\u00a0<\/strong>\u0130la\u00e7lar\u0131n piyasaya s\u00fcr\u00fclebilmesi i\u00e7in ruhsat almas\u0131 zorunludur. Bu husus, Be\u015feri ve T\u0131bbi \u00dcr\u00fcnler Ruhsatland\u0131rma Y\u00f6netmeli\u011fi m. 5\/1\u2019de T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu taraf\u0131ndan ruhsatland\u0131r\u0131lmayan hi\u00e7bir be\u015feri t\u0131bbi \u00fcr\u00fcn\u00fcn piyasaya sunulamayaca\u011f\u0131 \u015feklinde a\u00e7\u0131k\u00e7a h\u00fck\u00fcm alt\u0131na al\u0131nm\u0131\u015ft\u0131r. Ruhsat ba\u015fvurusunda, ilac\u0131n farmas\u00f6tik a\u00e7\u0131dan etkinli\u011finin ve g\u00fcvenli\u011finin ispat edilmesi gerekmektedir. Bu nedenle ila\u00e7lar klinik \u00f6ncesi a\u015famalar ile klinik a\u015famalar\u0131 olarak nitelendirilen faz 1 \/ faz 2 \/ faz 3 a\u015famalar\u0131n\u0131n tamamlanmas\u0131n\u0131n ard\u0131ndan ruhsat ba\u015fvurusu yapabilmektedir. Veri korumas\u0131n\u0131n konusu klinik \u00f6ncesi ve klinik ara\u015ft\u0131rmalar s\u00fcrecinde elde edilen ve ruhsat i\u00e7in gerekli b\u00fct\u00fcn verileri kapsamaktad\u0131r.[1]<\/a><\/p>\n \u00d6ncelikle \u00f6\u011fretide s\u0131kl\u0131kla birbirine kar\u0131\u015ft\u0131r\u0131lan kavramlar\u0131n a\u00e7\u0131klanmas\u0131 gere\u011fi duyulmaktad\u0131r:<\/p>\n Veri korumas\u0131 (data protection)<\/strong>: Bir t\u0131bbi \u00fcr\u00fcn\u00fcn sahibinin farmakolojik ve toksikolojik test ve deneyleri yap\u0131larak ruhsat\u0131n\u0131 ve sat\u0131\u015f iznini ald\u0131\u011f\u0131 \u00fcr\u00fcne ili\u015fkin yetkili idareye sundu\u011fu gizli verilerin korunmas\u0131d\u0131r.[2]<\/a> Veri korumas\u0131, temeli haks\u0131z rekabet hukukuna dayanan, \u00f6te yandan di\u011fer fikri m\u00fclkiyet haklar\u0131 gibi b\u00fct\u00fcn temel \u00f6zellikleri belirlenmi\u015f bir niteli\u011fe sahip olmayan, farkl\u0131 koruma metotlar\u0131na imk\u00e2n veren \u015femsiye bir koruma modelidir.[3]<\/a> (verilerin if\u015fa edilmemesi)<\/p>\n Veri imtiyaz\u0131\/m\u00fcnhas\u0131riyeti (data exclusivity): <\/strong>K\u0131saca orijinal ila\u00e7 \u00fcreticisinin haz\u0131rlad\u0131\u011f\u0131 test verilerinin belirli bir s\u00fcreyle s\u0131n\u0131rl\u0131 olarak yaln\u0131zca kendisi veya izin verdi\u011fi ki\u015filer taraf\u0131ndan kullan\u0131labilmesi ve bu verilere isnad edilebilmesidir4<\/sup><\/a>[4]<\/a>.<\/p>\n Pazar imtiyaz\u0131\/m\u00fcnhas\u0131riyeti (market exclusivity): <\/strong>Orijinal ila\u00e7 pazardayken jenerik ila\u00e7lar\u0131n piyasaya girmesini, sat\u0131\u015f\u0131n\u0131 engellemektedir.<\/p>\n Bu kapsamda, orijinal (inovat\u00f6r) ila\u00e7 <\/strong>ve jenerik ila\u00e7 <\/strong>terimlerinden de k\u0131saca bahsetmek gerekmektedir. Orijinal ila\u00e7, uzun ara\u015ft\u0131rmalar, laboratuvar ve klinik \u00e7al\u0131\u015fmalar sonucu belli bir hastal\u0131k \u00fczerinde etkinli\u011fi kan\u0131tlanm\u0131\u015f, yeni molek\u00fcl i\u00e7eren daha \u00f6nceden benzeri olmayan ila\u00e7lard\u0131r. Jenerik ila\u00e7 ise orijinal ila\u00e7la ayn\u0131 formda, ayn\u0131 farmas\u00f6tik maddeyi ihtiva eden biyoe\u015fde\u011fer ila\u00e7lar\u0131n genel ad\u0131d\u0131r. Orijinal ila\u00e7 ile ayn\u0131 \u015fekilde etki eder ve ayn\u0131 klinik fayday\u0131 sa\u011flar. Ba\u015fka bir deyi\u015fle, jenerik ila\u00e7 orijinal ilac\u0131n yerine, e\u015fde\u011feri\/ ikamesi olarak kullanabilir.[5]<\/a><\/p>\n K\u0131salt\u0131lm\u0131\u015f ruhsat ba\u015fvurular\u0131 jenerik firmalara \u00e7ok b\u00fcy\u00fck avantaj sa\u011flamaktad\u0131r. Zira jenerik ila\u00e7 firmalar\u0131, k\u0131salt\u0131lm\u0131\u015f ruhsat ba\u015fvurusu sayesinde, uzun y\u0131llar s\u00fcren AR-GE \u00e7al\u0131\u015fmalar\u0131n\u0131, klinik test ve ara\u015ft\u0131rmalar\u0131 yapmaks\u0131z\u0131n, sadece orijinal ila\u00e7 ruhsat dosyas\u0131nda yer alan test ve ara\u015ft\u0131rma sonu\u00e7lar\u0131n\u0131 referans g\u00f6stererek jenerik \u00fcr\u00fcn i\u00e7in ruhsat alabilmektedir.