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一个药品只有一个批准文号吗
释义
律师分析:
药品批准文号是药品生产合法性的标志。按规定,“每种药品的每一规格发给一个批准文号。除经国家药品监督管理局批准的药品委托生产和异地加工外,同一药品不同生产企业发给不同的药品批准文号”。药品批准文号应标注在药品包装的外标签以及用于运输、储藏的包装的标签上。除极个别药品,药品包装的外标签上只有一个药品批准文号。
【法律依据】:
《中华人民共和国药品管理法》 第三十一条 生产新药或者已有国家标准的药品的,须经国务院药品监督管理部门批准,并发给药品批准文号。
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更新时间:2025/11/15 2:12:11