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.
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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User guideA guide for using the TGA Business services (TBS) portal for listed and assessed listed medicine applications.
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PageInformation about including listed complementary medicines on the ARTG
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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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GuidanceGuidance on using literature based submissions for applications for listed, assessed listed and registered complementary medicines.
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PageHow to select and use permitted indications for your listed medicine
Dossier preparation
Learn how to prepare and submit your dossier.
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PageDossier requirements for non-prescription medicines
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PageExplore frequently asked questions raised by industry in relation to permitted indications.
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