论文部分内容阅读
最近,国家药品监督管理局印发《关于实施<药品包装用材料、容器管理办法>(暂行)加强药包材监督管理工作的通知》(国药管注[2000]462号),规定从2000年12月1日起,药品包装用材料、容器按规定程序申请注册。 各省级药品监督管理局受理1类药包材的注册申请,并按规定完成初审工作,经国家药品监督管理局复审合格后核发“药品包装材料和容器注册证”(以下简称“药包材注册证”)。各省级药品监督管理局受理2、3类药包注册申请,并按规定审查合格后核发“药包材注册证”,并报国家药品监督管理局备案。 通知规定从2000年12月1日起,国家药品监督管理
Recently, the State Drug Administration issued the Notice on the Implementation (Provisional) of Strengthening the Supervision and Administration of Drug Packaging Materials (Guoxintongjian [2000] No. 462), which stipulates that from December 12, 2000 From January 1, pharmaceutical packaging materials, containers according to the required procedures for registration. All provincial drug administrations accept the application for registration of Class 1 drug packaging materials and complete the preliminary examination as required. After passing the review by the State Drug Administration, the Drug Registration Certificate for Drug Packaging Materials and Containers (hereinafter referred to as “drug packaging materials Registration card ”). All provincial-level drug administrations shall accept application for registration of 2,3 types of drug packets and issue the “Registration Certificate of Drug Packaging Materials” after passing the examination as required and submit them to the State Drug Administration for the record. Notice from December 1, 2000 onwards, the State Drug Administration