{"id":23175,"date":"2022-07-01T09:52:02","date_gmt":"2022-07-01T09:52:02","guid":{"rendered":"https:\/\/www.esin.av.tr\/?p=23175"},"modified":"2022-07-01T09:52:02","modified_gmt":"2022-07-01T09:52:02","slug":"saglik-sektorunde-yeni-kilavuzlar","status":"publish","type":"post","link":"https:\/\/www.esin.av.tr\/tr\/2022\/07\/01\/saglik-sektorunde-yeni-kilavuzlar\/","title":{"rendered":"Sa\u011fl\u0131k Sekt\u00f6r\u00fcnde Yeni K\u0131lavuzlar"},"content":{"rendered":"

\"\"<\/a>\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0Bu b\u00fcltenimizi podcast olarak da dinleyebilirsiniz!<\/strong><\/p>\n

 <\/p>\n

Ge\u00e7ti\u011fimiz haftalarda T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (Kurum) taraf\u0131ndan (i) \u0130yi Farmakovijilans Uygulamalar\u0131 (\u0130FU) K\u0131lavuzu Mod\u00fcl X – Pazarlama \u00d6ncesi Yarar\/Risk De\u011ferlendirmesi ile (ii) \u0130yi Farmakovijilans Uygulamalar\u0131 (\u0130FU) K\u0131lavuzu Mod\u00fcl XI – Pazarlama Sonras\u0131 Yarar\/Risk De\u011ferlendirmesi ve (ii) Sa\u011fl\u0131k Beyan\u0131 Kullan\u0131m\u0131 Hakk\u0131nda K\u0131lavuz Tasla\u011f\u0131 yay\u0131mland\u0131.<\/p>\n

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

\u0130FU K\u0131lavuzu Mod\u00fcl X – Pazarlama \u00d6ncesi Yarar\/Risk De\u011ferlendirmesi ve Mod\u00fcl XI – Pazarlama Sonras\u0131 Yarar\/Risk De\u011ferlendirmesi Neleri D\u00fczenlemektedir? <\/strong><\/a>
\nSa\u011fl\u0131k Beyan\u0131 Kullan\u0131m\u0131 Hakk\u0131nda K\u0131lavuz Tasla\u011f\u0131 Neleri D\u00fczenlemektedir?<\/strong> <\/a><\/p>\n

\u0130FU K\u0131lavuzu Mod\u00fcl X – Pazarlama \u00d6ncesi Yarar\/Risk De\u011ferlendirmesi ve Mod\u00fcl XI – Pazarlama Sonras\u0131 Yarar\/Risk De\u011ferlendirmesi Neleri D\u00fczenlemektedir? <\/strong><\/p>\n

Kurum, 20 Haziran 2022 tarihinde \u0130FU K\u0131lavuzu Mod\u00fcl X – Pazarlama \u00d6ncesi Yarar\/Risk De\u011ferlendirmesi ve Mod\u00fcl XI – Pazarlama Sonras\u0131 Yarar\/Risk De\u011ferlendirmesi’ni yay\u0131mlad\u0131. S\u00f6z konusu k\u0131lavuzlar, yarar\/risk de\u011ferlendirmesine ili\u015fkin y\u00f6nlendirme sa\u011flamay\u0131, belirsizlikleri gidermeyi ve yarar\/risk de\u011ferlendirmesinin tutarl\u0131 ve \u015feffaf bir \u015fekilde yap\u0131labilmesi ve karar verme s\u00fcrecinin kolayla\u015ft\u0131r\u0131lmas\u0131 ad\u0131na ruhsat sahiplerine yol g\u00f6stermeyi ama\u00e7lamaktad\u0131r. Bu kapsamda k\u0131lavuzlar, yarar\/risk de\u011ferlendirmesinde yer alan b\u00f6l\u00fcmleri, her bir b\u00f6l\u00fcm\u00fcn amac\u0131n\u0131 ve dikkat edilmesi gereken hususlar\u0131 a\u00e7\u0131klamakta ve \u00f6rnekler sunmaktad\u0131r.<\/p>\n

