{"id":44,"date":"2026-04-24T14:01:00","date_gmt":"2026-04-24T05:01:00","guid":{"rendered":"https:\/\/taobe.consulting\/jp\/?page_id=44"},"modified":"2026-04-27T07:36:55","modified_gmt":"2026-04-26T22:36:55","slug":"pif","status":"publish","type":"page","link":"https:\/\/taobe.consulting\/jp\/service\/register\/pif\/","title":{"rendered":"EU\u5411\u3051PIF\u4f5c\u6210 + \u5b89\u5168\u6027\u8a55\u4fa1 CPSR - B"},"content":{"rendered":"\n<div class=\"wp-block-vk-blocks-button-outer vk_buttons vk_block-margin-md--margin-bottom\"><div class=\"vk_buttons_col vk_buttons_col-justify-left\">\n<div class=\"wp-block-vk-blocks-button vk_button vk_button-color-custom vk_button-align-left\"><a href=\"https:\/\/taobe.consulting\/jp\/service\/register\/prescription\/\" class=\"vk_button_link btn has-text-color is-style-outline has-vk-color-custom-2-color btn-sm\" role=\"button\" aria-pressed=\"true\" rel=\"noopener\"><div class=\"vk_button_link_caption\"><span class=\"vk_button_link_txt\"><strong>STEP-1<\/strong> \u6210\u5206\u30c1\u30a7\u30c3\u30af<\/span><\/div><\/a><\/div>\n\n\n\n<div class=\"wp-block-vk-blocks-button vk_button vk_button-color-custom vk_button-align-left\"><a href=\"https:\/\/taobe.consulting\/jp\/service\/register\/pif\/\" class=\"vk_button_link btn has-background has-vk-color-custom-2-background-color btn-sm\" role=\"button\" aria-pressed=\"true\" rel=\"noopener\"><div class=\"vk_button_link_caption\"><span class=\"vk_button_link_txt\"><strong>STEP-2<\/strong> PIF, CPSR \u4f5c\u6210<\/span><\/div><\/a><\/div>\n\n\n\n<div class=\"wp-block-vk-blocks-button vk_button vk_button-color-custom vk_button-align-left\"><a href=\"https:\/\/taobe.consulting\/jp\/service\/register\/label\/\" class=\"vk_button_link btn has-text-color is-style-outline has-vk-color-custom-2-color btn-sm\" role=\"button\" aria-pressed=\"true\" rel=\"noopener\"><div class=\"vk_button_link_caption\"><span class=\"vk_button_link_txt\"><strong>STEP-3<\/strong> \u30e9\u30d9\u30eb\u53ca\u3073\u52b9\u80fd\u8a55\u4fa1<\/span><\/div><\/a><\/div>\n\n\n\n<div class=\"wp-block-vk-blocks-button vk_button vk_button-color-custom vk_button-align-left\"><a href=\"https:\/\/taobe.consulting\/jp\/service\/register\/cpnp-scpn\/\" class=\"vk_button_link btn has-text-color is-style-outline has-vk-color-custom-2-color btn-sm\" role=\"button\" aria-pressed=\"true\" rel=\"noopener\"><div class=\"vk_button_link_caption\"><span class=\"vk_button_link_txt\"><strong>STEP-4 <\/strong>CPNP, SCPN\u5c4a\u3051\u51fa<\/span><\/div><\/a><\/div>\n\n\n\n<div class=\"wp-block-vk-blocks-button vk_button vk_button-color-custom vk_button-align-left\"><a href=\"https:\/\/taobe.consulting\/jp\/service\/register\/rp\/\" class=\"vk_button_link btn has-text-color is-style-outline has-vk-color-custom-2-color