{"id":20735,"date":"2021-11-04T11:52:34","date_gmt":"2021-11-04T11:52:34","guid":{"rendered":"https:\/\/www.esin.av.tr\/?p=20735"},"modified":"2022-06-09T13:33:58","modified_gmt":"2022-06-09T13:33:58","slug":"saglik-sektorunde-guncel-gelismeler-kasim-2021","status":"publish","type":"post","link":"https:\/\/www.esin.av.tr\/tr\/2021\/11\/04\/saglik-sektorunde-guncel-gelismeler-kasim-2021\/","title":{"rendered":"Sa\u011fl\u0131k Sekt\u00f6r\u00fcnde G\u00fcncel Geli\u015fmeler &#8211; Kas\u0131m 2021"},"content":{"rendered":"<p><strong><a href=\"https:\/\/podcast.esin.av.tr\/?lang=tr&amp;playing=PFC1886507385?updated=1636017584\" target=\"_blank\" rel=\"noopener\"><img decoding=\"async\" class=\"alignnone wp-image-18799\" src=\"https:\/\/www.esin.av.tr\/wp-content\/uploads\/2021\/02\/1.png\" alt=\"\" width=\"55\" height=\"55\" srcset=\"https:\/\/www.esin.av.tr\/wp-content\/uploads\/2021\/02\/1.png 186w, https:\/\/www.esin.av.tr\/wp-content\/uploads\/2021\/02\/1-150x150.png 150w\" sizes=\"(max-width: 55px) 100vw, 55px\" \/><\/a>\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0Bu b\u00fcltenimizi podcast olarak da dinleyebilirsiniz!<\/strong><\/p>\n<p>&nbsp;<\/p>\n<h2>T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (&#8220;Kurum&#8221;) ge\u00e7ti\u011fimiz haftalarda yetkilendirilmi\u015f laboratuvarlar, bilimsel toplant\u0131lara kat\u0131lan sa\u011fl\u0131k meslek mensuplar\u0131n\u0131n desteklenmesi, T\u0131bbi Cihazlara ili\u015fkin Avrupa Veri Taban\u0131 (European Database on Medical Devices &#8211; EUDAMED), yurtd\u0131\u015f\u0131ndan getirilen ila\u00e7lar ve Sosyal G\u00fcvenlik Kurumu Sa\u011fl\u0131k Uygulamalar\u0131 Tebli\u011fi (&#8220;SUT&#8221;) hakk\u0131nda duyurular yay\u0131mlad\u0131.<\/h2>\n<p>G\u00fcncel geli\u015fmeler \u00f6zelindeki notlar\u0131m\u0131za a\u015fa\u011f\u0131daki linklerden ula\u015fabilirsiniz:<\/p>\n<p><u><a href=\"#tr1\"><strong>Yetkilendirilmi\u015f Laboratuvar Ba\u015fvurular\u0131 Nas\u0131l Yap\u0131l\u0131r?<\/strong><\/a><br \/>\n<a href=\"#tr2\"><strong>Ruhsat\/\u0130zin Sahipleri Taraf\u0131ndan Destek Al\u0131nacak Toplant\u0131larda Hangi Belgeler \u0130stenir?<\/strong><\/a><\/u><br \/>\n<strong><u><a href=\"#tr3\">T\u0131bbi Cihaz Y\u00f6netmeli\u011fi Kapsam\u0131nda EUDAMED Akt\u00f6r Kayd\u0131 Nas\u0131l Yap\u0131l\u0131r?<\/a><\/u><\/strong><strong><u><br \/>\n<a href=\"#tr4\">Yurtd\u0131\u015f\u0131ndan \u0130la\u00e7 Temini K\u0131lavuzu G\u00fcncellemesi Hangi De\u011fi\u015fiklikleri Getiriyor?