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岭南老药师

硕士 | 31 年行业经验

专业领域 药品
技术职称 /

已入驻 434天

服务星级 5星

活跃度 1星

热度 5星

关注数 6

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中药饮片，也须“药品上市许可人（MAH）”！CIO合规保证组织岭南老药师解读新药品法

2019年8月26日，新修订的《中华人民共和国药品管理法》经十三届全国人大常委会第十二次会议表决通过，将药品领域改革成果和行之有效的做法上升为法律，贯彻“四个最严”的原则，为公众健康提供更有力的法治保障。并将于2019年12月1日施行。趁着新法仍未实施，趁着我们还有时间，在本栏目中合规君将持续为您带来行业专家对《药品管理法》的最新解读，全面分析各条款要求，帮助大家进一步理解新规范，把握行业发展的趋势！第三十九条中药饮片生产企业履行药品上市许可持有人的相关义务，对中药饮片生产、销售实行全过程管理，建立中药饮片追溯体系，保证中药饮片安全、有效、可追溯。老药师解读新修订《药品管理法》“中药饮片将迎来产业变革”。12月1日将实施新法，同时影响中药饮片行业。要求中药饮片生产企业严格履行药品上市许可持有人的义务。对生产、销售实行全过程持续质量合规管理。建立中药饮片追溯体系，管理成本会大幅增加。对检验要求更加严格，成品需要全程审核放行。专项整治趋严，质量公告占比较大。对制假售假给予更严厉处罚，对违规违法企业处以二至十倍罚款。生产成本将会增加，竞争更加激烈。企业整合速度加快，增高行业集中度。上期回顾：什么是假劣药？什么是造假行为？--岭南老药师解读新药品法

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什么是假劣药？什么是造假行为？--岭南老药师解读新药品法

