Heads of Medicines Agencies: CMDh

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class="icons"> </p></div><div id="c6949" class="frame frame-default frame-type-header frame-layout-0"><header><h3 class=""> CMDH | RECENTLY PUBLISHED </h3></header></div><div id="c4558" class="frame frame-box frame-type-list frame-layout-0"><div class="tx-usrwhatsnew-pi1"><div class="landingpage news"><div class="rss-link"><a href="/rss/recently-published-cmdh/rss.xml" title="Open rss feed"><span class="icon-rss"></span></a></div><p class="ident3213"><a href="/human-medicines/cmdh/pharmacovigilance/psur/psur-single-assessment.html#c4975">CMDh SOP on the processing of PSUR single assessment for nationally authorised…</a><br><i> modified 11/02/2025 </i></p><p class="ident3213"><a href="/human-medicines/cmdh/about-cmdh/cmdh-composition.html#c3591">Member: vacantAlternate: Elisa SulleiroAgencia Española del Medicamento y…</a><br><i> modified 11/02/2025 </i></p><p class="ident3213"><a href="/human-medicines/cmdh/statistics.html#c6897">2021 - Statistics for New Applications (MRP/DCP), Variations, Referrals and…</a><br><i> modified 10/02/2025 </i></p><p class="ident3213"><a href="/human-medicines/cmdh/statistics.html#c6711">2020 - Statistics for New Applications (MRP/DCP), Variations, Referrals and…</a><br><i> modified 10/02/2025 </i></p><p class="ident3213"><a href="/human-medicines/cmdh/recently-published-history.html#c7602">Added In February 2025 06 February UPDATE - Template for Request for RMS in…</a><br><i> modified 06/02/2025 </i></p><p class="ident3213"><a href="/human-medicines/cmdh/pharmacovigilance/psur/bpg-on-1-introduction-of-substances/combinations-onto-the-eurd-list-and-setting-the-initial-psur-dlp-and-frequency-and-2-assessment-of-psurs-of-products-where-the-eu-reference-date-is-not-yet-legally-binding.html#c7149">Best Practice Guide on (1) Introduction of substances/combinations onto the EURD…</a><br><i> modified 06/02/2025 </i></p><p class="ident3213"><a href="/human-medicines/cmdh/procedural-guidance/variation.html#c2126">Best Practice Guides (BPGs) for the Submission and Processing of Variations in…</a><br><i> modified 06/02/2025 </i></p><p class="ident3213"><a href="/human-medicines/cmdh/paediatric-regulation/assessment-reports/article-46-work-sharing.html#c7616">Pamorelin LA 22.5 mg (triptorelin pamoate)End of procedure: 04/12/2024Date of…</a><br><i> modified 06/02/2025 </i></p><p class="ident3213"><a href="/human-medicines/cmdh/procedural-guidance/application-for-ma.html#c4986">CMDh SOP on decision-making process for new active substance status or extension…</a><br><i> modified 06/02/2025 </i></p><p class="ident3213"><a href="/human-medicines/cmdh/procedural-guidance/application-for-ma/mrp/rup.html#c1636">Procedural Advice on Repeat Use</a><br><i> modified 06/02/2025 </i></p></div></div></div><div id="c6621" class="frame frame-default frame-type-textpic frame-layout-0"><div class="ce-textpic ce-left ce-intext ce-nowrap"><div class="ce-gallery" data-ce-columns="1" data-ce-images="1"><div class="ce-row"><div class="ce-column"><figure class="image"><a href="/index.php?eID=tx_cms_showpic&file=3&md5=b515c8d5fdb6fc57002e1a82760ecf7a0f1c399e&parameters%5B0%5D=eyJ3aWR0aCI6IjgwMG0iLCJoZWlnaHQiOiI2MDBtIiwiYm9keVRhZyI6Ijxib2R5&parameters%5B1%5D=IHN0eWxlPVwibWFyZ2luOjA7IGJhY2tncm91bmQ6I2ZmZjtcIj4iLCJ3cmFwIjoi&parameters%5B2%5D=PGEgaHJlZj1cImphdmFzY3JpcHQ6Y2xvc2UoKTtcIj4gfCA8XC9hPiJ9" data-window-url="/index.php?eID=tx_cms_showpic&file=3&md5=b515c8d5fdb6fc57002e1a82760ecf7a0f1c399e&parameters%5B0%5D=eyJ3aWR0aCI6IjgwMG0iLCJoZWlnaHQiOiI2MDBtIiwiYm9keVRhZyI6Ijxib2R5&parameters%5B1%5D=IHN0eWxlPVwibWFyZ2luOjA7IGJhY2tncm91bmQ6I2ZmZjtcIj4iLCJ3cmFwIjoi&parameters%5B2%5D=PGEgaHJlZj1cImphdmFzY3JpcHQ6Y2xvc2UoKTtcIj4gfCA8XC9hPiJ9" data-window-target="thePicture" data-window-features="width=600,height=600,status=0,menubar=0" target="thePicture"><img class="image-embed-item" src="/fileadmin/_migrated/pics/dot_07.jpg" width="17" height="17" loading="lazy" alt=""></a></figure></div></div></div><div class="ce-bodytext"><p><strong><a href="/human-medicines/cmdh/recently-published-history.html">Recently published history</a></strong></p></div></div></div><div