{"id":21436,"date":"2022-01-04T08:59:36","date_gmt":"2022-01-04T08:59:36","guid":{"rendered":"https:\/\/www.esin.av.tr\/?p=21436"},"modified":"2022-06-09T13:32:14","modified_gmt":"2022-06-09T13:32:14","slug":"yeni-beseri-tibbi-urun-ruhsatlandirma-yonetmeligi-neler-getiriyor","status":"publish","type":"post","link":"https:\/\/www.esin.av.tr\/tr\/2022\/01\/04\/yeni-beseri-tibbi-urun-ruhsatlandirma-yonetmeligi-neler-getiriyor\/","title":{"rendered":"Yeni Be\u015feri T\u0131bbi \u00dcr\u00fcn Ruhsatland\u0131rma Y\u00f6netmeli\u011fi Neler Getiriyor?"},"content":{"rendered":"

\"\"<\/a>\u00a0 \u00a0 \u00a0 \u00a0 \u00a0Bu b\u00fcltenimizi podcast olarak da dinleyebilirsiniz!<\/strong><\/p>\n

 <\/p>\n

T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (“Kurum<\/strong>“) yeni Be\u015feri T\u0131bbi \u00dcr\u00fcn Ruhsatland\u0131rma Y\u00f6netmeli\u011fi’ni (“Y\u00f6netmelik<\/strong>“) yay\u0131mlad\u0131. Y\u00f6netmelik, ruhsat ba\u015fvuru s\u00fcre\u00e7leri ve acil kullan\u0131m onay\u0131 gibi kritik \u00f6nem ta\u015f\u0131yan konulara y\u00f6nelik d\u00fczenlemeler i\u00e7eriyor.<\/h2>\n

Yeni Geli\u015fme<\/strong><\/h3>\n

Kurum, 11.12.2021 tarihli ve 31686 say\u0131l\u0131 Resmi Gazete’de Be\u015feri T\u0131bbi \u00dcr\u00fcn Ruhsatland\u0131rma Y\u00f6netmeli\u011fi’ni yay\u0131mlad\u0131. Y\u00f6netmelik, 6\/11\/2001 tarihli ve 2001\/83\/AT say\u0131l\u0131 Be\u015feri T\u0131bbi \u00dcr\u00fcnler Hakk\u0131ndaki Avrupa Parlamentosu ve Konsey Direktifi ile 29\/3\/2006 tarihli ve 507\/2006\/AT say\u0131l\u0131 Be\u015feri T\u0131bbi \u00dcr\u00fcnler \u0130\u00e7in Ko\u015fullu Ruhsata Dair Komisyon T\u00fcz\u00fc\u011f\u00fc dikkate al\u0131narak Avrupa Birli\u011fi mevzuat\u0131na uyum \u00e7er\u00e7evesinde haz\u0131rland\u0131. Bu kapsamda Y\u00f6netmelik, be\u015feri t\u0131bbi \u00fcr\u00fcnlerin ruhsat ba\u015fvurusu, ba\u015fvurular\u0131n de\u011ferlendirilmesi, ruhsatlar\u0131n yenilenmesi ve ask\u0131ya al\u0131nmas\u0131, y\u00fck\u00fcml\u00fcl\u00fckler, sat\u0131\u015f ve acil kullan\u0131m onay\u0131 gibi pek \u00e7ok farkl\u0131 konuda yeni d\u00fczenlemeler i\u00e7eriyor. Yay\u0131n tarihinde y\u00fcr\u00fcrl\u00fc\u011fe giren ilgili Y\u00f6netmelik’e buradan <\/a>ula\u015fabilirsiniz.<\/p>\n

