Influenza vaccines – submission and procedural requirements

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Current effective version

Adopted 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

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Superseded document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Superseded documentAdopted guidelineIn operation: 05/04/2004–present


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