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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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PageLearn about the process we follow when we get expert advice on some over-the-counter medicine applications.
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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GuidanceFind out whether your application for an umbrella-branded medicine requires a higher level of assessment.
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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GuidanceHow to confirm that your OTC application is an N1 application and how to compile the information and assurances for N1 applications.
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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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PageFind the monographs available for over-the-counter (OTC) new medicine N2 applications.
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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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FormsThe completed assurances form is required in Module 1.5 of your OTC new medicine N2 application
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GuidanceTo use the N2 application pathway using OTC medicine monographs, you must ensure that your application meets the requirements for N2 applications.
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).
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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Corporate reportsTGA 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
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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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FormsForms for notifying the TGA of a change in sponsorship.
Product types