[6]<\/a><\/p>\n Veri korumas\u0131 kavram\u0131, T\u00fcrkiye\u2019nin de taraf oldu\u011fu 1995 TRIPS s\u00f6zle\u015fmesinde yer bulmaktad\u0131r. Anla\u015fman\u0131n amac\u0131; uluslararas\u0131 ticaretteki engelleri ve d\u00fczensizlikleri azaltmak, fikri m\u00fclkiyet haklar\u0131n\u0131n uygulanmas\u0131na ili\u015fkin usul ve \u00f6nlemlerin ticaret i\u00e7in bir engel te\u015fkil etmemesini sa\u011flamakt\u0131r. Bu amaca y\u00f6nelik olarak, fikri m\u00fclkiyet haklar\u0131n\u0131n tan\u0131nmas\u0131, gerekli koruman\u0131n sa\u011flanmas\u0131, \u00fcye \u00fclkelerin ulusal planda ve birbirlerine ait fikri m\u00fclkiyet haklar\u0131n\u0131 korumalar\u0131 ba\u011flam\u0131nda asgari standartlar\u0131n belirlenmesi gibi hususlara anla\u015fma kapsam\u0131nda yer verilmi\u015ftir. TRIPS bir \u00e7er\u00e7eve anla\u015fma olup, \u00fcye \u00fclkeler ulusal mevzuatlar\u0131n\u0131 haz\u0131rlarken kabul edilen asgari standartlara uymak zorundad\u0131r.[7]<\/a> DT\u00d6\u2019n\u00fcn kurucu \u00fcyelerinden olan T\u00fcrkiye, TRIPS Anla\u015fmas\u0131\u2019na DT\u00d6 kurulurken taraf olmu\u015f, geli\u015fmekte olan \u00fclkeler i\u00e7in ge\u00e7i\u015f s\u00fcrecinden de faydalanarak DT\u00d6 kurulduktan 5 y\u0131l sonra 2000 y\u0131l\u0131nda anla\u015fma h\u00fck\u00fcmlerini uygulamaya ba\u015flam\u0131\u015ft\u0131r. DT\u00d6\u2019n\u00fcn kurucu anla\u015fmas\u0131na ek olarak kabul edilen TRIPS, bug\u00fcne kadar fikri m\u00fclkiyet alan\u0131nda uluslararas\u0131 d\u00fczeyde kabul edilen en kapsaml\u0131 anla\u015fma olarak ge\u00e7mektedir. Anla\u015fman\u0131n \u00f6nemi, Paris ve Bern Anla\u015fmalar\u0131na at\u0131fta bulunmakla birlikte, b\u0131rak\u0131lan bo\u015fluklar\u0131 da doldurma i\u015flevi g\u00f6rebilecek nitelikte olmas\u0131 ve kapsam-yapt\u0131r\u0131m a\u00e7\u0131s\u0131ndan daha geni\u015f kabul edilmesidir.8<\/sup><\/a>[8]<\/a> TRIPS Anla\u015fmas\u0131 belirli “esneklikler” i\u00e7ermektedir. Bu esneklikler \u00fclkelerin, ila\u00e7 \u00fcr\u00fcnlerine eri\u015fim veya biyolojik \u00e7e\u015fitlili\u011fin korunmas\u0131 gibi belirli alanlarda veya daha genel olarak ekonomik kalk\u0131nmay\u0131 destekleyen makroekonomik, kurumsal ko\u015fullar\u0131 olu\u015fturmada kendi kamu politikalar\u0131n\u0131 izlemelerini sa\u011flayacak \u015fekilde TRIPS uyumlu normlar\u0131 kullanmalar\u0131na izin vermeyi ama\u00e7lamaktad\u0131r.[9]<\/a><\/p>\n TRIPS 39 (3) h\u00fckm\u00fcne g\u00f6re \u201c\u00dcyeler, bunun yan\u0131 s\u0131ra, kamunun korunmas\u0131 i\u00e7in gerekli olmad\u0131k\u00e7a veya verilerin haks\u0131z ticari kullan\u0131ma <\/strong>kar\u015f\u0131 korunmas\u0131n\u0131 sa\u011flayacak \u00f6nlemler al\u0131nmad\u0131k\u00e7a, bu verileri if\u015fa edilmemeleri i\u00e7in koruyacaklard\u0131r.\u201d Bu kapsamda TRIPS\u2019in ilgili h\u00fckm\u00fcn\u00fcn temelinde haks\u0131z rekabet korumas\u0131n\u0131n yatt\u0131\u011f\u0131n\u0131 s\u00f6ylemek m\u00fcmk\u00fcnd\u00fcr. \u0130lgili h\u00fck\u00fcmde \u00f6ng\u00f6r\u00fclen \u201ca\u00e7\u0131klanmayan verinin korunmas\u0131\u201d y\u00fck\u00fcml\u00fcl\u00fc\u011f\u00fcn\u00fcn temel dayana\u011f\u0131 Paris S\u00f6zle\u015fmesi\u2019nin 10. maddesidir. \u201cA\u00e7\u0131klanmayan veriler\u201d ile kastedilen, pazarlama onay\u0131 almak i\u00e7in sunulmas\u0131 h\u00fck\u00fcmet taraf\u0131ndan zorunlu k\u0131l\u0131nan, h\u00fck\u00fcmete sunulan ve sunu\u015f esnas\u0131nda ve daha sonra da \u201ca\u00e7\u0131klanmayan\u201d verilerdir. Teslim edilen verilerin TRIPS md. 39\/3 kapsam\u0131nda veri korumas\u0131ndan faydalanabilmesi i\u00e7in ila\u00e7 ruhsat ba\u015fvurusunun onaylanmas\u0131 gerekmemektedir. Di\u011fer bir ifadeyle, ruhsat ba\u015fvurusu reddedilen ila\u00e7lar hakk\u0131ndaki test verileri de TRIPS m. 39\/3\u2019e g\u00f6re veri korumas\u0131ndan faydalanabilmektedir. Ba\u015fvurunun kabul \u015fart\u0131na ba\u011flanmamas\u0131 \u00f6\u011fretide isabetli g\u00f6r\u00fclmektedir.[10]<\/a><\/p>\n TRIPS anla\u015fmas\u0131n\u0131n 39. Maddesi, ila\u00e7 ruhsat\u0131 i\u00e7in sa\u011fl\u0131k otoritelerine verilen klinik deney ve test verilerine, di\u011fer ila\u00e7 \u015firketleri taraf\u0131ndan referans verilmesini engelleme zorunlulu\u011fu \u00f6ng\u00f6rmemektedir. Madde metninde hi\u00e7bir \u015fekilde \u201cimtiyaz\u201d ya da \u201cm\u00fcnhas\u0131r hak\u201d s\u00f6zc\u00fckleri ge\u00e7memektedir.[11]<\/a> Veri korumas\u0131na konu a\u00e7\u0131klanmam\u0131\u015f veriler TRIPS\u2019de de \u201cm\u00fclkiyet hakk\u0131\u201d olarak kabul edilmemi\u015ftir.[12]<\/a> TRIPS md. 39\/3\u2019\u00fcn kapsam\u0131n\u0131n veri korumas\u0131 m\u0131 veri imtiyaz\u0131 m\u0131 oldu\u011fu konusunda hen\u00fcz bir yarg\u0131 karar\u0131 bulunmamaktad\u0131r.