Neler De\u011fi\u015fecek?<\/strong><\/h3>\n

Ruhsat Ba\u015fvurusu<\/em><\/p>\n

Y\u00f6netmelik kapsam\u0131nda ruhsat ba\u015fvurular\u0131n\u0131n elektronik ortamda yap\u0131laca\u011f\u0131 d\u00fczenlenmekte olup, ruhsat ba\u015fvurusu s\u0131ras\u0131nda sunulmas\u0131 gereken belge listesi geni\u015fletilmi\u015ftir. Buna g\u00f6re ba\u015fvuru s\u0131ras\u0131nda be\u015feri t\u0131bbi \u00fcr\u00fcn \u00fcreticisi taraf\u0131ndan kullan\u0131lan kontrol metotlar\u0131n\u0131n tan\u0131m\u0131, klinik ara\u015ft\u0131rma sonu\u00e7lar\u0131 ile ara\u015ft\u0131rmalar\u0131n yurtd\u0131\u015f\u0131nda y\u00fcr\u00fct\u00fclmesi halinde \u0130la\u00e7 ve Biyolojik \u00dcr\u00fcnlerin Klinik Ara\u015ft\u0131rmalar\u0131 Hakk\u0131nda Y\u00f6netmelik’te d\u00fczenlenen etik gereklilikleri kar\u015f\u0131lad\u0131\u011f\u0131na ili\u015fkin a\u00e7\u0131klamay\u0131 i\u00e7eren ba\u015fvuru sahibi beyan\u0131 gibi bir tak\u0131m bilgi ve belgelerin sunulmas\u0131 gerekmektedir. Yurtd\u0131\u015f\u0131ndan temin edilen t\u00fcm resmi belgeler, Kurum taraf\u0131ndan uygun bulunan k\u0131s\u0131mlar hari\u00e7, T\u00fcrk\u00e7e olarak ve apostil \u015ferhi ya da konsolosluk onay\u0131 ile sunulmak zorundad\u0131r. Ayr\u0131ca\u00a0sa\u011fl\u0131k mesle\u011fi mensuplar\u0131na y\u00f6nelik olarak haz\u0131rlanan k\u0131sa \u00fcr\u00fcn bilgilerinin i\u00e7ermesi gereken unsurlar Y\u00f6netmelik’te liste halinde say\u0131lm\u0131\u015ft\u0131r.<\/p>\n

Ruhsat Ba\u015fvurusunun De\u011ferlendirilmesi<\/em><\/p>\n

Y\u00f6netmelik uyar\u0131nca ruhsatland\u0131rma s\u00fcre\u00e7leri \u015eubat, May\u0131s, A\u011fustos ve Kas\u0131m aylar\u0131nda ba\u015flat\u0131lmaktad\u0131r. Ancak Kurum \u00d6ncelik De\u011ferlendirme Kurulu taraf\u0131ndan uygun bulunan ba\u015fvurular ruhsatland\u0131rma i\u015flemlerinde \u00f6ncelikli olarak de\u011ferlendirilebilecektir.<\/p>\n

Ruhsat ba\u015fvurusu eksikliklerin s\u00fcresinde giderilmemesi, ruhsat bedelinin \u00f6denmemesi ve \u00f6n de\u011ferlendirme s\u00fcrecinde talep edilen bilgi ve belgelerin sunulamamas\u0131na y\u00f6nelik mazeretin Kurum’a zaman\u0131nda bildirilmemesi halinde usulden reddedilecektir.<\/p>\n

Ruhsat ba\u015fvurusu de\u011ferlendirme s\u00fcrecinde ortaya \u00e7\u0131kan bir tak\u0131m hallerde ba\u015fvuru sahibine en fazla 3 yaz\u0131l\u0131 ve 2 s\u00f6zl\u00fc cevap hakk\u0131 tan\u0131nacakt\u0131r. Bu s\u00fcrede gerekli bilgi ve belgelerin tamamlanmamas\u0131 halinde ba\u015fvuru esastan reddedilecektir. Ret karar\u0131 ba\u015fvuru sahibine bildirilir. Bildirim yap\u0131lam\u0131yor ise ret karar\u0131 Kurum’un internet sitesi \u00fczerinde ilan edilebilir. Ba\u015fvuru sahibi bildirim veya ilan tarihinden itibaren 45 g\u00fcn i\u00e7inde Kurum’a itiraz edebilecektir. \u0130tiraz hakk\u0131n\u0131n kullan\u0131lmas\u0131 durumunda \u00e7\u0131kan karar kesindir. Ancak bu durum ba\u015fvuru sahibinin yeniden bir ruhsat ba\u015fvurusu yapmas\u0131na itiraz te\u015fkil etmeyecektir.<\/p>\n

