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class="row"><div class="col"><div class="heading-title"><h1 class="content-banner-title card-title bcl-heading"><span>What we publish on medicines and when</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) publishes information on human medicines at various stages of their life cycle. </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="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="#also-on-this-topic-63259">Also on this topic</a></li><li class="nav-item" ><a class="nav-link" href="#human-medicines-67781">Human medicines</a></li><li class="nav-item" ><a class="nav-link" href="#veterinary-medicines-38654">Veterinary medicines</a></li><li class="nav-item" ><a class="nav-link" href="#eu-referrals-38659">EU referrals</a></li><li class="nav-item" ><a class="nav-link" href="#committee-agendas-and-outcomes-38662">Committee agendas and outcomes</a></li><li class="nav-item" ><a class="nav-link" href="#related-content-67796">Related content</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-63259" class="paragraph paragraph--type--oe-rich-text paragraph--view-mode--default"><div id="also-on-this-topic-63259"><h2 class="mb-4 rounded-title"> Also on this topic </h2></div><div class="ecl-editor"><ul><li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="a58c3cc1-5dfd-4cd8-a6b3-25561406217d" href="/en/medicines/what-we-publish-medicines-and-when/european-public-assessment-reports-background-and-context" title="European public assessment reports: background and context">European public assessment reports: background and context</a></li></ul></div></div></div><div class="item"><div class="bcl-featured-media default left text-start simple-cta"><div class="row gap-3 gap-md-0"><div class="col-12"><div id="human-medicines-67781"><h2 class="rounded-title mb-0 mb-md-3"> Human medicines </h2></div></div><div class="col-12 col-md-6 order-1"><h3 class="text-primary"> Guide to information published on human medicines </h3><p>This guide describes the different types of information EMA currently publishes for both centrally and non-centrally authorised medicines, as well as publication times and locations.</p><p>The main information is presented in a tabulated format further down, however full details about what we publish are available in the guide.</p><a href="https://www.ema.europa.eu/en/documents/other/guide-information-human-medicines-evaluated-european-medicines-agency-what-agency-publishes-and-when_en.pdf" class="text-uppercase">Guide to information on human medicines evaluated by EMA<svg class="ms-2-5 bi icon--s" ><use xlink:href="/themes/contrib/oe_bootstrap_theme/assets/icons/bcl-default-icons.svg#arrow-right"/></svg></a></div><div class="col-12 col-md-6 order-2"><figure class="mb-0 ema-image format-png rounded overflow-hidden"><img src="/sites/default/files/styles/oe_bootstrap_theme_medium_no_crop/public/2024-06/Guide%20to%20information%20published%20on%20human%20medicines_3.png?itok=O1xDfUqR" alt="Animated image of books, computer screen, a phone and a globe" title="" class="img-fluid" /></figure></div></div></div></div><div class="item"><div id="ema-inpage-item-38646" class="paragraph paragraph--type--oe-rich-text paragraph--view-mode--default"><div class="ecl-editor"><h3>Overview of publications and their location</h3><p><strong>Applications for centralised marketing authorisation</strong></p></div></div></div><div class="item"><div id="ema-inpage-item-38647"><div class="accordion d-flex flex-column" id="accordion-bcl-accordion--10"><div class="accordion-buttons d-flex flex-row align-items-center justify-content-end gap-3 mb-3"><button class="btn btn-primary" type="button" role="button" data-trigger="expand-section" aria-expanded="true">Expand section</button><button class="btn btn-light" type="button" role="button" data-trigger="collapse-section" aria-expanded="false">Collapse section</button></div><script type="text/javascript"> document.querySelectorAll('#accordion-bcl-accordion--10 [data-trigger]').forEach((button) => { button.addEventListener('click', event => { const item = event.target, action = item.getAttribute('data-trigger'), accordion = item.closest('#accordion-bcl-accordion--10'), accordion_items = accordion.querySelectorAll('.accordion-collapse'); accordion_items.forEach((accordion_item) => { if (action === 'expand-section') { bootstrap.Collapse.getOrCreateInstance(accordion_item, { toggle: false }).show(); } else if (action === 'collapse-section') { bootstrap.Collapse.getOrCreateInstance(accordion_item, { toggle: false }).hide(); } }); }, false); }); </script><div class="accordion-items-wrapper"><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--10-1"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--10-1" aria-controls="collapse-bcl-accordion--10-1" aria-expanded="false" type="button" ><span>Medicines under initial evaluation</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--10-1" aria-labelledby="heading-bcl-accordion--10-1" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><div><div class="table-responsive"><table class="ecl-table ecl-table--responsive table"><thead><tr><th style="text-transform:uppercase;">Publication type</th><th style="text-transform:uppercase;">Publication time</th><th style="text-transform:uppercase;">Location</th></tr></thead><tbody><tr><td data-th="Publication type ">List of medicines that are under evaluation</td><td data-th="Publication time">Monthly</td><td data-th="Location"><a href="/en/medicines/medicines-human-use-under-evaluation" data-entity-type="node" data-entity-uuid="69cae30c-7dcb-4d70-96fd-d02b3bf00014" data-entity-substitution="canonical" title="Medicines for human use under evaluation">Medicines under evaluation</a></td></tr><tr><td data-th="Publication type ">COMP monthly meeting reports (for orphan medicines)</td><td data-th="Publication time">Week following COMP plenary</td><td data-th="Location"><a href="/en/committees/committee-orphan-medicinal-products-comp" data-entity-type="node" data-entity-uuid="c4195fb4-7f01-40c4-afbf-5010acdce536" data-entity-substitution="canonical" title="Committee for Orphan Medicinal Products (COMP) ">COMP</a></td></tr></tbody></table></div></div></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--10-2"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--10-2" aria-controls="collapse-bcl-accordion--10-2" aria-expanded="false" type="button" ><span>Positive opinions</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--10-2" aria-labelledby="heading-bcl-accordion--10-2" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><div><div class="table-responsive"><table class="ecl-table ecl-table--responsive table"><thead><tr><th style="text-transform:uppercase;">Publication type</th><th style="text-transform:uppercase;">Publication time</th><th style="text-transform:uppercase;">Location</th></tr></thead><tbody><tr><td data-th="Publication type ">Summary of opinion</td><td data-th="Publication time">Friday following CHMP plenary</td><td data-th="Location"><ul><li><a href="https://www.ema.europa.eu/en/news?f%5B0%5D=ema_news_responsible_body%3A100002">CHMP meeting highlights</a></li><li><a href="https://www.ema.europa.eu/en/search?f%5B0%5D=ema_med_status%3A100103&f%5B1%5D=ema_med_status%3Aopinion&f%5B2%5D=ema_medicine_bundle%3Aema_medicine&f%5B3%5D=ema_search_categories%3A83&landing_from=73303">Medicines search: Medicines: Opinion</a><br>(document moved to medicine page after EC decision)</li></ul></td></tr><tr><td data-th="Publication type ">Dedicated press release (for selected medicines)</td><td data-th="Publication time">Friday following CHMP plenary</td><td data-th="Location"><ul><li><a href="/en/homepage" data-entity-type="node" data-entity-uuid="3fbd2621-0e24-4c6b-8a79-12054530e27e" data-entity-substitution="canonical" title="Homepage">EMA homepage</a></li><li><a href="https://www.ema.europa.eu/en/news?f%5B0%5D=ema_news_responsible_body%3A100002">CHMP meeting highlights</a></li></ul></td></tr><tr><td data-th="Publication type "><p>European public assessment report (EPAR)</p><p>This includes:</p><ul><li>medicine overview;</li><li>product information;</li><li>list of all authorised presentations;</li><li>public assessment report;</li><li>risk management plan.</li></ul></td><td data-th="Publication time"><p>2 weeks after EC decision</p><p> </p><p> </p></td><td data-th="Location"><a href="https://www.ema.europa.eu/en/search?f%5B0%5D=ema_med_status%3A100108&f%5B1%5D=ema_med_status%3Aauthorised&f%5B2%5D=ema_medicine_bundle%3Aema_medicine&f%5B3%5D=ema_search_categories%3A83&landing_from=73303">Medicines search: Medicines: Authorised</a></td></tr><tr><td data-th="Publication type ">Communication on medication error prevention (if applicable)</td><td data-th="Publication time">2 weeks after EC decision</td><td data-th="Location"><a href="/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/medication-errors/recommendations-medication-errors" data-entity-type="node" data-entity-uuid="93f29543-5147-4b88-9d62-c067682a2296" data-entity-substitution="canonical" title="Recommendations on medication errors">Recommendations on medication errors</a></td></tr><tr><td data-th="Publication type ">Orphan maintenance or withdrawal  assessment report (for orphan medicines)</td><td data-th="Publication time">2 weeks after EC decision</td><td data-th="Location"><a href="https://www.ema.europa.eu/en/search?f%5B0%5D=ema_med_status%3A100108&f%5B1%5D=ema_med_status%3Aauthorised&f%5B2%5D=ema_medicine_bundle%3Aema_medicine&f%5B3%5D=ema_search_categories%3A83&landing_from=73303">Medicines search: Medicines: Authorised</a> (on medicine page under 'Initial marketing authorisation documents')</td></tr></tbody></table></div></div><p> </p></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--10-3"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--10-3" aria-controls="collapse-bcl-accordion--10-3" aria-expanded="false" type="button" ><span>Negative opinions</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--10-3" aria-labelledby="heading-bcl-accordion--10-3" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><div><div class="table-responsive"><table class="ecl-table ecl-table--responsive table"><thead><tr><th style="text-transform:uppercase;">Publication type</th><th style="text-transform:uppercase;">Publication time</th><th style="text-transform:uppercase;">Location</th></tr></thead><tbody><tr><td data-th="Publication type ">Refusal questions and answers (Q&A)</td><td data-th="Publication time">Friday following CHMP plenary</td><td data-th="Location"><ul><li><a href="https://www.ema.europa.eu/en/news?f%5B0%5D=ema_news_responsible_body%3A100002">CHMP meeting highlights</a></li><li><a href="https://www.ema.europa.eu/en/search?f%5B0%5D=ema_med_status%3A100103&f%5B1%5D=ema_med_status%3Aopinion&f%5B2%5D=ema_medicine_bundle%3Aema_medicine&f%5B3%5D=ema_search_categories%3A83&landing_from=73303">Medicines search: Medicines: Opinion</a><br>(document moved to medicine page after EC decision)</li></ul></td></tr><tr><td data-th="Publication type ">Refusal public assessment report</td><td data-th="Publication time">2 weeks after EC decision</td><td data-th="Location"><a href="https://www.ema.europa.eu/en/search?f%5B0%5D=ema_med_status%3A100103&f%5B1%5D=ema_med_status%3Aopinion&f%5B2%5D=ema_medicine_bundle%3Aema_medicine&f%5B3%5D=ema_search_categories%3A83&landing_from=73303">Medicines search: Medicines: Opinion</a> (on medicine page under 'Assessment history')</td></tr></tbody></table></div></div></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--10-4"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--10-4" aria-controls="collapse-bcl-accordion--10-4" aria-expanded="false" type="button" ><span>Re-examinations of opinion</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--10-4" aria-labelledby="heading-bcl-accordion--10-4" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><div><div class="table-responsive"><table class="ecl-table ecl-table--responsive table"><thead><tr><th style="text-transform:uppercase;">Publication type</th><th style="text-transform:uppercase;">Publication time</th><th style="text-transform:uppercase;">Location</th></tr></thead><tbody><tr><td data-th="Publication type ">Re-examination questions and answers (for positive and negative outcomes)</td><td data-th="Publication time"><p>Friday following CHMP plenary</p><p> </p></td><td data-th="Location"><ul><li><a href="https://www.ema.europa.eu/en/news?f%5B0%5D=ema_news_responsible_body%3A100002">CHMP meeting highlights</a></li><li><a href="https://www.ema.europa.eu/en/search?f%5B0%5D=ema_med_status%3A100103&f%5B1%5D=ema_med_status%3Aopinion_under_re_examination&f%5B2%5D=ema_medicine_bundle%3Aema_medicine&f%5B3%5D=ema_search_categories%3A83&landing_from=73303">Medicines search: Medicines: Opinion under re-examination</a><br>(document moved to medicine page after EC decision)</li></ul></td></tr><tr><td data-th="Publication type ">Summary of opinion (for positive outcomes only)</td><td data-th="Publication time">Friday following CHMP plenary</td><td data-th="Location"><ul><li><a href="https://www.ema.europa.eu/en/news?f%5B0%5D=ema_news_responsible_body%3A100002">CHMP meeting highlights</a></li><li><a href="https://www.ema.europa.eu/en/search?f%5B0%5D=ema_med_status%3A100103&f%5B1%5D=ema_med_status%3Aopinion_under_re_examination&f%5B2%5D=ema_medicine_bundle%3Aema_medicine&f%5B3%5D=ema_search_categories%3A83&landing_from=73303">Medicines search: Medicines: Opinion under re-examination</a></li></ul></td></tr></tbody></table></div></div><p>After the EC decision, depending on the outcome of the re-examination, EMA publishes the same set of documents as for positive and negative opinions.