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Interpretation of the Supreme People's Court and the Supreme People's Procuratorate on the Several Issues regarding the Application of Law in the Handling of Criminal Cases of False Application Materials for the Registration of Drugs and Medical Devices [Effective]
最高人民法院、最高人民检察院关于办理药品、医疗器械注册申请材料造假刑事案件适用法律若干问题的解释 [现行有效]
【法宝引证码】

 
Announcement of the Supreme People's Court and the Supreme People's Procuratorate 

最高人民法院、最高人民检察院公告

The Interpretation of the Supreme People's Court and the Supreme People's Procuratorate on the Several Issues regarding the Application of Law in the Handling of the Criminal Cases of False Application Materials for the Registration of Drugs and Medical Devices, as adopted at the 1714th Session of the Judicial Committee of the Supreme People's Court on April 10, 2017 and at the 65th Session of the 12th Procuratorial Committee of the Supreme People's Procuratorate on June 8, 2017, is hereby issued and shall come into force on September 1, 2017. 《最高人民法院、最高人民检察院关于办理药品、医疗器械注册申请材料造假刑事案件适用法律若干问题的解释》已于2017年4月10日由最高人民法院审判委员会第1714次会议、2017年6月8日由最高人民检察院第十二届检察委员会第65次会议通过,现予公布,自2017年9月1日起施行。
Supreme People's Court 最高人民法院
Supreme People's Procuratorate 最高人民检察院
August 14, 2017 2017年8月14日
Interpretation of the Supreme People's Court and the Supreme People's Procuratorate on the Several Issues regarding the Application of Law in the Handling of the Criminal Cases of False Application Materials for the Registration of Drugs and Medical Devices 最高人民法院、最高人民检察院关于办理药品、医疗器械注册申请材料造假刑事案件适用法律若干问题的解释
(Interpretation No. 15 [2017] of the Supreme People's Court, adopted at the 1714th Session of the Judicial Committee of the Supreme People's Court on April 10, 2017 and at the 65th Session of the 12th Procuratorial Committee of the Supreme People's Procuratorate on June 8, 2017, and to come into force on September 1, 2017) (2017年4月10日最高人民法院审判委员会第1714次会议、2017年6月8日最高人民检察院第十二届检察委员会第65次会议通过,自2017年9月1日起施行 法释〔2017〕15号)
For the purposes of punishing the criminal behaviors of submitting false application materials for the registration of drugs and medical devices and protecting the life and health rights and interests of the people, under the relevant provisions of the Criminal Law of the People's Republic of China and the Criminal Procedure Law of the People's Republic of China, several issues concerning the application of law in the handling of such criminal cases are hereby interpreted as follows: 为依法惩治药品、医疗器械注册申请材料造假的犯罪行为,维护人民群众生命健康权益,根据《中华人民共和国刑法》《中华人民共和国刑事诉讼法》的有关规定,现就办理此类刑事案件适用法律的若干问题解释如下:
Article 1 A staff member of a non-clinical drug research institution, an institution for clinical drug trial, and a contract research organization that intentionally provides a false non-clinical drug research report, clinical drug trial report and related materials shall be determined as falling under the circumstance of “intentionally providing false certification documents” as prescribed in Article 229 of the Criminal Law.   第一条 药物非临床研究机构、药物临床试验机构、合同研究组织的工作人员,故意提供虚假的药物非临床研究报告、药物临床试验报告及相关材料的,应当认定为刑法二百二十九条规定的“故意提供虚假证明文件”。
...... 实施前款规定的行为,具有下列情形之一的,应当认定为刑法二百二十九条规定的“情节严重”,以提供虚假证明文件罪处五年以下有期徒刑或者拘役,并处罚金:
 ......

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