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{"id":17567,"date":"2020-12-18T07:40:06","date_gmt":"2020-12-18T04:40:06","guid":{"rendered":"https:\/\/borsahaberonline.com\/?p=17567"},"modified":"2020-12-18T07:40:06","modified_gmt":"2020-12-18T04:40:06","slug":"kovid-19-asisi-icin-yonetmelige-acil-kullanim-onayi-hukmu-eklendi","status":"publish","type":"post","link":"https:\/\/borsahaberonline.com\/kovid-19-asisi-icin-yonetmelige-acil-kullanim-onayi-hukmu-eklendi\/","title":{"rendered":"Kovid-19 a\u015f\u0131s\u0131 i\u00e7in y\u00f6netmeli\u011fe “acil kullan\u0131m onay\u0131” h\u00fckm\u00fc eklendi"},"content":{"rendered":"T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Ayg\u0131t Kurumunun “Be\u015feri T\u0131bbi Eserler Ruhsatland\u0131rma Y\u00f6netmeli\u011finde De\u011fi\u015fiklik Yap\u0131lmas\u0131na Dair Y\u00f6netmeli\u011fi”, Resmi Gazete’de yay\u0131mlanarak y\u00fcr\u00fcrl\u00fc\u011fe girdi.\u200b\u200b\u200b\u200b\u200b\u200b\u200b<\/p>\n
Bu kapsamda, Be\u015feri T\u0131bbi Eserler Ruhsatland\u0131rma Y\u00f6netmeli\u011fi’ne “D\u00fcnya S\u0131hhat \u00d6rg\u00fct\u00fc yahut Bakanl\u0131k taraf\u0131ndan bula\u015f\u0131c\u0131 hastal\u0131klar kapsam\u0131nda kabul edilen halk s\u0131hhatini \u00f6nemli olarak tehdit eden istisnai durumlarda kullan\u0131lacak ve ruhsatland\u0131rmaya temel tesirlilik, g\u00fcvenlilik ve kalite ile ilgili kapsaml\u0131 bilgilerin \u015fimdi sa\u011flanamad\u0131\u011f\u0131 a\u015f\u0131lar i\u00e7in bu datalar sa\u011flan\u0131ncaya kadar Kurum taraf\u0131ndan AKO verilebilir.” hususu eklendi.<\/p>\n
Ruhsatl\u0131 bir eserin terap\u00f6tik endikasyonlar\u0131nda de\u011fi\u015fiklik yap\u0131lmas\u0131 yahut yenilerinin eklenmesi ile ilgili de\u011fi\u015fiklikler i\u00e7in AKO m\u00fcracaat\u0131nda bulunulamayacak.<\/p>\n
AKO m\u00fcracaatlar\u0131na ait i\u015f ve s\u00fcre\u00e7ler, bu Y\u00f6netmelik do\u011frultusunda yay\u0131mlanacak ilgili k\u0131lavuz kararlar\u0131na nazaran yap\u0131lacak.<\/p>\n
Y\u00f6netmeli\u011fin kararlar\u0131n\u0131 T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Ayg\u0131t Kurumu Lideri y\u00fcr\u00fctecek.<\/p>\n<\/p>\n
Bloomberg HT<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Ayg\u0131t Kurumunun “Be\u015feri T\u0131bbi Eserler Ruhsatland\u0131rma Y\u00f6netmeli\u011finde De\u011fi\u015fiklik Yap\u0131lmas\u0131na Dair Y\u00f6netmeli\u011fi”, Resmi Gazete …<\/p>\n","protected":false},"author":1,"featured_media":17568,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4],"tags":[],"class_list":["post-17567","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-ekonomi"],"yoast_head":"\n
Kovid-19 a\u015f\u0131s\u0131 i\u00e7in y\u00f6netmeli\u011fe "acil kullan\u0131m onay\u0131" h\u00fckm\u00fc eklendi<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/borsahaberonline.com\/kovid-19-asisi-icin-yonetmelige-acil-kullanim-onayi-hukmu-eklendi\/\" \/>\n<meta property=\"og:locale\" content=\"tr_TR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Kovid-19 a\u015f\u0131s\u0131 i\u00e7in y\u00f6netmeli\u011fe "acil kullan\u0131m onay\u0131" h\u00fckm\u00fc eklendi\" \/>\n<meta property=\"og:description\" content=\"T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Ayg\u0131t Kurumunun "Be\u015feri T\u0131bbi Eserler Ruhsatland\u0131rma Y\u00f6netmeli\u011finde De\u011fi\u015fiklik Yap\u0131lmas\u0131na Dair Y\u00f6netmeli\u011fi", Resmi Gazete ...\" \/>\n<meta property=\"og:url\" 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