</p></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--10-5"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--10-5" aria-controls="collapse-bcl-accordion--10-5" aria-expanded="false" type="button" ><span>Withdrawals of application</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--10-5" aria-labelledby="heading-bcl-accordion--10-5" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><div><div class="table-responsive"><table class="ecl-table ecl-table--responsive table"><thead><tr><th style="text-transform:uppercase;">Publication type</th><th style="text-transform:uppercase;">Publication time</th><th style="text-transform:uppercase;">Location</th></tr></thead><tbody><tr><td data-th="Publication type ">Withdrawal questions and answers</td><td data-th="Publication time">Friday following upcoming CHMP plenary<sup>1</sup></td><td data-th="Location"><ul><li><a href="https://www.ema.europa.eu/en/news?f%5B0%5D=ema_news_responsible_body%3A100002">CHMP meeting highlights</a></li><li><a href="https://www.ema.europa.eu/en/search?f%5B0%5D=ema_med_status%3A100105&f%5B1%5D=ema_med_status%3Awithdrawn_application&f%5B2%5D=ema_medicine_bundle%3Aema_medicine&f%5B3%5D=ema_search_categories%3A83&landing_from=73303">Medicines search: withdrawn applications</a></li></ul></td></tr><tr><td data-th="Publication type ">Withdrawal letter</td><td data-th="Publication time">Friday following upcoming CHMP plenary<sup>1</sup></td><td data-th="Location"><a href="https://www.ema.europa.eu/en/search?f%5B0%5D=ema_med_status%3A100105&f%5B1%5D=ema_med_status%3Awithdrawn_application&f%5B2%5D=ema_medicine_bundle%3Aema_medicine&f%5B3%5D=ema_search_categories%3A83&landing_from=73303">Medicines search: withdrawn applications</a></td></tr><tr><td data-th="Publication type ">Withdrawal public assessment report</td><td data-th="Publication time">Within 3 months of receipt of withdrawal letter</td><td data-th="Location"><a href="https://www.ema.europa.eu/en/search?f%5B0%5D=ema_med_status%3A100105&f%5B1%5D=ema_med_status%3Awithdrawn_application&f%5B2%5D=ema_medicine_bundle%3Aema_medicine&f%5B3%5D=ema_search_categories%3A83&landing_from=73303">Medicines search: withdrawn applications</a></td></tr></tbody></table></div></div><p> </p><p><sup>1</sup> If a withdrawal letter is received during the CHMP plenary meeting, these documents will be published after the following plenary meeting. </p></div></div></div></div></div></div></div></div><div class="item"><div id="ema-inpage-item-38648" class="paragraph paragraph--type--oe-rich-text paragraph--view-mode--default"><div class="ecl-editor"><p><strong>Changes to centralised marketing authorisations</strong></p></div></div></div><div class="item"><div id="ema-inpage-item-38649"><div class="accordion d-flex flex-column" id="accordion-bcl-accordion--11"><div class="accordion-buttons d-flex flex-row align-items-center justify-content-end gap-3 mb-3"><button class="btn btn-primary" type="button" role="button" data-trigger="expand-section" aria-expanded="true">Expand section</button><button class="btn btn-light" type="button" role="button" data-trigger="collapse-section" aria-expanded="false">Collapse section</button></div><script type="text/javascript"> document.querySelectorAll('#accordion-bcl-accordion--11 [data-trigger]').forEach((button) => { button.addEventListener('click', event => { const item = event.target, action = item.getAttribute('data-trigger'), accordion = item.closest('#accordion-bcl-accordion--11'), accordion_items = accordion.querySelectorAll('.accordion-collapse'); accordion_items.forEach((accordion_item) => { if (action === 'expand-section') { bootstrap.Collapse.getOrCreateInstance(accordion_item, { toggle: false }).show(); } else if (action === 'collapse-section') { bootstrap.Collapse.getOrCreateInstance(accordion_item, { toggle: false }).hide(); } }); }, false); }); </script><div class="accordion-items-wrapper"><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--11-1"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--11-1" aria-controls="collapse-bcl-accordion--11-1" aria-expanded="false" type="button" ><span>Extensions of indication</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--11-1" aria-labelledby="heading-bcl-accordion--11-1" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><h3>Positive opinions<br> </h3><div><div class="table-responsive"><table class="ecl-table ecl-table--responsive table"><thead><tr><th style="text-transform:uppercase;">Publication type</th><th style="text-transform:uppercase;">Publication time</th><th style="text-transform:uppercase;">Location</th></tr></thead><tbody><tr><td data-th="Publication type ">Summary of opinion</td><td data-th="Publication time">Friday following CHMP plenary</td><td data-th="Location"><ul><li><a href="https://www.ema.europa.eu/en/news?f%5B0%5D=ema_news_responsible_body%3A100002">CHMP meeting highlights</a></li><li><a href="https://www.ema.europa.eu/en/search?f%5B0%5D=ema_medicine_bundle%3Aema_post_authorisation&f%5B1%5D=ema_search_categories%3A83&f%5B2%5D=ema_type_of_post_authorisation%3A100206&f%5B3%5D=ema_type_of_post_authorisation%3Aopinion&landing_from=73303">Medicines search: Post-authorisation procedures for medicines: Opinion</a><br>(document moved to medicine page after EC decision)</li></ul></td></tr><tr><td data-th="Publication type ">Dedicated press release<br>(for selected extensions of indication)</td><td data-th="Publication time">Friday following CHMP plenary</td><td data-th="Location"><ul><li><a href="/en/homepage" data-entity-type="node" data-entity-uuid="3fbd2621-0e24-4c6b-8a79-12054530e27e" data-entity-substitution="canonical" title="Homepage">EMA homepage</a></li><li><a href="https://www.ema.europa.eu/en/news?f%5B0%5D=ema_news_responsible_body%3A100002">CHMP meeting highlights</a></li></ul></td></tr><tr><td data-th="Publication type "><p>Update of EPAR documents, including:</p><ul><li>product information;</li><li>procedural steps document;</li><li>medicine overview (if applicable);</li><li>list of all authorised presentations (if applicable);</li><li>updated risk management plan (if applicable).</li></ul></td><td data-th="Publication time">2 weeks after EC decision</td><td data-th="Location"><a href="https://www.ema.europa.eu/en/search?f%5B0%5D=ema_med_status%3A100108&f%5B1%5D=ema_med_status%3Aauthorised&f%5B2%5D=ema_medicine_bundle%3Aema_medicine&f%5B3%5D=ema_search_categories%3A83&landing_from=73303">Medicines search: Medicines: Authorised</a></td></tr><tr><td data-th="Publication type ">Orphan maintenance or withdrawal assessment report<br>(if applicable)</td><td data-th="Publication time">2 weeks after EC decision</td><td data-th="Location"><a href="https://www.ema.europa.eu/en/search?f%5B0%5D=ema_med_status%3A100108&f%5B1%5D=ema_med_status%3Aauthorised&f%5B2%5D=ema_medicine_bundle%3Aema_medicine&f%5B3%5D=ema_search_categories%3A83&landing_from=73303">Medicines search: Medicines: Authorised</a> (on medicine page under 'Initial marketing authorisation documents')</td></tr><tr><td data-th="Publication type ">Public assessment report</td><td data-th="Publication time">2 weeks after EC decision</td><td data-th="Location"><a href="https://www.ema.europa.eu/en/search?f%5B0%5D=ema_med_status%3A100108&f%5B1%5D=ema_med_status%3Aauthorised&f%5B2%5D=ema_medicine_bundle%3Aema_medicine&f%5B3%5D=ema_search_categories%3A83&landing_from=73303">Medicines search: Medicines: Authorised</a> (on medicine page under 'Assessment history')</td></tr></tbody></table></div></div><h3>Negative opinions<br> </h3><div><div class="table-responsive"><table class="ecl-table ecl-table--responsive table"><thead><tr><th style="text-transform:uppercase;">Publication type</th><th style="text-transform:uppercase;">Publication time</th><th style="text-transform:uppercase;">Location</th></tr></thead><tbody><tr><td data-th="Publication type ">Refusal Q&A</td><td data-th="Publication time">Friday following CHMP plenary</td><td data-th="Location"><ul><li><a href="https://www.ema.europa.eu/en/news?f%5B0%5D=ema_news_responsible_body%3A100002">CHMP meeting highlights</a></li><li><a href="https://www.ema.europa.eu/en/search?f%5B0%5D=ema_medicine_bundle%3Aema_post_authorisation&f%5B1%5D=ema_search_categories%3A83&f%5B2%5D=ema_type_of_post_authorisation%3A100206&f%5B3%5D=ema_type_of_post_authorisation%3Aopinion&landing_from=73303">Medicines search: Post-authorisation procedures for medicines: Opinion</a><br>(document moved to medicine page after EC decision)</li></ul></td></tr><tr><td data-th="Publication type ">Update of procedural steps document</td><td data-th="Publication time">4–5 weeks after CHMP opinion</td><td data-th="Location"><a href="https://www.ema.europa.eu/en/search?f%5B0%5D=ema_med_status%3A100108&f%5B1%5D=ema_med_status%3Aauthorised&f%5B2%5D=ema_medicine_bundle%3Aema_medicine&f%5B3%5D=ema_search_categories%3A83&landing_from=73303">Medicines search: Medicines: Authorised</a> (on medicine page under 'Assessment history')</td></tr><tr><td data-th="Publication type ">Refusal public assessment report</td><td data-th="Publication time">4–5 weeks after CHMP opinion</td><td data-th="Location"><a href="https://www.ema.europa.eu/en/search?f%5B0%5D=ema_med_status%3A100108&f%5B1%5D=ema_med_status%3Aauthorised&f%5B2%5D=ema_medicine_bundle%3Aema_medicine&f%5B3%5D=ema_search_categories%3A83&landing_from=73303">Medicines search: Medicines: Authorised</a> (on medicine page under 'Assessment history')</td></tr></tbody></table></div></div><h3>Re-examinations</h3><p>After the European Commission (EC) decision, depending on the outcome of the re-examination, the same set of documents as for positive or negative opinions on extension of indication will be published.</p><div><div class="table-responsive"><table class="ecl-table ecl-table--responsive table"><thead><tr><th style="text-transform:uppercase;">Publication type</th><th style="text-transform:uppercase;">Publication time</th><th style="text-transform:uppercase;">Location</th></tr></thead><tbody><tr><td data-th="Publication type ">Re-examination Q&A (for both positive and negative outcomes)</td><td data-th="Publication time">Friday following CHMP plenary</td><td data-th="Location"><ul><li><a href="https://www.ema.europa.eu/en/news?f%5B0%5D=ema_news_responsible_body%3A100002">CHMP meeting highlights</a></li><li><a href="https://www.ema.europa.eu/en/search?f%5B0%5D=ema_medicine_bundle%3Aema_post_authorisation&f%5B1%5D=ema_search_categories%3A83&f%5B2%5D=ema_type_of_post_authorisation%3A100206&f%5B3%5D=ema_type_of_post_authorisation%3Aopinion&landing_from=73303">Medicines search: Post-authorisation procedures for medicines</a></li></ul><p>(Q&A moved to medicine page after EC decision)</p></td></tr><tr><td data-th="Publication type ">Summary of opinion (for positive outcomes only)</td><td data-th="Publication time">Friday following CHMP plenary</td><td data-th="Location"><ul><li><a href="https://www.ema.europa.eu/en/news?f%5B0%5D=ema_news_responsible_body%3A100002">CHMP meeting highlights</a></li><li><a href="https://www.ema.europa.eu/en/search?f%5B0%5D=ema_medicine_bundle%3Aema_post_authorisation&f%5B1%5D=ema_search_categories%3A83&f%5B2%5D=ema_type_of_post_authorisation%3A100206&f%5B3%5D=ema_type_of_post_authorisation%3Aopinion&landing_from=73303">Medicines search: Post-authorisation procedures for medicines: Opinion</a></li></ul></td></tr></tbody></table></div></div><h3>Withdrawal<br> </h3><div><div class="table-responsive"><table class="ecl-table ecl-table--responsive table"><thead><tr><th style="text-transform:uppercase;">Publication type</th><th style="text-transform:uppercase;">Publication time</th><th style="text-transform:uppercase;">Location</th></tr></thead><tbody><tr><td data-th="Publication type ">Withdrawal Q&A</td><td data-th="Publication time">Friday following upcoming CHMP plenary</td><td data-th="Location"><a href="https://www.ema.europa.eu/en/search?f%5B0%5D=ema_medicine_bundle%3Aema_post_authorisation&f%5B1%5D=ema_search_categories%3A83&f%5B2%5D=ema_type_of_post_authorisation%3A100204&f%5B3%5D=ema_type_of_post_authorisation%3Awithdrawn&landing_from=73303">Medicines search: Post-authorisation procedures for medicines: Withdrawn applications</a></td></tr><tr><td data-th="Publication type ">Withdrawal letter</td><td data-th="Publication time">Friday following upcoming CHMP plenary</td><td data-th="Location"><a href="https://www.ema.europa.eu/en/search?f%5B0%5D=ema_medicine_bundle%3Aema_post_authorisation&f%5B1%5D=ema_search_categories%3A83&f%5B2%5D=ema_type_of_post_authorisation%3A100204&f%5B3%5D=ema_type_of_post_authorisation%3Awithdrawn&landing_from=73303">Medicines search: Post-authorisation procedures for medicines: Withdrawn applications</a>  (on medicine pages under 'Documents')</td></tr><tr><td data-th="Publication type ">Withdrawal public assessment report</td><td data-th="Publication time">Within 3 months of receipt of withdrawal letter</td><td data-th="Location"><a href="https://www.ema.europa.eu/en/search?f%5B0%5D=ema_medicine_bundle%3Aema_post_authorisation&f%5B1%5D=ema_search_categories%3A83&f%5B2%5D=ema_type_of_post_authorisation%3A100204&f%5B3%5D=ema_type_of_post_authorisation%3Awithdrawn&landing_from=73303">Medicines search: Post-authorisation procedures for medicines: Withdrawn applications</a>  (on medicine pages under 'Documents')</td></tr><tr><td data-th="Publication type ">Update of procedural steps document</td><td data-th="Publication time">Within 3 months of receipt of withdrawal letter</td><td data-th="Location"><a href="https://www.ema.europa.eu/en/search?f%5B0%5D=ema_med_status%3A100108&f%5B1%5D=ema_med_status%3Aauthorised&f%5B2%5D=ema_medicine_bundle%3Aema_medicine&f%5B3%5D=ema_search_categories%3A83&landing_from=73303">Medicines search: Medicines: Authorised</a> (on medicine page under 'Assessment history')</td></tr></tbody></table></div></div><h3>Changes of scope during extension of indication applications<br> </h3><div><div class="table-responsive"><table class="ecl-table ecl-table--responsive table"><thead><tr><th style="text-transform:uppercase;">Publication type</th><th style="text-transform:uppercase;">Publication time</th><th style="text-transform:uppercase;">Location</th></tr></thead><tbody><tr><td data-th="Publication type ">Q&A for change in scope</td><td data-th="Publication time">Friday following CHMP plenary</td><td data-th="Location"><a href="https://www.ema.europa.eu/en/search?f%5B0%5D=ema_med_status%3A100108&f%5B1%5D=ema_med_status%3Aauthorised&f%5B2%5D=ema_medicine_bundle%3Aema_medicine&f%5B3%5D=ema_search_categories%3A83&landing_from=73303">Medicines search: Medicines: Authorised</a></td></tr><tr><td data-th="Publication type ">Update of procedural steps document</td><td data-th="Publication time">2 weeks after EC decision</td><td data-th="Location"><a href="https://www.ema.europa.eu/en/search?f%5B0%5D=ema_med_status%3A100108&f%5B1%5D=ema_med_status%3Aauthorised&f%5B2%5D=ema_medicine_bundle%3Aema_medicine&f%5B3%5D=ema_search_categories%3A83&landing_from=73303">Medicines search: Medicines: Authorised</a> (on medicine page under 'Assessment history')</td></tr><tr><td data-th="Publication type ">Updated product information</td><td data-th="Publication time">2 weeks after EC decision</td><td data-th="Location"><a href="https://www.ema.europa.eu/en/search?f%5B0%5D=ema_med_status%3A100108&f%5B1%5D=ema_med_status%3Aauthorised&f%5B2%5D=ema_medicine_bundle%3Aema_medicine&f%5B3%5D=ema_search_categories%3A83&landing_from=73303">Medicines search: Medicines: Authorised</a> (on medicine page under 'Product information')</td></tr><tr><td data-th="Publication type ">Public assessment report</td><td data-th="Publication time">2 weeks after EC decision</td><td data-th="Location"><a href="https://www.ema.europa.eu/en/search?f%5B0%5D=ema_med_status%3A100108&f%5B1%5D=ema_med_status%3Aauthorised&f%5B2%5D=ema_medicine_bundle%3Aema_medicine&f%5B3%5D=ema_search_categories%3A83&landing_from=73303">Medicines search: Medicines: Authorised</a> (on medicine page under 'Assessment history')</td></tr></tbody></table></div></div><p> </p></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--11-2"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--11-2" aria-controls="collapse-bcl-accordion--11-2" aria-expanded="false" type="button" ><span>Other variations, annual re-assessments, renewals and line extensions</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--11-2" aria-labelledby="heading-bcl-accordion--11-2" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><div><div class="table-responsive"><table class="ecl-table ecl-table--responsive table"><thead><tr><th style="text-transform:uppercase;">Publication type</th><th style="text-transform:uppercase;">Publication time</th><th style="text-transform:uppercase;">Location</th></tr></thead><tbody><tr><td data-th="Publication type "><p>Summary of opinion for:</p><ul><li>changes to contra-indications;</li><li>changes that significantly alter the medicine's use.