{"id":9718,"date":"2026-03-25T17:20:33","date_gmt":"2026-03-25T09:20:33","guid":{"rendered":"https:\/\/regask.com\/?p=9718"},"modified":"2026-03-25T17:20:33","modified_gmt":"2026-03-25T09:20:33","slug":"%e3%82%aa%e3%83%a9%e3%83%b3%e3%83%80%e3%81%ae%e5%8c%bb%e8%96%ac%e5%93%81%e8%a6%8f%e5%88%b6%e5%bd%93%e5%b1%80%ef%bc%88meb%ef%bc%89%e3%81%af%e3%80%81%e4%ba%8c%e9%87%8d%e8%b2%a9%e5%a3%b2%e6%89%bf","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/netherlands-meb-introduces-declaration-requirement-for-duplex-marketing-authorisation-applications\/","title":{"rendered":"\u30aa\u30e9\u30f3\u30c0MEB\u304c\u7533\u544a\u7fa9\u52d9\u3092\u5c0e\u5165\u2026"},"content":{"rendered":"<p>\u306e\u4e0a <strong>2026\u5e743\u670811\u65e5<\/strong>\u3001 <strong>\u30aa\u30e9\u30f3\u30c0\u306e\u533b\u85ac\u54c1\u8a55\u4fa1\u59d4\u54e1\u4f1a\uff08MEB\uff09<\/strong> \u65b0\u3057\u304f\u516c\u958b\u3055\u308c\u307e\u3057\u305f <strong>\u7533\u544a\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9<\/strong> \u5fdc\u52df\u8005\u5411\u3051 <strong>\u30c7\u30e5\u30d7\u30ec\u30c3\u30af\u30b9\u8ca9\u58f2\u627f\u8a8d<\/strong> \u30d2\u30c8\u7528\u533b\u85ac\u54c1\u306b\u3064\u3044\u3066\u3002\u4eca\u56de\u306e\u66f4\u65b0\u3067\u306f\u3001\u6b63\u5f0f\u306a\u7533\u544a\u624b\u7d9a\u304d\u306e\u6982\u8981\u3092\u5b9a\u3081\u305f <strong>\u88dc\u8db3\u7684\u306a\u898f\u5236\u6761\u4ef6<\/strong> \u627f\u8a8d\u304a\u3088\u3073\u7d99\u7d9a\u7684\u306a\u9075\u5b88\u306e\u305f\u3081\u306b\u6e80\u305f\u3055\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u8981\u4ef6\u3067\u3059\u3002\u3053\u308c\u306f\u3001\u516c\u8868\u65e5\u304b\u3089\u3059\u3079\u3066\u306e\u95a2\u9023\u7533\u8acb\u306b\u9069\u7528\u3055\u308c\u307e\u3059\u3002.<\/p>\n<div class=\"row\"  id=\"row-2118926858\">\n\n\t<div id=\"col-611683484\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\t<div id=\"gap-402760991\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-402760991 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u306e\u8a73\u7d30<\/h2>\n\t<div id=\"gap-1044545060\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1044545060 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u65b0\u3057\u3044\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3067\u306f\u3001\u7533\u8acb\u8005\u306f <strong>\u8a18\u5165\u6e08\u307f\u306e\u7533\u544a\u66f8<\/strong> \u4f55\u3089\u304b\u306e\u5f62\u3067 <strong>\u30c7\u30e5\u30d7\u30ec\u30c3\u30af\u30b9\u8ca9\u58f2\u627f\u8a8d\u7533\u8acb<\/strong>, \u3053\u308c\u306b\u3088\u308a\u3001\u540c\u4e00\u307e\u305f\u306f\u5bc6\u63a5\u306b\u95a2\u9023\u3059\u308b\u533b\u85ac\u54c1\u306e\u4e26\u884c\u8ca9\u58f2\u304c\u53ef\u80fd\u3068\u306a\u308b\u3002.<\/p>\n<p>\u5ba3\u8a00\u3067\u306f\u3001 <strong>\u88dc\u8db3\u6761\u4ef6<\/strong> \u5fdc\u52df\u8005\u304c\u6e80\u305f\u3055\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u8981\u4ef6\u306b\u306f\u3001 <strong>\u88fd\u54c1\u306e\u54c1\u8cea<\/strong>, <strong>\u5b89\u5168\u76e3\u8996<\/strong>\u3001 \u305d\u3057\u3066 <strong>\u7d99\u7d9a\u7684\u306a\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u7fa9\u52d9<\/strong>. \u3053\u308c\u3089\u306e\u6761\u4ef6\u306f\u3001\u4e26\u884c\u8ca9\u58f2\u3055\u308c\u308b\u533b\u85ac\u54c1\u304c\u305d\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u5168\u4f53\u3092\u901a\u3057\u3066\u30aa\u30e9\u30f3\u30c0\u306e\u898f\u5236\u57fa\u6e96\u306b\u6e96\u62e0\u3057\u7d9a\u3051\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3059\u308b\u305f\u3081\u306b\u8a2d\u3051\u3089\u308c\u3066\u3044\u307e\u3059\u3002.