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Internet Drug Information Service Qualification Certificate:Application conditions、材料清单与合规要求

Internet Drug Information Service Qualification Certificate:Application conditions、材料清单与合规要求

特殊经营许可证

During the epidemic,许多人的生活习惯发生了改变,此前以线下服务为主的企业也逐步调整了经营模式。大量企业努力将线下业务迁移至线上,借助5G、大数据等技术手段重塑服务方式,其中直播电商的变化尤为明显。

In this context,相关产业也在持续调整。For businesses,业务转型意味着对应的市场认证资格同样需要作出改变。therefore,以下就此类资质认证进行详细介绍。

什么是互联网药品信息服务

Internet drug information services are divided into two categories: commercial and non-commercial.。

  • 经营性互联网药品信息服务: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:通过互联网向上网用户无偿提供公开的、Activities to share drug information and other services。

According to Article 22 of the "Measures for the Administration of Internet Drug Information Services":未取得或者超出有效期使用《互联网药品信息服务资格证书》从事互联网药品信息服务的,by the State Food and Drug Administration or the Provincial、autonomous region、直辖市(食品)药品监督管理部门给予警告,and ordered it to stop engaging in Internet drug information services;Serious circumstances,Transfer to relevant departments,in accordance with relevant laws、Regulations impose penalties。

Application conditions

申请在本省从事通过互联网向上网用户提供药品(含医疗器械)信息服务(经营性和非经营性),The following conditions should be met。

  1. 互联网药品信息服务的提供者应当为依法设立的企事业单位或者其它组织;
  2. 具有与开展互联网药品信息服务活动相适应的专业人员、Facilities and related systems;
  3. 有两名以上熟悉药品、Medical device management laws、Regulations and Drugs、Medical device expertise,or a pharmacy that has been qualified in accordance with the law、Medical device technician;
  4. 提供互联网药品信息服务的申请应当以一个网站为基本单元。

资质申请材料

  1. 《互联网药品信息服务申请表》(一式三份);
  2. 企业营业执照复印件(新办企业提供工商行政管理部门出具的名称预核准通知书及相关材料);
  3. 网站域名注册的相关证书或者证明文件。从事互联网药品信息服务网站的中文名称,Except for those with the same name as the organizer,Names such as "China", "Zhonghua" and "National" are not allowed.;In addition to Internet websites run by units that have obtained the qualification certificate for pharmaceutical bidding agencies,Contents such as "e-commerce," "drug investment promotion," and "drug bidding" must not appear in the names of other websites that provide Internet drug information services.;
  4. 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);
  5. 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;
  6. 食品药品监督管理部门在线浏览网站上所有栏目、Content methods and operating instructions;
  7. 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、Copy of ID card and resume of the person in charge of the website,and a copy of the employee’s employment contract;
  8. Sound network and information security measures,Includes website security measures、Information security and confidentiality management system、User information security management system;
  9. Ensure that drug information comes from legal sources、reality、safe management measures、Situation description and relevant certificates;
  10. 申请材料真实性的自我保证声明,And make a commitment to bear legal responsibility if the submitted materials are false.;
  11. 申办人身份证复印件;The applicant is not the legal representative,A power of attorney for the legal representative should also be submitted。

在申请此类资格认证时,务必注意资料的完整性。只有将资料准备充分,才能避免在漫长的申请过程中浪费贵公司的时间。certainly,您也可以选择资质代办公司52代办网团队为您代理代办。

Related products:互联网药品信息服务许可证申请

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