</li></ul></td><td data-th="Publication time">Friday following CHMP plenary</td><td data-th="Location"><ul><li><a href="/committees/committee-medicinal-products-human-use-chmp" data-entity-type="node" data-entity-uuid="969118eb-ab58-4db2-82f6-ef253c1fddf6" data-entity-substitution="canonical">CHMP meeting highlights</a></li><li><a href="/search?f%5B0%5D=ema_medicine_bundle%3Aema_post_authorisation&f%5B1%5D=ema_search_categories%3A83&f%5B2%5D=ema_type_of_post_authorisation%3A100206&landing_from=73303">Medicines search: Post-authorisation procedures for medicines: Opinion</a></li></ul></td></tr><tr><td data-th="Publication type ">Public health communication<br>(for selected changes of major public health importance)</td><td data-th="Publication time">Friday following CHMP plenary</td><td data-th="Location"><ul><li><a href="/committees/committee-medicinal-products-human-use-chmp" data-entity-type="node" data-entity-uuid="969118eb-ab58-4db2-82f6-ef253c1fddf6" data-entity-substitution="canonical">CHMP meeting highlights</a></li><li><a href="/search?f%5B0%5D=ema_med_status%3A100108&f%5B1%5D=ema_medicine_bundle%3Aema_medicine&f%5B2%5D=ema_search_categories%3A83&landing_from=73303">Medicines search: Medicines: Authorised</a></li></ul></td></tr><tr><td data-th="Publication type "><p>Update of EPAR documents, including:</p><ul><li>product information;</li><li>procedural steps document;</li><li>medicine overview (if applicable);</li><li>list of all authorised presentations (if applicable);</li><li>risk management plan (or risk management plan summary) (if applicable).</li></ul></td><td data-th="Publication time">2 weeks after EC decision or 4–5 weeks after CHMP opinion / notification, as applicable</td><td data-th="Location"><a href="/search?f%5B0%5D=ema_med_status%3A100108&f%5B1%5D=ema_medicine_bundle%3Aema_medicine&f%5B2%5D=ema_search_categories%3A83&landing_from=73303">Medicines search: Medicines: Authorised</a></td></tr><tr><td data-th="Publication type ">Public assessment reports<br>(for those changes that are of particular importance*)</td><td data-th="Publication time">2 weeks after EC decision or 4–5 weeks after CHMP opinion / notification, as applicable</td><td data-th="Location"><a href="/search?f%5B0%5D=ema_med_status%3A100108&f%5B1%5D=ema_medicine_bundle%3Aema_medicine&f%5B2%5D=ema_search_categories%3A83&landing_from=73303">Medicines search: Medicines: Authorised</a> (on medicine page under 'All documents')</td></tr></tbody></table></div></div><p>*EMA may also publish reports for negative or withdrawn applications if evaluation is of particular importance.</p></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--11-3"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--11-3" aria-controls="collapse-bcl-accordion--11-3" aria-expanded="false" type="button" ><span>Withdrawals / expiry of authorisation</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--11-3" aria-labelledby="heading-bcl-accordion--11-3" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><div><div class="table-responsive"><table class="ecl-table ecl-table--responsive table"><thead><tr><th style="text-transform: uppercase">Publication type</th><th style="text-transform: uppercase">Publication time</th><th style="text-transform: uppercase">Location</th></tr></thead><tbody><tr><td data-th="Publication type ">Public statement</td><td data-th="Publication time">At time of withdrawal or expiry of marketing authorisation</td><td data-th="Location"><p><a href="/search?f%5B0%5D=ema_med_status%3A100111&f%5B1%5D=ema_medicine_bundle%3Aema_medicine&f%5B2%5D=ema_search_categories%3A83&landing_from=73303">Medicines search: Medicines: Withdrawn</a></p></td></tr><tr><td data-th="Publication type ">EPAR documents watermarked</td><td data-th="Publication time">At time of withdrawal or expiry of marketing authorisation</td><td data-th="Location"><p><a href="/search?f%5B0%5D=ema_med_status%3A100111&f%5B1%5D=ema_medicine_bundle%3Aema_medicine&f%5B2%5D=ema_search_categories%3A83&landing_from=73303">Medicines search: Medicines: Withdrawn</a></p></td></tr></tbody></table></div></div><p> </p></div></div></div></div></div></div></div></div><div class="item"><div id="ema-inpage-item-38650" class="paragraph paragraph--type--oe-rich-text paragraph--view-mode--default"><div class="ecl-editor"><p><strong>Referrals</strong></p></div></div></div><div class="item"><div id="ema-inpage-item-38651"><div class="accordion d-flex flex-column" id="accordion-bcl-accordion--12"><div class="accordion-buttons d-flex flex-row align-items-center justify-content-end gap-3 mb-3"><button class="btn btn-primary" type="button" role="button" data-trigger="expand-section" aria-expanded="true">Expand section</button><button class="btn btn-light" type="button" role="button" data-trigger="collapse-section" aria-expanded="false">Collapse section</button></div><script type="text/javascript"> document.querySelectorAll('#accordion-bcl-accordion--12 [data-trigger]').forEach((button) => { button.addEventListener('click', event => { const item = event.target, action = item.getAttribute('data-trigger'), accordion = item.closest('#accordion-bcl-accordion--12'), accordion_items = accordion.querySelectorAll('.accordion-collapse'); accordion_items.forEach((accordion_item) => { if (action === 'expand-section') { bootstrap.Collapse.getOrCreateInstance(accordion_item, { toggle: false }).show(); } else if (action === 'collapse-section') { bootstrap.Collapse.getOrCreateInstance(accordion_item, { toggle: false }).hide(); } }); }, false); }); </script><div class="accordion-items-wrapper"><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--12-1"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--12-1" aria-controls="collapse-bcl-accordion--12-1" aria-expanded="false" type="button" ><span>Article 20, 31 and 107i referrals</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--12-1" aria-labelledby="heading-bcl-accordion--12-1" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><div><div class="table-responsive"><table class="ecl-table ecl-table--responsive table"><thead><tr><th style="text-transform: uppercase">Publication type</th><th style="text-transform: uppercase">Publication time</th><th style="text-transform: uppercase">Location</th></tr></thead><tbody><tr><td data-th="Publication type ">Announcement of start of referral</td><td data-th="Publication time">Friday following PRAC or CHMP plenary where referral is started</td><td data-th="Location"><ul><li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="969118eb-ab58-4db2-82f6-ef253c1fddf6" href="/en/chmp-agendas-minutes-and-highlights">CHMP meeting highlights</a> or <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="369ab23e-ad7c-4e01-a338-a542250a0c7d" href="/en/prac-agendas-minutes-and-highlights">PRAC meeting highlights</a></li><li><a href="/search?f%5B0%5D=ema_medicine_bundle%3Aema_referral&f%5B1%5D=ema_search_categories%3A83&landing_from=73303">Medicine search: Referrals</a></li></ul></td></tr><tr><td data-th="Publication type "><ul><li>Notification</li><li>Draft list of medicines</li><li>List of questions</li><li>Timetable</li><li>Rationale for Art. 107i procedure</li></ul></td><td data-th="Publication time">Friday following PRAC or CHMP plenary where referral is started</td><td data-th="Location"><p><a href="/search?f%5B0%5D=ema_medicine_bundle%3Aema_referral&f%5B1%5D=ema_referral_type%3A111&f%5B2%5D=ema_referral_type%3A113&f%5B3%5D=ema_referral_type%3A117&f%5B4%5D=ema_search_categories%3A83&landing_from=73303">Medicine search: Referrals: Referral type: Article 20, 31 and 107i referrals</a> (on medicine page under 'All documents')</p></td></tr><tr><td data-th="Publication type ">PRAC list of questions addressed to stakeholders (for Art. 107i referrals)</td><td data-th="Publication time">Friday following PRAC plenary where referral is started</td><td data-th="Location"><p> <a href="/search?f%5B0%5D=ema_medicine_bundle%3Aema_referral&f%5B1%5D=ema_referral_type%3A111&f%5B2%5D=ema_referral_type%3A113&f%5B3%5D=ema_referral_type%3A117&f%5B4%5D=ema_search_categories%3A83&landing_from=73303">Medicine search: Referrals: Referral type: Article 20, 31 and 107i referrals</a> (on medicine page under 'Data submission')</p></td></tr><tr><td data-th="Publication type ">Communication on PRAC recommendation (when PRAC is involved)</td><td data-th="Publication time">Friday following PRAC plenary where PRAC recommendation is adopted</td><td data-th="Location"><ul><li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="369ab23e-ad7c-4e01-a338-a542250a0c7d" href="/en/prac-agendas-minutes-and-highlights">PRAC meeting highlights</a></li><li><a href="/search?f%5B0%5D=ema_medicine_bundle%3Aema_referral&f%5B1%5D=ema_search_categories%3A83&landing_from=73303">Medicine search: Referrals</a></li></ul></td></tr><tr><td data-th="Publication type ">Updated communication</td><td data-th="Publication time">Friday following CHMP or CMDh plenary where CHMP opinion or CMDh position is adopted</td><td data-th="Location"><ul><li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="3fbd2621-0e24-4c6b-8a79-12054530e27e" href="/en/homepage" title="Homepage">EMA homepage</a></li><li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="969118eb-ab58-4db2-82f6-ef253c1fddf6" href="/en/chmp-agendas-minutes-and-highlights">CHMP meeting highlights</a> (if applicable)</li><li><a href="/search?f%5B0%5D=ema_medicine_bundle%3Aema_referral&f%5B1%5D=ema_referral_type%3A111&f%5B2%5D=ema_referral_type%3A113&f%5B3%5D=ema_referral_type%3A117&f%5B4%5D=ema_search_categories%3A83&landing_from=73303">Medicine search: Referrals: Referral type: Article 20, 31 and 107i referrals</a></li></ul></td></tr><tr><td data-th="Publication type ">Text of the updated product information in English</td><td data-th="Publication time">Friday following CHMP or CMDh plenary where CHMP opinion or CMDh position is adopted</td><td data-th="Location"><p><a href="/search?f%5B0%5D=ema_medicine_bundle%3Aema_referral&f%5B1%5D=ema_referral_type%3A111&f%5B2%5D=ema_referral_type%3A113&f%5B3%5D=ema_referral_type%3A117&f%5B4%5D=ema_search_categories%3A83&landing_from=73303">Medicine search: Referrals: Referral type: Article 20, 31 and 107i referrals</a> (on medicine page under 'All documents')</p></td></tr><tr><td data-th="Publication type ">Timetable for implementation of CMDh consensus position</td><td data-th="Publication time">Friday following CMDh plenary where CMDh consensus position is adopted</td><td data-th="Location"><p><a href="/search?f%5B0%5D=ema_medicine_bundle%3Aema_referral&f%5B1%5D=ema_referral_type%3A111&f%5B2%5D=ema_referral_type%3A113&f%5B3%5D=ema_referral_type%3A117&f%5B4%5D=ema_search_categories%3A83&landing_from=73303">Medicine search: Referrals: Referral type: Article 20, 31 and 107i referrals</a> (on medicine page under 'All documents')</p></td></tr><tr><td data-th="Publication type ">Public assessment report</td><td data-th="Publication time">1 week after EC decision or CMDh consensus position</td><td data-th="Location"><p><a href="/search?f%5B0%5D=ema_medicine_bundle%3Aema_referral&f%5B1%5D=ema_referral_type%3A111&f%5B2%5D=ema_referral_type%3A113&f%5B3%5D=ema_referral_type%3A117&f%5B4%5D=ema_search_categories%3A83&landing_from=73303">Medicine search: Referrals: Referral type: Article 20, 31 and 107i referrals</a> (on medicine page under 'All documents')</p></td></tr><tr><td data-th="Publication type ">Annexes</td><td data-th="Publication time">4 weeks after EC decision or 8 weeks after CMDh consensus position</td><td data-th="Location"><p><a href="/search?f%5B0%5D=ema_medicine_bundle%3Aema_referral&f%5B1%5D=ema_referral_type%3A111&f%5B2%5D=ema_referral_type%3A113&f%5B3%5D=ema_referral_type%3A117&f%5B4%5D=ema_search_categories%3A83&landing_from=73303">Medicine search: Referrals: Referral type: Article 20, 31 and 107i referrals</a> (on medicine page under 'All documents')</p></td></tr><tr><td data-th="Publication type "><p>Update of EPAR documents  if CAPs are involved, including:</p><ul><li>product information;</li><li>procedural steps document;</li><li>medicine overview and list of all authorised presentations(if applicable)</li></ul></td><td data-th="Publication time">    <br> 2 weeks after EC decision</td><td data-th="Location"><p><a href="/search?f%5B0%5D=ema_med_status%3A100108&f%5B1%5D=ema_medicine_bundle%3Aema_medicine&f%5B2%5D=ema_search_categories%3A83&landing_from=73303">Medicines search: Medicines: Authorised</a></p></td></tr></tbody></table></div></div></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--12-2"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--12-2" aria-controls="collapse-bcl-accordion--12-2" aria-expanded="false" type="button" ><span>Article 13(2), 29(4) and 30 referrals</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--12-2" aria-labelledby="heading-bcl-accordion--12-2" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><div><div class="table-responsive"><table class="ecl-table ecl-table--responsive table"><thead><tr><th style="text-transform: uppercase">Publication type</th><th style="text-transform: uppercase">Publication time</th><th style="text-transform: uppercase">Location</th></tr></thead><tbody><tr><td data-th="Publication type ">Table ‘Start of community reviews’</td><td data-th="Publication time">Friday following CHMP plenary where referral is started</td><td data-th="Location"><ul><li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="969118eb-ab58-4db2-82f6-ef253c1fddf6" href="/en/chmp-agendas-minutes-and-highlights">CHMP meeting highlights</a></li></ul></td></tr><tr><td data-th="Publication type ">Announcement of start of referral (for Article 30 referrals only)</td><td data-th="Publication time">Friday following CHMP plenary where referral is started</td><td data-th="Location"><p> </p><ul><li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="969118eb-ab58-4db2-82f6-ef253c1fddf6" href="/en/chmp-agendas-minutes-and-highlights">CHMP meeting highlights</a> or <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="369ab23e-ad7c-4e01-a338-a542250a0c7d" href="/en/prac-agendas-minutes-and-highlights">PRAC