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Application and market authorisation for registered complementary medicines

Guidance and other information on the application process, including evaluation processes and fees, for registered complementary medicines.

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

You need to submit a complete application through our TGA Business Services (TBS) portal. This includes submitting data demonstrating the product’s quality, safety, and effectiveness. You must also pay the associated application and evaluation fees. 

We assess this information to ensure your product meets all legislative requirements. Once approved, we include your product in the ARTG and it is authorised for legal supply in Australia.  

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

  • Pre-submission meetings with TGA

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

Dossier preparation

Learn how to prepare and submit your dossier.

Product changes and variations

Access information to vary products and sponsorship.

Product types