Influenza vaccines - quality module

Keywords Quality requirements, influenza vaccines, inactivated, LAIV, seasonal, zoonotic, pandemic preparedness, pandemic, annual strain update, pandemic strain update
Description This document provides guidance on marketing authorisation applications for influenza vaccines and for strain updates of authorised influenza vaccines. It applies to inactivated non-adjuvanted vaccines and inactivated vaccines with adjuvant to be used in the seasonal, pre-pandemic or pandemic setting, and live attenuated seasonal influenza vaccines. This quality module replaces the quality requirements of the guidelines listed under 'Superseded documents'.

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