If you're planning to bring an over-the-counter (OTC) medicine to market in Australia, this is your starting point.
You need to understand how we regulate these products and your obligations at each stage of the medicine's lifecycle. This includes choosing the right pathway, preparing evidence, and meeting quality and safety requirements for your medicine.
Being well prepared helps ensure your product meets Australian requirements and avoids delays in the approval process.
Start by learning your responsibilities and planning each stage of your product’s lifecycle.
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.
General information
Learn about how products are regulated.
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PageOver-the-counter medicines (OTC) are not prescription medicines or complementary medicines.
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PageIngredient requirements for non-prescription medicines
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PageLearn about your on-going responsibilities once your non-prescription medicine is on the Australian Register of Therapeutic Goods.
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PageManufacturing information and standards for non-prescription 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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PageOverview of the application process for the different types of non-prescription medicines.
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GuidanceGuidance on generic and originator medicines in the context of over-the-counter (OTC) non-prescription medicine applications.
Ingredients and scheduling
Get information about ingredient approvals and scheduling requirements.
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PageLinks to public notices on invitations for and public comment on scheduling proposals, scheduling decisions, applications and other consultations and reviews.
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PageLinks to and information on scheduling and the Poisons Standard including public notices, state and territory information, the scheduling advisory committees and proposed committee meeting dates and decision timeframes.
Legislation, Acts and Orders
Review the laws and legal orders that regulate therapeutic goods.
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PageFind information about legislation, acts and regulations, legislative instruments and other legislative information.
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PageLearn about Required Advisory Statements for Medicine Labels (RASML).
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LegislationThe Poisons Standard classifies medicines and poisons into different Schedules, signifying the degree of risk and the control recommended to be exercised over their availability to the public. Sometimes referred to as the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP).
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LegislationTo read the full text, visit the Federal Register of Legislation.
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LegislationThis Instrument authorises the release of specified therapeutic goods information relating to medicine shortages and availability data either to a specified person, body or authority or to the public.
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LegislationThis Specification sets out the required advisory statements for specified non-prescription medicines, including over the counter and registered complementary medicines.
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LegislationThis Determination sets out the list of reportable medicines which forms the Medicines Watch List under s 30EJ(1) of the Therapeutic Goods Act 1989.
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LegislationThe TGO 100 Order sets forth the minimum microbiological quality standards that therapeutic goods must meet.
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LegislationThis Therapeutic Goods Order constitutes a standard relating to the kinds of information required to be included on the label of non-prescription medicines.
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LegislationThis Therapeutic Goods Order constitutes a standard for child-resistant packaging for specified kinds of medicines.
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LegislationThis Determination specifies the information that must accompany an application to register an over the counter medicine on the Australian Register of Therapeutic Goods (ARTG).
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LegislationThe Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019 outlines the quality standards for therapeutic goods such as tablets, capsules, and pills in Australia.
Standards and requirements
Understand product obligations for safety, quality and efficacy.
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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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PageThe ARGOM will help you navigate the regulatory requirements for over-the-counter (OTC) medicines in Australia.
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PageComplying with the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to Good Manufacturing Practice (GMP).
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FormsInformation on completing and submitting an OTC analytical validation summary form
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PageUnderstand the N2 application process for sponsors and find over-the-counter (OTC) medicine monographs.
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PagePharmacopoeias provide standards for pharmaceutical substances and medicinal products.
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PageOutlines the requirements for market authorisation of OTC medicines applied for via the New Medicine N2 application route.