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

Current effective version

PDF iconAdopted guideline

Reference number CHMP/VWP/263499/06
Published 24/01/2007
Effective from 01/02/2007
Keywords Pandemic influenza vaccines for human use, strains with pandemic potential, quality, non-clinical and clinical requirements
Description 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 The quality reguirements of this guideline have been replaced by the guideline on influenza vaccines - quality module.

Document history

First version

Current version

PDF iconAdopted guideline


PDF iconDraft guideline

In operation: 01/02/2007–present


Published: 24/07/2006

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