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

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The quality reguirements of this guideline have been replaced by the guideline on influenza vaccines - quality module.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

Current version - Superseded

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

Adopted Reference Number: EMEA/CHMP/VWP/263499/2006 Legal effective date: 01/02/2007

Document history - First version

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

Adopted Reference Number: EMEA/CHMP/VWP/263499/2006 Legal effective date: 01/02/2007

Draft guideline on dossier structure and content of marketing authorisation applications for influenza vaccines with avian strains with a pandemic potential for use outside of the core dossier context

Draft: consultation closed Reference Number: EMEA/CHMP/VWP/263499/2006