id="c2090" class="frame frame-default frame-type-textpic frame-layout-0"><div class="ce-textpic ce-left ce-intext ce-nowrap"><div class="ce-gallery" data-ce-columns="1" data-ce-images="1"><div class="ce-row"><div class="ce-column"><figure class="image"><a href="/index.php?eID=tx_cms_showpic&file=3&md5=b515c8d5fdb6fc57002e1a82760ecf7a0f1c399e&parameters%5B0%5D=eyJ3aWR0aCI6IjgwMG0iLCJoZWlnaHQiOiI2MDBtIiwiYm9keVRhZyI6Ijxib2R5&parameters%5B1%5D=IHN0eWxlPVwibWFyZ2luOjA7IGJhY2tncm91bmQ6I2ZmZjtcIj4iLCJ3cmFwIjoi&parameters%5B2%5D=PGEgaHJlZj1cImphdmFzY3JpcHQ6Y2xvc2UoKTtcIj4gfCA8XC9hPiJ9" data-window-url="/index.php?eID=tx_cms_showpic&file=3&md5=b515c8d5fdb6fc57002e1a82760ecf7a0f1c399e&parameters%5B0%5D=eyJ3aWR0aCI6IjgwMG0iLCJoZWlnaHQiOiI2MDBtIiwiYm9keVRhZyI6Ijxib2R5&parameters%5B1%5D=IHN0eWxlPVwibWFyZ2luOjA7IGJhY2tncm91bmQ6I2ZmZjtcIj4iLCJ3cmFwIjoi&parameters%5B2%5D=PGEgaHJlZj1cImphdmFzY3JpcHQ6Y2xvc2UoKTtcIj4gfCA8XC9hPiJ9" data-window-target="thePicture" data-window-features="width=600,height=600,status=0,menubar=0" target="thePicture"><img class="image-embed-item" src="/fileadmin/_migrated/pics/dot_07.jpg" width="17" height="17" loading="lazy" alt=""></a></figure></div></div></div><div class="ce-bodytext"><p><strong><a href="/fileadmin/dateien/Human_Medicines/CMD_h_/List_of_documents_published_on_CMDh_Website_-_April_2023.pdf">List of documents published on CMDh website</a> </strong>(April 2023)<br><em>(to be used to locate documents on the CMDh website)</em></p></div></div></div><div id="c252" class="frame frame-default frame-type-textpic frame-layout-0"><header><h1 class=""> Introduction </h1></header><div class="ce-textpic ce-right ce-intext"><div class="ce-bodytext"><p>The CMDh started its activities in November 2005, replacing the informal Mutual Recognition Facilitation Group (<abbr title="Mutual Recognition Facilitation Group" lang="">MRFG</abbr>), which was in operation over 10 years, to coordinate and facilitate the operation of the mutual recognition procedure.</p><p>The Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh), was set up in Directive 2004/27/<abbr title="Europena Community" lang="">EC</abbr> for the examination of any question relating to marketing authorisations of a medicinal product in two or more Member States in accordance with the mutual recognition procedure or the decentralised procedure. The task of the CMDh was substantially extended in 2012 by Directive 2010/84/<acronym title="European Union" lang="">EU</acronym>, amending Directive 2001/83/<abbr title="Europena Community" lang="">EC</abbr> as regards pharmacovigilance.</p><p>This very broad scope for the CMDh is complemented by specific tasks laid down in the legislation:<br>  </p><ul><li>aim to solve disagreements on the grounds of potential serious risk to public health between the Member States involved in a mutual recognition or decentralised procedure;</li><li>examination of questions related to the pharmacovigilance (Art. 107c, 107e, 107g, 107k and 107q of Directive 2001/83/<abbr title="Europena Community" lang="">EC</abbr>);</li><li>examination of questions related to variations;</li><li>laying down, yearly, a list of medicinal products for which a harmonised summary of product characteristics should be drawn up.</li></ul><p>To fulfil its tasks the CMDh has established several working parties/working groups, currently:<br>  </p><ul><li>Joint CMD/<abbr title="Committee for Medicinal Products for Human Use" lang="">CHMP</abbr>/<abbr title="Committee for Veterinary Medicinal Products" lang="">CVMP</abbr>/<acronym title="European Medicines Agency" lang="">EMA</acronym>/QWP/<abbr title="European Directorate for the Quality of Medicines" lang="">EDQM</abbr> working group on ASMF procedures - responsible for developing work-sharing procedures for ASMF assessment;</li><li>Joint CMD/<acronym title="European Medicines Agency" lang="">EMA</acronym> working party on variation regulation - responsible for drafting guidance documents relating to variations;</li><li>Joint CMDh/<acronym title="European Medicines Agency" lang="">EMA</acronym> working party on paediatric regulation - responsible for helping with the coordination of work-sharing assessment of