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

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.

Support to SMEs

EMA provides incentives and support for micro, small and medium-sized enterprises (SMEs) in order to promote innovation and the development of new medicines.

Learn about SME support

Fees for regulatory procedures

Information about EMA's fees and how to pay

View EMA's fees

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

Antimicrobial resistance

Find out about what EMA is doing to combat the threat of antimicoribal resistance in veterinary medicine.

Read about antimicrobial resistance

Medicines intended for limited markets

Developers of medicines intended for veterinary limited markets can benefit from reduced data requirements and enhanced regulatory support from EMA.

Read about veterinary limited markets

Veterinary Medicines information website

Visit the Veterinary Medicines informattion website for information on authorised veterinary medicines across all EU / EEA countries, including their availability in specific countries.

Visit veterinary medicines website

Services and databases

EMA has several websites and systems to support its work. Some of the information in these systems is available to all visitors, such as reports of suspected side effects and other medicine-related data.

Browse services and databases

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 dataVeterinary big dataVeterinary Medicinal Products RegulationVeterinary limited markets