CRED Managing Variations Effectively

Summary - Types of Variations: a risk analysis

Is the lowest category always appropriate? • Some Type IA changes impact on Q, S, E  Rejection • RMS/CA may upgrade Type IB to Type II at validation • MAH can elect to submit as higher category

Extension

Type IB

Type II

Design Space

Type IA

‘ Do & tell ’

‘ Tell, wait & do ’

No submission required if within an approved design space

Variations

Evaluation Procedure adapted to the level of risk

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Your responsibility, your judgement call