Mod\u00fcl X – Pazarlama \u00d6ncesi Yarar\/Risk De\u011ferlendirmesi’ne buradan<\/a>; Mod\u00fcl XI – Pazarlama Sonras\u0131 Yarar\/Risk De\u011ferlendirmesi’ne buradan<\/a> ula\u015fabilirsiniz.<\/p>\n

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

Mod\u00fcl X – Pazarlama \u00d6ncesi Yarar\/Risk De\u011ferlendirmesi K\u0131lavuzu<\/em><\/p>\n

Pazarlama \u00f6ncesi yarar\/risk de\u011ferlendirmesinde \u00f6ncelikle kabul edilebilir yarar ve riskler hastal\u0131\u011f\u0131n arka plan\u0131 ve tedavi s\u00fcreciyle birlikte k\u0131saca \u00f6zetlenmeli ve terap\u00f6tik endikasyon a\u00e7\u0131k\u00e7a belirtilmelidir.<\/p>\n

De\u011ferlendirmede, test ve ara\u015ft\u0131rmalar\u0131n teknik ayr\u0131nt\u0131lar\u0131ndan ziyade kilit bulgular\u0131n tan\u0131mlanmas\u0131 ve ana kan\u0131t ve belirsizliklerin tespit edilmesi \u00f6nem ta\u015f\u0131r. \u0130kincil olarak, \u00f6nemli yararlar ve riskler spesifik terap\u00f6tik ba\u011flamda birbirleriyle kar\u015f\u0131la\u015ft\u0131r\u0131larak yarar\/risk dengesi hakk\u0131nda ilkeler, veriler ve sonu\u00e7lar aras\u0131ndaki ili\u015fkiler ile \u00e7\u00f6z\u00fclmemi\u015f konular a\u00e7\u0131klanmal\u0131d\u0131r. De\u011ferlendirmeyi yapanlar\u0131n sonu\u00e7lar\u0131 desteklemek i\u00e7in kullan\u0131lan kan\u0131tlar hakk\u0131nda tarafs\u0131z ve a\u00e7\u0131k olmas\u0131 gerekmektedir.<\/p>\n

De\u011ferlendirmede, yararlar ile birlikte \u00e7\u00f6z\u00fclmemi\u015f sorunlar ve belirsizlikler de tespit edilmeli ve denge de\u011ferlendirmesinde etkileri belirtilmelidir. Ayr\u0131ca, \u00f6nemli riskler, meydana gelme olas\u0131l\u0131klar\u0131 ve advers olaylar\u0131n \u015fiddeti, zaman\u0131 gibi bilgilere yer verilmelidir.<\/p>\n

Yarar\/risk dengesinde, alternatif tedaviler veya m\u00fcdahaleler ile a\u00e7\u0131klanan yararlar ve riskler kar\u015f\u0131la\u015ft\u0131r\u0131lmal\u0131 ve yarar\/risk dengesinin pozitif olup olmad\u0131\u011f\u0131 de\u011ferlendirilmelidir. Yarar\/risk dengesine ili\u015fkin mevcut kan\u0131t miktar\u0131, \u00f6zellikle hastalar ve doktorlar gibi farkl\u0131 payda\u015flar\u0131n bak\u0131\u015f a\u00e7\u0131lar\u0131 ve yarar\/risk dengesine ili\u015fkin di\u011fer fakt\u00f6rlerin de a\u00e7\u0131klanmas\u0131 gerekmektedir.<\/p>\n

Mod\u00fcl XI – Pazarlama Sonras\u0131 Yarar\/Risk De\u011ferlendirmesi K\u0131lavuzu<\/em><\/p>\n

