Influenza vaccines - quality module

Current effective version

PDF iconRevision 1 - Adopted guideline

Reference numberEMA/CHMP/BWP/310834/2012 Rev. 1
Published28/07/2017
Effective from01/02/2018
KeywordsQuality requirements, influenza vaccines, inactivated, LAIV, seasonal, zoonotic, pandemic preparedness, pandemic, annual strain update, pandemic strain update
DescriptionThis document provides guidance on marketing authorisation applications for influenza vaccines and for strain updates of authorised influenza vaccines. It applies to inactivated non-adjuvanted vaccines and inactivated vaccines with adjuvant to be used in the seasonal, pre-pandemic or pandemic setting, and live attenuated seasonal influenza vaccines. This quality module replaces the quality requirements of the guidelines listed under 'Superseded documents'.


Document history

Revision 1

Current version

PDF iconAdopted guideline In operation: 01/02/2018-present
First version

Adopted guideline


PDF iconOverview of comments


PDF iconDraft guideline


PDF iconConcept paper

In operation: 01/11/2014-01/02/2018


Published: 02/06/2014


Published: 08/03/2013


Published: 03/10/2011


Superseded documents


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