Your OTC medicine must be included in the Australian Register of Therapeutic Goods (ARTG) to be legally supplied. Unless your OTC medicine fits the requirements of a listed medicine, it needs to be registered on the ARTG.
You must submit a complete application in our TGA Business Services (TBS) portal. To support your application, you need to submit data demonstrating the medicine’s quality, safety and efficacy. You must also pay fees.
We evaluate this information to ensure compliance with regulatory requirements.
This stage confirms your medicine meets all requirements and 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 over-the-counter 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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PageRegistered over-the-counter medicine application levels.
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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 guideThe OTC application categorisation framework defines the different OTC medicine application levels and identifies the key application criteria
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PageUse this tool to categorise an application to register a 'new' OTC medicine into the right application level.
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User guideDetermining the route for an OTC application and assessing the risk to consumers with the umbrella brand extension.
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PageUnderstand the N2 application process for sponsors and find over-the-counter (OTC) medicine monographs.
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PageThis guidance is intended for applicants submitting an N1 level application to register a new OTC medicine.
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PageFind out how applications to register an OTC medicine are categorised into five levels based on risk.
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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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PageOutlines the requirements for market authorisation of OTC medicines applied for via the New Medicine N2 application route.
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PageFind out about fees and charges that apply from January 2025.
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PageWe aim to complete the OTC medicine evaluation process within a specified target time.
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PageOverview of the application process for the different types of non-prescription medicines.
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GuidanceThis guidance explains requirements for registering a non-prescription OTC medicine on the Australian Register of Therapeutic Goods (ARTG).
Pre-submission planning
Access requirements for pre-submission planning and meetings.
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GuidanceGuidance on submitting an effective application to register an over-the-counter (OTC) medicine.
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PageUse this tool to categorise an application to register a 'new' OTC medicine into the right application level.
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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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FormsThe completed assurances form is required in Module 1.5 of your OTC new medicine N1 application
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FormsThe completed assurances form is required in Module 1.5 of your OTC new medicine N2 application
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GuidanceGuidance about administrative information to support over-the-counter (OTC) medicine applications in Australia.
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PageDossier requirements for non-prescription medicines
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User guideThe OTC Dossier Documents Matrix (the 'matrix') provides a summary of which documents are required for each application level (N1, N2, N3, N4, N5, C1, C2, C3 or C4)
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User guideThe cover letter (letter of application) needs to provide useful information regarding the nature and scope of the application
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FormsUse this form when submitting an updated RMP after regulatory approval
Product changes and variations
Access information to vary products and sponsorship.
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ChecklistsThis checklist assists sponsors to prepare a change application at the C1 level for a registered OTC medicine.
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GuidanceGuidance to change an OTC medicine, listed in the Australian Register of Therapeutic Goods (ARTG), using the Changes Table.
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User guideThis user guide is for sponsors applying to change the entry in the ARTG for a registered non-prescription OTC medicine.
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PageVary your Australian Register of Therapeutic Goods (ARTG) entry for your non-prescription medicine