K\u0131lavuz kapsam\u0131nda, yarar\/risk de\u011ferlendirmesinin par\u00e7as\u0131 olarak Kurum taraf\u0131ndan ruhsat sahiplerinden genel olarak talep edilen bilgilerin nas\u0131l d\u00fczenlenece\u011fini \u00f6zetlenmi\u015f olup Kurum’un ek talepte bulunmas\u0131 da m\u00fcmk\u00fcnd\u00fcr. \u0130lgili ruhsat sahibi, yaln\u0131zca kendi ilac\u0131na ili\u015fkin yarar\/risk de\u011ferlendirmesine dair kan\u0131tlar\u0131 sa\u011flamaktan sorumludur.<\/p>\n

Pazarlama sonras\u0131 yarar\/risk de\u011ferlendirmesinde; ilac\u0131n kullan\u0131m\u0131, \u00f6nceki g\u00fcvenlik m\u00fcdahaleleri, endike oldu\u011fu hastal\u0131klar ve arka plan bilgilerinin a\u00e7\u0131klanmas\u0131, ilgili mevzuat ile ruhsat tarihleri gibi bilgilerin sunulmas\u0131, mevcut risk minimizasyon stratejileri, maruziyet tahminleri, T\u00fcrkiye’ye \u00f6zg\u00fc hastal\u0131k ve durumlara ili\u015fkin bilgiler ve di\u011fer tedavi alternatiflerine yer verilmesi gerekmektedir.<\/p>\n

De\u011ferlendirmede ayr\u0131ca, yarar ve risk ayr\u0131 ayr\u0131 karakterize edilerek kar\u015f\u0131la\u015ft\u0131rmal\u0131 olarak tart\u0131\u015f\u0131lmal\u0131 ve yarar\/risk profili de\u011ferlendirilmelidir. Bu kapsamda, ilac\u0131n temel yararlar\u0131 ile kilit riskleri \u00f6zetlenmeli ve kan\u0131tlar\u0131n kalitesi ele al\u0131nmal\u0131d\u0131r.<\/p>\n

Sa\u011fl\u0131k Beyan\u0131 Kullan\u0131m\u0131 Hakk\u0131nda K\u0131lavuz Tasla\u011f\u0131 Neleri D\u00fczenlemektedir? <\/strong><\/p>\n

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

Kurum, 20 Haziran 2022 tarihinde Sa\u011fl\u0131k Beyan\u0131 Kullan\u0131m\u0131 Hakk\u0131nda K\u0131lavuz Tasla\u011f\u0131 ile sa\u011fl\u0131k beyanlar\u0131 listesini yay\u0131mlam\u0131\u015ft\u0131r. Taslak k\u0131lavuz, son t\u00fcketiciye arz edilen \u00fcr\u00fcnlerde sa\u011fl\u0131k beyan\u0131 kullan\u0131m\u0131na ili\u015fkin usul ve esaslar\u0131 d\u00fczenlemektedir.<\/p>\n

Taslak k\u0131lavuza ili\u015fkin g\u00f6r\u00fc\u015fler 1 A\u011fustos 2022 tarihine kadar bdud.saglikbeyani@titck.gov.tr<\/a> e-posta adresine iletilebilecektir.<\/p>\n

Taslak k\u0131lavuza buradan <\/a>ula\u015fabilirsiniz.<\/p>\n

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

Taslak k\u0131lavuz uyar\u0131nca, piyasaya arz edilen g\u0131dalar\u0131n etiketi, tan\u0131t\u0131m\u0131 ve rekl\u00e2m\u0131nda kullan\u0131lan sa\u011fl\u0131k beyanlar\u0131; yanl\u0131\u015f, yan\u0131lt\u0131c\u0131, \u015f\u00fcphe ve endi\u015feye neden olmamal\u0131 ve ortalama t\u00fcketicinin anlayaca\u011f\u0131 bi\u00e7imde olmal\u0131d\u0131r. Sa\u011fl\u0131k beyan\u0131 ifadelerinin yerine anlam\u0131 de\u011fi\u015ftirmeyen ve g\u00fc\u00e7lendirmeyen \u015fekilde e\u015fde\u011fer ifadeler kullan\u0131labilecektir. Bu kapsamda taslak k\u0131lavuzda, kullan\u0131labilecek ve kullan\u0131lamayacak ifadeleri \u00f6rneklendirilmi\u015ftir.<\/p>\n

