{"id":5488,"date":"2013-06-07T06:02:22","date_gmt":"2013-06-07T06:02:22","guid":{"rendered":"http:\/\/www.alohaber.net\/wp\/?p=5488"},"modified":"2013-06-07T06:02:22","modified_gmt":"2013-06-07T06:02:22","slug":"saglik-beyani-ile-satisa-sunulan-urunlerin-saglik-beyanlari-hakkinda-yonetmelik","status":"publish","type":"post","link":"https:\/\/www.alohaber.net\/wp\/2013\/06\/saglik-beyani-ile-satisa-sunulan-urunlerin-saglik-beyanlari-hakkinda-yonetmelik\/","title":{"rendered":"Sa\u011fl\u0131k Beyan\u0131 ile Sat\u0131\u015fa Sunulan \u00dcr\u00fcnlerin Sa\u011fl\u0131k Beyanlar\u0131 Hakk\u0131nda Y\u00f6netmelik"},"content":{"rendered":"

\"saglik_bakanligi\"<\/a>Bu Y\u00f6netmeli\u011fin amac\u0131; sa\u011fl\u0131k beyan\u0131 ile sat\u0131\u015fa sunulacak \u00fcr\u00fcnlerin sa\u011fl\u0131k beyanlar\u0131n\u0131n incelenerek<\/p>\n

 <\/p>\n

<\/p>\n

 <\/p>\n

07 Haziran 2013 Tarihli Resmi Gazete<\/span><\/p>\n

Say\u0131: 28670<\/span><\/p>\n

 <\/p>\n

T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumundan:<\/span><\/p>\n

SA\u011eLIK BEYANI \u0130LE SATI\u015eA SUNULAN \u00dcR\u00dcNLER\u0130N SA\u011eLIK BEYANLARI HAKKINDA Y\u00d6NETMEL\u0130K<\/b><\/span><\/p>\n

B\u0130R\u0130NC\u0130 B\u00d6L\u00dcM<\/b><\/span><\/p>\n

Ama\u00e7, Kapsam, Dayanak ve Tan\u0131mlar<\/b><\/span><\/p>\n

Ama\u00e7<\/span><\/strong><\/p>\n

MADDE 1 \u2013\u00a0<\/span><\/strong>(1) Bu Y\u00f6netmeli\u011fin amac\u0131; sa\u011fl\u0131k beyan\u0131 ile sat\u0131\u015fa sunulacak \u00fcr\u00fcnlerin sa\u011fl\u0131k beyanlar\u0131n\u0131n incelenerek bu beyanlara izin verilmesi, izinsiz veya ger\u00e7e\u011fe ayk\u0131r\u0131 sa\u011fl\u0131k beyan\u0131 ile yap\u0131lan sat\u0131\u015flar\u0131n denetlenmesi, gerekti\u011finde durdurma, toplama, toplatma ve imha i\u015f ve i\u015flemlerinin yap\u0131lmas\u0131 veya yapt\u0131r\u0131lmas\u0131, izin ve sa\u011fl\u0131k beyanlar\u0131 y\u00f6n\u00fcnden bunlar\u0131n reklam ve tan\u0131t\u0131mlar\u0131n\u0131n denetlenmesi ve ayk\u0131r\u0131 olanlar\u0131n durdurulmas\u0131 ile ilgili usul ve esaslar\u0131 belirlemektir.<\/span><\/p>\n

 <\/p>\n

Kapsam<\/span><\/strong><\/p>\n

 <\/p>\n

MADDE 2 \u2013\u00a0<\/span><\/strong>(1) Bu Y\u00f6netmelik, sa\u011fl\u0131k beyan\u0131nda bulunmak suretiyle sat\u0131\u015fa sunulan \u00fcr\u00fcnlerin sa\u011fl\u0131kla ilgili beyan i\u015flemlerini kapsar.<\/span><\/p>\n

 <\/p>\n

(2) Be\u015feri t\u0131bbi \u00fcr\u00fcnler ve t\u0131bbi cihazlar bu Y\u00f6netmeli\u011fin kapsam\u0131 d\u0131\u015f\u0131ndad\u0131r.<\/span><\/p>\n

