{"id":2948,"date":"2012-07-09T14:05:13","date_gmt":"2012-07-09T11:05:13","guid":{"rendered":"http:\/\/www.ced.org.tr\/?p=2948"},"modified":"2012-07-09T14:05:13","modified_gmt":"2012-07-09T11:05:13","slug":"geleneksel-bitkisel-tibbi-urunlerde-yeni-donem-basliyor","status":"publish","type":"post","link":"http:\/\/www.ced.org.tr\/?p=2948","title":{"rendered":"Geleneksel Bitkisel T\u0131bbi \u00dcr\u00fcnler&#8217;de yeni d\u00f6nem ba\u015fl\u0131yor"},"content":{"rendered":"<p><p>Geleneksel Bitkisel T\u0131bbi \u00dcr\u00fcnler Y\u00f6netmeli\u011fi&#8217;nin y\u00fcr\u00fcrl\u00fc\u011fe girdi\u011fi tarihten \u00f6nce Bakanl\u0131ktan izinli olarak piyasaya arz edilmi\u015f olan \u00fcr\u00fcnler i\u00e7in tan\u0131nan 2 y\u0131ll\u0131k ge\u00e7i\u015f s\u00fcresi <strong>06.10.2012<\/strong> tarihinde sona eriyor.<\/p>\n<p>06.10.2010 tarih ve 27721 say\u0131l\u0131 Resmi Gazete\u2019de yay\u0131mlanarak y\u00fcr\u00fcrl\u00fc\u011fe giren \u201cGeleneksel Bitkisel T\u0131bbi \u00dcr\u00fcnler Y\u00f6netmeli\u011fi&#8217;nin ge\u00e7ici 1. maddesine g\u00f6re izin sahibi ki\u015filerin bu Y\u00f6netmeli\u011fin y\u00fcr\u00fcrl\u00fc\u011fe girdi\u011fi tarihten itibaren iki y\u0131l i\u00e7erisinde Bakanl\u0131k\u00e7a istenilen belgeler ile ruhsat m\u00fcracaat\u0131nda bulunmalar\u0131 gerekiyor.<\/p>\n<\/p>\n<p>Bu tarihten sonra <strong>Geleneksel Bitkisel T\u0131bbi \u00dcr\u00fcnler<\/strong> &#8220;yeni hukuki stat\u00fc&#8221; ye tabi olacaklar.<\/p>\n<p><strong>Geleneksel Bitkisel T\u0131bbi \u00dcr\u00fcnler y\u00f6netmeli\u011fine g\u00f6re;<\/strong><\/p>\n<p>-Bu \u00fcr\u00fcnler \u0130yi \u0130malat Uygulamalar\u0131 (GMP) ko\u015fullar\u0131n\u0131 sa\u011flayan \u00fcretim yerlerinde \u00fcretilmek \u015fart\u0131yla Sa\u011fl\u0131k Bakanl\u0131\u011f\u0131 taraf\u0131ndan ruhsatland\u0131r\u0131lacak.<\/p>\n<p>-Ruhsat ba\u015fvurular\u0131 Ortak Teknik Dok\u00fcman (OTD) format\u0131nda yap\u0131lacak.<\/p>\n<p>-\u00dcr\u00fcnlerin pazara sunulmas\u0131 i\u00e7in ruhsat ba\u015fvurusunda bulunacak ger\u00e7ek ki\u015filerin; eczac\u0131l\u0131k, t\u0131p veya kimya bilim dallar\u0131nda e\u011fitim veren y\u00fcksek \u00f6\u011frenim kurumlar\u0131ndan birisinden mezun olmalar\u0131 , T\u00fczel ki\u015filerin; belirtilen vas\u0131flar\u0131 ta\u015f\u0131yan birini \u201cyetkili ki\u015fi\u201d s\u0131fat\u0131yla istihdam etmeleri, gerekecek.<\/p>\n<p>\u00dcr\u00fcn\u00fcn normal kullan\u0131m ko\u015fullar\u0131nda \u00f6ng\u00f6r\u00fclmeyen toksik bir etkisinin ortaya \u00e7\u0131kmas\u0131 ve Terap\u00f6tik etkisinin olmad\u0131\u011f\u0131n\u0131n veya yetersiz oldu\u011funun tespiti durumunda \u00fcr\u00fcne ait ruhsat Bakanl\u0131k taraf\u0131ndan ask\u0131ya al\u0131nacak.<\/p>\n<p>-\u00dcr\u00fcn\u00fcn ruhsat alm\u0131\u015f oldu\u011fu endikasyonu d\u0131\u015f\u0131nda bir endikasyon belirtilerek piyasaya arz\u0131n\u0131n tespiti h\u00e2linde, \u00fcr\u00fcn\u00fcn piyasaya arz\u0131 durdurulup \u00a0piyasadaki \u00fcr\u00fcnler geri \u00e7ekilecek.<\/p>\n<p>Sa\u011fl\u0131k Bakanl\u0131\u011f\u0131 taraf\u0131ndan d\u00fczenlenen izin belgeleri ile piyasaya arz edilmi\u015f \u00fcr\u00fcnlerin \u0130zin belgelerinin son ge\u00e7erlilik tarihi 06.10.2012.<\/p>\n<p>\u00a0<\/p>\n<p><a href=\"mevzuat\/geleneksel_bitkisel_tibbi_urunler_yonetmeligi.pdf\" target=\"_blank\">Geleneksel Bitkisel T\u0131bbi \u00dcr\u00fcnler y\u00f6netmeli\u011fi i\u00e7in t\u0131klay\u0131n\u0131z.<\/a><\/p>\n<div><\/div>\n<\/p>\n<p>\u00a0<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Geleneksel Bitkisel T\u0131bbi \u00dcr\u00fcnler Y\u00f6netmeli\u011fi&#8217;nin y\u00fcr\u00fcrl\u00fc\u011fe girdi\u011fi tarihten \u00f6nce Bakanl\u0131ktan izinli olarak piyasaya arz edilmi\u015f olan \u00fcr\u00fcnler i\u00e7in tan\u0131nan 2&#46;&#46;&#46;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[62],"tags":[],"class_list":["post-2948","post","type-post","status-publish","format-standard","hentry","category-sagliktan-haberler"],"aioseo_notices":[],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"jetpack-related-posts":[],"_links":{"self":[{"href":"http:\/\/www.ced.org.tr\/index.php?rest_route=\/wp\/v2\/posts\/2948","targetHints":{"allow":["GET"]}}],"collection":[{"href":"http:\/\/www.ced.org.tr\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"http:\/\/www.ced.org.tr\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"http:\/\/www.ced.org.tr\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"http:\/\/www.ced.org.tr\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=2948"}],"version-history":[{"count":0,"href":"http:\/\/www.ced.org.tr\/index.php?rest_route=\/wp\/v2\/posts\/2948\/revisions"}],"wp:attachment":[{"href":"http:\/\/www.ced.org.tr\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=2948"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/www.ced.org.tr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=2948"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/www.ced.org.tr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=2948"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}