meeting highlights</a></li><li><a href="/search?f%5B0%5D=ema_medicine_bundle%3Aema_referral&f%5B1%5D=ema_referral_type%3A116&f%5B2%5D=ema_search_categories%3A83&landing_from=73303">Medicine search: Referrals: Article 30 referrals</a></li></ul></td></tr><tr><td data-th="Publication type "><ul><li>Notification</li><li>Draft list of medicines</li><li>List of questions</li><li>Timetable (for Article 30 referrals only)</li></ul></td><td data-th="Publication time">Friday following CHMP plenary where referral is started</td><td data-th="Location"><p><a href="/search?f%5B0%5D=ema_medicine_bundle%3Aema_referral&f%5B1%5D=ema_referral_type%3A112&f%5B2%5D=ema_referral_type%3A115&f%5B3%5D=ema_referral_type%3A116&f%5B4%5D=ema_search_categories%3A83&landing_from=73303">Medicine search: Referrals: Article 13(2), 29(4) and 30 referrals</a> (on medicine page under 'All documents')</p></td></tr><tr><td data-th="Publication type ">Questions-and-answers document</td><td data-th="Publication time">Friday following CHMP plenary where CHMP opinion is adopted</td><td data-th="Location"><ul><li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="969118eb-ab58-4db2-82f6-ef253c1fddf6" href="/en/chmp-agendas-minutes-and-highlights">CHMP meeting highlights</a></li><li><a href="/search?f%5B0%5D=ema_medicine_bundle%3Aema_referral&f%5B1%5D=ema_referral_type%3A112&f%5B2%5D=ema_referral_type%3A115&f%5B3%5D=ema_referral_type%3A116&f%5B4%5D=ema_search_categories%3A83&landing_from=73303">Medicine search: Referrals: Article 13(2), 29(4) and 30 referrals</a></li></ul></td></tr><tr><td data-th="Publication type ">Text of the updated product information in English (if applicable)</td><td data-th="Publication time">Friday following CHMP plenary where CHMP opinion is adopted</td><td data-th="Location"><a href="/search?f%5B0%5D=ema_medicine_bundle%3Aema_referral&f%5B1%5D=ema_referral_type%3A112&f%5B2%5D=ema_referral_type%3A115&f%5B3%5D=ema_referral_type%3A116&f%5B4%5D=ema_search_categories%3A83&landing_from=73303">Medicine search: Referrals: Article 13(2), 29(4) and 30 referrals</a> (on medicine page under 'All documents')</td></tr><tr><td data-th="Publication type ">Public assessment report</td><td data-th="Publication time">1 week after EC decision</td><td data-th="Location"><p><a href="/search?f%5B0%5D=ema_medicine_bundle%3Aema_referral&f%5B1%5D=ema_referral_type%3A112&f%5B2%5D=ema_referral_type%3A115&f%5B3%5D=ema_referral_type%3A116&f%5B4%5D=ema_search_categories%3A83&landing_from=73303">Medicine search: Referrals: Article 13(2), 29(4) and 30 referrals</a> (on medicine page under 'All documents')</p></td></tr><tr><td data-th="Publication type ">Annexes</td><td data-th="Publication time">4 weeks after EC decision</td><td data-th="Location"><p><a href="/search?f%5B0%5D=ema_medicine_bundle%3Aema_referral&f%5B1%5D=ema_referral_type%3A112&f%5B2%5D=ema_referral_type%3A115&f%5B3%5D=ema_referral_type%3A116&f%5B4%5D=ema_search_categories%3A83&landing_from=73303">Medicine search: Referrals: Article 13(2), 29(4) and 30 referrals</a> (on medicine page under 'All documents')</p></td></tr></tbody></table></div></div></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--12-3"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--12-3" aria-controls="collapse-bcl-accordion--12-3" aria-expanded="false" type="button" ><span>Article 5(3) opinions</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--12-3" aria-labelledby="heading-bcl-accordion--12-3" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><div><div class="table-responsive"><table class="ecl-table ecl-table--responsive table"><thead><tr><th style="text-transform: uppercase">Publication type</th><th style="text-transform: uppercase">Publication time</th><th style="text-transform: uppercase">Location</th></tr></thead><tbody><tr><td data-th="Publication type ">Table ‘Start of community reviews’</td><td data-th="Publication time">Friday following CHMP plenary where referral is started</td><td data-th="Location"><ul><li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="969118eb-ab58-4db2-82f6-ef253c1fddf6" href="/en/chmp-agendas-minutes-and-highlights">CHMP meeting highlights</a></li></ul></td></tr><tr><td data-th="Publication type ">Press release (for selected opinions)</td><td data-th="Publication time">Friday following CHMP plenary where CHMP opinion is adopted</td><td data-th="Location"><p> </p><ul><li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="3fbd2621-0e24-4c6b-8a79-12054530e27e" href="/en/homepage" title="Homepage">EMA homepage</a></li><li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="969118eb-ab58-4db2-82f6-ef253c1fddf6" href="/en/chmp-agendas-minutes-and-highlights">CHMP meeting highlights</a></li></ul></td></tr><tr><td data-th="Publication type ">Public assessment report</td><td data-th="Publication time">15 days after CHMP opinion</td><td data-th="Location"><p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="b8bff2cd-d361-4085-975c-a386edd696aa" href="/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/referral-procedures-human-medicines/article-53-opinions-any-scientific-matter-human-medicines" title="Article 5(3) opinions on any scientific matter: human medicines">Article 5(3) opinions</a></p></td></tr></tbody></table></div></div></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--12-4"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--12-4" aria-controls="collapse-bcl-accordion--12-4" aria-expanded="false" type="button" ><span>Article 29 (Paediatrics) opinions</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--12-4" aria-labelledby="heading-bcl-accordion--12-4" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><div><div class="table-responsive"><table class="ecl-table ecl-table--responsive table"><thead><tr><th style="text-transform: uppercase">Publication type</th><th style="text-transform: uppercase">Publication time</th><th style="text-transform: uppercase">Location</th></tr></thead><tbody><tr><td data-th="Publication type ">Summary of CHMP conclusions</td><td data-th="Publication time">Friday following CHMP plenary where CHMP opinion is adopted</td><td data-th="Location"><a href="/search?f%5B0%5D=ema_medicine_bundle%3Aema_referral&f%5B1%5D=ema_referral_type%3A114&f%5B2%5D=ema_search_categories%3A83&landing_from=73303">Medicine search: Referrals: Article 29 (Paediatrics) referrals</a></td></tr><tr><td data-th="Publication type ">Public assessment report </td><td data-th="Publication time">15 days after CHMP opinion</td><td data-th="Location"><p><a href="/search?f%5B0%5D=ema_medicine_bundle%3Aema_referral&f%5B1%5D=ema_referral_type%3A114&f%5B2%5D=ema_search_categories%3A83&landing_from=73303">Medicine search: Referrals: Article 29 (Paediatrics) referrals</a> (on medicine page under 'Documents')</p></td></tr></tbody></table></div></div></div></div></div></div></div></div></div></div><div class="item"><div id="ema-inpage-item-38652" class="paragraph paragraph--type--oe-rich-text paragraph--view-mode--default"><div class="ecl-editor"><p><strong>Other documents and procedures</strong></p></div></div></div><div class="item"><div id="ema-inpage-item-38653"><div class="accordion d-flex flex-column" id="accordion-bcl-accordion--13"><div class="accordion-buttons d-flex flex-row align-items-center justify-content-end gap-3 mb-3"><button class="btn btn-primary" type="button" role="button" data-trigger="expand-section" aria-expanded="true">Expand section</button><button class="btn btn-light" type="button" role="button" data-trigger="collapse-section" aria-expanded="false">Collapse section</button></div><script type="text/javascript"> document.querySelectorAll('#accordion-bcl-accordion--13 [data-trigger]').forEach((button) => { button.addEventListener('click', event => { const item = event.target, action = item.getAttribute('data-trigger'), accordion = item.closest('#accordion-bcl-accordion--13'), accordion_items = accordion.querySelectorAll('.accordion-collapse'); accordion_items.forEach((accordion_item) => { if (action === 'expand-section') { bootstrap.Collapse.getOrCreateInstance(accordion_item, { toggle: false }).show(); } else if (action === 'collapse-section') { bootstrap.Collapse.getOrCreateInstance(accordion_item, { toggle: false }).hide(); } }); }, false); }); </script><div class="accordion-items-wrapper"><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--13-1"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--13-1" aria-controls="collapse-bcl-accordion--13-1" aria-expanded="false" type="button" ><span>Orphan designations</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--13-1" aria-labelledby="heading-bcl-accordion--13-1" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><div><div class="table-responsive"><table class="ecl-table ecl-table--responsive table"><thead><tr><th style="text-transform:uppercase;">Publication type</th><th style="text-transform:uppercase;">Publication time</th><th style="text-transform:uppercase;">Location</th></tr></thead><tbody><tr><td data-th="Publication type ">Orphan designation page</td><td data-th="Publication time">After EC decision on orphan designation</td><td data-th="Location"><a href="/search?f%5B0%5D=ema_medicine_bundle%3Aema_orphan&f%5B1%5D=ema_search_categories%3A83&landing_from=73303">Medicine search: Orphan designations</a></td></tr><tr><td data-th="Publication type ">Orphan maintenance / withdrawal assessment report</td><td data-th="Publication time">2 weeks after EC decision </td><td data-th="Location"><a href="/search?f%5B0%5D=ema_medicine_bundle%3Aema_orphan&f%5B1%5D=ema_search_categories%3A83&landing_from=73303">Medicine search: Orphan designations</a> (on medicine page under 'Review of designation')</td></tr><tr><td data-th="Publication type ">Orphan maintenance / withdrawal assessment report following Member State request</td><td data-th="Publication time">6-8 weeks after COMP opinion</td><td data-th="Location"><a href="/search?f%5B0%5D=ema_medicine_bundle%3Aema_orphan&f%5B1%5D=ema_search_categories%3A83&landing_from=73303">Medicine search: Orphan designations</a> (on medicine page under 'Review of designation')</td></tr></tbody></table></div></div></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--13-2"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--13-2" aria-controls="collapse-bcl-accordion--13-2" aria-expanded="false" type="button" ><span>Advanced therapy classifications</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--13-2" aria-labelledby="heading-bcl-accordion--13-2" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><div><div class="table-responsive"><table class="ecl-table ecl-table--responsive table"><thead><tr><th style="text-transform: uppercase">Publication type</th><th style="text-transform: uppercase">Publication time</th><th style="text-transform: uppercase">Location</th></tr></thead><tbody><tr><td data-th="Publication type "><p>Summary of scientific recommendations on classification of advanced-therapy medicinal products</p></td><td data-th="Publication time">After CAT conclusion</td><td data-th="Location"><p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="8fab92a9-3a20-4470-b10c-b504c2ad74d3" href="/en/human-regulatory-overview/marketing-authorisation/advanced-therapies-marketing-authorisation/scientific-recommendations-classification-advanced-therapy-medicinal-products" title="Scientific recommendations on classification of advanced therapy medicinal products">Summaries of scientific recommendations on classification of advanced therapy medicinal products</a></p></td></tr></tbody></table></div></div></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--13-3"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--13-3" aria-controls="collapse-bcl-accordion--13-3" aria-expanded="false" type="button" ><span>Requests for PRIME eligibility</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--13-3" aria-labelledby="heading-bcl-accordion--13-3" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><div class="table-responsive"><div class="table-responsive"><table class="ecl-table ecl-table--responsive table"><thead><tr><th style="text-transform: uppercase">Publication type</th><th style="text-transform: uppercase">Publication time</th><th style="text-transform: uppercase">Location</th></tr></thead><tbody><tr><td data-th="Publication type ">Recommendations on eligibility to PRIME scheme</td><td data-th="Publication time">After each CHMP meeting</td><td data-th="Location"><ul><li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="969118eb-ab58-4db2-82f6-ef253c1fddf6" href="/en/chmp-agendas-minutes-and-highlights">CHMP highlights</a></li><li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="1ad2812f-6fe2-48ce-a390-e48e74c3e170" href="/en/human-regulatory-overview/research-development/prime-priority-medicines" title="PRIME: priority medicines">PRIME: priority medicines</a></li><li><a xmlns:xlink="http://www.w3.org/1999/xlink" href="/en/documents/chmp-annex/recommendations-eligibility-prime-scheme-adopted-chmp-meeting-28-30-april-2020_en.pdf" target="_blank" hreflang="en"><svg class="me-2-5 bi icon--s"><use xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#file-pdf"></use></svg>Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 28-30 April 2020</a></li></ul></td></tr><tr><td data-th="Publication type ">List of products granted eligibility to PRIME </td><td data-th="Publication time">After each CHMP meeting</td><td data-th="Location"><ul><li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="1ad2812f-6fe2-48ce-a390-e48e74c3e170" href="/en/human-regulatory-overview/research-development/prime-priority-medicines" title="PRIME: priority medicines">PRIME: priority medicines</a></li><li></ul><p> </p></td></tr></tbody></table></div></div></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--13-4"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--13-4" aria-controls="collapse-bcl-accordion--13-4" aria-expanded="false" type="button" ><span>Paediatric investigation plans (PIP)</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--13-4" aria-labelledby="heading-bcl-accordion--13-4" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><div><div class="table-responsive"><table class="ecl-table ecl-table--responsive table"><thead><tr><th style="text-transform: uppercase">Publication type</th><th style="text-transform: uppercase">Publication time</th><th style="text-transform: uppercase">Location</th></tr></thead><tbody><tr><td data-th="Publication type ">Decisions on PIPs and waivers</td><td data-th="Publication time">6-8 weeks after EMA decision</td><td data-th="Location"><p><a href="/search?f%5B0%5D=ema_medicine_bundle%3Aema_pip&f%5B1%5D=ema_search_categories%3A83&landing_from=73303">Medicines search: Paediatric investigation plans</a></p></td></tr><tr><td data-th="Publication type ">Compliance check outcome</td><td data-th="Publication