Revision of procedural advice on the submission of variations for annual update of human influenza-inactivated-vaccine applications in the centralised procedure

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Download document Revision of procedural advice on the submission of variations for annual update of human influenza-inactivated-vaccine applications in the centralised procedure
Reference number EMA/CHMP/BWP/99698/2007 Rev. 2
Status draft: consultation closed
First published 22/03/2013
Last updated 22/03/2013

Summary

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