{"id":22263,"date":"2022-03-15T10:25:24","date_gmt":"2022-03-15T10:25:24","guid":{"rendered":"https:\/\/www.esin.av.tr\/?p=22263"},"modified":"2022-06-09T13:43:38","modified_gmt":"2022-06-09T13:43:38","slug":"saglik-hukukunda-yeni-kilavuzlar-ve-taslak-yonetmelik","status":"publish","type":"post","link":"https:\/\/www.esin.av.tr\/tr\/2022\/03\/15\/saglik-hukukunda-yeni-kilavuzlar-ve-taslak-yonetmelik\/","title":{"rendered":"Sa\u011fl\u0131k Hukukunda Yeni K\u0131lavuzlar ve Taslak Y\u00f6netmelik"},"content":{"rendered":"

\"\"<\/a>\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 B\u00fcltenlerimizi podcast olarak da dinleyebilirsiniz!<\/strong><\/p>\n

 <\/p>\n

T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (“Kurum<\/strong>“) ge\u00e7ti\u011fimiz haftalarda Alerjen \u00dcr\u00fcnlerin Ruhsatland\u0131r\u0131lmas\u0131na \u0130li\u015fkin K\u0131lavuz, \u0130yi Klinik Uygulamalar\u0131 Denetimleri \u0130\u00e7in Ba\u015fvuru K\u0131lavuzu ve Sa\u011fl\u0131k Beyan\u0131 Kullan\u0131m\u0131 Hakk\u0131nda Y\u00f6netmelik Tasla\u011f\u0131 yay\u0131mlad\u0131.<\/p>\n

G\u00fcncel geli\u015fmeler \u00f6zelindeki notlar\u0131m\u0131za a\u015fa\u011f\u0131daki linklerden ula\u015fabilirsiniz:<\/p>\n

Alerjen \u00dcr\u00fcnlerin Ruhsatland\u0131r\u0131lmas\u0131na \u0130li\u015fkin K\u0131lavuz Neleri D\u00fczenlemektedir?<\/strong><\/a>
\n\u0130yi Klinik Uygulamalar\u0131 Denetimleri \u0130\u00e7in Ba\u015fvuru K\u0131lavuzu Neleri D\u00fczenlemektedir?<\/a><\/strong>
\nSa\u011fl\u0131k Beyan\u0131 Kullan\u0131m\u0131 Hakk\u0131nda Y\u00f6netmelik Tasla\u011f\u0131 yay\u0131mland\u0131<\/a><\/strong><\/p>\n

Alerjen \u00dcr\u00fcnlerin Ruhsatland\u0131r\u0131lmas\u0131na \u0130li\u015fkin K\u0131lavuz Neleri D\u00fczenlemektedir?<\/strong><\/p>\n

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

Kurum, 9 Mart 2022 tarihinde yay\u0131mlad\u0131\u011f\u0131 Alerjen \u00dcr\u00fcnlerin Ruhsatland\u0131r\u0131lmas\u0131na \u0130li\u015fkin K\u0131lavuz’da (“K\u0131lavuz<\/strong>“) te\u015fhis ve tedavi amac\u0131yla kullan\u0131lan end\u00fcstriyel alerjen \u00fcr\u00fcnlerin basitle\u015ftirilmi\u015f ruhsatland\u0131rma ko\u015fullar\u0131na ili\u015fkin usul ve esaslar d\u00fczenlemi\u015ftir. K\u0131lavuz’a buradan <\/a>ula\u015fabilirsiniz.<\/p>\n

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

Alerjen, alerjik hastal\u0131k ve alerjen \u00fcr\u00fcn gibi kavramlar\u0131 tan\u0131mlayarak temel \u00f6zelliklerine yer veren K\u0131lavuz uyar\u0131nca, her bir alerjen \u00fcr\u00fcn i\u00e7in ayr\u0131 ruhsat ba\u015fvurusunda bulunulmas\u0131 gerekmektedir. Ba\u015fvuru s\u0131ras\u0131nda alerjen \u00fcr\u00fcne ili\u015fkin k\u0131sa \u00fcr\u00fcn bilgileri, kullanma talimat\u0131 ve ambalaj bilgileri; T\u0131bbi \u00dcr\u00fcnler Ruhsatland\u0131rma Y\u00f6netmeli\u011fi ve Be\u015feri T\u0131bbi \u00dcr\u00fcnlerin Ambalaj Bilgileri, Kullanma Talimat\u0131 ve Takibi Y\u00f6netmeli\u011fi ve ilgili k\u0131lavuzlar do\u011frultusunda haz\u0131rlanmal\u0131d\u0131r. Kalite verileriyse Avrupa Farmakopesi “Alerjen \u00fcr\u00fcnler” monografi, T\u00fcrk Farmakopesi “Alerjen \u00fcr\u00fcnler” monografi ve Avrupa \u0130la\u00e7 Ajans\u0131 Be\u015feri T\u0131bbi \u00dcr\u00fcnler Komitesi’nin\u00a0 “Alerjen \u00dcr\u00fcnler K\u0131lavuzu: \u00dcretim ve Kalite Konular\u0131” ba\u015fl\u0131kl\u0131 k\u0131lavuzu esas al\u0131narak haz\u0131rlan\u0131r.<\/p>\n

