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Your OTC medicine must be included in the Australian Register of Therapeutic Goods (ARTG) to be legally supplied. Unless your OTC medicine fits the requirements of a listed medicine, it needs to be registered on the ARTG.
You must submit a complete application in our TGA Business Services (TBS) portal. To support your application, you need to submit data demonstrating the medicine’s quality, safety and efficacy. You must also pay fees.
We evaluate this information to ensure compliance with regulatory requirements.
This stage confirms your medicine meets all requirements and 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 over-the-counter medicines. You may also have to meet obligations that apply to all medicines and all products.