<\/a><br \/>\n<a href=\"#tr5\">SGK Sa\u011fl\u0131k Uygulamalar\u0131 Tebi\u011fi&#8217;nde Ne De\u011fi\u015fiklikler Yap\u0131ld\u0131?<\/a><\/u> <\/strong><\/p>\n<h3><strong>Yetkilendirilmi\u015f Laboratuvar Ba\u015fvurular\u0131 Nas\u0131l Yap\u0131l\u0131r?<\/strong><\/h3>\n<p>Kurum 1.10.2021 tarihinde Yetkilendirilmi\u015f Laboratuvarlar\u0131n \u00c7al\u0131\u015fma Usul Esaslar\u0131 Hakk\u0131nda K\u0131lavuz (&#8220;<strong>K\u0131lavuz<\/strong>&#8220;) ile eklerini yay\u0131mlad\u0131. S\u00f6z konusu K\u0131lavuz, Kurum laboratuvarlar\u0131n\u0131n g\u00f6revi kapsam\u0131nda giren ila\u00e7, kozmetik ve insan v\u00fccuduna temas eden biyosidal \u00fcr\u00fcnler gibi bir tak\u0131m \u00fcr\u00fcnlerin analizini yapacak kurumlara ait laboratuvarlar\u0131n yetkilendirilmesine y\u00f6nelik d\u00fczenlemeler i\u00e7eriyor. K\u0131lavuz&#8217;a <a href=\"https:\/\/urldefense.com\/v3\/__https:\/esinxchange.com\/collect\/click.aspx?u=SXRCM3ZPWnVjeFE0NmxMdVdZSEU2WVJtVjRLU0hnUXhuK1BjZDVlUjZERWRvKzdMSWVJa21lVW4xMVVyWnZoejVhZXVRT3FRYktiVVZkb2F0b1JjZ3I3N3pRdE0xSnlYeEI4cGNyZWVvOGNtZHRTV3RxYkNyNnJaTlkrV0g0Z2loWmtTT0xYWEFUUHVQYVkwMThibDdNZEpPSno0dUhxOURkZEdzL2Z4dytCVlIyTmoxdkt2N1VzTzB0NlpoRVVWb0xVWjdsTkhUTDl0ZmRWYUUxWUhWZz09&amp;rh=ff0084eed2066358021c5679f14a9d0988a731d8__;!!Hj9Y_P0nvg!BiO-9KUA0peC_oxz861A-UQWqXnFgvftXI64AqiPsWtI40t5S0OrLNCiMAKD5xRhgvZ4TQ$\">buradan <\/a>ula\u015f\u0131labilir.<\/p>\n<h3><strong>Ne De\u011fi\u015fecek?<\/strong><\/h3>\n<p>K\u0131lavuz uyar\u0131nca ila\u00e7, kozmetik, insan v\u00fccuduna do\u011frudan temas eden biyosidal \u00fcr\u00fcnler, t\u0131bbi enteral beslenme \u00fcr\u00fcnleri, t\u0131bbi biyolojik \u00fcr\u00fcnler, biyoteknolojik \u00fcr\u00fcnler ile t\u0131bbi cihaz kalite kontrol analizi yapacak laboratuvarlar\u0131n \u00f6ncelikle analiz \u00e7al\u0131\u015fmas\u0131n\u0131 detayl\u0131 bir \u015fekilde a\u00e7\u0131klayacak ilgili belgeleri sunmak suretiyle Kurum&#8217;a ba\u015fvurmas\u0131 gerekmektedir. Ba\u015fvuru 90 g\u00fcn i\u00e7erisinde sonu\u00e7land\u0131r\u0131lacakt\u0131r. Kurum&#8217;ca ba\u015fvurusu uygun bulunan kurumlar Analiz Yetki Belgesi d\u00fczenlenerek yetkilendirilir.<\/p>\n<p>Analiz Yetki Belgesi&#8217;nin ge\u00e7erlili\u011fi bir y\u0131ld\u0131r. S\u00fcre bitiminden doksan g\u00fcn \u00f6nce yenileme i\u00e7in Kurum&#8217;a ba\u015fvurulur. Bu s\u00fcrenin ka\u00e7\u0131r\u0131lmas\u0131 halinde yenileme ba\u015fvurusu yeni bir ba\u015fvuru olarak nitelendirilecektir.