CINXE.COM

<!DOCTYPE html><html lang="en" dir="ltr" prefix="og: https://ogp.me/ns#"><head><meta charset="utf-8" /> <noscript><style>form.antibot * :not(.antibot-message) { display: none !important; }</style> </noscript><script type="application/json">{"utility":"cck","appendix":"\u003Cp class=\u0022ecl-visible\u0022\u003EWe use cookies on this website. \u003Cstrong\u003EEssential\u003C\/strong\u003E cookies allow it to work properly. \u003Cstrong\u003ENon-essential\u003C\/strong\u003E cookies allow us to collect anonymous data to improve our services. You can opt out of non-essential cookies at any time.\u003C\/p\u003E\u003Cp class=\u0022ecl-visible\u0022\u003EMore information: \u003Ca href=\u0022\/node\/68387\u0022 target=\u0022_blank\u0022\u003ECookies\u003C\/a\u003E and \u003Ca href=\u0022\/node\/247651\u0022 target=\u0022_blank\u0022\u003EEuropa Analytics\u003C\/a\u003E (user behaviour data)\u003C\/p\u003E","url":"\/about-us\/about-website\/cookies"}</script> <meta name="description" content="The list below includes the European Medicines Agency's (EMA) open public consultations." /> <link rel="canonical" href="https://www.ema.europa.eu/en/news-events/open-consultations" /> <link rel="image_src" href="https://www.ema.europa.eu/sites/default/files/styles/oe_bootstrap_theme_medium_no_crop/public/2024-07/EMA_building_202407_v1-copyright-EMA.png?itok=NBYia_Eu" /> <meta property="og:site_name" content="European Medicines Agency (EMA)" /> <meta property="og:type" content="website" /> <meta property="og:url" content="https://www.ema.europa.eu/en/news-events/open-consultations" /> <meta property="og:title" content="Open consultations | European Medicines Agency (EMA)" /> <meta property="og:description" content="The list below includes the European Medicines Agency's (EMA) open public consultations." /> <meta name="twitter:card" content="summary_large_image" /> <meta name="twitter:title" content="Open consultations | European Medicines Agency (EMA)" /> <meta name="twitter:description" content="The list below includes the European Medicines Agency's (EMA) open public consultations." /> <meta name="twitter:site" content="@EMA_News" /> <noscript><style type="text/css" name="oe-back-top-no-script"> @charset "utf-8"; .back-to-top { display: block !important; } .back-to-top .link { margin-bottom: 2rem; opacity: 1; } </style></noscript> <meta name="Generator" content="Drupal 10 (https://www.drupal.org)" /> <meta name="MobileOptimized" content="width" /> <meta name="HandheldFriendly" content="true" /> <meta name="viewport" content="width=device-width, initial-scale=1.0" /> <script type="application/ld+json">{ "@context": "https://schema.org", "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://www.ema.europa.eu/en/homepage" }, { "@type": "ListItem", "position": 2, "name": "News and events", "item": "https://www.ema.europa.eu/en/news-events" }, { "@type": "ListItem", "position": 3, "name": "Open consultations" } ] }</script> <link rel="icon" href="/themes/custom/ema_theme/favicon.ico" type="image/vnd.microsoft.icon" /> <link rel="alternate" hreflang="en" href="https://www.ema.europa.eu/en/news-events/open-consultations" /> <script type="text/javascript">window.MSInputMethodContext && document.documentMode && document.write("\u003Clink rel=\u0022stylesheet\u0022 href=\u0022https:\/\/www.ema.europa.eu\/themes\/contrib\/oe_bootstrap_theme\/assets\/css\/bootstrap-ie11.css\u0022\u003E\u003Cscript src=\u0022https:\/\/cdn.jsdelivr.net\/combine\/npm\/ie11-custom-properties@4,npm\/element-qsa-scope@1\u0022\u003E\u003C\/script\u003E\u003Cscript crossorigin=\u0022anonymous\u0022 src=\u0022https:\/\/cdnjs.cloudflare.com\/polyfill\/v3\/polyfill.min.js?version=3.111.0\u0026features=Array.prototype.find%2CArray.prototype.includes%2CNumber.parseFloat%2CNumber.parseInt%2Cdefault\u0022\u003E\u003C\/script\u003E");</script> <title>Open consultations | European Medicines Agency (EMA)</title><link rel="stylesheet" media="all" href="/sites/default/files/css/css_-kPngU1VFdD7TgAh8YasqDCjVH4cjbOwinFVAkzCHkM.css?delta=0&language=en&theme=ema_theme&include=eJxtjFGOwyAMRC9Ew9eeB5kwG1AAI2w27e2bolTtx8qSJb8ZPxRy646QlPuPRaFbID3HZ4g5T9dJU93sL1elA8IF33hDRac8kUYUTIXoY77fNae629BHo7xcp2E4T-vulNs7-kK3QqnODrOKdmqXeEpfwRGTIpNHvlijTttZjPL2fcgyahs-J4kIRkB9jY5acjSUVy4tQ0_1_9zIQxTFehKYv4RD7NxL4TAynr2_e5E" /> <link rel="stylesheet" media="all" href="/sites/default/files/css/css_f3qQKvCckPpyFXFQbGN8GIYyYqW706XmDd_tqEN5KXQ.css?delta=1&language=en&theme=ema_theme&include=eJxtjFGOwyAMRC9Ew9eeB5kwG1AAI2w27e2bolTtx8qSJb8ZPxRy646QlPuPRaFbID3HZ4g5T9dJU93sL1elA8IF33hDRac8kUYUTIXoY77fNae629BHo7xcp2E4T-vulNs7-kK3QqnODrOKdmqXeEpfwRGTIpNHvlijTttZjPL2fcgyahs-J4kIRkB9jY5acjSUVy4tQ0_1_9zIQxTFehKYv4RD7NxL4TAynr2_e5E" /> </head><body id="oe-back-to-top" class="context-ema_content_banner context-ema_general_search context-ema_sitewide path--node-10 path-node page-node-type-ema-general"><a role="navigation" aria-label="Skip to main content" class="visually-hidden-focusable skip-link" href="#main-content">Skip to main content</a><script type="application/json">{"utility":"globan","theme":"dark","logo":true,"link":true,"mode":false}</script><div id="cck_here" role="alert"></div><div class="dialog-off-canvas-main-canvas" data-off-canvas-main-canvas><div data-ema-glossary-ct="ema_general" class="ema-glossary-disabled page"><header class="bcl-header bcl-header--neutral" role="banner" aria-label="Header"><nav class="w-100 shadow-sm navbar navbar-expand-lg navbar-light" role="navigation" aria-label="Branding and Search navigation bar" ><div class='container'><a class="navbar-brand" href="/en/homepage" alt="Home - European Medicines Agency (EMA)" title="Home - European Medicines Agency (EMA)"><img src="/themes/custom/ema_theme/resources/images/logo_ema.svg" alt="European Medicines Agency's logo" title="European Medicines Agency"/></a><div class="ema-search-form"><a class="ema-search-icon" href="https://www.ema.europa.eu/search"><svg class="bi icon--s" ><use xlink:href="/themes/contrib/oe_bootstrap_theme/assets/icons/bcl-default-icons.svg#search"/></svg></a><div class="ema-search-form-wrapper"><form action="/en/news-events/open-consultations" method="post" id="oe-whitelabel-search-form" accept-charset="UTF-8" class="oe-whitelabel-search-form inline-form"><div class="js-form-item form-item js-form-type-search-api-autocomplete form-item-search-input js-form-item-search-input form-no-label"><label for="edit-search-input" class="visually-hidden form-label">Search</label><input placeholder="" data-drupal-selector="edit-search-input" data-search-api-autocomplete-search="ema_search" class="form-autocomplete form-control" data-autocomplete-path="/en/search_api_autocomplete/ema_search?display=ema_search_page&filter=search_api_fulltext" type="text" id="edit-search-input" name="search_input" value="" size="20" maxlength="500" /><span class="ico"></span></div><div class="form-actions"><input data-drupal-selector="edit-submit" type="submit" id="edit-submit--3" name="op" value="Search" class="button js-form-submit form-submit btn-primary btn" /><span class="ico"></span></div><input autocomplete="off" data-drupal-selector="form-aghubn2cszl6za0ouiewe53mpfggz4cwsakl-sf4wjy" type="hidden" name="form_build_id" value="form-AgHuBn2cszl6zA0oUIEwe53MpfgGz4cWsAKl-Sf4wjY" class="form-control" /><input data-drupal-selector="edit-oe-whitelabel-search-form" type="hidden" name="form_id" value="oe_whitelabel_search_form" class="form-control" /><input data-drupal-selector="edit-ema-search-url" type="hidden" name="ema_search_url" value="https://www.ema.europa.eu/search" class="form-control" /></form></div></div></div></nav><div class="bcl-header__project light"><div class="container"></div></div><nav class="bcl-header__navbar navbar navbar-expand-lg navbar-dark" role="navigation" aria-label="Main navigation bar" ><div class='container'><button class="navbar-toggler" type="button" data-bs-toggle="collapse" data-bs-target='#bcl-navbar--2' aria-controls='bcl-navbar--2' aria-expanded="false" aria-label="Toggle navigation" ><span class="navbar-toggler-icon"></span></button><div class="collapse navbar-collapse" id='bcl-navbar--2'><h2 class="visually-hidden" id="block-system-menu-block-main-menu">Main navigation</h2><ul class="me-auto navbar-nav" ><li class="nav-item dropdown" ><a href="/en/medicines" class="nav-link dropdown-toggle" aria-expanded="false" data-bs-toggle="dropdown" id="dropdown-434" role="button" data-drupal-link-system-path="node/73303">Medicines</a><ul class="dropdown-menu" aria-labelledby="dropdown-434" ><li><a href="/en/medicines" class="dropdown-item" data-drupal-link-system-path="node/73303">Find medicine</a></li><li><a href="/en/medicines/therapeutic-areas-latest-updates" class="dropdown-item" data-drupal-link-system-path="node/68943">Therapeutic areas: latest updates</a></li><li><a href="/en/medicines/download-medicine-data" class="dropdown-item" data-drupal-link-system-path="node/82422">Download medicine data</a></li><li><a href="/en/medicines/what-we-publish-medicines-when" class="dropdown-item" data-drupal-link-system-path="node/82426">What we publish on medicines and when</a></li><li><a href="/en/medicines/medicines-human-use-under-evaluation" class="dropdown-item" data-drupal-link-system-path="node/68492">Medicines under evaluation</a></li><li><a href="/en/medicines/national-registers-authorised-medicines" class="dropdown-item" data-drupal-link-system-path="node/70104">National registers</a></li></ul></li><li class="nav-item dropdown" ><a href="/en/human-regulatory-overview" class="nav-link dropdown-toggle" aria-expanded="false" data-bs-toggle="dropdown" id="dropdown-389" role="button" data-drupal-link-system-path="node/82389">Human regulatory</a><ul class="dropdown-menu" aria-labelledby="dropdown-389" ><li><a href="/en/human-regulatory-overview" class="dropdown-item" data-drupal-link-system-path="node/82389">Overview</a></li><li><a