Influenza vaccines - quality module

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Current effective version

Revision 1 - Adopted guideline

Reference numberEMA/CHMP/BWP/310834/2012 Rev. 1
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 This quality module replaces the quality requirements of the guidelines listed under 'Superseded documents'.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

Adopted guidelineIn operation: 01/02/2018-present
First version

Adopted guideline


Overview of comments


Draft guideline


Concept 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Superseded documents

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