 <\/p>\n

Dayanak<\/span><\/strong><\/p>\n

 <\/p>\n

MADDE 3 \u2013\u00a0<\/span><\/strong>(1) Bu Y\u00f6netmelik, 11\/10\/2011 tarihli ve\u00a0<\/span>663 say\u0131l\u0131 Sa\u011fl\u0131k Bakanl\u0131\u011f\u0131 ve Ba\u011fl\u0131 Kurulu\u015flar\u0131n\u0131n Te\u015fkilat ve G\u00f6revleri Hakk\u0131nda Kanun H\u00fckm\u00fcnde Kararname<\/span><\/a><\/span>\u2019nin 27 nci maddesinin ikinci f\u0131kras\u0131n\u0131n (b) bendi ile 40 \u0131nc\u0131 maddesine ve 29\/6\/2001 tarihli ve\u00a0<\/span>4703 say\u0131l\u0131 \u00dcr\u00fcnlere \u0130li\u015fkin Teknik Mevzuat\u0131n Haz\u0131rlanmas\u0131 ve Uygulanmas\u0131na Dair Kanunun<\/span><\/a><\/span>\u00a04 \u00fcnc\u00fc maddesine dayan\u0131larak haz\u0131rlanm\u0131\u015ft\u0131r.<\/span><\/p>\n

Tan\u0131mlar<\/span><\/strong><\/p>\n

MADDE 4 \u2013\u00a0<\/span><\/strong>(1) Bu Y\u00f6netmelikte ge\u00e7en;<\/span><\/p>\n

a) Bakanl\u0131k: Sa\u011fl\u0131k Bakanl\u0131\u011f\u0131n\u0131,<\/span><\/p>\n

b) Kurum: T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumunu,<\/span><\/p>\n

c) Sa\u011fl\u0131k beyan\u0131: \u0130nsan sa\u011fl\u0131\u011f\u0131na do\u011frudan veya dolayl\u0131 olarak faydal\u0131 oldu\u011funu yahut hastal\u0131klara veya belirtilerine kar\u015f\u0131 etkili oldu\u011funu, korudu\u011funu, tedavi etti\u011fini belirten, ileri s\u00fcren veya ima eden t\u00fcm ifadeleri,<\/span><\/p>\n

 <\/p>\n

\u00e7) Sa\u011fl\u0131k beyan\u0131 ile sat\u0131\u015fa sunulan \u00fcr\u00fcnler: Tan\u0131t\u0131m\u0131nda sa\u011fl\u0131k beyan\u0131 kullan\u0131lan \u00fcr\u00fcnleri,<\/span><\/p>\n

 <\/p>\n

d) Tan\u0131t\u0131m: \u00dcr\u00fcnlerin \u00f6zelliklerine ili\u015fkin; \u00fcr\u00fcn ambalaj\u0131 \u00fczerinde yer alan bilgiler, tan\u0131t\u0131m elemanlar\u0131n\u0131n aktiviteleri, kitap ve dergilere verilecek il\u00e2nlar, do\u011frudan postalama, televizyon, her t\u00fcrl\u00fc yaz\u0131l\u0131 bas\u0131n, gazete, internet, radyo, sinema, telefon gibi mecralar ve di\u011fer t\u00fcm medya ara\u00e7lar\u0131 yoluyla yap\u0131lacak duyurular, reklamlar, il\u00e2nlar, bilimsel veya e\u011fitsel faaliyetler ve benzeri etkinlikler ile yap\u0131lacak t\u00fcm faaliyetleri,<\/span><\/p>\n

 <\/p>\n

e) Tan\u0131t\u0131mc\u0131: Tan\u0131t\u0131mlar\u0131n yay\u0131mlanmas\u0131n\u0131 sa\u011flayan ger\u00e7ek veya t\u00fczel ki\u015fiyi,<\/span><\/p>\n

 <\/p>\n

f) Tan\u0131t\u0131m malzemeleri: \u00dcr\u00fcn hakk\u0131nda bilgi ihtiva eden kitap, kitap\u00e7\u0131k, bro\u015f\u00fcr, talimatname, ambalaj bilgisi gibi bas\u0131l\u0131 materyaller ile film, slayt, elektronik medya gibi g\u00f6rsel veya i\u015fitsel malzemeleri, ilgili \u00e7evrelerde bilgi, veri, ba\u015fvuru kayna\u011f\u0131 olarak kullan\u0131labilecek sa\u011fl\u0131k beyanlar\u0131n\u0131n yer ald\u0131\u011f\u0131 her t\u00fcrl\u00fc yay\u0131n ve malzemeleri,<\/span><\/p>\n