btn-sm\" role=\"button\" aria-pressed=\"true\" rel=\"noopener\"><div class=\"vk_button_link_caption\"><span class=\"vk_button_link_txt\"><strong>STEP-5<\/strong> EU, UK \u4ee3\u7406\u8cac\u4efb\u8005<\/span><\/div><\/a><\/div>\n<\/div><\/div>\n\n\n\n<p class=\"vk_block-margin-0--margin-bottom\">EU,UK\u5316\u7ca7\u54c1\u898f\u5236\u3000\u3054\u767b\u9332\u6e96\u5099<\/p>\n\n\n\n<h2 class=\"wp-block-heading vk_block-margin-0--margin-top ttl-step\" id=\"h-step-2-br-xs-pif-\u88fd\u54c1\u60c5\u5831\u30d5\u30a1\u30a4\u30eb\u306e\u4f5c\u6210-cpsr-\u3092\u542b\u3080\"><mark style=\"background-color:#004c6c\" class=\"has-inline-color has-white-color\">\u3000STEP-2\u3000<\/mark>\u3000<br class=\"vk_responsive-br vk_responsive-br-xs\"\/><strong>PIF\u3000\u88fd\u54c1\u60c5\u5831\u30d5\u30a1\u30a4\u30eb\u306e\u4f5c\u6210 \uff3bCPSR \u3092\u542b\u3080\uff3d<\/strong><\/h2>\n\n\n\n<h3 class=\"wp-block-heading has-large-font-size\" id=\"h-\u6b27\u5dde\u5411\u3051\u306e\u88fd\u54c1\u60c5\u5831\u30d5\u30a1\u30a4\u30eb-pif-\u3092\u4f5c\u6210\"><strong>\u6b27\u5dde\u5411\u3051\u306e\u88fd\u54c1\u60c5\u5831\u30d5\u30a1\u30a4\u30eb \u2013 PIF \u3092\u4f5c\u6210<\/strong><\/h3>\n\n\n\n<div class=\"wp-block-media-text has-media-on-the-right is-stacked-on-mobile\" style=\"grid-template-columns:auto 47%\"><div class=\"wp-block-media-text__content\">\n<p><a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2009\/1223\/oj\/eng\">EU\u5316\u7ca7\u54c1\u898f\u5236 1223\/2009<\/a> \u306e\u7b2c 11\u6761\u306f\u3001\u88fd\u54c1\u60c5\u5831\u30d5\u30a1\u30a4\u30eb PIF\u306b\u542b\u307e\u306a\u3051\u308c\u3070\u306a\u3089\u3044\u60c5\u5831\u306b\u3064\u3044\u3066\u660e\u8a18\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>EU\u898f\u5236\u306b\u6e96\u62e0\u3059\u308b\u305f\u3081\u306b\u5fc5\u9808\u3068\u3055\u308c\u308b\u5316\u7ca7\u54c1\u88fd\u54c1\u5b89\u5168\u6027\u5831\u544a\u66f8\uff08CPSR: Cosmetic Product Safety Report\uff09\u306f\u3001\u7b2c10\u6761 \u306b\u57fa\u3065\u304d\u4f5c\u6210\u304c\u7fa9\u52d9\u4ed8\u3051\u3089\u308c\u3066\u304a\u308a\u3001\u88fd\u54c1\u60c5\u5831\u30d5\u30a1\u30a4\u30eb\uff08PIF\uff09\u306e\u4e00\u90e8\u3068\u3057\u3066\u7d44\u307f\u8fbc\u307e\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u6b27\u5dde\u304c\u5b9a\u3081\u308b\u6cd5\u4ee4\u306b\u305d\u3063\u305f\u5b89\u5168\u6027\u5831\u544a\u66f8 - CPSR \u3092\u4f5c\u6210\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u5b89\u5168\u6027\u8a55\u4fa1\u3092\u5b9f\u65bd\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<\/div><figure class=\"wp-block-media-text__media\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"684\" src=\"https:\/\/taobe.consulting\/jp\/wp-content\/uploads\/2022\/04\/closeup-of-businessman-signing-business-contract-at-office-1024x684.jpg\" alt=\"\u6b27\u5dde