{"id":21755,"date":"2022-01-31T09:53:49","date_gmt":"2022-01-31T09:53:49","guid":{"rendered":"https:\/\/www.esin.av.tr\/?p=21755"},"modified":"2022-06-09T13:38:35","modified_gmt":"2022-06-09T13:38:35","slug":"turk-saglik-sektorune-giris-101","status":"publish","type":"post","link":"https:\/\/www.esin.av.tr\/tr\/2022\/01\/31\/turk-saglik-sektorune-giris-101\/","title":{"rendered":"T\u00fcrk Sa\u011fl\u0131k Sekt\u00f6r\u00fcne Giri\u015f 101"},"content":{"rendered":"<p><strong>T\u00fcrk Sa\u011fl\u0131k Sekt\u00f6r\u00fcne Giri\u015f 101 <\/strong><\/p>\n<p><strong>Sa\u011fl\u0131k Sekt\u00f6r\u00fcnde Temel Unsurlar<\/strong><\/p>\n<p><strong>Sa\u011fl\u0131k sekt\u00f6r\u00fcnde hangi d\u00fczenleyici kurumlar faaliyet g\u00f6sterir? <\/strong><\/p>\n<p>T\u00fcrk sa\u011fl\u0131k sekt\u00f6r\u00fcnde d\u00fczenleyici kurumlar Sa\u011fl\u0131k Bakanl\u0131\u011f\u0131 alt\u0131nda faaliyet g\u00f6steren T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (Kurum) ile (\u0130\u015f ve Sosyal G\u00fcvenlik Bakanl\u0131\u011f\u0131 alt\u0131nda faaliyet g\u00f6steren) Sosyal G\u00fcvenlik Kurumudur.<\/p>\n<p>Kurum a\u015fa\u011f\u0131daki faaliyetlerin y\u00fcr\u00fct\u00fclmesinden sorumludur:<\/p>\n<ul>\n<li>Be\u015feri t\u0131bbi \u00fcr\u00fcnlerin \u00fcretim, ithalat ve ruhsat i\u015flemlerini d\u00fczenler, y\u00fcksek kalitede ve uygun fiyatta olmalar\u0131n\u0131 sa\u011flar.<\/li>\n<li>\u00dcretim, da\u011f\u0131t\u0131m ve depolama tesisleri ile ila\u00e7 ve t\u0131bbi madde sat\u0131\u015f\u0131 yapan eczanelere ili\u015fkin d\u00fczenleyici i\u015flemler yapar.<\/li>\n<li>Narkotik ve psikotrop maddelerin ithalat\u0131n\u0131, \u00fcretimini, ihracat\u0131n\u0131 ve yerel t\u00fcketimini d\u00fczenler.<\/li>\n<li>T\u00fcrk farmakopesinin y\u00fcr\u00fcrl\u00fc\u011fe girmesini onaylar.<\/li>\n<li>Sa\u011fl\u0131k Bakanl\u0131\u011f\u0131 taraf\u0131ndan verilecek di\u011fer benzeri g\u00f6revleri yerine getirir.<\/li>\n<\/ul>\n<p><strong>\u0130la\u00e7lar\u0131n T\u00fcrkiye pazar\u0131na sunulmas\u0131 i\u00e7in temel gereksinim nedir?<\/strong><\/p>\n<p>Kural olarak, ila\u00e7 \u015firketleri be\u015feri t\u0131bbi \u00fcr\u00fcnlerini T\u00fcrkiye pazar\u0131na arz edebilmek i\u00e7in ruhsat almakla y\u00fck\u00fcml\u00fcd\u00fcr. Ruhsat gereklili\u011fi esas olarak \u00a02001\/83\/AT say\u0131l\u0131 Be\u015feri T\u0131bbi \u00dcr\u00fcnler Hakk\u0131ndaki Avrupa Parlamentosu ve Konsey Direktifi ile paralel olan Be\u015feri T\u0131bbi \u00dcr\u00fcnler Ruhsatland\u0131rma Y\u00f6netmeli\u011fi (&#8220;<strong>Ruhsat Y\u00f6netmeli\u011fi<\/strong>&#8220;) kapsam\u0131nda d\u00fczenlenmektedir.<\/p>\n<p>Belirli ila\u00e7 t\u00fcrleri (\u00f6rne\u011fin, eczanede haz\u0131rlanm\u0131\u015f ila\u00e7lar, ara\u015ft\u0131rma ve geli\u015ftirme denemelerine y\u00f6nelik t\u0131bbi \u00fcr\u00fcnler, ara \u00fcr\u00fcnler, radyon\u00fcklidler ve tam kan, plazma veya insan kaynakl\u0131 kan h\u00fccreleri) Ruhsat Y\u00f6netmeli\u011fi&#8217;nin kapsam\u0131 d\u0131\u015f\u0131ndad\u0131r.