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class="main-content-wrapper" role="main" aria-label="Main content"><div class="container mt-3"><div class="row"><div class="col-12"><div data-drupal-messages-fallback class="hidden"></div><div id="block-ema-content-banner--2"><div class="node ema-landing-page content-banner ema-landing-page--content-banner mb-4-75 bcl-content-banner ema-light-blue"><div class="container px-0"><div class="row"><div class="col-12"><article class="bg-transparent border-0 card container"><div class="row"><div class="left-col col-12 col-md-3 col-lg-2"><div class="img-wrapper format-svg"><img src="https://www.ema.europa.eu/sites/default/files/2023-12/Woman_veterinarian_dog_A.svg" alt="icon medical doctor with dog illustrating regulatory information for veterinary medicines" class="card-img-top rounded-1" /></div></div><div class="right-col col-12 col-md-9 col-lg-10"><div class="card-body container"><div class="row"><div class="col"><div class="heading-title"><h1 class="content-banner-title card-title bcl-heading"><span>Veterinary regulatory: overview</span></h1></div><div class="heading-actions align-self-stretch d-flex justify-content-end"><div class="action-bar"><div class="ema-social-media-share button"><script type="application/json">{"service":"share","version":"2.0","more":["email","linkedin","bluesky","facebook","whatsapp","blogger","digg","gmail","netvibes","pinterest","pocket","printfriendly","qzone","reddit","threads","tumblr","typepad","viadeo","weibo","yahoomail","yammer"],"selection":true,"stats":true,"target":"_blank"}</script></div></div></div><div class="card-content-block"><div class="card-content-wrapper"><div class="content"><div class="field string-long ema-landing-page__field-ema-summary">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.</div></div></div><div class="d-flex flex-column flex-lg-row justify-content-between gap-3"></div></div></div></div></div></div></div></article></div></div></div></div></div></div><div class="col-12 "><div class="row"><div class="col-12"><div id="block-system-main-block" class="main-content"><article class="node ema-landing-page ema-landing-page--full container content-without-sidebar"><div class="ema-node-content-wrapper node-sections"><div class="item"><div id="veterinary-medicines-in-the-product-lifecycle-59158" class="bcl-listing bcl-listing--highlight-3-col"><h2 class="rounded-title bcl-heading">Veterinary medicines in the product lifecycle</h2><div class="row row-cols-1 row-cols-lg-3 g-4-5" ><div class="col"><article class="listing-item--highlight border-0 bg-lighter h-100 rounded-2 card"><div class="img-wrapper format-svg"><img src="https://www.ema.europa.eu/sites/default/files/2023-12/Microscope_veterinary-research_96x96px.svg" alt="icon microscope with dog's face illustrating veterinary research." class="card-img-top mb-3" /></div><div class="card-body pt-0"><h4 class="listing-item-title card-title bcl-heading"><a href="/en/veterinary-regulatory-overview/research-development-veterinary-medicines" class="standalone">Research and development</a></h4><div class="card-text mb-2"> 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 </div></div></article></div><div class="col"><article class="listing-item--highlight border-0 bg-lighter h-100 rounded-2 card"><div class="img-wrapper format-svg"><img src="https://www.ema.europa.eu/sites/default/files/2023-12/Document_arrow_veterinary_96x96px.svg" alt="icon document with dog's face illustrating marketing authorisation for veterinary medicines" class="card-img-top mb-3" /></div><div class="card-body pt-0"><h4 class="listing-item-title card-title bcl-heading"><a href="/en/veterinary-regulatory-overview/marketing-authorisation-veterinary-medicines" class="standalone">Marketing authorisation </a></h4><div class="card-text mb-2"> 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 </div></div></article></div><div class="col"><article class="listing-item--highlight border-0 bg-lighter h-100 rounded-2 card"><div class="img-wrapper format-svg"><img src="https://www.ema.europa.eu/sites/default/files/2023-12/Document_veterinary_magnify-glass_96x96px.svg" alt="icon document with dog's face and magnifying glass illustrating post-authorisation for veterinary medicines" class="card-img-top mb-3" /></div><div class="card-body pt-0"><h4 class="listing-item-title card-title bcl-heading"><a href="/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines" class="standalone">Post-authorisation</a></h4><div class="card-text mb-2"> 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 </div></div></article></div></div><a href="https://ema.europa.eu/en/veterinary-regulatory-overview#ema-inpage-item-59182" class="btn btn-link mt-3-5 d-inline-block">Browse regulatory topics A-Z<svg class="ms-2-5 bi icon--s" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#arrow-right"/></svg></a></div></div><div class="item"><div id="ema-inpage-item-64310" class="paragraph paragraph--type--oe-rich-text paragraph--view-mode--default"><div class="ecl-editor"><p>Some regulatory <a href="https://www.ema.europa.eu/en/veterinary-regulatory-overview#ema-inpage-item-59164">topics span the medicinal product lifecycle</a>. This website offers an overview page for these topics, with links to relevant information in the product lifecycle stages.