CRED Managing Variations Effectively

Implementation of variations

- Type IA: implementation up to 12 months prior submission - Type IA IN : implementation immediately prior submission - Type IB: implementation after favourable notification (e.g. next production run, within 6 months) - Type II: implementation after favourable opinion - Non-immediate Commission Decision: implementation after favourable opinion - Immediate Commission Decision: implementation after Commission Decision

Introduction to Classification of CMC (Quality) / Clinical / PhV Variations 40