{"id":44923,"date":"2022-01-28T00:00:00","date_gmt":"2022-01-27T23:00:00","guid":{"rendered":"https:\/\/biorius.com\/2022\/01\/28\/cpsr-%e5%8c%96%e7%b2%a7%e5%93%81%e5%ae%89%e5%85%a8%e6%80%a7%e5%a0%b1%e5%91%8a%e6%9b%b8\/"},"modified":"2024-05-08T11:38:38","modified_gmt":"2024-05-08T09:38:38","slug":"cpsr-%e5%8c%96%e7%b2%a7%e5%93%81%e5%ae%89%e5%85%a8%e6%80%a7%e5%a0%b1%e5%91%8a%e6%9b%b8","status":"publish","type":"post","link":"https:\/\/biorius.com\/ja\/cosmetic-news\/cpsr-%e5%8c%96%e7%b2%a7%e5%93%81%e5%ae%89%e5%85%a8%e6%80%a7%e5%a0%b1%e5%91%8a%e6%9b%b8\/","title":{"rendered":"CPSR\uff08\u5316\u7ca7\u54c1\u5b89\u5168\u6027\u5831\u544a\u66f8\uff09\u307e\u305f\u306f\u5b89\u5168\u6027\u8a55\u4fa1\u66f8"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\">\u6b27\u5dde\u3068\u82f1\u56fd\u3067\u8ca9\u58f2\u3059\u308b\u305f\u3081\u306e4\u3064\u306e\u6761\u4ef6<\/h2>\n\n<p>CPSR\uff1a\u554f\u984c\u306e\u6838\u5fc3\u306b\u89e6\u308c\u308b\u524d\u306b\u3001\u6b27\u5dde\u3084\u82f1\u56fd\u3067\u5316\u7ca7\u54c1\u3092\u8ca9\u58f2\u3059\u308b\u305f\u3081\u306b\u306f\u4f55\u304c\u5fc5\u8981\u304b\u3092\u899a\u3048\u3066\u304a\u304f\u3068\u3088\u3044\u3067\u3057\u3087\u3046\u3002 <a href=\"https:\/\/biorius.com\/regulatory\/how-to-gain-eu-compliance-in-3-steps\/\">3\u3064\u306e\u30b9\u30c6\u30c3\u30d7\u3067EU\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u7372\u5f97\u3059\u308b\u65b9\u6cd5<\/a>\u300d\u3067\u3059\u3067\u306b\u8ff0\u3079\u305f\u3088\u3046\u306b\u3001\u4ee5\u4e0b\u306e4\u3064\u306e\u8981\u7d20\u304c\u5fc5\u8981\u3067\u3059\uff1a<\/p>\n\n<ol class=\"wp-block-list\" type=\"1\">\n<li>CPSR<strong>\uff08\u5316\u7ca7<\/strong> <strong>\u54c1<\/strong> <strong>\u5b89\u5168\u6027<\/strong> <strong>\u5831\u544a\u66f8<\/strong>\uff09\u3068\u88fd\u54c1\u60c5\u5831\u30d5\u30a1\u30a4\u30eb<strong>\uff08PIF<\/strong>\uff09\u3002 \u8a73\u3057\u3044\u8aac\u660e\u306f<a href=\"https:\/\/biorius.com\/regulatory\/what-is-a-product-information-file-pif\/\">\u3053\u3061\u3089\u306e<\/a>\u8a18\u4e8b\u3092\u3054\u89a7\u304f\u3060\u3055\u3044\uff1b  <\/li>\n\n\n\n<li><strong>\u9069\u5408\u30e9\u30d9\u30eb\u3068 <\/strong>\u305d\u306e<strong> \u4e3b\u5f35<\/strong>\uff1b<\/li>\n\n\n\n<li>\u6b27\u5dde\u306e\u30dd\u30fc\u30bf\u30eb\u30b5\u30a4\u30c8<strong>CPNP<\/strong>\u304a\u3088\u3073\u82f1\u56fd\u306e\u30dd\u30fc\u30bf\u30eb\u30b5\u30a4\u30c8<strong>SCPN\u3078\u306e<\/strong>\u901a\u77e5\uff08\u88fd\u54c1\u3092\u8f38\u51fa\u3057\u3001\u82f1\u56fd\u3067\u8ca9\u58f2\u3059\u308b\u610f\u56f3\u304c\u3042\u308b\u5834\u5408\uff09\uff1b<\/li>\n\n\n\n<li>\u6700\u5f8c\u306e\u8981\u7d20\u306f\u3001<strong>\u6cd5\u7684\u4ee3\u7406\u4eba<\/strong>\u3001\u3059\u306a\u308f\u3061\u3001EU\u304a\u3088\u3073\u82f1\u56fd\u306b\u62e0\u70b9\u3092\u7f6e\u304f\u8cac\u4efb\u8005\uff08\u8cb4\u793e\u306e\u5316\u7ca7\u54c1\u304c\u82f1\u56fd\u306b\u3082\u5b58\u5728\u3059\u308b\u5834\u5408\uff09\u3067\u3059\u3002<\/li>\n<\/ol>\n\n<p>\u6b27\u5dde\u3084\u82f1\u56fd\u3067\u306e\u8ca9\u58f2\u3092\u5e0c\u671b\u3059\u308b\u5316\u7ca7\u54c1\u30d6\u30e9\u30f3\u30c9\u304c\u3001\u4e0a\u8a18\u306e4\u3064\u306e\u8981\u4ef6\u306e\u3046\u30611\u3064\u3067\u3082\u6b20\u3051\u3066\u3044\u308c\u3070\u3001\u9593\u9055\u3044\u306a\u304f\u53d6\u5f15\u306f\u4e0d\u53ef\u80fd\u3068\u8a00\u3048\u308b\uff1a  <strong>\u5e02\u5834\u306a\u3057\uff0f\u975e\u516c\u8a8d\u5e02\u5834\uff0f\u516c\u8a8d\u53d6\u5f15\u306a\u3057\uff0fPas de March\u00e9\uff0fkein Markt\uff0fNing\u00fan Mercado\uff0f\u30ce\u30fc\u30de\u30fc\u30b1\u30c3\u30c8\u3002<\/strong><\/p>\n\n<p><a href=\"https:\/\/biorius.com\/regulatory\/how-to-gain-eu-compliance-in-3-steps\/\">5\u3064\u306e\u30b9\u30c6\u30c3\u30d7\u3068BIORIUS\u306eEU\u898f\u5236\u306b\u95a2\u3059\u308b\u5c02\u9580\u77e5\u8b58\u306b\u3064\u3044\u3066\u306f<\/a>\u3001\u3053\u3061\u3089\u3092\u3054\u89a7\u304f\u3060\u3055\u3044<strong>\u3002<\/strong><\/p>\n\n<h2 class=\"wp-block-heading\">\u5316\u7ca7\u54c1\u5b89\u5168\u6027\u5831\u544a\u66f8\uff08CPSR\uff09\u306e\u8aac\u660e<\/h2>\n\n<p>\u3053\u306e\u8a18\u4e8b\u306f\u3001<strong>\u5316\u7ca7\u54c1\u88fd\u54c1\u5b89\u5168\u6027\u5831\u544a\u66f8<\/strong><strong>\uff08CPSR<\/strong>\uff09\u306b\u3064\u3044\u3066\u3001\u3088\u308a\u660e\u78ba\u3067\u8ffd\u52a0\u7684\u306a\u60c5\u5831\u3092\u63d0\u4f9b\u3059\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u3066\u3044\u307e\u3059\u3002 \u82f1\u8a9e\u3067\u306f\u3001<strong>CPSR\u306f <\/strong>\u4e00\u822c\u7684\u306b<strong>\u300cSafety Assessment<\/strong>\u300d\u3068\u3082\u547c\u3070\u308c\u308b\u3002<\/p>\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full is-resized\"><img fetchpriority=\"high\" decoding=\"async\" src=\"https:\/\/biorius.com\/wp-content\/uploads\/2023\/10\/cpsr2.png\" alt=\"CPSR\" class=\"wp-image-18594\" width=\"564\" height=\"315\"\/><\/figure>\n<\/div>\n<h3 