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.
Application pathways and processes
Find application routes to market approval.
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PageThe intended purpose of assessed listed medicines pathway is not to assess complementary medicines that only make low level indications (indications that are, or meet the criteria to be included on the permitted indications list).
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PageThe assessed listed medicines pathway is a new listing pathway through which sponsors can apply to list a complementary medicine into the Australian Register of Therapeutic Goods (ARTG).
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FormsThis form must be completed and submitted for all L(A)1 applications in Module 1.5.7 of the application. Completing this form provides the assurances required to accompany a L(A)1 application.
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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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PageFind information about using reports from Comparable Overseas Bodies for applications for listed, assessed listed and registered complementary medicines.
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User guideThis user guide will assist you in providing the required information for completing (and submitting) an application for an assessed listed medicine (either for new ARTG entries or changes to existing ARTG entries)
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PageA new Data Protection Scheme is now available for assessed listed medicine applications.
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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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FormsThe Module 1.2.1: Assessed listed medicine general application information form must be completed in conjunction with the Assessed listed medicines application form.
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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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PageOverview of the application process for the different types of non-prescription medicines.
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GuidanceGuidance on the regulatory requirements for assessed listed 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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GuidanceGuidance on using reports from COBs and submission requirements for evaluation of these applications.
Pre-submission planning
Access requirements for pre-submission planning and meetings.
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GuidanceGuidance about information required for an assessed listed medicine application to pass preliminary assessment and proceed to evaluation.
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PageInformation for applicants on how to request and prepare for pre-submission meetings.
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LegislationThis Determination specifies what information must accompany applications to list complementary medicines on the Australian Register of Therapeutic Goods (ARTG).
Dossier preparation
Learn how to prepare and submit your dossier.
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GuidanceGuidance about the administrative information to support assessed listed medicine applications.
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FormsPlease include this form in CTD Module 1.5 of your application dossier.
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PageDossier requirements for non-prescription medicines
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FormsThe Module 1.2.1: Assessed listed medicine general application information form must be completed in conjunction with the Assessed listed medicines application form.
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