PIF\" class=\"wp-image-680 size-full\" srcset=\"https:\/\/taobe.consulting\/jp\/wp-content\/uploads\/2022\/04\/closeup-of-businessman-signing-business-contract-at-office-1024x684.jpg 1024w, https:\/\/taobe.consulting\/jp\/wp-content\/uploads\/2022\/04\/closeup-of-businessman-signing-business-contract-at-office-300x200.jpg 300w, https:\/\/taobe.consulting\/jp\/wp-content\/uploads\/2022\/04\/closeup-of-businessman-signing-business-contract-at-office-768x513.jpg 768w, https:\/\/taobe.consulting\/jp\/wp-content\/uploads\/2022\/04\/closeup-of-businessman-signing-business-contract-at-office-1536x1025.jpg 1536w, https:\/\/taobe.consulting\/jp\/wp-content\/uploads\/2022\/04\/closeup-of-businessman-signing-business-contract-at-office-2048x1367.jpg 2048w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure><\/div>\n\n\n\n<div style=\"height:48px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-media-text is-stacked-on-mobile\"><figure class=\"wp-block-media-text__media\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"683\" src=\"https:\/\/taobe.consulting\/jp\/wp-content\/uploads\/2022\/04\/business-analytic-working-with-documents-1024x683.jpg\" alt=\"EU \u5b89\u5168\u6027\u8a55\u4fa1\" class=\"wp-image-773 size-full\" srcset=\"https:\/\/taobe.consulting\/jp\/wp-content\/uploads\/2022\/04\/business-analytic-working-with-documents-1024x683.jpg 1024w, https:\/\/taobe.consulting\/jp\/wp-content\/uploads\/2022\/04\/business-analytic-working-with-documents-300x200.jpg 300w, https:\/\/taobe.consulting\/jp\/wp-content\/uploads\/2022\/04\/business-analytic-working-with-documents-768x512.jpg 768w, https:\/\/taobe.consulting\/jp\/wp-content\/uploads\/2022\/04\/business-analytic-working-with-documents.jpg 1500w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure><div class=\"wp-block-media-text__content\">\n<h2 class=\"wp-block-heading vk_block-margin-md--margin-top\" id=\"h-cpsr-\u5b89\u5168\u6027\u8a55\u4fa1\">CPSR - \u5b89\u5168\u6027\u8a55\u4fa1 <\/h2>\n\n\n\n<p class=\"has-regular-font-size\">CPSR\u306f\u3001A\u3068B\u306e\u4e8c\u3064\u306e\u30d1\u30fc\u30c8\u304b\u3089\u6210\u308a\u7acb\u3063\u3066\u304a\u308a\u3001\u7279\u306b\u30d1\u30fc\u30c8B\u306fPIF\u3092\u69cb\u6210\u3059\u308b\u60c5\u5831\u306e\u4e2d\u3067\u6700\u3082\u91cd\u8981\u306a\u90e8\u5206\u3068\u306a\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list is-style-vk-triangle-mark\">\n<li><strong>CPSR - A :  \u5316\u7ca7\u54c1\u306e\u5b89\u5168\u6027\u60c5\u5831<\/strong><\/li>\n<\/ul>\n\n\n\n<p>\u5316\u7ca7\u54c1\u306e\u5b89\u5168\u6027\u3092\u8a55\u4fa1\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u3068\u306a\u308b\u3055\u307e\u3056\u307e\u306a\u66f8\u985e\u3092\u7cbe\u67fb\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list is-style-vk-triangle-mark\">\n<li><strong>CPSR \u2013 B \uff1a \u5316\u7ca7\u54c1\u5b89\u5168\u6027\u8a55\u4fa1<\/strong><\/li>\n<\/ul>\n\n\n\n<p class=\"has-text-align-left\">\u3055\u307e\u3056\u307e\u306a\u66f8\u985e\u3084\u8a66\u9a13\u7d50\u679c\u3092\u3082\u3068\u306b\u3001\u5b89\u5168\u6027\u8a55\u4fa1\u3092\u5b9f\u65bd\u3002\u6700\u7d42\u7684\u306b\u88fd\u54c1\u304cEU\u898f\u5236\u306b\u6e96\u62e0\u3057\u3001\u6b27\u5dde\u3067\u4e0a\u5e02\u3059\u308b\u305f\u3081\u306e\u5b89\u5168\u6027\u3092\u6e80\u305f\u3057\u305f\u88fd\u54c1\u3067\u3042\u308b\u304b\u306b\u3064\u3044\u3066 EU\u898f\u5236\u3092\u719f\u77e5\u3057\u305f\u30bb\u30fc\u30d5\u30c6\u30a3\u30a2\u30bb\u30c3\u30b5\u30fc\u304c\u6700\u7d42\u7d50\u8ad6\u3092\u51fa\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<p class=\"vk_block-margin-sm--margin-top\"><\/p>\n<\/div><\/div>\n\n\n\n<div style=\"height:16px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p class=\"vk_block-margin-md--margin-top\"><\/p>\n\n\n\n<div class=\"wp-block-media-text has-media-on-the-right is-stacked-on-mobile\" style=\"grid-template-columns:auto 47%\"><div class=\"wp-block-media-text__content\">\n<h2 class=\"wp-block-heading\" id=\"h-cpsr-\u306b\u5fc5\u8981\u306a\u8cc7\u6599\">CPSR - \u5b89\u5168\u6027\u8a55\u4fa1\u306b\u5fc5\u8981\u306a\u66f8\u985e<\/h2>\n\n\n\n<p class=\"vk_block-margin-sm--margin-top\">CPSR\u3092\u5b9f\u65bd\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u6700\u7d42\u88fd\u54c1\u306e\u5206\u6790\u8a3c\u660e\u66f8- CoA \u3084\u5b89\u5168\u6027\u30c7\u30fc\u30bf\u30b7\u30fc\u30c8 - SDS\u304c\u5fc5\u8981\u3068\u306a\u308a\u307e\u3059\u3002\u305d\u306e\u4ed6\u306b\u3082\u3001\u88fd\u9020\u5de5\u7a0b\u306b\u95a2\u3059\u308b\u8a73\u7d30\u66f8\u985e\u3084CMR\u7269\u8cea\u3001\u30ca\u30ce\u30de\u30c6\u30ea\u30a2\u30eb\u3001\u9ad8\u61f8\u5ff5\u7269\u8cea\u306a\u3069\u306b\u95a2\u3059\u308b\u5831\u544a\u66f8\u3082\u5fc5\u8981\u3067\u3059\u3002\u5316\u7ca7\u54c1\u306e\u5185\u5bb9\u7269\u306b\u95a2\u3059\u308b\u66f8\u985e\u4ee5\u5916\u306b\u3082\u3001\u5bb9\u5668\u3084\u68b1\u5305\u6750\u306b\u95a2\u3059\u308b\u6280\u8853\u7684\u60c5\u5831\u3001\u307e\u305f\u3001\u5b89\u5b9a\u6027\/\u9069\u5408\u6027\u8a66\u9a13\u7d50\u679c\u3001\u4fdd\u5b58\u52b9\u529b\u8a66\u9a13\u7d50\u679c\u306a\u3069\u3001\u5316\u7ca7\u54c1\u306b\u95a2\u3059\u308b\u3055\u307e\u3056\u307e\u306a\u66f8\u985e\u306e\u5165\u624b\u304c\u5fc5\u8981\u3068\u306a\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u5f53\u793e\u3067\u306f\u3001\u30af\u30e9\u30a4\u30a2\u30f3\u30c8\u3055\u307e\u306e\u8ca0\u62c5\u304c\u5c11\u3057\u3067\u3082\u8efd\u6e1b\u3055\u308c\u308b\u3088\u3046\u3001\u30ab\u30b9\u30bf\u30de\u30a4\u30ba\u3057\u305f\u30a2\u30d7\u30ed\u30fc\u30c1\u306b\u3088\u308a\u5b89\u5168\u6027\u8a55\u4fa1\u3092\u884c\u3044\u307e\u3059\u3002 <\/p>\n\n\n\n<p>\u521d\u56de\u306e\u30b3\u30f3\u30b5\u30eb\u30c6\u30a3\u30f3\u30b0\u306b\u3066\u3001\u8cb4\u793e\u306b\u3068\u3063\u3066\u6700\u5584\u306e\u65b9\u6cd5\u306b\u3064\u3044\u3066\u3054\u6848\u5185\u3044\u305f\u3057\u307e\u3059\u306e\u3067\u304a\u6c17\u8efd\u306b<a href=\"https:\/\/taobe.consulting\/jp\/contact\/\">\u304a\u554f\u5408\u305b<\/a>\u4e0b\u3055\u3044\u3002<\/p>\n<\/div><figure class=\"wp-block-media-text__media\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"683\" src=\"https:\/\/taobe.consulting\/jp\/wp-content\/uploads\/2022\/04\/businessman-checking-documents-at-table-1024x683.jpg\" alt=\"\u6b27\u5dde CPSR\" class=\"wp-image-547 size-full\" srcset=\"https:\/\/taobe.consulting\/jp\/wp-content\/uploads\/2022\/04\/businessman-checking-documents-at-table-1024x683.jpg 1024w, https:\/\/taobe.consulting\/jp\/wp-content\/uploads\/2022\/04\/businessman-checking-documents-at-table-300x200.jpg 300w, https:\/\/taobe.consulting\/jp\/wp-content\/uploads\/2022\/04\/businessman-checking-documents-at-table-768x512.jpg 768w, https:\/\/taobe.consulting\/jp\/wp-content\/uploads\/2022\/04\/businessman-checking-documents-at-table-1536x1024.jpg 1536w, https:\/\/taobe.consulting\/jp\/wp-content\/uploads\/2022\/04\/businessman-checking-documents-at-table-2048x1365.jpg 2048w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure><\/div>\n\n\n\n<div style=\"height:34px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<hr class=\"wp-block-separator has-css-opacity\"\/>\n\n\n\n<p class=\"has-regular-font-size\"><strong>\u5316\u7ca7\u54c1\u304c\u6b27\u5dde\u306e\u5b89\u5168\u6027\u57fa\u6e96\u3092\u30af\u30ea\u30a2\u3057\u3001\u5316\u7ca7\u54c1\u5b89\u5168\u6027\u5831\u544a\u66f8\u306e\u4f5c\u6210\u304c\u5b8c\u4e86\u5f8c\u3001\u30b9\u30c6\u30c3\u30d73\u306b\u9032\u307f\u307e\u3059<\/strong><\/p>\n\n\n\n<div class=\"wp-block-vk-blocks-button vk_button vk_button-color-custom vk_button-align-left\"><a href=\"https:\/\/taobe.consulting\/jp\/service\/register\/label\/\" class=\"vk_button_link btn has-text-color is-style-outline has-vk-color-custom-2-color btn-md\" role=\"button\" aria-pressed=\"true\" rel=\"noopener\"><div class=\"vk_button_link_caption\"><span class=\"vk_button_link_txt\">STEP-3\u3078<\/span><\/div><\/a><\/div>\n\n\n\n<hr class=\"wp-block-separator has-css-opacity\"\/>\n\n\n\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-vk-blocks-border-box vk_borderBox vk_borderBox-background-transparent has-text-color has-vk-color-primary-color is-style-vk_borderBox-style-solid-kado-tit-onborder\"><div class=\"vk_borderBox_title_container\"><i class=\"\"><\/i><h4 class=\"vk_borderBox_title\">\u91cd\u8981\u30dd\u30a4\u30f3\u30c8<\/h4><\/div><div class=\"vk_borderBox_body\">\n<p>\u5b89\u5168\u6027\u8a55\u4fa1 CPSR \u2013 B \u3092\u5b9f\u65bd\u3001\u4f5c\u6210\u3067\u304d\u308b\u306e\u306f\u3001EU\u898f\u5236\u3067\u5b9a\u3081\u3089\u308c\u3066\u3044\u308b\u8981\u4ef6\u3092\u30af\u30ea\u30a2\u3057\u3066\u3044\u308b\u30bb\u30fc\u30d5\u30c6\u30a3\u30a2\u30bb\u30c3\u30b5\u30fc\u306e\u307f\u3068\u3055\u308c\u3066\u3044\u307e\u3059\uff08EC No. 1223\/2009 \u7b2c10\u67612\u9805\uff09<\/p>\n\n\n\n<p>\u4e00\u822c\u7684\u306b\u306f\u3001\u85ac\u5b66\u3001\u6bd2\u6027\u5b66\u3001\u533b\u5b66\u3001\u307e\u305f\u306f\u3053\u308c\u3089\u306b\u985e\u4f3c\u3059\u308b\u5206\u91ce\u306e\u5b66\u4f4d\u3092\u6709\u3057\u3001\u6bd2\u6027\u8a55\u4fa1\u304a\u3088\u3073\u30ea\u30b9\u30af\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u306e\u5b9f\u52d9\u7d4c\u9a13\u3092\u6301\u3061\u3001EU\u5316\u7ca7\u54c1\u898f\u5247\u306b\u7cbe\u901a\u3057\u305f\u5c02\u9580\u5bb6\u304c\u5b9f\u65bd<\/p>\n<\/div><\/div>\n\n\n\n<hr class=\"wp-block-separator has-text-color has-black-color has-css-opacity has-black-background-color has-background\"\/>\n\n\n\n<p class=\"vk_block-margin-0--margin-top\">\u6b27\u5dde\u898f\u5236\uff08EC\uff09No 1223\/2009 \u7b2c<strong>\uff13\u6761<\/strong>\u3001<strong>10\u6761\u300111\u6761<\/strong><\/p>\n\n\n\n<h6 class=\"wp-block-heading\"><strong>\u7b2c3\u6761 : \u5b89\u5168\u6027<\/strong><\/h6>\n\n\n\n<p>\u5e02\u5834\u306b\u63d0\u4f9b\u3055\u308c\u308b\u5316\u7ca7\u54c1\u306f\u3001\u7279\u306b\u4ee5\u4e0b\u306e\u4e8b\u9805\u3092\u8003\u616e\u3057\u305f\u4e0a\u3067\u3001\u901a\u5e38\u306e\u4f7f\u7528\u6761\u4ef6\u307e\u305f\u306f\u5408\u7406\u7684\u306b\u4e88\u898b\u53ef\u80fd\u306a\u4f7f\u7528\u6761\u4ef6\u4e0b\u3067\u4f7f\u7528\u3055\u308c\u305f\u5834\u5408\u3001\u4eba\u306e\u5065\u5eb7\u306b\u3068\u3063\u3066\u5b89\u5168\u3067\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002<\/p>\n\n\n\n<p>(a) \u5305\u88c5\uff08\u6307\u4ee487\/357\/EEC\u3078\u306e\u9069\u5408\u3092\u542b\u3080\uff09\uff1b<\/p>\n\n\n\n<p>(b) \u8868\u793a\uff1b<\/p>\n\n\n\n<p>(c) \u4f7f\u7528\u304a\u3088\u3073\u5ec3\u68c4\u306b\u95a2\u3059\u308b\u8aac\u660e\uff1b<\/p>\n\n\n\n<p>(d) \u7b2c4\u6761\u306b\u5b9a\u7fa9\u3055\u308c\u308b\u8cac\u4efb\u8005\u304c\u63d0\u4f9b\u3059\u308b\u305d\u306e\u4ed6\u306e\u8868\u793a\u307e\u305f\u306f\u60c5\u5831\u3002<\/p>\n\n\n\n<p>\u8b66\u544a\u306e\u8868\u793a\u306f\u3001\u7b2c2\u6761\u304a\u3088\u3073\u7b2c4\u6761\u306b\u5b9a\u7fa9\u3055\u308c\u308b\u8005\u304c\u3001\u672c\u898f\u5247\u306b\u5b9a\u3081\u3089\u308c\u305f\u305d\u306e\u4ed6\u306e\u8981\u4ef6\u3092\u9075\u5b88\u3059\u308b\u7fa9\u52d9\u3092\u514d\u9664\u3059\u308b\u3082\u306e\u3067\u306f\u306a\u3044\u3002<\/p>\n\n\n\n<p><\/p>\n\n\n\n<h6 class=\"wp-block-heading\"><strong>\u7b2c10\u6761 : \u5b89\u5168\u6027\u8a55\u4fa1<\/strong><\/h6>\n\n\n\n<p>1. \u5316\u7ca7\u54c1\u304c\u7b2c3\u6761\u306b\u9069\u5408\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u7acb\u8a3c\u3059\u308b\u305f\u3081\u3001\u8cac\u4efb\u8005\u306f\u3001\u5316\u7ca7\u54c1\u3092\u5e02\u5834\u306b\u6d41\u901a\u3055\u305b\u308b\u524d\u306b\u3001\u5f53\u8a72\u5316\u7ca7\u54c1\u304c\u95a2\u9023\u60c5\u5831\u306b\u57fa\u3065\u304d\u5b89\u5168\u6027\u8a55\u4fa1\u3092\u53d7\u3051\u3066\u3044\u308b\u3053\u3068\u3001\u304a\u3088\u3073\u9644\u5c5e\u66f8I\u306b\u5f93\u3063\u3066\u5316\u7ca7\u54c1\u5b89\u5168\u6027\u5831\u544a\u66f8\u304c\u4f5c\u6210\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u4fdd\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002<\/p>\n\n\n\n<p>\u8cac\u4efb\u8005\u306f\u3001\u4ee5\u4e0b\u306e\u4e8b\u9805\u3092\u78ba\u4fdd\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002<\/p>\n\n\n\n<p>(a) \u5b89\u5168\u8a55\u4fa1\u306b\u304a\u3044\u3066\u3001\u5f53\u8a72\u5316\u7ca7\u54c1\u306e\u4f7f\u7528\u76ee\u7684\u304a\u3088\u3073\u6700\u7d42\u88fd\u5264\u4e2d\u306e\u500b\u3005\u306e\u6210\u5206\u306b\u5bfe\u3059\u308b\u4e88\u60f3\u3055\u308c\u308b\u5168\u8eab\u66dd\u9732\u304c\u8003\u616e\u3055\u308c\u3066\u3044\u308b\u3053\u3068\uff1b<\/p>\n\n\n\n<p>(b) \u5b89\u5168\u8a55\u4fa1\u306b\u304a\u3044\u3066\u3001\u3042\u3089\u3086\u308b\u65e2\u5b58\u306e\u60c5\u5831\u6e90\u304b\u3089\u306e\u30c7\u30fc\u30bf\u3092\u691c\u8a0e\u3059\u308b\u305f\u3081\u306b\u3001\u9069\u5207\u306a\u8a3c\u62e0\u306e\u91cd\u307f\u4ed8\u3051\u30a2\u30d7\u30ed\u30fc\u30c1\u304c\u7528\u3044\u3089\u308c\u3066\u3044\u308b\u3053\u3068\uff1b<\/p>\n\n\n\n<p>(c) \u5f53\u8a72\u5316\u7ca7\u54c1\u306e\u5e02\u5834\u6295\u5165\u5f8c\u306b\u5f97\u3089\u308c\u305f\u8ffd\u52a0\u306e\u95a2\u9023\u60c5\u5831\u3092\u8e0f\u307e\u3048\u3001\u5316\u7ca7\u54c1\u5b89\u5168\u6027\u5831\u544a\u66f8\u304c\u6700\u65b0\u306e\u72b6\u614b\u306b\u7dad\u6301\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3002<\/p>\n\n\n\n<p>\u7b2c1\u9805\u306f\u3001\u6307\u4ee476\/768\/EEC\u306b\u57fa\u3065\u304d\u5c4a\u51fa\u304c\u306a\u3055\u308c\u305f\u5316\u7ca7\u54c1\u306b\u3082\u9069\u7528\u3055\u308c\u308b\u3002<\/p>\n\n\n\n<p>\u6b27\u5dde\u59d4\u54e1\u4f1a\u306f\u3001\u3059\u3079\u3066\u306e\u5229\u5bb3\u95a2\u4fc2\u8005\u3068\u7dca\u5bc6\u306b\u5354\u529b\u3057\u3001\u4e8b\u696d\u8005\u3001\u7279\u306b\u4e2d\u5c0f\u4f01\u696d\u304c\u9644\u5c5e\u66f8I\u306b\u5b9a\u3081\u3089\u308c\u305f\u8981\u4ef6\u3092\u9075\u5b88\u3067\u304d\u308b\u3088\u3046\u3001\u9069\u5207\u306a\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u63a1\u629e\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u5f53\u8a72\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306f\u3001\u7b2c32\u6761\u7b2c2\u9805\u306b\u898f\u5b9a\u3055\u308c\u308b\u898f\u5236\u624b\u7d9a\u306b\u5f93\u3063\u3066\u63a1\u629e\u3055\u308c\u308b\u3082\u306e\u3068\u3059\u308b