[13]<\/a> Veri imtiyaz\u0131 TRIPS Madde 39 (3) (ve 39 (2))’de ele al\u0131nan ve herhangi bir zaman s\u0131n\u0131r\u0131 belirtilmeyen \u00fc\u00e7\u00fcnc\u00fc \u015fah\u0131slara if\u015fa etme ya da ticari s\u0131rlarla ilgili de\u011fildir.[14]<\/a> T\u00fcm bunlar dikkate al\u0131nd\u0131\u011f\u0131nda TRIPS m.39 d\u00fczenlemesinin veri korumas\u0131 niteli\u011finde oldu\u011fu kanaati a\u011f\u0131r basmaktad\u0131r. TRIPS anla\u015fmas\u0131nda belirlenen koruma asgari d\u00fczeyde olup, \u00fcye devletler, TRIPS\u2019de kararla\u015ft\u0131r\u0131lan korumadan daha kapsaml\u0131 bir koruma sa\u011flayabilir. Bu kapsamda veri imtiyaz\u0131 ile ilgili uygulamalar TRIPS anla\u015fmas\u0131ndan do\u011fmamakta olup \u00fcye devletlerin kendi uygulamalar\u0131ndan ibarettir. Veri korumas\u0131 ve veri imtiyaz\u0131n\u0131n \u00fclkemizdeki uygulamas\u0131n\u0131 kar\u015f\u0131la\u015ft\u0131rmal\u0131 olarak inceleyebilmek amac\u0131yla AB\u2019de bu kavramlar\u0131n nas\u0131l uygulama alan\u0131 buldu\u011funa de\u011finilmelidir.<\/p>\n AB\u2019de veri imtiyaz\u0131 T\u00fcrkiye\u2019den farkl\u0131 uygulanmaktad\u0131r. AB\u2019de 2004\/27\/EC say\u0131l\u0131 Y\u00f6nergeyle 2001\/83\/ EC say\u0131l\u0131 Y\u00f6nerge ilga edilmi\u015ftir. Yeni Y\u00f6nergede veri imtiyaz\u0131 s\u00fcresi, 8+2(+1) \u015feklinde form\u00fcle edilmi\u015ftir (m. 10)[15]<\/a>. AB\u2019deki veri imtiyaz\u0131 T\u00fcrkiye\u2019den farkl\u0131 uygulanmakta olup koruma s\u00fcresi i\u00e7erisinde k\u0131salt\u0131lm\u0131\u015f ruhsat ba\u015fvurular\u0131n\u0131n yap\u0131lmas\u0131 Avrupa \u0130la\u00e7 Ajans\u0131 (EMA) taraf\u0131ndan kabul edilmemektedir. AB\u2019de belirlenen 8 y\u0131ll\u0131k veri imtiyaz\u0131 s\u00fcresinin tamamlanmas\u0131 ile k\u0131salt\u0131lm\u0131\u015f ba\u015fvurular incelemeye al\u0131nmaktad\u0131r. Di\u011fer bir deyi\u015fle orijinal ilac\u0131n ruhsat tarihini izleyen 8 y\u0131l boyunca jenerik ila\u00e7 \u00fcreticileri orijinal ila\u00e7 i\u00e7in ruhsat ba\u015fvurusunda sunulmu\u015f olan test verilerine at\u0131fta bulunarak k\u0131salt\u0131lm\u0131\u015f ruhsat ba\u015fvurusu yapamaz. Ayr\u0131ca veri imtiyaz\u0131 sonras\u0131 piyasa\/pazar koruma s\u00fcresi olan 2 y\u0131l ve ilaveten 1 y\u0131l pediatrik kullan\u0131m s\u00fcreleri de dolmadan e\u015fde\u011fer ilac\u0131n piyasaya \u00e7\u0131kmas\u0131 m\u00fcmk\u00fcn de\u011fildir. Pazar m\u00fcnhas\u0131riyeti sa\u011flayan ek 2 senelik bu s\u00fcre zarf\u0131nda art\u0131k jenerik ila\u00e7 firmalar\u0131 ruhsat ba\u015fvurusunda bulunabilecek olsa da jenerik ila\u00e7 piyasaya s\u00fcr\u00fclemeyecektir. 1 y\u0131ll\u0131k ek koruma ise orijinal ilac\u0131n yeni bir terap\u00f6tik endikasyonunun olmas\u0131 durumunda s\u00fcrenin uzamas\u0131na ili\u015fkindir.16<\/sup><\/a>[16]<\/a> Bu haliyle veri korumas\u0131n\u0131n veri ve Pazar m\u00fcnhas\u0131riyeti kavramlar\u0131yla i\u00e7 i\u00e7e ge\u00e7mi\u015f \u015fekilde 11 y\u0131la varan s\u00fcreyle uyguland\u0131\u011f\u0131, jenerik ila\u00e7lar\u0131n AB pazar\u0131nda yer alabilmesi i\u00e7in beklemesi gereken s\u00fcrenin 11 y\u0131la varabilece\u011fi y\u00f6n\u00fcndeki d\u00fczenleme ile orijinal ilaca bu s\u00fcrede b\u00fcy\u00fck bir pazar avantaj\u0131 sa\u011fland\u0131\u011f\u0131 g\u00f6r\u00fclmektedir.<\/p>\n T\u00fcrkiye, ila\u00e7lara ili\u015fkin test verilerine koruma sa\u011flama y\u00fck\u00fcml\u00fcl\u00fc\u011f\u00fcn\u00fc TRIPS Anla\u015fmas\u0131 ile kabul etmi\u015ftir. Bu do\u011frultuda 1995 y\u0131l\u0131nda 551 say\u0131l\u0131 m\u00fclga KHK m. 83\/3 ile veri korumas\u0131 d\u00fczenlenmi\u015ftir. Maddenin lafz\u0131 \u201cPatent ba\u015fvurusu yap\u0131lm\u0131\u015f olan be\u015feri, veteriner ve zirai ila\u00e7lar\u0131n imalat ve sat\u0131\u015f ruhsatlar\u0131n\u0131n tasdiki i\u00e7in ilgili makamlarca talep edilen ve yarat\u0131lmalar\u0131 ve birikimleri \u00f6nemli bir gayret ve masraf gerektiren ve sahipleri taraf\u0131ndan umuma a\u00e7\u0131klanmam\u0131\u015f olan bilgi ve test sonu\u00e7lar\u0131 talep sahibi makam taraf\u0131ndan gizli tutulur. Bilgi ve test sonu\u00e7lar\u0131n\u0131 talep eden makam bunlar\u0131n haks\u0131z kullan\u0131m\u0131n\u0131n \u00f6nlenmesi i\u00e7in gerekli tedbirleri al\u0131r.\u201d <\/em>\u015feklindedir.