Influenza vaccines - quality module

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Current effective version

Adopted guideline

Reference numberEMA/CHMP/BWP/310834/2012
Effective from01/11/2014
KeywordsQuality requirements, influenza vaccines, inactivated, live attenuated influenza vaccine (LAIV), seasonal, pre-pandemic, 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 This quality module replaces the quality requirements of the guidelines listed under 'Superseded documents'.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

Adopted guideline

Effective from: 01/02/2018


Published: 28/07/2017

First version

Current version

Adopted guideline


Overview of comments


Draft guideline


Concept paper

In operation: 01/11/2014-present


Published: 02/06/2014


Published: 08/03/2013


Published: 03/10/2011

Superseded documents

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