 <\/p>\n

g) \u00dcr\u00fcn sahibi: Bir \u00fcr\u00fcn\u00fc \u00fcreten, imal eden, \u0131slah eden veya \u00fcr\u00fcne ad\u0131n\u0131, ticar\u00ee markas\u0131n\u0131 veya ay\u0131rt edici i\u015faretini koymak suretiyle kendini \u00fcretici olarak tan\u0131tan ger\u00e7ek veya t\u00fczel ki\u015fiyi; \u00fcreticinin T\u00fcrkiye d\u0131\u015f\u0131nda olmas\u0131 h\u00e2linde, \u00fcretici taraf\u0131ndan yetkilendirilen temsilciyi veya ithalat\u00e7\u0131y\u0131; ayr\u0131ca, \u00fcr\u00fcn\u00fcn tedarik zincirinde yer alan ve faaliyetleri \u00fcr\u00fcn\u00fcn g\u00fcvenli\u011fine ili\u015fkin \u00f6zelliklerini etkileyen ger\u00e7ek veya t\u00fczel ki\u015fiyi,<\/span><\/p>\n

ifade eder.<\/span><\/p>\n

\u0130K\u0130NC\u0130 B\u00d6L\u00dcM<\/b><\/span><\/p>\n

Sa\u011fl\u0131k Beyanlar\u0131na \u0130li\u015fkin Esaslar<\/b><\/span><\/p>\n

Sa\u011fl\u0131k beyanlar\u0131n\u0131 kullanman\u0131n temel ilke ve esaslar\u0131<\/span><\/strong><\/p>\n

MADDE 5 \u2013\u00a0<\/span><\/strong>(1) \u00dcr\u00fcnlere ili\u015fkin \u00f6zel mevzuat h\u00fck\u00fcmleri sakl\u0131 kalmak kayd\u0131yla; sa\u011fl\u0131k beyan\u0131 ile tan\u0131t\u0131m a\u015fa\u011f\u0131daki esaslar \u00e7er\u00e7evesinde yap\u0131l\u0131r:<\/span><\/p>\n

 <\/p>\n

a) Bu Y\u00f6netmelik kapsam\u0131ndaki \u00fcr\u00fcnlerin, sa\u011fl\u0131k beyan\u0131 ile tan\u0131t\u0131m\u0131n\u0131n yap\u0131labilmesi ve piyasaya arz\u0131 i\u00e7in iddia edilen sa\u011fl\u0131k beyan\u0131 hakk\u0131nda Kurumdan izin al\u0131nmas\u0131 \u015fartt\u0131r.<\/span><\/p>\n

 <\/p>\n

b) Sa\u011fl\u0131k beyan\u0131 i\u00e7erisinde klinik \u00e7al\u0131\u015fmalar ile ispatlanmam\u0131\u015f bir ifadeye yer verilemez.<\/span><\/p>\n

 <\/p>\n

c) \u00dcr\u00fcnlerin tan\u0131t\u0131m\u0131, gereksiz kullan\u0131m ve beklenmeyen riskli durumlara neden olabilecek yan\u0131lt\u0131c\u0131, abart\u0131lm\u0131\u015fveya do\u011frulu\u011fu kan\u0131tlanmam\u0131\u015f bilgiler i\u00e7eren sa\u011fl\u0131k beyanlar\u0131 kullan\u0131larak yap\u0131lamaz.<\/span><\/p>\n

 <\/p>\n

\u00e7) Kurumun kullan\u0131m\u0131na izin verdi\u011fi sa\u011fl\u0131k beyan\u0131 metni d\u0131\u015f\u0131nda herhangi bir sa\u011fl\u0131k beyan\u0131 kullanarak \u00fcr\u00fcn tan\u0131t\u0131m\u0131 yap\u0131lamaz.<\/span><\/p>\n

 <\/p>\n

d) \u00dcr\u00fcnlerle ilgili yap\u0131lan sa\u011fl\u0131k beyan\u0131ndan \u00fcr\u00fcn sahibi ile tan\u0131t\u0131mc\u0131 m\u00fc\u015ftereken sorumludur.<\/span><\/p>\n

 <\/p>\n

e) \u00dcr\u00fcnlerin sa\u011fl\u0131k beyan\u0131nda tan\u0131kl\u0131\u011f\u0131na ba\u015fvurulan ki\u015finin tecr\u00fcbesine dayanan hi\u00e7bir te\u015fekk\u00fcr, \u00f6vg\u00fc, tavsiye veya onay ifadesine yer verilemez veya imada bulunulamaz.<\/span><\/p>\n

 <\/p>\n

f) Toplumu bilgilendirmek amac\u0131yla, \u00f6zellikle televizyon ve radyo programlar\u0131 olmak \u00fczere \u00e7e\u015fitli mecralarda, bilgisine ba\u015fvurulan ki\u015filerin, bilgi verdikleri konudaki uzmanl\u0131klar\u0131n\u0131 akademik olarak kan\u0131tlam\u0131\u015f olmalar\u0131, a\u00e7\u0131klamalar\u0131n\u0131 bilimsel nitelikte bilgilerle ve mevzuata uygun olarak yapmalar\u0131 zorunludur.<\/span><\/p>\n