[17]<\/a> Bu h\u00fck\u00fcmde veri sahibine bir imtiyaz ve imtiyaz s\u00fcresi tan\u0131nmamakta olup veri korumas\u0131 niteli\u011findedir. M\u00fclga KHK m. 83\/3\u2019\u00fcn lafz\u0131na g\u00f6re, veri korumas\u0131 patent ba\u015fvurusu yap\u0131lm\u0131\u015f ila\u00e7larla s\u0131n\u0131rl\u0131 tutulmaktad\u0131r. Oysa TRIPS Anla\u015fmas\u0131 m. 39\u2019da test verilerinin korunmas\u0131 i\u00e7in patent ba\u015fvurusu yap\u0131lmas\u0131 aranmamaktad\u0131r.[18]<\/a><\/p>\n Ayr\u0131ca, m\u00fclga T\u0131bbi Farmas\u00f6tik \u00dcr\u00fcnler Ruhsatland\u0131rma Y\u00f6netmeli\u011fi m. 9\u2019a g\u00f6re, jenerik ila\u00e7lar a\u00e7\u0131s\u0131ndan k\u0131salt\u0131lm\u0131\u015f ruhsat ba\u015fvurusu yap\u0131lmas\u0131na izin verilmekteydi[19]<\/a>. S\u00f6z konusu Y\u00f6netmelik m. 36\u2019da da veri korumas\u0131na ili\u015fkin bir h\u00fck\u00fcm bulunmaktayd\u0131. Bu durum dikkate al\u0131nd\u0131\u011f\u0131nda, m\u00fclga mevzuatta k\u0131salt\u0131lm\u0131\u015f ruhsat ba\u015fvurusunda bulunman\u0131n veri korumas\u0131na ayk\u0131r\u0131l\u0131k olu\u015fturmayaca\u011f\u0131n\u0131n benimsendi\u011fi s\u00f6ylenebilir.<\/p>\n 551 say\u0131l\u0131 KHK 6769 say\u0131l\u0131 SMK ile; T\u0131bbi Farmas\u00f6tik \u00dcr\u00fcnler Ruhsatland\u0131rma Y\u00f6netmeli\u011fi ise Be\u015feri T\u0131bbi \u00dcr\u00fcnler Ruhsatland\u0131rma Y\u00f6netmeli\u011fi ile y\u00fcr\u00fcrl\u00fckten kald\u0131r\u0131lm\u0131\u015ft\u0131r. SMK\u2019da gerek veri imtiyaz\u0131 gerekse veri korumas\u0131 hakk\u0131nda bir d\u00fczenleme bulunmamaktad\u0131r. Be\u015feri T\u0131bbi \u00dcr\u00fcnler Ruhsatland\u0131rma Y\u00f6netmeli\u011finde ise veri korumas\u0131 ve veri imtiyaz\u0131 d\u00fczenlenmektedir. Be\u015feri ve T\u0131bbi \u00dcr\u00fcnler Ruhsatland\u0131rma Y\u00f6netmeli\u011fi m.40 uyar\u0131nca bir be\u015feri t\u0131bbi \u00fcr\u00fcne ruhsat almak \u00fczere ba\u015fvuru sahibi taraf\u0131ndan Kuruma sunulan bilgiler gizlidir. Bu gizlilik Kurum taraf\u0131ndan korunur. T\u00fcrkiye\u2019nin test verilerine veri imtiyaz\u0131 tan\u0131mas\u0131 ise, AB ile m\u00fczakere s\u00fcrecinin bir sonucudur. T\u00fcrkiye, AB ile yap\u0131lan G\u00fcmr\u00fck Birli\u011fi Anla\u015fmas\u0131\u2019nda AB ile ticari y\u00f6nden uyumla\u015fmak i\u00e7in gerekli yasal d\u00fczenlemelerin yap\u0131lmas\u0131n\u0131 taahh\u00fct etmi\u015ftir. 2\/97 say\u0131l\u0131 Ortakl\u0131k Konseyi Karar\u0131nda belirtilen uyumla\u015ft\u0131r\u0131lmas\u0131 gerekli bir husus da ila\u00e7lara ili\u015fkin test verilerinin korunma \u015fekli olmu\u015ftur. Bu do\u011frultuda, Be\u015feri T\u0131bbi \u00dcr\u00fcnler Ruhsatland\u0131rma Y\u00f6netmeli\u011fi m. 9\u2019da veri imtiyaz\u0131na ili\u015fkin d\u00fczenlemeler \u00f6ng\u00f6r\u00fclm\u00fc\u015ft\u00fcr. Veri imtiyaz\u0131 orijinal ila\u00e7 firmas\u0131n\u0131n ruhsat ba\u015fvurusunda bulundu\u011fu \u00fclkeler y\u00f6n\u00fcnden s\u0131n\u0131rland\u0131r\u0131lmaktad\u0131r. Y\u00f6netmelik m. 9\/1-(a\/3)\u2019e g\u00f6re, 6 y\u0131ll\u0131k veri imtiyaz\u0131 korumas\u0131 d\u00fczenlenmi\u015f olup bu koruma yaln\u0131zca G\u00fcmr\u00fck Birli\u011fi Anla\u015fmas\u0131\u2019na taraf olan \u00fclkelerden birinde ruhsatland\u0131r\u0131lm\u0131\u015f\/ruhsatland\u0131r\u0131lacak \u00fcr\u00fcnler a\u00e7\u0131s\u0131ndan ge\u00e7erlidir. Buna g\u00f6re, 01.01.2001 tarihinden itibaren G\u00fcmr\u00fck Birli\u011fine taraf olan \u00fclkelerden birinde ruhsat al\u0131nmas\u0131 halinde, ruhsat konusu \u201corijinal \u00fcr\u00fcn\u201d i\u00e7in veri imtiyaz\u0131 tan\u0131nabilmektedir[20]<\/a>.<\/p>\n \u00a0<\/sup>Y\u00f6netmelik m. 9\/1-(a\/3)\u2019e g\u00f6re, k\u0131salt\u0131lm\u0131\u015f ruhsat ba\u015fvurusunda bulunmak i\u00e7in orijinal ilaca tan\u0131nan 6 y\u0131ll\u0131k veri imtiyaz\u0131 s\u00fcresinin dolmas\u0131 gerekti\u011fi d\u00fczenlense de, uygulamada veri imtiyaz\u0131 s\u00fcresi i\u00e7inde k\u0131salt\u0131lm\u0131\u015f ruhsat ba\u015fvurusu s\u00f6z konusu oldu\u011funda yetkili kurumun, ba\u015fvuruyu usulden reddetmedi\u011fi, imtiyaz s\u00fcresi sona erdikten sonra ba\u015fvuru hakk\u0131nda karar verdi\u011fi ifade edilmektedir[21]<\/a>. Yarg\u0131tay uygulamas\u0131 ise, k\u0131salt\u0131lm\u0131\u015f ruhsat ba\u015fvurusunda bulunman\u0131n veri imtiyaz\u0131n\u0131 ihlal etmedi\u011fi