Application and market authorisation for biologicials

To legally supply a biological, you must apply to include it in the Australian Register of Therapeutic Goods (ARTG). You can apply through our Business Services portal. 

You must submit evidence that your product meets safety, quality, and efficacy standards. Supporting documents and fees are required.

We will assess your application. If approved, your product will be included in the ARTG, allowing legal supply in Australia.

Understanding this process helps ensure compliance and supports market access.

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.