href="/en/human-regulatory-overview/research-development" class="dropdown-item" data-drupal-link-system-path="node/69491">Research and development</a></li><li><a href="/en/human-regulatory-overview/marketing-authorisation" class="dropdown-item" data-drupal-link-system-path="node/69601">Marketing authorisation</a></li><li><a href="/en/human-regulatory-overview/post-authorisation" class="dropdown-item" data-drupal-link-system-path="node/70358">Post-authorisation</a></li><li><a href="/en/human-regulatory-overview/medical-devices" class="dropdown-item" data-drupal-link-system-path="node/70079">Medical devices</a></li><li><a href="/en/human-regulatory-overview/herbal-medicinal-products" class="dropdown-item" data-drupal-link-system-path="node/69717">Herbal products</a></li></ul></li><li class="nav-item dropdown" ><a href="/en/veterinary-regulatory-overview" class="nav-link dropdown-toggle" aria-expanded="false" data-bs-toggle="dropdown" id="dropdown-329" role="button" data-drupal-link-system-path="node/82419">Veterinary regulatory</a><ul class="dropdown-menu" aria-labelledby="dropdown-329" ><li><a href="/en/veterinary-regulatory-overview" class="dropdown-item" data-drupal-link-system-path="node/82419">Overview</a></li><li><a href="/en/veterinary-regulatory-overview/research-development-veterinary-medicines" class="dropdown-item" data-drupal-link-system-path="node/69449">Research and development</a></li><li><a href="/en/veterinary-regulatory-overview/marketing-authorisation-veterinary-medicines" class="dropdown-item" data-drupal-link-system-path="node/69313">Marketing authorisation</a></li><li><a href="/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines" class="dropdown-item" data-drupal-link-system-path="node/68838">Post-authorisation</a></li></ul></li><li class="nav-item dropdown" ><a href="/en/committees" class="nav-link dropdown-toggle" aria-expanded="false" data-bs-toggle="dropdown" id="dropdown-483" role="button" data-drupal-link-system-path="node/82424">Committees</a><ul class="dropdown-menu" aria-labelledby="dropdown-483" ><li><a href="/en/committees" class="dropdown-item" data-drupal-link-system-path="node/82424">Overview</a></li><li><a href="/en/committees/how-committees-work" class="dropdown-item" data-drupal-link-system-path="node/68348">How the committees work</a></li><li><a href="/en/committees/committee-medicinal-products-human-use-chmp" class="dropdown-item" data-drupal-link-system-path="node/4879">CHMP</a></li><li><a href="/en/committees/committee-veterinary-medicinal-products-cvmp" class="dropdown-item" data-drupal-link-system-path="node/4882">CVMP</a></li><li><a href="/en/committees/pharmacovigilance-risk-assessment-committee-prac" class="dropdown-item" data-drupal-link-system-path="node/4886">PRAC</a></li><li><a href="/en/committees/committee-orphan-medicinal-products-comp" class="dropdown-item" data-drupal-link-system-path="node/4881">COMP</a></li><li><a href="/en/committees/committee-herbal-medicinal-products-hmpc" class="dropdown-item" data-drupal-link-system-path="node/4883">HMPC</a></li><li><a href="/en/committees/committee-advanced-therapies-cat" class="dropdown-item" data-drupal-link-system-path="node/4878">CAT</a></li><li><a href="/en/committees/paediatric-committee-pdco" class="dropdown-item" data-drupal-link-system-path="node/4885">PDCO</a></li><li><a href="/en/committees/working-parties-other-groups" class="dropdown-item" data-drupal-link-system-path="node/69598">Working parties and other groups</a></li></ul></li><li class="nav-item dropdown" ><a href="/en/news-events" class="nav-link active dropdown-toggle" aria-expanded="false" data-bs-toggle="dropdown" id="dropdown-343" role="button" data-drupal-link-system-path="node/82423">News & events</a><ul class="dropdown-menu" aria-labelledby="dropdown-343" ><li><a href="/en/news-events" class="dropdown-item" data-drupal-link-system-path="node/82423">Overview</a></li><li><a href="/en/news" class="dropdown-item" data-drupal-link-system-path="node/4">News</a></li><li><a href="/en/events/upcoming-events" class="dropdown-item" data-drupal-link-system-path="node/8">Events</a></li><li><a href="/en/news-events/whats-new" class="dropdown-item" data-drupal-link-system-path="news-events/whats-new">What's new</a></li><li><a href="/en/news-events/committee-highlights" class="dropdown-item" data-drupal-link-system-path="node/68454">Committee highlights</a></li><li><a href="/en/news-and-events/publications" class="dropdown-item" data-drupal-link-system-path="node/69163">Publications</a></li><li><a href="/en/news-events/press-social-media" class="dropdown-item" data-drupal-link-system-path="node/70061">Press and social media</a></li><li><a href="/en/news-events/open-consultations" class="active dropdown-item ema-active is-active" data-drupal-link-system-path="node/10">Open consultations</a></li><li><a href="/en/news-and-events/rss-feeds" class="dropdown-item" data-drupal-link-system-path="node/4876">RSS feeds</a></li></ul></li><li class="nav-item dropdown" ><a href="/en/partners-networks" class="nav-link dropdown-toggle" aria-expanded="false" data-bs-toggle="dropdown" id="dropdown-282" role="button" data-drupal-link-system-path="node/82420">Partners & networks</a><ul class="dropdown-menu" aria-labelledby="dropdown-282" ><li><a href="/en/partners-networks" class="dropdown-item" data-drupal-link-system-path="node/82420">Overview</a></li><li><a href="/en/partners-networks/eu-partners" class="dropdown-item" data-drupal-link-system-path="node/69559">EU partners</a></li><li><a href="/en/partners-networks/international-activities" class="dropdown-item" data-drupal-link-system-path="node/69859">International activities</a></li><li><a href="/en/partners-networks/patients-consumers" class="dropdown-item" data-drupal-link-system-path="node/69035">Patients and consumers</a></li><li><a href="/en/partners-networks/healthcare-professionals" class="dropdown-item" data-drupal-link-system-path="node/69297">Healthcare professionals</a></li><li><a href="/en/partners-networks/pharmaceutical-industry" class="dropdown-item" data-drupal-link-system-path="node/69655">Pharmaceutical industry</a></li><li><a href="/en/partners-networks/networks" class="dropdown-item" data-drupal-link-system-path="node/68770">Networks</a></li><li><a href="/en/partners-networks/health-technology-assessment-bodies" class="dropdown-item" data-drupal-link-system-path="node/68799">Health technology assessment bodies</a></li></ul></li><li class="nav-item dropdown" ><a href="/en/about-us" class="nav-link dropdown-toggle" aria-expanded="false" data-bs-toggle="dropdown" id="dropdown-524" role="button" data-drupal-link-system-path="node/82421">About us</a><ul class="dropdown-menu" aria-labelledby="dropdown-524" ><li><a href="/en/about-us" class="dropdown-item" data-drupal-link-system-path="node/82421">Overview</a></li><li><a href="/en/about-us/what-we-do" class="dropdown-item" data-drupal-link-system-path="node/69654">What we do</a></li><li><a href="/en/about-us/who-we-are" class="dropdown-item" data-drupal-link-system-path="node/69649">Who we are</a></li><li><a href="/en/about-us/how-we-work" class="dropdown-item" data-drupal-link-system-path="node/69885">How we work</a></li><li><a href="/en/about-us/fees-payable-european-medicines-agency" class="dropdown-item" data-drupal-link-system-path="node/70027">Fees</a></li><li><a href="/en/about-us/support-smes" class="dropdown-item" data-drupal-link-system-path="node/69589">Support to SMEs</a></li><li><a href="/en/about-us/annual-reports-work-programmes" class="dropdown-item" data-drupal-link-system-path="node/70025">Annual reports and work programmes</a></li><li><a href="/en/about-us/history-ema" class="dropdown-item" data-drupal-link-system-path="node/68954">History of EMA</a></li><li><a href="/en/about-us/careers" class="dropdown-item" data-drupal-link-system-path="node/69992">Careers</a></li><li><a href="/en/about-us/procurement" class="dropdown-item" data-drupal-link-system-path="node/69872">Procurement</a></li><li><a href="/en/about-us/glossaries" class="dropdown-item" data-drupal-link-system-path="node/5">Glossaries</a></li><li><a href="/en/about-us/about-website" class="dropdown-item" data-drupal-link-system-path="node/70271">About this website</a></li><li><a href="/en/about-us/data-protection-privacy-ema" class="dropdown-item" data-drupal-link-system-path="node/68881">Data protection and privacy</a></li><li><a href="/en/about-us/contacts-european-medicines-agency" class="dropdown-item" data-drupal-link-system-path="node/68696">Contacts</a></li></ul></li></ul></div></div></nav><div class="container"><div id="block-system-breadcrumb-block"><nav class="my-2-5" aria-label="breadcrumb" ><ol class="breadcrumb" ><li class="breadcrumb-item d-none d-md-block" ><a href="/en/homepage">Home</a></li><li class="breadcrumb-item" ><a href="https://www.ema.europa.eu/en/news-events"><svg class="d-md-none ms-0 me-2 me-2-5 bi icon--s" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#arrow-left"/></svg>News and events</a></li><li class="breadcrumb-item d-none d-md-block active" aria-current="page" >Open consultations</li></ol></nav></div></div></header><main id="main-content" class="main-content-wrapper" role="main" aria-label="Main content"><div class="container mt-3"><div class="row"><div class="col-12"><div data-drupal-messages-fallback class="hidden"></div><div id="block-ema-content-banner--2"><div class="node ema-general content-banner ema-general--content-banner mb-4-75 bcl-content-banner ema-light-blue"><div class="container px-0"><div class="row"><div class="col-12"><article class="bg-transparent border-0 card container"><div class="row"><div class="right-col"><div class="card-body container"><div class="row"><div class="col"><div class="heading-title"><h1 class="content-banner-title card-title bcl-heading"><span>Open consultations</span></h1></div><div class="heading-actions align-self-stretch d-flex justify-content-end"><div class="action-bar"><div class="ema-social-media-share button"><script type="application/json">{"service":"share","version":"2.0","more":["email","linkedin","bluesky","facebook","whatsapp","blogger","digg","gmail","netvibes","pinterest","pocket","printfriendly","qzone","reddit","threads","tumblr","typepad","viadeo","weibo","yahoomail","yammer"],"selection":false,"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 list below includes the European Medicines Agency's (EMA) open public consultations.