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After your biological product is on the market you have ongoing responsibilities.
You must:
manage your biological’s inclusion in the Australian Register of Therapeutic Goods (ARTG)
notify us of any changes or variations to your product
pay regulatory charges
monitor safety
report issues
support post-market surveillance.
We oversee these activities to protect public health and ensure biologicals remain safe and effective in Australia. Understanding your responsibilities helps you stay compliant and manage risks throughout your product’s life.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information about biologicals, and specific types of biologicals. You may also have to meet obligations that apply to all products