CRED Managing Variations Effectively

2. Structure of the Annex of Variations guidelines

A. Administrative changes B. Quality changes

B. I. Active Substance B. II. Finished product B. III. CEP / TSE / Monographs B. IV. Medical Devices B. V. Dossier changes due to other regulatory procedures

C. Safety, Efficacy and PhVig changes D. PMF / VAMF

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