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class="news-tittle"><h2>《捐赠药品进口管理规定》2016年5月20日起施行</h2><h3>来源:      2016-06-12 11:22:01</h3></div> <p></p><p style="color:#636363;font-family:宋体;font-size:14px;background-color:#FFFFFF;"> <span style="color:#000000;font-size:16px;font-family:NSimSun;">    为进一步规范捐赠药品进口管理,保证捐赠药品质量安全,根据《中华人民共和国公益事业捐赠法》《中华人民共和国药品管理法》《中华人民共和国药品管理法实施条例》《药品进口管理办法》有关要求,制定本规定。</span></p><p style="color:#636363;font-family:宋体;font-size:14px;background-color:#FFFFFF;"> <span style="color:#000000;font-size:16px;font-family:NSimSun;">  一、适用范围和要求</span></p><p style="color:#636363;font-family:宋体;font-size:14px;background-color:#FFFFFF;"> <span style="color:#000000;font-size:16px;font-family:NSimSun;">  国外政府、制药企业或相关组织、机构自愿无偿向国内受赠人捐赠药品办理进口备案,适用本规定。</span></p><p style="color:#636363;font-family:宋体;font-size:14px;background-color:#FFFFFF;"> <span style="color:#000000;font-size:16px;font-family:NSimSun;">  捐赠人应对捐赠药品的质量负责,捐赠时须向受赠人提供药品清单和捐赠药品检验报告。</span></p><p style="color:#636363;font-family:宋体;font-size:14px;background-color:#FFFFFF;"> <span style="color:#000000;font-size:16px;font-family:NSimSun;">  二、捐赠药品的条件</span></p><p style="color:#636363;font-family:宋体;font-size:14px;background-color:#FFFFFF;"> <span style="color:#000000;font-size:16px;font-family:NSimSun;">  捐赠药品必须满足以下条件:</span></p><p style="color:#636363;font-family:宋体;font-size:14px;background-color:#FFFFFF;"> <span style="color:#000000;font-size:16px;font-family:NSimSun;">  (一)捐赠药品应为我国已批准进口注册的品种。</span></p><p style="color:#636363;font-family:宋体;font-size:14px;background-color:#FFFFFF;"> <span style="color:#000000;font-size:16px;font-family:NSimSun;">  (二)捐赠药品有效期限距失效日期须在12个月以上;药品批准有效期为12个月及以下的,捐赠药品有效期限距失效日期须在6个月以上。</span></p><p style="color:#636363;font-family:宋体;font-size:14px;background-color:#FFFFFF;"> <span style="color:#000000;font-size:16px;font-family:NSimSun;">  (三)捐赠药品最小包装的标签上应加注“捐赠药品,不得销售”或类似字样,并附中文说明书。</span></p><p style="color:#636363;font-family:宋体;font-size:14px;background-color:#FFFFFF;"> <span style="color:#000000;font-size:16px;font-family:NSimSun;">  (四)捐赠药品不得上市销售,不得向使用者收取费用。</span></p><p style="color:#636363;font-family:宋体;font-size:14px;background-color:#FFFFFF;"> </p><p style="color:#636363;font-family:宋体;font-size:14px;background-color:#FFFFFF;"> <span style="color:#000000;font-size:16px;font-family:NSimSun;">    三、受赠人的条件和责任</span> </p> <p style="color:#636363;font-family:宋体;font-size:14px;background-color:#FFFFFF;"> <span style="color:#000000;font-size:16px;font-family:NSimSun;">  (一)捐赠药品的受赠人包括:</span> </p> <p style="color:#636363;font-family:宋体;font-size:14px;background-color:#FFFFFF;"> <span style="color:#000000;font-size:16px;font-family:NSimSun;">  1.国务院有关部门和各省、自治区、直辖市人民政府及其指定的公益性事业单位;</span> </p> <p style="color:#636363;font-family:宋体;font-size:14px;background-color:#FFFFFF;"> <span style="color:#000000;font-size:16px;font-family:NSimSun;">  2.