{"id":20223,"date":"2021-09-24T08:41:26","date_gmt":"2021-09-24T08:41:26","guid":{"rendered":"https:\/\/www.esin.av.tr\/?p=20223"},"modified":"2022-06-09T13:29:05","modified_gmt":"2022-06-09T13:29:05","slug":"saglik-sektorunde-guncel-gelismeler-24-eylul-2021","status":"publish","type":"post","link":"https:\/\/www.esin.av.tr\/tr\/2021\/09\/24\/saglik-sektorunde-guncel-gelismeler-24-eylul-2021\/","title":{"rendered":"Sa\u011fl\u0131k Sekt\u00f6r\u00fcnde G\u00fcncel Geli\u015fmeler &#8211; 24 Eyl\u00fcl 2021"},"content":{"rendered":"<p><strong><a href=\"https:\/\/podcast.esin.av.tr\/?lang=tr&amp;playing=PFC1256768245?updated=1632471004\" 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=\"53\" height=\"53\" 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: 53px) 100vw, 53px\" \/><\/a>\u00a0 \u00a0 \u00a0 \u00a0Bu b\u00fcltenimizi podcast olarak da dinleyebilirsiniz!<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p>T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (&#8220;<strong>Kurum<\/strong>&#8220;) ge\u00e7ti\u011fimiz haftalarda kozmetik \u00fcr\u00fcnler mevzuat\u0131nda de\u011fi\u015fiklik,\u00a0 homeopatik t\u0131bbi \u00fcr\u00fcnlerin ruhsatland\u0131r\u0131lmas\u0131 ve bedelsiz tan\u0131t\u0131m numunesi da\u011f\u0131t\u0131m\u0131 ve bas\u0131n duyurusu ba\u015fvurusu hakk\u0131nda duyurular yay\u0131mlad\u0131.<\/p>\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>Kozmetik \u00dcr\u00fcnler Y\u00f6netmeli\u011fi&#8217;nde De\u011fi\u015fiklik<\/strong><\/a><br \/>\n<strong><a href=\"#tr2\">Homeopoatik T\u0131bbi \u00dcr\u00fcnler Ruhsatland\u0131rma Y\u00f6netmeli\u011fi Tasla\u011f\u0131 Yay\u0131mland\u0131<\/a><\/strong><strong><br \/>\n<a href=\"#tr3\">Bedelsiz Tan\u0131t\u0131m Numunesi Da\u011f\u0131t\u0131m\u0131 ve Bas\u0131n Duyurusu Hakk\u0131nda<\/a><\/strong><\/u><\/p>\n<p><strong>Kozmetik \u00dcr\u00fcnler Y\u00f6netmeli\u011fi&#8217;nde De\u011fi\u015fiklik<\/strong><\/p>\n<p><strong>Yeni Geli\u015fme<\/strong><\/p>\n<p>Kozmetik Y\u00f6netmeli\u011finde (&#8220;<strong>Y\u00f6netmelik<\/strong>&#8220;) De\u011fi\u015fiklik Yap\u0131lmas\u0131na Dair Y\u00f6netmelik 08.09.2021 tarihli ve 31592 M\u00fckerrer Resmi Gazete&#8217;de yay\u0131mland\u0131. S\u00f6z konusu de\u011fi\u015fiklik, kozmetik \u00fcr\u00fcnlerde kullan\u0131lan maddelere ili\u015fkin listelerde \u00e7e\u015fitli de\u011fi\u015fiklikleri d\u00fczenliyor. \u0130lgili Y\u00f6netmelik de\u011fi\u015fikli\u011fine <a href=\"https:\/\/urldefense.com\/v3\/__https:\/esinxchange.com\/collect\/click.aspx?u=QVM4VHpVNmFnL2FxU2FaUjIway82K1Y4S3JOeXlGdjRYMHJiMms4clRMYjU2Z3IxQ2QvNG9Ia1JPb1JpeGVObHQwMUpUa0ZHdGx0aWozcGxtc25DaFZFc3BvbjFaOGR5bUVSd1pqN2lseUV5TTNCalhmM1dGK2h3dnNqRzhzWno=&amp;rh=ff008200fa5d8f0ec2fbda33a845bb1530e1bdd2__;!!Hj9Y_P0nvg!HReOHN41M3GYuprm0bk24DgNcpt4RSqJs-rPsj0-dDOvFP-kpIehqlgZFLGMIdwWdyM$\">buradan <\/a>ula\u015fabilirsiniz.