The purpose of this revision is to provide guidance for the submission of variations for annual update of human influenza inactivated vaccines applications in the centralised procedure following amendment of the Variations Regulation (EC) No 1234/2008 by Regulation (EU) No 712/2012.

 

Download document Revision of procedural advice on the submission of variations for annual update of human influenza inactivated vaccines applications in the centralised procedure
Reference number EMA/CHMP/BWP/99698/2007 Rev. 2
Status draft: consultation open
First published 22/03/2013
Last updated 22/03/2013
Consultation start date 22/03/2013
Consultation end date 05/04/2013
Email address for submissions elisa.pedone@ema.europa.eu; thomas.girard@ema.europa.eu

 

Posted on the EMA website on 22 March 2013