Influenza vaccines – submission and procedural requirements - Scientific guideline
Table of contents
This 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.
Keywords: Submission and procedural requirements, influenza vaccines, live attenuated influenza vaccines (LAIV), seasonal, pre-pandemic, pandemic, annual strain update, pandemic strain update
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Guideline on influenza vaccines – submission and procedural requirements (Rev.1) (PDF/204.37 KB)
Adopted
First published: 14/03/2017
Last updated: 14/03/2017
EMA/56793/2014 Rev. 1 -
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Guideline on influenza vaccines – submission and procedural requirements (PDF/314.45 KB)
Adopted
First published: 02/07/2015
Last updated: 02/07/2015
EMA/56793/2014 -
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Overview of comments on 'Guideline on influenza vaccines – submission and procedural requirements' (PDF/278.44 KB)
First published: 02/07/2015
Last updated: 02/07/2015
EMA/230639/2015 -
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Draft guideline on influenza vaccines – submission and procedural requirements (PDF/182.83 KB)
Draft: consultation closed
First published: 30/10/2014
Last updated: 30/10/2014
Consultation dates: 30/10/2014 to 30/01/2015
EMA/56793/2014
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Procedural advice on the submission of variations for annual update of human-influenza-inactivated-vaccine applications in the centralised procedure - Revision 2 - Superseded (PDF/291.49 KB)
Adopted
First published: 30/04/2013
Last updated: 30/04/2013
Legal effective date: 01/05/2013
EMA/CHMP/BWP/99698/2007 Rev. 2 -
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Overview of comments received on the draft of the procedural advice on the submission of variations for annual update of human-influenza-inactivated-vaccine applications in the centralised procedure (PDF/152.59 KB)
First published: 30/04/2013
Last updated: 30/04/2013
EMA/239916/2013 -
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Draft procedural advice on the submission of variations for annual update of human influenza-inactivated-vaccine applications in the centralised procedure - Revision 2 - Superseded (PDF/197.12 KB)
Draft: consultation closed
First published: 22/03/2013
Last updated: 22/03/2013
Consultation dates: 22/03/2013 to 05/04/2013
EMA/CHMP/BWP/99698/2007 Rev. 2 -
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Procedural advice on the submission of variations for annual update of human influenza inactivated vaccines applications in the centralised procedure - Revision 1 - Superseded (PDF/91.77 KB)
Adopted
First published: 01/12/2010
Last updated: 01/12/2010
Legal effective date: 08/02/2011
EMA/CHMP/BWP/99698/2007 Rev. 1 -
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Overview of comments received on 'Procedural advice on the submission of variations for annual update of human influenza inactivated vaccines applications in the centralised procedure' (EMA/CHMP/BWP/99698/2007) (PDF/106.03 KB)
First published: 01/12/2010
Last updated: 01/12/2010
EMA/CHMP/BWP/551725/2010 -
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Draft guideline on procedural advice on the submission of variations for annual update of human influenza inactivated vaccines applications in the centralised procedure - Revision 1 - Superseded (PDF/135.74 KB)
Draft: consultation closed
First published: 02/06/2010
Last updated: 02/06/2010
Consultation dates: 20/05/2010 to 01/09/2010
EMA/CHMP/BWP/99698/2007 Rev. 1 -
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Guideline on submission of marketing authorisation applications for pandemic influenza vaccines through the centralised procedure - Superseded (PDF/222.37 KB)
Adopted
First published: 05/04/2004
Last updated: 05/04/2004
Legal effective date: 30/04/2004
EMEA/CPMP/VEG/4986/03