</p></div></div></div><div class="item"><div class="bg-lighter text-dark bcl-banner overlay"><div class="bcl-banner__image" style="background-image:url(https://www.ema.europa.eu/sites/default/files/2023-12/D10_WEB_innovation%20in%20med%20development.png)"></div><div class="container"><div class="bcl-banner__content"><div class="banner-heading"><div class="display-6 mb-3 bcl-heading"><div id="support-to-smes-59172"><span> Support to SMEs </span></div></div></div><div class="banner-description"><p class="mb-4"> EMA provides incentives and support for micro, small and medium-sized enterprises (SMEs) in order to promote innovation and the development of new medicines. </p></div><div class="banner-cta"><a href="/en/about-us/support-smes" class="btn btn-secondary">Learn about SME support<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#chevron-right"/></svg></a></div></div></div></div></div><div class="item"><div class="bg-lighter text-dark bcl-banner"><div class="container"><div class="bcl-banner__content"><div class="banner-heading"><div class="display-6 mb-3 bcl-heading"><div id="fees-for-regulatory-procedures-59171"><span> Fees for regulatory procedures </span></div></div></div><div class="banner-description"><p class="mb-4"> Information about EMA's fees and how to pay </p></div><div class="banner-cta"><a href="/en/about-us/fees-payable-european-medicines-agency" class="btn btn-secondary">View EMA's fees<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#chevron-right"/></svg></a></div></div></div></div></div><div class="item"><div id="topics-that-span-the-product-lifecycle-59164" class="bcl-listing bcl-listing--default-2-col"><h2 class="rounded-title bcl-heading">Topics that span the product lifecycle</h2><div class="row row-cols-1 row-cols-md-2 g-4" ><div class="col"><article class="listing-item border-bottom border-md-0 border-0 card"><div class="card-body p-0 pb-3"><h4 class="listing-item-title card-title bcl-heading"><a href="/en/veterinary-regulatory-overview/antimicrobial-resistance-veterinary-medicine" class="standalone">Antimicrobial resistance in veterinary medicine</a></h4><div class="card-text mb-2"> Antimicrobials strategy, EU data on the use of veterinary antimicrobials and recommendations on using antimicrobials in animals </div></div></article></div><div class="col"><article class="listing-item border-bottom border-md-0 border-0 card"><div class="card-body p-0 pb-3"><h4 class="listing-item-title card-title bcl-heading"><a href="/en/veterinary-regulatory-overview/buying-veterinary-medicines-online" class="standalone">Buying veterinary medicines online</a></h4><div class="card-text mb-2"> What you can do to reduce the risk of buying sub-standard medicines online </div></div></article></div><div class="col"><article class="listing-item border-bottom border-md-0 border-0 card"><div class="card-body p-0 pb-3"><h4 class="listing-item-title card-title bcl-heading"><a href="/en/veterinary-regulatory-overview/compliance-overview-veterinary-medicines" class="standalone">Compliance</a></h4><div class="card-text mb-2"> Standards that veterinary medicine developers, manufacturers and distributors must comply with </div></div></article></div><div class="col"><article class="listing-item border-bottom border-md-0 border-0 card"><div class="card-body p-0 pb-3"><h4 class="listing-item-title card-title bcl-heading"><a href="/en/veterinary-regulatory-overview/substance-product-organisation-referential-spor-master-data" class="standalone">SPOR master data</a></h4><div class="card-text mb-2"> International standards to facilitate the reliable exchange of medicinal product information </div></div></article></div><div class="col"><article class="listing-item border-bottom border-md-0 border-0 card"><div class="card-body p-0 pb-3"><h4 class="listing-item-title card-title bcl-heading"><a href="/en/veterinary-regulatory-overview/covid-19-information-veterinary-medicines" class="standalone">COVID-19: information on veterinary medicines</a></h4><div class="card-text mb-2"> Regulatory information on the impact