y\u00f6n\u00fcndedir[22]<\/a>. Yarg\u0131tay\u2019a g\u00f6re, ruhsat ba\u015fvurusunda bulunmak ki\u015filere tan\u0131nan yasal bir hakt\u0131r ve tek ba\u015f\u0131na ba\u015fvuru i\u015flemi haks\u0131z rekabet olu\u015fturmamaktad\u0131r[23]<\/a>. Ba\u015fvuru i\u015fleminin yetkili kurum taraf\u0131ndan kabul edilece\u011fi kesin de\u011fildir. Bu nedenle, yetkili kurumun verece\u011fi karara g\u00f6re ger\u00e7ekle\u015fmesi muhtemel bir zarar i\u00e7in, bu zarar ger\u00e7ekle\u015fmeden dava a\u00e7\u0131lamayaca\u011f\u0131 kabul edilmektedir[24]<\/a>. Bu do\u011frultuda, T\u00fcrkiye\u2019de her ne kadar veri korumas\u0131 kapsam\u0131nda veri imtiyaz\u0131 kavram\u0131na y\u00f6nelik d\u00fczenleme yap\u0131ld\u0131\u011f\u0131 g\u00f6r\u00fclse de uygulamada imtiyaz s\u00fcresinde jenerik ilac\u0131n ba\u015fvuru yap\u0131labildi\u011finin g\u00f6r\u00fclmesi kafa kar\u0131\u015f\u0131kl\u0131\u011f\u0131na sebebiyet verdi\u011fi gibi, veri imtiyaz\u0131n\u0131n pazar imtiyaz\u0131na yak\u0131n bir etki do\u011furmas\u0131na sebep olmaktad\u0131r.<\/p>\n Son olarak patent ve veri imtiyaz\u0131 aras\u0131ndaki ili\u015fkiye de\u011finilerek patent hakk\u0131 kapsam\u0131ndaki uygulamalar\u0131n veri imtiyaz\u0131na etkisi de\u011ferlendirilecektir. Patent hakk\u0131n\u0131n korunmas\u0131 i\u00e7in hak sahibinin talepte bulunmas\u0131 gerekirken, veri imtiyaz\u0131 korumas\u0131n\u0131n sa\u011flanmas\u0131 TRIPS (3) uyar\u0131nca resmi kurumlara, devlete y\u00fcklenen bir y\u00fck\u00fcml\u00fcl\u00fckt\u00fcr.[25]<\/a> Yeni bir molek\u00fcl\u00fcn ya da ila\u00e7 bile\u015fiminin patent konusu olabilmesi i\u00e7in patentlenebilirlik kriterlerini kar\u015f\u0131lamas\u0131 gerekmektedir. Bu kriterler, yenilik, tekni\u011fin bilinen durumunun a\u015f\u0131lmas\u0131 ve sanayiye uygulanabilirliktir. Veri imtiyaz\u0131 ile sa\u011flanan daha k\u0131sa s\u00fcreli korumadan yararlanmas\u0131 i\u00e7in ise molek\u00fcl\u00fcn yeni bir kimyasal madde olmas\u0131 yeterli g\u00f6r\u00fclm\u00fc\u015ft\u00fcr.[26]<\/a> Patent korumas\u0131 bulu\u015fun a\u00e7\u0131klanmas\u0131 kar\u015f\u0131l\u0131\u011f\u0131nda tan\u0131nmaktayken, veri imtiyaz\u0131n\u0131n konusu olan bilgiler alenile\u015ftirilmemektedir[27]<\/a>. Veri imtiyaz\u0131 ile patent korumas\u0131 birbirinden ba\u011f\u0131ms\u0131z kavramlar olsa da veri korumas\u0131, patent korumas\u0131 ile bir anlamda s\u0131n\u0131rland\u0131r\u0131lmaktad\u0131r.<\/p>\n \u00d6ncelikle belirtilmelidir ki veri imtiyaz\u0131na konu ilac\u0131n etken maddesi patent ile koruma alt\u0131ndaysa, ilgili ila\u00e7 verileri i\u00e7in tan\u0131nan 6 y\u0131ll\u0131k veri imtiyaz s\u00fcresi patent koruma s\u00fcresi ile s\u0131n\u0131rl\u0131 olacakt\u0131r[28]<\/a>. Yukar\u0131da belirtildi\u011fi gibi, orijinal ilac\u0131n veri imtiyaz s\u00fcreleri G\u00fcmr\u00fck Birli\u011findeki ruhsat tarihinden ba\u015flamakta oldu\u011fundan, ilac\u0131n veri imtiyaz\u0131 s\u00fcresi tamamen dolmu\u015f oldu\u011fu evrede T\u00fcrkiye\u2019ye gelmi\u015f olmas\u0131 dahi m\u00fcmk\u00fcn olup T\u00fcrkiye\u2019de ayr\u0131ca bir veri imtiyaz\u0131 s\u00fcresinden faydalanamayacakt\u0131r. Benzer \u015fekilde, Yenilik kriterini kaybetme endi\u015fesiyle patentlenmi\u015f molek\u00fcle dayanarak, \u00f6rne\u011fin 18 y\u0131l sonra ruhsat ba\u015fvurusunda bulunuldu\u011funda T\u00fcrkiye\u2019de de veri imtiyaz\u0131 s\u00fcresi olan 6 y\u0131l ancak patent s\u00fcresinin sonuna kadar uygulanabilece\u011finden, yaln\u0131zca 20 y\u0131la tamamlayacak \u015fekilde 2 y\u0131l olarak uygulanabilecektir.<\/p>\n Bir di\u011fer s\u0131n\u0131rlama SMK m.85\/3. f\u0131kras\u0131n\u0131n (c) bendinde yer alan \u201c\u0130la\u00e7lar\u0131n ruhsatland\u0131r\u0131lmas\u0131 ve bunun i\u00e7in gerekli test ve deneyler de d\u00e2hil olmak \u00fczere, patent konusu bulu\u015fu i\u00e7eren deneme ama\u00e7l\u0131 fiiller\u201d olup SMK\u2019da bu fiillerin patent korumas\u0131 kapsam\u0131nda kalmayaca\u011f\u0131 belirtilmi\u015ftir. Bolar istisnas\u0131 olarak bilinen bu kapsamda ila\u00e7 \u00fcreticisinin \u00fcr\u00fcn\u00fcne ruhsat ve sat\u0131\u015f izni al\u0131ncaya kadar ger\u00e7ekle\u015ftirdi\u011fi faaliyetleri patent tecav\u00fcz\u00fc fiilini olu\u015fturmayacakt\u0131r.