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变更是否需要启动体考?规定审评时限60日包括现场核查吗?

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a1694241 一阶会员 User from: 广东省深圳市
2023-08-31 23:07

变更注册申请除了原材料和工艺变更,一般不需要启动质量体系核查。变更注册申请的技术审评时限为60日,申请资料补正后的技术审评时限为60日。对有必要开展体系核查的,启动核查工作,与注册审评工作并行开展。原则上自接到体系核查通知后30日内完成核查。


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2023-08-31 23:04
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