全国性械商大督查将启新手段

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                    <p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="line-height: 24.381px;">《关于整治医疗器械流通领域违法经营行为的公告》(2016年第112号)要求，企业提交自查报告之后，地方药监局要及时采取异地交叉检查方式，有针对性、有重点地实施监督检查。</span><br  /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"  /></p><p style="text-align:center"><img data-s="300,640" data-type="jpeg" src="http://mmbiz.qpic.cn/mmbiz/dx3KibwtDhvdshliclyvDlk5sBUXsmVvMEH0spMq9c7qhplycWXauB2PqSqyK0AugqGPic5j2vhm3AOfKrlWz6t3Q/0?wx_fmt=jpeg" data-ratio="0.6567164179104478" data-w="335"  /></p><p style="text-align:center"><br  /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">重点检查对象主要有3个：</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"  /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">一：日常管理水平低、购销渠道混乱、案件多发等问题较多，且自查发现问题少、整改措施不力的企业；</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"  /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">二：从事需要低温、冷藏医疗器械经营企业；</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"  /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">三：进口医疗器械境内代理商</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"  /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="color: rgb(62, 62, 62); line-height: 24.381px; white-space: pre-wrap; background-color: rgb(255, 255, 255);">国家药监总局限定的医疗器械经营企业自查整改最后限期<span style="color: rgb(62, 62, 62); line-height: 24.381px; white-space: pre-wrap; background-color: rgb(255, 255, 255);">是</span><span style="color: rgb(62, 62, 62); line-height: 24.381px; white-space: pre-wrap; background-color: rgb(255, 255, 255);">7月15日</span>。</span><span style="line-height: 24.381px;"><br  /></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="color: rgb(62, 62, 62); line-height: 24.381px; white-space: pre-wrap; background-color: rgb(255, 255, 255);"><br  /></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="line-height: 24.381px;">地方药监局需在</span><span style="line-height: 24.381px;">2016年9月30日前</span><span style="line-height: 24.381px;">将整治情况总结报国家总局。</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"  /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">全国性的械商大督查行动即将启动，<span style="max-width: 100%; line-height: 1.6; box-sizing: border-box !important; word-wrap: break-word !important;">很多地方的药监部门也将启用医疗器械经营检查的新手段“上下游延伸检查”。</span><span style="line-height: 24.381px;">将证、票、账、货、款、物流单关联起来，进行</span><span style="line-height: 24.381px;">全供应链的检查</span><span style="line-height: 24.381px;">。通过检查发现企业是否存在票货款不一致，或隐瞒真实购销存记录、票据、凭证等情况，甚至能查出是否存在挂靠、走票行为。</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br  /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">针对“上下游延伸检查”，各地方药监局花样百出——</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"  /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">湖北省药监局在其落实方案中，要求做到向上至少追溯至1家药品生产企业或批发企业，向下至少追溯至1家医疗机构及药品经营企业（含零售药店）。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"  /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">陕西省药监局、重庆九龙坡药监局等规定，在追查销售终端和医院，追溯票、账、货、款的一致性同时，必要时可以协同税务部门一同检查。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br  /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="color: rgb(62, 62, 62); line-height: 24.381px; white-space: pre-wrap; background-color: rgb(255, 255, 255);">在医疗器械经营行为大整治中，这些地方药监部门的“上下游延伸检查”手段应会延续下来。</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br  /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="color: rgb(62, 62, 62); line-height: 24.381px; white-space: pre-wrap; background-color: rgb(255, 255, 255);">对于存在虚构购销流向等行为的械商来说，“上下游延伸检查”或将成为生死存在的关键。</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="color: rgb(62, 62, 62); line-height: 24.381px; white-space: pre-wrap; background-color: rgb(255, 255, 255);"><br  /></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-family: Arial, Verdana, sans-serif; font-size: 14px; line-height: 24px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(249, 249, 249);">广州市设备维修有限公司</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; line-height: 24px; font-family: Arial, Verdana, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">地址：广州市天河区银利街银利茶叶博览中心E栋4楼E4030室 &nbsp; &nbsp; &nbsp; 邮编：510507</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; line-height: 24px; font-family: Arial, Verdana, sans-serif; box-sizing: border-box !important; 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