Sa\u011fl\u0131k Beyan\u0131 Kullan\u0131m\u0131 Hakk\u0131nda Y\u00f6netmelik uyar\u0131nca sa\u011fl\u0131k beyan\u0131 kullanmas\u0131 uygun olan g\u0131dalar\u0131n, ticari markas\u0131, \u00f6zel ismi veya etiket g\u00f6rselleri; kullan\u0131lan sa\u011fl\u0131k beyan\u0131 ile ili\u015fkili ve s\u0131n\u0131rl\u0131 olmas\u0131 \u015fart\u0131yla sa\u011fl\u0131k beyan\u0131 i\u00e7erebilecektir. Bu gibi hallerde, sorumluluk g\u0131da i\u015fletmecisinde olmak \u00fczere bu kullan\u0131m i\u00e7in ba\u015fvuru yap\u0131lmas\u0131na gerek olmayacakt\u0131r. G\u0131dalar\u0131n etiketi, tan\u0131t\u0131m\u0131 ve rekl\u00e2m\u0131nda yer alan ve sa\u011fl\u0131k beyan\u0131 olarak yorumlanabilecek g\u00f6rseller, ilgili g\u0131dan\u0131n beyan ko\u015fulunu kar\u015f\u0131lamas\u0131 ve t\u00fcketicide endi\u015feye neden olmamas\u0131 \u015fart\u0131yla kullan\u0131labilecektir.<\/p>\n

\u0130zin verilen sa\u011fl\u0131k beyanlar\u0131 veya taslak k\u0131lavuzda yer alan \u00f6nerilerin de\u011fi\u015ftirilmesi yasakt\u0131r. Ancak, etiket \u00fczerinde, beyan\u0131n anlam\u0131n\u0131 de\u011fi\u015ftirmedi\u011fi ve g\u00fc\u00e7lendirmedi\u011fi s\u00fcrece ve beyan\u0131n tam haliyle birlikte yaz\u0131lmas\u0131 ko\u015fulu ile k\u0131salt\u0131lm\u0131\u015f ifadeler kullan\u0131labilecektir.<\/p>\n

Taslak k\u0131lavuzda ayr\u0131ca \u00e7ocuklar\u0131n geli\u015fimi ve sa\u011fl\u0131\u011f\u0131na ili\u015fkin sa\u011fl\u0131k beyanlar\u0131, kullan\u0131m\u0131 kesinlikle yasak beyanlar ve besin \u00f6gesi profiline uygunlu\u011funa ili\u015fkin de\u011ferlendirmeler \u00f6rneklendirilerek a\u00e7\u0131klanm\u0131\u015ft\u0131r.<\/p>\n

Yeni sa\u011fl\u0131k beyan\u0131 ba\u015fvurular\u0131nda, ba\u015fvuru sahibinin talebi \u00fczerine, Kurum, tescilli olarak izin verilen bir sa\u011fl\u0131k beyan\u0131 kullan\u0131m\u0131n\u0131 ba\u015fvuran\u0131n yarar\u0131na be\u015f y\u0131l s\u00fcre ile s\u0131n\u0131rland\u0131rmak suretiyle veri korumas\u0131 sa\u011flayabilir. Bu kapsamda, be\u015f y\u0131ll\u0131k s\u00fcre bitmeden ve s\u00f6z konusu sa\u011fl\u0131k beyan\u0131n\u0131n k\u0131lavuz ekine d\u00e2hil edilmeden, sonraki ba\u015fvuru sahibi, \u00f6nceki ba\u015fvuru sahibi taraf\u0131ndan tescilli olarak belirtilen veriyi referans g\u00f6steremeyecektir.<\/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, yay\u0131mlanan k\u0131lavuzlar\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":"

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