</div></div></div><div class="d-flex flex-column flex-lg-row justify-content-between gap-3"><div class="card-badge-wrapper d-flex flex-row flex-wrap gap-3 align-items-start"><span class="ema-bg-category badge rounded-pill badge-outline-primary" title="Human"><span class="label">Human</span></span><span class="ema-bg-category badge rounded-pill badge-outline-primary" title="Veterinary"><span class="label">Veterinary</span></span><span class="ema-bg-topic badge rounded-pill badge-outline-primary" title="Scientific guidelines"><span class="label">Scientific guidelines</span></span></div></div></div></div></div></div></div></div></article></div></div></div></div></div></div><div class="col-12 "><div class="row"><div class="col-12"><div id="block-system-main-block" class="main-content"><article class="content-with-sidebar node ema-general ema-general--full container"><div class="row"><div class="bcl-sidebar col-md-3"><nav class="bcl-inpage-navigation position-sticky" id="bcl-inpage-navigation"><h2 class="mb-0 dropdown-toggle bcl-heading" aria-expanded="false" type="button" id="bcl-inpage-navigation-dropdown" data-bs-toggle="dropdown"> Page content<svg class="bi icon--s" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.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="#templates-62">Templates</a></li><li class="nav-item" ><a class="nav-link" href="#open-consultations-68954">Open consultations</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-39" class="paragraph paragraph--type--oe-rich-text paragraph--view-mode--default"><div class="ecl-editor"><p>To reply to a consultation, please use the dedicated EUSurvey link included in the relevant consultation document.</p><p>In case this link is not available, you can use the form below for comments:</p></div></div></div><div class="item"><div class="paragraph paragraph--type--ema-documents paragraph--view-mode--default" id="ema-inpage-item-62"><div id="templates-62"><h2 class="mb-4 rounded-title documents-title"> Templates </h2></div><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="template-form" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-word"/></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Template for submission of comments on scientific guidelines</p></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (232 KB - DOC)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2023-01-27T11:28:55Z">27/01/2023</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/template-form/form-submission-comments-scientific-guidelines_en.doc">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#eye"/></svg></a></div></div></div></div></div><div class="item"><div id="ema-inpage-item-41" class="paragraph paragraph--type--oe-rich-text paragraph--view-mode--default"><div class="ecl-editor"><p>To submit comments specifically on <strong>ICH draft guidelines </strong>under consultation, use the form below:</p></div></div></div><div class="item"><div class="paragraph paragraph--type--ema-documents paragraph--view-mode--default" id="ema-inpage-item-63262"><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="template-form" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-excel"/></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Template for submission of comments on ICH guidelines</p></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (208.69 KB - XLSX)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2023-02-15T16:29:00Z">15/02/2023</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/template-form/template-submission-comments-ich-guidelines_en.xlsx">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#eye"/></svg></a></div></div></div></div></div><div class="item"><div id="ema-inpage-item-63263" class="paragraph paragraph--type--oe-rich-text paragraph--view-mode--default"><div class="ecl-editor"><p>Please note that EMA may collect and further process some personal data of stakeholders and interested parties who submit contributions to the consultations. For more information, see:</p></div></div></div><div class="item"><div class="paragraph paragraph--type--ema-documents paragraph--view-mode--default" id="ema-inpage-item-63264"><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="other" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"/></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">European Medicines Agency’s privacy statement public and targeted consultations</p><div class="file-metadata d-grid gap-2 gap-md-0"><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row reference-number fw-normal text-muted"><span class="label">Reference Number: </span><span class="value">EMA/472380/2019</span></small></div></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (134.32 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2020-02-14T13:00:00Z">14/02/2020</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/other/european-medicines-agencys-privacy-statement-public-and-targeted-consultations_en.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#eye"/></svg></a></div></div></div></div></div><div class="item"><div id="ema-inpage-item-68954" class="paragraph paragraph--type--oe-rich-text paragraph--view-mode--default"><div id="open-consultations-68954"><h2 class="mb-4 rounded-title"> Open consultations </h2></div></div></div><div class="item"><div id="ema-inpage-item-61" class="paragraph paragraph--type--ema-embedded-item paragraph--view-mode--default"><div class="ema-embedded-view"><div class="views-element-container"><div class="js-view-dom-id-256b5bd8332b281dbf208b3bc5d139b9d96e8eeb222e219f6a03b2ade77f5f84"><div class="ema-open-consultations"><div class="accordion d-flex flex-column" id="accordion-bcl-accordion--2"><div class="accordion-buttons d-flex flex-row align-items-center justify-content-end gap-3 mb-3"><button class="btn btn-secondary" type="button" role="button" data-trigger="expand-section" aria-label="Expand content in section">Expand section</button><button class="btn btn-outline-secondary" type="button" role="button" data-trigger="collapse-section" aria-label="Collapse content in section">Collapse section</button></div><script type="text/javascript"> document.querySelectorAll('#accordion-bcl-accordion--2 [data-trigger]').forEach((button) => { button.addEventListener('click', event => { const item = event.target, action = item.getAttribute('data-trigger'), old_action_texts = item.querySelectorAll('.action-text'), action_text = document.createElement('span'), accordion = item.closest('#accordion-bcl-accordion--2'), accordion_items = accordion.querySelectorAll('.accordion-collapse'), action_message = (action === 'expand-section' ? "Expanded content in section" : "Collapsed content in section"); old_action_texts.forEach((old_action_text) => { old_action_text.remove(); }); action_text.classList.add('visually-hidden'); action_text.classList.add('action-text'); action_text.setAttribute('role', 'alert'); action_text.setAttribute('aria-live', 'polite'); action_text.setAttribute('aria-atomic', true); item.appendChild(action_text); action_text.textContent = action_message; 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--2-1"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--2-1" aria-controls="collapse-bcl-accordion--2-1" aria-expanded="false" type="button" >28/02/2025 - Call for scientific data for the periodic review of the monograph on Passiflorae herba</button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--2-1" aria-labelledby="heading-bcl-accordion--2-1" role="region"><div class="accordion-body"><div class="views-field views-field-rendered-entity"><span class="field-content"><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="herbal-call-data" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"/></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Call for scientific data for the periodic review of the monograph on Passiflorae herba</p><div class="file-metadata d-grid gap-2 gap-md-0"><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row fw-normal text-muted"><span class="value">Draft: consultation open</span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row consultation-dates fw-normal text-muted"><span class="label">Consultation dates: </span><span class="value"><time datetime="2025-03-01T12:00:00Z">01/03/2025</time> to <time datetime="2025-05-31T12:00:00Z">31/05/2025</time></span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row reference-number fw-normal text-muted"><span class="label">Reference Number: </span><span class="value">EMA/HMPC/64557/2025</span></small></div></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (128.46 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2025-02-28T14:15:41Z">28/02/2025</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-passiflorae-herba_en.