Influenza vaccines – submission and procedural requirements

  • Email
  • Help
Current effective version

Adopted 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

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

First version


Adopted guideline

Overview of comments

Draft guideline

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

Published: 02/07/2015

Published: 30/10/2014

Superseded document


Adopted guideline - Rev. 2

Overview of comments - Rev. 2

Draft guideline - Rev. 2

Adopted guideline - Rev. 1

Overview of comments - Rev. 1

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Superseded documentAdopted guidelineIn operation: 05/04/2004–present

Related content

How helpful is this page?

Average rating:

 Based on 25 ratings

Add your rating:

See all ratings
5 ratings
5 ratings
5 ratings
5 ratings
5 ratings

Tell us more