class=\"wp-block-heading\">CPSR\u306f\u3069\u3053\u306b\u3042\u308b\u306e\u304b\uff1f<\/h3>\n\n<p>\u307e\u305a\u3001\u3053\u306e\u6587\u66f8\u304c<strong>\u5404\u5316\u7ca7\u54c1\u306ePIF\u5185\u306b\u8a18\u8f09\u3055\u308c\u3066<\/strong>\u3044\u308b\u3053\u3068\u3092\u77e5\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002 \u5b9f\u969b\u306b\u306f\u3001\u88fd\u54c1\u60c5\u5831\u30d5\u30a1\u30a4\u30eb\u306f\u3044\u304f\u3064\u304b\u306e\u30b5\u30d6\u30d5\u30a9\u30eb\u30c0\u304b\u3089\u306a\u308b\u96fb\u5b50\u30d5\u30a9\u30eb\u30c0\u3067\u3042\u308a\u3001\u305d\u3053\u306b\u306fCPSR\u3092\u542b\u3080\u30d5\u30a1\u30a4\u30eb\uff08\u901a\u5e38\u306fPDF\uff09\u304c\u542b\u307e\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u304a\u5fd8\u308c\u306a\u304f\u3002<\/p>\n\n<h3 class=\"wp-block-heading\">CPSR\u306e\u91cd\u8981\u6027\u3068\u56fd\u5bb6\u5f53\u5c40\u306e\u691c\u67fb<\/h3>\n\n<p><strong>CPSR\u306f\u3001\u5316\u7ca7\u54c1\u3092\u6b27\u5dde\u304a\u3088\u3073\u82f1\u56fd\u5e02\u5834\u306b\u6295\u5165\u3059\u308b\u969b\u306b\u6700\u3082\u91cd\u8981\u306a\u5831\u544a\u66f8<\/strong>\u3067\u3042\u308b\u3068\u3055\u3048\u8a00\u3048\u308b\u304b\u3082\u3057\u308c\u307e\u305b\u3093\u3002\u3057\u304b\u3057\u3001PIF\u306e\u4ed6\u306e\u6587\u66f8\u306e\u91cd\u8981\u6027\u3092\u53d6\u308a\u4e0a\u3052\u308b\u3064\u3082\u308a\u306f\u3042\u308a\u307e\u305b\u3093\u3002 \u30e9\u30d9\u30eb\u3068\u9069\u5408\u51e6\u65b9\u3001\u30dd\u30fc\u30bf\u30eb\u30b5\u30a4\u30c8\u3078\u306e\u901a\u77e5\u3001\u8cac\u4efb\u8005\u3082\u307e\u305f\u3001<a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/ALL\/?uri=celex%3A32009R1223\">\u6b27\u5dde\u3068<\/a> <a href=\"https:\/\/www.gov.uk\/government\/publications\/cosmetic-products-enforcement-regulations-2013\/regulation-20091223-and-the-cosmetic-products-enforcement-regulations-2013-great-britain\">\u82f1\u56fd\u306e\u898f\u5236\u3092<\/a>\u5b8c\u5168\u306b\u9075\u5b88\u3059\u308b\u305f\u3081\u306b\u4e0d\u53ef\u6b20\u306a\u8981\u7d20\u3067\u3042\u308b\u3002<\/p>\n\n<p>\u305d\u306e\u305f\u3081\u3001PIF\u306bCPSR\u306e\u75d5\u8de1\u304c\u306a\u3044\u5834\u5408\u3001\u3042\u308b\u3044\u306fCPSR\u306e\u4f5c\u6210\u306b\u6020\u6162\u304c\u3042\u3063\u305f\u5834\u5408\u306f\u3001<strong>CPSR\u3092<\/strong>\u63d0\u51fa\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3001  <strong>\u3053\u306e\u5834\u5408\u3001\u975e\u5e38\u306b\u53b3\u3057\u3044\u7f70\u91d1\u3001\u5373\u6642\u9000\u4f1a\u3001RAPEX\u3078\u306e\u901a\u544a\u306b\u3064\u306a\u304c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u3002 \u307e\u3060\u3054\u5b58\u3058\u306a\u3044\u65b9\u306e\u305f\u3081\u306b\u8aac\u660e\u3057\u3066\u304a\u304f\u3068\u3001RAPEX\u306fEU\u5404\u56fd\u306e\u5f53\u5c40\u306b\u3088\u308b\u76e3\u7763\u30b7\u30b9\u30c6\u30e0\u3067\u3042\u308b\u3002<\/strong>. \u8cb4\u793e\u306e\u5316\u7ca7\u54c1\u30d6\u30e9\u30f3\u30c9\u304cRAPEX\u306b\u767b\u9332\u3055\u308c\u308c\u3070\u3001\u5168\u88fd\u54c1\u306e\u4f53\u7cfb\u7684\u3067\u7dbf\u5bc6\u306a\u691c\u67fb\u304c\u671f\u5f85\u3067\u304d\u308b\u3002<\/p>\n\n<h3 class=\"wp-block-heading\">CPSR\u306f\u3069\u306e\u3088\u3046\u306a\u60c5\u5831\u3092\u542b\u307e\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u306e\u304b\uff1f<\/h3>\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full\"><img decoding=\"async\" width=\"602\" height=\"336\" src=\"https:\/\/biorius.com\/wp-content\/uploads\/2023\/10\/cpsr.png\" alt=\"CPSR\" class=\"wp-image-18593\"\/><\/figure>\n<\/div>\n<p>\u5b9f\u969b\u306b\u306f\u3001CPSR\u306f2\u3064\u306e\u90e8\u5206\u3067\u69cb\u6210\u3055\u308c\u3066\u3044\u308b\u3001  <strong><u>\u30d1\u30fc\u30c8A<\/u><\/strong> \u305d\u3057\u3066  <strong><u>\u30d1\u30fc\u30c8B<\/u><\/strong>\u306e  <strong>\u9644\u5c5e\u66f8 I<\/strong> \u306e  <strong><em><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/ALL\/?uri=celex%3A32009R1223\">\u5316\u7ca7\u54c1\u306b\u95a2\u3059\u308b2009\u5e7411\u670830\u65e5\u4ed8\u6b27\u5dde\u8b70\u4f1a\u304a\u3088\u3073\u6b27\u5dde\u7406\u4e8b\u4f1a\u898f\u5247\uff08EC\uff09\u7b2c1223\/2009\u53f7<\/a><\/em><\/strong> \u306b\u306f\u3001\u5316\u7ca7\u54c1\u304c\u4eba\u306e\u5065\u5eb7\u306b\u53ca\u307c\u3059\u5371\u967a\u6027\u3092\u7279\u5b9a\u3057\u3001\u5b9a\u91cf\u5316\u3059\u308b\u305f\u3081\u306b\u3001\u5b89\u5168\u6027\u8a55\u4fa1\u8005\u304c\u53ce\u96c6\u3057\u3001\u51e6\u7406\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3059\u3079\u3066\u306e\u60c5\u5831\u304c\u660e\u8a18\u3055\u308c\u3066\u3044\u307e\u3059\u3002 <strong>\u9644\u5c5e\u66f8\u2160\u306b\u306f<\/strong>\u30012\u3064\u306e\u30d1\u30fc\u30c8\u304c\u3069\u306e\u3088\u3046\u306a\u8981\u7d20\u3092\u542b\u307e\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u304b\u304c\u8a73\u7d30\u306b\u8a18\u3055\u308c\u3066\u3044\u308b\uff1a<\/p>\n\n<p>PART A\u306b\u306f\u3001<strong>\u5316\u7ca7\u54c1\u306e\u5b89\u5168\u6027\u306b\u95a2\u3059\u308b<\/strong>\u60c5\u5831\u304c\u8a18\u8f09\u3055\u308c\u3066\u3044\u307e\u3059\uff1a<\/p>\n\n<div