{"id":77726,"date":"2021-11-03T11:39:00","date_gmt":"2021-11-03T09:39:00","guid":{"rendered":"http:\/\/life.karpat.in.ua\/?p=77726"},"modified":"2021-11-03T07:44:04","modified_gmt":"2021-11-03T05:44:04","slug":"ukrajnaban-engedelyeztek-a-covid-19-elleni-gyogyszerek-soron-kivuli-regisztraciojat","status":"publish","type":"post","link":"https:\/\/life.karpat.in.ua\/?p=77726&lang=hu","title":{"rendered":"Ukrajn\u00e1ban enged\u00e9lyezt\u00e9k a Covid-19 elleni gy\u00f3gyszerek soron k\u00edv\u00fcli regisztr\u00e1ci\u00f3j\u00e1t"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>A Parlament t\u00e1mogatta azt a t\u00f6rv\u00e9nyjavaslatot, amely lehet\u0151v\u00e9 teszi a Covid-19 elleni gy\u00f3gyszerek \u00e9s olt\u00f3anyagok gyors\u00edtott elj\u00e1r\u00e1s r\u00e9v\u00e9n val\u00f3 regisztr\u00e1ci\u00f3j\u00e1t.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">A november 2-i \u00fcl\u00e9sen 262 k\u00e9pvisel\u0151 szavazta meg a 6121. sz\u00e1m\u00fa, \u201eA gy\u00f3gyszerek \u00e1llami nyilv\u00e1ntart\u00e1sba v\u00e9tel\u00e9r\u0151l\u201d sz\u00f3l\u00f3 ukr\u00e1n t\u00f6rv\u00e9ny 9-2. cikkely\u00e9nek m\u00f3dos\u00edt\u00e1s\u00e1r\u00f3l sz\u00f3l\u00f3 t\u00f6rv\u00e9nyjavaslatot.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u201eA t\u00f6rv\u00e9nyjavaslat lehet\u0151v\u00e9 teszi a gy\u00f3gyszerek, olt\u00f3anyagok vagy m\u00e1s orvosi immunbiol\u00f3giai gy\u00f3gyszerek gyors\u00edtott elj\u00e1r\u00e1s alkalmaz\u00e1s\u00e1val val\u00f3 \u00e1llami nyilv\u00e1ntart\u00e1sba v\u00e9tel\u00e9t rendk\u00edv\u00fcli helyzet\/karant\u00e9n idej\u00e9n\u201d \u2013 olvashat\u00f3 a Parlament honlapj\u00e1n.<\/p>\n\n\n\n<div class=\"wp-block-image\"><figure class=\"aligncenter size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"640\" src=\"http:\/\/life.karpat.in.ua\/wp-content\/uploads\/2021\/08\/covid-gyogyszer-1024x640.jpg\" alt=\"\" class=\"wp-image-67117\" srcset=\"https:\/\/life.karpat.in.ua\/wp-content\/uploads\/2021\/08\/covid-gyogyszer-1024x640.jpg 1024w, https:\/\/life.karpat.in.ua\/wp-content\/uploads\/2021\/08\/covid-gyogyszer-300x188.jpg 300w, https:\/\/life.karpat.in.ua\/wp-content\/uploads\/2021\/08\/covid-gyogyszer-768x480.jpg 768w, https:\/\/life.karpat.in.ua\/wp-content\/uploads\/2021\/08\/covid-gyogyszer-1536x960.jpg 1536w, https:\/\/life.karpat.in.ua\/wp-content\/uploads\/2021\/08\/covid-gyogyszer.jpg 1600w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure><\/div>\n\n\n\n<p class=\"wp-block-paragraph\">\u201eA s\u00fcrg\u0151ss\u00e9gi felhaszn\u00e1l\u00e1sra vonatkoz\u00f3 enged\u00e9ly (EUA) \u2013 egy olyan mechanizmus, amely megk\u00f6nny\u00edti a gy\u00f3gyszerek, vakcin\u00e1k vagy egy\u00e9b orvosi immunbiol\u00f3giai anyagok el\u00e9rhet\u0151s\u00e9g\u00e9t \u00e9s haszn\u00e1lat\u00e1t rendk\u00edv\u00fcli helyzet \u00e9s\/vagy karant\u00e9n idej\u00e9n\u201d \u2013 \u00e1ll a t\u00f6rv\u00e9nyjavaslat \u00e9rtelmez\u0151 dokumentum\u00e1ban.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ez a t\u00f6rv\u00e9nytervezet el\u0151\u00edrja: a gyors\u00edtott regisztr\u00e1ci\u00f3 elj\u00e1r\u00e1s\u00e1nak alkalmaz\u00e1sa csak abban az esetben enged\u00e9lyezett, ha a k\u00e9relmez\u0151 bizony\u00edtani tudja, hogy objekt\u00edv okok miatt nem rendelkezik a gy\u00f3gyszer, olt\u00f3anyag vagy egy\u00e9b orvosi immunbiol\u00f3giai gy\u00f3gyszer hat\u00e9konys\u00e1g\u00e1ra \u00e9s biztons\u00e1goss\u00e1g\u00e1ra vonatkoz\u00f3 adatokkal.