PDF《中华人民共和国》

9 Any drug substance used by a drug manufacturer to produce drug products shall have a drug approval 第6页共40 页 中华人民共和国药品管理法实施条例 证书、医药产品注册证书;

但是,未实施 批准文号管理的中药材、中药饮片除外. number or an import drug license or a pharmaceutical product license issued by the drug regulatory department under the State Council upon examination, with the exception of Chinese crude drugs and the prepared slices of Chinese crude drugs over which no control by approval number is exercised. 第十条 依据 《药品管理法》 第十三条规定, 接受委托生产药品的,受托方必须是持有 与其受托生产的药品相适应的《药品生产 质量管理规范》认证证书的药品生产企业. 疫苗、血液制品和国务院药品监督管理部 门规定的其他药品,不得委托生产. Article

10 In accordance with the provisions in Article

13 of the Drug Administration Law, any drug manufacturer being entrusted with contract production of the drug shall have a GMP certificate corresponding to the contracted drug. No vaccines, blood products or other drugs specified by the drug regulatory department under the State Council may be contracted for produ........