<\/p>\n<p>Buna ek olarak, Kurum taraf\u0131ndan ruhsatland\u0131r\u0131larak ilk kez piyasaya sunulacak \u00fcr\u00fcnler i\u00e7in sat\u0131\u015f izni al\u0131nmas\u0131 zorunludur.<\/p>\n<p><strong>Nas\u0131l ruhsat ba\u015fvurusunda bulunabilirim? <\/strong><\/p>\n<p>Ruhsat almak i\u00e7in ilk se\u00e7enek Kurum&#8217;a ba\u015fvurmakt\u0131r. \u0130stisnai hallerde, klinik \u00f6ncesi testler ve klinik ara\u015ft\u0131rmalar\u0131n sonu\u00e7lar\u0131n\u0131 g\u00f6ndermeksizin jenerik ila\u00e7 ruhsat\u0131 ba\u015fvurusu yap\u0131lmas\u0131 m\u00fcmk\u00fcnd\u00fcr. Bu t\u00fcr ruhsat ba\u015fvurular\u0131 a\u015fa\u011f\u0131daki \u015fartlar dahilinde yap\u0131labilmektedir:<\/p>\n<ul>\n<li>\u0130lgili ilac\u0131n, hali haz\u0131rda ruhsatl\u0131 ba\u015fka bir ilaca \u00f6z\u00fcnde benzer olmas\u0131 ve ikinci ilac\u0131n ruhsat sahibinin, \u00fcr\u00fcnlerinin klinik \u00f6ncesi testlerinin ve klinik ara\u015ft\u0131rmalar\u0131n\u0131n kullan\u0131lmas\u0131na izin vermesi durumunda.<\/li>\n<li>\u0130lgili ilac\u0131n, hali haz\u0131rda ruhsatl\u0131 ba\u015fka bir ilaca \u00f6z\u00fcnde benzer olmas\u0131 ve ikinci \u00fcr\u00fcn\u00fcn veri imtiyaz\u0131 s\u00fcresinin sona ermesi durumunda.<\/li>\n<li>T\u0131bbi \u00fcr\u00fcn\u00fcn bile\u015fen(ler)inin ayr\u0131nt\u0131l\u0131 bilimsel bibliyografya sonucunda kabul edilen makul etkililik ve kabul edilebilir bir g\u00fcvenlik d\u00fczeyi ile, k\u00f6kl\u00fc bir t\u0131bbi kullan\u0131m ge\u00e7mi\u015fi bulunmas\u0131 durumunda.<\/li>\n<\/ul>\n<p><strong>Ruhsat sahibi de\u011fi\u015fikli\u011fi nas\u0131l yap\u0131l\u0131r? <\/strong><\/p>\n<p>Ruhsat sahipli\u011finin devri, \u00f6zellikle ila\u00e7 firmalar\u0131n\u0131n mevcut distrib\u00fct\u00f6rl\u00fck ili\u015fkilerini sona erdirip do\u011frudan T\u00fcrkiye pazar\u0131na girdikleri durumlarda uygulamada s\u0131k\u00e7a kar\u015f\u0131la\u015f\u0131lan konulardan biridir. Ruhsat Y\u00f6netmeli\u011fi&#8217;nin 26. Maddesi uyar\u0131nca Sa\u011fl\u0131k Bakanl\u0131\u011f\u0131, di\u011fer gerekli belgelerin yan\u0131 s\u0131ra, mevcut ve gelecekteki ruhsat sahibi aras\u0131nda ruhsat devrine ili\u015fkin noter tasdikli bir s\u00f6zle\u015fme veya ruhsat sahibinin de\u011fi\u015fikli\u011fine ili\u015fkin mahkeme karar\u0131 sunulmas\u0131n\u0131 talep etmektedir. Bu nedenle, bir ila\u00e7 firmas\u0131n\u0131n T\u00fcrkiye&#8217;deki distrib\u00fct\u00f6rl\u00fck ili\u015fkisini sona erdirmek ve T\u00fcrkiye&#8217;deki \u00fc\u00e7\u00fcnc\u00fc bir ki\u015fiyi veya yan kurulu\u015funu atamak istemesi durumunda &#8211; bu durum ayn\u0131 zamanda ruhsat sahibinin de\u011fi\u015fmesini de