CRED Managing Variations Effectively

Grouping of Variations

Change 4 (Type IA)

Change 2 (Type IB)

Change 1 (Type IA)

Change 5 (Type IA)

Change 1 (Type IA)

Change 3 (Type II)

Single Filing for Product A

Single Filing for Products A and B

Option 1: Same Product (all strengths/forms); >1 related changes

Option 2: Multiple Products ; ≥1 identical changes

 Must make sense!  Must be from same MAH  Agreement from CA/EMA may be obtained in advance, including justification for grouping  Usually one discipline only (e.g. not mixed Quality and Clinical)