{"id":14570,"date":"2018-10-04T08:28:40","date_gmt":"2018-10-04T08:28:40","guid":{"rendered":"http:\/\/upt.esin.av.tr\/2018\/10\/04\/ozel-tibbi-amacli-gidalar-yonetmelik-taslagi-yayinlandi\/"},"modified":"2022-06-09T12:18:58","modified_gmt":"2022-06-09T12:18:58","slug":"ozel-tibbi-amacli-gidalar-yonetmelik-taslagi-yayinlandi","status":"publish","type":"post","link":"https:\/\/www.esin.av.tr\/tr\/2018\/10\/04\/ozel-tibbi-amacli-gidalar-yonetmelik-taslagi-yayinlandi\/","title":{"rendered":"\u00d6zel T\u0131bbi Ama\u00e7l\u0131 G\u0131dalar Y\u00f6netmelik Tasla\u011f\u0131 Yay\u0131nland\u0131"},"content":{"rendered":"

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

T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (“T\u0130TCK<\/strong>“), internet sitesinde \u00d6zel T\u0131bbi Ama\u00e7l\u0131 G\u0131dalar Y\u00f6netmelik Tasla\u011f\u0131’n\u0131 (“Y\u00f6netmelik<\/strong>“) yay\u0131mlad\u0131. Taslak, AB mevzuat\u0131na uyum \u00e7al\u0131\u015fmalar\u0131 kapsam\u0131nda 609\/2013\/AT say\u0131l\u0131 Avrupa Parlamentosu ve Konsey T\u00fcz\u00fc\u011f\u00fc dikkate al\u0131narak haz\u0131rland\u0131.<\/p>\n

Genelge Neler Getiriyor?<\/strong>
\nY\u00f6netmelik, t\u0131bbi g\u00f6zetim alt\u0131nda kullan\u0131lmas\u0131 gereken \u00f6zel t\u0131bbi ama\u00e7l\u0131 g\u0131dalar\u0131n insan sa\u011fl\u0131\u011f\u0131 ve g\u0131da g\u00fcvenli\u011fine uygun olmas\u0131n\u0131 temin etmek amac\u0131yla; bu \u00fcr\u00fcnlerin izin belgesi i\u015flemlerinde uygulanacak usul ve esaslar ile ambalajlama, etiket bilgileri ve piyasaya arz edilmelerine y\u00f6nelik uygulamalar\u0131 belirliyor.<\/p>\n

Y\u00f6netmelik uyar\u0131nca \u00f6zel t\u0131bbi ama\u00e7l\u0131 g\u0131dalar\u0131n uluslararas\u0131 ge\u00e7erlili\u011fi olan t\u0131p ve beslenme prensiplerine uygun olarak form\u00fcle edilmesi gerekiyor. Ayn\u0131 zamanda bu \u00fcr\u00fcnlerin, \u00fcreticinin talimatlar\u0131 do\u011frultusunda kullan\u0131ld\u0131\u011f\u0131nda \u00f6zel beslenme gereksinimleri kar\u015f\u0131lad\u0131\u011f\u0131n\u0131n ve yararl\u0131 ve etkili oldu\u011funun bilimsel verilerle tespit edilmesi b\u00fcy\u00fck \u00f6nem ta\u015f\u0131yor.<\/p>\n

Bununla birlikte, \u00f6zel t\u0131bbi ama\u00e7l\u0131 g\u0131dalar\u0131n piyasaya s\u00fcr\u00fclmeden \u00f6nce T\u0130TCK’dan izin belgesi al\u0131nmas\u0131 gerekiyor. Bu kapsamda \u00fcreticilerin, izin belgesi ba\u015fvurusu i\u00e7in Y\u00f6netmelik’te \u00f6ng\u00f6r\u00fclen bilgi ve belgeleri T\u0130TCK’ya usul\u00fcne uygun olarak sunmalar\u0131 gerekiyor.<\/p>\n

\u00d6zel T\u0131bbi Ama\u00e7l\u0131 G\u0131dalar Y\u00f6netmelik tasla\u011f\u0131na 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\u015fme T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (“T\u0130TCK“), internet sitesinde \u00d6zel T\u0131bbi Ama\u00e7l\u0131 G\u0131dalar Y\u00f6netmelik Tasla\u011f\u0131’n\u0131 (“Y\u00f6netmelik“) yay\u0131mlad\u0131. Taslak, […]<\/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-14570","post","type-post","status-publish","format-standard","hentry","category-legal-alerts","tag-healthcare-tr"],"acf":[],"yoast_head":"\n\u00d6zel T\u0131bbi Ama\u00e7l\u0131 G\u0131dalar Y\u00f6netmelik Tasla\u011f\u0131 Yay\u0131nland\u0131<\/title>\n<meta name=\"description\" content=\"Yeni Geli\u015fme T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu ("T\u0130TCK"), internet sitesinde \u00d6zel T\u0131bbi Ama\u00e7l\u0131 G\u0131dalar Y\u00f6netmelik Tasla\u011f\u0131'n\u0131 ("Y\u00f6netmelik") yay\u0131mlad\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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