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regulatory: overview</a></li><li class="breadcrumb-item d-none d-md-block active" aria-current="page" >Marketing authorisation (veterinary medicines)</li></ol></nav></div></div></header><main id="main-content" 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-general content-banner ema-general--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="right-col"><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>Marketing authorisation (veterinary medicines)</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","x","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-general__field-ema-summary">The European Medicines Agency (EMA) is responsible for the scientific evaluation of centralised marketing authorisation applications (MAA). Once granted by the European Commission, the centralised marketing authorisation is valid in all European Union (EU) Member States, Iceland, Norway and Liechtenstein.</div></div></div><div class="d-flex flex-column flex-lg-row justify-content-between gap-3"><div class="card-badge-wrapper d-flex flex-row flex-wrap gap-3 align-items-start"><span class="ema-bg-category badge rounded-pill badge-outline-primary" title="Veterinary"><span class="label">Veterinary</span></span><span class="ema-bg-topic badge rounded-pill badge-outline-primary" title="Regulatory and procedural guidance"><span class="label">Regulatory and procedural guidance</span></span></div></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="content-with-sidebar node ema-general ema-general--full container"><div class="row"><div class="bcl-sidebar col-md-3"><nav class="bcl-inpage-navigation position-sticky" id="bcl-inpage-navigation"><h2 class="mb-0 dropdown-toggle bcl-heading" aria-expanded="false" type="button" id="bcl-inpage-navigation-dropdown" data-bs-toggle="dropdown"> Page contents<svg class="bi icon--s" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#chevron-down"/></svg></h2><div class="dropdown-menu" role="navigation" aria-labelledby="bcl-inpage-navigation-dropdown"><ul class="nav nav-pills flex-column" ><li class="nav-item" ><a class="nav-link" href="#in-this-section-63052">In this section</a></li><li class="nav-item" ><a class="nav-link" href="#steps-involved-in-obtaining-an-eu-marketing-authorisation-63053">Steps involved in obtaining an EU marketing authorisation</a></li><li class="nav-item" ><a class="nav-link" href="#related-content-18354">Related content</a></li><li class="nav-item" ><a class="nav-link" href="#related-eu-legislation-18355">Related EU legislation</a></li><li class="nav-item" ><a class="nav-link" href="#external-links-18356">External links</a></li><li class="nav-item" ><a class="nav-link" href="#contact-point-18357">Contact point</a></li><li class="nav-item" ><a class="nav-link" href="#topics">Topics</a></li></ul></div></nav></div><div class="col-md-9"><div class="ema-node-content-wrapper node-sections"><div class="item"><div id="ema-inpage-item-63052" class="paragraph paragraph--type--oe-rich-text paragraph--view-mode--default"><div id="in-this-section-63052"><h2 class="mb-4 rounded-title"> In this section </h2></div><div class="ecl-editor"><ul><li><a href="/en/veterinary-regulatory-overview/marketing-authorisation-veterinary-medicines/application-guidance-veterinary-medicines" data-entity-type="node" data-entity-uuid="9509da94-34cf-4f5d-a2b8-3f67e6bdfcc2" data-entity-substitution="canonical" title="Application guidance (veterinary medicines)">Application guidance (veterinary medicines)</a></li><li><a href="/en/human-regulatory-overview/marketing-authorisation/compliance-marketing-authorisation" data-entity-type="node" data-entity-uuid="a9dca5ae-0be4-46dc-ba2f-10f70a8dddd5" data-entity-substitution="canonical" title="Compliance: marketing authorisation">Compliance: marketing authorisation</a></li><li><a href="/en/veterinary-regulatory-overview/marketing-authorisation-veterinary-medicines/environmental-risk-assessment-veterinary-medicines" data-entity-type="node" data-entity-uuid="0d6630cd-84bf-4cc4-99a8-b3f46f130487" data-entity-substitution="canonical" title="Environmental risk assessment of veterinary medicines">Environmental risk assessment of veterinary medicines</a></li><li><a href="/en/veterinary-regulatory-overview/marketing-authorisation-veterinary-medicines/guidance-documents" data-entity-type="node" data-entity-uuid="47d0fc30-11b7-42b6-91ac-5faa0a396d19" data-entity-substitution="canonical" title="Guidance documents">Guidance documents</a></li><li><a