{"id":1368,"date":"2025-04-10T19:25:16","date_gmt":"2025-04-10T19:25:16","guid":{"rendered":"https:\/\/karierawfarmacji.pl\/?p=1368"},"modified":"2025-06-06T09:33:05","modified_gmt":"2025-06-06T07:33:05","slug":"procedura-zdecentralizowana","status":"publish","type":"post","link":"https:\/\/karierawfarmacji.pl\/en\/procedura-zdecentralizowana\/","title":{"rendered":"Procedura zdecentralizowana (Decentralized Procedure &#8211; DCP)"},"content":{"rendered":"<p class=\"wp-block-paragraph\"><strong>Procedura zdecentralizowana stosowana jest, gdy lek nie zosta\u0142 jeszcze zarejestrowany na terenie \u017cadnego z pa\u0144stw Unii Europejskiej, a firma farmaceutyczna chce wprowadzi\u0107 go r\u00f3wnolegle w kilku pa\u0144stwach UE.<\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Procedura zdecentralizowana \u2013 kto wydaje pozwolenie?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Pozwolenie na dopuszczenie leku wydawane jest przez pa\u0144stwo wskazane przez podmiot odpowiedzialny we wniosku referencyjnym. Jest to tzw. pa\u0144stwo referencyjne (Reference Member State \u2013 RMS). Rol\u0105 pa\u0144stwa referencyjnego jest sporz\u0105dzenie raportu oceniaj\u0105cego oraz koordynacja ca\u0142ego procesu rejestracji leku.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Na podstawie raportu przygotowanego przez RMS, pa\u0144stwa zainteresowane (Concerned Member States \u2013 CMS) wydaj\u0105 decyzj\u0119 o dopuszczeniu produktu leczniczego w swoim pa\u0144stwie.<\/p>\n\n\n\n<figure class=\"wp-block-image\"><a href=\"https:\/\/karierawfarmacji.pl\/en\/specjalista-ds-rejestracji-lekow\/\"><img decoding=\"async\" src=\"https:\/\/karierawfarmacji.pl\/wp-content\/uploads\/2024\/02\/baner-specialista-ds-rejestracji-lekow.png\" alt=\"\" class=\"wp-image-47511\"\/><\/a><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\">Przebieg procesu<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Rejestracja leku zgodnie z procedur\u0105 zdecentralizowan\u0105 trwa 210 dni. Po jej zako\u0144czeniu pa\u0144stwa bior\u0105ce w niej udzia\u0142 (RMS i CMS) maj\u0105 30 dni na weryfikacj\u0119 z\u0142o\u017conych przez podmiot odpowiedzialny narodowych wersji druk\u00f3w informacyjnych oraz wydanie narodowej decyzji o dopuszczeniu do obrotu.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Sprawd\u017a sam!<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Wszystko, co powiniene\u015b wiedzie\u0107 o rejestracji lek\u00f3w<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/karierawfarmacji.pl\/en\/rejestracja-lekow\/\">Baza wiedzy \u2013 rejestracja lek\u00f3w<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/karierawfarmacji.pl\/en\/kursy\/?term_id=60\">Kursy z rejestracji lek\u00f3w<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Procedura zdecentralizowana stosowana jest, gdy lek nie zosta\u0142 jeszcze zarejestrowany na terenie \u017cadnego z pa\u0144stw Unii Europejskiej, a firma farmaceutyczna chce wprowadzi\u0107 go r\u00f3wnolegle w kilku pa\u0144stwach UE. Procedura zdecentralizowana \u2013 kto wydaje pozwolenie? Pozwolenie na dopuszczenie leku wydawane jest przez pa\u0144stwo wskazane przez podmiot odpowiedzialny we wniosku referencyjnym. Jest to tzw. pa\u0144stwo referencyjne (Reference [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":2466,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_angie_page":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"page_builder":"","_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_post_was_ever_published":false},"categories":[39],"tags":[47,48],"class_list":["post-1368","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-rejestracja-lekow-kategoria","tag-definicje","tag-procedury"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Procedura zdecentralizowana (Decentralized Procedure - DCP) - Kariera w farmacji<\/title>\n<meta name=\"description\" content=\"Procedura zdecentralizowana rejestracji lek\u00f3w w UE \u2013 jak dzia\u0142a i dlaczego jest wa\u017cna? 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