<\/p>\n<p><strong>Ne De\u011fi\u015fecek? \u00a0<\/strong><\/p>\n<p>Yap\u0131lan de\u011fi\u015fiklik do\u011frultusunda Y\u00f6netmelik&#8217;in eklerinde d\u00fczenlenen a\u015fa\u011f\u0131daki listeler geni\u015fletildi:<\/p>\n<ul>\n<li>Kozmetik \u00dcr\u00fcnlerde Yasakl\u0131 Maddeler Listesi<\/li>\n<li>Belirli S\u0131n\u0131rlamalar D\u0131\u015f\u0131nda Kozmetik \u00dcr\u00fcnlerin \u0130\u00e7ermemesi Geren Maddeler Listesi<\/li>\n<li>Kozmetik \u00dcr\u00fcnlerde Kullan\u0131lmas\u0131na \u0130zin Verilen Boyar Maddelerin Listesi<\/li>\n<li>Kozmetik \u00dcr\u00fcnlerde Kullan\u0131lmas\u0131na \u0130zin Verilen Koruyucular\u0131n Listesi<\/li>\n<li>Kozmetik \u00dcr\u00fcnlerde Kullan\u0131lmas\u0131na \u0130zin Verilen UV Filtrelerin Listesi<\/li>\n<\/ul>\n<p><strong>Homeopoatik T\u0131bbi \u00dcr\u00fcnler Ruhsatland\u0131rma Y\u00f6netmeli\u011fi Tasla\u011f\u0131 Yay\u0131mland\u0131<\/strong><\/p>\n<p><strong>Yeni Geli\u015fme<\/strong><\/p>\n<p>Kurum 09.09.2021 tarihinde Homeopoatik T\u0131bbi \u00dcr\u00fcnler Ruhsatland\u0131rma Y\u00f6netmeli\u011fi Tasla\u011f\u0131 (&#8220;<strong>Taslak Y\u00f6netmelik<\/strong>&#8220;) yay\u0131mland\u0131. \u0130lgili Taslak Y\u00f6netmelik homeopatik t\u0131bbi \u00fcr\u00fcnlerin istenen etkilili\u011fe, g\u00fcvenlili\u011fe ve kaliteye sahip olmalar\u0131n\u0131 sa\u011flamak \u00fczere ruhsatland\u0131rma s\u00fcrecini d\u00fczenliyor. Taslak Y\u00f6netmelik 20.09.2021 tarihine kadar kamuoyu g\u00f6r\u00fc\u015f\u00fcne a\u00e7\u0131k kalacak. Taslak Y\u00f6netmelik&#8217;e buradan <a href=\"https:\/\/urldefense.com\/v3\/__https:\/esinxchange.com\/collect\/click.aspx?u=QVM4VHpVNmFnL2FxU2FaUjIway82K1Y4S3JOeXlGdjRYMHJiMms4clRMYmo4NU9lMHFmNXBMVEdBc1dleW9LSDM2ZGYzWitIcWo5cFZzbjY0QWJIeDVIRXVuRWUyaklraWxWTk1tWnRnWkxiK0xDTWdrbXB1VnpGRGdDQng0TmJlZzM5VHhZM0RqMUorbGpXVDY0cTMvaWZwUXB6QlNMSUdMZTJOVVpVT015MEdXYkIrWlBlN2JGanZyUldQQ3pxQm5yTVBERE5TeFRYSTB1VG9TOEJ6NWNZUlBTMTlWV29ubzNQVlpxQ1FHVT0=&amp;rh=ff008200fa5d8f0ec2fbda33a845bb1530e1bdd2__;!!Hj9Y_P0nvg!HReOHN41M3GYuprm0bk24DgNcpt4RSqJs-rPsj0-dDOvFP-kpIehqlgZFLGMtcIGRjA$\">buradan <\/a>ula\u015fabilirsiniz.<\/p>\n<p><strong>Yeni Geli\u015fme<\/strong><\/p>\n<p>Taslak Y\u00f6netmelik&#8217;te homeopatik t\u0131bbi \u00fcr\u00fcnlerin ruhsatland\u0131r\u0131lmas\u0131n\u0131n zorunlu k\u0131l\u0131nmas\u0131n\u0131 \u00f6ng\u00f6r\u00fclmektedir.<br \/>\nTaslak Y\u00f6netmelik uyar\u0131nca T\u0130TCK yaln\u0131zca a\u015fa\u011f\u0131da belirtilen ko\u015fullar\u0131 sa\u011flayan homeopatik t\u0131bbi \u00fcr\u00fcnlere y\u00f6nelik ruhsat ba\u015fvurular\u0131 de\u011ferlendirilecektir:<\/p>\n<ul>\n<li>\u0130lgili \u00fcr\u00fcn\u00fcn oral veya haricen kullan\u0131lmas\u0131.