href="/en/veterinary-regulatory-overview/marketing-authorisation-veterinary-medicines/product-information-requirements-veterinary-medicines" data-entity-type="node" data-entity-uuid="54f61c0c-2a09-40a5-9f7c-d97d72dcb90b" data-entity-substitution="canonical" title="Product-information requirements for veterinary medicines">Product-information requirements for veterinary medicines</a></li><li><a href="/en/veterinary-regulatory-overview/marketing-authorisation-veterinary-medicines/veterinary-pre-authorisation-guidance/pre-authorisation-guidance-under-veterinary-medicinal-products-regulation-regulation-eu-2019-6" data-entity-type="node" data-entity-uuid="6e1e446f-2b59-4a9a-b22f-400b5423e3d3" data-entity-substitution="canonical" title="Pre-authorisation guidance under the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6)">Veterinary pre-authorisation guidance</a></li><li><a href="/en/veterinary-regulatory-overview/marketing-authorisation-veterinary-medicines/submission-dates-veterinary-medicines" data-entity-type="node" data-entity-uuid="6beb7701-d1eb-4ff8-8f56-b02c9f166611" data-entity-substitution="canonical" title="Submission dates (veterinary medicines)">Submission dates (veterinary medicines)</a></li><li><a href="/en/veterinary-regulatory-overview/marketing-authorisation-veterinary-medicines/assessment-templates-and-guidance-veterinary-medicines" data-entity-type="node" data-entity-uuid="c9c81675-7df7-438d-ad9e-68f08eb8711b" data-entity-substitution="canonical" title="Assessment templates and guidance (veterinary medicines)">Assessment templates and guidance (veterinary medicines)</a></li></ul></div></div></div><div class="item"><div id="ema-inpage-item-63053" class="paragraph paragraph--type--oe-rich-text paragraph--view-mode--default"><div id="steps-involved-in-obtaining-an-eu-marketing-authorisation-63053"><h2 class="mb-4 rounded-title"> Steps involved in obtaining an EU marketing authorisation </h2></div><div class="ecl-editor"><div><div class="table-responsive"><table class="general table"><thead><tr style="text-align:center;"><th style="background-color:rgb(227, 227, 227);font-size:14px;text-align:center;"><h3>Submission of eligibility request</h3></th></tr><tr><th style="font-size:14px;text-align:center;">Up to 7 months before submission of marketing authorisation application (MAA)</th></tr></thead><tbody><tr><td><p>To find out whether a product can be evaluated under the centralised procedure, applicants should always submit an <strong>eligibility request</strong> using the specific form and accompanied by a justification.</p><p>More information:</p><ul><li><p><a href="/en/veterinary-regulatory-overview/marketing-authorisation-veterinary-medicines/veterinary-pre-authorisation-guidance/pre-authorisation-guidance-under-veterinary-medicinal-products-regulation-regulation-eu-2019-6" data-entity-type="node" data-entity-uuid="6e1e446f-2b59-4a9a-b22f-400b5423e3d3" data-entity-substitution="canonical" title="Pre-authorisation guidance under the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6)">Veterinary pre-submission Q&A</a></p><div class="mt-4 ema-file-wrapper" xmlns:xlink="http://www.w3.org/1999/xlink"><div data-ema-document-type="template-form" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl"><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#file-word" /></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Pre-submission request form to the European Medicines Agency for veterinary medicinal product in accordance with Regulation (EU) 2019/6</p></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (143.62 KB - DOCX)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2021-03-22T08:55:00Z">22/03/2021</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/template-form/pre-submission-request-form-european-medicines-agency-veterinary-medicinal-product-accordance-regulation-eu-20196_en.docx">View<svg class="ms-2-5 bi icon--fluid"><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#eye" /></svg></a></div></div></div></li></ul></td></tr></tbody></table></div></div><div style="text-align:center;"><div class="ema-media-image-wysiwyg text-align-center mx-auto my-2"><img src="/sites/default/files/styles/oe_bootstrap_theme_medium_no_crop/public/2018-09/arrow.gif?itok=CBkQyEJk" width="53" height="41" alt="arrow.gif" title="arrow.gif" loading="lazy" class="img-fluid"></div></div><div><div class="table-responsive"><table class="general table"><thead><tr style="text-align:center;"><th style="background-color:rgb(227, 227, 227);font-size:14px;text-align:center;"><h3>Notification of intention to submit an application</h3></th></tr><tr><th style="font-size:14px;text-align:center;">4 months before submission of MAA</th></tr></thead><tbody><tr><td><p>Applicants should consider the date of submission carefully.