{"id":21912,"date":"2022-02-15T11:26:41","date_gmt":"2022-02-15T11:26:41","guid":{"rendered":"https:\/\/www.esin.av.tr\/?p=21912"},"modified":"2022-06-09T13:38:08","modified_gmt":"2022-06-09T13:38:08","slug":"saglik-sektorunde-guncel-gelismeler","status":"publish","type":"post","link":"https:\/\/www.esin.av.tr\/tr\/2022\/02\/15\/saglik-sektorunde-guncel-gelismeler\/","title":{"rendered":"Sa\u011fl\u0131k Sekt\u00f6r\u00fcnde G\u00fcncel Geli\u015fmeler"},"content":{"rendered":"

T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (“Kurum<\/strong>“) ge\u00e7ti\u011fimiz haftalarda \u201cFarmas\u00f6tik \u00dcr\u00fcn Sertifikas\u0131\u201d, \u201cSerbest Sat\u0131\u015f Sertifikas\u0131\u201d ve \u201cFarmas\u00f6tik \u00dcr\u00fcn Ruhsat Durumu Beyan\u0131\u201d Belgelerinin D\u00fczenlenmesine \u0130li\u015fkin K\u0131lavuz (“K\u0131lavuz<\/strong>“) ile \u00d6zel T\u0131bbi Ama\u00e7l\u0131 G\u0131dalara \u0130zin Verilmesi Hakk\u0131nda Y\u00f6netmelik Tasla\u011f\u0131’n\u0131 (“Taslak Y\u00f6netmelik<\/strong>“) yay\u0131mlad\u0131 ve Yeni Be\u015feri T\u0131bbi \u00dcr\u00fcnler Ruhsatland\u0131rma Y\u00f6netmeli\u011fi kapsam\u0131ndaki ba\u015fvuru formunu g\u00fcncelledi.<\/p>\n

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

\u201cFarmas\u00f6tik \u00dcr\u00fcn Sertifikas\u0131\u201d, \u201cSerbest Sat\u0131\u015f Sertifikas\u0131\u201d ve \u201cFarmas\u00f6tik \u00dcr\u00fcn Ruhsat Durumu Beyan\u0131\u201d Belgelerinin D\u00fczenlenmesine \u0130li\u015fkin K\u0131lavuz Neleri D\u00fczenlemektedir? <\/strong><\/a>
\nBe\u015feri T\u0131bbi \u00dcr\u00fcnler Ruhsatland\u0131rma Y\u00f6netmeli\u011fi Kapsam\u0131ndaki Ba\u015fvuruda Hangi De\u011fi\u015fiklikler yap\u0131lm\u0131\u015ft\u0131r?<\/strong><\/a>
\n\u00d6zel T\u0131bbi Ama\u00e7l\u0131 G\u0131dalara \u0130zin Verilmesi Hakk\u0131nda Y\u00f6netmelik Tasla\u011f\u0131 yay\u0131mland\u0131<\/strong> <\/a><\/p>\n

\u201cFarmas\u00f6tik \u00dcr\u00fcn Sertifikas\u0131\u201d, \u201cSerbest Sat\u0131\u015f Sertifikas\u0131\u201d ve \u201cFarmas\u00f6tik \u00dcr\u00fcn Ruhsat Durumu Beyan\u0131\u201d Belgelerinin D\u00fczenlenmesine \u0130li\u015fkin K\u0131lavuz Neleri D\u00fczenlemektedir? <\/strong><\/p>\n

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

Kurum, 11.01.2022 tarihinde yay\u0131mlad\u0131\u011f\u0131 K\u0131lavuz ile farmas\u00f6tik \u00fcr\u00fcn sertifikas\u0131, serbest sat\u0131\u015f sertifikas\u0131 ve farmas\u00f6tik \u00fcr\u00fcn ruhsat durumu beyan\u0131 belgelerinin d\u00fczenlenmesi i\u00e7in gerekli ba\u015fvuru \u015fartlar\u0131 ile s\u00f6z konusu belgelerin d\u00fczenlenmesinde dikkat edilecek usul ve esaslar\u0131 belirlemi\u015ftir. K\u0131lavuz’a buradan<\/a> ula\u015fabilirsiniz.<\/p>\n

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

Be\u015feri t\u0131bbi \u00fcr\u00fcnler, geleneksel bitkisel t\u0131bbi \u00fcr\u00fcnler, \u00f6zel t\u0131bbi ama\u00e7l\u0131 g\u0131dalar ve homeopatik t\u0131bbi \u00fcr\u00fcnler ile bunlar i\u00e7in ruhsat ba\u015fvurusunda bulunan ve\/veya ruhsat\/izin verilmi\u015f ger\u00e7ek ve t\u00fczel ki\u015fileri kapsayan K\u0131lavuz 01.02.2022 tarihinde y\u00fcr\u00fcrl\u00fc\u011fe girmi\u015f olup, bu tarihten itibaren yap\u0131lacak ba\u015fvurular i\u00e7in k\u0131lavuz h\u00fck\u00fcmleri ge\u00e7erli olacakt\u0131r.<\/p>\n

