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Application and market authorisation for medicines

Guidance for ways to apply, your legal obligations, the evaluation processes, and fees and charges.

To legally supply a medicine in Australia, it must be included in the Australian Register of Therapeutic Goods (ARTG).    
 

You can submit your application through our TGA Business Services (TBS) portal. You may need to provide evidence of quality, safety and effectiveness, and pay the required fees.   
 

Applications for higher-risk medicines are assessed to ensure they meet all requirements. If approved, your medicine is added to the ARTG.  
 

Lower-risk medicines are included following your certification that all legal requirements are met. Once included in the ARTG, your medicine can be legally supplied in Australia.  

 

You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to medicines. 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.

  • Pre-submission meetings with TGA

    Page
    Information for applicants on requesting and preparing for pre-submission meetings for medicines and biologicals.

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.

Product types