以保护人民生命健康、从事人道主义工作为主要宗旨的全国性人民团体;</span> </p> <p style="color:#636363;font-family:宋体;font-size:14px;background-color:#FFFFFF;"> <span style="color:#000000;font-size:16px;font-family:NSimSun;">  3.在省级以上民政部门依法登记并取得3A以上评估等级、以从事医疗救助、紧急救援、扶贫济困为主要宗旨的慈善组织。</span> </p> <p style="color:#636363;font-family:宋体;font-size:14px;background-color:#FFFFFF;"> <span style="color:#000000;font-size:16px;font-family:NSimSun;">  (二)受赠人应保证捐赠药品储存、运输、分发等环节符合《药品经营质量管理规范》要求,以保证药品质量。</span> </p> <p style="color:#636363;font-family:宋体;font-size:14px;background-color:#FFFFFF;"> <span style="color:#000000;font-size:16px;font-family:NSimSun;">  (三)受赠人应当制定捐赠药品管理的相关制度,严格按规范对捐赠药品登记造册、妥善保管,并详细记录捐赠药品的核销注销情况,确保捐赠药品的可追溯性。捐赠药品质量验收合格的,由受赠人或其委托的代理机构在外包装上加贴“捐赠品已查验”的标识后,方可分发。同时,受赠人应负责捐赠药品的监督使用,承担使用过程中风险的防范和处理职责。如需销毁捐赠药品,应按药品销毁的有关法规和技术要求进行。</span> </p> <p style="color:#636363;font-family:宋体;font-size:14px;background-color:#FFFFFF;"> <span style="color:#000000;font-size:16px;font-family:NSimSun;">  (四)受赠人应及时将捐赠药品分发使用情况向省级食品药品监管和卫生计生行政管理部门报告,并向所在地省级食品药品监管和卫生计生行政管理部门提交书面报告。</span> </p> <p style="color:#636363;font-family:宋体;font-size:14px;background-color:#FFFFFF;"> <span style="color:#000000;font-size:16px;font-family:NSimSun;">  四、捐赠药品的进口备案程序要求</span> </p> <p style="color:#636363;font-family:宋体;font-size:14px;background-color:#FFFFFF;"> <span style="color:#000000;font-size:16px;font-family:NSimSun;">  国家食品药品监督管理总局授权的药品进口口岸所在地食品药品监督管理局负责受理捐赠药品进口的备案申请,办理进口备案的有关事项,通知口岸药品检验所对捐赠药品实施口岸检验,并对捐赠药品进口备案和口岸检验中发现的问题进行监督处理。</span> </p> <p style="color:#636363;font-family:宋体;font-size:14px;background-color:#FFFFFF;"> <span style="color:#000000;font-size:16px;font-family:NSimSun;">    捐赠药品进口备案按以下程序办理:</span> </p> <p style="color:#636363;font-family:宋体;font-size:14px;background-color:#FFFFFF;"> <span style="color:#000000;font-size:16px;font-family:NSimSun;">  (一)受赠人或其委托的代理机构向口岸食品药品监督管理局申请办理《进口药品通关单》时,应同时报送以下资料:</span> </p> <p style="color:#636363;font-family:宋体;font-size:14px;background-color:#FFFFFF;"> <span style="color:#000000;font-size:16px;font-family:NSimSun;">  1.捐赠药品进口备案的书面申请,内容包括捐赠药品的名称、剂型、规格、产地、生产批号、有效期、数量、拟进口口岸等内容,以及对捐赠药品监督使用和风险防范的承诺。</span> </p> <p style="color:#636363;font-family:宋体;font-size:14px;background-color:#FFFFFF;"> <span style="color:#000000;font-size:16px;font-family:NSimSun;">  2.受赠人社会组织登记证或组织机构代码证复印件及资质条件证明。</span> </p> <p style="color:#636363;font-family:宋体;font-size:14px;background-color:#FFFFFF;"> <span style="color:#000000;font-size:16px;font-family:NSimSun;">  3.捐赠协议复印件。</span> </p> <p style="color:#636363;font-family:宋体;font-size:14px;background-color:#FFFFFF;"> <span style="color:#000000;font-size:16px;font-family:NSimSun;">  4.相关药品的《进口药品注册证》(或者《医药产品注册证》)(正本或者副本)复印件。</span> </p> <p style="color:#636363;font-family:宋体;font-size:14px;background-color:#FFFFFF;"> <span style="color:#000000;font-size:16px;font-family:NSimSun;">  5.药品说明书及包装、标签等资料的复印件,外文资料需附相应的中文译本。