<\/p>\n<p>Yetkilendirilen laboratuvarlar Kurum taraf\u0131ndan y\u0131lda en az bir kez denetime tabii tutulacakt\u0131r. Denetim, yerinde denetim ya da yetki belgesinin ask\u0131ya al\u0131nmas\u0131 ve\/veya iptali karar\u0131 ile sonu\u00e7lanabilir. Denetim sonucu analiz yetkisi iptal edilen laboratuvarlar 1 y\u0131l i\u00e7erisinde yeni bir yetki m\u00fcracaat\u0131nda bulunamayacakt\u0131r.<\/p>\n<h3><strong>Ruhsat\/\u0130zin Sahipleri Taraf\u0131ndan Destek Al\u0131nacak Toplant\u0131larda Hangi Belgeler \u0130stenir?<\/strong><\/h3>\n<p>Kurum 04.10.2021 tarihli yaz\u0131s\u0131 ile Be\u015feri T\u0131bbi \u00dcr\u00fcnlerin Tan\u0131t\u0131m Faaliyetleri Hakk\u0131nda Y\u00f6netmelik (&#8220;<strong>Y\u00f6netmelik<\/strong>&#8220;) kapsam\u0131nda d\u00fczenlenen bilimsel toplant\u0131lara kat\u0131lacak sa\u011fl\u0131k meslek mensuplar\u0131na y\u00f6nelik Kurum&#8217;a yap\u0131lan ba\u015fvurularda gerekli belge listesinde yap\u0131lan de\u011fi\u015fiklikleri duyurmaktad\u0131r. \u0130lgili duyuruya <a href=\"https:\/\/urldefense.com\/v3\/__https:\/esinxchange.com\/collect\/click.aspx?u=SXRCM3ZPWnVjeFE0NmxMdVdZSEU2WVJtVjRLU0hnUXhuK1BjZDVlUjZERWRvKzdMSWVJa21lVW4xMVVyWnZoejVhZXVRT3FRYktiVVZkb2F0b1JjZ3I3N3pRdE0xSnlYeEI4cGNyZWVvOGNJblkyZWFQWENhU0pzV2wvWk1UdDZ6RlpiRkQwV3ZxZ2lwL1d5eVBQekI1bW1pajVqYUxVb0Q4SEtGQVpra3dtb0thbVlVajc5aEoyaXBnMkNEaDcvNGd4N2VYQWxFblU9&amp;rh=ff0084eed2066358021c5679f14a9d0988a731d8__;!!Hj9Y_P0nvg!BiO-9KUA0peC_oxz861A-UQWqXnFgvftXI64AqiPsWtI40t5S0OrLNCiMAKD5xSLhGolXw$\">buradan <\/a>ula\u015f\u0131labilir.<\/p>\n<h3><strong>Ne De\u011fi\u015fecek? <\/strong><\/h3>\n<p>Y\u00f6netmelik uyar\u0131nca ruhsat\/izin sahiplerinin yurt i\u00e7i ve yurt d\u0131\u015f\u0131 bilimsel toplant\u0131lara kat\u0131lacak sa\u011fl\u0131k meslek mensuplar\u0131n\u0131 belirli \u015fartlara uymak ko\u015fuluyla desteklenmesi m\u00fcmk\u00fcnd\u00fcr. Kurum&#8217;a ad\u0131na destek ba\u015fvurusu yap\u0131lm\u0131\u015f sa\u011fl\u0131k meslek mensuplar\u0131ndan Covid-19 salg\u0131n\u0131 sebebiyle bilimsel toplant\u0131ya y\u00fcz y\u00fcze kat\u0131l\u0131m sa\u011flayabileceklerine ili\u015fkin ba\u011fl\u0131 bulunduklar\u0131 sa\u011fl\u0131k kurumu yetkilisi taraf\u0131ndan verilmi\u015f izin belgesi talep edilmekteydi. Ancak normalle\u015fme s\u00fcreci kapsam\u0131nda 04.10.2021 tarihinden itibaren d\u00fczenlenecek bilimsel toplant\u0131lar i\u00e7in Kurum ruhsat\/izin sahiplerinden sa\u011fl\u0131k meslek mensuplar\u0131na destek ba\u015fvurular\u0131nda s\u00f6z konusu yaz\u0131y\u0131 talep etmeyecektir.