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General information on how we regulate registered complementary medicines in Australia.
Australian Regulatory Guidelines for Registered Complementary Medicines (ARGRCM)
The ARGRCM will help you navigate the regulatory requirements for registered complementary medicines in Australia. This includes requirements for applications, quality, product labelling and ingredients.
Last updated
Regulation basics
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GuidanceGuidance providing an overview of the regulation of listed medicines and registered complementary medicines in Australia.
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Definition typeView terms and acronyms commonly used in Australian therapeutic goods regulation, and their definitions. This list is intended for general informational purposes and is not exhaustive.
Applications and submissions
General information about application and submission requirements.
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GuidanceGuidance on the evaluation process and information required for new registered complementary medicines.
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GuidanceGuidance on information required for an effective application to register a complementary medicine and proceed to evaluation.
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GuidanceGuidance on using literature based submissions for applications for listed, assessed listed and registered complementary medicines.
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GuidanceGuidance for applicants on information required for Module 1 in dossiers for applications for registered complementary medicines to be consistent with the Common Technical Document (CTD) format.
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GuidanceGuidance on dossier information required for registered complementary medicine applications, to be consistent with the Common Technical Document (CTD) format.
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User guideStep by step user guide on submitting applications to register a complementary medicine or over the counter (OTC) medicine in the Australian Register of Therapeutic Goods, using the TGA Business services.
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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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PageFind information about using reports from Comparable Overseas Bodies for applications for listed, assessed listed and registered complementary medicines.
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GuidanceGuidance for sponsors on changing information in the Australian Register of Therapeutic Goods (ARTG) for registered complementary medicines.
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GuidanceGuidance explaining types of variations, for registered medicines and biologicals, that can be submitted as notifications due to being very low risk.
Safety and quality
Information on quality and safety requirements and international guidelines we have adopted.
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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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Resource typeAccess a list of international guidelines that have been adopted in Australia before manufacturing and supplying your medicine or biological.
Ingredients and substances
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GuidanceGuidance on our approved terminology for medicines.
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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.
Manufacturing
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PageLinks to information on therapeutic goods manufacturing licenses and overseas Good Manufacturing Practice (GMP) clearance and certification.
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PageComplying with the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to Good Manufacturing Practice (GMP).
Labelling and advertising
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GuidanceGuidance for using the 'TGA assessed' claim on labels for assessed listed medicines and registered complementary medicines.
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PageThe Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (the Code) outlines requirements when advertising to the public.
Legislation
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LegislationThe Therapeutic Goods Act 1989 provides for the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia.
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LegislationThese regulations provide requirements relating to the manufacturing, supply and advertising of therapeutic goods in Australia.
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LegislationThis Instrument contains the Therapeutic Goods Advertising Code. The Code specifies a range of requirements to protect the Australian public from the personal and public health risks associated with unethical, inaccurate or misleading advertising practices relating to the advertising of therapeutic goods.
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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 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 Determination sets legally enforceable standards to ensure therapeutic goods in Australia are manufactured safely, consistently, and to high quality.
More information about legislation
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PageThe Poisons Standard consists of decisions regarding the classification of medicines and poisons into Schedules for inclusion in the relevant legislation of the States and Territories.
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PageGroup orders document the differences that result in goods being considered separate and distinct from other goods.
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PageTherapeutic Goods (Excluded Goods) determinations and specifications.
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GuidanceGuidance for industry organisations applying to add a medicine to the Australian Register of Therapeutic Goods (ARTG).
Product types