CRED Managing Variations Effectively

What can be Grouped? Variations can be grouped together into bundles ● There are no conditions for the grouping of Type IA or IA IN variations (but need to consider if immediate notification) ● Groups containing Type IB or higher (Type II or extensions) need to be justified (see Annex III of Regulation 1234/2008) – Must be related changes, e.g. change to a method that affects the release specification – OR Needs to be confirmed by Agency; present justification for grouping in correspondence for agreement/confirmation ● Will follow the review timelines of the highest category change ● TIP: Cover letter templates available from CMDh and EMA Potential to use enquiry emails – EMA Procedure Management Team mailboxes ( IAquery@ema.europa.eu or IBquery@ema.europa.eu ) ● Need to provide your company position in the correspondence ● Benefits of doing this are early review and pre-agreed classification so goes through validation quicker

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