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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.