<\/p>\n<p>Kurum taraf\u0131ndan bu hususta verilecek onay yaln\u0131zca ilgili ruhsat\/izin sahibinin s\u00f6z konusu sa\u011fl\u0131k meslek mensubuna destek olmas\u0131na dair bir onay olup sa\u011fl\u0131k meslek mensuplar\u0131n\u0131n toplant\u0131ya kat\u0131l\u0131m uygunlu\u011fu onay\u0131 anlam\u0131na gelmemektedir.<\/p>\n<h3><strong>T\u0131bbi Cihaz Y\u00f6netmeli\u011fi Kapsam\u0131nda EUDAMED Akt\u00f6r Kayd\u0131 Nas\u0131l Yap\u0131l\u0131r?<\/strong><\/h3>\n<p>Kurum, 18.10.2021 tarihli duyurusu ile 02.06.2021 tarihli 31499 say\u0131l\u0131 Resmi Gazete&#8217;de yay\u0131mlanan T\u0131bbi Cihaz Y\u00f6netmeli\u011fi (&#8220;<strong>Y\u00f6netmelik<\/strong>&#8220;) kapsam\u0131nda Avrupa Komisyonu taraf\u0131ndan yay\u0131mlanan EUDAMED Kullanma Rehberi&#8217;nin T\u00fcrk\u00e7e versiyonunu (&#8220;<strong>Rehber<\/strong>&#8220;) yay\u0131mlam\u0131\u015ft\u0131r. Rehber, Y\u00f6netmelik kapsam\u0131ndaki iktisadi i\u015fletmecilerin EUDAMED&#8217;te akt\u00f6r kay\u0131t mod\u00fcl\u00fcne kay\u0131tlar\u0131n\u0131 ger\u00e7ekle\u015ftirmelerine y\u00f6nelik y\u00f6nlendirmeler i\u00e7ermektedir. Rehber&#8217;e <a href=\"https:\/\/urldefense.com\/v3\/__https:\/esinxchange.com\/collect\/click.aspx?u=SXRCM3ZPWnVjeFE0NmxMdVdZSEU2WVJtVjRLU0hnUXhuK1BjZDVlUjZERWRvKzdMSWVJa21lVW4xMVVyWnZoejVhZXVRT3FRYktiVVZkb2F0b1JjZ3I3N3pRdE0xSnlYeEI4cGNyZWVvOGRiUmVqUTZoeEJLNy9oblJNSG03VUEycUVNZFkwNjhKMm51S3VwUVZrL29LY0oxeEtobytTK3BGZ1lFVlVNZkJ1RUV2bTU4dm81dDkrK090MFFDUDlHT1VQTmRIY3RpL0k9&amp;rh=ff0084eed2066358021c5679f14a9d0988a731d8__;!!Hj9Y_P0nvg!BiO-9KUA0peC_oxz861A-UQWqXnFgvftXI64AqiPsWtI40t5S0OrLNCiMAKD5xRF3NFjSA$\">buradan <\/a>ula\u015f\u0131labilir.<\/p>\n<h3><strong>Ne De\u011fi\u015fecek?<\/strong><\/h3>\n<p>Y\u00f6netmelik iktisadi i\u015fletmecileri piyasaya arz edilen t\u0131bbi cihazlar ya da onaylanm\u0131\u015f kurulu\u015flarca d\u00fczenlenen sertifikalar gibi bir tak\u0131m verileri EUDAMED&#8217;e kaydetmekte y\u00fck\u00fcml\u00fc k\u0131lm\u0131\u015ft\u0131r. Rehber, bu y\u00fck\u00fcml\u00fcl\u00fc\u011f\u00fcn gere\u011fi gibi yerine getirilebilmesi i\u00e7in EUDAMED kullan\u0131m\u0131na ili\u015fkin detayl\u0131 a\u00e7\u0131klamalar i\u00e7ermektedir. Bu \u00e7er\u00e7evede Rehber, EUDAMED&#8217;e iktisadi olarak kay\u0131t olma, hesap sonland\u0131rma, kay\u0131tl\u0131 akt\u00f6rleri g\u00f6r\u00fcnt\u00fcleme, kullan\u0131c\u0131 eri\u015fimi y\u00f6netimi, kullan\u0131c\u0131 eri\u015fimi ve yetki belgelerinin y\u00f6netimi gibi pek \u00e7ok konuda anlat\u0131mlara yer verilmi\u015ftir.