 <\/p>\n

g) Tan\u0131t\u0131mlarda, Bakanl\u0131\u011f\u0131n veya Kurumun ad\u0131 veya logosu kullan\u0131lamaz.<\/span><\/p>\n

 <\/p>\n

\u011f) Sa\u011fl\u0131k beyan\u0131 i\u00e7eren tan\u0131t\u0131mda kurum veya kurulu\u015f, ki\u015fi ad\u0131 veya amblem, logo veya di\u011fer \u00f6zg\u00fcn kurumsal kimlik unsurlar\u0131, t\u00fcketicinin aldanmas\u0131na yol a\u00e7acak \u015fekilde kullan\u0131lamaz. \u00dcr\u00fcn ara\u015ft\u0131rmas\u0131na kat\u0131lan kurum, kurulu\u015f veya ki\u015filerin adlar\u0131 ve belgeleri izinsiz kullan\u0131lamaz.<\/span><\/p>\n

 <\/p>\n

h) Sa\u011fl\u0131k beyan\u0131, bilimsel \u00e7al\u0131\u015fmalardan yap\u0131lacak al\u0131nt\u0131lar, tablolar veya di\u011fer g\u00f6rsel materyaller kullan\u0131larak yap\u0131lacaksa, bilimsel \u00e7al\u0131\u015fman\u0131n asl\u0131na sad\u0131k kal\u0131narak ve kaynaklar\u0131 tam olarak belirtilmek suretiyle kullan\u0131l\u0131r.<\/span><\/p>\n

 <\/p>\n

\u0131) \u00dcr\u00fcne ait tan\u0131t\u0131m\u0131n \u201ctan\u0131t\u0131m\u201d oldu\u011fu a\u00e7\u0131k\u00e7a anla\u015f\u0131lacak \u015fekilde olmak zorundad\u0131r. \u00dcr\u00fcne ili\u015fkin tan\u0131t\u0131m; haber, yorum, bilgilendirme, tavsiye ve benzeri \u00f6\u011feleri i\u00e7eren bir mecrada yay\u0131mland\u0131\u011f\u0131nda, \u201ctan\u0131t\u0131m\u201d oldu\u011fu kolayl\u0131kla alg\u0131lanacak bi\u00e7imde belirtilir.<\/span><\/p>\n

 <\/p>\n

i) \u00dcr\u00fcn\u00fcn tan\u0131t\u0131m\u0131nda sa\u011fl\u0131k meslek mensuplar\u0131n\u0131n tavsiyelerine at\u0131fta bulunulamaz.<\/span><\/p>\n

 <\/p>\n

j) \u00dcr\u00fcne ait tan\u0131t\u0131mlarda sa\u011fl\u0131k meslek \u00f6rg\u00fctleri ile sa\u011fl\u0131kla ili\u015fkili hay\u0131r kurumlar\u0131n\u0131n tavsiyeleri veya bu \u00f6rg\u00fctler ve kurumlar taraf\u0131ndan verilen desteklere yer verilmez.<\/span><\/p>\n

 <\/p>\n

k) \u00dcr\u00fcn\u00fcn tan\u0131t\u0131m\u0131nda, \u00fcr\u00fcn\u00fcn kullan\u0131lmamas\u0131 durumunda sa\u011fl\u0131\u011f\u0131n olumsuz etkilenebilece\u011fini ileri s\u00fcren beyanlara yer verilemez.<\/span><\/p>\n

 <\/p>\n

l) Kurumun talebi h\u00e2linde tan\u0131t\u0131mc\u0131, be\u015f i\u015f g\u00fcn\u00fc i\u00e7erisinde \u00fcr\u00fcn sahibi veya da\u011f\u0131t\u0131c\u0131ya ili\u015fkin unvan, vergi numaras\u0131, vergi dairesi bilgileri ile posta adresi ve ileti\u015fim bilgilerini Kuruma vermekle y\u00fck\u00fcml\u00fcd\u00fcr.<\/span><\/p>\n

 <\/p>\n

\u0130nternetten yap\u0131lan tan\u0131t\u0131mlar<\/span><\/strong><\/p>\n

 <\/p>\n

MADDE 6 \u2013\u00a0<\/span><\/strong>(1) \u00dcr\u00fcn tan\u0131t\u0131m\u0131n\u0131n yap\u0131ld\u0131\u011f\u0131 internet sayfas\u0131nda, \u00fcr\u00fcn sahibinin ad\u0131, unvan\u0131 ve ileti\u015fim bilgilerinin yer almas\u0131 zorunludur.<\/span><\/p>\n