Ruhsatland\u0131r\u0131lan alerjen \u00fcr\u00fcnde meydana gelen varyasyonlar\u0131n ilgili d\u00fczenleme ve k\u0131lavuzlar uyar\u0131nca ruhsat sahibi taraf\u0131ndan Kurum’a bildirilmesi gerekmektedir. Ayr\u0131ca, sat\u0131\u015f izni bulunan ruhsatl\u0131 veya ge\u00e7ici izne sahip alerjen \u00fcr\u00fcnleri piyasaya s\u00fcrmek isteyen ruhsat\/ge\u00e7ici izin sahiplerinin Kurum’a ba\u015fvurarak piyasaya sunum izni almas\u0131 gerekmektedir.<\/p>\n

Avrupa Birli\u011fi’nde \u00fcretilen ve piyasada bulunan alerjen \u00fcr\u00fcnler K\u0131lavuz’da g\u00f6sterilen gerekliliklerin kar\u015f\u0131lanmas\u0131 halinde 31 Aral\u0131k 2024 tarihine kadar piyasaya arz edilebilecektir. Bu tarihe kadar ruhsatland\u0131rma i\u015flemi tamamlanmayan veya ruhsat ba\u015fvurusu reddedilen \u00fcr\u00fcnlerin ge\u00e7ici izni iptal edilecek ve piyasaya arz\u0131 durdurulacakt\u0131r. Ba\u015fvurusu reddedilen \u00fcr\u00fcnler i\u00e7in yeniden yap\u0131lacak ge\u00e7ici izin ba\u015fvurular\u0131 Kurum taraf\u0131ndan de\u011ferlendirmeye al\u0131nmayacakt\u0131r.<\/p>\n

\u0130yi Klinik Uygulamalar\u0131 Denetimleri \u0130\u00e7in Ba\u015fvuru K\u0131lavuzu Neleri D\u00fczenlemektedir?<\/strong><\/p>\n

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

Kurum, 8 Mart 2022 tarihinde yay\u0131mlad\u0131\u011f\u0131 \u0130yi Klinik Uygulamalar\u0131 Denetimleri \u0130\u00e7in Ba\u015fvuru K\u0131lavuzu’nda (“K\u0131lavuz<\/strong>“) iyi klinik uygulamalar\u0131 denetimleri ile ilgili olarak Denetim Hizmetleri Ba\u015fkan Yard\u0131mc\u0131l\u0131\u011f\u0131’na yap\u0131lacak olan ba\u015fvurular ve s\u00fcre\u00e7leri ile ilgili hususlar\u0131 d\u00fczenlemi\u015ftir. K\u0131lavuz’a buradan <\/a>ula\u015fabilirsiniz.<\/p>\n

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

Faz 1 klinik ara\u015ft\u0131rmalar\u0131 ve Biyoyararlan\u0131m\/Biyoe\u015fde\u011ferlik (“BY\/BE<\/strong>“) \u00e7al\u0131\u015fmalar\u0131 Kurum onayl\u0131 ve Sa\u011fl\u0131k Bakanl\u0131\u011f\u0131 veya \u00fcniversitelere ba\u011fl\u0131 olan sa\u011fl\u0131k kurum ve kurulu\u015flar\u0131 ve ara\u015ft\u0131rma-geli\u015ftirme merkezlerinde yap\u0131l\u0131r. Bu merkezlerin denetimleri rutin olarak; yurtd\u0131\u015f\u0131nda faaliyet g\u00f6steren BY\/BE merkezleri ile destekleyici ve\/veya s\u00f6zle\u015fmeli ara\u015ft\u0131rma kurulu\u015flar\u0131n\u0131n denetimleri ise talep \u00fczerine ger\u00e7ekle\u015ftirilecektir.<\/p>\n

