富平头条 发表于 2022-9-11 17:48:02

明确了!这些药品,将不得网售

<section style="margin: 0px 0px 24px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: rgb(34, 34, 34); font-family: system-ui, -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif; letter-spacing: 0.544px; white-space: normal; background-color: rgb(255, 255, 255); visibility: visible;">近日,国家市场监管总局网站发布《药品网络销售监督管理办法》(国家市场监督管理总局令第58号),自2022年12月1日起施行。全文如下:<br style="margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; visibility: visible;"/></section><p></p><section style="margin: 0px 0px 24px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: rgb(34, 34, 34); font-family: system-ui, -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif; letter-spacing: 0.544px; white-space: normal; background-color: rgb(255, 255, 255); visibility: visible;"><br style="margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; visibility: visible;"/></section><section style="margin: 0px 0px 24px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: rgb(34, 34, 34); font-family: system-ui, -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif; letter-spacing: 0.544px; white-space: normal; background-color: rgb(255, 255, 255); text-align: center; visibility: visible;"><span style="margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: rgb(0, 122, 170); font-size: 18px; visibility: visible;"><strong style="margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; visibility: visible;">市场监管总局发布</strong></span></section><section style="margin: 0px 0px 24px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: rgb(34, 34, 34); font-family: system-ui, -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif; letter-spacing: 0.544px; white-space: normal; background-color: rgb(255, 255, 255); text-align: center; visibility: visible;"><span style="margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: rgb(0, 122, 170); font-size: 18px; visibility: visible;"><strong style="margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; visibility: visible;">《药品网络销售监督管理办法》</strong></span></section><section style="margin: 0px 0px 24px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: rgb(34, 34, 34); font-family: system-ui, -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif; letter-spacing: 0.544px; white-space: normal; background-color: rgb(255, 255, 255); text-align: center; visibility: visible;"><span style="margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: rgb(0, 122, 170); font-size: 18px; visibility: visible;"><strong style="margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; visibility: visible;">自2022年12月1日起施行</strong></span></section><section style="margin: 0px 0px 24px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: rgb(34, 34, 34); font-family: system-ui, -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif; letter-spacing: 0.544px; white-space: normal; background-color: rgb(255, 255, 255); text-align: center; visibility: visible;"><br style="margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; visibility: visible;"/></section><p></p><p style="margin-top: 0px; margin-bottom: 24px; padding: 0px; outline: 0px; max-width: 100%; clear: both; min-height: 1em; color: rgb(34, 34, 34); font-family: system-ui, -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif; letter-spacing: 0.544px; white-space: normal; background-color: rgb(255, 255, 255); visibility: visible; box-sizing: border-box !important; overflow-wrap: break-word !important;">近日,市场监管总局发布《药品网络销售监督管理办法》(国家市场监督管理总局令第58号),自2022年12月1日起施行。</p><p style="margin-top: 0px; margin-bottom: 24px; padding: 0px; outline: 0px; max-width: 100%; clear: both; min-height: 1em; color: rgb(34, 34, 34); font-family: system-ui, -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif; letter-spacing: 0.544px; white-space: normal; background-color: rgb(255, 255, 255); visibility: visible; box-sizing: border-box !important; overflow-wrap: break-word !important;">药品安全责任重大,事关人民群众生命健康,党中央、国务院高度重视。为贯彻党中央、国务院关于药品监管“四个最严”要求及一系列决策部署,细化、具化药品管理法关于药品网络销售的规定,统筹群众购药便利性和药品安全监管,切实保障公众用药安全和合法权益,市场监管总局、药监局在深入研究、充分论证的基础上,制定了《药品网络销售监督管理办法》。《办法》共6章42条,对药品网络销售管理、平台责任履行、监督检查措施及法律责任作出了规定,主要内容包括:&nbsp;</p><p style="margin-top: 0px; margin-bottom: 24px; padding: 0px; outline: 0px; max-width: 100%; clear: both; min-height: 1em; color: rgb(34, 34, 34); font-family: system-ui, -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif; letter-spacing: 0.544px; white-space: normal; background-color: rgb(255, 255, 255); visibility: visible; box-sizing: border-box !important; overflow-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: rgb(123, 12, 0); visibility: visible;"><strong style="margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; visibility: visible;">一是落实药品经营企业主体责任。