{"id":14296,"date":"2024-07-13T16:20:04","date_gmt":"2024-07-13T08:20:04","guid":{"rendered":"https:\/\/greenoo.tw\/?p=14296"},"modified":"2024-07-13T16:20:37","modified_gmt":"2024-07-13T08:20:37","slug":"%e3%80%90%e7%b6%a0%e5%9c%88%e5%9c%88%e8%aa%aa%e8%b7%a8%e5%a2%83%e3%80%91-%e6%ad%90%e7%9b%9f%e5%8c%96%e5%a6%9d%e5%93%81%e6%b3%95%e8%a6%8f-ec-no-1223-2009-%e4%b8%ad%e8%b2%ac%e4%bb%bb%e4%ba%ba%e7%9a%84","status":"publish","type":"post","link":"https:\/\/greenoo.tw\/zh\/%e3%80%90%e7%b6%a0%e5%9c%88%e5%9c%88%e8%aa%aa%e8%b7%a8%e5%a2%83%e3%80%91-%e6%ad%90%e7%9b%9f%e5%8c%96%e5%a6%9d%e5%93%81%e6%b3%95%e8%a6%8f-ec-no-1223-2009-%e4%b8%ad%e8%b2%ac%e4%bb%bb%e4%ba%ba%e7%9a%84\/","title":{"rendered":"\u3010\u7da0\u5708\u5708\u8aaa\u8de8\u5883\u3011-\u6b50\u76df\u5316\u599d\u54c1\u6cd5\u898f (EC) No 1223\/2009 \u4e2d\u8cac\u4efb\u4eba\u7684\u8077\u8cac\u8a73\u89e3"},"content":{"rendered":"<p>\u6b50\u76df\u5316\u599d\u54c1\u6cd5\u898f (EC) No 1223\/2009 \u4e2d\u8cac\u4efb\u4eba\u7684\u8077\u8cac\u8a73\u89e3<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li>\u8cac\u4efb\u4eba\u7684\u5b9a\u7fa9<br>\u8cac\u4efb\u4eba\u5fc5\u9808\u662f\u6b50\u76df\u5167\u7684\u81ea\u7136\u4eba\u6216\u6cd5\u4eba\uff0c\u8ca0\u8cac\u78ba\u4fdd\u5316\u599d\u54c1\u7684\u5408\u898f\u6027\u3002\u8cac\u4efb\u4eba\u53ef\u4ee5\u662f\u88fd\u9020\u5546\u3001\u9032\u53e3\u5546\u3001\u5206\u92b7\u5546\u6216\u7d93\u6388\u6b0a\u7684\u7b2c\u4e09\u65b9\u3002<\/li>\n\n\n\n<li>\u4e3b\u8981\u8077\u8cac<\/li>\n<\/ol>\n\n\n\n<p>a. \u78ba\u4fdd\u7522\u54c1\u5b89\u5168<br>\u8cac\u4efb\u4eba\u5fc5\u9808\u78ba\u4fdd\u6240\u6709\u6295\u653e\u5e02\u5834\u7684\u5316\u599d\u54c1\u5728\u6b63\u5e38\u6216\u5408\u7406\u53ef\u9810\u898b\u7684\u4f7f\u7528\u689d\u4ef6\u4e0b\u5c0d\u4eba\u9ad4\u5065\u5eb7\u7121\u5bb3\u3002\u9019\u9700\u8981\u9032\u884c\u8a73\u7d30\u7684\u5b89\u5168\u8a55\u4f30\uff0c\u4e26\u7531\u5177\u5099\u8cc7\u683c\u7684\u4eba\u54e1\u9032\u884c\u5be9\u67e5\u3002<br>b. \u4fe1\u606f\u4fdd\u7559\u548c\u7522\u54c1\u4fe1\u606f\u6587\u4ef6 (P.I.F.)