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.
Veterinary medicines in the product lifecycle
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
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
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
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
Antimicrobial resistance in veterinary medicine
Antimicrobials strategy, EU data on the use of veterinary antimicrobials and recommendations on using antimicrobials in animals
Buying veterinary medicines online
What you can do to reduce the risk of buying sub-standard medicines online
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
COVID-19: information on veterinary medicines
Regulatory information on the impact of the COVID-19 pandemic on veterinary medicines
Veterinary big data
Joint EMA / Heads of Medicines Agencies (HMA) veterinary big data strategy and workplan and implementation
Veterinary Medicinal Products Regulation
Implementation of the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) which became applicable on 28 January 2022
Union Product Database
Information on the Union Product Database, including guidance for national competent authorities and marketing authorisation holders
Topics A-Z
Antimicrobial resistance in veterinary medicineApplication guidance (veterinary medicines)Availability of veterinary vaccinesComplianceBuying veterinary medicines onlineEthical use of animals in medicine testingFeesGuidance documentsInnovation in veterinary medicinesMaximum residue limitsPharmacovigilanceProduct defects and recallsProduct-information requirements for veterinary medicinesQuality by designReferral procedures: veterinary medicinesScientific adviceScientific guidelinesSubstance, product, organisation and referential (SPOR) master dataSupport to SMEsVeterinary big dataVeterinary Medicinal Products RegulationVeterinary limited markets