Spring Intro 2023

Practical Tips for Submission (2)

3. Copy of relevant pages of Commission Guideline showing conditions and documentation requirements are met for Type IA and Type IB (or copy of Article 5 recommendation received)

4. Supporting data/documentation • Amended CTD components where relevant • TIP: Generate CTD components with tracked changes first, to aid completion of the application form’s “present and proposed” section • For Type II variations need an updated Mod 2 QOS or an addendum to the QOS with expert signature and CV in the Mod 1.4 • Note: The supporting data does not always need to be incorporated into CTD components, and may need to make a judgement call on how to present (based on future life cycle flexibility).

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Practical Aspects of Submission: Application Form

EMA practical guidance on Type IA/IB application form (Oct 2022): • EMA/233564/2014 - Rev. 4

Latest EMA/CMDh guidance (July 2022): • CMDh/EMA/133/2010 rev.9

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