{"id":62961,"date":"2025-08-21T10:01:00","date_gmt":"2025-08-21T07:01:00","guid":{"rendered":"https:\/\/economic.karpat.in.ua\/?p=62961"},"modified":"2025-08-20T21:07:23","modified_gmt":"2025-08-20T18:07:23","slug":"ukrajnaban-kotelezove-valt-az-uj-gyogyszer-regisztracios-eljaras","status":"publish","type":"post","link":"https:\/\/economic.karpat.in.ua\/?p=62961&lang=hu","title":{"rendered":"Ukrajn\u00e1ban k\u00f6telez\u0151v\u00e9 v\u00e1lt az \u00faj gy\u00f3gyszer-regisztr\u00e1ci\u00f3s elj\u00e1r\u00e1s"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Ukrajn\u00e1ban k\u00f6telez\u0151v\u00e9 v\u00e1lt az elektronikus szabv\u00e1ny a gy\u00f3gyszerek regisztr\u00e1ci\u00f3s dokument\u00e1ci\u00f3j\u00e1nak (eCTD) beny\u00fajt\u00e1s\u00e1t illet\u0151en. Eddig 72 dokument\u00e1ci\u00f3csomagot ny\u00fajtottak be eCTD form\u00e1tumban.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ezek k\u00f6z\u00fcl 18-at az els\u0151dleges gy\u00f3gyszer-regisztr\u00e1ci\u00f3s elj\u00e1r\u00e1s keret\u00e9ben, \u00f6t csomag eset\u00e9ben \u00fajra kellett regisztr\u00e1lni, 49 esetben pedig a regisztr\u00e1ci\u00f3s anyagok m\u00f3dos\u00edt\u00e1s\u00e1ra volt sz\u00fcks\u00e9g, jelentette be az Eg\u00e9szs\u00e9g\u00fcgyi Miniszt\u00e9rium.<\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"900\" height=\"450\" src=\"https:\/\/economic.karpat.in.ua\/wp-content\/uploads\/2025\/08\/be0c52bd3cff105cc8eb9d210bb8e756.webp\" alt=\"\" class=\"wp-image-62957\" srcset=\"https:\/\/economic.karpat.in.ua\/wp-content\/uploads\/2025\/08\/be0c52bd3cff105cc8eb9d210bb8e756.webp 900w, https:\/\/economic.karpat.in.ua\/wp-content\/uploads\/2025\/08\/be0c52bd3cff105cc8eb9d210bb8e756-300x150.webp 300w, https:\/\/economic.karpat.in.ua\/wp-content\/uploads\/2025\/08\/be0c52bd3cff105cc8eb9d210bb8e756-768x384.webp 768w\" sizes=\"auto, (max-width: 900px) 100vw, 900px\" \/><\/figure>\n<\/div>\n\n\n<p class=\"wp-block-paragraph\">Ezenk\u00edv\u00fcl 343 elektronikus k\u00e9relmet fogadtak m\u00e1r be az \u00faj egyablakos funkci\u00f3n (k\u00e9relmez\u0151i iroda) kereszt\u00fcl.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">A gy\u00f3gyszerek regisztr\u00e1ci\u00f3j\u00e1hoz sz\u00fcks\u00e9ges regisztr\u00e1ci\u00f3s anyagok beny\u00fajt\u00e1s\u00e1ra vonatkoz\u00f3 nemzetk\u00f6zi elektronikus szabv\u00e1ny \u2013 az eCTD (elektronikus m\u0171szaki dokumentum \u2013 electronic Common Technical Document) \u2013 2025. augusztus 18. \u00f3ta k\u00f6telez\u0151 Ukrajn\u00e1ban. Minden v\u00e1llalatnak, amely \u00faj gy\u00f3gyszer regisztr\u00e1ci\u00f3j\u00e1hoz ny\u00fajt be dokumentumokat, azt eCTD form\u00e1tumban kell megtennie.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Az Eg\u00e9szs\u00e9g\u00fcgyi Miniszt\u00e9rium elmond\u00e1sa szerint az eCTD Ukrajn\u00e1ban val\u00f3 bevezet\u00e9s\u00e9nek f\u0151 el\u0151nyei k\u00f6z\u00e9 tartozik a dokumentumok beny\u00fajt\u00e1si form\u00e1tum\u00e1nak szabv\u00e1nyos\u00edt\u00e1sa, amely \u00e1tl\u00e1that\u00f3bb\u00e1 \u00e9s \u00e9rthet\u0151bb\u00e9 teszi a folyamatot minden piaci szerepl\u0151 sz\u00e1m\u00e1ra, a regisztr\u00e1ci\u00f3s anyagok feldolgoz\u00e1s\u00e1nak \u00e9s \u00e9rt\u00e9kel\u00e9s\u00e9nek felgyorsul\u00e1sa a folyamatok \u00e9s szabv\u00e1nyok egys\u00e9ges\u00edt\u00e9se a k\u00fcl\u00f6nb\u00f6z\u0151 orsz\u00e1gok k\u00f6z\u00f6tt, valamint a regisztr\u00e1ci\u00f3 id\u0151- \u00e9s p\u00e9nz\u00fcgyi k\u00f6lts\u00e9geinek minimaliz\u00e1l\u00e1sa.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">&lt;!&#8211;translatorid:ild5234 &#8211;&gt;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Ukrajn\u00e1ban k\u00f6telez\u0151v\u00e9 v\u00e1lt az elektronikus szabv\u00e1ny a gy\u00f3gyszerek regisztr\u00e1ci\u00f3s dokument\u00e1ci\u00f3j\u00e1nak (eCTD) beny\u00fajt\u00e1s\u00e1t illet\u0151en. Eddig 72 dokument\u00e1ci\u00f3csomagot ny\u00fajtottak be eCTD form\u00e1tumban. <\/p>\n","protected":false},"author":12,"featured_media":62957,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[41,11,33],"tags":[32887,940071],"class_list":["post-62961","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cikkek","category-kiemelt-tema","category-ukrajna","tag-gyogyszerek","tag-gyogyszerek-regisztracios-dokumentacioja-ectd"],"_links":{"self":[{"href":"https:\/\/economic.karpat.in.ua\/index.php?rest_route=\/wp\/v2\/posts\/62961","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/economic.karpat.in.ua\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/economic.karpat.in.ua\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/economic.karpat.in.ua\/index.php?rest_route=\/wp\/v2\/users\/12"}],"replies":[{"embeddable":true,"href":"https:\/\/economic.karpat.in.ua\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=62961"}],"version-history":[{"count":1,"href":"https:\/\/economic.karpat.in.ua\/index.php?rest_route=\/wp\/v2\/posts\/62961\/revisions"}],"predecessor-version":[{"id":62962,"href":"https:\/\/economic.karpat.in.ua\/index.php?rest_route=\/wp\/v2\/posts\/62961\/revisions\/62962"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/economic.karpat.in.ua\/index.php?rest_route=\/wp\/v2\/media\/62957"}],"wp:attachment":[{"href":"https:\/\/economic.karpat.in.ua\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=62961"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/economic.karpat.in.ua\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=62961"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/economic.karpat.in.ua\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=62961"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}