time">Twice a year</td><td data-th="Location"><a href="/search?f%5B0%5D=ema_medicine_bundle%3Aema_pip&f%5B1%5D=ema_search_categories%3A83&landing_from=73303">Medicines search: Paediatric investigation plans</a></td></tr><tr><td data-th="Publication type ">Compliance statement</td><td data-th="Publication time">2 weeks after EC decision or 4-5 weeks after CHMP opinion / notification, as applicable</td><td data-th="Location"><p><a href="/search?f%5B0%5D=ema_medicine_bundle%3Aema_pip&f%5B1%5D=ema_search_categories%3A83&landing_from=73303">Medicines search: Paediatric investigation plans</a></p></td></tr></tbody></table></div></div></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--13-5"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--13-5" aria-controls="collapse-bcl-accordion--13-5" aria-expanded="false" type="button" ><span>Safety signals</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--13-5" aria-labelledby="heading-bcl-accordion--13-5" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><div><div class="table-responsive"><table class="ecl-table ecl-table--responsive table"><thead><tr><th style="text-transform: uppercase">Publication type</th><th style="text-transform: uppercase">Publication time</th><th style="text-transform: uppercase">Location</th></tr></thead><tbody><tr><td data-th="Publication type ">PRAC recommendations on signals</td><td data-th="Publication time">Within a month of PRAC plenary</td><td data-th="Location"><p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="de8659f1-77eb-4366-9f5d-dd1c0bcbe242" href="/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/signal-management/prac-recommendations-safety-signals" title="PRAC recommendations on safety signals">PRAC recommendations on safety signals</a></p></td></tr><tr><td data-th="Publication type ">New product information wording (if applicable)</td><td data-th="Publication time">Within a month of PRAC plenary</td><td data-th="Location"><p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="de8659f1-77eb-4366-9f5d-dd1c0bcbe242" href="/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/signal-management/prac-recommendations-safety-signals" title="PRAC recommendations on safety signals">PRAC recommendations on safety signals</a></p></td></tr></tbody></table></div></div></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--13-6"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--13-6" aria-controls="collapse-bcl-accordion--13-6" aria-expanded="false" type="button" ><span>Medicines under additional monitoring</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--13-6" aria-labelledby="heading-bcl-accordion--13-6" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><div><div class="table-responsive"><table class="ecl-table ecl-table--responsive table"><thead><tr><th style="text-transform: uppercase">Publication type</th><th style="text-transform: uppercase">Publication time</th><th style="text-transform: uppercase">Location</th></tr></thead><tbody><tr><td data-th="Publication type ">List of medicines under additional monitoring</td><td data-th="Publication time">Monthly</td><td data-th="Location"><p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="b24f2432-e751-49e3-95eb-49c3f6201799" href="/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/medicines-under-additional-monitoring/list-medicines-under-additional-monitoring" title="List of medicines under additional monitoring">List of medicines under additional monitoring</a></p></td></tr></tbody></table></div></div></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--13-7"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--13-7" aria-controls="collapse-bcl-accordion--13-7" aria-expanded="false" type="button" ><span>Compassionate use</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--13-7" aria-labelledby="heading-bcl-accordion--13-7" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><div><div class="table-responsive"><table class="ecl-table ecl-table--responsive table"><thead><tr><th style="text-transform: uppercase">Publication type</th><th style="text-transform: uppercase">Publication time</th><th style="text-transform: uppercase">Location</th></tr></thead><tbody><tr><td data-th="Publication type ">Summary of compassionate use</td><td data-th="Publication time">After CHMP opinion</td><td data-th="Location"><p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="18c30ef8-f4a2-4a80-916c-2ea4fdfe0a6b" href="/en/human-regulatory-overview/research-development/compassionate-use" title="Compassionate use">Compassionate use</a></p></td></tr><tr><td data-th="Publication type "><ul><li>Conditions of use</li><li>Conditions for distribution</li><li>Patients targeted</li><li>Conditions for safety monitoring</li></ul></td><td data-th="Publication time">After CHMP opinion</td><td data-th="Location"><p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="18c30ef8-f4a2-4a80-916c-2ea4fdfe0a6b" href="/en/human-regulatory-overview/research-development/compassionate-use" title="Compassionate use">Compassionate use</a></p></td></tr><tr><td data-th="Publication type ">Dedicated press release (for selected opinions)</td><td data-th="Publication time"><p>Friday following CHMP plenary</p></td><td data-th="Location"><ul><li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="3fbd2621-0e24-4c6b-8a79-12054530e27e" href="/en/homepage" title="Homepage">EMA homepage</a></li><li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="969118eb-ab58-4db2-82f6-ef253c1fddf6" href="/en/chmp-agendas-minutes-and-highlights">CHMP</a><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="969118eb-ab58-4db2-82f6-ef253c1fddf6" href="/en/chmp-agendas-minutes-and-highlights">meeting highlights</a></li></ul></td></tr><tr><td data-th="Publication type ">Public statement on end of compassionate use programme</td><td data-th="Publication time">Following notification from company</td><td data-th="Location"><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="18c30ef8-f4a2-4a80-916c-2ea4fdfe0a6b" href="/en/human-regulatory-overview/research-development/compassionate-use" title="Compassionate use">Compassionate use</a></td></tr></tbody></table></div></div></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--13-8"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--13-8" aria-controls="collapse-bcl-accordion--13-8" aria-expanded="false" type="button" ><span>Medicine supply shortages</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--13-8" aria-labelledby="heading-bcl-accordion--13-8" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><div><div class="table-responsive"><table class="ecl-table ecl-table--responsive table"><thead><tr><th style="text-transform: uppercase">Publication type</th><th style="text-transform: uppercase">Publication time</th><th style="text-transform: uppercase">Location</th></tr></thead><tbody><tr><td data-th="Publication type ">Ongoing medicine shortage</td><td data-th="Publication time">At time of shortage</td><td data-th="Location"><p><a href="https://www.ema.europa.eu/search?f%5B0%5D=ema_medicine_bundle%3Adocument&f%5B1%5D=ema_search_categories%3A83&f%5B2%5D=ema_search_entity_is_document%3ADocument">Medicines search: Ongoing and resolved shortages</a></p></td></tr><tr><td data-th="Publication type ">Resolved medicine shortage</td><td data-th="Publication time">When shortage is resolved</td><td data-th="Location"><a href="https://www.ema.europa.eu/search?f%5B0%5D=ema_medicine_bundle%3Adocument&f%5B1%5D=ema_search_categories%3A83&f%5B2%5D=ema_search_entity_is_document%3ADocument">Medicines search: Ongoing and resolved shortages</a></td></tr></tbody></table></div></div></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--13-9"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--13-9" aria-controls="collapse-bcl-accordion--13-9" aria-expanded="false" type="button" ><span>Periodic safety update reports</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--13-9" aria-labelledby="heading-bcl-accordion--13-9" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><h3>Periodic safety update report single assessments (PSUSAs) for active substances in centrally authorised medicines only</h3><div><div class="table-responsive"><table class="ecl-table ecl-table--responsive table"><thead><tr><th style="text-transform: uppercase">Publication type</th><th style="text-transform: uppercase">Publication time</th><th style="text-transform: uppercase">Location</th></tr></thead><tbody><tr><td data-th="Publication type "><p>Update of EPAR documents, including:</p><ul><li>product information;</li><li>procedural steps document</li><li>EPAR summary (if applicable)</li><li>list of all authorised presentations (if applicable)</li></ul></td><td data-th="Publication time">2 weeks after EC decision</td><td data-th="Location"><p><a href="/search?f%5B0%5D=ema_med_status%3A100108&f%5B1%5D=ema_medicine_bundle%3Aema_medicine&f%5B2%5D=ema_search_categories%3A83&landing_from=73303">Medicines search: Medicines: Authorised</a> (on medicine page)</p></td></tr><tr><td data-th="Publication type ">Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation<br> (for PSUSAs that lead to changes to product information)</td><td data-th="Publication time">2 weeks after EC decision</td><td data-th="Location"><p><a href="/search?f%5B0%5D=ema_med_status%3A100108&f%5B1%5D=ema_medicine_bundle%3Aema_medicine&f%5B2%5D=ema_search_categories%3A83&landing_from=73303">Medicines search: Medicines: Authorised</a> (on medicine page under 'Assessment history')</p></td></tr><tr><td data-th="Publication type ">Public assessment report<br> (for PSUSAs that are of significant clinical relevance)</td><td data-th="Publication time">2 weeks after EC decision</td><td data-th="Location"><p><a href="/search?f%5B0%5D=ema_med_status%3A100108&f%5B1%5D=ema_medicine_bundle%3Aema_medicine&f%5B2%5D=ema_search_categories%3A83&landing_from=73303">Medicines search: Medicines: Authorised</a> (on medicine page under 'Assessment history')</p></td></tr></tbody></table></div></div><h3>PSUSAs for active substances in nationally authorised medicines only</h3><div><div class="table-responsive"><table class="ecl-table ecl-table--responsive table"><thead><tr><th style="text-transform: uppercase">Publication type</th><th style="text-transform: uppercase">Publication time</th><th style="text-transform: uppercase">Location</th></tr></thead><tbody><tr><td data-th="Publication type ">List of medicines </td><td data-th="Publication time">Within 1 week or 2 months of conclusion of PSUSA<br> (for maintenance or variation, respectively)</td><td data-th="Location"><p><a href="/search?f%5B0%5D=ema_medicine_bundle%3Aema_psusa&f%5B1%5D=ema_search_categories%3A83&landing_from=73303">Medicines search: PSUSAs</a></p></td></tr><tr><td data-th="Publication type ">Scientific conclusions and grounds for variation to the terms of the marketing authorisations<br> (if applicable)</td><td data-th="Publication time">Within 2 months after conclusion of PSUSA</td><td data-th="Location"><p><a href="/search?f%5B0%5D=ema_medicine_bundle%3Aema_psusa&f%5B1%5D=ema_search_categories%3A83&landing_from=73303">Medicines search: PSUSAs</a></p></td></tr><tr><td data-th="Publication type ">Public assessment report<br> (for PSURs that are of significant clinical relevance)</td><td data-th="Publication time">Within 2 months after conclusion of PSUSA</td><td data-th="Location"><p><a href="/search?f%5B0%5D=ema_medicine_bundle%3Aema_psusa&f%5B1%5D=ema_search_categories%3A83&landing_from=73303">Medicines search: PSUSAs</a></p></td></tr></tbody></table></div></div></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--13-10"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--13-10" aria-controls="collapse-bcl-accordion--13-10" aria-expanded="false" type="button" ><span>Imposed non-interventional post-authorisation safety studies (PASS)</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--13-10" aria-labelledby="heading-bcl-accordion--13-10" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><p>Post-authorisation safety studies (PASS) are studies carried out after a medicine has been authorised in order to obtain further information on the medicine's safety, or to measure the effectiveness of risk-management measures. The PRAC assesses both the protocols and the final study results of all imposed non-interventional PASS.</p><p>All procedures to assess final results of imposed non-interventional PASS result in a change to the marketing authorisation (i.e. a variation).</p><p>The assessment of results from imposed non-interventional PASS for active substances found only in centrally authorised medicines will result in an update of relevant EPAR documents, as described in Section 3.2. A document called <strong>Scientific conclusions, amendments to product information and implementation timetable </strong>is also published on the medicine’s page in the section ‘Assessment history’.</p><p>The outcomes of assessments of imposed non-interventional PASS results for active substances found only in nationally authorised medicines are published on the page <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="48c17c3b-8e5b-447c-9802-c60199b3b9e1" href="/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/post-authorisation-safety-studies-pass/outcomes-imposed-non-interventional-post-authorisation-safety-studies" title="Outcomes of imposed non-interventional post-authorisation safety studies">Outcomes of imposed noninterventional post-authorisation safety studies</a> within 2 months of the conclusion of the procedure. EMA publishes on this page the <strong>List of medicines</strong> that were assessed in the PASS together with the <strong>Scientific conclusions, amendments to product information and implementation timetable</strong>. This latter document is available in all official EU languages. An <strong>Assessment report</strong> is only published when changes are considered to be of significant clinical relevance.