{"id":8218,"date":"2018-06-07T15:03:36","date_gmt":"2018-06-07T12:03:36","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?page_id=8218"},"modified":"2025-05-13T14:24:40","modified_gmt":"2025-05-13T11:24:40","slug":"farmacovigilenta-informatii-pentru-detinatorii-de-autorizatii-de-punere-pe-piata","status":"publish","type":"page","link":"https:\/\/www.anm.ro\/en\/medicamente-de-uz-uman\/farmacovigilenta-informatii-pentru-detinatorii-de-autorizatii-de-punere-pe-piata\/","title":{"rendered":"Information for marketing authorisation holders"},"content":{"rendered":"<p><strong>Information regarding the nomination of a contact person for pharmacovigilance issues at national level<\/strong><br \/>\n<a href=\"\/en\/_\/FARMACOVIGILENTA\/Information regarding the FV local contact person.pdf\" target=\"_blank\" rel=\"noopener\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<p><strong>Electronic Reporting of Spontaneous Individual Case Safety Reports (ICSRs) by marketing authorization holders<\/strong><br \/>\n<a href=\"\/en\/_\/Electronic Reporting of Spontaneous Individual Case Safety Reports (ICSRs) by marketing authorization holders.pdf\" target=\"_blank\" rel=\"noopener\">download document\u00a0&#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<p><strong>Electronic Reporting of Suspected Unexpected Serious Adverse Reactions (SUSARs) by sponsors of clinical trials<\/strong><br \/>\n<a href=\"\/en\/_\/Electronic Reporting of Suspected Unexpected Serious Adverse Reactions (SUSARs) by sponsors of clinical trials.pdf\" target=\"_blank\" rel=\"noopener\">download document\u00a0&#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<p><strong>Questions and answers on the PSUR Repository and Periodic Safety Update Report submission<\/strong><br \/>\n<a href=\"\/en\/_\/INTREBARI SI RASPUNSURI\/PSUR repository - Q&#038;A for MAHs.pdf\" target=\"_blank\" rel=\"noopener\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<p><strong>Substances and medical literature covered by EMA\u2019s service<\/strong><br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory-overview\/post-authorisation\/pharmacovigilance-post-authorisation\/medical-literature-monitoring\" target=\"_blank\" rel=\"noopener\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Information regarding the nomination of a contact person for pharmacovigilance issues at national level download document &#8230; Electronic Reporting of [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":467,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-8218","page","type-page","status-publish","hentry"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/8218","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/types\/page"}],"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=8218"}],"version-history":[{"count":4,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/8218\/revisions"}],"predecessor-version":[{"id":10130,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/8218\/revisions\/10130"}],"up":[{"embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/467"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=8218"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}