{"id":11471,"date":"2025-12-18T08:00:23","date_gmt":"2025-12-18T05:00:23","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?p=11471"},"modified":"2025-12-22T12:26:44","modified_gmt":"2025-12-22T09:26:44","slug":"important-notification-18-12-2025","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/important-notification-18-12-2025\/","title":{"rendered":"Important notification"},"content":{"rendered":"<p><strong>18.12.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of marketing authorization holders<\/strong><\/span><br \/>\nConsidering that <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:02008R1234-20250101\" target=\"_blank\">Regulation (CE) 2024\/1701<\/a> amending Regulation (EC) no. 1234\/2008 was published on 17 June 2024 and became applicable on 1 January 2025, and the <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=OJ:C_202505045\" target=\"_blank\">New Guidelines on the details of the various categories of variation<\/a> was published on 22 September 2025, the NAMMDR informs all MAHs that these Guidelines apply starting with 15 January 2026.<br \/>\nWhen submitting documentation supporting variations, the MAH should consider using the new form available at <a href=\"https:\/\/esubmission.ema.europa.eu\/eaf\/index.html\" target=\"_blank\">https:\/\/esubmission.ema.europa.eu\/eaf\/index.html<\/a><br \/>\nTo support the implementation of the changes regarding variations, the EMA\/CMDh has published various documents available to the MAHs via the following links:<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/guidance-application-revised-variations-framework\" target=\"_blank\">https:\/\/www.ema.europa.eu\/en\/guidance-application-revised-variations-framework<\/a> si <a href=\"https:\/\/www.hma.eu\/human-medicines\/cmdh\/procedural-guidance\/variation\/revised-variations-framework.html\" target=\"_blank\">https:\/\/www.hma.eu\/human-medicines\/cmdh\/procedural-guidance\/variation\/revised-variations-framework.html<\/a><br \/>\nMoreover, the NAMMDR informs that the EMA will organize a virtual webinar on this topic on 13 January 2026 (13:00-15:00 CEST). (<a href=\"https:\/\/www.ema.europa.eu\/en\/events\/new-variations-guidelines-webinar-marketing-authorisation-holders-human\" target=\"_blank\">https:\/\/www.ema.europa.eu\/en\/events\/new-variations-guidelines-webinar-marketing-authorisation-holders-human<\/a>)<\/p>\n","protected":false},"excerpt":{"rendered":"<p>18.12.2025 To the attention of marketing authorization holders Considering that Regulation (CE) 2024\/1701 amending Regulation (EC) no. 1234\/2008 was published [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[10],"tags":[],"class_list":["post-11471","post","type-post","status-publish","format-standard","hentry","category-anunturi-importante-medicamente-de-uz-uman"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/11471","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/comments?post=11471"}],"version-history":[{"count":0,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/11471\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=11471"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=11471"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=11471"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}