gerektirece\u011finden &#8211; mevcut distrib\u00fct\u00f6rl\u00fck ili\u015fkisinin feshedilmesi ruhsatlar\u0131n devri i\u00e7in yeterli olmayacakt\u0131r. Bu durumda, mevcut ve gelecekteki ruhsat sahibi aras\u0131nda noter huzurunda kar\u015f\u0131l\u0131kl\u0131 bir s\u00f6zle\u015fme yap\u0131lmas\u0131, icra dairesince ruhsat\u0131n cebri icra yoluyla sat\u0131ld\u0131\u011f\u0131na ili\u015fkin karar veya ruhsat\u0131n devredildi\u011fine dair mahkeme ilan\u0131n\u0131n sunulmas\u0131 gerekecektir.<\/p>\n<p><strong>T\u00fcrkiye&#8217;de be\u015feri t\u0131bbi \u00fcr\u00fcnlerimin reklam\u0131n\u0131 yapabilir miyim? <\/strong><\/p>\n<p>T\u0131bbi \u00fcr\u00fcnlere y\u00f6nelik tan\u0131t\u0131m faaliyetleri mevzuat kapsam\u0131nda s\u0131n\u0131rland\u0131r\u0131lm\u0131\u015ft\u0131r. Buna g\u00f6re, be\u015feri t\u0131bbi \u00fcr\u00fcnlerin tan\u0131t\u0131m\u0131 yaln\u0131zca a\u015fa\u011f\u0131daki hallerde m\u00fcmk\u00fcnd\u00fcr:<\/p>\n<ul>\n<li>Sa\u011fl\u0131k meslek mensuplar\u0131na sat\u0131lan\/da\u011f\u0131t\u0131lan yay\u0131nlarda veya bilimsel t\u0131bbi ya da mesleki dergilerdeki yay\u0131n yap\u0131lmas\u0131.<\/li>\n<li>\u00dcr\u00fcn tan\u0131t\u0131m personeli taraf\u0131ndan t\u0131p doktorlar\u0131, di\u015f hekimleri ve eczac\u0131lara ziyaretler d\u00fczenlenmesi ve di\u011fer sa\u011fl\u0131k meslek mensuplar\u0131na \u00fcr\u00fcnlerin uygulanmas\u0131 ve yan etkileri hakk\u0131nda bilgi verilmesi.<\/li>\n<\/ul>\n<p><strong>T\u0131bbi cihazlar i\u00e7in ne t\u00fcr kurallar bulunmaktad\u0131r? <\/strong><\/p>\n<p>T\u0131bbi cihazlar, 2 Haziran 2021&#8217;de y\u00fcr\u00fcrl\u00fc\u011fe giren yeni T\u0131bbi Cihaz Y\u00f6netmeli\u011fi kapsam\u0131nda d\u00fczenlenmektedir. T\u0131bbi \u00fcr\u00fcnlerin aksine, t\u0131bbi cihazlar\u0131n piyasaya s\u00fcr\u00fclmesi i\u00e7in ruhsat gerekmemektedir. T\u0131bbi Cihaz Y\u00f6netmeli\u011fi uyar\u0131nca t\u0131bbi cihazlar\u0131n \u00dcr\u00fcn Takip Sistemi&#8217;ne (\u00dcr\u00fcn Takip Sistemi) kay\u0131t edilmesi gerekmektedir. Ayr\u0131ca t\u0131bbi cihaz sekt\u00f6r\u00fcnde \u015feffafl\u0131\u011f\u0131 art\u0131rmak ve izlenebilirlik seviyesini iyile\u015ftirmek amac\u0131yla T\u0131bbi Cihaz Y\u00f6netmeli\u011fi, \u00a0Avrupa Komisyonu&#8217;nun T\u0131bbi Cihazlara ili\u015fkin Avrupa Veri Taban\u0131 (EUDAMED) sistemini benimsemi\u015ftir. T\u0131bbi Cihaz Y\u00f6netmeli\u011fi bu do\u011frultuda \u00fcreticilere, ithalat\u00e7\u0131lara ve yetkili temsilcilere EUDAMED&#8217;e kay\u0131t yapt\u0131rma y\u00fck\u00fcml\u00fcl\u00fc\u011f\u00fc getirmektedir.