</p><p>To notify the Agency of the intended submission date, please submit a <a href="https://www.ema.europa.eu/system/files/documents/template-form/presubmissionrequestformforvmpunderregulation2019-6_en.docx">Pre-submission request form to the European Medicines Agency for veterinary medicinal product in accordance with Regulation (EU) 2019/6</a> via <a href="https://support.ema.europa.eu/esc?id=emp_taxonomy_topic&topic_id=25c518021b97a910bde8dac8b04bcbcb">Service Now</a> by selecting Veterinary Regulatory > Pre-Submission-Vets. The selected scope of request should be: 'Centralised Procedure – Intent to submit a MAA'.</p><p>More information: <a href="https://www.ema.europa.eu/en/veterinary-regulatory-overview/marketing-authorisation-veterinary-medicines/veterinary-pre-authorisation-guidance/pre-authorisation-guidance-under-veterinary-medicinal-products-regulation-regulation-eu-2019-6">Veterinary pre-submission Q&A</a></p><div class="mt-4 ema-file-wrapper" xmlns:xlink="http://www.w3.org/1999/xlink"><div data-ema-document-type="regulatory-procedural-guideline" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl"><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#file-pdf" /></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Best practice guide on measures improving predictability of submissions/responses and adherence to communicated submission/responses deadlines</p><div class="file-metadata d-grid gap-2 gap-md-0"><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row reference-number fw-normal text-muted"><span class="label">Reference Number: </span><span class="value">EMA/488783/2017</span></small></div></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (107.8 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2017-12-11T17:30:00Z">11/12/2017</time></span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value"><time datetime="2017-12-11T17:30:00Z">11/12/2017</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/regulatory-procedural-guideline/best-practice-guide-measures-improving-predictability-submissionsresponses-and-adherence-communicated-submissionresponses-deadlines_en.pdf">View<svg class="ms-2-5 bi icon--fluid"><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#eye" /></svg></a></div></div></div></td></tr></tbody></table></div></div><div style="text-align:center;"><div class="ema-media-image-wysiwyg text-align-center mx-auto my-2"><img src="/sites/default/files/styles/oe_bootstrap_theme_medium_no_crop/public/2018-09/arrow.gif?itok=CBkQyEJk" width="53" height="41" alt="arrow.gif" title="arrow.gif" loading="lazy" class="img-fluid"></div></div><div style="text-align:center;"><div><div class="table-responsive"><table class="general table"><thead><tr style="text-align:center;"><th style="background-color:rgb(227, 227, 227);font-size:14px;text-align:center;"><h3>Appointment of rapporteurs</h3></th></tr><tr><th style="font-size:14px;text-align:center;">4 months before submission of MAA</th></tr></thead><tbody><tr><td style="text-align:left;"><p>The Committee for Veterinary Medicinal Products (CVMP)<strong> appoints (co-)rapporteurs</strong> to conduct the scientific assessment.</p><p>More information:</p><ul><li><a href="/en/veterinary-regulatory-overview/marketing-authorisation-veterinary-medicines/veterinary-pre-authorisation-guidance/pre-authorisation-guidance-under-veterinary-medicinal-products-regulation-regulation-eu-2019-6" data-entity-type="node" data-entity-uuid="6e1e446f-2b59-4a9a-b22f-400b5423e3d3" data-entity-substitution="canonical" title="Pre-authorisation guidance under the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6)">Veterinary pre-submission Q&A</a></li><li><a href="https://data.ec.europa.eu/ewp/media/ad6b2203-8c13-4901-af44-28fa10f67433"><a href="/en/documents/regulatory-procedural-guideline/procedural-advice-appointment-and-responsibilities-cvmp-rapporteur-and-co-rapporteur-according-article-62-1-regulation-ec-no-7262004_en.pdf" target="_blank" hreflang="en" xmlns:xlink="http://www.w3.org/1999/xlink"><svg class="me-2-5 bi icon--s"><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#file-pdf" /></svg>Procedural advice on appointment and responsibilities of the CVMP rapporteur and co-rapporteur (according to Article 62 (1) of Regulation (EC) No 726/2004)</a></a></li></ul></td></tr></tbody></table></div></div><div style="text-align:center;"><div class="ema-media-image-wysiwyg text-align-center mx-auto my-2"><img src="/sites/default/files/styles/oe_bootstrap_theme_medium_no_crop/public/2018-09/arrow.gif?itok=CBkQyEJk" width="53" height="41" alt="arrow.gif" title="arrow.gif" loading="lazy" class="img-fluid"></div></div><div><div class="table-responsive"><table class="general table"><thead><tr style="text-align:center;"><th style="background-color:rgb(227, 227, 227);font-size:14px;text-align:center;"><h3>Pre-submission</h3></th></tr><tr><th style="font-size:14px;text-align:center;"> </th></tr></thead><tbody><tr><td><p style="text-align:left;">Companies that consider that a pre-submission meeting would be useful should complete the request form and submit it via EMA’s Veterinary Regulatory Service Now (instructions are included in the form).