 <\/p>\n

(2) Birden fazla \u00fcreticiye ait \u00fcr\u00fcnlerin tan\u0131t\u0131m ve sat\u0131\u015f\u0131n\u0131n yap\u0131ld\u0131\u011f\u0131 internet sitelerinde \u00fcr\u00fcn sahibinin unvan\u0131 ve ileti\u015fim bilgilerinin \u00fcr\u00fcn bilgileri ile birlikte ayn\u0131 sayfada yer almas\u0131 zorunludur.<\/span><\/p>\n

 <\/p>\n

Kozmetik \u00fcr\u00fcnlerin tan\u0131t\u0131m\u0131<\/span><\/strong><\/p>\n

 <\/p>\n

MADDE 7 \u2013\u00a0<\/span><\/strong>(1) Kozmetik \u00fcr\u00fcnlerin tan\u0131t\u0131mlar\u0131nda;<\/span><\/p>\n

 <\/p>\n

a) Herhangi bir hastal\u0131\u011f\u0131 tedavi etmek veya \u00f6nlemek, tedavisine yard\u0131mc\u0131 olmak, te\u015fhis etmek veya bir fizyolojik fonksiyonu d\u00fczeltmek, d\u00fczenlemek veya de\u011fi\u015ftirmeye ili\u015fkin ibareler veya imalar,<\/span><\/p>\n

 <\/p>\n

b) Farmakolojik, imm\u00fcnolojik veya metabolik etkilerin sonucunda, fizyolojik fonksiyonlar\u0131 yeniledi\u011fini, d\u00fczeltti\u011fini veya de\u011fi\u015ftirdi\u011fini iddia eden veya ima eden beyanlar,<\/span><\/p>\n

 <\/p>\n

c) Be\u015feri t\u0131bbi \u00fcr\u00fcn etkisine at\u0131fta bulunan beyanlar,<\/span><\/p>\n

kullan\u0131lamaz.<\/span><\/p>\n

Ba\u015fvuru ve istenilecek belgeler<\/span><\/strong><\/p>\n

MADDE 8 \u2013<\/span><\/strong>\u00a0(1) Bir \u00fcr\u00fcne sa\u011fl\u0131k beyan\u0131 izni almak isteyen ger\u00e7ek veya t\u00fczel ki\u015fi, a\u015fa\u011f\u0131daki belgelerle birlikte Kuruma ba\u015fvuru yapar;<\/span><\/p>\n

 <\/p>\n

a) \u00dcr\u00fcn sahibinin ad\u0131, kay\u0131tl\u0131 unvan\u0131 ve adresi, e-posta ve internet adresi, telefon ve faks numaras\u0131, t\u00fczel ki\u015fi ise ticaret sicil gazetesinin asl\u0131 veya sureti ile yetkili bayilere ait bilgileri,<\/span><\/p>\n

 <\/p>\n

b) \u00dcr\u00fcn\u00fcn ad\u0131, markas\u0131, ayn\u0131 ad ve markaya sahip di\u011fer \u00fcr\u00fcnler bulunmas\u0131 h\u00e2linde ay\u0131rt edici \u00f6zelli\u011fi,<\/span><\/p>\n

 <\/p>\n

c) Kullan\u0131lmas\u0131 talep edilen sa\u011fl\u0131k beyanlar\u0131n\u0131 i\u00e7eren beyanname,<\/span><\/p>\n

 <\/p>\n

\u00e7) \u00dcr\u00fcn\u00fcn i\u00e7 ve d\u0131\u015f ambalaj\u0131 \u00fczerinde yer alan bilgiler, ithal \u00fcr\u00fcnlerde \u00fcr\u00fcn\u00fcn orijinal ambalaj\u0131 ile birlikte T\u00fcrk\u00e7e terc\u00fcmesi ve T\u00fcrk\u00e7e etiket \u00f6rne\u011fi,<\/span><\/p>\n

 <\/p>\n

d) \u00dcr\u00fcn\u00fcn iddia edilen sa\u011fl\u0131k beyan\u0131n\u0131 kan\u0131tlayan ve 13\/4\/2013 tarihli ve 28617 say\u0131l\u0131 Resm\u00ee Gazete\u2019 de yay\u0131mlanan Klinik Ara\u015ft\u0131rmalar Hakk\u0131nda Y\u00f6netmeli\u011fe uygun olarak yap\u0131lm\u0131\u015f klinik \u00e7al\u0131\u015fmalar\u0131n bir \u00f6rne\u011fi, klinik \u00e7al\u0131\u015fman\u0131n yurt d\u0131\u015f\u0131nda yap\u0131lm\u0131\u015f olmas\u0131 h\u00e2linde klinik \u00e7al\u0131\u015fma, T\u00fcrk\u00e7e terc\u00fcmesi ve klinik ara\u015ft\u0131rman\u0131n onaylanm\u0131\u015f merkezlerde yap\u0131ld\u0131\u011f\u0131n\u0131 g\u00f6sterir belgeleri,<\/span><\/p>\n

