CRED Managing Variations Effectively

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CCDS updating : advice on MHRA website Are the SPC changes related? Yes

No

Consider the nature and extent of supporting data for each individual change

Submit grouped application – without prior approval Appropriate grouped eg Type II grouped for multiple changes

Extensive stand alone data packages eg • s4.1, 4.2 new indication • s4.3 contraindication (unrelated)

Eg series of minor changes to different SPC sections

Submit 2 separate applications

Is the gouping; • published? • previously agreed?

Yes

Contact MHRA (RIS) if you have practical difficulties – we will try to seek a pragmatic solution

No

Seek prior approval (RIS)

Grouping might be feasible

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