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ebben az esetben a Covid-19 elleni gy\u00f3gyszerek s\u00fcrg\u0151ss\u00e9gi alkalmaz\u00e1sa csak az al\u00e1bbi felt\u00e9telek mellett lehets\u00e9ges:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>ha rendelkezik a klinikai vizsg\u00e1latok el\u0151tti sikeres tesztel\u00e9s lefolytat\u00e1s\u00e1r\u00f3l, a klinikai vizsg\u00e1latok\/tesztel\u00e9sek egyes f\u00e1zisair\u00f3l \u00e9s az eredm\u00e9nyek tudom\u00e1nyosan megalapozott bizony\u00edt\u00e9kot tartalmaznak, t\u00f6bbek k\u00f6z\u00f6tt megfelel\u0151 \u00e9s ellen\u0151rz\u00f6tt vizsg\u00e1latok adatait.<\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Ezen adatok meger\u0151s\u00edtik a gy\u00f3gyszer hat\u00e9konys\u00e1g\u00e1t olyan s\u00falyos vagy \u00e9letvesz\u00e9lyes betegs\u00e9gek megel\u0151z\u00e9s\u00e9ben, diagnosztiz\u00e1l\u00e1s\u00e1ban vagy kezel\u00e9s\u00e9ben, amelyek k\u00e1rt okoztak a k\u00f6zeg\u00e9szs\u00e9gnek \u00e9s \u00e9letvesz\u00e9lyesek a polg\u00e1rok sz\u00e1m\u00e1ra, t\u00f6bbek k\u00f6z\u00f6tt vil\u00e1gj\u00e1rv\u00e1ny idej\u00e9n.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>a klinikai vizsg\u00e1latokat az illet\u00e9kes hat\u00f3s\u00e1gok enged\u00e9ly\u00e9vel \u00e9s\/vagy fel\u00fcgyelete (ellen\u0151rz\u00e9se) mellett v\u00e9gezt\u00e9k;<\/li><li>a gy\u00f3gyszer ismert \u00e9s lehets\u00e9ges el\u0151nyei meghaladj\u00e1k a kock\u00e1zatokat;<\/li><li>egy adott betegs\u00e9g vagy \u00e1llapot diagnosztiz\u00e1l\u00e1s\u00e1ra, megel\u0151z\u00e9s\u00e9re vagy kezel\u00e9s\u00e9re a gy\u00f3gyszernek nincs megfelel\u0151, j\u00f3v\u00e1hagyott \u00e9s el\u00e9rhet\u0151 alternat\u00edv\u00e1ja.<\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><a>&nbsp;<\/a>&lt;!&#8211;translatorid:ild5234 &#8211;&gt;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>A Parlament t\u00e1mogatta azt a t\u00f6rv\u00e9nyjavaslatot, amely lehet\u0151v\u00e9 teszi a Covid-19 elleni gy\u00f3gyszerek \u00e9s olt\u00f3anyagok gyors\u00edtott elj\u00e1r\u00e1s r\u00e9v\u00e9n val\u00f3 regisztr\u00e1ci\u00f3j\u00e1t.<\/p>\n","protected":false},"author":12,"featured_media":67117,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[41,4383,594,596,11,592,33],"tags":[67465,33889,291],"class_list":["post-77726","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cikkek","category-covid-19-hu","category-egeszseg","category-erdekes","category-kiemelt-tema","category-tarsadalom","category-ukrajna","tag-covid-gyogyszer","tag-engedelyek","tag-ukrajna"],"_links":{"self":[{"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=\/wp\/v2\/posts\/77726","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=\/wp\/v2\/users\/12"}],"replies":[{"embeddable":true,"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=77726"}],"version-history":[{"count":0,"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=\/wp\/v2\/posts\/77726\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=\/wp\/v2\/media\/67117"}],"wp:attachment":[{"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=77726"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=77726"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=77726"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}