e) \u00dcr\u00fcnle ilgili izin veya bildirim belgeleri.<\/span><\/p>\n

Ba\u015fvurunun de\u011ferlendirilmesi<\/span><\/strong><\/p>\n

MADDE 9 \u2013<\/span><\/strong>\u00a0(1) 8 inci maddede belirtilen belgeler ile birlikte yap\u0131lan ba\u015fvurular, Kurum taraf\u0131ndan de\u011ferlendirilir ve \u00fcr\u00fcn\u00fcn sa\u011fl\u0131k beyan\u0131 ile tan\u0131t\u0131m ve sat\u0131\u015f\u0131na izin verilir. Ancak, verilen izinde sa\u011fl\u0131k beyan\u0131n\u0131n kullan\u0131laca\u011f\u0131 mecralar Kurumca belirlenir.<\/span><\/p>\n

 <\/p>\n

(2) Kurum taraf\u0131ndan gerekli g\u00f6r\u00fclmesi h\u00e2linde ba\u015fvurunun niteli\u011fine g\u00f6re te\u015fekk\u00fcl ettirilecek bilimsel komisyonlardan g\u00f6r\u00fc\u015f al\u0131nabilir.<\/span><\/p>\n

 <\/p>\n

(3) Yap\u0131lan inceleme sonucunda sa\u011fl\u0131k beyan\u0131nda bulunmak \u00fczere izin talep edilen \u00fcr\u00fcn\u00fcn ba\u015fka bir teknik mevzuata g\u00f6re ruhsatland\u0131r\u0131lmas\u0131, izin al\u0131nmas\u0131 veya bildirim yap\u0131lmas\u0131 gerekti\u011fine karar verilir ise ilgili mevzuat h\u00fck\u00fcmleri uygulan\u0131r.<\/span><\/p>\n

 <\/p>\n

(4) Kurum taraf\u0131ndan yap\u0131lacak de\u011ferlendirmede, \u00fcr\u00fcnlerin teknik mevzuat\u0131nda tan\u0131t\u0131ma ili\u015fkin h\u00fck\u00fcmler varsa bu h\u00fck\u00fcmler de g\u00f6z \u00f6n\u00fcne al\u0131n\u0131r.<\/span><\/p>\n

 <\/p>\n

(5) \u0130lgili mevzuat\u0131 gere\u011fince tan\u0131t\u0131m\u0131nda sa\u011fl\u0131k beyan\u0131 bulunmamas\u0131 gereken \u00fcr\u00fcnler i\u00e7in yap\u0131lan ba\u015fvurular de\u011ferlendirmeye al\u0131nmaz.<\/span><\/p>\n

 <\/p>\n

\u00dcr\u00fcn sahibinin sorumlulu\u011fu<\/span><\/strong><\/p>\n

 <\/p>\n

MADDE 10 \u2013<\/span><\/strong>\u00a0(1) \u00dcr\u00fcn sahibi, \u00fcr\u00fcn\u00fcn\u00fcn tan\u0131t\u0131m\u0131nda kullanaca\u011f\u0131 sa\u011fl\u0131k beyan\u0131na ili\u015fkin klinik \u00e7al\u0131\u015fmalar\u0131 tamamlad\u0131ktan sonra izin almak \u00fczere Kuruma ba\u015fvurur.<\/span><\/p>\n

 <\/p>\n

(2) Ba\u015fvuru yap\u0131lan sa\u011fl\u0131k beyan\u0131na Kurum taraf\u0131ndan izin verildi\u011fi takdirde, \u00fcr\u00fcn\u00fcn tan\u0131t\u0131m\u0131, 5 inci, 6 nc\u0131 ve 7 nci maddelerde belirtilen h\u00fck\u00fcmlere uygun olarak yap\u0131l\u0131r.<\/span><\/p>\n

 <\/p>\n

(3) \u00dcr\u00fcn sahibi, Kurumun talebi h\u00e2linde sa\u011fl\u0131k beyan\u0131 ve iddia edilen sa\u011fl\u0131k beyan\u0131n\u0131n yer ald\u0131\u011f\u0131 tan\u0131t\u0131mla ilgili gereken her t\u00fcrl\u00fc bilgi ve belgeyi sunmakla y\u00fck\u00fcml\u00fcd\u00fcr.<\/span><\/p>\n

