{"id":14569,"date":"2018-10-04T11:47:55","date_gmt":"2018-10-04T11:47:55","guid":{"rendered":"http:\/\/upt.esin.av.tr\/2018\/10\/04\/geleneksel-bitkisel-tibbi-urunler-ruhsatlandirma-yonetmelik-taslagi-yayinlandi\/"},"modified":"2022-06-09T12:18:57","modified_gmt":"2022-06-09T12:18:57","slug":"geleneksel-bitkisel-tibbi-urunler-ruhsatlandirma-yonetmelik-taslagi-yayinlandi","status":"publish","type":"post","link":"https:\/\/www.esin.av.tr\/tr\/2018\/10\/04\/geleneksel-bitkisel-tibbi-urunler-ruhsatlandirma-yonetmelik-taslagi-yayinlandi\/","title":{"rendered":"Geleneksel Bitkisel T\u0131bbi \u00dcr\u00fcnler Ruhsatland\u0131rma Y\u00f6netmelik Tasla\u011f\u0131 Yay\u0131nland\u0131"},"content":{"rendered":"

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

T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (“T\u0130TCK<\/strong>“), internet sitesinde Geleneksel Bitkisel T\u0131bbi \u00dcr\u00fcnler Ruhsatland\u0131rma Y\u00f6netmelik Tasla\u011f\u0131’n\u0131 (“Y\u00f6netmelik<\/strong>“) yay\u0131mlad\u0131. Taslak Y\u00f6netmelik, AB mevzuat\u0131na uyum \u00e7al\u0131\u015fmalar\u0131 kapsam\u0131nda 2004\/24\/AT say\u0131l\u0131 Geleneksel Bitkisel T\u0131bbi \u00dcr\u00fcnler hakk\u0131ndaki Avrupa Parlamentosu ve Konsey Direktifi dikkate al\u0131narak haz\u0131rland\u0131.<\/p>\n

Genelge Neler Getiriyor?<\/strong>
\nY\u00f6netmelik kapsam\u0131nda geleneksel kullan\u0131ma sahip t\u0131bbi bitkilerden haz\u0131rlanan bitkisel t\u0131bbi \u00fcr\u00fcnlerin istenen etkilili\u011fe, g\u00fcvenlili\u011fe ve gereken kaliteye sahip olmalar\u0131n\u0131 sa\u011flamak \u00fczere ruhsatland\u0131rma, ambalajlama ve da\u011f\u0131t\u0131m i\u015flemlerinde uygulanacak usul ve esaslar ile ruhsatland\u0131r\u0131lm\u0131\u015f geleneksel bitkisel t\u0131bbi \u00fcr\u00fcnlere ili\u015fkin uygulamalar d\u00fczenleniyor.<\/p>\n

Y\u00f6netmelik’e uygun olarak ruhsatland\u0131r\u0131lmayan geleneksel bitkisel t\u0131bbi \u00fcr\u00fcnler piyasaya s\u00fcr\u00fclemeyecek. Bu kapsamda Y\u00f6netmelik, ruhsatland\u0131rma i\u00e7in gerekli olan belgeleri ve izlenmesi gereken usul\u00fc d\u00fczenliyor. Ruhsatland\u0131rma ba\u015fvurular\u0131n\u0131n de\u011ferlendirme esaslar\u0131 da detayl\u0131 olarak d\u00fczenleniyor ve de\u011ferlendirme sonu\u00e7lar\u0131na kar\u015f\u0131 itiraz mekanizmalar\u0131 sunuluyor.<\/p>\n

Bununla birlikte, Y\u00f6netmelik uyar\u0131nca \u00fcr\u00fcnlerin \u00fczerinde Y\u00f6netmelik’te \u00f6ng\u00f6r\u00fclen \u015fekilde haz\u0131rlanan kullanma talimatlar\u0131 bulunmas\u0131 gerekecek. Y\u00f6netmelik, \u00fcr\u00fcnlerin ambalajlanmas\u0131na ili\u015fkin \u00f6zel birtak\u0131m \u015fartlar da \u00f6ng\u00f6r\u00fcyor.<\/p>\n

Y\u00f6netmelik tasla\u011f\u0131’na buradan<\/a><\/u> ula\u015fabilirsiniz.<\/p>\n

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

T\u0130TCK, d\u00fczenli olarak ila\u00e7 ve t\u0131bbi cihaz \u015firketlerine yol g\u00f6stermeye devam ediyor. Y\u00f6netmelik kapsam\u0131nda yer alan \u015firketler, \u00fcr\u00fcnlerini piyasaya s\u00fcrmeden \u00f6nce Y\u00f6netmelik’te \u00f6ng\u00f6r\u00fclen gereklilikleri g\u00f6zden ge\u00e7irmeli, izlenmesi gereken usul ve esaslara uygun hareket etmelidir.<\/p>\n","protected":false},"excerpt":{"rendered":"

Yeni Geli\u015fmeler T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (“T\u0130TCK“), internet sitesinde Geleneksel Bitkisel T\u0131bbi \u00dcr\u00fcnler Ruhsatland\u0131rma Y\u00f6netmelik Tasla\u011f\u0131’n\u0131 (“Y\u00f6netmelik“) yay\u0131mlad\u0131. […]<\/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-14569","post","type-post","status-publish","format-standard","hentry","category-legal-alerts","tag-healthcare-tr"],"acf":[],"yoast_head":"\nGeleneksel Bitkisel T\u0131bbi \u00dcr\u00fcnler Ruhsatland\u0131rma Y\u00f6netmelik Tasla\u011f\u0131 Yay\u0131nland\u0131<\/title>\n<meta name=\"description\" content=\"Yeni Geli\u015fmeler T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu ("T\u0130TCK"), internet sitesinde Geleneksel Bitkisel T\u0131bbi \u00dcr\u00fcnler Ruhsatland\u0131rma Y\u00f6netmelik Tasla\u011f\u0131'n\u0131\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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