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

Current effective version

PDF iconRevision 1 - Adopted guideline - Superseded

Reference number CHMP/VEG/4717/03 Rev. 1
Published 18/12/2008
Effective from 01/01/2009
Keywords Pandemic influenza vaccine for human use, core pandemic dossier, mock-up vaccine, quality requirements, non-clinical requirements, clinical requirements

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The quality requirements of this guideline have been replaced by the guideline on influenza vaccines - quality module.

Document history

Revision 1

Current version

PDF iconAdopted guideline - Superseded


PDF iconDraft guideline - Superseded


PDF iconConcept paper - Superseded

In operation: 01/02/2009–present


Published: 30/05/2008


Published: 15/05/2007

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