Influenza vaccines – submission and procedural requirements

Current effective version

PDF iconAdopted guideline

Reference numberEMA/56793/2014 Rev.1
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Superseded document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Superseded documentAdopted guidelineIn operation: 05/04/2004–present

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