<\/p>\n<p>\u3053\u306e\u8981\u4ef6\u306f\u4ee5\u4e0b\u306b\u9069\u7528\u3055\u308c\u307e\u3059 <strong>\u3059\u3079\u3066\u306e\u65b0\u898f\u7533\u8acb<\/strong> Duplex\u306e\u8ca9\u58f2\u627f\u8a8d\u306b\u3064\u3044\u3066 <strong>\u4eba\u9593\u7528\u533b\u85ac\u54c1<\/strong> \u30aa\u30e9\u30f3\u30c0\u3067\u306f\u3001\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306f2026\u5e74\u306b\u767a\u8868\u3055\u308c\u307e\u3057\u305f\u304c\u3001 <strong>\u6709\u52b9\u306a\u9075\u5b88\u8981\u4ef6\u306f2022\u5e741\u67081\u65e5\u306b\u9061\u308b\u3002<\/strong>, \u3064\u307e\u308a\u3001\u5e02\u5834\u3078\u306e\u30a2\u30af\u30bb\u30b9\u3092\u7d99\u7d9a\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u9075\u5b88\u304c\u5fc5\u9808\u3068\u306a\u308b\u3068\u3044\u3046\u3053\u3068\u3060\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-611683484 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1743038602\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>\u306a\u305c\u305d\u308c\u304c\u91cd\u8981\u306a\u306e\u304b<\/h2>\n\t<div id=\"gap-908491173\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-908491173 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u3053\u306e\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u3067\u306f\u3001 <strong>\u898f\u5236\u306e\u660e\u78ba\u3055<\/strong> Duplex\u306e\u8ca9\u58f2\u627f\u8a8d\u7533\u8acb\u306b\u5bfe\u3059\u308b\u671f\u5f85\u3092\u6b63\u5f0f\u5316\u3059\u308b\u3053\u3068\u3067\u3001 <strong>\u4e00\u8cab\u3057\u305f\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u57fa\u6e96<\/strong> \u4e26\u884c\u8ca9\u58f2\u3055\u308c\u3066\u3044\u308b\u533b\u85ac\u54c1\u5168\u4f53\u306b\u308f\u305f\u3063\u3066\u5f37\u5316\u3057\u306a\u304c\u3089 <strong>\u7d99\u7d9a\u7684\u306a\u5b89\u5168\u304a\u3088\u3073\u54c1\u8cea\u7ba1\u7406<\/strong>. \u69cb\u9020\u5316\u3055\u308c\u305f\u7533\u544a\u30d7\u30ed\u30bb\u30b9\u3092\u5c0e\u5165\u3059\u308b\u3053\u3068\u3067\u3001MEB\u306f\u307e\u305f\u3001 <strong>\u904b\u7528\u52b9\u7387<\/strong> \u307e\u305f\u3001\u63d0\u51fa\u8981\u4ef6\u306b\u304a\u3051\u308b\u66d6\u6627\u3055\u3092\u8efd\u6e1b\u3057\u3001\u4e0d\u5b8c\u5168\u306a\u7533\u8acb\u66f8\u3084\u4e0d\u6574\u5408\u306a\u7533\u8acb\u66f8\u306b\u4f34\u3046\u898f\u5236\u4e0a\u306e\u8ca0\u62c5\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u307e\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1743038602 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-277798737\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>\u5f71\u97ff\u3092\u53d7\u3051\u308b\u4eba\u3005<\/h2>\n\t<div id=\"gap-344026123\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-344026123 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u3053\u306e\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u306f\u3001 <strong>\u898f\u5236\u95a2\u9023\u696d\u52d9<\/strong>, <strong>\u54c1\u8cea\u4fdd\u8a3c<\/strong>, <strong>\u60a3\u8005\u5b89\u5168<\/strong>, <strong>\u6cd5\u52d9\uff0f\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9<\/strong>\u3001 \u305d\u3057\u3066 <strong>\u55b6\u696d\u30c1\u30fc\u30e0<\/strong> \u88fd\u85ac\u4f1a\u793e\u5185\u3067 <strong>\u30d2\u30c8\u7528\u533b\u85ac\u54c1\u306e\u958b\u767a\u3001\u7533\u8acb\u3001\u304a\u3088\u3073\u5546\u696d\u5316<\/strong> \u30aa\u30e9\u30f3\u30c0\u3067\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-277798737 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1622740688\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>\u6b21\u306e\u30b9\u30c6\u30c3\u30d7<\/h2>\n\t<div id=\"gap-366225539\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-366225539 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u7d44\u7e54\u306f <strong>\u66f4\u65b0\u3055\u308c\u305f\u7533\u544a\u66f8\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u3068\u88dc\u8db3\u6761\u4ef6\u3092\u78ba\u8a8d\u3059\u308b<\/strong> \u73fe\u5728\u304a\u3088\u3073\u4eca\u5f8c\u306e\u30c7\u30e5\u30d7\u30ec\u30c3\u30af\u30b9\u793e\u306e\u8ca9\u58f2\u627f\u8a8d\u7533\u8acb\u3068\u306e\u6574\u5408\u6027\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u3002 <strong>\u63d0\u51fa\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u3001\u6587\u66f8\u5316\u57fa\u6e96\u3001\u304a\u3088\u3073\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8<\/strong> \u3053\u308c\u3089\u306e\u8981\u4ef6\u3092\u53cd\u6620\u3055\u305b\u308b\u305f\u3081\u3001\u90e8\u9580\u6a2a\u65ad\u7684\u306a\u30c1\u30fc\u30e0\u3068\u9023\u643a\u3057\u3066\u66f4\u65b0\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002.<\/p>\n<p>\u898f\u5236\u8981\u4ef6\u306f\u5e02\u5834\u3054\u3068\u306b\u9032\u5316\u3057\u7d9a\u3051\u3066\u3044\u308b\u305f\u3081\u3001\u5404\u56fd\u56fa\u6709\u306e\u63d0\u51fa\u8981\u4ef6\u306b\u5e38\u306b\u6e96\u62e0\u3057\u3066\u304a\u304f\u3053\u3068\u304c\u6975\u3081\u3066\u91cd\u8981\u3067\u3059\u3002.<\/p>\n<p><a href=\"https:\/\/regask.com\/ja\/\">RegASK<\/a> \u306f\u3001\u6d88\u8cbb\u8ca1\u3084\u30e9\u30a4\u30d5\u30b5\u30a4\u30a8\u30f3\u30b9\u306a\u3069\u3001\u898f\u5236\u306e\u53b3\u3057\u3044\u5206\u91ce\u306e\u30b0\u30ed\u30fc\u30d0\u30eb\u7d44\u7e54\u304c\u8907\u96d1\u306a\u898f\u5236\u74b0\u5883\u3092\u7a4d\u6975\u7684\u306b\u4e57\u308a\u8d8a\u3048\u3089\u308c\u308b\u3088\u3046\u652f\u63f4\u3059\u308b\u3001\u696d\u754c\u3092\u30ea\u30fc\u30c9\u3059\u308b\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u578bAI\u898f\u5236\u30a4\u30f3\u30c6\u30ea\u30b8\u30a7\u30f3\u30b9\u304a\u3088\u3073\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u30aa\u30fc\u30b1\u30b9\u30c8\u30ec\u30fc\u30b7\u30e7\u30f3\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u3067\u3059\u3002\u9ad8\u5ea6\u306a\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u578bAI\u3068\u5c02\u9580\u5bb6\u306e\u77e5\u898b\u3092\u7d44\u307f\u5408\u308f\u305b\u308b\u3053\u3068\u3067\u3001, <a