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

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Current effective version

Adopted guideline

Reference numberCHMP/VWP/263499/06
Published24/01/2007
Effective from01/02/2007
KeywordsPandemic influenza vaccines for human use, strains with pandemic potential, quality, non-clinical and clinical requirements
DescriptionThis 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 The quality reguirements of this guideline have been replaced by the guideline oninfluenza vaccines - quality module.


Document history

First version

Current version

Adopted guideline


Draft guideline

In operation: 01/02/2007–present


Published: 24/07/2006


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