Site notifications

Sub menu

 

 

Application and market authorisation for human cell and tissue products

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

To legally supply human cell and tissue products in Australia, you must apply to include them in the Australian Register of Therapeutic Goods (ARTG).  

Submit your application through our Business Services Portal. You’ll need to provide evidence that your product meets safety, quality, and efficacy standards. Supporting documents and fees are required.  

Good preparation helps ensure compliance and smooth market entry. 

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.

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