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

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