If you're planning to bring an assessed listed 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 Australian Register of Therapeutic Goods (ARTG) entry pathway, preparing evidence, and meeting quality and safety requirements for the medicine.
Being well prepared helps ensures your product meets Australian requirements and avoids delays getting your product to market.
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 assessed listed 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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PageAssessed listed medicines have low risk ingredients, but slightly higher risk indications (intended uses) than listed medicines.
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PageThe ARGLM will help you navigate the regulatory requirements for listed and assessed listed medicines in Australia.
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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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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.
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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User guideA user guide for applicants using the TGA Business services (TBS) portal to complete an online application form for a new substance application.
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GuidanceGuidance on how to access and use the Permissible Ingredients Determination for the purposes of submitting applications for substances in listed and assessed listed 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 Determination specifies what information must accompany applications to list complementary medicines on the Australian Register of Therapeutic Goods (ARTG).
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LegislationThis Specification specifies therapeutic goods information that may be released by the Secretary in relation to compliance reviews of listed medicines.
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LegislationThis Determination sets out conditions for listing specified listed medicines on the Australian Register of Therapeutic Goods (ARTG).
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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 sets out the list of permitted therapeutic claims (indications) which may be made in relation to medicines that are listed on the Australian Register of Therapeutic Goods (ARTG) under sections 26A, or 26AE, of the Therapeutic Goods Act 1989 (these are listed, and listed assessed medicines).
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LegislationThis Determination sets out a list of ingredients which have been assessed or otherwise considered to be safe for use in medicines that are listed in the Australian Register of Therapeutic Goods (ARTG) (including assessed listed medicines), and associated requirements to be followed when using particular ingredients in such medicines.
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LegislationThis Determination specifies the kind of information that must accompany an application for a recommendation by the Secretary that the Minister vary a section 26BB determination made under the Therapeutic Goods Act 1989.
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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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PageAssuring the safety and quality of non-prescription 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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PageExplains what our compositional guidelines are, how they are used and how to develop them by using compositional guideline templates.
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GuidanceGuidance on the use of permitted indications in listed medicines.
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PagePharmacopoeias provide standards for pharmaceutical substances and medicinal products.
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PageOverview of stability testing of listed complementary medicines for sponsors and manufacturers.
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GuidanceGuidance providing an overview of the regulation of listed medicines and registered complementary medicines in Australia.
Product types