paediatric data;</li><li>Working Party on Pharmacovigilance Procedures Work Sharing - responsible for the finalisation of the <abbr title="Periodic Safety Update Report" lang="">PSUR</abbr> work-sharing project for purely national active substances and to develop procedures for RMPs; </li><li>Joint CMDh/GCP Inspectors working party - responsible for preparing inspection programmes;</li><li>Communication Tracking System (CTS) working group - responsible for maintaining and developing the <abbr title="Mutual Recognition Procedure" lang="">MRP</abbr> and <abbr title="Decentralised Procedure" lang="">DCP</abbr> tracking system and the publicly available product index.</li></ul><p>The CMDh is composed of one representative per Member State and Norway, Iceland and Liechtenstein, appointed for a renewable period of three years. Member States may appoint an alternate to the CMDh member. The list of the CMDh Members and alternates, their professional qualifications and declarations of interest are published on the CMDh and <acronym title="European Medicines Agency" lang="">EMA</acronym> websites. The European Commission participates on a regular basis as an observer. Observer status can be granted in line with the CMDh Rules of Procedure to other institutions (e.g. accession countries).</p><p>The Chairperson of the CMDh is elected for a term of three years.<br> According to the Rules of Procedure, the CMDh has one elected Vice-Chairperson elected for a term of three years. A second Vice-Chairperson is appointed by the Member State currently holding the Presidency of the Council of the European Union for the duration of the term of the presidency.</p><p>The CMDh holds monthly meetings at the European Medicines Agency which usually have a duration of 3 days. The European Medicines Agency provides the secretariat of the CMDh.</p><p>Press releases with statistics, guidance documents, and Q&As are published monthly on the CMDh website.</p><p>The CMDh also publishes, on a yearly basis, a summary of the activities carried out by the CMDh and statistics for new applications in the mutual recognition and decentralised procedures and for the applications referred to the CMDh.</p><p>There is regular co-operation and exchanges of information on matters of mutual interest to both human and veterinary Co-ordination Groups, with regards to the mutual recognition and decentralised procedures.</p><p>August 2016<br>  </p><ul><li><a href="/human-medicines/cmdh/about-cmdh/cmdh-composition.html">CMDh members and alternates</a></li><li><a href="/human-medicines/cmdh/about-cmdh/cmdh-activities.html">CMDh Rules of Procedure</a></li></ul></div></div></div></div><aside role="complementary"></aside></div><footer id="footer" role="contentinfo"><p class="footer-note">For the United Kingdom, as of 1 January 2021, European Union law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland / NI.</p><nav role="navigation"><ul><li><a href="/usefullinks.html">Useful Links</a></li><li><a href="/privacypolicy.html">Privacy Policy</a></li><li><a href="/credits.html">Credits & Disclaimer</a></li><li><a href="/contact.html">Contact</a></li></ul></nav><div id="printfooter" class="print-only">© Heads of Medicines Agencies - https://www.hma.eu/human-medicines/cmdh.html</div></footer></div> <script src="/typo3temp/assets/compressed/merged-fd3440dd297d9f3eb56a8b686a508198.js?1728390920" type="text/javascript"></script> <script async="async" src="/_assets/2a58d7833cb34b2a67d37f5b750aa297/JavaScript/default_frontend.js?1737422418"></script>  <script type="text/javascript"> var _paq = _paq || []; _paq.push(['trackPageView']); _paq.push(['enableLinkTracking']); (function() { var u="//www.hma.eu/statistics/"; _paq.push(['setTrackerUrl', u+'piwik.php']); _paq.push(['setSiteId', 1]); var d=document, g=d.createElement('script'), s=d.getElementsByTagName('script')[0]; g.type='text/javascript'; g.async=true; g.defer=true; g.src=u+'piwik.js'; s.parentNode.insertBefore(g,s); })(); </script> <noscript><p><img src="//www.hma.eu/statistics/piwik.php?idsite=1" style="border:0;" alt=""></p></noscript>  </body> </html>

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Heads of Medicines Agencies: CMDh