Ruhsat\u0131n Yenilenmesi ve Ask\u0131ya Al\u0131nmas\u0131<\/em><\/p>\n

Ruhsat ge\u00e7erlilik s\u00fcresi 5 y\u0131l olup, bu s\u00fcresinin dolmas\u0131ndan 9 ay \u00f6nce yenileme amac\u0131yla Kurum’a ba\u015fvuru yap\u0131lmas\u0131 gerekmektedir. Ruhsat bir kez yenilendikten sonra Kurum, \u00e7e\u015fitli nedenlerle ek bir be\u015f y\u0131ll\u0131k yenileme de\u011ferlendirmesi yap\u0131lmas\u0131na karar vermedi\u011fi s\u00fcrece ruhsat s\u00fcresiz olarak ge\u00e7erli olacakt\u0131r.<\/p>\n

Y\u00f6netmelik ile be\u015feri t\u0131bbi \u00fcr\u00fcn ruhsat\u0131n\u0131n ask\u0131ya al\u0131nmas\u0131 gereken haller geni\u015fletilmi\u015ftir. Buna g\u00f6re 11\/12\/2022 tarihinden itibaren a\u015fa\u011f\u0131daki hallerden birinin tespiti halinde ruhsat ask\u0131ya al\u0131nacakt\u0131r:<\/p>\n

    \n
  • Belirli istisnalar d\u0131\u015f\u0131nda, be\u015feri t\u0131bbi \u00fcr\u00fcn\u00fcn ruhsatland\u0131r\u0131ld\u0131\u011f\u0131 tarihten itibaren ilk 30 ay i\u00e7erisinde<\/u> en az bir ticari serisinin piyasaya sunulmam\u0131\u015f olmas\u0131 veya<\/li>\n
  • T\u00fcrkiye’de imal edilen ve daha \u00f6nce piyasaya sunulmu\u015f olan karekod uygulamas\u0131 kapsam\u0131nda ruhsatl\u0131 bir be\u015feri t\u0131bbi \u00fcr\u00fcn\u00fcn kesintisiz 30 ay boyunca<\/u> en az bir ticari serisinin T\u00fcrkiye veya yurtd\u0131\u015f\u0131nda piyasaya sunulmamas\u0131.<\/li>\n<\/ul>\n

    Ruhsat Sahibinin Y\u00fck\u00fcml\u00fcl\u00fckleri<\/em><\/p>\n

    Y\u00f6netmelik ile be\u015feri t\u0131bbi \u00fcr\u00fcn ruhsat sahibinin y\u00fck\u00fcml\u00fcl\u00fckleri geni\u015fletilmi\u015ftir. Buna g\u00f6re ruhsat sahibi herhangi bir \u00fcr\u00fcn\u00fc piyasaya veremeyecek olmas\u0131 halinde, bu durumun olu\u015fmas\u0131ndan en az 30 g\u00fcn \u00f6nce Kurum’u duruma y\u00f6nelik bilgilendirmekle y\u00fck\u00fcml\u00fcd\u00fcr. Ayr\u0131ca ithal veya ihra\u00e7 edilen ya da lisans alt\u0131nda T\u00fcrkiye’de \u00fcretilen be\u015feri t\u0131bbi \u00fcr\u00fcnlerin kalite, etkililik veya g\u00fcvenlilik nedeniyle ruhsatl\u0131 oldu\u011fu \u00fclkede ruhsat\u0131n\u0131n iptali, ask\u0131ya al\u0131nmas\u0131 veya \u00fcr\u00fcn\u00fcn geri ge\u00e7ilmesi ya da toplat\u0131lmas\u0131 halinde bu durumun Kurum’a bildirilmesi mecburidir.<\/p>\n

    Be\u015feri T\u0131bbi \u00dcr\u00fcnlerin Sat\u0131\u015f \u0130zni<\/em><\/p>\n

    Kurum taraf\u0131ndan ruhsatland\u0131r\u0131larak ilk kez piyasaya sunulacak \u00fcr\u00fcnler i\u00e7in sat\u0131\u015f izni al\u0131nmas\u0131 zorunludur. \u0130zin ba\u015fvurusu Y\u00f6netmelik taraf\u0131ndan belirlenen belgeleri Kurum’a sunmak suretiyle yap\u0131l\u0131r. \u00dcretim yeri, ambalaj boyutu de\u011fi\u015fikli\u011fi, ruhsat devir i\u015flemi ve ruhsat\u0131n bir tak\u0131m sebeplerle ask\u0131da olma durumu hari\u00e7 be\u015feri t\u0131bbi \u00fcr\u00fcndeki sair de\u011fi\u015fikler i\u00e7in yeniden sat\u0131\u015f izni al\u0131nmas\u0131na gerek yoktur.<\/p>\n

