{"id":611,"date":"2020-12-20T16:06:52","date_gmt":"2020-12-20T13:06:52","guid":{"rendered":"http:\/\/www.istesaglikdergisi.com.tr\/?p=611"},"modified":"2020-12-20T16:06:52","modified_gmt":"2020-12-20T13:06:52","slug":"covid-19-asisi-icin-ruhsatlandirma-yonetmeligine-acil-kullanim-hukmu-eklendi","status":"publish","type":"post","link":"http:\/\/www.istesaglikdergisi.com.tr\/index.php\/2020\/12\/20\/covid-19-asisi-icin-ruhsatlandirma-yonetmeligine-acil-kullanim-hukmu-eklendi\/","title":{"rendered":"Covid-19 a\u015f\u0131s\u0131 i\u00e7in ruhsatland\u0131rma y\u00f6netmeli\u011fine ‘Acil Kullan\u0131m’ h\u00fckm\u00fc eklendi"},"content":{"rendered":"

Resm\u00ee Gazete’de yay\u0131mlanan Be\u015feri T\u0131bbi \u00dcr\u00fcnler Ruhsatland\u0131rma Y\u00f6netmeli\u011fine \u201cAcil Kullan\u0131m Onay\u0131 (AKO) ile ilgili madde eklendi.<\/p>\n

\n

Resmi Gazete’de yay\u0131mlanan y\u00f6netmelikte \u015fu maddeler yer ald\u0131;<\/p>\n

\u201cD\u00fcnya Sa\u011fl\u0131k \u00d6rg\u00fct\u00fc veya Bakanl\u0131k taraf\u0131ndan bula\u015f\u0131c\u0131 hastal\u0131klar kapsam\u0131nda kabul edilen halk sa\u011fl\u0131\u011f\u0131n\u0131 ciddi olarak tehdit eden istisnai durumlarda kullan\u0131lacak ve ruhsatland\u0131rmaya esas etkililik, g\u00fcvenlilik ve kalite ile ilgili kapsaml\u0131 verilerin hen\u00fcz sa\u011flanamad\u0131\u011f\u0131 a\u015f\u0131lar i\u00e7in bu veriler sa\u011flan\u0131ncaya kadar Kurum taraf\u0131ndan AKO verilebilir.<\/p>\n

Ruhsatl\u0131 bir \u00fcr\u00fcn\u00fcn terap\u00f6tik endikasyonlar\u0131nda de\u011fi\u015fiklik yap\u0131lmas\u0131 veya yenilerinin eklenmesi ile ilgili de\u011fi\u015fiklikler i\u00e7in AKO ba\u015fvurusunda bulunulamaz.<\/p>\n

AKO ba\u015fvurular\u0131na ili\u015fkin i\u015f ve i\u015flemler bu Y\u00f6netmelik do\u011frultusunda yay\u0131mlanacak ilgili k\u0131lavuz h\u00fck\u00fcmlerine g\u00f6re y\u00fcr\u00fct\u00fcl\u00fcr.\u201d<\/p>\n

Ayr\u0131ca, \u00d6zel Ruhsat Dosyalar\u0131 ve \u015eartlar\u0131 b\u00f6l\u00fcm\u00fcne ise \u201cAKO ba\u015fvurular\u0131; \u00fcr\u00fcn\u00fcn etkilili\u011fi, g\u00fcvenlili\u011fi ve kalitesi ile ilgili ba\u015fvuru sahibinin sa\u011flayabildi\u011fi t\u00fcm verilerle, bu Ekin B\u00f6l\u00fcm I ve gerekti\u011finde B\u00f6l\u00fcm III’\u00fcne uygun olarak haz\u0131rlanan ba\u015fvuru dosyas\u0131n\u0131 ifade eder\u201d ifadeleri yer ald\u0131.<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

Resm\u00ee Gazete’de yay\u0131mlanan Be\u015feri T\u0131bbi \u00dcr\u00fcnler Ruhsatland\u0131rma Y\u00f6netmeli\u011fine \u201cAcil Kullan\u0131m Onay\u0131 (AKO) ile ilgili madde<\/p>\n","protected":false},"author":1,"featured_media":592,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[61],"tags":[],"_links":{"self":[{"href":"http:\/\/www.istesaglikdergisi.com.tr\/index.php\/wp-json\/wp\/v2\/posts\/611"}],"collection":[{"href":"http:\/\/www.istesaglikdergisi.com.tr\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"http:\/\/www.istesaglikdergisi.com.tr\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"http:\/\/www.istesaglikdergisi.com.tr\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"http:\/\/www.istesaglikdergisi.com.tr\/index.php\/wp-json\/wp\/v2\/comments?post=611"}],"version-history":[{"count":1,"href":"http:\/\/www.istesaglikdergisi.com.tr\/index.php\/wp-json\/wp\/v2\/posts\/611\/revisions"}],"predecessor-version":[{"id":612,"href":"http:\/\/www.istesaglikdergisi.com.tr\/index.php\/wp-json\/wp\/v2\/posts\/611\/revisions\/612"}],"wp:featuredmedia":[{"embeddable":true,"href":"http:\/\/www.istesaglikdergisi.com.tr\/index.php\/wp-json\/wp\/v2\/media\/592"}],"wp:attachment":[{"href":"http:\/\/www.istesaglikdergisi.com.tr\/index.php\/wp-json\/wp\/v2\/media?parent=611"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/www.istesaglikdergisi.com.tr\/index.php\/wp-json\/wp\/v2\/categories?post=611"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/www.istesaglikdergisi.com.tr\/index.php\/wp-json\/wp\/v2\/tags?post=611"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}