Influenza vaccines – submission and procedural requirements - Scientific guideline

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

Current effective version

Guideline on influenza vaccines – submission and procedural requirements (Rev.2)

Adopted Reference Number: EMA/56793/2014 Rev. 2

Document history

Guideline on influenza vaccines – submission and procedural requirements (Rev.1)

Adopted Reference Number: EMA/56793/2014 Rev. 1 Summary:

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.

Guideline on influenza vaccines – submission and procedural requirements

Adopted Reference Number: EMA/56793/2014 Summary:

The need to update the current guidelines regarding the development of influenza vaccines was recognised in the wake of the 2009-2010 influenza pandemic, as the Agency conducted its “lessons learned” exercise. Since then, experience has also been gained through the evaluation of scientific advice and marketing authorisation applications for influenza vaccines.

Overview of comments on 'Guideline on influenza vaccines – submission and procedural requirements'

Reference Number: EMA/230639/2015 Summary:

Overview of comments on 'Guideline on influenza vaccines – submission and procedural requirements’ (EMA/56793/2014)

Draft guideline on influenza vaccines – submission and procedural requirements

Draft: consultation closed Consultation dates: 30/10/2014 to 30/01/2015 Reference Number: EMA/56793/2014 Summary:

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. Currently, the regulatory requirements on influenza vaccines are stated in several documents.

The revision of the guidelines aimed at developing a consolidated influenza guideline that covers the regulatory, quality, non-clinical and clinical aspects of influenza vaccine development and dossier submission.

Superseded documents

Procedural advice on the submission of variations for annual update of human-influenza-inactivated-vaccine applications in the centralised procedure - Revision 2 - Superseded

Adopted Reference Number: EMA/CHMP/BWP/99698/2007 Rev. 2 Legal effective date: 01/05/2013 Summary:

Seasonal influenza vaccines for human use authorised via the centralised procedure in accordance with Regulation (EC) No 726/2004, must be varied annually according to Article 18 of Commission Regulation (EC) No 1234/2008 and the Commission “Guideline on the operation of the procedures laid down in Chapters II, III and IV of Commission Regulation (EC) No 1234/2008 as well as on the documentation to be submitted pursuant to these procedures”. This document describes the specific procedure, timelines and data requirements for the adoption of an opinion of such change(s) by the CHMP.

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

Reference Number: EMA/239916/2013

Draft procedural advice on the submission of variations for annual update of human influenza-inactivated-vaccine applications in the centralised procedure - Revision 2 - Superseded

Draft: consultation closed Consultation dates: 22/03/2013 to 05/04/2013 Reference Number: EMA/CHMP/BWP/99698/2007 Rev. 2 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.

Procedural advice on the submission of variations for annual update of human influenza inactivated vaccines applications in the centralised procedure - Revision 1 - Superseded

Adopted Reference Number: EMA/CHMP/BWP/99698/2007 Rev. 1 Legal effective date: 08/02/2011

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)

Reference Number: EMA/CHMP/BWP/551725/2010

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

Draft: consultation closed Consultation dates: 20/05/2010 to 01/09/2010 Reference Number: EMA/CHMP/BWP/99698/2007 Rev. 1

Guideline on submission of marketing authorisation applications for pandemic influenza vaccines through the centralised procedure - Superseded

Adopted Reference Number: EMEA/CPMP/VEG/4986/03 Legal effective date: 30/04/2004