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To legally supply an assessed listed medicine in Australia, it must be included in the Australian Register of Therapeutic Goods (ARTG).
These medicines contain low-risk ingredients but can make health claims (indications) that are higher risk than other listed medicines, but lower risk than registered medicines. These indications are premarket evaluated by us and you must submit an application with a supportive dossier package for us to evaluate.
You must apply through our TGA Business Services (TBS) portal. Application fees apply.
Once approved by us, your product is included in the ARTG 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 assessed listed medicines. You may also have to meet obligations that apply to all medicines and all products.