Data requirements for multi-strain dossiers for Inactivated vaccines against avian influenza (AI), blue tongue (BT) and foot-and-mouth disease (FMD)

This document applies to new applications for authorisation of vaccines defined in multi-strain dossiers and variations to such dossiers concerning the addition or replacement of strains of inactivated vaccines intended for use against avian influenza, bluetongue and foot-and-mouth disease. It describes the requirements that should be presented in the analytical, safety and efficacy part of the multi-strain dossier.

Keywords: Multi-strain dossier, avian influenza, bluetongue, foot-and-mouth disease

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