CEP的微小变更是否需要提前通知
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请问一下各位老师,CEP的MIN变更是实施前要通知当局还是想AN那样实施后更新资料就行,谢谢

2022-12-09 09:54 匿名     
1个回答

对于CEP微小变更也就是欧洲常说的IB类变更,这类变更一般都是30天的审评期限,需要和CEP分类为Notification (按照AN提交,12个月)也就是IA类的变更区分

另外:EDQM有如下规定, 

(PA/PH/CEP (04) 2, 7R corr) lists different notifications and associated conditions, and that any change not classified as a notification or a major change should be classified as a minor change by default (with the exception of editorial changes for which specific guidance is given in the policy document). If the change cannot be classified by the document and specifically as a notification, a minor revision (by default) should be submitted. Any submission of a notification which includes changes not classifiable as a notification will be rejected and the changes will then need to be resubmitted using the correct classification (with associated documentation and fee)

也就是说针对非指南列举的变更,既不是通知也不是重大,可以归类于微小变更,但是这个归类EDQM不一定会认可,所以一旦归类错误是需要按照新的分类提交新的变更申请,如果归类于微小的变更EDQM不接受,基本都需要按照重大变更重新提交。

2022-12-11 10:27 匿名