CRED Managing Variations Effectively

Summary - Types of Variations: a risk analysis

REMINDER: procedure type is adapted to the level of risk  Type IA variations have only a minimal impact, or  no impact at all on the quality, safety or efficacy of the medicinal product.

Art 3(3)

Changes requiring prior approval

Changes not requiring any prior approval

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