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#eye"/></svg></a></div></div></div></span></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--2-2"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--2-2" aria-controls="collapse-bcl-accordion--2-2" aria-expanded="false" type="button" >28/02/2025 - Call for scientific data for the periodic review of the monograph on Hederae helicis folium</button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--2-2" aria-labelledby="heading-bcl-accordion--2-2" role="region"><div class="accordion-body"><div class="views-field views-field-rendered-entity"><span class="field-content"><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="herbal-call-data" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"/></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Call for scientific data for the periodic review of the monograph on Hederae helicis folium</p><div class="file-metadata d-grid gap-2 gap-md-0"><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row fw-normal text-muted"><span class="value">Draft: consultation open</span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row consultation-dates fw-normal text-muted"><span class="label">Consultation dates: </span><span class="value"><time datetime="2025-03-01T12:00:00Z">01/03/2025</time> to <time datetime="2025-05-31T12:00:00Z">31/05/2025</time></span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row reference-number fw-normal text-muted"><span class="label">Reference Number: </span><span class="value">EMA/HMPC/64513/2025</span></small></div></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (128.02 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2025-02-28T14:12:01Z">28/02/2025</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-hederae-helicis-folium_en.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#eye"/></svg></a></div></div></div></span></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--2-3"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--2-3" aria-controls="collapse-bcl-accordion--2-3" aria-expanded="false" type="button" >28/02/2025 - Call for scientific data for the periodic review of the monograph on Eleutherococci radix</button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--2-3" aria-labelledby="heading-bcl-accordion--2-3" role="region"><div class="accordion-body"><div class="views-field views-field-rendered-entity"><span class="field-content"><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="herbal-call-data" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"/></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Call for scientific data for the periodic review of the monograph on Eleutherococci radix</p><div class="file-metadata d-grid gap-2 gap-md-0"><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row fw-normal text-muted"><span class="value">Draft: consultation open</span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row consultation-dates fw-normal text-muted"><span class="label">Consultation dates: </span><span class="value"><time datetime="2025-03-01T12:00:00Z">01/03/2025</time> to <time datetime="2025-05-31T12:00:00Z">31/05/2025</time></span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row reference-number fw-normal text-muted"><span class="label">Reference Number: </span><span class="value">EMA/HMPC/64400/2025</span></small></div></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (129.24 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2025-02-28T14:03:41Z">28/02/2025</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-eleutherococci-radix_en.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#eye"/></svg></a></div></div></div></span></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--2-4"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--2-4" aria-controls="collapse-bcl-accordion--2-4" aria-expanded="false" type="button" >28/02/2025 - Call for scientific data for the periodic review of the monograph on Betulae folium</button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--2-4" aria-labelledby="heading-bcl-accordion--2-4" role="region"><div class="accordion-body"><div class="views-field views-field-rendered-entity"><span class="field-content"><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="herbal-call-data" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"/></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Call for scientific data for the periodic review of the monograph on Betulae folium</p><div class="file-metadata d-grid gap-2 gap-md-0"><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row fw-normal text-muted"><span class="value">Draft: consultation open</span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row consultation-dates fw-normal text-muted"><span class="label">Consultation dates: </span><span class="value"><time datetime="2025-03-01T12:00:00Z">01/03/2025</time> to <time datetime="2025-05-31T12:00:00Z">31/05/2025</time></span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row reference-number fw-normal text-muted"><span class="label">Reference Number: </span><span class="value">EMA/HMPC/64356/2025</span></small></div></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (129.34 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2025-02-28T13:58:46Z">28/02/2025</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-betulae-folium_en.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#eye"/></svg></a></div></div></div></span></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--2-5"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--2-5" aria-controls="collapse-bcl-accordion--2-5" aria-expanded="false" type="button" >28/02/2025 - Call for scientific data for the periodic review of the monograph on Primulae radix</button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--2-5" aria-labelledby="heading-bcl-accordion--2-5" role="region"><div class="accordion-body"><div class="views-field views-field-rendered-entity"><span class="field-content"><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="herbal-call-data" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"/></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Call for scientific data for the periodic review of the monograph on Primulae radix</p><div class="file-metadata d-grid gap-2 gap-md-0"><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row fw-normal text-muted"><span class="value">Draft: consultation open</span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row consultation-dates fw-normal text-muted"><span class="label">Consultation dates: </span><span class="value"><time datetime="2025-03-01T12:00:00Z">01/03/2025</time> to <time datetime="2025-05-31T12:00:00Z">31/05/2025</time></span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row reference-number fw-normal text-muted"><span class="label">Reference Number: </span><span class="value">EMA/HMPC/64684/2025</span></small></div></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (129.37 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2025-02-28T13:43:59Z">28/02/2025</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-primulae-radix_en.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#eye"/></svg></a></div></div></div></span></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--2-6"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--2-6" aria-controls="collapse-bcl-accordion--2-6" aria-expanded="false" type="button" >28/02/2025 - Call for scientific data for the periodic review of the monograph on Primulae flos</button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--2-6" aria-labelledby="heading-bcl-accordion--2-6" role="region"><div class="accordion-body"><div class="views-field views-field-rendered-entity"><span class="field-content"><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="herbal-call-data" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"/></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Call for scientific data for the periodic review of the monograph on Primulae flos</p><div class="file-metadata d-grid gap-2 gap-md-0"><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row fw-normal text-muted"><span class="value">Draft: consultation open</span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row consultation-dates fw-normal text-muted"><span class="label">Consultation dates: </span><span class="value"><time datetime="2025-03-01T12:00:00Z">01/03/2025</time> to <time datetime="2025-05-31T12:00:00Z">31/05/2025</time></span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row reference-number fw-normal text-muted"><span class="label">Reference Number: </span><span class="value">EMA/HMPC/64619/2025</span></small></div></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (129.32 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2025-02-28T13:34:37Z">28/02/2025</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-primulae-flos_en.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#eye"/></svg></a></div></div></div></span></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--2-7"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--2-7" aria-controls="collapse-bcl-accordion--2-7" aria-expanded="false" type="button" >28/02/2025 - Draft guideline on the clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome - Revision 2</button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--2-7" aria-labelledby="heading-bcl-accordion--2-7" role="region"><div class="accordion-body"><div class="views-field views-field-rendered-entity"><span class="field-content"><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="scientific-guideline" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"/></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Draft guideline on the clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome - Revision 2</p><div class="file-metadata d-grid gap-2 gap-md-0"><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row fw-normal text-muted"><span class="value">Draft: consultation open</span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row consultation-dates fw-normal text-muted"><span class="label">Consultation dates: </span><span class="value"><time datetime="2025-02-28T12:00:00Z">28/02/2025</time> to <time datetime="2025-05-31T12:00:00Z">31/05/2025</time></span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row reference-number fw-normal text-muted"><span class="label">Reference Number: </span><span class="value">EMA/67201/2025</span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row summary fw-normal text-muted"><span class="label">Summary: </span><span class="value"><p>This guideline replaces the guideline on clinical investigation of medicinal products for the treatment of patients with acute respiratory distress syndrome (EMEA/CPMP/EWP/504/97 Rev.1).