<\/li>\n<li>\u0130lgili \u00fcr\u00fcn\u00fcn ambalaj ve di\u011fer bilgilerinde spesifik terap\u00f6tik endikasyonun bulunmamas\u0131.<\/li>\n<li>T\u0131bbi \u00fcr\u00fcn g\u00fcvenlili\u011fini garanti edecek \u015fekilde seyreltilmi\u015f olmas\u0131.<\/li>\n<\/ul>\n<p>Taslak Y\u00f6netmelik, ruhsat ba\u015fvurusu i\u00e7in ibraz\u0131 zorunlu olan bilgi ve belgelerin yan\u0131 s\u0131ra, bu s\u00fcre\u00e7te at\u0131lmas\u0131 gereken ad\u0131mlar detayl\u0131ca d\u00fczenlemektedir. Ek olarak, homeopatik t\u0131bbi \u00fcr\u00fcnlerin d\u0131\u015f ve i\u00e7 ambalajlar\u0131nda bulunmas\u0131 zorunlu unsurlar ile prospekt\u00fcs\u00fcn i\u00e7eri\u011fi gibi konular da detayl\u0131ca ele al\u0131nm\u0131\u015ft\u0131r.<br \/>\nRuhsat s\u00fcresiz olarak ge\u00e7erlidir. Ancak istisnai olarak Kurum ruhsat\u0131n belirli bir s\u00fcreyle s\u0131n\u0131rland\u0131r\u0131lmas\u0131na karar verebilir. Ruhsat sahibi ilk kez piyasaya s\u00fcrece\u011fi homeopatik t\u0131bbi \u00fcr\u00fcnler i\u00e7in ayr\u0131ca Kurum&#8217;dan sat\u0131\u015f izni almak zorundad\u0131r. Ancak \u00fcr\u00fcn\u00fcn ruhsata esas ambalaj bilgilerinin, \u00f6zelliklerinin veya prospekt\u00fcs\u00fcn de\u011fi\u015fmesine yol a\u00e7an i\u015flemler i\u00e7in yeniden sat\u0131\u015f izni al\u0131nmas\u0131na gerek yoktur. Ruhsat sahibi ayr\u0131ca \u00fcr\u00fcn\u00fcn\u00fcn kabul edilen ko\u015fullarda \u00fcretimi, do\u011fru ve g\u00fcvenli kullan\u0131m i\u00e7in gerekmesi halinde prospekt\u00fcs\u00fcn g\u00fcncellenmesi, Kurum taraf\u0131ndan talep edilen hususlara zaman\u0131nda cevap verilmesi, \u00fcr\u00fcn\u00fcn piyasada bulunabilirli\u011finin sa\u011flanmas\u0131 gibi konulardan sorumludur.<\/p>\n<p>Ruhsata ili\u015fkin y\u00fck\u00fcml\u00fcl\u00fcklerin yerine getirilmemesi halinde ruhsat\u0131n ask\u0131ya al\u0131nmas\u0131 ve ruhsat\u0131n iptali yapt\u0131r\u0131mlar\u0131 \u00f6ng\u00f6r\u00fclm\u00fc\u015ft\u00fcr. Yapt\u0131r\u0131m uygulanan homeopatik t\u0131bbi \u00fcr\u00fcnlerin listesi Kurum&#8217;un internet sitesinde yay\u0131mlanacakt\u0131r.<\/p>\n<p>Homeopatik t\u0131bbi \u00fcr\u00fcnlerin tan\u0131t\u0131m\u0131 ise Be\u015fer\u00ee T\u0131bbi \u00dcr\u00fcnlerin Tan\u0131t\u0131m Faaliyetleri Hakk\u0131nda Y\u00f6netmeli\u011fe tabi k\u0131l\u0131nm\u0131\u015ft\u0131r.