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To legally supply a listed medicine in Australia, it must be included in the Australian Register of Therapeutic Goods (ARTG). These medicines use low-risk ingredients and can only make permitted health claims (indications).
You must apply through our TGA Business Services (TBS) portal and self-certify that your product meets all legal requirements.
We don’t assess your product before listing but may review it at any time that it's included in the ARTG. Once accepted in the ARTG, your product gets an AUST L number and can be legally sold in Australia.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to listed medicines. You may also have to meet obligations that apply to all medicines and all products.