Draft guideline on influenza vaccines – quality module

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Document details

Download document Draft guideline on influenza vaccines – quality module
Reference number EMA/CHMP/BWP/310834/2012
Status draft: consultation open
First published 08/03/2013
Last updated 08/03/2013
Consultation start date 08/03/2013
Consultation end date 08/08/2013
Email address for submissions quality-influenzaguideline@ema.europa.eu

Summary

The purpose of this guideline is to provide guidance on development, manufacturing and control for marketing-authorisation applications for influenza vaccines. The quality module has been updated in the light of experience gained during the recent influenza pandemic and also consolidates the current existing guidelines for influenza vaccines.