If you're planning to bring a registered complementary 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 your medicine’s lifecycle. This includes choosing the right pathway, preparing evidence and meeting all applicable quality and safety requirements.
Being well prepared helps ensure your product meets Australian requirements and avoids delays in getting your medicine approved.
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 registered complementary 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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PageIngredient requirements for non-prescription medicines
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PageFind out the differences between food and medicine regulation and use our tool to know how your product is classified.
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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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PageResources for sponsors of listed medicines and 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 providing an overview of the regulation of listed medicines and registered complementary medicines in Australia.
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GuidanceGuidance to help you understand the different types of complementary medicines.
Definitions and classification
Understand how products are defined and classified.
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GuidanceGuidance providing an overview of the regulation of listed medicines and registered complementary medicines in Australia.
Ingredients and scheduling
Get information about ingredient approvals and scheduling requirements.
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PageFind information on the Poisons Standard (the SUSMP), amending the Poisons Standard and Scheduling.
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GuidanceGuidance for data requirements for microorganisms used as active ingredients in listed or registered complementary medicines. These are generally referred to as probiotics or postbiotics.
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GuidanceGuidance on the use of modified unprocessed herbal materials in complementary medicines
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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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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LegislationThis Specification provides what information must accompany an application to register complementary medicines on the Australian Register of Therapeutic Goods (ARTG).
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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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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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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.
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GuidanceGuidance providing an overview of the regulation of listed medicines and registered complementary medicines in Australia.
Standards and requirements
Understand product obligations for safety, quality and efficacy.
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PageKnow the minimum acceptable approach to achieve validation of test procedures used for complementary medicines (products) and starting materials for use in complementary medicines.
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PageComplying with the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to Good Manufacturing Practice (GMP).
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PageFind out what standards and requirements you must comply with to legally sell or supply your medicine in Australia.
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PagePharmacopoeias provide standards for pharmaceutical substances and medicinal products.
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GuidanceGuidance providing an overview of the regulation of listed medicines and registered complementary medicines in Australia.