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.
Application pathways and processes
Find application routes to market approval.
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PageThe ARGLM will help you navigate the regulatory requirements for listed and assessed listed medicines in Australia.
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PageLearn about sponsor certification of regulatory requirements for listed and assessed listed medicines
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ServiceOutline of the process for entering your non-prescription medicine onto the Australian Register of Therapeutic Goods.
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User guideA guide for using the TGA Business services (TBS) portal for listed and assessed listed medicine applications.
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PageKnow which ingredients we permit in listed and assessed listed medicines and learn about why and when we make changes.
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GuidanceGuidance for holding acceptable evidence to support indications and claims made about your listed medicine.
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PageOverview of the application process for the different types of non-prescription medicines.
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GuidanceThis guidance describes the requirements for sunscreens (and their ingredients), that we regulate as therapeutic goods in Australia.
Dossier preparation
Learn how to prepare and submit your dossier.
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PageDossier requirements for non-prescription medicines
Product changes and variations
Access information to vary products and sponsorship.
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PageVary your Australian Register of Therapeutic Goods (ARTG) entry for your non-prescription medicine