<section><section><section><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; clear: both; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; font-size: 15px;"><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(0, 145, 64); color: rgb(255, 255, 255);"></span></span></p></section></section><section><section><section><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; clear: both; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; font-size: 15px;"><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(0, 145, 64); color: rgb(255, 255, 255);"> 第九十八条 </span> 禁止生产（包括配制，下同）、销售、使用假药、劣药。</span></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; clear: both; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><br/></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; clear: both; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; font-size: 15px;">有下列情形之一的，为假药:</span></p><ol class=" list-paddingleft-2" style="padding: 0px 0px 0px 2.2em; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><li><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; clear: both; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; font-size: 15px;">药品所含成份与国家药品标准规定的成份不符；</span></p></li><li><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; clear: both; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; font-size: 15px;">以非药品冒充药品或者以他种药品冒充此种药品；</span></p></li><li><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; clear: both; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; font-size: 15px;">变质的药品；</span></p></li><li><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; clear: both; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; font-size: 15px;">药品所标明的适应症或者功能主治超出规定范围。</span></p></li></ol><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; clear: both; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><br/></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; clear: both; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; font-size: 15px;">有下列情形之一的，为劣药：</span></p><ol class=" list-paddingleft-2" style="padding: 0px 0px 0px 2.2em; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><li><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; clear: both; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; font-size: 15px;">药品成份的含量不符合国家药品标准；</span></p></li><li><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; clear: both; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; font-size: 15px;">被污染的药品；</span></p></li><li><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; clear: both; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; font-size: 15px;">未标明或者更改有效期的药品；</span></p></li><li><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; clear: both; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; font-size: 15px;">未注明或者更改产品批号的药品；</span></p></li><li><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; clear: both; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; font-size: 15px;">超过有效期的药品；</span></p></li><li><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; clear: both; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; font-size: 15px;">擅自添加防腐剂、辅料的药品；</span></p></li><li><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; clear: both; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; font-size: 15px;">其他不符合药品标准的药品。</span></p></li></ol><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; clear: both; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><br/></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; clear: both; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; font-size: 15px;">　　禁止未取得药品批准证明文件生产、进口药品；禁止使用未按照规定审评、审批的原料药、包装材料和容器生产药品。</span></p></section></section><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; clear: both; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><br/></p><section><section><section><section><section><section></section><section></section></section></section><section><section><section><strong style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; border-color: rgb(0, 145, 64); color: inherit;">岭南老药师解读新版《药品管理法》</span></strong><span class="" style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; border-color: rgb(0, 145, 64); color: inherit; font-family: 微软雅黑, "microsoft yahei";"></span></section></section><section><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; clear: both; min-height: 1em; color: inherit; border-color: rgb(0, 145, 64); box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; border-color: rgb(0, 145, 64); color: inherit; font-family: inherit;"></span></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; clear: both; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; color: rgb(0, 0, 0); font-size: 15px;">一、重新界定了假药和劣药《新法98条》的范围，将“假药”“劣药”和“按假药论处”“按劣药论处”两类四种违法行为所列情形综合考虑。</span></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; clear: both; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><br/></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; clear: both; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; color: rgb(0, 0, 0); font-size: 15px;">除了原本就属于“假药”的两种情形…所含成分与国家药品标准规定的成分不符的药品，以非药品冒充药品或者以他种药品冒充此种药品之外，变质药品也被界定为假药。</span></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; clear: both; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><br/></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; clear: both; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; color: rgb(0, 0, 0); font-size: 15px;">此外，所标明的适应症或者功能主治超出规定范围的药品，也被定性为假药。对“劣药”和“按劣药论处”的条款进行了整合。与修改前相比，进口国内未批的境外合法新药不再按假药论处。</span></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; clear: both; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><br/></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; clear: both; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; color: rgb(0, 0, 0); font-size: 15px;">但新法也明确，禁止未取得药品批准证明文件生产、进口药品，使用未批准原料及未检验放行等改以违法行为处罚，依照124条款进行处罚。</span></p></section></section></section></section></section><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; clear: both; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><br/></p></section><section><section><section><section><section><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; clear: both; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; color: rgb(0, 0, 0);"></span></p></section></section></section></section></section></section><p><br/></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px 0.5em; max-width: 100%; clear: both; min-height: 1em; color: rgb(51, 51, 51); font-family: -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; font-size: 17px; letter-spacing: 0.544px; text-align: justify; white-space: normal; background-color: rgb(255, 255, 255); box-sizing: border-box !important; word-wrap: break-word !important;"><a href="http://www.ciopharma.com/article/info/12" target="_self"><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; font-size: 15px;">上期回顾：</span><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">本想开个小药店养家糊口，不小心将倾家荡产！--岭南老药师解读新药品法专栏</span></a></p><p><br/></p>