</p><ul><li style="text-align:left;"><a href="https://data.ec.europa.eu/ewp/media/dd655ca9-c862-4e68-8cc3-92d2b9e1f08c"><a href="/en/documents/template-form/veterinary-pre-submission-meeting-request-form-accordance-regulation-eu-no-2019-6_en.doc" target="_blank" hreflang="en" xmlns:xlink="http://www.w3.org/1999/xlink"><svg class="me-2-5 bi icon--s"><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#file-word" /></svg>Veterinary pre-submission meeting request form - in accordance with Regulation (EU) No 2019/6</a></a></li></ul><p style="text-align:left;">Successful pre-submission meetings along with the information in the guidance should enable applicants to submit applications in line with legal and regulatory requirements. This speeds up the validation process.</p><p style="text-align:left;">More information: <a href="/en/veterinary-regulatory-overview/marketing-authorisation-veterinary-medicines/veterinary-pre-authorisation-guidance/pre-authorisation-guidance-under-veterinary-medicinal-products-regulation-regulation-eu-2019-6" data-entity-type="node" data-entity-uuid="6e1e446f-2b59-4a9a-b22f-400b5423e3d3" data-entity-substitution="canonical" title="Pre-authorisation guidance under the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6)">Veterinary pre-submission Q&A</a></p></td></tr></tbody></table></div></div><div><div class="table-responsive"><table class="table"><tbody><tr><td> </td></tr></tbody></table></div></div><div style="text-align:center;"><div class="ema-media-image-wysiwyg text-align-center mx-auto my-2"><img src="/sites/default/files/styles/oe_bootstrap_theme_medium_no_crop/public/2018-09/arrow.gif?itok=CBkQyEJk" width="53" height="41" alt="arrow.gif" title="arrow.gif" loading="lazy" class="img-fluid"></div></div><div><div class="table-responsive"><table class="general table"><thead><tr style="text-align:center;"><th style="background-color:rgb(227, 227, 227);font-size:14px;text-align:center;"><h3>Submission and validation of the application</h3></th></tr><tr><th><p style="text-align:left;">Applicants submit the application to the Agency.</p><p style="text-align:left;">If the Agency needs additional information to complete its validation of the application, it will ask the applicant to supply this by a deadline.</p><p style="text-align:left;">More information:</p><ul><li style="text-align:left;"><a href="http://esubmission.ema.europa.eu/tiges/vetesub.htm">VET eSubmission</a></li><li style="text-align:left;"><a href="/en/veterinary-regulatory-overview/marketing-authorisation-veterinary-medicines/veterinary-pre-authorisation-guidance/pre-authorisation-guidance-under-veterinary-medicinal-products-regulation-regulation-eu-2019-6" data-entity-type="node" data-entity-uuid="6e1e446f-2b59-4a9a-b22f-400b5423e3d3" data-entity-substitution="canonical" title="Pre-authorisation guidance under the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6)">Veterinary pre-submission Q&A</a></li></ul></th></tr></thead></table></div></div><div style="text-align:center;"><div class="ema-media-image-wysiwyg text-align-center mx-auto my-2"><img src="/sites/default/files/styles/oe_bootstrap_theme_medium_no_crop/public/2018-09/arrow.gif?itok=CBkQyEJk" width="53" height="41" alt="arrow.gif" title="arrow.gif" loading="lazy" class="img-fluid"></div></div><div><div class="table-responsive"><table class="general table"><thead><tr style="text-align:center;"><th style="background-color:rgb(227, 227, 227);font-size:14px;text-align:center;"><h3>Scientific evaluation</h3></th></tr><tr><th style="font-size:14px;text-align:center;">Up to 210 active days of assessment</th></tr></thead><tbody><tr><td><p style="text-align:left;">The CVMP evaluates MAA submitted through the centralised procedure.