\u00dc\u00c7\u00dcNC\u00dc B\u00d6L\u00dcM<\/b><\/span><\/p>\n

G\u0131da ve G\u0131da Takviyelerine \u0130li\u015fkin Tan\u0131t\u0131mlar, Denetim ve \u0130dari Yapt\u0131r\u0131mlar<\/b><\/span><\/p>\n

G\u0131da ve g\u0131da takviyelerine ili\u015fkin tan\u0131t\u0131mlar<\/span><\/strong><\/p>\n

MADDE 11 \u2013<\/span><\/strong>\u00a0(1) G\u0131da takviyeleri ve g\u0131dalara ili\u015fkin sa\u011fl\u0131k beyanlar\u0131n\u0131n izin i\u015flemleri 29\/12\/2011 tarihli ve 28157 3 \u00fcnc\u00fc m\u00fckerrer say\u0131l\u0131 Resm\u00ee Gazete\u2019de yay\u0131mlanan T\u00fcrk G\u0131da Kodeksi Etiketleme Y\u00f6netmeli\u011finde yer alan h\u00fck\u00fcmlere g\u00f6re ilgili Bakanl\u0131k taraf\u0131ndan yerine getirilir. G\u0131da ve g\u0131da takviyelerinin s\u00f6z konusu Y\u00f6netmelikte belirtilen sa\u011fl\u0131k beyan\u0131 haricinde tan\u0131t\u0131lmas\u0131 halinde Kurum, tan\u0131t\u0131m\u0131 ve \u00fcr\u00fcn\u00fcn piyasaya arz\u0131n\u0131 durdurma, toplama, toplatma, imha i\u015f ve i\u015flemlerini yapar veya yapt\u0131r\u0131r.<\/span><\/p>\n

 <\/p>\n

Denetim ve idari yapt\u0131r\u0131mlar<\/span><\/strong><\/p>\n

 <\/p>\n

MADDE 12 \u2013\u00a0<\/span><\/strong>(1) Kurum, sa\u011fl\u0131k beyan\u0131 i\u00e7eren tan\u0131t\u0131m veya tan\u0131t\u0131m malzemesini izinli olup olmad\u0131\u011f\u0131 veya sa\u011fl\u0131k beyanlar\u0131n\u0131n verilen izin \u00e7er\u00e7evesinde yap\u0131l\u0131p yap\u0131lmad\u0131\u011f\u0131n\u0131 re\u2019sen veya \u015fik\u00e2yet \u00fczerine denetler. Denetimler Kurum taraf\u0131ndan g\u00f6revlendirilen personel taraf\u0131ndan, tan\u0131t\u0131m ve sat\u0131\u015f\u0131n yap\u0131ld\u0131\u011f\u0131 her t\u00fcrl\u00fc mecrada y\u00fcr\u00fct\u00fcl\u00fcr.<\/span><\/p>\n

 <\/p>\n

(2) Denetim veya incelemeler sonucunda, bu Y\u00f6netmelik h\u00fck\u00fcmlerinden herhangi birine ayk\u0131r\u0131 davran\u0131ld\u0131\u011f\u0131n\u0131n tespiti h\u00e2linde, Kurum taraf\u0131ndan d\u00fczeltme, tan\u0131t\u0131m\u0131 ve piyasaya arz\u0131 durdurma veya toplatma karar\u0131 verilebilir. Kurum taraf\u0131ndan verilen karar \u00fcr\u00fcn sahibine tebli\u011f edilir ve \u00fcr\u00fcn sahibi Kurumun kararlar\u0131n\u0131 ivedilikle yerine getirir. Durdurma ve toplatma i\u015flemi \u00fcr\u00fcn sahibi taraf\u0131ndan yap\u0131l\u0131r. Bu i\u015flemler Kurum taraf\u0131ndan yap\u0131labilece\u011fi gibi Kurumun talebi h\u00e2linde \u00fcr\u00fcn\u00fcn piyasa g\u00f6zetim ve denetiminden sorumlu kurum veya kurulu\u015flar taraf\u0131ndan da uygulanabilir. Toplat\u0131lan \u00fcr\u00fcnlerin imha edilmesine karar verilmesi halinde, bu i\u015flemler \u00fcretici taraf\u0131ndan yap\u0131labilece\u011fi gibi, masraflar \u00fcreticiye ait olmak \u00fczere Kurum taraf\u0131ndan da ger\u00e7ekle\u015ftirilebilir.<\/span><\/p>\n

