{"id":8998,"date":"2021-03-01T14:29:16","date_gmt":"2021-03-01T11:29:16","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?page_id=8998"},"modified":"2025-08-18T09:33:40","modified_gmt":"2025-08-18T06:33:40","slug":"serializare","status":"publish","type":"page","link":"https:\/\/www.anm.ro\/en\/medicamente-de-uz-uman\/serializare\/","title":{"rendered":"Serialisation"},"content":{"rendered":"<p>The attitudes of the Romanian population towards falsified medicinal products<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/SERIALIZARE\/Atitudinile popula\u021biei Rom\u00e2niei fa\u021b\u0103 de medicamentele falsificate.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">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>List of medicinal products with marketing authorisations which should bear safety features<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/SERIALIZARE\/Lista cu medicamentele care trebuie sa prezinte elemente de siguranta.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">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>About serialisation and the Romanian Organisation for Serialisation of Medicinal Products (OSMR)<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/SERIALIZARE\/Despre OSMR.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">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>For the purpose of protecting patients, all interested parties, especially end users (UF) registered in the OSMR, must be aware of the obligations under the delegated regulation (EU) 2016\/161 of the Commission to supplement Directive 2001\/83\/EC of the European Parliament and of the Council by establishing detailed rules for the safety elements on the packaging of medicinal products for human use.<br \/>\nFailure to comply with the legal obligations mentioned in the Directive related to falsified medicinal products and in the Delegated Regulation of the Commission are a violation of the EU legislation. In fulfilling their duties, NAMMDR inspectors shall verify, during the inspections carried out, compliance with the obligations provided in the Commission Delegated Regulation (EU) 2016\/161 and in Order of the Minister of Health no. 1473\/2018.<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/anunt site serializare.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document \u2026<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"http:\/\/www.anm.ro\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<p>To the attention of interested persons: \u2018Patient safety due to medicinal product safety\u2019 \u2013 OSMR &#038; NAMMDR<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/Articol_Importanta Proiectului de Serializare_v03.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document \u2026<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"http:\/\/www.anm.ro\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The attitudes of the Romanian population towards falsified medicinal products download document &#8230; List of medicinal products with marketing authorisations [&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-8998","page","type-page","status-publish","hentry"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/8998","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=8998"}],"version-history":[{"count":3,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/8998\/revisions"}],"predecessor-version":[{"id":11098,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/8998\/revisions\/11098"}],"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=8998"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}