This document concerns the annual change in vaccine composition (influenza A and B virus variants) of a centrally authorised seasonal influenza vaccine in order to meet the EU recommendations for human influenza virus strain(s) vaccine composition for the coming season. It provides guidance on the procedure, timelines and dossier content, marketing authorisation holder should fulfil in order for the CHMP to issue its appropriate scientific opinion. The procedural requirements of this guideline have been superseded by the guideline on influenza vaccines – submission and procedural requirements. The quality requirements of this guideline have been superseded by the guideline on influenza vaccines - quality module.
Keywords: Human influenza inactivated vaccine, variation procedure, annual strain update, fast-track, season