CRED Managing Variations Effectively

3. Handling of variations in the centralised procedure

Validation of documentation (IA) / Assessment phase (IB, II)

Submission

Start

Notification / CHMP Opinion

Pre-submission queries service (PQS): For IA/IBs

Procedure Manager (PM) - oversees all aspects of the management of procedure;  first point of contact with MAHs and Rapporteurs Procedure assistant (PA) – supports PM and MAH (Annexes, EPAR updates) For IBs, MAH informed of PM at start of procedure or during validation phase (if RSI during validation)

IAquery@ema.europa.eu IBquery@ema.europa.eu For Type IIs /other: Procedure designated PM

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