</p><p>Comments should be provided using this <a href="https://ec.europa.eu/eusurvey/runner/84772fdd-ea0e-5888-a5dd-20b463d4782c">EUSurvey form</a>. For any technical issues, please contact the <a href="https://ec.europa.eu/eusurvey/home/support">EUSurvey Support</a>.</p></span></small></div></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (453.45 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2025-02-28T07:00:59Z">28/02/2025</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/scientific-guideline/draft-guideline-clinical-investigation-medicinal-products-treatment-patients-acute-respiratory-distress-syndrome-revision-2_en.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#eye"/></svg></a></div></div></div></span></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--2-8"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--2-8" aria-controls="collapse-bcl-accordion--2-8" aria-expanded="false" type="button" >14/02/2025 - Draft European Union herbal monograph on Hypericum perforatum L, herba and Cimicifuga racemosa (L.) Nutt., rhizoma</button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--2-8" aria-labelledby="heading-bcl-accordion--2-8" role="region"><div class="accordion-body"><div class="views-field views-field-rendered-entity"><span class="field-content"><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="herbal-monograph" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"/></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Draft European Union herbal monograph on Hypericum perforatum L, herba and Cimicifuga racemosa (L.) Nutt., rhizoma</p><div class="file-metadata d-grid gap-2 gap-md-0"><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row fw-normal text-muted"><span class="value">Draft: consultation open</span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row consultation-dates fw-normal text-muted"><span class="label">Consultation dates: </span><span class="value"><time datetime="2025-02-15T12:00:00Z">15/02/2025</time> to <time datetime="2025-05-15T12:00:00Z">15/05/2025</time></span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row reference-number fw-normal text-muted"><span class="label">Reference Number: </span><span class="value">EMA/HMPC/884573/2022</span></small></div></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (341.96 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2025-02-14T14:25:35Z">14/02/2025</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/herbal-monograph/draft-european-union-herbal-monograph-hypericum-perforatum-l-herba-cimicifuga-racemosa-l-nutt-rhizoma_en.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#eye"/></svg></a></div></div></div></span></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--2-9"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--2-9" aria-controls="collapse-bcl-accordion--2-9" aria-expanded="false" type="button" >14/02/2025 - Call for scientific data for the periodic review of the monograph on Valerianae radix</button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--2-9" aria-labelledby="heading-bcl-accordion--2-9" role="region"><div class="accordion-body"><div class="views-field views-field-rendered-entity"><span class="field-content"><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="herbal-call-data" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"/></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Call for scientific data for the periodic review of the monograph on Valerianae radix</p><div class="file-metadata d-grid gap-2 gap-md-0"><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row fw-normal text-muted"><span class="value">Draft: consultation open</span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row consultation-dates fw-normal text-muted"><span class="label">Consultation dates: </span><span class="value"><time datetime="2025-02-15T12:00:00Z">15/02/2025</time> to <time datetime="2025-05-15T12:00:00Z">15/05/2025</time></span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row reference-number fw-normal text-muted"><span class="label">Reference Number: </span><span class="value">EMA/HMPC/42303/2025</span></small></div></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (128.8 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2025-02-14T12:15:24Z">14/02/2025</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-valerianae-radix_en.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#eye"/></svg></a></div></div></div></span></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--2-10"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--2-10" aria-controls="collapse-bcl-accordion--2-10" aria-expanded="false" type="button" >14/02/2025 - Call for scientific data for the periodic review of the monograph on Valerianae aetheroleum</button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--2-10" aria-labelledby="heading-bcl-accordion--2-10" role="region"><div class="accordion-body"><div class="views-field views-field-rendered-entity"><span class="field-content"><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="herbal-call-data" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"/></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Call for scientific data for the periodic review of the monograph on Valerianae aetheroleum</p><div class="file-metadata d-grid gap-2 gap-md-0"><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row fw-normal text-muted"><span class="value">Draft: consultation open</span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row consultation-dates fw-normal text-muted"><span class="label">Consultation dates: </span><span class="value"><time datetime="2025-02-15T12:00:00Z">15/02/2025</time> to <time datetime="2025-05-15T12:00:00Z">15/05/2025</time></span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row reference-number fw-normal text-muted"><span class="label">Reference Number: </span><span class="value">EMA/HMPC/42266/2025</span></small></div></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (128.72 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2025-02-14T12:09:25Z">14/02/2025</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-valerianae-aetheroleum_en.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#eye"/></svg></a></div></div></div></span></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--2-11"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--2-11" aria-controls="collapse-bcl-accordion--2-11" aria-expanded="false" type="button" >14/02/2025 - Call for scientific data for the periodic review of the monograph on Salviae officinalis folium</button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--2-11" aria-labelledby="heading-bcl-accordion--2-11" role="region"><div class="accordion-body"><div class="views-field views-field-rendered-entity"><span class="field-content"><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="herbal-call-data" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"/></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Call for scientific data for the periodic review of the monograph on Salviae officinalis folium</p><div class="file-metadata d-grid gap-2 gap-md-0"><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row fw-normal text-muted"><span class="value">Draft: consultation open</span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row consultation-dates fw-normal text-muted"><span class="label">Consultation dates: </span><span class="value"><time datetime="2025-02-15T12:00:00Z">15/02/2025</time> to <time datetime="2025-05-15T12:00:00Z">15/05/2025</time></span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row reference-number fw-normal text-muted"><span class="label">Reference Number: </span><span class="value">EMA/HMPC/42211/2025</span></small></div></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (120.59 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2025-02-14T12:06:51Z">14/02/2025</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-salviae-officinalis-folium_en.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#eye"/></svg></a></div></div></div></span></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--2-12"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--2-12" aria-controls="collapse-bcl-accordion--2-12" aria-expanded="false" type="button" >14/02/2025 - Call for scientific data for the periodic review of the monograph on Centaurii herba</button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--2-12" aria-labelledby="heading-bcl-accordion--2-12" role="region"><div class="accordion-body"><div class="views-field views-field-rendered-entity"><span class="field-content"><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="herbal-call-data" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"/></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Call for scientific data for the periodic review of the monograph on Centaurii herba</p><div class="file-metadata d-grid gap-2 gap-md-0"><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row fw-normal text-muted"><span class="value">Draft: consultation open</span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row consultation-dates fw-normal text-muted"><span class="label">Consultation dates: </span><span class="value"><time datetime="2025-02-15T12:00:00Z">15/02/2025</time> to <time datetime="2025-05-15T12:00:00Z">15/05/2025</time></span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row reference-number fw-normal text-muted"><span class="label">Reference Number: </span><span class="value">EMA/HMPC/41748/2025</span></small></div></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (122.67 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2025-02-14T12:03:07Z">14/02/2025</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-centaurii-herba_en.