If you want market authorisation to sell or supply a prescription medicine, this is where your journey begins.
Market authorisation is the approval given by TGA to supply a therapeutic good in Australia. For prescription medicines it involves entry on the Australian Register of Therapeutic Goods (ARTG) and the generation of an AUST R number for your medicine.
You need to understand how prescription medicines are regulated and what your obligations are at each stage of the market authorisation process.
This includes:
selecting the appropriate registration pathway
preparing supporting evidence
being aware of fees
ensuring your product meets applicable standards and requirements
meeting ongoing responsibilities post-market.
Being well prepared helps ensure your product complies with Australian requirements and reduces the risk of regulatory delays.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to prescription 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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PageInformation for sponsors on how the Therapeutic Goods Administration (TGA) defines and regulates prescription medicines.
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GuidanceGuidance on the process and regulatory requirements to register prescription medicines.
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PageInformation on how to legally supply a prescription medicine in Australia. This includes how to register the product in the Australian Register of Therapeutic Goods (ARTG) and guidance to understand the ongoing responsibilities.
Definitions and classification
Understand how products are defined and classified.
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PageHow the TGA defines generic and biosimilar medicines and where to find information on generic and biosimilar prescription medicine registrations.
Ingredients and scheduling
Get information about ingredient approvals and scheduling requirements.
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PageUnderstand what ingredient requirements apply to your therapeutic good.
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FormsPrescription medicines Minor Variation E-form now available
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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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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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 prescription and other related medicines.
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LegislationThis Determination specifies the information that must accompany an application to register a prescription medicine on the Australian Register of Therapeutic Goods (ARTG).
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LegislationThis Specification facilitates the release of specified therapeutic goods information relating to prescription medicines to Therapeutic Guidelines Ltd (TGL) to facilitate the publication of specified information in the journal Australian Prescriber.
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LegislationThis Specification facilitates the publication of specified therapeutic goods information relating to applications for the registration of prescription medicines in 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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PageComplying with the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to Good Manufacturing Practice (GMP).
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PageInformation on special considerations required for medicines for use in special populations.
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PagePharmacopoeias provide standards for pharmaceutical substances and medicinal products.
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PageStandards and guidelines for prescription medicines