K\u0131lavuz kapsam\u0131nda, her bir belge i\u00e7in ayr\u0131 ba\u015fvuru yap\u0131lmas\u0131 gerekti\u011fi, ba\u015fvuru yaz\u0131s\u0131nda yer almas\u0131 gereken bilgiler ve kullan\u0131lacak dil gibi ba\u015fvuru s\u0131ras\u0131nda dikkat edilecek hususlar d\u00fczenlenmi\u015ftir. K\u0131lavuzda ayr\u0131ca, ba\u015fvuruda istenen bilgi ve belgeler say\u0131larak \u00f6rneklendirilmi\u015f ve ba\u015fvuru sahiplerinin sundu\u011fu bilgi ve belgelerden do\u011fabilecek her t\u00fcrl\u00fc sorumlulu\u011fu \u00fcstlendi\u011fi d\u00fczenlenmi\u015ftir.<\/p>\n

K\u0131lavuz uyar\u0131nca, Farmas\u00f6tik \u00dcr\u00fcn Sertifikas\u0131 ile Serbest Sat\u0131\u015f Sertifikas\u0131, sunulan ve onaylanan bilgiler de\u011fi\u015fmedi\u011fi s\u00fcrece Kurum onay tarihinden itibaren iki y\u0131l s\u00fcreyle ge\u00e7erlidir. Farmas\u00f6tik \u00dcr\u00fcn Ruhsat Durumu Beyan\u0131 belgesi ise yaln\u0131zca belgenin d\u00fczenlendi\u011fi tarih itibariyle ge\u00e7erli olan mevcut durumu g\u00f6stermektedir.<\/p>\n

Be\u015feri T\u0131bbi \u00dcr\u00fcnler Ruhsatland\u0131rma Y\u00f6netmeli\u011fi Kapsam\u0131ndaki Ba\u015fvuruda Hangi De\u011fi\u015fiklikler yap\u0131lm\u0131\u015ft\u0131r?<\/strong><\/p>\n

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

18.01.2022 tarihinde yap\u0131lan duyuru ile Kurum, ge\u00e7ti\u011fimiz aylarda yay\u0131mlanan Be\u015feri T\u0131bbi \u00dcr\u00fcnler Ruhsatland\u0131rma Y\u00f6netmeli\u011fi kapsam\u0131nda ruhsat Ba\u015fvuru Formu ve CTD K\u0131lavuzu’nu g\u00fcncellemi\u015ftir. Duyuruya buradan <\/a>ula\u015fabilirsiniz.<\/p>\n

Ayr\u0131ca Be\u015feri T\u0131bbi \u00dcr\u00fcnler Ruhsatland\u0131rma Y\u00f6netmeli\u011fi kapsam\u0131nda getirilen yenilikleri \u00f6zetledi\u011fimize B\u00fclten’imize buradan<\/a> ula\u015fabilirsiniz.<\/p>\n

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

Bilindi\u011fi \u00fczere 11.12.2021 tarihinde yay\u0131mlanan yeni Be\u015feri T\u0131bbi \u00dcr\u00fcnler Ruhsatland\u0131rma Y\u00f6netmeli\u011fi kapsam\u0131nda ruhsatland\u0131rma s\u00fcre\u00e7lerinde \u00e7e\u015fitli de\u011fi\u015fiklikler getirilmi\u015ftir. Be\u015feri t\u0131bbi \u00fcr\u00fcn ruhsat ba\u015fvuru formunda bu do\u011frultuda de\u011fi\u015fiklikler yap\u0131larak yeni d\u00fczenlemeler uyar\u0131nca g\u00fcncellenmi\u015ftir. Bu kapsamda ba\u015fvuru formuna \u00f6ncelikli de\u011ferlendirme, ko\u015fullu ruhsatland\u0131rma ve istisnai ruhsatland\u0131rma ba\u015fvurular\u0131 eklenmi\u015f, ilaveten \u00e7e\u015fitleme ve ili\u015fkili alerjen \u00fcr\u00fcn ba\u015fvurusu ile ilgili k\u0131lavuz yay\u0131mlanaca\u011f\u0131 duyurulmu\u015ftur.<\/p>\n

Ayr\u0131ca, hibrit ba\u015fvuruya ili\u015fkin detaylar a\u00e7\u0131klanm\u0131\u015f ve bu kapsamda referans al\u0131nan t\u0131bbi \u00fcr\u00fcn\u00fcn hibrit \u00fcr\u00fcn ile ayn\u0131 etkin maddeleri i\u00e7ermesi ve tam bir dosya olarak ruhsatland\u0131r\u0131lm\u0131\u015f olmas\u0131 gerekti\u011fi belirtilmi\u015ftir. Hibrit ba\u015fvuru ve \u00e7e\u015fitleme ba\u015fvurular\u0131 i\u00e7in ek veri gerektiren hallerde yap\u0131lmas\u0131 gereken i\u015flemlere yer verilmi\u015ftir.<\/p>\n

