Veterinary regulatory: overviewInformation 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 lifecycleResearch 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-ZSome regulatory 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 feesTopics that span the product lifecycleAntimicrobial 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 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 databasesTopics A-ZAntimicrobial resistance in veterinary medicineApplication guidance (veterinary medicines)Availability of veterinary vaccinesComplianceBuying veterinary medicines onlineEthical use of animals in medicine testingSupport to SMEsVeterinary big dataVeterinary Medicinal Products RegulationVeterinary limited marketsShare this pageBack to top
Veterinary medicines in the product lifecycleResearch 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-ZSome regulatory 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 feesTopics that span the product lifecycleAntimicrobial 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 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 databasesTopics A-ZAntimicrobial resistance in veterinary medicineApplication guidance (veterinary medicines)Availability of veterinary vaccinesComplianceBuying veterinary medicines onlineEthical use of animals in medicine testingSupport to SMEsVeterinary big dataVeterinary Medicinal Products RegulationVeterinary limited marketsShare this pageBack to top
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
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
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
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 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 databasesTopics A-ZAntimicrobial resistance in veterinary medicineApplication guidance (veterinary medicines)Availability of veterinary vaccinesComplianceBuying veterinary medicines onlineEthical use of animals in medicine testingSupport to SMEsVeterinary big dataVeterinary Medicinal Products RegulationVeterinary limited marketsShare this pageBack to top
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 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 databasesTopics A-ZAntimicrobial resistance in veterinary medicineApplication guidance (veterinary medicines)Availability of veterinary vaccinesComplianceBuying veterinary medicines onlineEthical use of animals in medicine testingSupport to SMEsVeterinary big dataVeterinary Medicinal Products RegulationVeterinary limited marketsShare this pageBack to top
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 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 databasesTopics A-ZAntimicrobial resistance in veterinary medicineApplication guidance (veterinary medicines)Availability of veterinary vaccinesComplianceBuying veterinary medicines onlineEthical use of animals in medicine testingSupport to SMEsVeterinary big dataVeterinary Medicinal Products RegulationVeterinary limited marketsShare this pageBack to top
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 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 databasesTopics A-ZAntimicrobial resistance in veterinary medicineApplication guidance (veterinary medicines)Availability of veterinary vaccinesComplianceBuying veterinary medicines onlineEthical use of animals in medicine testingSupport to SMEsVeterinary big dataVeterinary Medicinal Products RegulationVeterinary limited marketsShare this pageBack to top
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 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 databasesTopics A-ZAntimicrobial resistance in veterinary medicineApplication guidance (veterinary medicines)Availability of veterinary vaccinesComplianceBuying veterinary medicines onlineEthical use of animals in medicine testingSupport to SMEsVeterinary big dataVeterinary Medicinal Products RegulationVeterinary limited marketsShare this pageBack to top
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 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 databasesTopics A-ZAntimicrobial resistance in veterinary medicineApplication guidance (veterinary medicines)Availability of veterinary vaccinesComplianceBuying veterinary medicines onlineEthical use of animals in medicine testingSupport to SMEsVeterinary big dataVeterinary Medicinal Products RegulationVeterinary limited marketsShare this pageBack to top
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 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 databasesTopics A-ZAntimicrobial resistance in veterinary medicineApplication guidance (veterinary medicines)Availability of veterinary vaccinesComplianceBuying veterinary medicines onlineEthical use of animals in medicine testingSupport to SMEsVeterinary big dataVeterinary Medicinal Products RegulationVeterinary limited marketsShare this pageBack to top
Union Product Database Information on the Union Product Database, including guidance for national competent authorities and marketing authorisation holders