Dossier structure and content for pandemic-influenza-vaccine marketing-authorisation application - Scientific guideline

This document provides the basis for a fast track authorisation procedure for pandemic influenza vaccines within the European Union. It assists with the documentation to be included in the core pandemic dossier and pandemic variation application for inactivated influenza vaccines.

The quality requirements of this guideline have been replaced by the guideline on influenza vaccines - quality module.

Keywords: Pandemic influenza vaccine for human use, core pandemic dossier, mock-up vaccine, quality requirements, non-clinical requirements, clinical requirements