S\u00f6z konusu denetim ba\u015fvurular\u0131, Elektronik Ba\u015fvuru Sistemi (“EBS<\/strong>“) \u00fczerinden K\u0131lavuz’da belirtilen y\u00f6nlendirmeler do\u011frultusunda Kurum’a elektronik olarak iletilebilecektir. EBS kayd\u0131 Elektronik Ba\u015fvuru ve S\u00fcre\u00e7 Y\u00f6netim Sistemi (EBS-ESY) (titck.gov.tr)<\/a> internet sitesi \u00fczerinden ger\u00e7ekle\u015ftirilebilir.<\/p>\n

Sa\u011fl\u0131k Beyan\u0131 Kullan\u0131m\u0131 Hakk\u0131nda Y\u00f6netmelik Tasla\u011f\u0131 yay\u0131mland\u0131<\/strong><\/p>\n

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

Kurum, 8 Mart 2022 tarihinde Sa\u011fl\u0131k Beyan\u0131 Kullan\u0131m\u0131 Hakk\u0131nda Y\u00f6netmelik Tasla\u011f\u0131’n\u0131 (“Taslak Y\u00f6netmelik<\/strong>“) yay\u0131mlad\u0131. Taslak Y\u00f6netmelik yeni sa\u011fl\u0131k beyan\u0131 izin s\u00fcrecine ve \u00fcr\u00fcnlerde sa\u011fl\u0131k beyan\u0131 kullan\u0131m\u0131na ili\u015fkin usul ve esaslar\u0131 d\u00fczenlemektedir. Taslak Y\u00f6netmelik’in y\u00fcr\u00fcrl\u00fc\u011fe girmesiyle, Sa\u011fl\u0131k Beyan\u0131 ile Sat\u0131\u015fa Sunulan \u00dcr\u00fcnlerin Sa\u011fl\u0131k Beyanlar\u0131 Hakk\u0131nda Y\u00f6netmelik’i y\u00fcr\u00fcrl\u00fckten kald\u0131r\u0131lacakt\u0131r. Taslak Y\u00f6netmelik’e buradan <\/a>ula\u015fabilirsiniz.<\/p>\n

Taslak Y\u00f6netmelik’e ili\u015fkin g\u00f6r\u00fc\u015fler 1 Nisan 2022 tarihine kadar bdud.saglikbeyani@titck.gov.tr<\/a> e-posta adresine iletilebilecektir.<\/p>\n

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

Taslak Y\u00f6netmelik uyar\u0131nca g\u0131da ve takviye edici g\u0131dalar haricindeki \u00fcr\u00fcnlerde ve Kurum’un endikasyon veya kullan\u0131m amac\u0131 belirtilerek ruhsat veya izin verdi\u011fi \u00fcr\u00fcnler ile ayn\u0131 veya benzer ismi ta\u015f\u0131yan \u00fcr\u00fcnlerde sa\u011fl\u0131k beyan\u0131 kullan\u0131lmas\u0131 yasakt\u0131r. G\u0131da ve takviye edici g\u0131dalara ili\u015fkin sa\u011fl\u0131k beyanlar\u0131n\u0131n; (i) belirsiz, yanl\u0131\u015f veya yan\u0131lt\u0131c\u0131 olmamas\u0131, (ii) Di\u011fer \u00fcr\u00fcnlerin yeterlili\u011fi veya g\u00fcvenilirli\u011fi konusunda \u015f\u00fcpheye neden olmamas\u0131, (iii) belirli bir g\u0131dan\u0131n a\u015f\u0131r\u0131 t\u00fcketimini desteklememesi veya \u00f6zendirmemesi ve (iv) t\u00fcketicide korkuya neden olabilecek bi\u00e7imde; yaz\u0131l\u0131, resimli, grafik veya sembolik g\u00f6sterimler ile v\u00fccut fonksiyonlar\u0131ndaki de\u011fi\u015fikliklere at\u0131fta bulunmamas\u0131 gerekmektedir.<\/p>\n

Hastal\u0131k riskinin azalt\u0131lmas\u0131na, \u00e7ocuklar\u0131n geli\u015fimi ve sa\u011fl\u0131\u011f\u0131na ili\u015fkin beyanlar\u0131n yer ald\u0131\u011f\u0131 etiket, sunum ve reklamlarda; at\u0131f yap\u0131lan hastal\u0131\u011f\u0131n \u00e7oklu risk fakt\u00f6rlerinin oldu\u011funu ve bu risk fakt\u00f6rlerinden birini de\u011fi\u015ftirmenin yararl\u0131 bir etkisinin olabilece\u011fi veya olmayabilece\u011fini belirten bir ifade yer alacakt\u0131r. Hastal\u0131k riskinin azalt\u0131lmas\u0131na, \u00e7ocuklar\u0131n geli\u015fimi ve sa\u011fl\u0131\u011f\u0131na ili\u015fkin beyanlar d\u0131\u015f\u0131ndaki sa\u011fl\u0131k beyanlar\u0131n\u0131n ise genel kabul g\u00f6rm\u00fc\u015f bilimsel kan\u0131tlara, yeni geli\u015ftirilmi\u015f bilimsel kan\u0131tlara veya koruma alt\u0131na al\u0131nan tescilli verilere dayanmas\u0131 gerekmektedir.<\/p>\n