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#eye"/></svg></a></div></div></div></span></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--2-13"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--2-13" aria-controls="collapse-bcl-accordion--2-13" aria-expanded="false" type="button" >14/02/2025 - Call for scientific data for the periodic review of the monograph on Anisi fructus</button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--2-13" aria-labelledby="heading-bcl-accordion--2-13" role="region"><div class="accordion-body"><div class="views-field views-field-rendered-entity"><span class="field-content"><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="herbal-call-data" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"/></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Call for scientific data for the periodic review of the monograph on Anisi fructus</p><div class="file-metadata d-grid gap-2 gap-md-0"><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row fw-normal text-muted"><span class="value">Draft: consultation open</span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row consultation-dates fw-normal text-muted"><span class="label">Consultation dates: </span><span class="value"><time datetime="2025-02-15T12:00:00Z">15/02/2025</time> to <time datetime="2025-05-15T12:00:00Z">15/05/2025</time></span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row reference-number fw-normal text-muted"><span class="label">Reference Number: </span><span class="value">EMA/HMPC/41594/2025</span></small></div></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (121.13 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2025-02-14T12:00:19Z">14/02/2025</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-anisi-fructus_en.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#eye"/></svg></a></div></div></div></span></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--2-14"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--2-14" aria-controls="collapse-bcl-accordion--2-14" aria-expanded="false" type="button" >14/02/2025 - Call for scientific data for the periodic review of the monograph on Anisi aetheroleum</button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--2-14" aria-labelledby="heading-bcl-accordion--2-14" role="region"><div class="accordion-body"><div class="views-field views-field-rendered-entity"><span class="field-content"><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="herbal-call-data" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"/></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Call for scientific data for the periodic review of the monograph on Anisi aetheroleum</p><div class="file-metadata d-grid gap-2 gap-md-0"><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row fw-normal text-muted"><span class="value">Draft: consultation open</span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row consultation-dates fw-normal text-muted"><span class="label">Consultation dates: </span><span class="value"><time datetime="2025-02-15T12:00:00Z">15/02/2025</time> to <time datetime="2025-05-15T12:00:00Z">15/05/2025</time></span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row reference-number fw-normal text-muted"><span class="label">Reference Number: </span><span class="value">EMA/HMPC/41176/2025</span></small></div></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (120.81 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2025-02-14T11:56:55Z">14/02/2025</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-anisi-aetheroleum_en.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#eye"/></svg></a></div></div></div></span></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--2-15"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--2-15" aria-controls="collapse-bcl-accordion--2-15" aria-expanded="false" type="button" >14/02/2025 - Concept paper on the development of a Guideline on assessment and reporting of mechanistic models used in the context of model informed drug development</button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--2-15" aria-labelledby="heading-bcl-accordion--2-15" role="region"><div class="accordion-body"><div class="views-field views-field-rendered-entity"><span class="field-content"><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="scientific-guideline" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"/></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Concept paper on the development of a Guideline on assessment and reporting of mechanistic models used in the context of model informed drug development</p><div class="file-metadata d-grid gap-2 gap-md-0"><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row fw-normal text-muted"><span class="value">Draft: consultation open</span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row consultation-dates fw-normal text-muted"><span class="label">Consultation dates: </span><span class="value"><time datetime="2025-02-14T12:00:00Z">14/02/2025</time> to <time datetime="2025-05-31T12:00:00Z">31/05/2025</time></span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row reference-number fw-normal text-muted"><span class="label">Reference Number: </span><span class="value">EMA/5875/2025</span></small></div></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (187.72 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2025-02-14T08:38:17Z">14/02/2025</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/scientific-guideline/concept-paper-development-guideline-assessment-reporting-mechanistic-models-used-context-model-informed-drug-development_en.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#eye"/></svg></a></div></div></div></span></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--2-16"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--2-16" aria-controls="collapse-bcl-accordion--2-16" aria-expanded="false" type="button" >13/02/2025 - Draft reflection paper on the current regulatory testing requirements for veterinary medicinal products and opportunities for implementation of the 3Rs - Revision 1</button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--2-16" aria-labelledby="heading-bcl-accordion--2-16" role="region"><div class="accordion-body"><div class="views-field views-field-rendered-entity"><span class="field-content"><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="scientific-guideline" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"/></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Draft reflection paper on the current regulatory testing requirements for veterinary medicinal products and opportunities for implementation of the 3Rs - Revision 1</p><div class="file-metadata d-grid gap-2 gap-md-0"><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row fw-normal text-muted"><span class="value">Draft: consultation open</span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row consultation-dates fw-normal text-muted"><span class="label">Consultation dates: </span><span class="value"><time datetime="2025-02-13T12:00:00Z">13/02/2025</time> to <time datetime="2025-06-30T12:00:00Z">30/06/2025</time></span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row reference-number fw-normal text-muted"><span class="label">Reference Number: </span><span class="value">EMA/CHMP/CVMP/3Rs/164002/2016 Rev. 1</span></small></div></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (576.14 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2025-02-13T14:07:33Z">13/02/2025</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/scientific-guideline/draft-reflection-paper-current-regulatory-testing-requirements-veterinary-medicinal-products-opportunities-implementation-3rs-revision-1_en.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#eye"/></svg></a></div></div></div></span></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--2-17"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--2-17" aria-controls="collapse-bcl-accordion--2-17" aria-expanded="false" type="button" >13/02/2025 - Draft reflection paper on the current regulatory testing requirements for medicinal products for human use and opportunities for implementation of the 3Rs - Revision 1</button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--2-17" aria-labelledby="heading-bcl-accordion--2-17" role="region"><div class="accordion-body"><div class="views-field views-field-rendered-entity"><span class="field-content"><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="scientific-guideline" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"/></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Draft reflection paper on the current regulatory testing requirements for medicinal products for human use and opportunities for implementation of the 3Rs - Revision 1</p><div class="file-metadata d-grid gap-2 gap-md-0"><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row fw-normal text-muted"><span class="value">Draft: consultation open</span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row consultation-dates fw-normal text-muted"><span class="label">Consultation dates: </span><span class="value"><time datetime="2025-02-13T12:00:00Z">13/02/2025</time> to <time datetime="2025-06-30T12:00:00Z">30/06/2025</time></span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row reference-number fw-normal text-muted"><span class="label">Reference Number: </span><span class="value">EMA/CHMP/CVMP/3Rs/742466/2015 Rev. 1</span></small></div></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (698.16 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2025-02-13T14:02:32Z">13/02/2025</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/scientific-guideline/draft-reflection-paper-current-regulatory-testing-requirements-medicinal-products-human-use-opportunities-implementation-3rs-revision-1_en.