibilities and our role helps you stay compliant and protect public health in Australia.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to biologicals. You may also have to meet obligations that apply to all biologicals and all products.