<\/p>\n<h3><strong>Yurtd\u0131\u015f\u0131ndan \u0130la\u00e7 Temini K\u0131lavuzu G\u00fcncellemesi Hangi De\u011fi\u015fiklikleri Getiriyor?<\/strong><\/h3>\n<p>Kurum 23.10.2021 tarihli duyurusu ile Yurtd\u0131\u015f\u0131ndan \u0130la\u00e7 Tedariki ve Kullan\u0131m K\u0131lavuzu&#8217;nu (&#8220;<strong>K\u0131lavuz<\/strong>&#8220;) g\u00fcncelledi\u011fine ve EK-5&#8217;te bir tak\u0131m de\u011fi\u015fikler ger\u00e7ekle\u015ftirdi\u011fine ili\u015fkin duyuru yay\u0131mlad\u0131. G\u00fcncelleme kapsam\u0131nda yurtd\u0131\u015f\u0131ndan tedarik edilen be\u015feri t\u0131bbi \u00fcr\u00fcnlerin uymas\u0131 gereken ilave standartlar belirlenmi\u015ftir. K\u0131lavuz&#8217;a ve Ek-5&#8217;e <a href=\"https:\/\/urldefense.com\/v3\/__https:\/esinxchange.com\/collect\/click.aspx?u=SXRCM3ZPWnVjeFE0NmxMdVdZSEU2WVJtVjRLU0hnUXhuK1BjZDVlUjZERkNxTElnYzl4eHlBOUxXMGw4OEVlcmpuYzJwdmg3RTA5SGdDbkFHTEtCeXlCVko0QzVNay92SWhkR2Z0Y1ZJbHVncHhtaXkzMjU3ZSt2WEx3QmJQa2g3MzJoVTdpTVkzU2VGM1AzZDBySzBoVUxWVVdCM2xzSFdyY3h1NHlwSm1wUU9LNTZGVkgrc1E9PQ==&amp;rh=ff0084eed2066358021c5679f14a9d0988a731d8__;!!Hj9Y_P0nvg!BiO-9KUA0peC_oxz861A-UQWqXnFgvftXI64AqiPsWtI40t5S0OrLNCiMAKD5xS90DUV7A$\">buradan <\/a>ula\u015f\u0131labilir.<\/p>\n<h3><strong>Ne De\u011fi\u015fecek? <\/strong><\/h3>\n<p>G\u00fcncelleme kapsam\u0131nda be\u015feri t\u0131bbi \u00fcr\u00fcn temininde uyumluluk aranan uluslararas\u0131 kurum ve d\u00fczenlemeler hususunda de\u011fi\u015fiklik yap\u0131lm\u0131\u015ft\u0131r. Buna g\u00f6re art\u0131k Amerikan G\u0131da ve \u0130la\u00e7 Kurumu, Avrupa \u0130la\u00e7 Kurumu, \u0130la\u00e7 Denetim S\u00f6zle\u015fmesi ve \u0130la\u00e7 Denetim \u0130\u015fbirli\u011fi Program\u0131 yerine Uluslararas\u0131 Be\u015feri T\u0131bbi \u00dcr\u00fcn Kullan\u0131m\u0131nda Teknik Gerekliliklerin Hamonizasyonu Konseyi (<em>ing<\/em>. ICH) ile daimi ve kurucu \u00fcyeleri Birle\u015fik Krall\u0131k Yetkili Otoritesi (<em>ing<\/em>. MHRA) ve Avustralya Yetkili Otoritesi (<em>ing<\/em>. TGA) faaliyetleri esas al\u0131nacakt\u0131r. Tebli\u011f&#8217;in EK-1&#8217;inde yer alan Yurtd\u0131\u015f\u0131 \u0130la\u00e7 Listesi&#8217;ndeki be\u015feri t\u0131bbi \u00fcr\u00fcnlerinin temini g\u00fcncellenen Ek-5&#8217;te (Yurtd\u0131\u015f\u0131ndan \u0130la\u00e7 Tedariki S\u0131ras\u0131nda Tedarik\u00e7iler Taraf\u0131ndan Uyulmas\u0131 Gereken Kurallar) getirilen