<br>\u8cac\u4efb\u4eba\u9700\u6839\u64da\u6cd5\u898f\u7b2c11\u689d\uff0c\u4fdd\u7559\u6bcf\u500b\u7522\u54c1\u7684\u8a73\u7d30\u4fe1\u606f\uff0c\u5305\u62ec\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u7522\u54c1\u7684\u914d\u65b9\u548c\u539f\u6750\u6599\u4fe1\u606f<\/li>\n\n\n\n<li>\u7522\u54c1\u7684\u88fd\u9020\u65b9\u6cd5<\/li>\n\n\n\n<li>\u7522\u54c1\u7684\u6a19\u7c64\u548c\u5305\u88dd\u4fe1\u606f<\/li>\n\n\n\n<li>\u7522\u54c1\u7684\u5b89\u5168\u8a55\u4f30\u5831\u544a<br>\u9019\u4e9b\u4fe1\u606f\u5fc5\u9808\u96a8\u6642\u6e96\u5099\u597d\uff0c\u4ee5\u4fbf\u5728\u4e3b\u7ba1\u7576\u5c40\u8981\u6c42\u6642\u63d0\u4f9b\u3002<br>c. \u7b26\u5408\u6a19\u7c64\u8981\u6c42<br>\u6bcf\u500b\u5316\u599d\u54c1\u6a19\u7c64\u4e0a\u5fc5\u9808\u6a19\u660e\u8cac\u4efb\u4eba\u7684\u59d3\u540d\u548c\u5b8c\u6574\u5730\u5740\u3002\u5982\u679c\u6709\u591a\u500b\u5730\u5740\uff0c\u61c9\u7a81\u51fa\u986f\u793a\u4fdd\u5b58P.I.F.\u7684\u5730\u5740\u3002\u6b64\u5916\uff0c\u6a19\u7c64\u9084\u9700\u5305\u542b\u7522\u54c1\u985e\u5225\u3001\u539f\u7522\u570b\u3001\u7d0d\u7c73\u6750\u6599\u5b58\u5728\u3001CMR\u7269\u8cea\u7b49\u4fe1\u606f\u3002<\/li>\n<\/ul>\n\n\n\n<p>d. \u63d0\u4ea4\u901a\u77e5<br>\u5728\u7522\u54c1\u6295\u653e\u5e02\u5834\u4e4b\u524d\uff0c\u8cac\u4efb\u4eba\u5fc5\u9808\u901a\u904e\u6b50\u6d32\u5316\u599d\u54c1\u7522\u54c1\u901a\u77e5\u9580\u6236\u7db2\u7ad9 (CPNP) \u63d0\u4ea4\u7522\u54c1\u4fe1\u606f\uff0c\u5305\u62ec\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u8cac\u4efb\u4eba\u4fe1\u606f<\/li>\n\n\n\n<li>\u7522\u54c1\u7684\u914d\u65b9\u548c\u6210\u5206<\/li>\n\n\n\n<li>\u7522\u54c1\u7684\u6a19\u7c64\u548c\u5305\u88dd\u4fe1\u606f<\/li>\n<\/ul>\n\n\n\n<ol class=\"wp-block-list\">\n<li>\u5316\u599d\u54c1\u8b66\u6212 (Cosmetovigilance)<br>\u6839\u64da\u6cd5\u898f\u7b2c23\u689d\uff0c\u8cac\u4efb\u4eba\u548c\u5206\u92b7\u5546\u5fc5\u9808\u5831\u544a\u6240\u6709\u5df2\u77e5\u7684\u6216\u5408\u7406\u9810\u671f\u7684\u56b4\u91cd\u4e0d\u826f\u53cd\u61c9\u3002\u56b4\u91cd\u4e0d\u826f\u53cd\u61c9\u5305\u62ec\u4efb\u4f55\u5c0e\u81f4\u4f4f\u9662\u3001\u81f4\u6b98\u6216\u81f4\u547d\u7684\u53cd\u61c9\u3002\u8cac\u4efb\u4eba\u9700\u5411\u767c\u73fe\u56b4\u91cd\u4e0d\u826f\u53cd\u61c9\u7684\u6210\u54e1\u570b\u4e3b\u7ba1\u7576\u5c40\u5831\u544a\uff0c\u4e26\u63a1\u53d6\u5fc5\u8981\u7684\u7cfe\u6b63\u63aa\u65bd\u3002<\/li>\n\n\n\n<li>\u7cfe\u6b63\u63aa\u65bd\u548c\u7522\u54c1\u53ec\u56de<br>\u5982\u679c\u767c\u73fe\u5316\u599d\u54c1\u4e0d\u7b26\u5408\u898f\u5b9a\uff0c\u8cac\u4efb\u4eba\u5fc5\u9808\u8fc5\u901f\u63a1\u53d6\u7cfe\u6b63\u63aa\u65bd\uff0c\u4f7f\u7522\u54c1\u7b26\u5408\u6cd5\u898f\u8981\u6c42\u3002\u5728\u67d0\u4e9b\u60c5\u6cc1\u4e0b\uff0c\u5982\u679c\u7522\u54c1\u5c0d\u6