{"id":14710,"date":"2019-07-26T08:15:39","date_gmt":"2019-07-26T08:15:39","guid":{"rendered":"http:\/\/upt.esin.av.tr\/2019\/07\/26\/titck-ilac-denetim-faaliyetlerine-iliskin-karsilikli-tanima-kilavuzunu-yayimladi\/"},"modified":"2022-06-09T12:33:23","modified_gmt":"2022-06-09T12:33:23","slug":"titck-ilac-denetim-faaliyetlerine-iliskin-karsilikli-tanima-kilavuzunu-yayimladi","status":"publish","type":"post","link":"https:\/\/www.esin.av.tr\/tr\/2019\/07\/26\/titck-ilac-denetim-faaliyetlerine-iliskin-karsilikli-tanima-kilavuzunu-yayimladi\/","title":{"rendered":"T\u0130TCK \u0130la\u00e7 Denetim Faaliyetlerine \u0130li\u015fkin Kar\u015f\u0131l\u0131kl\u0131 Tan\u0131ma K\u0131lavuzu’nu Yay\u0131mlad\u0131"},"content":{"rendered":"

Yeni Geli\u015fmeler<\/strong><\/p>\n

T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (“T\u0130TCK<\/strong>“) 9 Temmuz 2019 tarihinde \u0130la\u00e7 Denetim Faaliyetlerine \u0130li\u015fkin Kar\u015f\u0131l\u0131kl\u0131 Tan\u0131ma K\u0131lavuzu’nu (“K\u0131lavuz”<\/strong>) yay\u0131mlad\u0131. K\u0131lavuz, \u00fclke sa\u011fl\u0131k otoritelerinin \u0130yi \u0130malat Uygulamalar\u0131 (GMP) denetimleri konusunda T\u0130TCK ile kar\u015f\u0131l\u0131kl\u0131 tan\u0131ma talep etmesi halinde uygulanacak usul ve esaslar\u0131 belirlemek i\u00e7in haz\u0131rland\u0131.<\/p>\n

Ne De\u011fi\u015fecek?<\/strong><\/p>\n

K\u0131lavuz uyar\u0131nca, a\u015fa\u011f\u0131daki firma veya \u00fcretim tesislerinin bulundu\u011fu \u00fclkelerin denetleyici\/d\u00fczenleyici sa\u011fl\u0131k otoriteleri, T\u0130TCK’ya kar\u015f\u0131l\u0131kl\u0131 tan\u0131ma talebinde bulunabilecek: (i) be\u015feri t\u0131bbi \u00fcr\u00fcn ve bunlar\u0131n etkin maddelerinin \u00fcretimini yapmak \u00fczere T\u0130TCK’dan faaliyet izni alan \u00fcretim tesislerinin bulundu\u011fu \u00fclkelerin denetleyici\/d\u00fczenleyici sa\u011fl\u0131k otoriteleri ve (ii) T\u00fcrkiye’de ruhsatl\u0131 ilac\u0131 bulunan veya T\u00fcrkiye’de ila\u00e7 ruhsatland\u0131rma s\u00fcreci devam eden firmalar\u0131n bulundu\u011fu \u00fclkelerin denetleyici\/d\u00fczenleyici sa\u011fl\u0131k otoriteleri. Otoriteler ayr\u0131ca T\u00fcrkiye’de temsilcili\u011fi bulunan ya da faaliyet g\u00f6steren firmalar\u0131n ila\u00e7 sekt\u00f6r\u00fcnde \u00fcyesi oldu\u011fu sendika veya dernekler arac\u0131l\u0131\u011f\u0131 ile de ba\u015fvuru yapabilecek.<\/p>\n

Kar\u015f\u0131l\u0131kl\u0131 tan\u0131ma anla\u015fmas\u0131 i\u00e7in ba\u015fvuruda bulunan her otorite i\u00e7in de\u011ferlendirmeler ba\u011f\u0131ms\u0131z ve kapsaml\u0131 \u015fekilde ayr\u0131 ayr\u0131 yap\u0131lacak. De\u011ferlendirme s\u0131ras\u0131nda ba\u015fvuruda bulunan otoritenin GMP ile ilgili mevzuat\u0131, kalite sistemi, GMP denetim s\u00fcre\u00e7leri, m\u00fcfetti\u015f kalifikasyonu, \u00e7\u0131kar \u00e7at\u0131\u015fmas\u0131 politikalar\u0131, \u00fclkede yer alan \u00fcretim tesislerinin GMP uyum seviyesi, piyasa kontrol program\u0131 ve di\u011fer mevzuat ve prosed\u00fcrler incelenecek.<\/p>\n

K\u0131lavuza buradan<\/a><\/u><\/strong> ula\u015fabilirsiniz.<\/p>\n

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

Kar\u015f\u0131l\u0131kl\u0131 tan\u0131ma anla\u015fmalar\u0131, ila\u00e7 ticaretindeki teknik engellerin azalt\u0131lmas\u0131 ve ila\u00e7lar\u0131n d\u0131\u015f pazarlara eri\u015fimindeki k\u0131s\u0131tlamalar\u0131n kald\u0131r\u0131lmas\u0131 bak\u0131m\u0131ndan b\u00fcy\u00fck \u00f6nem ta\u015f\u0131yor. T\u0130TCK bu kapsamda ila\u00e7 \u015firketlerinin GMP denetimlerine ili\u015fkin \u00e7al\u0131\u015fmalar\u0131na devam ediyor. T\u0130TCK, yap\u0131lan kar\u015f\u0131l\u0131kl\u0131 tan\u0131ma anla\u015fmalar\u0131 ile anla\u015fma yap\u0131lan otoritenin \u00fclkesinde bulunan \u00fcretim tesislerini GMP bak\u0131m\u0131ndan denetleyebilecek.<\/p>\n","protected":false},"excerpt":{"rendered":"

Yeni Geli\u015fmeler T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (“T\u0130TCK“) 9 Temmuz 2019 tarihinde \u0130la\u00e7 Denetim Faaliyetlerine \u0130li\u015fkin Kar\u015f\u0131l\u0131kl\u0131 Tan\u0131ma K\u0131lavuzu’nu […]<\/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-14710","post","type-post","status-publish","format-standard","hentry","category-legal-alerts","tag-healthcare-tr"],"acf":[],"yoast_head":"\nT\u0130TCK \u0130la\u00e7 Denetim Faaliyetlerine \u0130li\u015fkin Kar\u015f\u0131l\u0131kl\u0131 Tan\u0131ma K\u0131lavuzu'nu Yay\u0131mlad\u0131<\/title>\n<meta name=\"description\" content=\"Yeni Geli\u015fmeler T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu ("T\u0130TCK") 9 Temmuz 2019 tarihinde \u0130la\u00e7 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