Discuz! Board

 找回密码
 立即注册
搜索
热搜: 活动 交友 discuz
查看: 7|回复: 0

比飞检更可怕,医械经营交叉检查要来!

[复制链接]

1万

主题

1万

帖子

5万

积分

管理员

Rank: 9Rank: 9Rank: 9

积分
58026
发表于 2020-10-19 23:56:06 | 显示全部楼层 |阅读模式

                    

                    

                    
                    
                    <p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 22.2609px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">&nbsp;《总局关于整治医疗器械流通领域经营行为的公告》中指出,在企业自查整改之后,“各省级食品药品监管部门要及时汇总、认真分析企业自查和整改的情况。统一培训检查人员,组织精干力量,采取异地交叉检查方式,有针对性、有重点地实施监督检查。”</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 22.2609px; 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: 22.2609px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; color: rgb(2, 30, 170); box-sizing: border-box !important; word-wrap: break-word !important;">异地交叉检查是什么鬼?</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 22.2609px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; color: rgb(2, 30, 170); box-sizing: border-box !important; word-wrap: break-word !important;"><br  /></span></p><p style="text-align:center"><span style="max-width: 100%; color: rgb(2, 30, 170); box-sizing: border-box !important; word-wrap: break-word !important;"><img data-s="300,640" data-type="jpeg" src="http://mmbiz.qpic.cn/mmbiz/dx3KibwtDhvea5iaWRibKLDObGJr6p7ptjMegqsz60HlNPcCUMXPMXlCd5iawjFxUg6HRdNlRx3v72ricxGRdJ1n1hg/0?wx_fmt=jpeg" data-ratio="0.6283662477558348" data-w=""  /><br  /></span></p><p style="text-align:center"><span style="max-width: 100%; color: rgb(2, 30, 170); box-sizing: border-box !important; word-wrap: break-word !important;"><br  /></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 22.2609px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">在各省药监局发布的具体落实政策中,也纷纷提出了采取异地交叉检查的方式进行整治。业内经常谈飞检色变,但是,异地交叉检查又到底是怎么检查呢?和飞行检查有什么关系呢?</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 22.2609px; 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: 22.2609px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">一般来说,异地交叉检查是协同飞行检查进行的。简单来讲,就是药监局的执法人员在飞行检查的时候,不参加本县(市、区)辖区内药品医疗器械经营企业检查,作为观察员参加。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 22.2609px; 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: 22.2609px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">这样一来,既整治了药械市场,也为药监人员提供了学习交流、取长补短的机会。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 22.2609px; 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: 22.2609px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">在各省目前已经出台的整治医疗器械流通领域经营行为工作方案中,有些也提出了异地交叉检查协同飞行检查一起进行,不过更多的则是只有异地交叉检查。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 22.2609px; 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: 22.2609px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">比如,近日,广西自治区发布的整治医疗器械流通领域经营行为工作方案是这么部署的:2016年8月20日-9月20日,自治区局组织5个交叉督查组,交叉督查组人员由医疗器械监管处、局直属3个中心、部分市局人员等组成,对各市开展整治工作的情况进行交叉督查。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 22.2609px; 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: 22.2609px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">由于,目前针对医疗器械经营行为的大整治还只在企业自查阶段,也找不到直接具体的参照物。不过,南充市药监局近期发布的《南充市药品流通领域异地交叉稽查执法检查实施方案》,对异地交叉检查进行了详细说明,可以作为医疗器械行业的一个参照:</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 22.2609px; 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: 22.2609px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; color: rgb(2, 30, 170); box-sizing: border-box !important; word-wrap: break-word !important;">南充市异地交叉检查组织安排</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 22.2609px; 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: 22.2609px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">(一)市局从各县(市、区)局抽调2名稽查执法人员分三组实施交叉检查,要求1名具有药品GSP认证检查经验,1名具有药品稽查执法经验。所抽调执法人员原则上不参加本县(市、区)辖区内药品经营企业检查,作为观察员参加。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 22.2609px; 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: 22.2609px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">(二)检查企业的确定采取事先确定和随机确定两种方式,事先确定的检查企业不预先告知检查员,不提前通知所在地县(市、区)局和被检查企业;随机确定就是检查组到现场后随机确定检查的零售企业。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 22.2609px; 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: 22.2609px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">(三)检查员到达现场后,立即实施现场检查,检查中至少追溯上、下业务相关的2至4家药品购销企业。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 22.2609px; 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: 22.2609px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">(四)检查组随机确定的检查企业可不受市局确定的名单限制、时间限制、企业数量限制,自主开展工作。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 22.2609px; 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: 22.2609px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">(五)市局食品药品稽查支队负责交叉检查的安排布置、组织协调和检查指导,制定实施方案,督促方案执行,督导现场检查,审查检查报告;负责对企业存在的违法行为进行查办或转办。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 22.2609px; 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: 22.2609px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; color: rgb(2, 30, 170); box-sizing: border-box !important; word-wrap: break-word !important;">异地交叉检查要求</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 22.2609px; 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: 22.2609px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">(一)按照《药品管理法》、国家总局《药品经营质量管理规范现场检查指导原则》规定,交叉检查工作必须遵循依法、审慎、及时、客观、公正的原则。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 22.2609px; 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: 22.2609px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">(二)检查人员按规定着装,亮证执法、文明执法、规范执法,做到程序合法。严禁走过场,走形式,对所检查的单位要认真开展检查工作,做好检查记录,固定违法证据,确保检查实效。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 22.2609px; 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: 22.2609px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">(三)检查中发现的一般违法行为由市局统一书面移交属地食品药品监督管理局立案查处,重大违法行为由市局立案查处,涉嫌犯罪的由属地食品药品监督管理局移送司法机关查处。</p><p><br  /></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; 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;">电话:(+86)020-8722 8723 &nbsp; &nbsp;8764 5360 &nbsp; &nbsp;8764 2943 &nbsp; &nbsp; 传真:020-8722 8623</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;">全国统一免费服务热线:400-020-6788</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;">微信公众帐号:</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);"><img data-ratio="1" data-type="jpeg" data-w="120" width="auto" width="auto" src="http://mmbiz.qpic.cn/mmbiz/dx3KibwtDhvfCZvZq5PcthnDKlnnq3AalhbichW77J3B70osicTickklZybNKUZqc44DZ0oaWaHm2p0TaA9478icwPg/640?wx_fmt=jpeg" style="box-sizing: border-box !important; word-wrap: break-word !important; width: auto !important; visibility: visible !important;"  /></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;">维修咨询:QQ: &nbsp;712638 404</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;">设备咨询: &nbsp; QQ: &nbsp;712638 405</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;">软件咨询:QQ: 712638 406</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;">配件咨询:QQ: &nbsp; 712638 407</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;">交流Q群:1106 11074</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;">网址:http://www.yiliaoshebeiweixiu.com</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;">电子邮箱:service@yiliaoshebeiweixiu.com</span></p><p><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;"><br  /></span></p><p><br  /></p>
               
回复

使用道具 举报

您需要登录后才可以回帖 登录 | 立即注册

本版积分规则

Archiver|手机版|小黑屋|Comsenz Inc. ( 浙ICP备17000336号-1 )

GMT+8, 2025-9-16 02:59 , Processed in 0.093448 second(s), 33 queries .

Powered by Discuz! X3.4

© 2001-2017 Comsenz Inc.

快速回复 返回顶部 返回列表