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title="分享到新浪微博"></a><a href="#" class="bds_tqq" data-cmd="tqq" title="分享到腾讯微博"></a><a href="#" class="bds_renren" data-cmd="renren" title="分享到人人网"></a><a href="#" class="bds_weixin" data-cmd="weixin" title="分享到微信"></a></div> <script>window._bd_share_config={"common":{"bdSnsKey":{},"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":"0","bdSize":"16"},"share":{}};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')).src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];</script>  </span><span id="i2i2jyu4k" class="fr">分享到：<img src="http://www.rmzxb.com.cn/images/fx.jpg" /> </span> </div> <div id="i2i2jyu4k" class="text_box"> <p align="center"> <p style="text-indent: 2em; text-align: center;"><img src="/upload/resources/image/2018/11/12/2212967_600x450.jpg" style="text-align: center; text-indent: 2em; font-family: inherit; border-width: 0px; border-style: initial; max-width: 580px;"/></p><div style="text-indent: 2em; text-align: left;"><p style="text-indent: 2em; text-align: left;">对疫苗实行全生命周期监督管理、加大对严重违法行为的处罚、更改产品批号的企业将停产停业……昨日，国家市场监督管理总局官网发布《中华人民共和国疫苗管理法(征求意见稿)》公开征求意见的公告。北京青年报记者梳理发现，《征求意见稿》共十一章，覆盖疫苗的研制和上市许可、生产和批签发、上市后研究和管理、疫苗流通、预防接种、异常反应监测与补偿、保障措施、监督管理、法律责任等各个环节，对疫苗监管的特殊要求作出具体规定。</p><p style="text-indent: 2em; text-align: left;"><strong>生产</strong></p><p style="text-indent: 2em; text-align: left;"><strong>严于一般药品生产企业的准入</strong></p><p style="text-indent: 2em; text-align: left;">国家对疫苗生产企业实行严于一般药品生产企业的准入制度。从事疫苗生产活动，应当经省、自治区、直辖市药品监督管理部门批准。疫苗上市应当经国务院药品监督管理部门批准，取得药品上市许可证明文件。申请疫苗上市许可，应当提供充分、可靠的研究数据和资料。</p><p style="text-indent: 2em; text-align: left;">疫苗临床试验不得以婴幼儿作为受试者，因研制婴幼儿疫苗确需以婴幼儿作为受试者的，应当从成人开始选择受试人群，审慎选择受试者，合理设置受试者群体和年龄组。</p><p style="text-indent: 2em; text-align: left;">疫苗实行上市许可持有人制度。疫苗上市许可持有人应当为具备疫苗生产能力的药品生产企业。疫苗上市许可持有人依法对疫苗研制、生产、流通的安全、有效和质量可控负责。</p><p style="text-indent: 2em; text-align: left;"><strong>流通</strong></p><p style="text-indent: 2em; text-align: left;"><strong>疫苗企业不得向个人供应疫苗</strong></p><p style="text-indent: 2em; text-align: left;">在供应和配送方面，疫苗上市许可持有人应当按照采购合同的约定，向省级疾病预防控制机构供应疫苗，不得向其他单位或者个人供应疫苗。疫苗上市许可持有人负责将疫苗配送至省级疾病预防控制机构，省级疾病预防控制机构负责将疫苗配送至接种单位。疫苗上市许可持有人、省级疾病预防控制机构应当具备疫苗冷链储运条件，或者委托具备符合条件的配送企业配送疫苗。</p><p style="text-indent: 2em; text-align: left;">疫苗记录需保存五年，疾病预防控制机构应当依照国务院卫生行政部门的规定，建立真实、完整的购进、储存、分发、供应记录，做到票、账、货、款一致，并保存至疫苗有效期后五年备查。