href=\"https:\/\/regask.com\/ja\/\">RegASK<\/a> \u30bf\u30a4\u30e0\u30ea\u30fc\u306a\u4e88\u6e2c\u7684\u304b\u3064\u5b9f\u7528\u7684\u306a\u6d1e\u5bdf\u3068\u30a8\u30f3\u30c9\u30c4\u30fc\u30a8\u30f3\u30c9\u306e\u81ea\u52d5\u5316\u3092\u63d0\u4f9b\u3057\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9 \u30d7\u30ed\u30bb\u30b9\u3092\u5408\u7406\u5316\u3057\u3001\u30ea\u30b9\u30af\u3092\u8efd\u6e1b\u3057\u3001160 \u304b\u56fd\u4ee5\u4e0a\u3067\u5e02\u5834\u30a2\u30af\u30bb\u30b9\u3092\u52a0\u901f\u3057\u307e\u3059\u3002. <a href=\"https:\/\/regask.com\/ja\/%e8%a3%bd%e5%93%81\/\">\u3082\u3063\u3068\u8a73\u3057\u304f\u77e5\u308b<\/a> \u307e\u305f\u306f <a href=\"https:\/\/regask.com\/ja\/%e3%83%87%e3%83%a2%e3%82%92%e4%ba%88%e7%b4%84%e3%81%99%e3%82%8b\/\">\u30c7\u30e2\u3092\u4e88\u7d04\u3059\u308b<\/a> \u4eca\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1622740688 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>\n<div class=\"row\"  id=\"row-1138689918\">\n\n\t<div id=\"col-13106366\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<div class=\"is-divider divider clearfix\" style=\"margin-top:2em;margin-bottom:2em;max-width:20%;height:1px;background-color:#a5acd9;\"><\/div>\n<h3>\u3088\u304f\u3042\u308b\u8cea\u554f<\/h3>\n\t<div id=\"gap-1069185922\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1069185922 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4>\u30aa\u30e9\u30f3\u30c0\u306b\u304a\u3051\u308b\u30c7\u30e5\u30d7\u30ec\u30c3\u30af\u30b9\u306e\u8ca9\u58f2\u627f\u8a8d\u3068\u306f\u4f55\u3067\u3059\u304b\uff1f<\/h4>\n\t<div id=\"gap-1307392683\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1307392683 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u3053\u308c\u306f\u3001 <strong>\u540c\u4e00\u307e\u305f\u306f\u5bc6\u63a5\u306b\u95a2\u9023\u3059\u308b\u533b\u85ac\u54c1\u306e\u4e26\u884c\u8ca9\u58f2<\/strong> \u7279\u5b9a\u306e\u898f\u5236\u6761\u4ef6\u4e0b\u306b\u304a\u3044\u3066\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-13106366 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-553186561\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>MEB\u306b\u3088\u3063\u3066\u65b0\u305f\u306b\u5c0e\u5165\u3055\u308c\u305f\u8981\u4ef6\u306f\u4f55\u3067\u3059\u304b\uff1f<\/h4>\n\t<div id=\"gap-374610062\" class=\"gap-element clearfix\" style=\"display:block; 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The update introduces a formal declaration process outlining supplementary regulatory conditions that must be met for approval and ongoing compliance. It applies to all relevant applications from the date of publication.<\/p>","protected":false},"author":32,"featured_media":9719,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33,39,35,562],"tags":[],"class_list":["post-9718","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-medical-devices-insights","category-pharma-biotech-latest-insights","category-netherlands-regulations"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Netherlands MEB Introduces Declaration Requirement Update<\/title>\n<meta name=\"description\" content=\"Stay informed about the Netherlands MEB&#039;s updated declaration guidance for Duplex marketing authorisation applications for medicines.\" \/>\n<meta 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