[29]<\/a> Bolar istisnas\u0131na g\u00f6re, patent s\u00fcresi dolmadan jenerik firmaya, biyoe\u015fde\u011ferlilik \u00e7al\u0131\u015fmas\u0131 ve ruhsatland\u0131rma ba\u015fvurusu yapma imk\u00e2n\u0131 verilmektedir. Bu y\u00f6ntemle jenerik ila\u00e7, patent s\u00fcresi doldu\u011fu g\u00fcn piyasaya \u00e7\u0131kabilecektir. Gerek T\u00fcrkiye\u2019deki ila\u00e7lar\u0131n ruhsatland\u0131rma otoritesi (T\u0130TCK) gerek T\u00fcrk yarg\u0131s\u0131, jenerik ila\u00e7 k\u0131salt\u0131lm\u0131\u015f ruhsat ba\u015fvurusu yap\u0131lmas\u0131n\u0131 ve hatta ruhsat verilmesini, patent ihlali olarak kabul etmemektedir.[30]<\/a> Bu kapsamda, ila\u00e7 patentleri i\u00e7in halihaz\u0131rda kabul edilen \u201cBolar istisnas\u0131n\u0131n\u201d T\u00fcrkiye\u2019de geni\u015f bir \u015fekilde yorumlanarak \u201ck\u0131salt\u0131lm\u0131\u015f ruhsat ba\u015fvurusu kapsam\u0131nda kalan i\u015flemler\u201d i\u00e7in veri imtiyaz\u0131n\u0131n uygulama alan\u0131n\u0131 k\u0131s\u0131tlad\u0131\u011f\u0131 g\u00f6r\u00fclmektedir.<\/p>\n \u0130stanbul B\u00f6lge Adliye Mahkemesi 16. Hukuk Dairesi\u2019nce verilen 28.06.2017 tarihli ve 2017\/2538 E. ve 2017\/2224K.56 say\u0131l\u0131 kararda[31]<\/a> yer alan az\u0131nl\u0131k g\u00f6r\u00fc\u015f\u00fc, Bolar istisnas\u0131n\u0131n veri imtiyaz\u0131 i\u00e7in de uygulama alan\u0131 bulmas\u0131 gerekti\u011fini desteklemektedir.[32]<\/a> \u0130lgili karar, veri imtiyaz s\u00fcresi devam eden bir ila\u00e7 dosyas\u0131 referans g\u00f6sterilmek suretiyle yap\u0131lan k\u0131salt\u0131lm\u0131\u015f ruhsat ba\u015fvurusuna ili\u015fkin olarak a\u00e7\u0131lan hukuk davas\u0131nda, veri imtiyaz hakk\u0131 sahibi davac\u0131n\u0131n, daval\u0131ya ait k\u0131salt\u0131lm\u0131\u015f ruhsat ba\u015fvurusuna ili\u015fkin i\u015flemlerin durdurulmas\u0131na dair tedbir taleplerinin reddine ili\u015fkin Yerel Mahkeme karar\u0131na kar\u015f\u0131 yap\u0131lan istinaf ba\u015fvurusu \u00fczerine tanzim edilmi\u015ftir. \u0130lgili kararda istinaf ba\u015fvurusu reddedilmi\u015f olup, karar tanzim edildi\u011fi s\u0131rada, davaya dayanak veri imtiyaz hakk\u0131 s\u00fcresi sona erdi\u011fi i\u00e7in ret karar\u0131n\u0131n gerek\u00e7esi oy \u00e7oklu\u011fu ile \u201cistinaf a\u015famas\u0131nda veri koruma s\u00fcresinin doldu\u011fu anla\u015f\u0131ld\u0131\u011f\u0131ndan tedbir ko\u015fullar\u0131n\u0131n ortadan kalkm\u0131\u015f olmas\u0131\u201d olarak belirtilmi\u015ftir.[33]<\/a> Ancak kararda yer alan az\u0131nl\u0131k g\u00f6r\u00fc\u015f\u00fcnde ayr\u0131ca; \u201cK\u0131salt\u0131lm\u0131\u015f ruhsat ba\u015fvurusunun yap\u0131ld\u0131\u011f\u0131 tarih itibar\u0131yla, 6 y\u0131ll\u0131k veri imtiyaz\u0131 s\u00fcresinin dolmas\u0131na k\u0131sa bir s\u00fcrenin kalm\u0131\u015f olu\u015fu nedeniyle, ruhsat ba\u015fvurusu ile ruhsat ba\u015fvurusuna ili\u015fkin Sa\u011fl\u0131k Bakanl\u0131\u011f\u0131 inceleme s\u00fcresi g\u00f6z \u00f6n\u00fcne al\u0131nd\u0131\u011f\u0131nda, 6 y\u0131ll\u0131k s\u00fcrenin fiilen uzayaca\u011f\u0131 hususlar\u0131 bir arada de\u011ferlendirildi\u011finde dahi ihtiyati tedbir ko\u015fullar\u0131n\u0131n mevcut olmad\u0131\u011f\u0131\u201d belirtilmi\u015f ve Yerel Mahkemece verilen ret karar\u0131n\u0131n yerinde oldu\u011funa h\u00fckmedilmi\u015ftir.[34]<\/a><\/p>\n Benzer \u015fekilde, Yarg\u0131tay 11. H.D.\u2019nin 2015\/6706E. 2016\/4935K. say\u0131l\u0131 ve 02.05.2016 tarihli karar\u0131 ve sair yerle\u015fik i\u00e7tihatlar\u0131nda, jenerik ila\u00e7 firmas\u0131n\u0131n, imtiyaz s\u00fcresi i\u00e7erisinde ve referans ila\u00e7 firmas\u0131ndan izin almadan yapm\u0131\u015f oldu\u011fu k\u0131salt\u0131lm\u0131\u015f ruhsat ba\u015fvurusu \u201cT.C. Anayasas\u0131n\u0131n Sa\u011fl\u0131k Hakk\u0131na ili\u015fkin 56 ve dolay\u0131s\u0131yla Ya\u015fam Hakk\u0131na ili\u015fkin 17. maddelerinin devlete y\u00fckledi\u011fi \u00f6devlere paralel olarak ger\u00e7ekle\u015ftirilen yasal d\u00fczenlemeler den kaynaklanan ba\u015fvuru hakk\u0131n\u0131n kullan\u0131lmas\u0131d\u0131r\u201d olarak tan\u0131mlanm\u0131\u015ft\u0131r[35]<\/a>.<\/p>\n Bu halde, Bolar istisnas\u0131n\u0131n geni\u015f \u00f6l\u00e7ekte uygulanarak veri imtiyaz\u0131n\u0131 etki alan\u0131na ald\u0131\u011f\u0131, veri imtiyaz\u0131na ili\u015fkin yarg\u0131 kararlar\u0131 ve idari uygulamalar ile kanuni d\u00fczenlemenin uygulamada ayr\u0131\u015ft\u0131\u011f\u0131 g\u00f6r\u00fclmektedir. Bu noktada, patent korumas\u0131n\u0131n d\u0131\u015f\u0131nda b\u0131rak\u0131lan Bolar istisnas\u0131 kapsam\u0131nda jenerik firmaya ruhsat verilmese de ruhsat ba\u015fvurusunda bulunulmas\u0131na fiili bir engel olmad\u0131\u011f\u0131 g\u00f6r\u00fclmektedir.