d\u00fczenlemeler ile uyumlu olmal\u0131d\u0131r. Buna g\u00f6re tedarik edilen \u00fcr\u00fcnlerin MHRA ve TGA taraf\u0131ndan bilimsel olarak etkililik, g\u00fcvenlilik ve kalite verilerinin sa\u011flanarak ruhsatland\u0131r\u0131lm\u0131\u015f ve piyasaya arz edilmi\u015f olmas\u0131 gerekir. Ayr\u0131ca tedarik edilen \u00fcr\u00fcnler MHRA ve TGA taraf\u0131ndan denetlenerek \u0130yi \u00dcretim Uygulamalar\u0131 \u00e7er\u00e7evesinde faaliyet g\u00f6steren tesislerde \u00fcretilmi\u015f olmal\u0131d\u0131r.<\/p>\n<p>Ek olarak yurtd\u0131\u015f\u0131 ila\u00e7 tedarik\u00e7ilerin \u00fcr\u00fcnlerin teslimi s\u0131ras\u0131nda Men\u015fe \u015eahadetnamesi, Analiz Sertifikas\u0131 ve Serbest B\u0131rakma Sertikas\u0131&#8217;n\u0131n sunulmas\u0131 zorunlu tutulmu\u015ftur. Ayr\u0131ca Yurtd\u0131\u015f\u0131 \u0130la\u00e7 De\u011ferlendirme Komisyonu taraf\u0131ndan K\u0131lavuz&#8217;un 5. maddesinin 3. f\u0131kras\u0131n\u0131n a ve b alt bentlerinde belirlenen \u00fclkelerde \u00fcretilen \u00fcr\u00fcnler hari\u00e7, Yurtd\u0131\u015f\u0131 \u0130la\u00e7 Listesi&#8217;ne \u00fcr\u00fcn eklenmesi talebinde bulunulmas\u0131 halinde, \u00fcr\u00fcn bazl\u0131 \u0130yi \u00dcretim Uygulamalar\u0131 (<em>ing<\/em>. GMP) denetimi yap\u0131lmas\u0131na karar verilebilecektir.<\/p>\n<p>K\u0131lavuz&#8217;un yay\u0131mland\u0131\u011f\u0131 tarihte K\u0131lavuz h\u00fck\u00fcmlerine uymayan fakat yurtd\u0131\u015f\u0131 ila\u00e7 tedarik\u00e7ileri taraf\u0131ndan ihalesi duyurulmu\u015f veya yap\u0131lm\u0131\u015f olan \u00fcr\u00fcnlerin mevcut ihale \u015fartlar\u0131 ve s\u00fcresi temini boyunca devam edecektir.<\/p>\n<h3><strong>SGK Sa\u011fl\u0131k Uygulamalar\u0131 Tebi\u011fi&#8217;nde Ne De\u011fi\u015fiklikler Yap\u0131ld\u0131?\u00a0<\/strong><\/h3>\n<p>26.10.2021 tarihli ve 31640 say\u0131l\u0131 Resmi Gazete ile Sosyal G\u00fcvenlik Kurumu Sa\u011fl\u0131k Uygulamalar\u0131 Tebli\u011fi (&#8220;<strong>SUT<\/strong>&#8220;) de\u011fi\u015ftirildi. Tebli\u011f ile baz\u0131 \u00f6zel hastal\u0131klarda kullan\u0131lacak ila\u00e7lar ile e\u015fde\u011fer ila\u00e7lara y\u00f6nelik \u00e7e\u015fitli d\u00fczenlemeler i\u00e7eriyor. S\u00f6z konusu de\u011fi\u015fikli\u011fe <a href=\"https:\/\/urldefense.com\/v3\/__https:\/esinxchange.com\/collect\/click.aspx?u=SXRCM3ZPWnVjeFE0NmxMdVdZSEU2WVJtVjRLU0hnUXhuK1BjZDVlUjZESEVaNncyRTFROXhlWHlHdzN2MEFLM2NBZ0k1ZUVqclFOQjZERGMyS1MrYjA0SHl6Z3J1eHJXRlc1RURNQWxZUXVSMWpnS2JyS2E0QWZkWXVyVm5qeFI=&amp;rh=ff0084eed2066358021c5679f14a9d0988a731d8__;!!Hj9Y_P0nvg!BiO-9KUA0peC_oxz861A-UQWqXnFgvftXI64AqiPsWtI40t5S0OrLNCiMAKD5xQtX5ihBg$\">buradan <\/a>ula\u015f\u0131labilir.