class=\"wp-block-media-text is-stacked-on-mobile is-style-default\" style=\"grid-template-columns:27% auto\"><figure class=\"wp-block-media-text__media\"><img decoding=\"async\" src=\"https:\/\/biorius.com\/wp-content\/uploads\/2023\/10\/icone-dossier.png\" alt=\"\" class=\"wp-image-15924 size-full\"\/><\/figure><div class=\"wp-block-media-text__content\">\n<ol class=\"wp-block-list\" type=\"1\">\n<li>\u5316\u7ca7\u54c1\u306e\u91cf\u7684\u304a\u3088\u3073\u8cea\u7684\u7d44\u6210\uff1b<\/li>\n\n\n\n<li>\u5316\u7ca7\u54c1\u306e\u7269\u7406\u7684\/\u5316\u5b66\u7684\u7279\u6027\u3068\u5b89\u5b9a\u6027\uff1b<\/li>\n\n\n\n<li>\u5fae\u751f\u7269\u5b66\u7684\u54c1\u8cea\uff1b<\/li>\n\n\n\n<li>\u4e0d\u7d14\u7269\u3001\u75d5\u8de1\u3001\u5305\u88c5\u6750\u6599\u306b\u95a2\u3059\u308b\u60c5\u5831\uff1b<\/li>\n\n\n\n<li>\u901a\u5e38\u306e\u3001\u5408\u7406\u7684\u306b\u4e88\u6e2c\u53ef\u80fd\u306a\u4f7f\u7528\uff1b<\/li>\n\n\n\n<li>\u5316\u7ca7\u54c1\u3078\u306e\u66b4\u9732\uff1b<\/li>\n\n\n\n<li>\u7269\u8cea\u3078\u306e\u66b4\u9732\uff1b<\/li>\n\n\n\n<li>\u7269\u8cea\u306e\u6bd2\u6027\u5b66\u7684\u30d7\u30ed\u30d5\u30a3\u30fc\u30eb\uff1b<\/li>\n\n\n\n<li>\u671b\u307e\u3057\u304f\u306a\u3044\u5f71\u97ff\u3068\u91cd\u5927\u306a\u671b\u307e\u3057\u304f\u306a\u3044\u5f71\u97ff\uff1b<\/li>\n\n\n\n<li>\u5316\u7ca7\u54c1\u306b\u95a2\u3059\u308b\u60c5\u5831\u3002<\/li>\n<\/ol>\n<\/div><\/div>\n\n<p>\u4e00\u65b9 <strong>\n  <u>\u30d1\u30fc\u30c8B<\/u>\n<\/strong>\u306b\u306f\u3001\u5316\u7ca7\u54c1\u306e\u5b89\u5168\u6027\u8a55\u4fa1\u3001\u3059\u306a\u308f\u3061<\/p>\n\n<div class=\"wp-block-media-text has-media-on-the-right is-stacked-on-mobile is-style-default\" style=\"grid-template-columns:auto 22%\"><div class=\"wp-block-media-text__content\">\n<ol class=\"wp-block-list\" type=\"1\">\n<li><strong>\u8a55\u4fa1\u7d50\u8ad6<\/strong>\uff1a\u7b2c3\u6761\u306b\u95a2\u9023\u3059\u308b\u5316\u7ca7\u54c1\u306e\u5b89\u5168\u6027\u306b\u95a2\u3059\u308b\u58f0\u660e\uff1b<\/li>\n\n\n\n<li><strong>\u8b66\u544a\u53ca\u3073\u4f7f\u7528\u8aac\u660e\u306e\u8868\u793a<\/strong>\uff1a\u7b2c19\u6761(1)(d)\u306b\u5f93\u3044\u3001\u7279\u5b9a\u306e\u8b66\u544a\u53ca\u3073\u4f7f\u7528\u8aac\u660e\u3092\u8868\u793a\u3059\u308b\u5fc5\u8981\u6027\u306b\u3064\u3044\u3066\u306e\u8a18\u8ff0\uff1b<\/li>\n\n\n\n<li><strong>\u63a8\u8ad6<\/strong>\uff1a\u30bb\u30af\u30b7\u30e7\u30f3 1 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