Sa\u011fl\u0131k beyan\u0131 kullan\u0131labilecek g\u0131da ve takviye edici g\u0131dalarda bulunmas\u0131 gereken \u00f6zellikler Taslak Y\u00f6netmelik’te detayl\u0131 olarak d\u00fczenlenmi\u015ftir. Sa\u011fl\u0131k Beyan\u0131 Kullan\u0131m K\u0131lavuzu eklerinde yer alan sa\u011fl\u0131k beyanlar\u0131, Tar\u0131m ve Orman Bakanl\u0131\u011f\u0131’na kay\u0131tl\u0131 veya onayl\u0131 i\u015fletmelerin \u00fcretti\u011fi g\u0131da ve takviye edici g\u0131dalarda Kurum’a ba\u015fvuru veya bildirim yap\u0131lmaks\u0131z\u0131n kullan\u0131labilecektir.<\/p>\n

Sa\u011fl\u0131k Beyan\u0131 Kullan\u0131m K\u0131lavuzu ekinde yer almayan bir sa\u011fl\u0131k beyan\u0131n\u0131n eklenmesini isteyenler, Taslak Y\u00f6netmelik’te g\u00f6sterilen bilgi ve belgeler ve Yeni Sa\u011fl\u0131k Beyan\u0131 Ba\u015fvuru K\u0131lavuzu do\u011frultusunda Kurum’a elektronik ba\u015fvuruda bulunabilecektir.<\/p>\n

Bir \u00fcr\u00fcnde sa\u011fl\u0131k beyan\u0131 kullan\u0131labilmesi, \u00fcr\u00fcn sahibinin hukuki ve cezai sorumlulu\u011funu azaltmayacak olup \u00fcr\u00fcn sahibi; (i) g\u0131da veya takviye g\u0131da i\u00e7eri\u011finin mevzuata uygun olmas\u0131, (ii) Kurum’un taleplerine belirlenen s\u00fcrede cevap verilmesi ve (iii) sa\u011fl\u0131k beyan\u0131 kullan\u0131lan \u00fcr\u00fcnlere ili\u015fkin T\u00fcrk G\u0131da Kodeksi’nde \u00f6ng\u00f6r\u00fclen d\u00fczenlemelere uyulmas\u0131nda Kurum’a kar\u015f\u0131 sorumludur.<\/p>\n

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

Kurum sa\u011fl\u0131k sekt\u00f6r\u00fcnde faaliyet g\u00f6steren \u015firketlere rehberlik etmeye devam etmektedir. Sa\u011fl\u0131k sekt\u00f6r\u00fcnde faaliyet g\u00f6steren t\u00fcm ilgili \u015firketler, Kurum’un duyuru ve k\u0131lavuzlar\u0131n\u0131 yak\u0131ndan takip etmeli ve mevzuatta yer alan y\u00fck\u00fcml\u00fcl\u00fcklerini Kurum’un y\u00f6nlendirmeleri do\u011frultusunda yerine getirmelidir.<\/p>\n","protected":false},"excerpt":{"rendered":"

\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 B\u00fcltenlerimizi podcast olarak da dinleyebilirsiniz!   T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (“Kurum“) ge\u00e7ti\u011fimiz haftalarda […]<\/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-22263","post","type-post","status-publish","format-standard","hentry","category-legal-alerts","tag-healthcare-tr"],"acf":[],"yoast_head":"\nSa\u011fl\u0131k Hukukunda Yeni K\u0131lavuzlar ve Taslak Y\u00f6netmelik<\/title>\n<meta name=\"description\" content=\"\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 B\u00fcltenlerimizi podcast olarak da dinleyebilirsiniz!   T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu ("Kurum") ge\u00e7ti\u011fimiz haftalarda Alerjen \u00dcr\u00fcnlerin\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.esin.av.tr\/tr\/2022\/03\/15\/saglik-hukukunda-yeni-kilavuzlar-ve-taslak-yonetmelik\/\" \/>\n<meta property=\"og:locale\" content=\"tr_TR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Sa\u011fl\u0131k Hukukunda Yeni K\u0131lavuzlar ve Taslak Y\u00f6netmelik\" \/>\n<meta property=\"og:description\" content=\"\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 B\u00fcltenlerimizi podcast olarak da dinleyebilirsiniz! 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