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#eye"/></svg></a></div></div></div></span></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--2-18"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--2-18" aria-controls="collapse-bcl-accordion--2-18" aria-expanded="false" type="button" >31/01/2025 - Draft reflection paper on the use of information in European Union herbal monographs and assessment reports for borderline issues</button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--2-18" aria-labelledby="heading-bcl-accordion--2-18" role="region"><div class="accordion-body"><div class="views-field views-field-rendered-entity"><span class="field-content"><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="scientific-guideline" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"/></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Draft reflection paper on the use of information in European Union herbal monographs and assessment reports for borderline issues</p><div class="file-metadata d-grid gap-2 gap-md-0"><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row fw-normal text-muted"><span class="value">Draft: consultation open</span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row consultation-dates fw-normal text-muted"><span class="label">Consultation dates: </span><span class="value"><time datetime="2025-02-01T12:00:00Z">01/02/2025</time> to <time datetime="2025-05-01T12:00:00Z">01/05/2025</time></span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row reference-number fw-normal text-muted"><span class="label">Reference Number: </span><span class="value">EMA/HMPC/224438/2024</span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row summary fw-normal text-muted"><span class="label">Summary: </span><span class="value"><p>Comments should be provided using this <a href="https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fdocuments%2Ftemplate-form%2Ftemplate-submission-comments-draft-european-union-herbal-monograph-or-draft-european-union-list-entry_en.doc&wdOrigin=BROWSELINK">template</a> to <a href="mailto:"hmpc.secretariat@ema.europa.eu">hmpc.secretariat@ema.europa.eu</a></p></span></small></div></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (241.92 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2025-01-31T12:26:19Z">31/01/2025</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/scientific-guideline/draft-reflection-paper-use-information-european-union-herbal-monographs-assessment-reports-borderline-issues_en.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#eye"/></svg></a></div></div></div></span></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--2-19"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--2-19" aria-controls="collapse-bcl-accordion--2-19" aria-expanded="false" type="button" >31/01/2025 - Paclitaxel (nanoparticle albumin-bound) powder for suspension for infusion, 5mg/ml</button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--2-19" aria-labelledby="heading-bcl-accordion--2-19" role="region"><div class="accordion-body"><div class="views-field views-field-rendered-entity"><span class="field-content"><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="scientific-guideline" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"/></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Paclitaxel (nanoparticle albumin-bound) powder for suspension for infusion, 5mg/ml</p><div class="file-metadata d-grid gap-2 gap-md-0"><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row fw-normal text-muted"><span class="value">Draft: consultation open</span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row consultation-dates fw-normal text-muted"><span class="label">Consultation dates: </span><span class="value"><time datetime="2025-01-31T12:00:00Z">31/01/2025</time> to <time datetime="2025-04-30T12:00:00Z">30/04/2025</time></span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row reference-number fw-normal text-muted"><span class="label">Reference Number: </span><span class="value">EMA/418520/2024</span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row summary fw-normal text-muted"><span class="label">Summary: </span><span class="value"><p>Comments should be provided using this <a href="https://ec.europa.eu/eusurvey/runner/bb9e8dae-5cf1-8c2f-8d74-e39acd1a181a">EUSurvey form</a>. For any technical issues, please contact the <a href="https://ec.europa.eu/eusurvey/home/support">EUSurvey Support</a>.</p></span></small></div></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (146.49 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2025-01-31T09:23:35Z">31/01/2025</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/scientific-guideline/paclitaxel-nanoparticle-albumin-bound-powder-suspension-infusion-5mg-ml_en.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#eye"/></svg></a></div></div></div></span></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--2-20"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--2-20" aria-controls="collapse-bcl-accordion--2-20" aria-expanded="false" type="button" >31/01/2025 - Aprepitant, hard capsules, 80mg, 125mg, 80+125mg and powder for oral suspension 125mg product-specific bioequivalence guidance</button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--2-20" aria-labelledby="heading-bcl-accordion--2-20" role="region"><div class="accordion-body"><div class="views-field views-field-rendered-entity"><span class="field-content"><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="scientific-guideline" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"/></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Aprepitant, hard capsules, 80mg, 125mg, 80+125mg and powder for oral suspension 125mg product-specific bioequivalence guidance</p><div class="file-metadata d-grid gap-2 gap-md-0"><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row fw-normal text-muted"><span class="value">Draft: consultation open</span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row consultation-dates fw-normal text-muted"><span class="label">Consultation dates: </span><span class="value"><time datetime="2025-01-31T12:00:00Z">31/01/2025</time> to <time datetime="2025-04-30T12:00:00Z">30/04/2025</time></span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row reference-number fw-normal text-muted"><span class="label">Reference Number: </span><span class="value">EMA/13174/2025</span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row summary fw-normal text-muted"><span class="label">Summary: </span><span class="value"><p>Comments should be provided using this <a href="https://ec.europa.eu/eusurvey/runner/e4aa2cfd-0e15-cb64-da8d-1e43c5f66604">EUSurvey form</a>. For any technical issues, please contact the <a href="https://ec.europa.eu/eusurvey/home/support">EUSurvey Support</a>.</p></span></small></div></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (145.79 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2025-01-31T09:19:29Z">31/01/2025</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/scientific-guideline/aprepitant-hard-capsules-80mg-125mg-80125mg-powder-oral-suspension-125mg-product-specific-bioequivalence-guidance_en.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#eye"/></svg></a></div></div></div></span></div></div></div></div></div></div></div><hr class="d-none d-md-block mt-4-5"><nav class="pager" role="navigation" ><ul class="pagination pager__items js-pager__items justify-content-center"><li class="page-item pager__item active"><a aria-label="1" aria-current="page" class="page-link" href="?page=0">1</a></li><li class="page-item pager__item"><a aria-label="2" class="page-link" href="?page=1">2</a></li><li class="page-item pager__item"><a aria-label="Next" class="page-link" href="?page=1">Next ›</a></li><li class="page-item pager__item"><a aria-label="Last" class="page-link" href="?page=1"><svg class="bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#chevron-double-right"/></svg></a></li></ul></nav></div></div></div></div></div><div class="ema-social-media-share inline mb-4"><h2>Share this page</h2><script type="application/json">{"service":"share","version":"2.0","networks":["email","linkedin","bluesky","facebook","more"],"more":["whatsapp","blogger","digg","gmail","netvibes","pinterest","pocket","printfriendly","qzone","reddit","threads","tumblr","typepad","viadeo","weibo","yahoomail","yammer"],"target":"_blank","stats":true,"selection":false}</script></div></div></div></div><div class="rate-widget fivestar"><form class="node-ema-general-10-fivestar-ema-page-rating-0 vote-form" id="rate-widget-base-form" data-drupal-selector="node-ema-general-10-fivestar-ema-page-rating-0" action="/en/news-events/open-consultations" method="post" accept-charset="UTF-8"></form></div></article></div></div></div></div></div></div></main><div class="back-to-top hide position-fixed bottom-0 end-0 pe-4"><a title="Back to top" href="#main-content" class="link d-flex flex-row justify-content-center align-items-center px-3 py-2 bg-secondary text-white shadow-lg rounded-pill" role="navigation" aria-label="Back to top"><svg class="bi icon--l" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#chevron-double-up"/></svg><span class="label fs-6 fst-normal fw-bold lh-base ps-2">Back to top</span></a></div><div