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各省、自治区、直辖市药品监督管理局: 为全面贯彻实施《药品包装、标签和说明书管理规定(暂行)》(第23号局令),统一药品批准文号,我局于2001年4月下发了《关于贯彻实施23号局令统一药品批准文号工作的通知》(国药监注[2001]187号),对整个工作做了全面的安排。在全国各有关单位的共同努力下,规范药品包装、标签和说明书的工作取得了一定的进展,目前已进入统一换发批准文号工作阶段。为做好些项工作,现通知如下:
The Drug Administrations of all provinces, autonomous regions and municipalities directly under the Central Government: In order to fully implement the Provisions on the Administration of Pharmaceutical Packaging, Labeling and Instruction (Provisional) (Decree No.23) and the unified drug approval number, our bureau issued in April 2001 Notice of Implementing No. 23 Decree on the Uniform Drug Approval No. (Guojianjingzhu [2001] No. 187) made a comprehensive arrangement for the entire work. With the joint efforts of all the relevant units in the country, some progress has been made in standardizing the packaging, labeling and manual of pharmaceutical products. At present, the work has been progressing through the unified renewal and approval document numbering. To do a good job, we hereby notify you as follows: