Influenza vaccines prepared from viruses with the potential to cause a pandemic and intended for use outside of the core dossier context

This document addresses the non-clinical and clinical dossier requirements, and post-authorisation issues for influenza vaccines. It applies to medicinal products prepared from viruses with a pandemic potential that are intended for use outside of the context of a core dossier.

The quality reguirements of this guideline have been replaced by the guideline on influenza vaccines - quality module.

Keywords: Pandemic influenza vaccines for human use, strains with pandemic potential, quality, non-clinical and clinical requirements

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