Australian Regulatory Guidelines for OTC Medicines (ARGOM)
The ARGOM will help you navigate the regulatory requirements for over-the-counter (OTC) medicines in Australia. This includes registering a new medicine, varying an existing registration, dossier requirements and more.
Last updated
Application process for over-the-counter (OTC) medicines
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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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GuidanceThis guidance explains requirements for registering a non-prescription OTC medicine on the Australian Register of Therapeutic Goods (ARTG).
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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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GuidanceGuidance to change an OTC medicine, listed in the Australian Register of Therapeutic Goods (ARTG), using the Changes Table.
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TopicLearn about our fees and charges, which recover the cost of regulation from industry.
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PageWe aim to complete the OTC medicine evaluation process within a specified target time.
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GuidanceGuidance on whether medicines are evaluated as prescription medicines or complementary or over-the-counter (OTC) medicines.
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User guideHow to get approved PI and CMI documents for OTC medicines published on our website.
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PageWe may decide to seek advice from an expert advisory committee during the evaluation of an application to register or change an over-the-counter (OTC) medicine.
Application levels for OTC medicines
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PageRegistered over-the-counter medicine application levels.
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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.
General application and dossier requirements
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GuidanceGuidance on submitting an effective application to register an over-the-counter (OTC) medicine.
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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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GuidanceGuidance about administrative information to support over-the-counter (OTC) medicine applications in Australia.
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GuidanceGuidance providing an overview of the Common Technical Document (CTD), modules 1-5. The CTD is a set of dossier specifications for the registration of medicines.
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User guideThe cover letter (letter of application) needs to provide useful information regarding the nature and scope of the application
Specific application and dossier requirements
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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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FormsThe completed assurances form is required in Module 1.5 of your OTC new medicine N1 application
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PageUnderstand the N2 application process for sponsors and find over-the-counter (OTC) medicine monographs.
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PageOutlines the requirements for market authorisation of OTC medicines applied for via the New Medicine N2 application route.
Specific technical guidance for OTC medicines
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GuidanceThis guidance describes the safety and efficacy data you will need for Common Technical Document (CTD) Module 4 and Module 5 to support applications for over-the-counter (OTC) medicines.
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GuidanceGuidance about evidence required to substantiate the quality of the product, for over-the-counter (OTC) medicine registration applications.
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GuidanceAustralian regulatory guidelines for over-the-counter medicines (ARGOM) Appendix 3.
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GuidanceAustralian regulatory guidelines for over-the-counter medicines (ARGOM) Appendix 4.
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GuidanceGuidance to assist you with submitting acceptable applications for registration of over-the-counter (OTC) medicines.
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PageLearn about Required Advisory Statements for Medicine Labels (RASML).
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User guideWe have made templates for Product Information (PI) and Consumer Medicine Information (CMI) documents to assist sponsors lodging variation applications for solid-dose single ingredient paracetamol products affected by scheduling changes.
Other Guidance and resources
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PageFind information about legislation, acts and regulations, legislative instruments and other legislative information.
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GuidanceGuidance on how the Poisons Standard is amended and the processes that underpin scheduling policy
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PublicationsTGA approach to disclosure of commercially confidential information (CCI)
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PageAll ingredients used in therapeutic goods require an Australian Approved Name.
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PageInformation on colourings in medicines for topical and oral use.
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User guideInformation on how to compile a literature based submission (including mixed applications).
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PageFind out about obtaining Good Manufacturing Practice (GMP) clearance for an overseas manufacturing site.
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GuidanceGuidance on providing adventitious agent safety information in applications for medicines containing, or manufactured using, materials of animal or human origin.
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GuidanceGuidance on the two mechanisms to provide information about a drug substance sourced from a third-party manufacturer.
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GuidanceGuidance on bioavailability and/or bioequivalence aspects of medicines including information on biowaivers.
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GuidanceGuidance to assist sponsors and manufacturers comply with Therapeutic Goods (Microbiological standards for medicines) (TGO 100) Order 2018.
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GuidanceGuidance about application pathways and data requirements for new generic medicines, and variations to existing medicines.
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GuidanceThis guidance describes the requirements for sunscreens (and their ingredients), that we regulate as therapeutic goods in Australia.
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GuidanceGuidance for sponsors and manufacturers of prescription medicines that contain, or are produced by, genetically modified organisms (GMOs).
International guidelines
Get access to European union and International Conference on Harmonisation (ICH) guidelines.
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Resource typeAccess a list of international guidelines that have been adopted in Australia before manufacturing and supplying your medicine or biological.
Forms
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FormsUpdated form used to notify us of proprietary ingredient mixtures for use in therapeutic goods.
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