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

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Current effective version

Revision 1 - Adopted guideline

Reference numberCHMP/VEG/4717/03 Rev. 1
Effective from01/01/2009
KeywordsPandemic influenza vaccine for human use, core pandemic dossier, mock-up vaccine, quality requirements, non-clinical requirements, clinical requirements
DescriptionThis 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 The quality requirements of this guideline have been replaced by the guideline oninfluenza vaccines - quality module.

Document history

Revision 1

Current version

Adopted guideline

Draft guideline

Concept paper 

In operation: 01/02/2009–present

Published: 30/05/2008

Published: 15/05/2007

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