<\/p>\n<p><strong>T\u0131bbi cihazlar\u0131m\u0131n reklam\u0131n\u0131 yapabilir miyim? <\/strong><\/p>\n<p>A\u015fa\u011f\u0131daki t\u0131bbi cihazlar\u0131n t\u00fcketicilere tan\u0131t\u0131m\u0131n\u0131n yap\u0131lmas\u0131 T\u0131bbi Cihaz Sat\u0131\u015f, Reklam ve Tan\u0131t\u0131m Y\u00f6netmeli\u011fi uyar\u0131nca yasaklanm\u0131\u015ft\u0131r:<\/p>\n<ul>\n<li>Yaln\u0131zca i\u015fitme cihaz\u0131 merkezlerinde, ki\u015fiye \u00f6zel protez ve ortez merkezlerinde, g\u00f6zl\u00fck\u00e7\u00fc ofislerinde veya di\u015f protez laboratuvarlar\u0131nda sat\u0131lan, uyarlanan veya uygulanan cihazlar.<\/li>\n<li>Yaln\u0131zca sa\u011fl\u0131k meslek mensuplar\u0131 taraf\u0131ndan kullan\u0131lmas\u0131 veya uygulanmas\u0131 ama\u00e7lanan veya t\u0131bbi cihaz sat\u0131\u015f merkezlerinde uygulama gerektiren cihazlar.<\/li>\n<\/ul>\n<p>Ki\u015fisel hijyen i\u00e7in kullan\u0131lan t\u0131bbi cihazlar\u0131n (\u00f6rne\u011fin di\u015f macunu, pamuk vb.) tan\u0131t\u0131m\u0131n\u0131n yap\u0131lmas\u0131 serbesttir. Bunlar\u0131n d\u0131\u015f\u0131nda kalan t\u0131bbi cihazlar\u0131n t\u00fcketicilere y\u00f6nelik tan\u0131t\u0131m\u0131 yaln\u0131zca cihaz\u0131n sat\u0131ld\u0131\u011f\u0131 internet sitesi \u00fczerinden yap\u0131labilmektedir.<\/p>\n<p><strong>Kozmetik \u00fcr\u00fcnler i\u00e7in nas\u0131l izin al\u0131r\u0131m? <\/strong><\/p>\n<p>\u0130la\u00e7 ve t\u0131bbi cihazlardan farkl\u0131 olarak kozmetik \u00fcr\u00fcnlerin piyasaya arz\u0131 i\u00e7in Kozmetik Kanunu uyar\u0131nca Kurum&#8217;a bildirim yap\u0131lmas\u0131 gerekmektedir.<\/p>\n<p><strong>Kozmetik \u00fcr\u00fcnlerimin reklam\u0131n\u0131 yapabilir miyim?<\/strong><\/p>\n<p>Kozmetik \u00fcr\u00fcnlerin tan\u0131t\u0131m\u0131 belirli kurallara ve k\u0131s\u0131tlamalara tabidir. Kozmetik \u00fcr\u00fcnlerin tan\u0131t\u0131m\u0131 s\u0131ras\u0131nda hastal\u0131klar\u0131n tedavi edilece\u011fini ve\/veya \u00f6nlenece\u011fini veya fizyolojik bir fonksiyonun d\u00fczeltilece\u011fini, d\u00fczenlenece\u011fini ve\/veya de\u011fi\u015ftirilece\u011fini ima eden ifadeler kullan\u0131lmas\u0131 yasaklanm\u0131\u015ft\u0131r.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>T\u00fcrk Sa\u011fl\u0131k Sekt\u00f6r\u00fcne Giri\u015f 101 Sa\u011fl\u0131k Sekt\u00f6r\u00fcnde Temel Unsurlar Sa\u011fl\u0131k sekt\u00f6r\u00fcnde hangi d\u00fczenleyici kurumlar faaliyet g\u00f6sterir? T\u00fcrk sa\u011fl\u0131k sekt\u00f6r\u00fcnde d\u00fczenleyici [&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":[118],"tags":[92],"class_list":["post-21755","post","type-post","status-publish","format-standard","hentry","category-publications","tag-healthcare-tr"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>T\u00fcrk Sa\u011fl\u0131k Sekt\u00f6r\u00fcne Giri\u015f 101<\/title>\n<meta name=\"description\" content=\"T\u00fcrk Sa\u011fl\u0131k Sekt\u00f6r\u00fcne Giri\u015f 101 Sa\u011fl\u0131k Sekt\u00f6r\u00fcnde Temel Unsurlar Sa\u011fl\u0131k sekt\u00f6r\u00fcnde hangi d\u00fczenleyici kurumlar faaliyet g\u00f6sterir? 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