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To legally supply therapeutic sunscreens in Australia, your product must be included in the Australian Register of Therapeutic Goods (ARTG).
You will need to apply through our TGA Business Services (TBS) portal and certify that your product meets all legislative requirements.
Sunscreens that use permitted ingredients and permitted sunscreen therapeutic indications can be listed in the ARTG. These sunscreens do not undergo a TGA premarket evaluation.
Sunscreens that use non-permitted ingredients or therapeutic indications must be registered in the ARTG. In this case, we evaluate your product to ensure it meets safety, quality and efficacy requirements.
You can find consumer information and the latest sunscreen news and alerts on our sunscreens page.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to therapeutic sunscreens. You may also have to meet obligations that apply to all medicines and all products.