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class="bds_more" data-cmd="more"></a><a href="#" class="bds_qzone" data-cmd="qzone" title="分享到QQ空间"></a><a href="#" class="bds_tsina" data-cmd="tsina" 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="/images/fx.jpg" /> </span> </div> <div id="i2i2jyu4k" class="text_box"> <p align="center"> <p style="text-align: left; text-indent: 2em;">十三届全国人大常委会第十二次会议昨日在京闭幕?；嵋榫砭觯ü诵滦薅┑囊┢饭芾矸?，关于修改土地管理法、城市房地产管理法的决定，资源税法。国家主席习近平分别签署第31、32、33号主席令予以公布。其中，新修订的药品管理法共12章155条，将于今年12月1日起施行。</p><p style="text-align: left; text-indent: 2em;">本次修法，是药品管理法时隔18年的首次全面修改。针对群众反映强烈的假药、劣药、药价高、药品短缺等突出问题，新修订的药品管理法体现了最严谨的标准、最严格的监管、最严厉的处罚、最严肃的问责“四个最严”精神，进一步健全了覆盖药品研制、生产、经营、使用全过程的法律制度。</p><p style="text-align: left; text-indent: 2em;">对比旧法，新修订的药品管理法重新界定了何为假药、劣药；建立上市许可证制度，落实药品全生命周期的主体责任；针对常用药、急（抢）救药短缺问题，设专章“药品储备和供应”。新法还回应了“代购境外抗癌新药，算不算假药？”“网售处方药该禁还是该放”等备受关注的焦点问题。</p><p style="text-align: left; text-indent: 2em;"><strong>焦点</strong></p><p style="text-align: left; text-indent: 2em;"><strong>代购境外抗癌新药算不算卖假药？</strong></p><p style="text-align: left; text-indent: 2em;">旧法：依照本法必须批准而未经批准生产、进口，或者依照本法必须检验而未经检验即销售的，按假药论处。</p><p style="text-align: left; text-indent: 2em;">新法：禁止未取得药品批准证明文件生产、进口药品；未经批准进口少量境外已合法上市的药品，情节较轻的，可以依法减轻或者免予处罚。</p><p style="text-align: left; text-indent: 2em;"><strong>【解读】</strong></p><p style="text-align: left; text-indent: 2em;">代购境外抗癌新药，算不算假药？该不该处罚？如何处罚？电影《我不是药神》主人公独家代理印度仿制药“格列宁”的故事，以及今年的聊城假药案，引发各界对代购境外抗癌新药的关注。</p><p style="text-align: left; text-indent: 2em;">根据新法，代购的境外抗癌新药，只要在境外是合法的，那么即便没有获得我国的进口审批，也不再按假药论处。对于这些行为，将视代购数量、情节轻重，少量、情节较轻的，可以减轻乃至于免除处罚。</p><p style="text-align: left; text-indent: 2em;">全国人大常委会法工委行政法室主任袁杰表示，这些修改回应了对“我不是药神”反映的社会问题的关切。</p><p style="text-align: left; text-indent: 2em;">不过，新法虽然为代购海外新药“开了一个小口”，可并不意味着放开，海外代购药品依然存在法律风险。</p><p style="text-align: left; text-indent: 2em;">袁杰表示，新药品管理法规定，从境外进口药品，依然必须经过批准，这是一个原则。没有经过批准的，即使是在国外已经合法上市的药品，也不能进口。虽然把未经批准进口的药品从假药里面拿出来单独规定，但是不等于就降低了处罚力度，而是从严设定了法律责任。</p><p style="text-align: left; text-indent: 2em;">新药品管理法明确规定：未取得药品批准证明文件生产、进口药品，将面临没收违法生产、进口、销售的药品和违法所得以及违法生产所用的原料、辅料、包装材料和生产设备，责令停产停业整顿，并处违法生产、进口、销售的药品货值金额十五倍以上三十倍以下的罚款等处罚。</p><p style="text-align: left; text-indent: 2em;">也就是说，如果大量代购境外新药，或代购的药品造成延误治疗、人身伤害等后果，仍然面临严厉处罚。</p><p style="text-align: left; text-indent: 2em;"><strong>新规</strong></p><p style="text-align: left; text-indent: 2em;"><strong>有条件允许网售处方药</strong></p><p style="text-align: left; text-indent: 2em;">旧法和二审稿：药品上市许可持有人、药品经营企业不得通过药品网络销售第三方平台直接销售处方药。</p><p style="text-align: left; text-indent: 2em;">新法：药品上市许可持有人、药品经营企业通过网络销售药品，应当遵守本法药品经营的有关规定。具体管理办法由国务院药品监督管理部门会同国务院卫生健康主管部门等部门制定。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。</p><p style="text-align: left; text-indent: 2em;"><strong>【解读】</strong></p><p style="text-align: left; text-indent: 2em;">全国人大常委会法工委行政法室主任袁杰表示，对于网售处方药，现行做法是明确规定网络不可以直接向公众销售处方药。此前二审，根据现行做法规定了禁止通过网络直接销售处方药。不过，审议过程中，有两种不同意见，一种认为应当禁止通过网络直接销售处方药；另一种认为不要一刀切，可以在加强监管的前提下允许网络销售处方药。</p><p style="text-align: left; text-indent: 2em;">“考虑到有两种不同的意见，我们综合各方面的意见，坚持线上线下相同标准、一体监管的原则，法律就网络销售药品作了比较原则的规定，即要求网络销售药品要遵守药品经营的有关规定，并授权国务院药品监督管理部门会同国务院健康卫生主管部门等部门具体制定办法，同时规定了几类特殊管理药品不能在网上销售，为实践探索留有空间”。</p><p style="text-align: left; text-indent: 2em;">国家药品监督管理局政策法规司司长刘沛也表示，对于网售处方药，“一个观点是如果允许网络销售处方药，会放大药品安全风险，带来安全隐患，所以希望禁止。但是另外一种意见认为，在国家简政放权和‘互联网+’的背景下，本着便民的原则，应当加强药品监管，同时也应当为满足人民的用药需求，对网售处方药加强事中事后监管，优化公共服务，不要一禁了之?！绷跖姹硎荆壳罢谄鸩菀┢吠缦奂喽焦芾戆旆?，“以规范和引导药品网络销售健康发展”。</p><p><br style="text-indent: 2em; text-align: left;"/></p> </div> <p class="Editor">编辑：刘畅 </p> <div id="i2i2jyu4k" class="Paging"> </div> <p class="Keyword">关键词：药品销售进口</p> <h1 class="pv_title_2 mt_15"><a href="/index.shtml" target="_blank" class="more mtb_14">更多</a><span id="i2i2jyu4k" class="t" id="a3"><a href="/index.shtml"><img src="/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/2019-06-03/2356313.shtml">简化备案流程建立网上平台业内人士热议非特化妆品备案管理办法征求意见稿</a></li> <li><a target="_blank" href="/c/2019-05-27/2352575.shtml">9.4元暴涨到349.9元百种药价为何“火箭式”上涨</a></li> <li><a target="_blank" href="/c/2019-05-21/2348705.shtml">使用有风险！4款日本网红眼药水被加拿大下架召回</a></li> <li><a target="_blank" 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