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岭南老药师：1分钟带你读懂新版《药品管理法》！

<p style="margin-top: 0px; margin-bottom: 0px; padding: 0px 0.5em; max-width: 100%; clear: both; min-height: 1em; color: rgb(51, 51, 51); font-family: -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; font-size: 17px; text-align: justify; white-space: normal; background-color: rgb(255, 255, 255); text-indent: 2em; letter-spacing: 0.5px; line-height: 1.5em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; font-size: 15px;">2019年8月26日，新修订的《中华人民共和国药品管理法》经十三届全国人大常委会第十二次会议表决通过，将药品领域改革成果和行之有效的做法上升为法律，贯彻“四个最严”的原则，为公众健康提供更有力的法治保障。并将于2019年12月1日施行。</span></p><p></p><section><br/></section><p></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px 0.5em; max-width: 100%; clear: both; min-height: 1em; color: rgb(51, 51, 51); font-family: -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; font-size: 17px; text-align: justify; white-space: normal; background-color: rgb(255, 255, 255); text-indent: 2em; letter-spacing: 0.5px; line-height: 1.5em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; font-size: 15px;">趁着新法仍未实施，趁着我们还有时间，在本栏目中合规君将持续为您带来行业专家对《药品管理法》的最新解读，全面分析<span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">各条款要求</span>，帮助大家进一步理解新规范，把握行业发展的趋势！</span></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px 0.5em; max-width: 100%; clear: both; min-height: 1em; color: rgb(51, 51, 51); font-family: -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; font-size: 17px; letter-spacing: 0.544px; text-align: justify; white-space: normal; background-color: rgb(255, 255, 255); box-sizing: border-box !important; word-wrap: break-word !important;"><br/></p><blockquote class="" style="margin: 1em 0px; padding: 4px 0.5em 0px; border-left: 3px solid rgb(219, 219, 219); color: rgba(0, 0, 0, 0.5); font-size: 15px; max-width: 100%; font-family: -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; letter-spacing: 0.544px; text-align: justify; white-space: normal; background-color: rgb(255, 255, 255); box-sizing: border-box !important; word-wrap: break-word !important;"><section><section><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(0, 145, 64); color: rgb(255, 255, 255);"> 第六十条 </span><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; color: rgb(0, 145, 64);"> 城乡集市贸易市场可以出售中药材，国务院另有规定的除外。</span></span></section></section></blockquote><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px 0.5em; max-width: 100%; clear: both; min-height: 1em; color: rgb(51, 51, 51); font-family: -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; font-size: 17px; letter-spacing: 0.544px; text-align: justify; white-space: normal; background-color: rgb(255, 255, 255); box-sizing: border-box !important; word-wrap: break-word !important;"><br/></p><p></p><section><section><section><section><section><section></section><section></section></section></section><section><section><section><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; font-size: 16px;"><strong style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span class="" style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; border-color: rgb(0, 145, 64); color: inherit; font-family: 微软雅黑, "microsoft yahei";">岭南老药师解读《药品管理法》：</span></strong></span></section></section><section><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; clear: both; min-height: 1em; color: inherit; border-color: rgb(0, 145, 64); box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; border-color: rgb(0, 145, 64); color: inherit; font-family: inherit;"></span></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; clear: both; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; color: rgb(0, 0, 0); font-size: 15px;">全国中药材交易专业市场全面放开。根据新修订药品管理法条款，农贸市场均可销售中药材，法律上不需要审批，至此全面放开药材流通，振兴中医中药。</span></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; clear: both; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><br/></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; clear: both; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; color: rgb(0, 0, 0); font-size: 15px;">条款中国务院规定，是指受保护动植物药材未经批准不能在市场上销售。</span></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; clear: both; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; color: rgb(0, 0, 0); font-size: 15px;"><br/></span></p></section></section></section></section></section><p></p><p><a href="http://www.ciopharma.com/article/info/12" target="_self">下期阅读：<span style="background-color: rgb(255, 255, 255); color: rgb(51, 51, 51); font-family: Helvetica, STHeiti, "Microsoft YaHei", Verdana, Arial, Tahoma, sans-serif; text-align: center;">本想开个小药店养家糊口，不小心将倾家荡产！ --岭南老药师解读新药品法专栏</span></a></p><p><br/></p>

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本想开个小药店养家糊口，不小心将倾家荡产！ --岭南老药师解读新药品法专栏

