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Application and market authorisation for prescription medicines

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

Market authorisation is the formal approval required to supply a therapeutic good in Australia. In most cases, this includes entering the product in the Australian Register of Therapeutic Goods (ARTG).  

 

To obtain market authorisation, you must submit a complete application via the TGA Business Services (TBS) portal. Your application must be supported by data demonstrating the quality, safety, and efficacy of the medicine, and you are required to pay applicable fees.  

 

We assess this information to ensure it meets all regulatory standards. If the product complies with requirements, market authorisation is granted, the product is added to the ARTG, and it becomes legally available for supply in Australia.  
 

You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to prescription medicines. You may also have to meet obligations that apply to all medicines 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.

Product types