 <\/p>\n

(3) Tan\u0131t\u0131m internet arac\u0131l\u0131\u011f\u0131 ile yap\u0131l\u0131yor ise 4\/5\/2007 tarihli ve 5651 say\u0131l\u0131 \u0130nternet Ortam\u0131nda Yap\u0131lan Yay\u0131nlar\u0131n D\u00fczenlenmesi ve Bu Yay\u0131nlar Yoluyla \u0130\u015flenen Su\u00e7larla M\u00fccadele Edilmesi Hakk\u0131nda Kanun h\u00fck\u00fcmleri uyar\u0131nca i\u015flem yap\u0131l\u0131r.<\/span><\/p>\n

 <\/p>\n

(4) Kurum, tan\u0131t\u0131mlar\u0131n durdurulmas\u0131 ve internet eri\u015fiminin engellenmesi ve di\u011fer yapt\u0131r\u0131mlar konusunda tan\u0131t\u0131m\u0131n yap\u0131ld\u0131\u011f\u0131 mecraya g\u00f6re ilgili kurum ve kurulu\u015flarla i\u015fbirli\u011fi yapar.<\/span><\/p>\n

 <\/p>\n

(5) Bu Y\u00f6netmelikte belirtilen h\u00fck\u00fcmlere ayk\u0131r\u0131 davranan ve faaliyette bulunanlar hakk\u0131nda fiillerinin niteli\u011fine g\u00f6re, 26\/9\/2004 tarihli ve 5237 say\u0131l\u0131 T\u00fcrk Ceza Kanunu, 29\/6\/2001 tarihli ve 4703 say\u0131l\u0131 \u00dcr\u00fcnlere \u0130li\u015fkin Teknik Mevzuat\u0131n Haz\u0131rlanmas\u0131 ve Uygulanmas\u0131na Dair Kanun, 23\/2\/1995 tarihli ve 4077 say\u0131l\u0131 T\u00fcketicinin Korunmas\u0131 Hakk\u0131nda Kanun, 15\/2\/2011 tarihli ve 6112 say\u0131l\u0131 Radyo ve Televizyonlar\u0131n Kurulu\u015f ve Yay\u0131n Hizmetleri Hakk\u0131nda Kanun, 14\/5\/1928 tarihli ve 1262 say\u0131l\u0131 \u0130spen\u00e7iyari ve T\u0131bbi M\u00fcstahzarlar Kanunu ve di\u011fer ilgili mevzuat h\u00fck\u00fcmleri uygulan\u0131r.<\/span><\/p>\n

D\u00d6RD\u00dcNC\u00dc B\u00d6L\u00dcM<\/b><\/span><\/p>\n

Son H\u00fck\u00fcmler<\/b><\/span><\/p>\n

Y\u00fcr\u00fcrl\u00fck<\/span><\/strong><\/p>\n

MADDE 13 \u2013<\/span><\/strong>\u00a0(1) Bu Y\u00f6netmelik yay\u0131m\u0131 tarihinde y\u00fcr\u00fcrl\u00fc\u011fe girer.<\/span><\/p>\n

Y\u00fcr\u00fctme<\/span><\/strong><\/p>\n

MADDE 14 \u2013\u00a0<\/span><\/strong>(1) Bu Y\u00f6netmelik h\u00fck\u00fcmlerini T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu Ba\u015fkan\u0131 y\u00fcr\u00fct\u00fcr.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

Bu Y\u00f6netmeli\u011fin amac\u0131; sa\u011fl\u0131k beyan\u0131 ile sat\u0131\u015fa sunulacak \u00fcr\u00fcnlerin sa\u011fl\u0131k beyanlar\u0131n\u0131n incelenerek  <\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[],"class_list":["post-5488","post","type-post","status-publish","format-standard","hentry","category-mevzuat-haberleri"],"_links":{"self":[{"href":"https:\/\/www.alohaber.net\/wp\/wp-json\/wp\/v2\/posts\/5488","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.alohaber.net\/wp\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.alohaber.net\/wp\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.alohaber.net\/wp\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.alohaber.net\/wp\/wp-json\/wp\/v2\/comments?post=5488"}],"version-history":[{"count":1,"href":"https:\/\/www.alohaber.net\/wp\/wp-json\/wp\/v2\/posts\/5488\/revisions"}],"predecessor-version":[{"id":5489,"href":"https:\/\/www.alohaber.net\/wp\/wp-json\/wp\/v2\/posts\/5488\/revisions\/5489"}],"wp:attachment":[{"href":"https:\/\/www.alohaber.net\/wp\/wp-json\/wp\/v2\/media?parent=5488"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.alohaber.net\/wp\/wp-json\/wp\/v2\/categories?post=5488"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.alohaber.net\/wp\/wp-json\/wp\/v2\/tags?post=5488"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}