<\/p>\n Veri imtiyaz\u0131ndan kaynaklanabilecek uyu\u015fmazl\u0131klarda hangi mahkemelerin g\u00f6revli oldu\u011fu hususunun da de\u011ferlendirilmesi gerekli g\u00f6r\u00fclm\u00fc\u015ft\u00fc. Bu hususta \u00f6\u011fretide farkl\u0131 g\u00f6r\u00fc\u015fler bulunmaktad\u0131r. Veri imtiyaz\u0131n\u0131 fikri m\u00fclkiyet hakk\u0131 olarak nitelendiren ve FSHHM\u2019lerinin g\u00f6revli olmas\u0131 y\u00f6n\u00fcnde yasal bir d\u00fczenleme yap\u0131lmas\u0131 gerekti\u011fi y\u00f6n\u00fcnde g\u00f6r\u00fc\u015f[36]<\/a> mevcuttur. Aksi y\u00f6nde, 551 say\u0131l\u0131 KHK\u2019n\u0131n 83. maddesinde verilere ili\u015fkin madde bulundu\u011fundan KHK\u2019n\u0131n ihtisas mahkemelerine ili\u015fkin d\u00fczenlemesi gere\u011fi Fikri S\u0131nai Haklar Mahkemelerinde g\u00f6r\u00fclen bu davalar 6769 say\u0131l\u0131 Kanun\u2019a bu maddenin ta\u015f\u0131nmamas\u0131 nedeniyle konunun ihtisas mahkemeleri ile ilgisi kalmad\u0131\u011f\u0131n\u0131, t\u00fcm\u00fcyle Ticaret mahkemelerini ilgilendiren dava \u00e7e\u015fidi haline geldi\u011fine y\u00f6nelik g\u00f6r\u00fc\u015f[37]<\/a> bulunmakta olup uygulaman\u0131n da bu y\u00f6nde oldu\u011fu g\u00f6r\u00fclmektedir.<\/p>\n \u00a0<\/strong>[1]<\/a> Andanda, s. 145; Correa, Carlos M.: Trade Related Aspects of Intellectual Property Rights A Commentary on the TRIPS Agreement, Oxford Unversity Press, Oxford, 2007, s. 375. naklen Hakan KO\u00c7AK, \u201c<\/em>\u0130la\u00e7larda Test Verilerinin Korunmas\u0131 ve Veri \u0130mtiyaz\u0131\u201d Yarg\u0131tay Dergisi <\/em>47\/2 (Nisan 2021): 602.<\/p>\n [2]<\/a> Canan K\u00dc\u00c7\u00dcKAL\u0130, \u201c\u0130la\u00e7 Ruhsatland\u0131r\u0131lmas\u0131 A\u015famas\u0131nda Veri Koruma S\u00fcresinin 6769 Say\u0131l\u0131 SMK\u2019n\u0131n 85. Maddesi Kapsam\u0131nda De\u011ferlendirilmesi\u201d \u0130stanbul K\u00fclt\u00fcr \u00dcniversitesi Hukuk Fak\u00fcltesi Dergisi <\/em>18\/1 (Ocak 2019): 157.<\/p>\n [3]<\/a> KO\u00c7AK, \u201c\u0130la\u00e7larda Test Verilerinin Korunmas\u0131 ve Veri \u0130mtiyaz\u0131\u201d,603<\/p>\n [4]<\/a> Huysal, s. 34, 36; Kaya, Bar\u0131\u015f: \u201cS\u0131nai M\u00fclkiyet Kanunu Madde 85\/3 H\u00fckm\u00fc Kapsam\u0131nda Bolar \u0130stisnas\u0131n\u0131n Uygulanmas\u0131\u201d, (\u0130stanbul Hukuk Mecmuas\u0131, 76(2), 2019, s. 430) naklen<\/em>, KO\u00c7AK,\u201c\u0130la\u00e7larda Test Verilerinin Korunmas\u0131 ve Veri \u0130mtiyaz\u0131\u201d,603<\/p>\n [5]<\/a> https:\/\/www.fda.gov\/drugs\/frequently-asked-questions-popular-topics\/generic-drugs-questions-answers<\/a><\/p>\n [6]<\/a> Yasemin AKTA\u015e DA\u011e, \u201cVeri \u0130mtiyaz\u0131 Korumas\u0131 Ve Bolar \u0130stisnas\u0131n\u0131n Bu Koruma \u00dczerindeki Etkisi\u201d, Legal Fikri ve <\/em><\/p>\n S\u0131nai Haklar Dergisi <\/em>49\/13 (2017): 38<\/p>\n [7]<\/a> K\u00fclt\u00fcr ve Turizm Bakanl\u0131\u011f\u0131, Ticaretle Ba\u011flant\u0131l\u0131 Fikri M\u00fclkiyet Anla\u015fmas\u0131 (TRIPS)<\/em><\/p>\n https:\/\/telifhaklari.ktb.gov.tr\/TR-332365\/ticaretle-baglantili-fikri-mulkiyet-anlasmasi-trips.html<\/a><\/p>\n [8]<\/a> K\u00fclt\u00fcr ve Turizm Bakanl\u0131\u011f\u0131, Ticaretle Ba\u011flant\u0131l\u0131 Fikri M\u00fclkiyet Anla\u015fmas\u0131 (TRIPS)<\/em><\/p>\n [9]<\/a> Advice on Flexibilities under the TRIPS Agreement https:\/\/www.wipo.int\/ipdevelopment\/en\/policy_legislative_assistance\/advice_trips.html<\/a><\/p>\n [10]<\/a> 10<\/sup> KO\u00c7AK s.612<\/p>\n [11]<\/a> U\u011fur \u00c7OLAK, Fikri M\u00fclkiyet Y\u0131ll\u0131\u011f\u0131, 2009, K\u0131salt\u0131lm\u0131\u015f Ruhsat Ba\u015fvurusundan Kaynaklanan Hukuki Uyu\u015fmazl\u0131klar ve Veri \u0130mtiyaz\u0131 Uygulamas\u0131, s. 245 naklen AKTA\u015e, \u201cVeri \u0130mtiyaz\u0131 Korumas\u0131 Ve Bolar \u0130stisnas\u0131n\u0131n Bu Koruma<\/p>\n \u00dczerindeki Etkisi\u201d s.52<\/p>\n [12]<\/a> Carlos M. CORRERA, Protecting Test Data for Pharmaceutical and Agrochemical Products Under Free Trade Agreements, s.44 naklen AKTA\u015e, s.52<\/p>\n [13]<\/a> KO\u00c7AK s.610<\/p>\n [14]<\/a> Charles CLIFT, Data Protection and Data Exclusivity in Pharmaceutical and Agro chemicals Handbook of Best Practices s.433 naklen AKTA\u015e, s.49<\/p>\n [15]<\/a> Cahit SULUK, \u201cT\u00fcrkiye\u2019de \u0130lac\u0131n Patent Ser\u00fcveni ve T\u00fcrk \u0130la\u00e7 Sekt\u00f6r\u00fcne Etkileri\u201d,(2025) TFM, 11\/1, s.208.