{"id":7737,"date":"2017-10-17T09:00:03","date_gmt":"2017-10-17T06:00:03","guid":{"rendered":"http:\/\/wwwen.anm.ro\/?p=7737"},"modified":"2017-10-17T15:36:26","modified_gmt":"2017-10-17T12:36:26","slug":"anunt-important-17-10-2017-2","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/anunt-important-17-10-2017-2\/","title":{"rendered":"Important notification"},"content":{"rendered":"<p><strong>17.10.2017<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\n<strong>Information for marketing authorization holders (MAHs) regarding alternative arrangements for electronic submission of ICSRs to NAMMD, Romania, during the cutover period 07-22 November 2017<\/strong><br \/>\nThe Romanian Agency (HQ ORG-ID NMA) will stop receiving ICSRs from MAHs as of 7 (00:00) November 2017.<br \/>\nThe Romanian Agency (HQ ORG-ID NMA) will stop sending ICSRs to MAHs as of 7 (00:00) November 2017.<br \/>\nFrom 7 (00:00) to 21 (24:00) November 2017, MAHs have to report individual cases originating from the Romania in CIOMS I format to the following email address: <a href=\"mailto:farmacovigilenta@anm.ro\">farmacovigilenta@anm.ro<\/a><br \/>\nAny ICSRs from 7 November should be submitted by MAHs to EVPM after 22 November along with the other cutover legacy ICSRs (according to GVP Module VI, rev. 2 coming into effect on 22 November 2017).<br \/>\nDetailed information is available in the document <a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Other\/2017\/09\/WC500235774.pdf\" target=\"_blank\" rel=\"noopener\">EudraVigilance go-live plan<\/a> (for Romania please see option 2B, Table 4, page 33).<br \/>\nFor further information please see <a href=\"http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/news_and_events\/news\/2017\/10\/news_detail_002820.jsp&amp;mid=WC0b01ac058004d5c1\" target=\"_blank\" rel=\"noopener\">EMA press release<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>17.10.2017 To the attention of interested persons Information for marketing authorization holders (MAHs) regarding alternative arrangements for electronic submission of [&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-7737","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\/7737","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=7737"}],"version-history":[{"count":0,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/7737\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=7737"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=7737"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=7737"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}