of the COVID-19 pandemic on veterinary medicines </div></div></article></div><div class="col"><article class="listing-item border-bottom border-md-0 border-0 card"><div class="card-body p-0 pb-3"><h4 class="listing-item-title card-title bcl-heading"><a href="/en/veterinary-regulatory-overview/veterinary-big-data" class="standalone">Veterinary big data</a></h4><div class="card-text mb-2"> Joint EMA / Heads of Medicines Agencies (HMA) veterinary big data strategy and workplan and implementation </div></div></article></div><div class="col"><article class="listing-item border-bottom border-md-0 border-0 card"><div class="card-body p-0 pb-3"><h4 class="listing-item-title card-title bcl-heading"><a href="/en/veterinary-regulatory-overview/veterinary-medicinal-products-regulation" class="standalone">Veterinary Medicinal Products Regulation </a></h4><div class="card-text mb-2"> Implementation of the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) which became applicable on 28 January 2022 </div></div></article></div><div class="col"><article class="listing-item border-bottom border-md-0 border-0 card"><div class="card-body p-0 pb-3"><h4 class="listing-item-title card-title bcl-heading"><a href="/en/veterinary-regulatory-overview/veterinary-medicinal-products-regulation/union-product-database" class="standalone">Union Product Database</a></h4><div class="card-text mb-2"> Information on the Union Product Database, including guidance for national competent authorities and marketing authorisation holders </div></div></article></div></div></div></div><div class="item"><div class="bg-lighter bcl-banner shade"><div class="bcl-banner__image" style="background-image:url(https://www.ema.europa.eu/sites/default/files/2023-12/D10_WEB_Antimicrobial%20resistance_1.png)"></div><div class="container"><div class="bcl-banner__content"><div class="banner-heading"><div class="display-6 mb-3 bcl-heading"><div id="antimicrobial-resistance-59160"><span> Antimicrobial resistance </span></div></div></div><div class="banner-description"><p class="mb-4"> Find out about what EMA is doing to combat the threat of antimicoribal resistance in veterinary medicine. </p></div><div class="banner-cta"><a href="/en/veterinary-regulatory-overview/antimicrobial-resistance-veterinary-medicine" class="btn btn-secondary">Read about antimicrobial resistance<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#chevron-right"/></svg></a></div></div></div></div></div><div class="item"><div class="bg-ema-dark-blue text-white bcl-banner"><div class="container"><div class="bcl-banner__content"><div class="banner-heading"><div class="display-6 mb-3 bcl-heading"><div id="medicines-intended-for-limited-markets-63318"><span> Medicines intended for limited markets </span></div></div></div><div class="banner-description"><p class="mb-4"> Developers of medicines intended for veterinary limited markets can benefit from reduced data requirements and enhanced regulatory support from EMA. </p></div><div class="banner-cta"><a href="/en/veterinary-regulatory-overview/research-development-veterinary-medicines/veterinary-limited-markets" class="btn btn-light">Read about veterinary limited markets<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#chevron-right"/></svg></a></div></div></div></div></div><div class="item"><div class="bg-lighter bcl-banner shade"><div class="bcl-banner__image" style="background-image:url(https://www.ema.europa.eu/sites/default/files/2023-12/D10_WEB_Vet%20med%20info%20website.png)"></div><div class="container"><div class="bcl-banner__content"><div class="banner-heading"><div class="display-6 mb-3 bcl-heading"><div id="veterinary-medicines-information-website-63316"><span> Veterinary Medicines information website </span></div></div></div><div class="banner-description"><p class="mb-4"> Visit the Veterinary Medicines informattion website for information on authorised veterinary medicines across all EU / EEA countries, including their availability in specific countries. </p></div><div class="banner-cta"><a href="https://medicines.health.europa.eu/veterinary" class="btn btn-secondary">Visit veterinary medicines website<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#chevron-right"/></svg></a></div></div></div></div></div><div class="item"><div class="bg-lighter bcl-banner shade"><div class="bcl-banner__image" style="background-image:url(https://www.ema.europa.eu/sites/default/files/2023-12/AdobeStock_493875849.jpeg)"></div><div class="container"><div class="bcl-banner__content"><div class="banner-heading"><div class="display-6 mb-3 bcl-heading"><div id="services-and-databases-64700"><span> Services and databases </span></div></div></div><div