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
Loading...
Regulation basics
General information on how we regulate registered complementary medicines in Australia.
-
GuidanceGeneral Guidance on the regulation of listed medicines and registered complementary medicines (RCM) in Australia.
-
Definition typeTerms, definitions and acronyms used in Australian therapeutic goods regulation.
Applications and submissions
General information about application and submission requirements.
-
GuidanceGuidance on the evaluation process and information required for new registered complementary medicines.
-
GuidanceGuidance on information required for an effective application to register a complementary medicine and proceed to evaluation.
-
GuidanceGuidance on using literature based submissions for applications for listed, assessed listed and registered complementary medicines.
-
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.
-
GuidanceGuidance on dossier information required for registered complementary medicine applications, to be consistent with the Common Technical Document (CTD) format.
-
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.
-
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.
-
PageFind information about using reports from Comparable Overseas Bodies for applications for listed, assessed listed and registered complementary medicines.
-
GuidanceGuidance for sponsors on changing information in the Australian Register of Therapeutic Goods (ARTG) for registered complementary medicines.
-
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.
-
PageDescribes the minimum approach considered to be acceptable to achieve validation of the test procedures used for complementary medicines (products) and starting materials for use in complementary medicines.
-
Resource typeAccess a list of international guidelines that have been adopted in Australia before manufacturing and supplying your medicine or biological.
-
International scientific guidelines adopted in AustraliaAccess European Union guidelines adopted in Australia that are related to complementary medicines.
Manufacturing
-
PageLinks to information on therapeutic goods manufacturing licenses and overseas Good Manufacturing Practice (GMP) clearance and certification.
-
PublicationsThis guide applies to the manufacture of medicines, active pharmaceutical ingredients and sunscreens, unless exempt under provisions in the Therapeutic Goods Act 1989.
Labelling and advertising
-
GuidanceGuidance for using the 'TGA assessed' claim on labels for assessed listed medicines and registered complementary medicines.
-
PageThe Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (the Code) outlines requirements when advertising to the general public.
Legislation
-
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.
-
LegislationThese regulations provide requirements relating to the manufacturing, supply and advertising of therapeutic goods in Australia. These regulations also set out a number of important elements of the therapeutic goods regulatory scheme in Australia, including for instance specifying fees for applying for marketing approval for a therapeutic good or for a manufacturing licence, and setting out exemptions from the requirement for therapeutic goods other than medical devices to be included in the Australian Register of Therapeutic Goods.
-
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.
-
LegislationThis Therapeutic Goods Order constitutes a standard for child-resistant packaging for specified kinds of medicines.
-
LegislationTo read the full text, visit the Federal Register of Legislation.
-
LegislationThis Therapeutic Goods Order constitutes a standard relating to the kinds of information required to be included on the label of non-prescription medicines.
-
LegislationThis Determination sets legally enforceable standards to ensure therapeutic goods in Australia are manufactured safely, consistently, and to high quality.
-
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.
-
-
PageGroup orders document the differences that result in goods being considered separate and distinct from other goods.
-
PageTherapeutic Goods (Excluded Goods) determinations and specifications.
-
-
GuidanceGuidance for industry organisations applying to add a medicine to the Australian Register of Therapeutic Goods (ARTG).