d88\u8cbb\u8005\u7684\u5065\u5eb7\u69cb\u6210\u98a8\u96aa\uff0c\u8cac\u4efb\u4eba\u9700\u8981\u5f9e\u5e02\u5834\u4e0a\u53ec\u56de\u7522\u54c1\u3002<\/li>\n\n\n\n<li>\u9078\u64c7\u8cac\u4efb\u4eba<br>\u6839\u64da\u6cd5\u898f\u7b2c4\u689d\uff0c\u8cac\u4efb\u4eba\u53ef\u4ee5\u662f\uff1a<\/li>\n<\/ol>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u88fd\u9020\u5546\uff1a\u5982\u679c\u5316\u599d\u54c1\u5728\u6b50\u76df\u5167\u88fd\u9020\u4e14\u672a\u51fa\u53e3\uff0c\u5247\u88fd\u9020\u5546\u7232\u8cac\u4efb\u4eba\u3002<\/li>\n\n\n\n<li>\u9032\u53e3\u5546\uff1a\u5982\u679c\u5316\u599d\u54c1\u5f9e\u975e\u6b50\u76df\u570b\u5bb6\u9032\u53e3\uff0c\u9032\u53e3\u5546\u7232\u8cac\u4efb\u4eba\u3002<\/li>\n\n\n\n<li>\u5206\u92b7\u5546\uff1a\u5982\u679c\u5206\u92b7\u5546\u4ee5\u81ea\u5df1\u7684\u540d\u7fa9\u6216\u5546\u6a19\u92b7\u552e\u5316\u599d\u54c1\uff0c\u6216\u5c0d\u7522\u54c1\u9032\u884c\u91cd\u5927\u4fee\u6539\uff0c\u5206\u92b7\u5546\u7232\u8cac\u4efb\u4eba\u3002<\/li>\n<\/ul>\n\n\n\n<ol class=\"wp-block-list\">\n<li>\u5be6\u969b\u64cd\u4f5c\u6307\u5357<br>a. \u6aa2\u67e5\u5408\u898f\u6027<br>\u8cac\u4efb\u4eba\u9700\u5b9a\u671f\u6aa2\u67e5\u5316\u599d\u54c1\u662f\u5426\u7b26\u5408\u6700\u65b0\u7684\u9069\u7528\u6cd5\u898f\uff0c\u5305\u62ec\u6210\u5206\u3001\u6a19\u7c64\u548c\u5b89\u5168\u8a55\u4f30\u3002<br>b. \u7522\u54c1\u5b89\u5168\u5831\u544a (CPSR)<br>\u8cac\u4efb\u4eba\u5fc5\u9808\u9032\u884c\u5168\u9762\u7684\u7522\u54c1\u5b89\u5168\u8a55\u4f30\uff0c\u4e26\u4fdd\u7559\u6240\u6709\u76f8\u95dc\u6578\u64da\uff0c\u5f62\u6210CPSR\u3002\u8a72\u5831\u544a\u61c9\u6839\u64da\u6700\u65b0\u7684\u79d1\u5b78\u548c\u6cd5\u898f\u4fe1\u606f\u5b9a\u671f\u66f4\u65b0\u3002<br>c. \u901a\u77e5\u8207\u5099\u6848<br>\u8cac\u4efb\u4eba\u9700\u901a\u904eCPNP\uff08\u6b50\u76df\u5e02\u5834\uff09\u548cSCPN\uff08\u82f1\u570b\u5e02\u5834\uff09\u63d0\u4ea4\u7522\u54c1\u4fe1\u606f\uff0c\u4ee5\u78ba\u4fdd\u7522\u54c1\u5728\u5404\u5e02\u5834\u7684\u5408\u6cd5\u6027\u3002<br>d. \u6d77\u95dc\u6e05\u95dc<br>\u8cac\u4efb\u4eba\u9700\u8981\u78ba\u4fdd\u5728\u9032\u5165\u6b50\u76df\u7684\u53e3\u5cb8\u6642\uff0c\u80fd\u5920\u63d0\u4f9b\u6240\u6709\u5fc5\u8981\u7684\u6587\u4ef6\u548c\u8072\u660e\uff0c\u4ee5\u4fbf\u9806\u5229\u901a\u904e\u6d77\u95dc\u6e05\u95dc\u7a0b\u5e8f\u3002<\/li>\n<\/ol>\n\n\n\n<p>\u7e3d\u7d50<br>\u8cac\u4efb\u4eba\u5728\u5316\u599d\u54c1\u6cd5\u898f (EC) No 1223\/2009 \u4e2d\u626e\u6f14\u7740\u81f3\u95dc\u91cd\u8981\u7684\u89d2\u8272\u3002\u901a\u904e\u78ba\u4fdd\u7522\u54c1\u7684\u5b89\u5168\u6027\u3001\u5408\u898f\u6027\u548c\u900f\u660e\u5ea6\uff0c\u8cac\u4efb\u4eba\u5e6b\u52a9\u7dad\u8b77\u6d88\u8cbb\u8005\u7684\u5065\u5eb7\u548c\u5b89\u5168\u3002\u7232\u4e86\u6210\u529f\u5c65\u884c\u9019\u4e9b\u8077\u8cac\uff0c\u8cac\u4efb\u4eba\u9700\u8981\u5177\u5099\u6df1\u5165\u7684\u6cd5\u898f\u77e5\u8b58\u548c\u56b4\u683c\u7684\u64cd\u4f5c\u6d41\u7a0b\u3002<\/p>\n\n\n\n<p>\u7e3d\u7684\u4f86\u8aaa\uff0c\u9078\u64c7\u4e00\u500b\u5408\u9069\u7684\u8cac\u4efb\u4eba\u4e26\u78ba\u4fdd\u5176\u80fd\u5920\u6709\u6548\u5c65\u884c\u6240\u6709\u6cd5\u898f\u8981\u6c42\uff0c\u662f\u5728\u6b50\u76df\u5e02\u5834\u4e0a\u92b7\u552e\u5316\u599d\u54c1\u7684\u95dc\u9375\u6b65\u9a5f\u3002\u901a\u904e\u5c08\u696d\u7684\u652f\u6301\u548c\u56b4\u683c\u7684\u5408\u898f\u7ba1\u7406\uff0c\u5316\u599d\u54c1\u516c\u53f8\u53ef\u4ee5\u9806\u5229\u9032\u5165\u6b50\u76df\u5e02\u5834\uff0c\u4e26\u78ba\u4fdd\u5176\u7522\u54c1\u7b26\u5408\u6240\u6709\u6cd5\u898f\u548c\u5b89\u5168\u6a19\u6e96\u3002<\/p>","protected":false},"excerpt":{"rendered":"<p>\u6b50\u76df\u5316\u599d\u54c1\u6cd5\u898f (EC) No 1223\/2009 \u4e2d\u8cac\u4efb\u4eba\u7684\u8077\u8cac\u8a73\u89e3 a. \u78ba\u4fdd\u7522\u54c1\u5b89\u5168\u8cac\u4efb\u4eba\u5fc5\u9808\u78ba\u4fdd\u6240\u6709\u6295 [\u2026]<\/p>","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"footnotes":""},"categories":[42,1,46],"tags":[],"class_list":["post-14296","post","type-post","status-publish","format-standard","hentry","category-42","category-uncategorized","category-46"],"_links":{"self":[{"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/posts\/14296"}],"collection":[{"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/comments?post=14296"}],"version-history":[{"count":1,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/posts\/14296\/revisions"}],"predecessor-version":[{"id":14297,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/posts\/14296\/revisions\/14297"}],"wp:attachment":[{"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/media?parent=14296"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/categories?post=14296"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/tags?post=14296"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}