CRED Managing Variations Effectively

Strategy (2): Type IA grouping illustrated – Article 7(a)

No prior agreement from CA

MAH

MR Procedure Group number

IA in

QC and BR site

UK/H/0254/IA/048/G

UK/H/ 0254 /001 UK/H/ 0254 /002

IA in

tablet markings

IA updated CEP

Combined MRP group number*

UK/H/xxxx/IA/210/G

MR Procedure Group number

No prior agreement from CA

UK/H/0255/IA/025/G

IAin QC and BR site IAin tablet markings IA updated CEP

UK/H/ 0255 /001 UK/H/ 0255 /003

* Note: this is ‘Grouping’ not Worksharing

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