<\/p>\n<h3><strong>Ne De\u011fi\u015fecek? <\/strong><\/h3>\n<p>Yap\u0131lan de\u011fi\u015fiklik kapsam\u0131nda \u00e7ocuklarda kronik b\u00f6brek yetmezli\u011fi ya da Prader Will sendromu gibi \u00e7e\u015fitli hastal\u0131klarda kullan\u0131lacak ila\u00e7 ve etkin maddelere y\u00f6nelik bir tak\u0131m d\u00fczenlemeler getirilmi\u015ftir. Ek olarak ila\u00e7larda uygulanacak indirim uygulamas\u0131nda de\u011fi\u015fiklik yap\u0131lm\u0131\u015ft\u0131r. Bu kapsamda SGK e\u015fde\u011fer grup\/ ve\/veya ter\u00f6patik referans grubu olu\u015fturabilecektir. Yaln\u0131zca e\u015fde\u011fer grupta yer alan ila\u00e7lar eczanelerde ikame edilebilecektir.<br \/>\nAyr\u0131ca Tebli\u011f&#8217;in a\u015fa\u011f\u0131da yer alan eklerinde de\u011fi\u015fiklikler yap\u0131lm\u0131\u015ft\u0131r:<\/p>\n<ul>\n<li>Ek-4\/A Bedeli \u00d6denecek \u0130la\u00e7lar Listesi<\/li>\n<li>Ek-4\/D Hasta Kat\u0131l\u0131m Pay\u0131ndan Muaf \u0130la\u00e7lar Listesi<\/li>\n<li>Ek-4\/E Sistemik Antimikrobik ve Di\u011fer \u0130la\u00e7lar\u0131n Re\u00e7eteleme Kurallar\u0131 Listesi<\/li>\n<li>Ek-4\/F Ayakta Tedavide Sa\u011fl\u0131k Raporu ile Verilebilecek \u0130la\u00e7lar Listesi<\/li>\n<li>EK-4\/G Sadece Yatarak Tedavilerde Kullan\u0131m\u0131 Halinde Bedelleri \u00d6denecek \u0130la\u00e7lar Listesi<\/li>\n<\/ul>\n<h3><strong>Sonu\u00e7<\/strong><\/h3>\n<p>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&#8217;un duyurular\u0131n\u0131 yak\u0131ndan takip etmeli ve mevzuatta yer alan y\u00fck\u00fcml\u00fcl\u00fcklerini Kurum&#8217;un y\u00f6nlendirmeleri do\u011frultusunda yerine getirmelidir.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0Bu b\u00fcltenimizi podcast olarak da dinleyebilirsiniz! &nbsp; T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (&#8220;Kurum&#8221;) [&hellip;]<\/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-20735","post","type-post","status-publish","format-standard","hentry","category-legal-alerts","tag-healthcare-tr"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Sa\u011fl\u0131k Sekt\u00f6r\u00fcnde G\u00fcncel Geli\u015fmeler - Kas\u0131m 2021<\/title>\n<meta name=\"description\" content=\"\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0Bu b\u00fcltenimizi podcast olarak da dinleyebilirsiniz! 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