\u3002<\/p>\n\n\n\n<p>2. \u9644\u5c5e\u66f8I\u306eB\u90e8\u306b\u898f\u5b9a\u3055\u308c\u308b\u5316\u7ca7\u54c1\u5b89\u5168\u8a55\u4fa1\u306f\u3001\u85ac\u5b66\u3001\u6bd2\u7269\u5b66\u3001\u533b\u5b66\u307e\u305f\u306f\u985e\u4f3c\u306e\u5206\u91ce\u306b\u304a\u3051\u308b\u5927\u5b66\u8ab2\u7a0b\u306e\u7406\u8ad6\u7684\u304a\u3088\u3073\u5b9f\u8df5\u7684\u306a\u5b66\u7fd2\u3092\u4fee\u4e86\u3057\u305f\u3053\u3068\u3092\u8a3c\u660e\u3059\u308b\u5b66\u4f4d\u307e\u305f\u306f\u305d\u306e\u4ed6\u306e\u6b63\u5f0f\u306a\u8cc7\u683c\u3001\u3082\u3057\u304f\u306f\u52a0\u76df\u56fd\u306b\u3088\u308a\u540c\u7b49\u3068\u8a8d\u3081\u3089\u308c\u305f\u8ab2\u7a0b\u3092\u4fee\u4e86\u3057\u305f\u3053\u3068\u3092\u8a3c\u660e\u3059\u308b\u8cc7\u683c\u3092\u6709\u3059\u308b\u8005\u306b\u3088\u3063\u3066\u884c\u308f\u308c\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002<\/p>\n\n\n\n<p>3. 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\u88fd\u54c1\u60c5\u5831\u30d5\u30a1\u30a4\u30eb  [PIF]<\/strong><\/h6>\n\n\n\n<p>1. \u5316\u7ca7\u54c1\u304c\u5e02\u5834\u306b\u6d41\u901a\u3055\u308c\u308b\u5834\u5408\u3001\u8cac\u4efb\u8005\u306f\u5f53\u8a72\u5316\u7ca7\u54c1\u306b\u95a2\u3059\u308b\u88fd\u54c1\u60c5\u5831\u30d5\u30a1\u30a4\u30eb\u3092\u4fdd\u7ba1\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u88fd\u54c1\u60c5\u5831\u30d5\u30a1\u30a4\u30eb\u306f\u3001\u5f53\u8a72\u5316\u7ca7\u54c1\u306e\u6700\u5f8c\u306e\u30ed\u30c3\u30c8\u304c\u5e02\u5834\u306b\u6d41\u901a\u3055\u308c\u305f\u65e5\u304b\u308910\u5e74\u9593\u4fdd\u7ba1\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002<\/p>\n\n\n\n<p>2. \u88fd\u54c1\u60c5\u5831\u30d5\u30a1\u30a4\u30eb\u306b\u306f\u3001\u4ee5\u4e0b\u306e\u60c5\u5831\u53ca\u3073\u30c7\u30fc\u30bf\u3092\u542b\u3081\u3001\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u66f4\u65b0\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\uff1a<\/p>\n\n\n\n<p>(a) \u5f53\u8a72\u5316\u7ca7\u54c1\u3092\u660e\u78ba\u306b\u7279\u5b9a\u3067\u304d\u308b\u5f53\u8a72\u5316\u7ca7\u54c1\u306e\u8aac\u660e\uff1b<\/p>\n\n\n\n<p>(b) \u7b2c10\u6761\u7b2c1\u9805\u306b\u898f\u5b9a\u3059\u308b\u5316\u7ca7\u54c1\u5b89\u5168\u6027\u5831\u544a\u66f8\uff1b<\/p>\n\n\n\n<p>(c) \u88fd\u9020\u65b9\u6cd5\u306e\u8aac\u660e\u53ca\u3073\u7b2c8\u6761\u306b\u898f\u5b9a\u3059\u308b\u9069\u6b63\u88fd\u9020\u898f\u7bc4\uff08GMP\uff09\u3078\u306e\u9069\u5408\u306b\u95a2\u3059\u308b\u58f0\u660e\uff1b<\/p>\n\n\n\n<p>(d) \u5f53\u8a72\u5316\u7ca7\u54c1\u306e\u6027\u8cea\u307e\u305f\u306f\u52b9\u679c\u306b\u3088\u3063\u3066\u6b63\u5f53\u5316\u3055\u308c\u308b\u5834\u5408\u3001\u5f53\u8a72\u5316\u7ca7\u54c1\u306b\u3064\u3044\u3066\u4e3b\u5f35\u3055\u308c\u308b\u52b9\u679c\u306e\u8a3c\u660e\uff1b<\/p>\n\n\n\n<p>(e) 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