{"id":1137,"date":"2017-02-17T10:39:40","date_gmt":"2017-02-17T10:39:40","guid":{"rendered":"http:\/\/wwwro.anm.ro\/?page_id=1137"},"modified":"2026-01-13T15:35:52","modified_gmt":"2026-01-13T12:35:52","slug":"autorizare-medicamente","status":"publish","type":"page","link":"https:\/\/www.anm.ro\/en\/medicamente-de-uz-uman\/autorizare-medicamente\/","title":{"rendered":"Medicinal product authorisation"},"content":{"rendered":"<p><span style=\"color: #333399;\"><strong>Information regarding medicinal product authorisation<\/strong><\/span><\/p>\n<p>&gt;\u00a0<a href=\"https:\/\/www.anm.ro\/medicamente-de-uz-uman\/rezultate-la-zi-evaluare-autorizare-medicamente\/\">Updated results \u2013 Assessment of medicinal product authorisation<\/a><br \/>\n&gt; <a href=\"https:\/\/www.anm.ro\/_\/Comunicare%20catre%20partile%20interesate%20referitoare%20la%20indicatiile%20medicamentului%20protejate%20de%20brevet.pdf\" target=\"_blank\" rel=\"noopener\">Indications of medicinal products protected by patent law<\/a><\/p>\n<p><span style=\"color: #333399;\"><strong>PARALLEL IMPORT AUTHORISATIONS<\/strong><\/span><\/p>\n<p>&gt; <a href=\"https:\/\/www.anm.ro\/en\/medicamente-de-uz-uman\/autorizare-medicamente\/autorizatii-de-import-paralel\/\">Parallel import authorisations<\/a><\/p>\n<p><span style=\"color: #333399;\"><strong>AUTHORISATIONS FOR SPECIAL NEEDS<\/strong><\/span><\/p>\n<p>&gt; <a href=\"https:\/\/www.anm.ro\/_\/AUTORIZATII%20NEVOI%20SPECIALE\/ANS-FEBRUARIE-OCTOMBRIE.pdf\" target=\"_blank\" rel=\"noopener\">Authorisations for special needs<\/a><\/p>\n<p><span style=\"color: #333399;\"><strong>MRP \/ DCP \/ NATIONAL PROCEDURE<\/strong><\/span><\/p>\n<p>&gt;\u00a0<a href=\"https:\/\/www.anm.ro\/medicamente-de-uz-uman\/autorizare-medicamente\/autorizare-reinnoire\/\">Authorisation \u2013 Renewal<\/a><br \/>\n&gt; Variations<br \/>\n&gt;\u00a0<a href=\"https:\/\/www.anm.ro\/en\/medicamente-de-uz-uman\/autorizare-medicamente\/national-step\/\">National step<\/a><br \/>\n&gt;\u00a0<a href=\"https:\/\/www.anm.ro\/medicamente-de-uz-uman\/autorizare-medicamente\/ghiduri-procedurale\/\">Procedural guidelines<\/a><br \/>\n&gt; Notice to applicants<br \/>\n&gt; <a href=\"https:\/\/www.anm.ro\/_\/Centralizator%20adrese%20de%20e-mail%20MRP-DCP-actualizat.pdf\" target=\"_blank\" rel=\"noopener\">E-mail addresses used in the authorisation of medicinal products through European MRP\/DCP procedure and MRP\/DCP variations<\/a><\/p>\n<p><span style=\"color: #333399;\"><strong>CENTRALISED PROCEDURE<\/strong><\/span><\/p>\n<p><strong>All information regarding the centralised procedure are available online: \u2013<\/strong>\u00a0<a href=\"https:\/\/www.ema.europa.eu\/en\/about-us\/how-we-work\/governance-documents\/policies-procedures\/product-authorisation-lifecycle\/centralised-procedure#human-section\" target=\"_blank\" rel=\"noopener\"><span style=\"color: #225599;\">Centralised procedure | European Medicines Agency (europa.eu)<\/span><\/a><\/p>\n<p>&gt;\u00a0<a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory-overview\/marketing-authorisation\/pharmacovigilance-marketing-authorisation\/risk-management\/risk-management-plans\" target=\"_blank\" rel=\"noopener\"><span style=\"color: #225599;\">CENTRALISED PROCEDURE \u2013 Procedural guidelines<\/span><\/a><br \/>\n&gt;\u00a0<a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/marketing-authorisation\" target=\"_blank\" rel=\"noopener\"><span style=\"color: #225599;\">CENTRALISED procedure &#8211; Forms<\/span><\/a><br \/>\n&gt;\u00a0<a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/marketing-authorisation\" target=\"_blank\" rel=\"noopener\"><span style=\"color: #225599;\">CENTRALISED procedure &#8211; Fees<\/span><\/a><br \/>\n&gt; <a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/marketing-authorisation\" target=\"_blank\" rel=\"noopener\"><span style=\"color: #225599;\">CENTRALISED procedure &#8211; Blue-Box<\/span><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Information regarding medicinal product authorisation &gt;\u00a0Updated results \u2013 Assessment of medicinal product authorisation &gt; Indications of medicinal products protected by [&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-1137","page","type-page","status-publish","hentry"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/1137","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=1137"}],"version-history":[{"count":3,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/1137\/revisions"}],"predecessor-version":[{"id":11506,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/1137\/revisions\/11506"}],"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=1137"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}