<\/p>\n<p><strong>Bedelsiz Tan\u0131t\u0131m Numunesi Da\u011f\u0131t\u0131m\u0131 ve Bas\u0131n Duyurusu Hakk\u0131nda<\/strong><\/p>\n<p><strong>Yeni D\u00fczenlemeler<\/strong><\/p>\n<p>Kurum 03.09.2021 tarihinde g\u00fcncellenen Bedelsiz Tan\u0131t\u0131m Numunesi Da\u011f\u0131t\u0131m\u0131 ve Bas\u0131n Duyurusu Ba\u015fvuru K\u0131lavuz&#8217;u (&#8220;<strong>K\u0131lavuz<\/strong>&#8220;) yay\u0131mland\u0131. \u0130lgili g\u00fcncelleme kapsam\u0131nda K\u0131lavuz&#8217;a bir tak\u0131m yeni tan\u0131mlar eklenmi\u015f, ayr\u0131ca bedelsiz tan\u0131t\u0131m numunesi ba\u015fvuru ko\u015fullar\u0131nda baz\u0131 de\u011fi\u015fikliklere gidilmi\u015ftir. K\u0131lavuz&#8217;a <a href=\"https:\/\/urldefense.com\/v3\/__https:\/esinxchange.com\/collect\/click.aspx?u=QVM4VHpVNmFnL2FxU2FaUjIway82K1Y4S3JOeXlGdjRYMHJiMms4clRMWnNvYmRwZkZ0T1prdGpKdTRENWVLV1RUMmVxZ0RwWGgwczU0cDJJM3RJM1BNN0l6Z0ljMmovV0lQZTNSMzdsU3drazFKVU9JNE5YYmtPNWdCd0VhT3hRa1h4Q0Q3Ukd0UEUvODhVMmJ3WkUyTng4aTlIbks2Vg==&amp;rh=ff008200fa5d8f0ec2fbda33a845bb1530e1bdd2__;!!Hj9Y_P0nvg!HReOHN41M3GYuprm0bk24DgNcpt4RSqJs-rPsj0-dDOvFP-kpIehqlgZFLGMRN0TJtA$\">buradan <\/a>ula\u015fabilirsiniz.<\/p>\n<p><strong>Ne De\u011fi\u015fecek?<\/strong><\/p>\n<p>G\u00fcncelleme kapsam\u0131nda K\u0131lavuz&#8217;a bedelsiz tan\u0131t\u0131m numunesi, demo cihaz\u0131, \u0130la\u00e7 Takip Sistemi (\u0130TS) gibi bir tak\u0131m yeni tan\u0131mlar eklenmi\u015ftir. Buna ek olarak bedelsiz tan\u0131t\u0131m numunelerinin ba\u015fvuru ko\u015fullar\u0131nda bir tak\u0131m yenilikler getirilmi\u015ftir. Buna g\u00f6re tan\u0131t\u0131m\u0131 yap\u0131lacak \u00fcr\u00fcn\u00fcn ruhsat\/izin sahibi \u0130TS \u00fczerinden bedelsiz tan\u0131t\u0131m numunesi \u00fcretim bildirimi yapmakla y\u00fck\u00fcml\u00fcd\u00fcr. Bunun ard\u0131ndan sa\u011fl\u0131k meslek mensubuna bildirimi yap\u0131lan bedelsiz tan\u0131t\u0131m numunesi sa\u011flanabilir. Ancak bedelsiz tan\u0131t\u0131m numunesinin verildi\u011fi tarihten itibaren en ge\u00e7 60 (altm\u0131\u015f) g\u00fcn i\u00e7inde, da\u011f\u0131t\u0131m bildirimi yap\u0131lmal\u0131d\u0131r. \u0130laveten, bedelsiz tan\u0131t\u0131m numunesi ba\u015fvurusu s\u0131ras\u0131nda sunulmas\u0131 gereken evrak listesine geni\u015fletilmi\u015ftir.<\/p>\n<p><strong>Sonu\u00e7 <\/strong><\/p>\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\u2019un duyurular\u0131n\u0131 yak\u0131ndan takip etmeli ve mevzuatta yer alan y\u00fck\u00fcml\u00fcl\u00fcklerini Kurum\u2019un y\u00f6nlendirmeleri do\u011frultusunda yerine getirmelidir.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u00a0 \u00a0 \u00a0 \u00a0Bu b\u00fcltenimizi podcast olarak da dinleyebilirsiniz! &nbsp; T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (&#8220;Kurum&#8220;) ge\u00e7ti\u011fimiz haftalarda kozmetik [&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-20223","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 - 24 Eyl\u00fcl 2021<\/title>\n<meta name=\"description\" content=\"\u00a0 \u00a0 \u00a0 \u00a0Bu b\u00fcltenimizi podcast olarak da dinleyebilirsiniz! 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