</strong></span>明确从事药品网络销售的药品经营企业主体资格和要求,并<span style="margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: rgb(123, 12, 0); visibility: visible;"><strong style="margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; visibility: visible;">依法明确疫苗、血液制品、麻醉药品、精神药品、医疗用毒性药品、放射性药品、药品类易制毒化学品等国家实行特殊管理的药品不得在网络上销售。</strong></span>同时,严格药品经营全过程管理,对药品网络销售企业的质量安全管理制度、药学服务、药品储存配送、药品追溯、风险控制、信息公开等全过程管理提出明确要求。&nbsp;</p><p style="margin-top: 0px; margin-bottom: 24px; padding: 0px; outline: 0px; max-width: 100%; clear: both; min-height: 1em; color: rgb(34, 34, 34); font-family: system-ui, -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif; letter-spacing: 0.544px; white-space: normal; background-color: rgb(255, 255, 255); visibility: visible; box-sizing: border-box !important; overflow-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: rgb(123, 12, 0); visibility: visible;"><strong style="margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; visibility: visible;">二是压实药品网络销售平台责任。</strong></span>明确第三方平台应当设立药品质量安全管理机构,配备药学技术人员,建立并实施药品质量安全、药品信息展示、处方审核、处方药实名购买、药品配送、交易记录保存、不良反应报告、投诉举报处理等管理制度,并按规定备案。同时,要求平台与药品网络销售企业签订协议,明确双方药品质量安全责任,规定平台应当履行审核、检查监控以及发现严重违法行为的停止服务和报告等义务,并强化平台在药品召回、突发事件应急处置以及监督检查中的配合义务。&nbsp;</p><p style="margin-top: 0px; margin-bottom: 24px; padding: 0px; outline: 0px; max-width: 100%; clear: both; min-height: 1em; color: rgb(34, 34, 34); font-family: system-ui, -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif; letter-spacing: 0.544px; white-space: normal; background-color: rgb(255, 255, 255); visibility: visible; box-sizing: border-box !important; overflow-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: rgb(123, 12, 0); visibility: visible;"><strong style="margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; visibility: visible;">三是明确处方药网络销售管理。</strong></span>考虑用药安全风险和线上线下一致性管理要求,明确对处方药网络销售实行实名制,并按规定进行处方审核调配;规定处方药与非处方药应当区分展示,并明确在处方药销售主页面、首页面不得直接公开展示包装、标签等信息;通过处方审核前,不得展示说明书等信息,不得提供处方药购买的相关服务,意在强调“先方后药”和处方审核的管理要求。同时,要求处方药销售前应当向消费者充分告知相关风险警示信息并经消费者确认知情,切实防范用药安全风险。&nbsp;</p><p style="margin-top: 0px; margin-bottom: 24px; padding: 0px; outline: 0px; max-width: 100%; clear: both; min-height: 1em; color: rgb(34, 34, 34); font-family: system-ui, -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif; letter-spacing: 0.544px; white-space: normal; background-color: rgb(255, 255, 255); box-sizing: border-box !important; overflow-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: rgb(123, 12, 0);"><strong style="margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;">四是落实“四个最严”要求,强化各级监管部门的监管措施。</strong></span>明确各级药品监督管理部门在药品网络销售监管中的职责划分和违法行为查处的管辖权,要求强化药品网络销售监测工作,对监测发现的违法行为依法按照职责进行调查处置。强化药品安全风险控制,对有证据证明可能存在安全隐患的,依法明确药品监管部门可以采取告诫、约谈、限期整改以及暂停生产、销售、使用、进口等措施。此外,《办法》还对药品网络销售违法行为依法明确了相应的法律责任。&nbsp;</p><p style="margin-top: 0px; margin-bottom: 0em; padding: 0px; outline: 0px; max-width: 100%; clear: both; min-height: 1em; color: rgb(34, 34, 34); font-family: system-ui, -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif; letter-spacing: 0.544px; white-space: normal; background-color: rgb(255, 255, 255); text-align: center; box-sizing: border-box !important; overflow-wrap: break-word !important;"></p><p style="margin-top: 0px; margin-bottom: 24px; padding: 0px; outline: 0px; max-width: 100%; clear: both; min-height: 1em; box-sizing: border-box !important; overflow-wrap: break-word !important;"><br style="margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;"/></p><p></p><section data-support="96编辑器" data-style-id="33465" style="margin: 0px 0px 24px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: rgb(34, 34, 34); font-family: system-ui, -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif; letter-spacing: 0.544px; white-space: normal; background-color: rgb(255, 255, 255); visibility: visible;"><section style="margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;"><section style="margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; letter-spacing: 0.544px; font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;"><section style="margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; letter-spacing: 0.544px;"><section style="margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; font-size: 14px; color: rgb(136, 136, 136);">来源:国家市场监管总局网站</span><span style="margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; font-size: 14px; color: rgb(136, 136, 136);"></span></section><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; outline: 0px; max-width: 100%; clear: both; min-height: 1em; caret-color: rgb(34, 34, 34); font-family: system-ui, -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif; letter-spacing: 0.544px; -webkit-tap-highlight-color: rgba(0, 0, 0, 0); line-height: normal; box-sizing: border-box !important; overflow-wrap: break-word !important;"><br/></p></section></section></section></section><p></p><link rel="stylesheet" href="//www.dafuping.cn/source/plugin/wcn_editor/public/wcn_editor_fit.css?v134_dk0" id="wcn_editor_css"/>
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