</p></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--13-11"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--13-11" aria-controls="collapse-bcl-accordion--13-11" aria-expanded="false" type="button" ><span>Direct healthcare professional communications (DHPC)</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--13-11" aria-labelledby="heading-bcl-accordion--13-11" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><div><div class="table-responsive"><table class="ecl-table ecl-table--responsive table"><thead><tr><th style="text-transform: uppercase">Publication type</th><th style="text-transform: uppercase">Publication time</th><th style="text-transform: uppercase">Location</th></tr></thead><tbody><tr><td data-th="Publication type ">DHPC</td><td data-th="Publication time">At the time of dissemination of the DHPC</td><td data-th="Location"><p><a href="/search?f%5B0%5D=ema_medicine_bundle%3Aema_dhpc_document&f%5B1%5D=ema_search_categories%3A83&landing_from=73303">Medicines search: DHPCs</a></p></td></tr></tbody></table></div></div></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--13-12"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--13-12" aria-controls="collapse-bcl-accordion--13-12" aria-expanded="false" type="button" ><span>Medicines for use outside the EU (Article 58) opinions</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--13-12" aria-labelledby="heading-bcl-accordion--13-12" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><div><div class="table-responsive"><table class="ecl-table ecl-table--responsive table"><thead><tr><th style="text-transform: uppercase">Publication type</th><th style="text-transform: uppercase">Publication time</th><th style="text-transform: uppercase">Location</th></tr></thead><tbody><tr><td data-th="Publication type ">Same documents as for centrally authorised medicines (see 'Applications for centralised marketing authorisations')</td><td data-th="Publication time">Within 2 months of CHMP opinion</td><td data-th="Location"><p><a href="/search?f%5B0%5D=ema_medicine_bundle%3Aema_opinion_med_use_outside_eu&f%5B1%5D=ema_search_categories%3A83&landing_from=73303">Medicines search: Opinions on medicines for use outside the European Union</a></p></td></tr></tbody></table></div></div></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--13-13"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--13-13" aria-controls="collapse-bcl-accordion--13-13" aria-expanded="false" type="button" ><span>Ancillary medicinal substances</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--13-13" aria-labelledby="heading-bcl-accordion--13-13" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><div class="table-responsive"><div class="table-responsive"><table class="ecl-table ecl-table--responsive table"><thead><tr><th style="text-transform: uppercase">Publication type</th><th style="text-transform: uppercase">Publication time</th><th style="text-transform: uppercase">Location</th></tr></thead><tbody><tr><td data-th="Publication type ">Consultation public assessment report</td><td data-th="Publication time">2 weeks after notified body confirms issue of CE mark</td><td data-th="Location"><p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="550b6f01-f01b-415b-b81e-431c66ff164f" href="/en/human-regulatory-overview/medical-devices/consultation-procedure-ancillary-medicinal-substances-medical-devices/chmp-opinions-consultation-procedures" title="CHMP opinions on consultation procedures">CHMP opinions on consultation procedures</a></p></td></tr><tr><td data-th="Publication type ">Procedural steps and scientific information after initial consultation</td><td data-th="Publication time">2 weeks after finalisation of a post-consultation procedure</td><td data-th="Location"><p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="550b6f01-f01b-415b-b81e-431c66ff164f" href="/en/human-regulatory-overview/medical-devices/consultation-procedure-ancillary-medicinal-substances-medical-devices/chmp-opinions-consultation-procedures" title="CHMP opinions on consultation procedures">CHMP opinions on consultation procedures</a></p></td></tr></tbody></table></div></div></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--13-14"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--13-14" aria-controls="collapse-bcl-accordion--13-14" aria-expanded="false" type="button" ><span>Medical literature monitoring</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--13-14" aria-labelledby="heading-bcl-accordion--13-14" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><div class="table-responsive"><div class="table-responsive"><table class="ecl-table ecl-table--responsive table"><thead><tr><th style="text-transform: uppercase">Publication type</th><th style="text-transform: uppercase">Publication time</th><th style="text-transform: uppercase">Location</th></tr></thead><tbody><tr><td data-th="Publication type ">Medical literature monitoring: substance and herbal substance groups</td><td data-th="Publication time">Annually</td><td data-th="Location"><p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="c20dc0b0-a1a3-444d-b5ed-854143b52d67" href="/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/medical-literature-monitoring" title="Medical literature monitoring">Monitoring of medical literature and entry of adverse reaction reports into EudraVigilance</a></p></td></tr></tbody></table></div></div></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--13-15"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--13-15" aria-controls="collapse-bcl-accordion--13-15" aria-expanded="false" type="button" ><span>Clinical data publication*</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--13-15" aria-labelledby="heading-bcl-accordion--13-15" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><div class="table-responsive"><div class="table-responsive"><table class="ecl-table ecl-table--responsive table"><thead><tr><th style="text-transform: uppercase">Publication type</th><th style="text-transform: uppercase">Publication time</th><th style="text-transform: uppercase">Location</th></tr></thead><tbody><tr><td data-th="Publication type ">Clinical reports for marketing authorisation applications, line extensions and extensions of indication</td><td data-th="Publication time">Within 60 days after EC decision and following publication of the EPAR</td><td data-th="Location"><p><a href="https://clinicaldata.ema.europa.eu/home">Clinical data website</a></p></td></tr><tr><td data-th="Publication type ">Clinical reports for medicines for use outside the EU (Article 58 applications)</td><td data-th="Publication time">Within 150 days after the CHMP opinion</td><td data-th="Location"><p><a href="https://clinicaldata.ema.europa.eu/home">Clinical data website</a></p></td></tr><tr><td data-th="Publication type ">Clinical reports for withdrawn applications</td><td data-th="Publication time">Within 150 days after the receipt of the withdrawal letter</td><td data-th="Location"><p><a href="https://clinicaldata.ema.europa.eu/home">Clinical data website</a></p></td></tr></tbody></table></div></div><p>For more information on EMA's policy on the publication of clinical data, see <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="8207ae0d-85eb-426d-b893-d2f60c857f7c" href="/en/human-regulatory-overview/marketing-authorisation/clinical-data-publication" title="Clinical data publication">Clinical data publication</a>.</p><p>* temporarily suspended</p></div></div></div></div></div></div></div></div><div class="item"><div id="ema-inpage-item-38654" class="paragraph paragraph--type--oe-rich-text paragraph--view-mode--default"><div id="veterinary-medicines-38654"><h2 class="mb-4 rounded-title"> Veterinary medicines </h2></div><div class="ecl-editor"><h3>Overview of publications and their location</h3><p><strong>Applications for centralised marketing authorisation</strong></p></div></div></div><div class="item"><div id="ema-inpage-item-38655"><div class="accordion d-flex flex-column" id="accordion-bcl-accordion--14"><div class="accordion-buttons d-flex flex-row align-items-center justify-content-end gap-3 mb-3"><button class="btn btn-primary" type="button" role="button" data-trigger="expand-section" aria-expanded="true">Expand section</button><button class="btn btn-light" type="button" role="button" data-trigger="collapse-section" aria-expanded="false">Collapse section</button></div><script type="text/javascript"> document.querySelectorAll('#accordion-bcl-accordion--14 [data-trigger]').forEach((button) => { button.addEventListener('click', event => { const item = event.target, action = item.getAttribute('data-trigger'), accordion = item.closest('#accordion-bcl-accordion--14'), accordion_items = accordion.querySelectorAll('.accordion-collapse'); accordion_items.forEach((accordion_item) => { if (action === 'expand-section') { bootstrap.Collapse.getOrCreateInstance(accordion_item, { toggle: false }).show(); } else if (action === 'collapse-section') { bootstrap.Collapse.getOrCreateInstance(accordion_item, { toggle: false }).hide(); } }); }, false); }); </script><div class="accordion-items-wrapper"><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--14-1"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--14-1" aria-controls="collapse-bcl-accordion--14-1" aria-expanded="false" type="button" ><span>Positive opinions</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--14-1" aria-labelledby="heading-bcl-accordion--14-1" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><div><div class="table-responsive"><table class="ecl-table ecl-table--responsive table"><thead><tr><th style="text-transform:uppercase;">Publication type</th><th style="text-transform:uppercase;">Publication time</th><th style="text-transform:uppercase;">Location</th></tr></thead><tbody><tr><td data-th="Publication type ">Summary of opinion</td><td data-th="Publication time">Friday following CVMP plenary</td><td data-th="Location"><ul><li><a href="/en/committees/committee-veterinary-medicinal-products-cvmp" data-entity-type="node" data-entity-uuid="c9f8ab45-4376-44e5-9371-94b6cd1e4bfc" data-entity-substitution="canonical" title="Committee for Veterinary Medicinal Products (CVMP)">CVMP meeting highlights</a></li><li><a href="https://www.ema.europa.eu/en/search?f%5B0%5D=ema_med_status%3A100103&f%5B1%5D=ema_med_status%3Aopinion&f%5B2%5D=ema_medicine_bundle%3Aema_medicine&f%5B3%5D=ema_search_categories%3A84&landing_from=73303">Medicines search: Medicines: Opinion</a></li></ul><p>(document moved to medicine page after EC decision)</p></td></tr><tr><td data-th="Publication type ">Dedicated press release (for selected medicines)</td><td data-th="Publication time">Friday following CVMP plenary</td><td data-th="Location"><ul><li><a href="/en/homepage" data-entity-type="node" data-entity-uuid="3fbd2621-0e24-4c6b-8a79-12054530e27e" data-entity-substitution="canonical" title="Homepage">EMA homepage</a></li><li>CVMP meeting highlights</li></ul></td></tr><tr><td><p>Product summary</p><p>This includes:</p><ul><li>product name and authorisation number;</li><li>authorisation status;</li><li>pharmacotherapeutic group;</li><li>summary of opinion.</li></ul></td><td>2 weeks after EC decision</td><td><ul><li><a href="https://www.ema.europa.eu/search?f%5B0%5D=ema_medicine_bundle%3Aema_medicine&f%5B1%5D=ema_search_categories%3A84&landing_from=73303">Medicines search: Medicines: Authorised</a></li></ul></td></tr><tr><td data-th="Publication type "><p>European public assessment report (EPAR)</p><p>This includes:</p><ul><li>authorisation details;</li><li>product information;</li><li>public assessment reports.</li></ul></td><td data-th="Publication time">6 weeks after EC decision</td><td data-th="Location"><a href="https://medicines.health.europa.eu/veterinary/select-language?destination=/node/210934">Veterinary Medicines Information website</a></td></tr></tbody></table></div></div><p> </p></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--14-2"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--14-2" aria-controls="collapse-bcl-accordion--14-2" aria-expanded="false" type="button" ><span>Negative opinions</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--14-2" aria-labelledby="heading-bcl-accordion--14-2" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><div class="table-responsive"><table class="ecl-table ecl-table--responsive table"><thead><tr><th style="text-transform:uppercase;">Publication type</th><th style="text-transform:uppercase;">Publication time</th><th style="text-transform:uppercase;">Location</th></tr></thead><tbody><tr><td data-th="Publication type ">Refusal questions and answers (Q&A)</td><td data-th="Publication time">1 month after EC decision</td><td data-th="Location"><ul><li><a href="https://www.ema.europa.eu/en/news?f%5B0%5D=ema_news_responsible_body%3A100006">CVMP meeting highlights</a></li><li><a href="https://www.ema.europa.eu/en/search?f%5B0%5D=ema_med_status%3A100103&f%5B1%5D=ema_med_status%3Aopinion&f%5B2%5D=ema_medicine_bundle%3Aema_medicine&f%5B3%5D=ema_search_categories%3A84&landing_from=73303">Medicines search: Medicines: Opinion</a></li></ul><p>(document moved to medicine page after EC decision)</p></td></tr><tr><td data-th="Publication type ">Refusal public assessment report</td><td data-th="Publication time">6 weeks after EC decision</td><td data-th="Location"><a href="https://www.ema.europa.eu/en/search?f%5B0%5D=ema_med_status%3Arefused&f%5B1%5D=ema_medicine_bundle%3Aema_medicine&f%5B2%5D=ema_search_categories%3A84&landing_from=73303">Medicines search: Medicines: Refused</a> <span style="background-color:var(--bs-table-bg);color:var(--bs-table-color);font-family:var(--bs-body-font-family);font-size:var(--bs-body-font-size);font-weight:var(--bs-body-font-weight);text-align:var(--bs-body-text-align);">(on medicine page under 'Assessment history')</span></td></tr></tbody></table></div><p> </p></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--14-3"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--14-3" aria-controls="collapse-bcl-accordion--14-3" aria-expanded="false" type="button" ><span>Re-examinations of opinion</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--14-3" aria-labelledby="heading-bcl-accordion--14-3" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><p>After the EC decision, depending on the outcome of the re-examination, EMA publishes the same set of documents as for positive and negative opinions.