CRED Managing Variations Effectively

Worksharing

Change 2 (Type IB)

Applies to: Multiple Products ; ≥1 identical changes • Only applicable to Type IBs and IIs (however IAs can be grouped with the IB or II) • Extensions excluded

Change 1 (Type IA)

Change 3 (Type II)

Single Filing for Products A and B

 Apply where there is more than one CA to assess a variation  Useful for mixed national and/or MRP procedures. One authority (the ‘reference authority’) is chosen to examine the variation on behalf of the other concerned authorities. Will avoid different outcomes from individual authorities  Can apply for single or grouped variations from same MAH  Letter of intent to be submitted 2 months prior to variation application - TIP: LoI and Cover letter templates available from CMDh and EMA  Generally will follow a 60 day review (similar to Type II)