\u00d6zel T\u0131bbi Ama\u00e7l\u0131 G\u0131dalara \u0130zin Verilmesi Hakk\u0131nda Y\u00f6netmelik Tasla\u011f\u0131 yay\u0131mland\u0131<\/strong><\/p>\n

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

Kurum 26.01.2022 tarihinde \u00d6zel T\u0131bbi Ama\u00e7l\u0131 G\u0131dalara \u0130zin Verilmesi Hakk\u0131nda Y\u00f6netmelik Tasla\u011f\u0131’n\u0131 yay\u0131mlad\u0131. Taslak Y\u00f6netmelik \u00f6zel t\u0131bbi ama\u00e7l\u0131 g\u0131dalar\u0131n istenen etkililik, g\u00fcvenlilik ve gereken kaliteye sahip olmalar\u0131n\u0131 sa\u011flamak \u00fczere d\u00fczenlenecek izin belgesi ve izin verilmi\u015f \u00fcr\u00fcnlere ili\u015fkin i\u015f ve i\u015flemlerde uygulanacak usul ve esaslar\u0131 d\u00fczenlemektedir. Taslak Y\u00f6netmelik\u2019e buradan <\/a>ula\u015fabilirsiniz.<\/p>\n

Taslak Y\u00f6netmelik’e ili\u015fkin g\u00f6r\u00fc\u015fler 24.02.2022 tarihine kadar t\u0131bbi.beslenme@titck.gov.tr<\/a> e-posta adresine iletilebilecektir.<\/p>\n

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

End\u00fcstriyel olarak haz\u0131rlanm\u0131\u015f \u00f6zel t\u0131bbi ama\u00e7l\u0131 g\u0131dalar (“\u00d6TAG<\/strong>“) ile bunlar i\u00e7in izin belgesi ba\u015fvurusunda bulunan veya halihaz\u0131rda izin belgesi verilmi\u015f ger\u00e7ek veya t\u00fczel ki\u015fileri kapsayan Taslak Y\u00f6netmelik, \u00f6zel t\u0131bbi ama\u00e7l\u0131 g\u0131dalar\u0131 s\u0131n\u0131fland\u0131rarak bebekler ile \u00e7ocuklar i\u00e7in geli\u015ftirilen \u00fcr\u00fcnlere ili\u015fkin gereklilikleri d\u00fczenlemektedir.<\/p>\n

Taslak Y\u00f6netmelik, izin ba\u015fvurular\u0131nda gerekli bilgi ve belgeleri belirterek Kurum taraf\u0131ndan izin belgesi d\u00fczenlenmeyen hi\u00e7bir \u00d6TAG’\u0131n piyasaya s\u00fcr\u00fclemeyece\u011finin alt\u0131n\u0131 \u00e7izmi\u015ftir. Al\u0131nan izin belgesi verildi\u011fi tarihten itibaren 5 y\u0131l sonra Kurum taraf\u0131ndan de\u011ferlendirmeye tabi tutulacak ve yenilenmesi halinde s\u00fcresiz hale gelecektir.<\/p>\n

Ek olarak, Taslak Y\u00f6netmelik ile izin belgesinin verilmesine ili\u015fkin usul, izin belgesinin ask\u0131ya al\u0131nmas\u0131, iptali, zayi olmas\u0131 ve devri d\u00fczenlenmi\u015f; izin belgesi sahibinin \u00fcr\u00fcn\u00fc piyasaya sunmamas\u0131, spesifikasyonlara uygun \u00fcretmemesi ve gerekti\u011finde ambalaj bilgilerini g\u00fcncellememesi gibi durumlarda sorumlu olaca\u011f\u0131 belirtilmi\u015ftir.<\/p>\n

Son olarak, \u00fcr\u00fcnlerin i\u00e7 ve d\u0131\u015f ambalajlar\u0131 ile ambalaj \u00fczerinde yer almas\u0131 gereken sembol ve uyar\u0131lara ili\u015fkin detayl\u0131 d\u00fczenlemeler getirilmektedir.<\/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 duyurular\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":"

T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (“Kurum“) ge\u00e7ti\u011fimiz haftalarda \u201cFarmas\u00f6tik \u00dcr\u00fcn Sertifikas\u0131\u201d, \u201cSerbest Sat\u0131\u015f Sertifikas\u0131\u201d ve \u201cFarmas\u00f6tik \u00dcr\u00fcn Ruhsat Durumu […]<\/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-21912","post","type-post","status-publish","format-standard","hentry","category-legal-alerts","tag-healthcare-tr"],"acf":[],"yoast_head":"\nSa\u011fl\u0131k Sekt\u00f6r\u00fcnde G\u00fcncel Geli\u015fmeler<\/title>\n<meta name=\"description\" content=\"T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu ("Kurum") ge\u00e7ti\u011fimiz haftalarda \u201cFarmas\u00f6tik \u00dcr\u00fcn Sertifikas\u0131\u201d, \u201cSerbest 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