</p></td></tr></tbody></table></div></div><div style="text-align:center;"><div class="ema-media-image-wysiwyg text-align-center mx-auto my-2"><img src="/sites/default/files/styles/oe_bootstrap_theme_medium_no_crop/public/2018-09/arrow.gif?itok=CBkQyEJk" width="53" height="41" alt="arrow.gif" title="arrow.gif" loading="lazy" class="img-fluid"></div></div><div><div class="table-responsive"><table class="general table"><thead><tr style="text-align:center;"><th style="background-color:rgb(227, 227, 227);font-size:14px;text-align:center;"><h3>CVMP scientific opinion</h3></th></tr></thead><tbody><tr><td><p style="text-align:left;">After the evaluation, the CVMP must issue a scientific opinion on whether the medicine may be authorised or not.</p><p style="text-align:left;">EMA sends this opinion to the European Commission, which issues the marketing authorisation. The Agency then publishes a summary of the committee's opinion.</p><p style="text-align:left;">More information: <a href="/en/find-medicine/veterinary-medicines/pending-ec-decision">Pending European Commission decisions</a></p></td></tr></tbody></table></div></div><div style="text-align:center;"><div class="ema-media-image-wysiwyg text-align-center mx-auto my-2"><img src="/sites/default/files/styles/oe_bootstrap_theme_medium_no_crop/public/2018-09/arrow.gif?itok=CBkQyEJk" width="53" height="41" alt="arrow.gif" title="arrow.gif" loading="lazy" class="img-fluid"></div></div><div><div class="table-responsive"><table class="general table"><thead><tr style="text-align:center;"><th style="background-color:rgb(227, 227, 227);font-size:14px;text-align:center;"><h3>European Commission decision</h3></th></tr><tr><th style="font-size:14px;text-align:center;">Within 67 days of receipt of CVMP opinion</th></tr><tr><th><p style="text-align:left;">Commission decisions are published in the <a href="http://ec.europa.eu/health/veterinary-use_en">Community Register</a> of medicinal products for veterinary use and EMA publishes the public assessment report on the <a href="https://medicines.health.europa.eu/veterinary/en">Veterinary Medicines Information</a> website.</p><p style="text-align:left;">When a new marketing authorisation application is refused, the Agency publishes a refusal EPAR, including a question and answer document and an assessment report.</p></th></tr></thead></table></div></div></div><p style="text-align:left;"> </p></div></div></div><div class="item"><div class="related-section-wrapper" id="ema-inpage-item-18354"><h4 id="related-content-18354" class="rounded-title d-flex align-items-center p-2 mb-3"><span class="title flex-grow-1"> Related content </span><span class="icon"><svg class="bi icon--s" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#"/></svg></span></h4><div class="item"><div id="ema-inpage-item-15630" 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medicines)</a></li><li><a href="/en/about-us/fees-payable-european-medicines-agency" data-entity-type="node" data-entity-uuid="70bfa450-9f18-4c10-bc35-e003269a2883" data-entity-substitution="canonical" title="Fees payable to the European Medicines Agency">Fees payable to the European Medicines Agency</a></li><li><a href="/en/veterinary-regulatory-overview/research-development-veterinary-medicines/maximum-residue-limits-mrl" data-entity-type="node" data-entity-uuid="f9172e9d-393a-4e72-887d-12a7009de813" data-entity-substitution="canonical" title="Maximum residue limits (MRL)">Maximum residue limits (MRL)</a></li><li><a href="/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/pharmacovigilance-veterinary-medicines" data-entity-type="node" data-entity-uuid="de7756f7-422d-4332-be43-6b6d6bb0ac2a" data-entity-substitution="canonical" title="Pharmacovigilance (veterinary medicines)">Pharmacovigilance (veterinary medicines)</a></li><li><a href="/en/about-us/support-smes" data-entity-type="node" data-entity-uuid="23d3803f-91ba-4f62-a6cf-c81b9db0c549" data-entity-substitution="canonical" title="Support to SMEs">Support to SMEs</a></li></ul></div></div></div></div></div><div class="item"><div class="related-section-wrapper" id="ema-inpage-item-18355"><h4 id="related-eu-legislation-18355" class="rounded-title d-flex align-items-center p-2 mb-3"><span class="title flex-grow-1"> Related EU legislation </span><span class="icon"><svg class="bi icon--s" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#"/></svg></span></h4><div class="item"><div id="ema-inpage-item-15631" class="paragraph paragraph--type--oe-rich-text paragraph--view-mode--related-section"><div class="ecl-editor"><ul><li><a href="http://ec.europa.eu/health/documents/eudralex/vol-5/index_en.htm">EudraLex - Volume 5 - Pharmaceutical legislation for medicinal products for veterinary use</a></li><li><a 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