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Application and market authorisation for biologicials

Information about how to submit an application and our evaluation processes and application fees.

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.

Application pathways and processes

Find application routes to market approval.

Pre-submission planning

Access requirements for pre-submission planning and meetings.

Fees and charges

Understand fees, exemptions and how to make payments.

Dossier preparation

Learn how to prepare and submit your dossier.

Product changes and variations

Access information to vary products and sponsorship.

  • New biologicals based on a parent biological

    Page
    This guidance is for sponsors of biologicals included in the Australian Register of Therapeutic Goods who want to make a change to that biological (parent biological) where the change creates a separate and distinct good (new biological)

  • Varying biological entries on the ARTG

    Guidance
    This guidance is for sponsors applying for a variation to the Australian Register of Therapeutic Goods (ARTG) entry of a biological
Product types