{"id":10869,"date":"2025-06-12T09:00:11","date_gmt":"2025-06-12T06:00:11","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?p=10869"},"modified":"2025-06-12T14:53:39","modified_gmt":"2025-06-12T11:53:39","slug":"important-notification-12-06-2025-2","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/important-notification-12-06-2025-2\/","title":{"rendered":"Important notification"},"content":{"rendered":"<p><strong>12.06.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of marketing authorization holders and of interested persons<\/strong><\/span><br \/>\nPlease be informed that NAMMDR has published on its website general information regarding various types of pharmacovigilance activities, such as: <a href=\"https:\/\/www.anm.ro\/en\/medicamente-de-uz-uman\/farmacovigilenta\/plan-de-management-al-riscului\/\" target=\"_blank\"><span style=\"color: #225599;\">Risk management plan (RMP)<\/span><\/a>, <a href=\"https:\/\/www.anm.ro\/en\/medicamente-de-uz-uman\/farmacovigilenta\/rapoarte-periodice-privind-siguranta\/\" target=\"_blank\"><span style=\"color: #225599;\">Periodic safety update reports (PSURs)<\/span><\/a>, <a href=\"https:\/\/www.anm.ro\/en\/medicamente-de-uz-uman\/farmacovigilenta\/semnale-de-siguranta\/\" target=\"_blank\"><span style=\"color: #225599;\">Safety signals<\/span><\/a>, <a href=\"https:\/\/www.anm.ro\/en\/medicamente-de-uz-uman\/farmacovigilenta\/proceduri-de-arbitraj-privind-aspecte-de-siguranta\/\" target=\"_blank\"><span style=\"color: #225599;\">Pharmacovigilance referrals<\/span><\/a>, <a href=\"https:\/\/www.anm.ro\/en\/medicamente-de-uz-uman\/farmacovigilenta\/studii-de-siguranta-post-autorizare\/\" target=\"_blank\"><span style=\"color: #225599;\">Post-authorisation safety studies (PASS)<\/span><\/a>.<br \/>\nAlso, the section <a href=\"https:\/\/www.anm.ro\/en\/medicamente-de-uz-uman\/farmacovigilenta\/materiale-educationale\/\" target=\"_blank\"><span style=\"color: #225599;\">Educational materials<\/span><\/a> has been updated in regards to \u201dInstructions for MAHs regarding submission for approval of educational materials\u201d.<br \/>\nThese documents contain important information to be considered by the MAHs in their pharmacovigilance activities.<br \/>\nPlease consult the NAMMDR website, section <a href=\"https:\/\/www.anm.ro\/en\/medicamente-de-uz-uman\/farmacovigilenta\/\" target=\"_blank\"><span style=\"color: #225599;\">Medicinal products for human use \u2013 Pharmacovigilance<\/span><\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>12.06.2025 To the attention of marketing authorization holders and of interested persons Please be informed that NAMMDR has published on [&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-10869","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\/10869","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=10869"}],"version-history":[{"count":3,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/10869\/revisions"}],"predecessor-version":[{"id":10872,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/10869\/revisions\/10872"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=10869"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=10869"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=10869"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}