id="block-ema-footer-block"><footer class="ema-footer text-white bcl-footer bcl-footer--neutral" role="contentinfo" aria-label="Footer"><div class="container"><div class="ema-footer-product-hotline row"><div class="col-12"><div class="border"><svg class="bi icon--s" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#telephone-fill"/></svg><a href="/en/about-us/contacts-european-medicines-agency" class="ema-footer-eu-agencies" target="_blank" hreflang="en"><p class="product-hotline-title">Product emergency hotline</p><p class="product-hotline-information">OUTSIDE WORKING HOURS</p></a></div></div></div><div class="ema-footer-footer-links row"><div class="col-12 col-md-6 col-lg-3 footer-links"><div class="link d-block"><a class="standalone" href="/en/about-us">About us</a></div><div class="link d-block"><a class="standalone" href="/en/about-us/what-we-do">What we do</a></div><div class="link d-block"><a class="standalone" href="/en/about-us/careers">Careers</a></div><div class="link d-block"><a class="standalone" href="/en/committees">Committees & working parties</a></div><div class="link d-block"><a class="standalone" href="/en/about-us/how-we-work/european-medicines-regulatory-network">Regulatory network</a></div><div class="link d-block"><a class="standalone" href="/en/about-us/how-we-work/european-medicines-regulatory-network/european-experts">European experts</a></div></div><div class="col-12 col-md-6 col-lg-3 footer-links"><div class="link d-block"><a class="standalone" href="/en/about-us/about-website/languages-website">Languages</a></div><div class="link d-block"><a class="standalone" href="/en/about-us/frequently-asked-questions">Frequently asked questions</a></div><div class="link d-block"><a class="standalone" href="/en/about-us/glossaries">Glossaries</a></div><div class="link d-block"><a class="standalone" href="/en/about-us/about-website">About this website</a></div><div class="link d-block"><a class="standalone" href="/en/about-us/about-website/cookies">Cookies</a></div><div class="link d-block"><a class="standalone" href="/en/about-us/about-website/website-data-protection-notice">Website data protection notice</a></div><div class="link d-block"><a class="standalone" href="/en/about-us/data-protection-privacy-ema">Data protection at EMA</a></div></div><div class="col-12 col-md-6 col-lg-3 footer-links"><div class="link d-block"><a class="standalone" href="/en/about-us/about-website/search-tips">Search tips</a></div><div class="link d-block"><a class="standalone" href="/en/about-us/how-we-work/access-documents">Access to documents</a></div><div class="link d-block"><a class="standalone" href="/en/about-us/contacts-european-medicines-agency">Contacts</a></div><div class="link d-block"><a class="standalone" href="/en/about-us/contacts-european-medicines-agency/send-question-european-medicines-agency">Send a question</a></div><div class="link d-block"><a class="standalone" href="/en/about-us/contacts-european-medicines-agency">EMA Service Desk (system support)</a></div><div class="link d-block"><a class="standalone" href="/en/about-us/how-we-work/services-databases">Services and databases</a></div></div><div class="col-12 col-md-6 col-lg-3 ema-footer--footer-contact"><p>European Medicines Agency<br>Domenico Scarlattilaan 6<br>1083 HS Amsterdam<br>The Netherlands</p><p>Tel: +31 (0)88 781 6000</p><p><a href="/about-us/contacts-european-medicines-agency/how-find-us" data-entity-type="node" data-entity-uuid="4b93fc56-414f-4edc-85a1-62989537c1b9" data-entity-substitution="canonical">How to find us</a><br><a href="/about-us/contacts-european-medicines-agency/how-find-us#addresses-6923" data-entity-type="node" data-entity-uuid="4b93fc56-414f-4edc-85a1-62989537c1b9" data-entity-substitution="canonical">Postal address and deliveries</a><br><a href="/about-us/contacts-european-medicines-agency/business-hours-holidays" data-entity-type="node" data-entity-uuid="7cac129c-d271-4ead-854a-ed65cdb60ddc" data-entity-substitution="canonical">Business hours and holidays</a></p></div></div><div class="ema-footer-social-media-links row"><div class="col-12 social-media-links-wrapper"><ul class="social-links-list"><li class="list-item"><a href="/news-event/rss-feeds" class="link standalone" target="_blank"><svg class="bi icon--s" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#rss"/></svg> RSS Feed </a></li><li class="list-item"><a href="https://bsky.app/profile/ema.europa.eu" class="link standalone" target="_blank"><svg class="bi icon--s" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#bsky"/></svg> Bluesky </a></li><li class="list-item"><a href="https://www.youtube.com/user/emainfo" class="link standalone" target="_blank"><svg class="bi icon--s" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#youtube"/></svg> YouTube </a></li><li class="list-item"><a href="https://www.linkedin.com/company/european-medicines-agency/" class="link standalone" target="_blank"><svg class="bi icon--s" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#linkedin"/></svg> LinkedIn </a></li></ul></div></div><div class="ema-footer-footer-agencies row"><div class="col-12 col-md-12 col-lg-4 bottom-links medicines-agency"><a href="https://www.ema.europa.eu/" class="ema-footer__copyright"> © 1995 - 2025 European Medicines Agency </a></div><div class="col-12 col-md-6 col-lg-4 bottom-links agencies-network"><a href="https://euagencies.eu/" class="ema-footer__eu_agencies" target="_blank"> European Union agencies network <span class="logo"></span></a></div><div class="col-12 col-md-6 col-lg-4 bottom-links eu"><a href="https://european-union.europa.eu/" class="ema-footer__eu_agencies" target="_blank"> An agency of the European Union <span class="logo"></span></a></div></div></div></footer></div></div></div><script type="application/json">{"utility":"piwik","siteID":"109","sitePath":["www.ema.europa.eu"],"instance":"europa.eu"}</script><script type="application/json">{"utility":"cck","url":"\/about-us\/about-website\/cookies"}</script><script type="application/json" data-drupal-selector="drupal-settings-json">{"path":{"baseUrl":"\/","pathPrefix":"en\/","currentPath":"node\/10","currentPathIsAdmin":false,"isFront":false,"currentLanguage":"en"},"pluralDelimiter":"\u0003","suppressDeprecationErrors":true,"ajaxPageState":{"libraries":"eJx1UNtuwyAM_aFQnvY9yAEvQTEYYdO0fz9Ck60PnZBA52IfG_Cea4icHT4K5OA8E0ERdEBkF8xYgSZM4Lzf7Pm-8IYhKtevgzUBtJ-ZUIYY2LeEWV_aCYyyybibAgsO10IsAvXpClTBaj9ww1dBY17sN2eFHYUTvtPvQ-qKCUeo6HMM81CKebOhtgJ0O-HE6Gbwm1Mul_RGmQQxDw-zilYoZ-OYj9ldhntcejh_NI3kQ9hxVmaSK-HCRhJUJYbQ9zt8a1QkmJHO2r46LL3h-lv6x9xaLm2mKCuGqf8A2pbvrGhWpNL7CUL1q4MSHTRlz6kQdtc__CRPUUx2BsHpHnEXO-5b4tAIfwB5QdVE","theme":"ema_theme","theme_token":null},"ajaxTrustedUrl":{"form_action_p_pvdeGsVG5zNF_XLGPTvYSKCf43t8qZYSwcfZl2uzM":true},"cckContentAppendix":"\u003Cp class=\u0022ecl-visible\u0022\u003EWe use cookies on this website. \u003Cstrong\u003EEssential\u003C\/strong\u003E cookies allow it to work properly. \u003Cstrong\u003ENon-essential\u003C\/strong\u003E cookies allow us to collect anonymous data to improve our services. You can opt out of non-essential cookies at any time.\u003C\/p\u003E\u003Cp class=\u0022ecl-visible\u0022\u003EMore information: \u003Ca href=\u0022\/node\/68387\u0022 target=\u0022_blank\u0022\u003ECookies\u003C\/a\u003E and \u003Ca href=\u0022\/node\/247651\u0022 target=\u0022_blank\u0022\u003EEuropa Analytics\u003C\/a\u003E (user behaviour data)\u003C\/p\u003E","ema_document":{"base_url":"\/documents\/"},"ema_glossary_parser":{"json_uri":"https:\/\/www.ema.europa.eu\/sites\/default\/files\/glossary_parser\/1740960532.json"},"data":{"extlink":{"extTarget":true,"extTargetAppendNewWindowLabel":"(opens in a new window)","extTargetNoOverride":false,"extNofollow":true,"extTitleNoOverride":false,"extNoreferrer":false,"extFollowNoOverride":false,"extClass":"ext","extLabel":"(link is external)","extImgClass":false,"extSubdomains":false,"extExclude":"","extInclude":"","extCssExclude":".bcl-featured-media, .bcl-fact-figures, .bcl-listing, .ema-subscribe-button, .addtocal-links","extCssInclude":"","extCssExplicit":"main","extAlert":false,"extAlertText":"This link will take you to an external web site. We are not responsible for their content.","extHideIcons":false,"mailtoClass":"0","telClass":"0","mailtoLabel":"(link sends email)","telLabel":"","extUseFontAwesome":false,"extIconPlacement":"append","extPreventOrphan":false,"extFaLinkClasses":"fa fa-external-link","extFaMailtoClasses":"fa fa-envelope-o","extAdditionalLinkClasses":"","extAdditionalMailtoClasses":"","extAdditionalTelClasses":"","extFaTelClasses":"fa fa-phone","whitelistedDomains":[],"extExcludeNoreferrer":""}},"oe_back_top":{"selected_anchor":"main-content","mobile_multiplier":0.5,"desktop_multiplier":4},"search_api_autocomplete":{"ema_search":{"auto_submit":true,"min_length":3}},"user":{"uid":0,"permissionsHash":"050c69a6f5e553b4987d6e191794df7bd9f76b56ce83dde10a12ab7b0a9371fc"}}</script> <script src="/sites/default/files/js/js_HOqvG9HcIqRGAP2Bkp7r5v2b9GP5dQJyPcfDqzhaRDU.js?scope=footer&delta=0&language=en&theme=ema_theme&include=eJx1jlFuwyAQRC8UylfPg9YwspEXFi3rJrl9CbGlVmrFB5o3TzAUo2jKUgMejWoKUZipdQRi9isqlPiGQiHG3Z_3O-9I2UQ_X9QlsnEWRp9lkngUVHt3Z3AmruLuGq2Y1srSO-kzNNIO9X-w6SlZruuvNbahYL7e7Tl_fRjnuvukRyP-OONNEBaKezBpV_UDuUK5vpw7FhPhfjlXdr2QGgulMWXMgD_qlxjcBm4DdZDGLVDLgQ6TKKUxhvUP_wbx2o8g"></script> <script src="https://webtools.europa.eu/load.js" defer></script> <script src="/sites/default/files/js/js_2E-DggYzKlRYjijF5XSyHwDDhtP1ct9n7eYWS2g8tzc.js?scope=footer&delta=2&language=en&theme=ema_theme&include=eJx1jlFuwyAQRC8UylfPg9YwspEXFi3rJrl9CbGlVmrFB5o3TzAUo2jKUgMejWoKUZipdQRi9isqlPiGQiHG3Z_3O-9I2UQ_X9QlsnEWRp9lkngUVHt3Z3AmruLuGq2Y1srSO-kzNNIO9X-w6SlZruuvNbahYL7e7Tl_fRjnuvukRyP-OONNEBaKezBpV_UDuUK5vpw7FhPhfjlXdr2QGgulMWXMgD_qlxjcBm4DdZDGLVDLgQ6TKKUxhvUP_wbx2o8g"></script> </body></html>