Influenza vaccines – submission and procedural requirements

Current effective version

PDF iconAdopted guideline

Reference numberEMA/56793/2014 Rev.1
Published13/03/2017
Effective from13/03/2017
KeywordsSubmission and procedural requirements, influenza vaccines, live attenuated influenza vaccines (LAIV), seasonal, pre-pandemic, pandemic, annual strain update, pandemic strain update
DescriptionThis guideline lays down the procedural aspects related to the submission of marketing authorisation applications for influenza vaccines and subsequent updates of vaccine composition in the centralised procedure and also provides guidance on labelling particulars (strain descriptions) in Annex II.


Document history

Revision 1

Current version

PDF iconAdopted guideline - Rev. 1 In operation: 13/03/2017 - present

First version

PDF iconAdopted guideline


PDF iconOverview of comments


PDF iconDraft guideline

In operation: 02/07/2015 - 13/03/2017


Published: 02/07/2015


Published: 30/10/2014

Superseded document

PDF iconAdopted guideline - Rev. 2


PDF iconOverview of comments - Rev. 2


PDF iconDraft guideline - Rev. 2


PDF iconAdopted guideline - Rev. 1


PDF iconOverview of comments - Rev. 1


PDF iconDraft guideline - Rev. 1

In operation: 01/05/2013–02/07/2015


Published: 30/04/2013


Published: 22/03/2013


In operation: 08/02/2011–01/05/2013


Published: 01/10/2010


Published: 02/06/2010

Superseded documentAdopted guidelineIn operation: 05/04/2004–present


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