class="banner-description"><p class="mb-4"> 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. </p></div><div class="banner-cta"><a href="/en/about-us/how-we-work/services-databases" class="btn btn-secondary">Browse services and databases<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#chevron-right"/></svg></a></div></div></div></div></div><div class="item"><div class="paragraph paragraph--type--ema-links-block-multiple paragraph--view-mode--default" id="ema-inpage-item-59183"><div class="links-block-multiple-wrapper"><div class="d-flex flex-row justify-content-between row row-cols-1 row-cols-lg-3 g-4-5"><div class="flex-fill col"><div class="links-block-multiple-column section links-list" id="ema-inpage-item-59182"><h4 id="topics-a-z-59182" class="rounded-title">Topics A-Z</h4><div class="links-block-multiple-column-links"><div class="ema-links-block-multiple-item__field-oe-links"><ul class="field__items"><li class="field__item"><a href="/en/veterinary-regulatory-overview/antimicrobial-resistance-veterinary-medicine">Antimicrobial resistance in veterinary medicine</a></li><li class="field__item"><a href="/en/veterinary-regulatory-overview/marketing-authorisation-veterinary-medicines/application-guidance-veterinary-medicines">Application guidance (veterinary medicines)</a></li><li class="field__item"><a href="/en/veterinary-regulatory-overview/research-development-veterinary-medicines/availability-veterinary-vaccines">Availability of veterinary vaccines</a></li><li class="field__item"><a href="/en/veterinary-regulatory-overview/compliance-overview-veterinary-medicines">Compliance</a></li><li class="field__item"><a href="/en/veterinary-regulatory-overview/buying-veterinary-medicines-online">Buying veterinary medicines online</a></li><li class="field__item"><a href="/en/human-regulatory-overview/research-development/ethical-use-animals-medicine-testing">Ethical use of animals in medicine testing</a></li><li class="field__item"><a href="/en/about-us/fees-payable-european-medicines-agency">Fees</a></li><li class="field__item"><a href="/en/veterinary-regulatory-overview/marketing-authorisation-veterinary-medicines/guidance-documents">Guidance documents</a></li><li class="field__item"><a href="/en/veterinary-regulatory-overview/research-development-veterinary-medicines/innovation-veterinary-medicines">Innovation in veterinary medicines</a></li><li class="field__item"><a href="/en/veterinary-regulatory-overview/research-development-veterinary-medicines/maximum-residue-limits-mrl">Maximum residue limits</a></li><li class="field__item"><a href="/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/pharmacovigilance-veterinary-medicines">Pharmacovigilance</a></li><li class="field__item"><a href="/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/compliance-post-authorisation-veterinary-medicines/product-defects-recalls">Product defects and recalls</a></li><li class="field__item"><a href="/en/veterinary-regulatory-overview/marketing-authorisation-veterinary-medicines/product-information-requirements-veterinary-medicines">Product-information requirements for veterinary medicines</a></li><li class="field__item"><a href="/en/veterinary-regulatory-overview/research-and-development-veterinary-medicines/quality-design">Quality by design</a></li><li class="field__item"><a href="/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/referral-procedures-veterinary-medicines">Referral procedures: veterinary medicines</a></li><li class="field__item"><a href="/en/veterinary-regulatory-overview/research-and-development-veterinary-medicines/scientific-advice">Scientific advice</a></li><li class="field__item"><a href="/en/veterinary-regulatory-overview/research-development-veterinary-medicines/scientific-guidelines-veterinary-medicines">Scientific guidelines</a></li><li class="field__item"><a href="/en/veterinary-regulatory-overview/substance-product-organisation-referential-spor-master-data">Substance, product, organisation and referential (SPOR) master data</a></li><li class="field__item"><a href="/en/about-us/support-smes">Support to SMEs</a></li><li class="field__item"><a href="/en/veterinary-regulatory-overview/veterinary-big-data">Veterinary big data</a></li><li class="field__item"><a href="/en/veterinary-regulatory-overview/veterinary-medicinal-products-regulation">Veterinary Medicinal Products Regulation</a></li><li class="field__item"><a href="/en/veterinary-regulatory-overview/research-development-veterinary-medicines/veterinary-limited-markets">Veterinary limited markets</a></li></ul></div></div></div></div></div></div></div></div><div class="ema-social-media-share inline 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