CRED Managing Variations Effectively

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Acceptable grouping ??? Possible answers: Yes No Not sure/grey area

131 MAH No. 2 One Type II variation: To update sections 4.4, 4.6, 4.8 & 4.9 of the SPC, in line with an updated company core datasheet. QRD and/ or editorial changes have also been incorporated throughout the SmPC, leaflet and labelling. Pharmaceutical CCDS changes eg Section 6 of the SPC, should submit by the appropriate Type IA, Type IB or Type II variation. Separate variation required for each change, unless justified as consequential MAH No. 1 Six separate Type II variations: To update the SmPC in line with the CCDS and in line with the QRD template with consequential updates to the PIL – Sections 4.3, 4.4, 4.5, 4.6, 4.8 and 5.3 CCDS updating : experiences, 2 examples submitted to MHRA