Spring Intro 2023

Worksharing

Change 2 (Type IB)

Change 1 (Type IA)

Change 3 (Type II)

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

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)

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Practical Tips for Submission (1)

 Tell a clear and simple story  Utilise the agency FAQ’s that are posted online  Contact EMA/RMS in case of questions or doubts!

Submission Requirements 1. Cover letter (templates available from CMDh and EMA) 2. Application form ● Scope and background ● Present and proposed table is critical ● Implementation dates • Type IAs must be within the last 12 months • Type IBs must be in the future ● OMS/IDMP Considerations

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