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Veterinary regulatory: overview

Information on the regulation of medicines for veterinary use in the European Union (EU), with a focus on the centralised procedure. The European Medicines Agency (EMA) plays a key role in this procedure.

Croatian is available via eTranslation, the European Commission's machine translation service.

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Veterinary medicines in the product lifecycle

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Research and development

How to design and run clinical trials for veterinary medicines, compliance standards, how to establish maximum residue limits for medicines and biocides, and developing medicines for veterinary limited markets
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Marketing authorisation

Process and requirements for obtaining a centralised marketing authorisation for a veterinary medicine that is valid in all EU Member States as well as in Iceland, Liechtenstein and Norway
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Post-authorisation

Activities after a veterinary medicine has been authorised, including safety monitoring, applying to vary a marketing authorisation, submitting product data to EMA and reporting product defects or recalls
Browse regulatory topics A-Z

Some regulatory topics span the medicinal product lifecycle. This website offers an overview page for these topics, with links to relevant information in the product lifecycle stages.

Topics that span the product lifecycle

Compliance

Standards that veterinary medicine developers, manufacturers and distributors must comply with

SPOR master data

International standards to facilitate the reliable exchange of medicinal product information

Veterinary big data

Joint EMA / Heads of Medicines Agencies (HMA) veterinary big data strategy and workplan and implementation

Union Product Database

Information on the Union Product Database, including guidance for national competent authorities and marketing authorisation holders

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