<\/p>\n [16]<\/a> \u00d6zge At\u0131lgan KARAKULAK- Fatma Sevde TAN, \u201cAB \u0130la\u00e7 Paketi \u2013 AB \u0130la\u00e7 Mevzuat\u0131 Reformu ve T\u00fcrkiye\u2019ye Etkileri\u201d 03 Haziran 2024<\/p>\n https:\/\/gun.av.tr\/tr\/goruslerimiz\/guncel-yazilar\/ab-ilac-paketi-ab-ilac-mevzuati-reformu-ve-tu-rkiye-ye-etkileri<\/a><\/p>\n <\/p>\n [17]<\/a> KO\u00c7AK s.626<\/p>\n [18]<\/a> KOCAK s. 627<\/p>\n [19]<\/a> KO\u00c7AK s.627<\/p>\n [20]<\/a> KO\u00c7AK s.630<\/p>\n [21]<\/a> Akta\u015f Da\u011f, s. 72; D\u00fc\u011fer, s. 648. Kanada\u2019da benzer y\u00f6nde bir uygulaman\u0131n oldu\u011fu y\u00f6n\u00fcnde ayr\u0131ca bkz. Correa, Protection of Data, s. 37-39. naklen KO\u00c7AK s.631<\/p>\n [22]<\/a> Yar. 11. HD. E. 2007\/3574, K.2008\/11727, T. 23.10.2008; Yar. 11. HD. E. 2007\/6521, K. 2009\/4003, T. 02.04.2009. Ayr\u0131ca bkz. Suluk, s. 733; Akta\u015f Da\u011f, s. 73. KO\u00c7AK s.631<\/p>\n [23]<\/a> \u0130stanbul BAM 16. HD. E. 2017\/6327, K. 2019\/1228, T. 29.05.2019; Yar. 11. HD. E. 2007\/6358, K. 2009\/11166, T.03.02.2009; Yar. 11. HD. E. 2007\/6521, K. 2009\/4003, T. 02.04.2009; Yar. 11. HD. E. 2015\/6706, K. 2016\/4935, T.02.05.2016.<\/p>\n [24]<\/a> Yar. HGK, E. 2008\/5-427, K. 2008\/440, T. 18.06.2008; Yar. HGK, E. 2007\/14 83, K. 142, T. 14.3.2007.<\/p>\n [25]<\/a> AKTA\u015e s.51<\/p>\n [26]<\/a> AKTA\u015e s.50<\/p>\n [27]<\/a> Shaikh, s. 11. Naklen KO\u00c7AK s. 629<\/p>\n [28]<\/a> AKTA\u015e s.71<\/p>\n [29]<\/a> K\u00dc\u00c7\u00dcKAL\u0130 s.156<\/p>\n [30]<\/a> AKTA\u015e s.57<\/p>\n [31]<\/a> Karar yay\u0131nlanmam\u0131\u015ft\u0131r, naklen AKTA\u015e s.59<\/p>\n [32]<\/a> AKTA\u015e s.59<\/p>\n [33]<\/a> AKTA\u015e s.59<\/p>\n [34]<\/a> AKTA\u015e s.59<\/p>\n [35]<\/a> AKTA\u015e s.73<\/p>\n [36]<\/a> KO\u00c7AK s.633<\/p>\n [37]<\/a> K\u00dc\u00c7\u00dcKAL\u0130 s.173<\/p>","protected":false},"excerpt":{"rendered":" \u0130LA\u00c7LARDA VER\u0130 KORUMASI VE VER\u0130 \u0130MT\u0130YAZININ T\u00dcRK\u0130YE\u2019DEK\u0130 UYGULAMASI \u00a0\u0130la\u00e7lar\u0131n piyasaya s\u00fcr\u00fclebilmesi i\u00e7in ruhsat almas\u0131 zorunludur. Bu husus, Be\u015feri ve T\u0131bbi \u00dcr\u00fcnler Ruhsatland\u0131rma Y\u00f6netmeli\u011fi m. 5\/1\u2019de T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu taraf\u0131ndan ruhsatland\u0131r\u0131lmayan hi\u00e7bir be\u015feri t\u0131bbi \u00fcr\u00fcn\u00fcn piyasaya sunulamayaca\u011f\u0131 \u015feklinde a\u00e7\u0131k\u00e7a h\u00fck\u00fcm alt\u0131na al\u0131nm\u0131\u015ft\u0131r. Ruhsat ba\u015fvurusunda, ilac\u0131n farmas\u00f6tik a\u00e7\u0131dan etkinli\u011finin ve g\u00fcvenli\u011finin ispat edilmesi gerekmektedir. … Continue reading \u0130LA\u00c7LARDA VER\u0130 KORUMASI VE VER\u0130 \u0130MT\u0130YAZININ T\u00dcRK\u0130YE\u2019DEK\u0130 UYGULAMASI<\/span><\/a><\/p>","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[],"class_list":["post-1155","post","type-post","status-publish","format-standard","hentry","category-blog"],"_links":{"self":[{"href":"https:\/\/www.eyubogluas.com.tr\/en\/wp-json\/wp\/v2\/posts\/1155","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.eyubogluas.com.tr\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.eyubogluas.com.tr\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.eyubogluas.com.tr\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.eyubogluas.com.tr\/en\/wp-json\/wp\/v2\/comments?post=1155"}],"version-history":[{"count":1,"href":"https:\/\/www.eyubogluas.com.tr\/en\/wp-json\/wp\/v2\/posts\/1155\/revisions"}],"predecessor-version":[{"id":1156,"href":"https:\/\/www.eyubogluas.com.tr\/en\/wp-json\/wp\/v2\/posts\/1155\/revisions\/1156"}],"wp:attachment":[{"href":"https:\/\/www.eyubogluas.com.tr\/en\/wp-json\/wp\/v2\/media?parent=1155"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.eyubogluas.com.tr\/en\/wp-json\/wp\/v2\/categories?post=1155"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.eyubogluas.com.tr\/en\/wp-json\/wp\/v2\/tags?post=1155"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Stj. 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