{"id":14664,"date":"2017-09-29T11:18:30","date_gmt":"2017-09-29T11:18:30","guid":{"rendered":"http:\/\/upt.esin.av.tr\/2017\/09\/29\/ruhsatli-beseri-tibbi-urunlerdeki-varyasyonlara-dair-yonetmelik-taslagi-yayinlandi\/"},"modified":"2022-06-09T12:08:37","modified_gmt":"2022-06-09T12:08:37","slug":"ruhsatli-beseri-tibbi-urunlerdeki-varyasyonlara-dair-yonetmelik-taslagi-yayinlandi","status":"publish","type":"post","link":"https:\/\/www.esin.av.tr\/tr\/2017\/09\/29\/ruhsatli-beseri-tibbi-urunlerdeki-varyasyonlara-dair-yonetmelik-taslagi-yayinlandi\/","title":{"rendered":"Ruhsatl\u0131 Be\u015feri T\u0131bbi \u00dcr\u00fcnlerdeki Varyasyonlara Dair Y\u00f6netmelik Tasla\u011f\u0131 Yay\u0131nland\u0131"},"content":{"rendered":"<p><strong>Yeni Geli\u015fme<\/strong><\/p>\n<p>T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (&#8220;<strong>T\u0130TCK<\/strong>&#8220;), internet sitesinde Ruhsatl\u0131 Be\u015feri T\u0131bbi \u00dcr\u00fcnlerdeki Varyasyonlara Dair Y\u00f6netmelik Tasla\u011f\u0131\u2019n\u0131 (\u201c<strong>Varyasyon Y\u00f6netmeli\u011fi<\/strong>\u201d) ve ilgili k\u0131lavuz taslaklar\u0131n\u0131 yay\u0131mlad\u0131.<\/p>\n<p><strong>Y\u00f6netmelik Neler Getiriyor? <\/strong><\/p>\n<p><strong>\u00a0<\/strong>Taslak Varyasyon Y\u00f6netmeli\u011fi Avrupa Komisyonu\u2019nun 1234\/2008 AT T\u00fcz\u00fc\u011f\u00fc, 712\/2012 AT T\u00fcz\u00fc\u011f\u00fc ve 2001\/83\/AT Direktifi esas al\u0131narak haz\u0131rlanm\u0131\u015f olup temel itibariyle be\u015feri t\u0131bbi \u00fcr\u00fcnler i\u00e7in yap\u0131lacak varyasyon ba\u015fvurular\u0131nda uyulmas\u0131 gereken usul ve prosed\u00fcrleri belirlemeyi ama\u00e7lamaktad\u0131r. Varyasyon; ruhsat ba\u015fvurular\u0131nda sunulan bilgilerde, \u00fcr\u00fcn bilgisinde, be\u015feri t\u0131bbi \u00fcr\u00fcn\u00fcn ruhsat\u0131n\u0131 etkileyen ko\u015fullar, y\u00fck\u00fcml\u00fcl\u00fckler veya k\u0131s\u0131tlamalarda, ambalaj bilgileri veya kullanma talimat\u0131nda ger\u00e7ekle\u015fen de\u011fi\u015fikliklerin t\u00fcm\u00fcn\u00fc ifade etmektedir.<\/p>\n<p>Bu kapsamda Varyasyon Y\u00f6netmeli\u011fi, farkl\u0131 varyasyon s\u0131n\u0131flar\u0131n\u0131 tan\u0131mlamakta ve ruhsat sahiplerinin T\u0130TCK\u2019ya yapacaklar\u0131 varyasyon ba\u015fvurular\u0131nda yerine getirmeleri gereken y\u00fck\u00fcml\u00fcl\u00fckleri ortaya koymaktad\u0131r.<\/p>\n<p>Varyasyon Y\u00f6netmeli\u011fi\u2019nin yan\u0131 s\u0131ra, T\u0130TCK be\u015feri t\u0131bbi \u00fcr\u00fcnlerdeki varyasyonlara ili\u015fkin i\u015flemlere uygulamada a\u00e7\u0131kl\u0131k getirmesi amac\u0131yla T\u0131bbi \u00dcr\u00fcnlerdeki Varyasyonlara Dair K\u0131lavuz Tasla\u011f\u0131 ve \u00c7e\u015fitleme Ba\u015fvurular\u0131 ile Varyasyon Ba\u015fvurular\u0131n\u0131n S\u0131n\u0131fland\u0131r\u0131lmas\u0131na Dair K\u0131lavuz Tasla\u011f\u0131\u2019n\u0131 da yay\u0131mlam\u0131\u015ft\u0131r.<\/p>\n<p>Taslak Varyasyon Y\u00f6netmeli\u011fi ile Ruhsatl\u0131 Be\u015feri T\u0131bbi \u00dcr\u00fcnlerdeki Varyasyonlara Dair K\u0131lavuz Tasla\u011f\u0131 ve \u00c7e\u015fitleme Ba\u015fvurular\u0131 ile Varyasyon Ba\u015fvurular\u0131n\u0131n S\u0131n\u0131fland\u0131r\u0131lmas\u0131na Dair K\u0131lavuz Tasla\u011f\u0131\u2019na T\u0130TCK\u2019n\u0131n internet sitesinden ula\u015fabilirsiniz.<\/p>\n<p><strong>Sonu\u00e7<\/strong><\/p>\n<p><strong>\u00a0<\/strong>T\u0130TCK, d\u00fczenli olarak be\u015feri t\u0131bbi \u00fcr\u00fcn \u015firketlerine ruhsatland\u0131rmaya dair hususlarda yol g\u00f6stermeye devam ediyor. \u00a0Bu kapsamda yer alan \u015firketler, yeni yay\u0131mlanan taslak Varyasyon Y\u00f6netmeli\u011fi\u2019nde ve ilgili taslak k\u0131lavuzlarda yer alan gereklilikleri g\u00f6zden ge\u00e7irmeli ve varyasyon bildiriminde bulunurken izlenmesi gereken usul ve esaslara uygun hareket etmelidir.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Yeni Geli\u015fme T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (&#8220;T\u0130TCK&#8220;), internet sitesinde Ruhsatl\u0131 Be\u015feri T\u0131bbi \u00dcr\u00fcnlerdeki Varyasyonlara Dair Y\u00f6netmelik Tasla\u011f\u0131\u2019n\u0131 (\u201cVaryasyon [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_stopmodifiedupdate":false,"_modified_date":"","footnotes":""},"categories":[120],"tags":[92],"class_list":["post-14664","post","type-post","status-publish","format-standard","hentry","category-legal-alerts","tag-healthcare-tr"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.0 - 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