    \u0130stisnai olarak sat\u0131\u015f izni bulunan, izinli olup ruhsat ba\u015fvurusunda bulunulmu\u015f olan veya ruhsatl\u0131 olan kan \u00fcr\u00fcnlerinin her bir serisinin piyasaya sunumu i\u00e7in 01\/01\/2025 tarihinden itibaren ek bir sat\u0131\u015f izni al\u0131nmas\u0131 zorunlu tutulmu\u015ftur. Benzer \u015fekilde, alerjen \u00fcr\u00fcnler istisna olmak kayd\u0131yla sat\u0131\u015f izni bulunan, ruhsatl\u0131 veya izinli olup ruhsat ba\u015fvurusunda bulunulmu\u015f olan imm\u00fcnolojik be\u015feri t\u0131bbi \u00fcr\u00fcnler i\u00e7in; \u00fcr\u00fcn\u00fcn\u00fc piyasaya sunmadan \u00f6nce \u00fcr\u00fcn\u00fcn her serisi i\u00e7in piyasaya sunum izni almak \u00fczere Kurum’a ba\u015fvuru yap\u0131lmas\u0131 zorunludur.<\/p>\n

    Ko\u015fullu Ruhsatland\u0131rma (Acil Kullan\u0131m Onay\u0131)<\/em><\/p>\n

    Y\u00f6netmelik uyar\u0131nca ya\u015fam\u0131 tehdit eden veya ciddi derecede engellilik yaratacak hastal\u0131klar\u0131n tedavisinde, \u00f6nlenmesinde veya te\u015fhisinde kullan\u0131lacak be\u015feri t\u0131bbi \u00fcr\u00fcnler ile D\u00fcnya Sa\u011fl\u0131k \u00d6rg\u00fct\u00fc, Avrupa Birli\u011fi veya Sa\u011fl\u0131k Bakanl\u0131\u011f\u0131 taraf\u0131ndan kabul g\u00f6ren halk sa\u011fl\u0131\u011f\u0131 tehditlerine kar\u015f\u0131 acil durumlarda kullan\u0131lacak kritik \u00f6nem arz eden be\u015feri t\u0131bbi \u00fcr\u00fcnlerin h\u0131zl\u0131ca ruhsatland\u0131r\u0131lmas\u0131 i\u00e7in bir tak\u0131m ko\u015fullara dayal\u0131 \u00f6zel bir ruhsat ba\u015fvuru usul\u00fc d\u00fczenlenmi\u015ftir. Acil kullan\u0131m onay\u0131n\u0131n ge\u00e7erlilik s\u00fcresi 1 y\u0131l ile s\u0131n\u0131rland\u0131r\u0131lm\u0131\u015ft\u0131r. Bu s\u00fcrenin sona ermesinden 90 g\u00fcn \u00f6nce Kurum’a ba\u015fvurarak yenilenmesi talep edilebilecektir. Konuya ili\u015fkin detayl\u0131 d\u00fczenlemeler Kurum taraf\u0131ndan ayr\u0131ca yay\u0131nlanacakt\u0131r.<\/p>\n

    Sonu\u00e7<\/strong><\/h3>\n

    Y\u00f6netmelik be\u015feri t\u0131bbi \u00fcr\u00fcnlerin ruhsatland\u0131rma s\u00fcre\u00e7lerine y\u00f6nelik olduk\u00e7a \u00f6nemli yenilikler getirmektedir. Sa\u011fl\u0131k sekt\u00f6r\u00fcnde faaliyet g\u00f6steren t\u00fcm ilgili \u015firketler, Y\u00f6netmelik d\u00fczenlemelerini ve Kurum’un Y\u00f6netmelik uygulamas\u0131na y\u00f6nelik duyurular\u0131n\u0131 yak\u0131ndan takip etmeli, mevzuatta yer alan y\u00fck\u00fcml\u00fcl\u00fcklerini Kurum’un y\u00f6nlendirmeleri do\u011frultusunda yerine getirmelidir.<\/p>\n","protected":false},"excerpt":{"rendered":"

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