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      当前位置:首页 > 进出口许可证申请 > 互联网药品信息服务许可证

      互联网药品信息服务许可证

      • 作者:深圳公司注册
      • 时间:2019-01-25 11:46:35

      一、什么是互联网药品信息服务许可证:
      行政许可项目名称:经营性或非经营性互联网药品信息服务核发
      (注:如申请企业已取得药品经营许可证,则可直接申请经营性互联网药品信息服务资格证)
      互联网药品信息服务分为经营性和非经营性两类。经营性互联网药品信息服务是指通过互联网向上网用户有偿提供药品信息等服务的活动。非经营性互联网药品信息服务是指通过互联网向上网用户无偿提供公开的、共享性药品信息等服务的活动。
      拟提供互联网药品信息服务的网站,应当在向国务院信息产业主管部门或者省级电信管理机构申请办理经营许可证或者办理备案手续之前,按照属地监督管理的原则,向该网站主办单位所在地省、自治区、直辖市(食品)药品监督管理部门提出申请,经审核同意后取得提供互联网药品信息服务的资格。
       
      二、互联网药品信息服务许可证办理条件:
      (一)通过自身网站与本企业成员之外的其他企业进行互联网药品交易的药品生产企业和药品批发企业应当具备以下条件:
      1、提供互联网药品交易服务的网站必须是取得《互联网药品信息服务资格证书至少期满三个月;  
      2、具有与开展业务相适应的场所、设施、设备,并具备自我管理和维护的能力;  
      3、具有健全的管理机构,具备网络与交易安全保障措施以及完整的管理制度;  
      4、具有完整保存交易记录的设施、设备;  
      5、具备网上查询、生成订单、电子合同等基本交易服务功能;  
      6、具有保证网上交易的资料和信息的合法性、真实性的完善管理制度、设施、设备与技术措施。
      (二)向个人消费者提供互联网药品交易服务的企业,应当具备以下条件:  
      1、依法设立的药品连锁零售企业;  
      2、提供互联网药品交易服务的网站必须是取得《互联网药品信息服务资格证书至少期满三个月;  
      3、具有健全的网络与交易安全保障措施以及完整的管理制度;  
      4、具有完整保存交易记录的能力、设施和设备;  
      5、具备网上咨询、网上查询、生成定单、电子合同等基本交易服务功能;  
      6、对上网交易的品种有完整的管理制度与措施;  
      7、具有与上网交易的品种相适应的药品配送系统;  
      8、具有执业药师负责网上实时咨询,并有保存完整咨询内容的设施、设备及相关管理制度;
      9、从事医疗器械交易服务,应当配备拥有医疗器械相关专业学历、熟悉医疗器械相关法规的专职专业人员。
      互联网药品信息服务许可证
       
      三、互联网药品信息服务许可证申请材料:
      1、营业执照复印件;
      2、网站域名注册的相关证书或者证明文件;

       

      深圳公司注册,了解深圳公司注册流程咨询潮鼎盛



      3、网站栏目设置说明(申请经营性互联网药品信息服务的网站需提供收费栏目及收费方式的说明);
      4、网站对历史发布信息进行备份和查阅的相关管理制度及执行情况说明;
      5、省食品药品监督管理部门在线浏览网站上所有栏目、内容的方法及操作说明;
      6、药品及医疗器械相关专业技术人员学历证明或者其专业技术资格证书复印件、网站负责人身份证复印件及简历;
      7、健全的网络与信息安全保障措施,包括网站安全保障措施、信息安全保密管理制度、用户信息安全管理制度和服务器所在单位(指:提供互联网接入服务)的《中华人民共和国增值电信业务经营许可证或《国际联网备案登记证书的复印件;  
      8、保证药品信息来源合法、真实、安全的管理措施、情况说明及相关证明;
       
      四、互联网药品信息服务许可证申请流程:
      (一)申请企业,须先登录国家食品药品监督管理总局行政事项受理服务页,“新建申请”进行网上填报公司基本信息。
      基本信息填报完毕后,会生成国家食品药品监督管理局统一制发的《互联网药品信息服务申请表,同时生成企业ID号,可以打印/修改基本信息。
      (二)完成第一步之后,按照各省市食品药品监督管理部门网上公布的互联网药品信息服务申请服务指南或者直接咨询各省市食品药品监督管理部门相关要求,准备申请材料。
      (三)申请材料准备齐备后,根据各省市食品药品监督管理部门的不同要求,或者网上申报,或者窗口提交。各省市食品药品监督管理部门在收到申请材料之日起5日内会做出受理与否的决定,受理的,发给受理通知书;不受理的,通知申请人并说明理由。对于申请材料不规范、不完整的,一般会一次告知需要补正的全部内容。
      (四)自受理之日起20日内,各省市食品药品监督管理部门会对申请材料进行审核,并作出同意或者不同意的决定。同意的,核发《互联网药品信息服务资格证书,同时报国家食品药品监督管理总局备案并发布公告;不同意的,会书面通知申请人并说明理由。
       
      五、互联网药品信息服务许可证审批机关:
      拟提供互联网药品信息服务的网站,按照属地监督管理的原则,向该网站主办单位所在地省、自治区、直辖市食品药品监督管理部门提出申请,经审核同意后取得提供互联网药品信息服务的资格。
       
      六、哪些企业需要办理互联网药品信息服务许可证:
      1、经营性互联网药品信息服务是指通过互联网向上网用户有偿提供药品信息等服
      务的活动。非经营性互联网药品信息服务是指通过互联网向上网用户无偿提供公开的、共享性药品信息等服务的活动。
      2、拟提供互联网药品信息服务的网站,应当在向国务院信息产业主管部门或者省级电信管理机构申请办理经营许可证或者办理备案手续之前,按照属地监督管理的原则,向该网站主办单位所在地省、自治区、直辖市(食品)药品监督管理部门提出申请,经审核同意后取得提供互联网药品信息服务的资格。
      简单概括为:
      1、利用自身或他人网站媒介进行药品信息传播、推广的企业
      2、小程序,提供医疗诊察咨询的企业
      3、从事互联网保健食品销售的企业
      4、从事互联网美容化妆品销售的企业
      5、从事互联网药品、医疗器械销售的企业
       
      七、行政许可时限:自受理之日起,30个工作日内。
       
      八、行政许可证件及有效期限:《互联网药品信息服务资格证书有效期为5年。有效期届满前6个月内,向原发证机关申请换发《互联网药品信息服务资格证书。


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