</p></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--14-4"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--14-4" aria-controls="collapse-bcl-accordion--14-4" aria-expanded="false" type="button" ><span>Withdrawals of initial applications</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--14-4" aria-labelledby="heading-bcl-accordion--14-4" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><div><div class="table-responsive"><table class="ecl-table ecl-table--responsive table"><thead><tr><th style="text-transform:uppercase;">Publication type</th><th style="text-transform:uppercase;">Publication time</th><th style="text-transform:uppercase;">Location</th></tr></thead><tbody><tr><td data-th="Publication type ">Withdrawal letter</td><td data-th="Publication time">Published together with Withdrawal European public assessment report (WEPAR)</td><td data-th="Location"><a href="https://www.ema.europa.eu/en/search?f%5B0%5D=ema_med_status%3A100105&f%5B1%5D=ema_med_status%3Awithdrawn_application&f%5B2%5D=ema_medicine_bundle%3Aema_medicine&f%5B3%5D=ema_search_categories%3A84&landing_from=73303">Medicines search: Medicines: Application withdrawn</a></td></tr><tr><td data-th="Publication type ">Withdrawal public assessment report</td><td data-th="Publication time">Within 3 months of receipt of withdrawal letter</td><td data-th="Location"><a href="https://www.ema.europa.eu/en/search?f%5B0%5D=ema_med_status%3A100105&f%5B1%5D=ema_med_status%3Awithdrawn_application&f%5B2%5D=ema_medicine_bundle%3Aema_medicine&f%5B3%5D=ema_search_categories%3A84&landing_from=73303">Medicines search: Medicines: Application withdrawn</a></td></tr><tr><td data-th="Publication type ">Withdrawal key facts</td><td data-th="Publication time">Within 3 months of receipt of withdrawal letter</td><td data-th="Location"><a href="https://www.ema.europa.eu/en/search?f%5B0%5D=ema_med_status%3A100105&f%5B1%5D=ema_med_status%3Awithdrawn_application&f%5B2%5D=ema_medicine_bundle%3Aema_medicine&f%5B3%5D=ema_search_categories%3A84&landing_from=73303">Medicines search: Medicines: Application withdrawn</a></td></tr></tbody></table></div></div></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--14-5"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--14-5" aria-controls="collapse-bcl-accordion--14-5" aria-expanded="false" type="button" ><span>Maximum residue limits (MRL)</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--14-5" aria-labelledby="heading-bcl-accordion--14-5" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><div><div class="table-responsive"><table class="ecl-table ecl-table--responsive table"><thead><tr><th style="text-transform: uppercase">Publication type</th><th style="text-transform: uppercase">Publication time</th><th style="text-transform: uppercase">Location</th></tr></thead><tbody><tr><td data-th="Publication type ">MRL summaries of opinion (pending EC decision)</td><td data-th="Publication time">Friday following CVMP plenary</td><td data-th="Location"><p><a href="/search?f%5B0%5D=document_type%3AMaximum%20Residue%20Limits%20-%20Summary%20of%20opinion&f%5B1%5D=ema_search_entity_is_document%3ADocument">Medicine search: Opinions on MRLs</a></p></td></tr><tr><td data-th="Publication type ">European public maximum-residue-limit assessment report (EPMAR)</td><td data-th="Publication time">Following publication of the respective MRL regulation by the European Commission<br> (within 4 weeks)</td><td data-th="Location"><p><a href="/search?f%5B0%5D=document_type%3AMaximum%20Residue%20Limits%20-%20Report&f%5B1%5D=ema_search_entity_is_document%3ADocument">Medicines search: MRLs</a></p></td></tr><tr><td data-th="Publication type ">MRL opinions</td><td data-th="Publication time">Following publication of the respective MRL regulation by the European Commission <br> (within 4 weeks)</td><td data-th="Location"><p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="360b3515-f09d-41d6-9295-f513fad2dcaf" href="/en/veterinary-regulatory-overview/research-and-development-veterinary-medicines/maximum-residue-limits-mrl/maximum-residue-limit-opinions" title="Maximum residue limit opinions">Maximum residue limit opinions</a></p></td></tr></tbody></table></div></div></div></div></div></div></div></div></div></div><div class="item"><div id="ema-inpage-item-38656" class="paragraph paragraph--type--oe-rich-text paragraph--view-mode--default"><div class="ecl-editor"><p><strong>Changes to centralised marketing authorisations</strong></p></div></div></div><div class="item"><div id="ema-inpage-item-38657"><div class="accordion d-flex flex-column" id="accordion-bcl-accordion--15"><div class="accordion-buttons d-flex flex-row align-items-center justify-content-end gap-3 mb-3"><button class="btn btn-primary" type="button" role="button" data-trigger="expand-section" aria-expanded="true">Expand section</button><button class="btn btn-light" type="button" role="button" data-trigger="collapse-section" aria-expanded="false">Collapse section</button></div><script type="text/javascript"> document.querySelectorAll('#accordion-bcl-accordion--15 [data-trigger]').forEach((button) => { button.addEventListener('click', event => { const item = event.target, action = item.getAttribute('data-trigger'), accordion = item.closest('#accordion-bcl-accordion--15'), accordion_items = accordion.querySelectorAll('.accordion-collapse'); accordion_items.forEach((accordion_item) => { if (action === 'expand-section') { bootstrap.Collapse.getOrCreateInstance(accordion_item, { toggle: false }).show(); } else if (action === 'collapse-section') { bootstrap.Collapse.getOrCreateInstance(accordion_item, { toggle: false }).hide(); } }); }, false); }); </script><div class="accordion-items-wrapper"><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--15-1"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--15-1" aria-controls="collapse-bcl-accordion--15-1" aria-expanded="false" type="button" ><span>Variations requiring assessment (VRA) and variations not requiring assessment (VNRA), annual reassessments</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--15-1" aria-labelledby="heading-bcl-accordion--15-1" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><div><div class="table-responsive"><table class="ecl-table ecl-table--responsive table"><thead><tr><th style="text-transform:uppercase;">Publication type</th><th style="text-transform:uppercase;">Publication time</th><th style="text-transform:uppercase;">Location</th></tr></thead><tbody><tr><td data-th="Publication type "><p>Summary of opinion for VRAs, if applicable:</p><ul><li>changes to contra-indications;</li><li>changes that significantly alter the medicine's use.</li></ul></td><td data-th="Publication time">Friday following CVMP plenary</td><td data-th="Location"><a href="https://www.ema.europa.eu/en/news?f%5B0%5D=ema_news_responsible_body%3A100006">CVMP meeting highlights</a></td></tr><tr><td data-th="Publication type "><p>Update of EPAR documents, if applicable, that include:</p><ul><li>product information;</li><li>public assessment report (for those changes that are of significant clinical relevance).</li></ul></td><td data-th="Publication time">2 months after EC decision or within 2 months after CVMP opinion/notification, as applicable</td><td data-th="Location"><a href="https://medicines.health.europa.eu/veterinary/select-language?destination=/node/210934">Veterinary Medicines information website</a></td></tr></tbody></table></div></div><p> </p></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--15-2"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--15-2" aria-controls="collapse-bcl-accordion--15-2" aria-expanded="false" type="button" ><span>Withdrawal of VRA applications</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--15-2" aria-labelledby="heading-bcl-accordion--15-2" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><div><div class="table-responsive"><table class="ecl-table ecl-table--responsive table"><thead><tr><th style="text-transform:uppercase;">Publication type</th><th style="text-transform:uppercase;">Publication time</th><th style="text-transform:uppercase;">Location</th></tr></thead><tbody><tr><td data-th="Publication type ">Withdrawal public assessment report</td><td data-th="Publication time">Within 3 months of receipt of withdrawal letter</td><td data-th="Location"><a href="https://www.ema.europa.eu/en/search?f%5B0%5D=ema_medicine_bundle%3Aema_post_authorisation&f%5B1%5D=ema_search_categories%3A84&f%5B2%5D=ema_type_of_post_authorisation%3A100204&f%5B3%5D=ema_type_of_post_authorisation%3Awithdrawn">Medicines search: Post-authorisation procedures for medicines: Application withdrawn</a> (on medicine pages under 'All documents')</td></tr></tbody></table></div></div><p> </p></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--15-3"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--15-3" aria-controls="collapse-bcl-accordion--15-3" aria-expanded="false" type="button" ><span>Withdrawals of marketing authorisation</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--15-3" aria-labelledby="heading-bcl-accordion--15-3" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><div><div class="table-responsive"><table class="ecl-table ecl-table--responsive table"><thead><tr><th style="text-transform:uppercase;">Publication type</th><th style="text-transform:uppercase;">Publication time</th><th style="text-transform:uppercase;">Location</th></tr></thead><tbody><tr><td data-th="Publication type ">Public statement</td><td data-th="Publication time">At the time of withdrawal of marketing authorisation</td><td data-th="Location"><a href="https://www.ema.europa.eu/en/search?f%5B0%5D=ema_med_status%3A100105&f%5B1%5D=ema_med_status%3Awithdrawn&f%5B2%5D=ema_medicine_bundle%3Aema_medicine&f%5B3%5D=ema_search_categories%3A84&landing_from=73303">Medicines search: Medicines: Withdrawn</a></td></tr><tr><td>EPAR documents watermarked</td><td>At the time of withdrawal of marketing authorisation</td><td><a href="https://medicines.health.europa.eu/veterinary/select-language?destination=/node/210934"><u>Veterinary Medicines information website</u></a></td></tr></tbody></table></div></div><p> </p></div></div></div></div></div></div></div></div><div class="item"><div id="ema-inpage-item-38658" class="paragraph paragraph--type--oe-rich-text paragraph--view-mode--default"><div class="ecl-editor"><p><strong>Referrals</strong></p></div></div></div><div class="item"><div id="ema-inpage-item-38659"><h2 id="eu-referrals-38659" class="rounded-title mb-4">EU referrals</h2><div class="accordion d-flex flex-column" id="accordion-bcl-accordion--16"><div class="accordion-buttons d-flex flex-row align-items-center justify-content-end gap-3 mb-3"><button class="btn btn-primary" type="button" role="button" data-trigger="expand-section" aria-expanded="true">Expand section</button><button class="btn btn-light" type="button" role="button" data-trigger="collapse-section" aria-expanded="false">Collapse section</button></div><script type="text/javascript"> document.querySelectorAll('#accordion-bcl-accordion--16 [data-trigger]').forEach((button) => { button.addEventListener('click', event => { const item = event.target, action = item.getAttribute('data-trigger'), accordion = item.closest('#accordion-bcl-accordion--16'), accordion_items = accordion.querySelectorAll('.accordion-collapse'); accordion_items.forEach((accordion_item) => { if (action === 'expand-section') { bootstrap.Collapse.getOrCreateInstance(accordion_item, { toggle: false }).show(); } else if (action === 'collapse-section') { bootstrap.Collapse.getOrCreateInstance(accordion_item, { toggle: false }).hide(); } }); }, false); }); </script><div class="accordion-items-wrapper"><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--16-1"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--16-1" aria-controls="collapse-bcl-accordion--16-1" aria-expanded="false" type="button" ><span>Article 82 and Article 82 based on Article 129(3) referrals</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--16-1" aria-labelledby="heading-bcl-accordion--16-1" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><div><div class="table-responsive"><table class="ecl-table ecl-table--responsive table"><thead><tr><th style="text-transform:uppercase;">Publication type</th><th style="text-transform:uppercase;">Publication time</th><th style="text-transform:uppercase;">Location</th></tr></thead><tbody><tr><td data-th="Publication type "><p>Announcement of start of referral, including:</p><ul><li>notification;</li><li>draft list of medicines;</li><li>list of questions;</li><li>timetable;</li><li>list of questions addressed to stakeholders;</li><li>stakeholders form.</li></ul></td><td data-th="Publication time">Friday following CVMP plenary at which referral started</td><td data-th="Location"><a href="https://www.ema.europa.eu/en/search?f%5B0%5D=ema_medicine_bundle%3Aema_referral&f%5B1%5D=ema_referral_type%3A66962&f%5B2%5D=ema_search_categories%3A84&landing_from=73303">Medicines search: Referrals<u>: Referral type: Article 82, 82 based on 129(3) referrals</u></a> (on medicine page under 'All documents')</td></tr><tr><td data-th="Publication type ">Updated communication: CVMP opinion</td><td data-th="Publication time">Friday following CVMP plenary where opinion is adopted</td><td data-th="Location"><ul><li><a href="https://www.ema.europa.eu/en/news?f%5B0%5D=ema_news_responsible_body%3A100006">CVMP meeting highlights</a></li><li><a href="https://www.ema.europa.eu/en/search?f%5B0%5D=ema_medicine_bundle%3Aema_referral&f%5B1%5D=ema_referral_type%3A66962&f%5B2%5D=ema_search_categories%3A84&landing_from=73303">Medicines search: Referrals: Referral type: Article 82, 82 based on 129(3) referrals</a> (on medicine page under 'All documents')</li></ul></td></tr><tr><td data-th="Publication type ">Annexes of CVMP opinion</td><td data-th="Publication time">4 weeks after EC decision</td><td data-th="Location"><a href="https://www.ema.europa.eu/en/search?f%5B0%5D=ema_medicine_bundle%3Aema_referral&f%5B1%5D=ema_referral_type%3A66962&f%5B2%5D=ema_search_categories%3A84&landing_from=73303">Medicines search: Referrals<u>: Referral type: Article 82, 82 based on 129(3) referrals</u></a> (on medicine page under 'All documents')</td></tr><tr><td data-th="Publication type ">Questions-and-answers document, summarising the subject and outcome of the referral procedure</td><td data-th="Publication time">4 weeks after EC decision</td><td data-th="Location"><a href="https://www.ema.europa.eu/en/search?f%5B0%5D=ema_medicine_bundle%3Aema_referral&f%5B1%5D=ema_referral_type%3A66962&f%5B2%5D=ema_search_categories%3A84&landing_from=73303">Medicines search: Referrals<u>: Referral type: Article 82, 82 based on 129(3) referrals</u></a> (on medicine page under 'All documents')</td></tr><tr><td data-th="Publication type ">Updated product information (for centrally authorised products only) </td><td data-th="Publication time">2 weeks after EC decision</td><td data-th="Location"><a href="https://medicines.health.europa.eu/veterinary/select-language?destination=/node/210934">Veterinary Medicines information website</a></td></tr></tbody></table></div></div></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--16-2"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--16-2" aria-controls="collapse-bcl-accordion--16-2" aria-expanded="false" type="button" ><span>Article 130(4) opinions</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--16-2" aria-labelledby="heading-bcl-accordion--16-2" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><div><div class="table-responsive"><table class="ecl-table ecl-table--responsive table"><thead><tr><th style="text-transform:uppercase;">Publication type</th><th style="text-transform:uppercase;">Publication time</th><th style="text-transform:uppercase;">Location</th></tr></thead><tbody><tr><td data-th="Publication type "><p>Announcement of start of procedure, including:</p><ul><li>notification;</li><li>draft list of medicines;</li><li>list of questions.