PDF《中华人民共和国》

(一)申办人应当向拟办企业所在地省、 自治区、直辖市人民政府药品监督管理部 门提出申请.省、自治区、直辖市人民政 府药品监督管理部门应当自收到申请之日 起30个工作日内,按照国家发布的药品行 业发展规划和产业政策进行审查,并作出 是否同意筹建的决定.

(二)申办人完成拟办企业筹建后,应当 向原审批部门申请验收.原审批部门应当 自收到申请之日起30个工作日内, 依据 《药 品管理法》第八条规定的开办条件组织验 收;

验收合格的, 发给 《药品生产许可证》 . 申办人凭《药品生产许可证》到工商行政 管理部门依法办理登记注册. Article

3 A Drug Manufacturing Certificate shall be acquired for establishment of a drug manufacturer according to the following procedures: (1) The applicant shall submit an application to the drug regulatory department of the people'

s government of the province, autonomous region or municipality directly under the Central Government, where the manufacturing site is to be located. The drug regulatory department of the people'

s government of the province, autonomous region or municipality directly under the Central Government shall, within

30 working days from the date it receives the application, make a review according to the pharmaceutical industry development programs and policies issued by the State and make a decision on approval or disapproval. (2) After completion of establishment of the planned manufacturer, the applicant shall apply to the original approving department for acceptance inspection. The original approving department shall, within

30 working days from the date it receives the application, arrange an acceptance inspection according to the requirements for the establishment of such manufacturers set forth in Article

8 of the Drug Administration Law;

a Drug Manufacturing Certificate shall be issued to the applicant if the inspection is passed. The applicant shall, by holding the Drug Manufacturing Certificate, register with the administrative department for industry and commerce in accordance with law. 第4页共40 页 中华人民共和国药品管理法实施条例 第四条 药品生产企业变更《药品生产许可 证》许可事项的,应当在许可事项发生变 更30日前,向原发证机关申请《药品生产 许可证》变更登记;

未经批准,不得变更 许可事项.原发证机关应当自收到申请之 日起15个工作日内作出决定.申请人凭变 更后的《药品生产许可证》到工商行政管 理部门依法办理变更登记手续. Article

4 Any drug manufacturer that intends to alter the approved items in the Drug Manufacturing Certificate shall,

30 days prior to alteration of any approved items, apply to the original certificate-issuing authority for registration of alteration;

no approved items may be altered without approval. The original certificate-issuing authority shall make a decision within

15 working days from the date it receives the application. The application shall, by holding the Drug Manufacturing Certificate with altered items, register the alteration with the administrative department for industry and commerce in accordance with law. 第五条 省级以上人民政府药品监督管理 部门应当按照《药品生产质量管理规范》 和国务院药品监督管理部门规定的实施办 法和实施步骤,组织对药品生产企业的认 证工作;

符合《药品生产质量管理规范》 的,发给认证证书.其中,生产注射剂、 放射性药品和国务院药品监督管理部门规 定的生物制品的药品生产企业的认证工 作,由国务院药品监督管理部门负责. 《药品生产质量管理规范》认证证书的格 式由国务院药品监督管理部门统一规定. Article