<section><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; font-size: 15px;">2019年8月26日，新修订的《中华人民共和国药品管理法》经十三届全国人大常委会第十二次会议表决通过，将药品领域改革成果和行之有效的做法上升为法律，贯彻“四个最严”的原则，为公众健康提供更有力的法治保障。</span><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; font-size: 15px;">并将于2019年12月1日施行。</span></section><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px 0.5em; max-width: 100%; clear: both; min-height: 1em; color: rgb(51, 51, 51); font-family: -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; font-size: 17px; letter-spacing: 0.544px; text-align: justify; white-space: normal; background-color: rgb(255, 255, 255); box-sizing: border-box !important; word-wrap: break-word !important;"><br/></p><p></p><section><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; font-size: 15px;">趁着新法仍未实施，趁着我们还有时间，在本栏目中合规君将持续为您带来行业专家对《药品管理法》的最新解读，全面分析各条款要求，帮助大家进一步理解新规范，把握行业发展的趋势！</span></section><p></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px 0.5em; max-width: 100%; clear: both; min-height: 1em; color: rgb(51, 51, 51); font-family: -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; font-size: 17px; letter-spacing: 0.544px; text-align: justify; white-space: normal; background-color: rgb(255, 255, 255); box-sizing: border-box !important; word-wrap: break-word !important;"><br/></p><blockquote class="" style="margin: 1em 0px; padding: 4px 0.5em 0px; border-left: 3px solid rgb(219, 219, 219); color: rgba(0, 0, 0, 0.5); font-size: 15px; max-width: 100%; font-family: -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; letter-spacing: 0.544px; text-align: justify; white-space: normal; background-color: rgb(255, 255, 255); box-sizing: border-box !important; word-wrap: break-word !important;"><section><section><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(0, 145, 64);"> </span><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(0, 145, 64); color: rgb(255, 255, 255);">第一百二十九条 </span> 违反本法规定，药品上市许可持有人、药品生产企业、药品经营企业或者医疗机构未从药品上市许可持有人或者具有药品生产、经营资格的企业购进药品的，责令改正，没收违法购进的药品和违法所得，并处违法购进药品货值金额二倍以上十倍以下的罚款；情节严重的，并处货值金额十倍以上三十倍以下的罚款，吊销药品批准证明文件、药品生产许可证、药品经营许可证或者医疗机构执业许可证；货值金额不足五万元的，按五万元计算。</section></section></blockquote><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px 0.5em; max-width: 100%; clear: both; min-height: 1em; color: rgb(51, 51, 51); font-family: -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; font-size: 17px; letter-spacing: 0.544px; text-align: justify; white-space: normal; background-color: rgb(255, 255, 255); box-sizing: border-box !important; word-wrap: break-word !important;"><br/></p><p></p><section><section><section><section><section><section></section><section></section></section></section><section><section><section><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; font-size: 16px;"><strong style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; border-color: rgb(0, 145, 64); color: inherit;">老药师解读《药品管理法》之药品流通罚则</span></strong></span><strong style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; border-color: rgb(0, 145, 64); color: inherit;"></span></strong></section></section><section><section><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; font-size: 15px; color: rgb(0, 0, 0);">从非法渠道、购销假劣及无证购进药品的行政处罚，新修订药品法都进行了单列并且加以明确，</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-size: 15px; box-sizing: border-box !important; word-wrap: break-word !important;">新法取消按假劣药论处，增加以违法行为处罚内容，比旧法更加明晰和可操作性</span><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; font-size: 15px; color: rgb(0, 0, 0);">，体现最严厉处罚和监管。</span></section><section><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; font-size: 15px; color: rgb(0, 0, 0);"><br/></span></section><section><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; font-size: 15px; color: rgb(0, 0, 0);">非法渠道购销药品分常规和严重处罚，常规罚款二至五倍或10～50万元，情况严重顶格处罚则是货值三十倍。</span><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; font-size: 15px; color: rgb(0, 0, 0);">所购之为合格药品按本规定处罚，如果所购销药品为假劣药，则可按116、117、118、119条款对企业、医疗机构及个人进行从重处罚。</span><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; font-size: 15px; color: rgb(0, 0, 0);">无证购销药品则按115条款进行处罚，最低处罚150万元，上不封顶。</span></section><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; clear: both; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><br/></p><section><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; font-size: 15px; color: rgb(0, 0, 0);">对于药店零售企业来说，从非法渠道购进药品虽然以10～50万元起进行处罚，由于企业规模小，但在实际执行中可操作难度还是比较大，基层监管面临较大压力。</span></section><section><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; font-size: 15px; color: rgb(0, 0, 0);"><br/></span></section></section></section></section></section></section><p></p><p><a href="http://www.ciopharma.com/article/info/11" target="_self">上期回顾：分析丨岭南老药师：1分钟带你读懂新版《药品管理法》！</a></p>

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