Influenza vaccines - quality module - Scientific guideline

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 This quality module replaces the quality requirements of the guidelines listed under 'Superseded documents'.

Keywords: Quality requirements, influenza vaccines, inactivated, LAIV, seasonal, zoonotic, pandemic preparedness, pandemic, annual strain update, pandemic strain update

Document history

Superseded documents


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