European Medicines Agency consultation: Guideline on Procedural advice on the Submission of Variations for Annual Update of Human Influenza Inactivated Vaccines Applications in the Centralised Procedure

The European Medicines Agency has published a Guideline 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 Rev. 1).

The document is available on the following webpage:

http://www.ema.europa.eu/pdfs/human/bwp/9969807en.pdf

This procedural guidance document concerns the annual change in vaccine composition (influenza A and B virus variants) of a centrally authorised seasonal influenza vaccine in order to meet the EU recommendations for human influenza virus strain(s) vaccine composition for the coming season. It provides guidance on the procedure, timelines and dossier content MAHs should fulfil in order for the CHMP to issue its appropriate scientific opinion.

Your comments on this document are most welcomed by 01 September 2010 to the address elisa.pedone@ema.europa.eu.

Please kindly use the template in the link below to submit your comments:

http://www.ema.europa.eu/pdfs/human/regaffair/submitcomment.doc

We would be grateful if you could disseminate this e-mail to anyone else who might be interested in this document.

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