To legally supply a registered complementary medicine in Australia, it must be included in the Australian Register of Therapeutic Goods (ARTG).
You need to submit a complete application through our TGA Business Services (TBS) portal. This includes submitting data demonstrating the product’s quality, safety, and effectiveness. You must also pay the associated application and evaluation fees.
We assess this information to ensure your product meets all legislative requirements. Once approved, we include your product in the ARTG and it 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 registered complementary 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 ARGRCM will help you navigate the regulatory requirements for registered complementary medicines in Australia.
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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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ServiceOutline of the process for entering your non-prescription medicine onto the Australian Register of Therapeutic Goods.
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User guideStep by step user guide on submitting applications to register a complementary medicine or over the counter (OTC) medicine in the Australian Register of Therapeutic Goods, using the TGA Business services.
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GuidanceGuidance on the evaluation process and information required for new registered complementary medicines.
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PageOverview of the application process for the different types of non-prescription medicines.
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GuidanceGuidance explaining how the Comparable Overseas Bodies report-based process is associated with shortened evaluation timeframes for applications.
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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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PageInformation for applicants on how to request and prepare for pre-submission meetings.
Dossier preparation
Learn how to prepare and submit your dossier.
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GuidanceGuidance for applicants on information required for Module 1 in dossiers for applications for registered complementary medicines to be consistent with the Common Technical Document (CTD) format.
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GuidanceGuidance on dossier information required for registered complementary medicine applications, to be consistent with the Common Technical Document (CTD) format.
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PageDossier requirements for non-prescription medicines
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GuidanceGuidance on information required for an effective application to register a complementary medicine and proceed to evaluation.
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LegislationThis Specification provides what information must accompany an application to register complementary medicines on the Australian Register of Therapeutic Goods (ARTG).
Product changes and variations
Access information to vary products and sponsorship.
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GuidanceGuidance for sponsors on changing information in the Australian Register of Therapeutic Goods (ARTG) for registered complementary medicines.
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FormsThe Registered medicine variation form (complementary medicines) should only be used when you wish to vary the particulars of complementary medicines which are already registered in the ARTG.
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PageVary your Australian Register of Therapeutic Goods (ARTG) entry for your non-prescription medicine