</li></ul></td><td data-th="Publication time">Friday following CVMP plenary at which procedure started</td><td width="214"><ul><li><a href="https://www.ema.europa.eu/en/news?f%5B0%5D=ema_news_responsible_body%3A100006">CVMP meeting highlights</a></li><li><a href="https://www.ema.europa.eu/en/search?f%5B0%5D=ema_medicine_bundle%3Aema_referral&f%5B1%5D=ema_referral_type%3A67676&f%5B2%5D=ema_search_categories%3A84">Medicines search: Referrals: Referral type: Article 130(4)</a> (on referral page under 'All documents')</li></ul></td></tr><tr><td data-th="Publication type ">Updated communication: CVMP opinion</td><td data-th="Publication time">Friday following CVMP plenary at which procedure started</td><td width="214"><ul><li><a href="https://www.ema.europa.eu/en/news?f%5B0%5D=ema_news_responsible_body%3A100006">CVMP meeting highlights</a></li><li><a href="https://www.ema.europa.eu/en/search?f%5B0%5D=ema_medicine_bundle%3Aema_referral&f%5B1%5D=ema_referral_type%3A67676&f%5B2%5D=ema_search_categories%3A84">Medicines search: Referrals: Referral type: Article 130(4)</a> (on referral page under 'All documents')</li></ul></td></tr><tr><td data-th="Publication type ">Annexes of CVMP opinion</td><td data-th="Publication time">4 weeks after EC decision</td><td data-th="Location"><a href="https://www.ema.europa.eu/en/search?f%5B0%5D=ema_medicine_bundle%3Aema_referral&f%5B1%5D=ema_referral_type%3A67676&f%5B2%5D=ema_search_categories%3A84">Medicines search: Referrals: Referral type: Article 130(4)</a> (on referral page under 'All documents')</td></tr><tr><td data-th="Publication type ">Questions-and-answers document, summarising the subject and outcome of the referral procedure</td><td data-th="Publication time">4 weeks after EC decision</td><td data-th="Location"><a href="https://www.ema.europa.eu/en/search?f%5B0%5D=ema_medicine_bundle%3Aema_referral&f%5B1%5D=ema_referral_type%3A67676&f%5B2%5D=ema_search_categories%3A84">Medicines search: Referrals: Referral type: Article 130(4)</a> (on referral page under 'All documents')</td></tr><tr><td data-th="Publication type "><p>Updated CAP documents, including:</p><ul><li>product information;</li><li>medicine overview and list of all authorised presentations (if applicable).</li></ul></td><td data-th="Publication time">2 weeks after EC decision</td><td width="214"><a href="https://medicines.health.europa.eu/veterinary/select-language?destination=/node/210934">Veterinary Medicines information website</a></td></tr></tbody></table></div></div></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--16-3"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--16-3" aria-controls="collapse-bcl-accordion--16-3" aria-expanded="false" type="button" ><span>Article 70(11) referrals</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--16-3" aria-labelledby="heading-bcl-accordion--16-3" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><div><div class="table-responsive"><table class="ecl-table ecl-table--responsive table"><thead><tr><th style="text-transform:uppercase;">Publication type</th><th style="text-transform:uppercase;">Publication time</th><th style="text-transform:uppercase;">Location</th></tr></thead><tbody><tr><td data-th="Publication type "><p>Announcement of start of referral, including:</p><ul><li>notification;</li><li>draft list of medicines;</li><li>list of questions;</li><li>timetable.</li></ul></td><td data-th="Publication time">Friday following CVMP plenary at which referral started</td><td width="214"><ul><li><a href="https://www.ema.europa.eu/en/news?f%5B0%5D=ema_news_responsible_body%3A100006">CVMP meeting highlights</a></li><li><a href="https://www.ema.europa.eu/en/search?f%5B0%5D=ema_medicine_bundle%3Aema_referral&f%5B1%5D=ema_search_categories%3A84">Medicines search: Referrals: Referral type: Article 70(11) referral</a> (on referral page under 'All documents')</li></ul></td></tr><tr><td data-th="Publication type ">Updated communication: CVMP opinion</td><td data-th="Publication time">Friday following CVMP plenary at which referral started</td><td width="214"><ul><li><a href="https://www.ema.europa.eu/en/news?f%5B0%5D=ema_news_responsible_body%3A100006">CVMP meeting highlights</a></li><li><a href="https://www.ema.europa.eu/en/search?f%5B0%5D=ema_medicine_bundle%3Aema_referral&f%5B1%5D=ema_search_categories%3A84">Medicines search: Referrals: Referral type: Article 70(11) referral</a> (on referral page under 'All documents')</li></ul></td></tr><tr><td data-th="Publication type ">Annexes of CVMP opinion</td><td data-th="Publication time">4 weeks after EC decision</td><td data-th="Location"><a href="https://www.ema.europa.eu/en/search?f%5B0%5D=ema_medicine_bundle%3Aema_referral&f%5B1%5D=ema_search_categories%3A84">Medicines search: Referrals: Referral type: Article 70(11) referral</a> (on referral page under 'All documents')</td></tr><tr><td data-th="Publication type ">Questions-and-answers document, summarising the subject and outcome of the procedure</td><td data-th="Publication time">4 weeks after EC decision</td><td data-th="Location"><a href="https://www.ema.europa.eu/en/search?f%5B0%5D=ema_medicine_bundle%3Aema_referral&f%5B1%5D=ema_search_categories%3A84">Medicines search: Referrals: Referral type: Article 70(11) referral</a> (on referral page under 'All documents')</td></tr></tbody></table></div></div></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--16-4"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--16-4" aria-controls="collapse-bcl-accordion--16-4" aria-expanded="false" type="button" ><span>Article 54(8) clarifications</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--16-4" aria-labelledby="heading-bcl-accordion--16-4" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><div><div class="table-responsive"><table class="ecl-table ecl-table--responsive table"><thead><tr><th style="text-transform:uppercase;">Publication type</th><th style="text-transform:uppercase;">Publication time</th><th style="text-transform:uppercase;">Location</th></tr></thead><tbody><tr><td data-th="Publication type ">Announcement of start of procedure </td><td data-th="Publication time">Friday following CVMP plenary at which procedure started</td><td width="214"><ul><li><a href="https://www.ema.europa.eu/en/news?f%5B0%5D=ema_news_responsible_body%3A100006">CVMP meeting highlights</a></li></ul></td></tr><tr><td data-th="Publication type ">CVMP clarifications</td><td data-th="Publication time">Friday following CVMP plenary where clarifications are adopted</td><td width="214"><ul><li><a href="https://www.ema.europa.eu/en/news?f%5B0%5D=ema_news_responsible_body%3A100006">CVMP meeting highlights</a></li></ul></td></tr></tbody></table></div></div></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--16-5"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--16-5" aria-controls="collapse-bcl-accordion--16-5" aria-expanded="false" type="button" ><span>Article 141(1)(c) or (e) opinions</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--16-5" aria-labelledby="heading-bcl-accordion--16-5" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><div><div class="table-responsive"><table class="ecl-table ecl-table--responsive table"><thead><tr><th style="text-transform:uppercase;">Publication type</th><th style="text-transform:uppercase;">Publication time</th><th style="text-transform:uppercase;">Location</th></tr></thead><tbody><tr><td data-th="Publication type ">Announcement of start of procedure </td><td data-th="Publication time">Friday following CVMP plenary at which procedure started</td><td width="214"><a href="https://www.ema.europa.eu/en/news?f%5B0%5D=ema_news_responsible_body%3A100006">CVMP meeting highlights</a></td></tr><tr><td data-th="Publication type ">Updated communication: CVMP opinion</td><td data-th="Publication time">Friday following CVMP plenary where opinion is adopted</td><td width="214"><a href="https://www.ema.europa.eu/en/news?f%5B0%5D=ema_news_responsible_body%3A100006">CVMP meeting highlights</a></td></tr><tr><td>Scientific opinion</td><td>15 days after CVMP opinion</td><td><a href="/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/referral-procedures-veterinary-medicines/article-1411-opinions-any-scientific-matter-veterinary-medicines" data-entity-type="node" data-entity-uuid="5f290e15-f149-442b-ae77-ed88303dfe8f" data-entity-substitution="canonical" title="Article 141(1) opinions on any scientific matter: veterinary medicines">Article 141(1) opinions</a></td></tr></tbody></table></div></div></div></div></div></div></div></div></div></div><div class="item"><div id="ema-inpage-item-38660" class="paragraph paragraph--type--oe-rich-text paragraph--view-mode--default"><div class="ecl-editor"><p><strong>Other documents and procedures</strong></p></div></div></div><div class="item"><div id="ema-inpage-item-38661"><div class="accordion d-flex flex-column" id="accordion-bcl-accordion--17"><div class="accordion-buttons d-flex flex-row align-items-center justify-content-end gap-3 mb-3"><button class="btn btn-primary" type="button" role="button" data-trigger="expand-section" aria-expanded="true">Expand section</button><button class="btn btn-light" type="button" role="button" data-trigger="collapse-section" aria-expanded="false">Collapse section</button></div><script type="text/javascript"> document.querySelectorAll('#accordion-bcl-accordion--17 [data-trigger]').forEach((button) => { button.addEventListener('click', event => { const item = event.target, action = item.getAttribute('data-trigger'), accordion = item.closest('#accordion-bcl-accordion--17'), accordion_items = accordion.querySelectorAll('.accordion-collapse'); accordion_items.forEach((accordion_item) => { if (action === 'expand-section') { bootstrap.Collapse.getOrCreateInstance(accordion_item, { toggle: false }).show(); } else if (action === 'collapse-section') { bootstrap.Collapse.getOrCreateInstance(accordion_item, { toggle: false }).hide(); } }); }, false); }); </script><div class="accordion-items-wrapper"><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--17-1"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--17-1" aria-controls="collapse-bcl-accordion--17-1" aria-expanded="false" type="button" ><span>Limited market classifications</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--17-1" aria-labelledby="heading-bcl-accordion--17-1" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><div><div class="table-responsive"><table class="ecl-table ecl-table--responsive table"><thead><tr><th style="text-transform:uppercase;">Publication type</th><th style="text-transform:uppercase;">Publication time</th><th style="text-transform:uppercase;">Location</th></tr></thead><tbody><tr><td data-th="Publication type ">Recommendations on limited market classifications</td><td data-th="Publication time">Twice a year</td><td data-th="Location"><a href="/en/veterinary-regulatory-overview/research-development-veterinary-medicines/veterinary-limited-markets/cvmp-recommendations-limited-market-classification-eligibility-authorisation-under-article-23" data-entity-type="node" data-entity-uuid="fc379df7-a540-4cb9-9b20-9fd90a62a06d" data-entity-substitution="canonical" title="CVMP recommendations on limited market classification and eligibility for authorisation under Article 23">CVMP recommendations on limited market classification and eligibility for authorisation under Article 23</a></td></tr></tbody></table></div></div></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--17-2"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--17-2" aria-controls="collapse-bcl-accordion--17-2" aria-expanded="false" type="button" ><span>Direct animal healthcare professional communications (DaHPC)</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--17-2" aria-labelledby="heading-bcl-accordion--17-2" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><div><div class="table-responsive"><table class="ecl-table ecl-table--responsive table"><thead><tr><th style="text-transform:uppercase;">Publication type</th><th style="text-transform:uppercase;">Publication time</th><th style="text-transform:uppercase;">Location</th></tr></thead><tbody><tr><td data-th="Publication type ">DaHPC</td><td data-th="Publication time">At the time of dissemination of the DaHPC</td><td data-th="Location"><a href="/search?f%5B0%5D=ema_medicine_bundle%3Aema_dhpc_document&f%5B1%5D=ema_search_categories%3A84">Medicines search: DHPCs (categories: veterinary)</a> </td></tr></tbody></table></div></div></div></div></div></div></div></div></div></div><div class="item"><div id="ema-inpage-item-38662"><h2 id="committee-agendas-and-outcomes-38662" class="rounded-title mb-4">Committee agendas and outcomes</h2><div class="accordion" id="accordion-bcl-accordion--18"><div class="accordion-items-wrapper"><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--18-1"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--18-1" aria-controls="collapse-bcl-accordion--18-1" aria-expanded="false" type="button" ><span>Agendas, minutes and reports of meetings of EMA's scientific committees</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--18-1" aria-labelledby="heading-bcl-accordion--18-1" role="region" data-bs-parent="#accordion-bcl-accordion--18"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><div class="table-responsive"><table class="ecl-table ecl-table--responsive table"><thead><tr><th style="text-transform:uppercase;">Publication type</th><th style="text-transform:uppercase;">Publication time</th><th style="text-transform:uppercase;">Location</th></tr></thead><tbody><tr><td data-th="Publication type ">Committees agendas</td><td data-th="Publication time">Before start of Committee plenary</td><td data-th="Location"><a href="/en/committees/committee-veterinary-medicinal-products-cvmp" data-entity-type="node" data-entity-uuid="c9f8ab45-4376-44e5-9371-94b6cd1e4bfc" data-entity-substitution="canonical" title="Committee for Veterinary Medicinal Products (CVMP)">CVMP</a></td></tr><tr><td data-th="Publication type ">Committees minutes</td><td data-th="Publication time">After Committee plenary where minutes are adopted</td><td data-th="Location"><a href="/en/committees/committee-veterinary-medicinal-products-cvmp" data-entity-type="node" data-entity-uuid="c9f8ab45-4376-44e5-9371-94b6cd1e4bfc" data-entity-substitution="canonical" title="Committee for Veterinary Medicinal Products (CVMP)">CVMP</a></td></tr><tr><td data-th="Publication type ">CVMP meeting highlights</td><td data-th="Publication time">Friday following CVMP plenary</td><td data-th="Location"><ul><li><a href="/en/homepage" data-entity-type="node" data-entity-uuid="3fbd2621-0e24-4c6b-8a79-12054530e27e" data-entity-substitution="canonical" title="Homepage">EMA homepage</a></li><li><a href="/en/committees/committee-veterinary-medicinal-products-cvmp" data-entity-type="node" data-entity-uuid="c9f8ab45-4376-44e5-9371-94b6cd1e4bfc" data-entity-substitution="canonical" title="Committee for Veterinary Medicinal Products (CVMP)">CVMP</a></li></ul></td></tr></tbody></table></div></div></div></div></div></div></div></div></div><div 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