</p><p style="text-indent: 2em; text-align: left;"><strong>接种</strong></p><p style="text-indent: 2em; text-align: left;"><strong>发现未接种免疫规划疫苗儿童应报告</strong></p><p style="text-indent: 2em; text-align: left;">国家对儿童实行预防接种证制度。在儿童出生后一个月内，其监护人应当到儿童居住地承担预防接种工作的接种单位为其办理预防接种证。接种单位对儿童实施接种时，应当查验预防接种证，并做好记录。儿童离开原居住地期间，由现居住地承担预防接种工作的接种单位负责对其实施接种。</p><p style="text-indent: 2em; text-align: left;">儿童入托、入学时，托幼机构、学校应当查验预防接种证，发现未依照国家免疫规划受种的儿童，应当向儿童居住地承担预防接种工作的接种单位报告，并配合接种单位督促其监护人在儿童入托、入学后及时到接种单位补种，因医学原因不能接种的除外。</p><p style="text-indent: 2em; text-align: left;">接种费用方面，接种单位接种免疫规划疫苗不得收取任何费用。接种单位接种非免疫规划疫苗除收取疫苗费用外，还可以收取服务费、接种耗材费，具体收费标准由所在地的省、自治区、直辖市价格主管部门核定。</p><p style="text-indent: 2em; text-align: left;"><strong>处罚</strong></p><p style="text-indent: 2em; text-align: left;"><strong>问题疫苗受种者可要求惩罚性赔偿</strong></p><p style="text-indent: 2em; text-align: left;">在法律责任中，《疫苗管理法(征求意见稿)》用了较大篇幅细化了各类违法行为的处罚，包括托幼机构学校行为处罚、擅自接种行为处罚、违反收费规定的处罚、未履行异常反应报告义务的处罚、接种违法行为处罚等。</p><p style="text-indent: 2em; text-align: left;">疫苗上市许可持有人违反本法规定，《中华人民共和国药品管理法》的法律责任中有规定的，依照相关规定从重处罚。构成犯罪的，依法追究刑事责任。因疫苗质量问题造成受种者损害的，疫苗上市许可持有人应当依法承担赔偿责任。疫苗上市许可持有人明知疫苗存在质量问题仍然销售，造成受种者死亡或者健康严重损害的，受种者有权请求相应的惩罚性赔偿。</p><p style="text-indent: 2em; text-align: left;">药品监督管理、卫生行政等部门在疫苗管理中不履行或者不正确履行职责，导致出现重大疫苗安全事故、造成严重后果、产生恶劣影响的，依法严肃追究责任。参与、包庇、纵容疫苗违法犯罪行为，弄虚作假、隐瞒事实、干扰阻碍责任调查，或者帮助伪造、隐匿、销毁证据的，依法从重追究责任。</p><p style="text-indent: 2em; text-align: left;">散布虚假疫苗信息也将面临处罚。任何单位和个人编造、散布虚假的疫苗质量安全信息，由公安机关依照《中华人民共和国治安管理处罚法》予以行政拘留，并处以二万元以上二十万元以下?？睢?/p><p style="text-indent: 2em; text-align: left;">公众可通过以下途径和方式提出意见建议：一、将意见和建议发送电子邮件至：FGS@saic.gov.cn；二、将意见和建议邮寄至：北京市西城区三里河东路8号(邮编100820)国家市场监督管理总局法规司，并在信封上注明“《中华人民共和国疫苗管理法(征求意见稿)》反馈意见”字样。意见反馈截止时间为2018年11月25日。</p></div> </div> <p class="Editor">编辑：周佳佳 </p> <div id="i2i2jyu4k" class="Paging"> <a href="/c/2018-11-12/2214219.shtml" class="a">01</a> <a href="/c/2018-11-12/2214219_1.shtml">02</a>  </div> <p class="Keyword">关键词：疫苗管理法征求意见稿</p> <h1 class="pv_title_2 mt_15"><a target="_blank" class="more mtb_14">更多</a><span id="i2i2jyu4k" class="t" id="a3"><a ><img src="http://www.rmzxb.com.cn/images/xg_t1.jpg" /></a></span></h1> <div id="i2i2jyu4k" class="pa_0_5_0_10"> <ul class="Related_ul bh_150"> <li><a target="_blank" href="/c/2018-11-12/2214209.shtml">疫苗管理法征求意见这些违法行为将被严惩重处！</a></li> <li><a target="_blank" href="/c/2018-11-12/2214208.shtml">《疫苗管理法》征求意见：受种者有权要惩罚性赔偿</a></li> <li><a target="_blank" href="/c/2018-08-10/2137873.shtml">国家基本药物制度面临调整报销比例或将提高</a></li> <li><a target="_blank" 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