【CODEX翻译】中华人民共和国药品管理法(9-10)-EN
第九章 法律责任
Chapter IX Legal Liabilities
第七十二条 未取得《药品生产许可证》、《药品经营许可证》或者《医疗机构制剂许可证》生产药品、经营药品的,依法予以取缔,没收违法生产、销售的药品和违法所得,并处违法生产、销售的药品(包括已售出的和未售出的药品,下同)货值金额二倍以上五倍以下的罚款;构成犯罪的,依法追究刑事责任。
Article 72.Any drug manufacturer or distributor that manufactures or distributes drugs without obtaining Drug Manufacturing License, Drug Supply License or Pharmaceutical Preparation Certificate for Medical Institution shall be banned, the drugs illegally produced or sold and the illegal gains there from shall be confiscated, and they shall also be fined not less than two times but not more than five times the value of the drugs (including the drugs sold and not sold, the same below). If a crime is constituted, criminal liabilities shall be investigated in accordance with law.
第七十三条 生产、销售假药的,没收违法生产、销售的药品和违法所得,并处违法生产、销售药品货值金额二倍以上五倍以下的罚款;有药品批准证明文件的予以撤销,并责令停产、停业整顿;情节严重的,吊销《药品生产许可证》、《药品经营许可证》或者《医疗机构制剂许可证》;构成犯罪的,依法追究刑事责任。
Article 73.Where counterfeit drugs are produced or sold, the drugs illegally produced or sold and the illegal gains shall be confiscated, and a fine not less than two times but not more than five times the value of the said drugs shall be imposed. The approval documents, if any, shall be withdrawn and an order shall be given to suspend production or business operation for rectification. If the circumstances are serious, the Drug Manufacturing License, Drug Supply License or Pharmaceutical Preparation Certificate for Medical Institution shall be revoked. If a crime is constituted, criminal liabilities shall be investigated in accordance with law.