</span> </p> <p style="color:#636363;font-family:宋体;font-size:14px;background-color:#FFFFFF;"> <span style="color:#000000;font-size:16px;font-family:NSimSun;">  6.原产地证明复印件。</span> </p> <p style="color:#636363;font-family:宋体;font-size:14px;background-color:#FFFFFF;"> <span style="color:#000000;font-size:16px;font-family:NSimSun;">  7.装箱单、提运单和货运发票复印件。</span> </p> <p style="color:#636363;font-family:宋体;font-size:14px;background-color:#FFFFFF;"> <span style="color:#000000;font-size:16px;font-family:NSimSun;">  8.出厂检验报告书复印件。</span> </p> <p style="color:#636363;font-family:宋体;font-size:14px;background-color:#FFFFFF;"> <span style="color:#000000;font-size:16px;font-family:NSimSun;">  上述各类复印件应当加盖申请进口单位公章或受赠单位公章。</span> </p> <p style="color:#636363;font-family:宋体;font-size:14px;background-color:#FFFFFF;"> <span style="color:#000000;font-size:16px;font-family:NSimSun;">   (二)口岸食品药品监督管理局受理上述资料后,按照《药品进口管理办法》规定程序对有关资料进行审查,逐项核查捐赠药品进口申请资料和证明性文件的完整性、真实性。</span> </p> <p style="color:#636363;font-family:宋体;font-size:14px;background-color:#FFFFFF;"> <span style="color:#000000;font-size:16px;font-family:NSimSun;">  (三)口岸食品药品监督管理局审查全部资料无误后,准予进口备案,发出《进口药品通关单》,同时向负责检验的口岸药品检验所发出《进口药品口岸检验通知书》并附《药品进口管理办法》所规定的有关资料。对于国家食品药品监督管理总局规定的生物制品,须经口岸药品检验所检验符合标准规定后,方可办理进口备案手续。</span> </p> <p style="color:#636363;font-family:宋体;font-size:14px;background-color:#FFFFFF;"> <span style="color:#000000;font-size:16px;font-family:NSimSun;">  (四)口岸药品检验所应当到《进口药品口岸检验通知书》规定的抽样地点抽取样品,进行质量检验,将检验结果送交所在地口岸食品药品监督管理局并通知送检单位。捐赠药品须经检验合格后方可分发使用。对检验不符合标准规定的捐赠药品,由口岸食品药品监督管理局依照《中华人民共和国药品管理法》及有关规定处理。对于捐赠药品,口岸药品检验机构可优先予以检验。</span> </p> <p style="color:#636363;font-family:宋体;font-size:14px;background-color:#FFFFFF;"> <span style="color:#000000;font-size:16px;font-family:NSimSun;">  口岸食品药品监督管理局应于每年12月底前向国家食品药品监督管理总局提交本年度受理的捐赠药品进口情况报告,内容包括捐赠药品的品种、数量、剂型、规格、生产厂名称等信息。</span> </p> <p style="color:#636363;font-family:宋体;font-size:14px;background-color:#FFFFFF;"> <span style="color:#000000;font-size:16px;font-family:NSimSun;">  五、捐赠药品的监督管理</span> </p> <p style="color:#636363;font-family:宋体;font-size:14px;background-color:#FFFFFF;"> <span style="color:#000000;font-size:16px;font-family:NSimSun;">  食品药品监管和卫生计生行政管理部门依职责对捐赠药品的进口备案和分发使用管理情况进行监督检查,海关按《药品进口管理办法》有关要求对其实施监管。</span> </p> <p style="color:#636363;font-family:宋体;font-size:14px;background-color:#FFFFFF;"> <span style="color:#000000;font-size:16px;font-family:NSimSun;">  受赠人未按要求建立捐赠药品管理和追溯制度,未按有关规定贮存、运输、分发捐赠药品,或未对污染或变质的捐赠药品按要求销毁的,监管部门将责令其改正,并向社会公告;若发现存在销售捐赠药品或向受赠者收取费用、使用超过有效期的捐赠药品,以及监管部门认定的其他违法违规情形的,监管部门将根据《中华人民共和国公益事业捐赠法》《中华人民共和国药品管理法》有关规定依法查处。</span> </p> <p style="color:#636363;font-family:宋体;font-size:14px;background-color:#FFFFFF;"> <span style="color:#000000;font-size:16px;font-family:NSimSun;">  本规定自印发之日起施行。</span> </p><span style="color:#000000;font-size:16px;font-family:NSimSun;"></span> </div></div> <!-- JS --> <script type="text/javascript"> $(document).ready(function(){ /*返回顶部*/ 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