Submission of marketing-authorisation applications for pandemic influenza vaccines through the centralised procedure

This document provides guidance on submission of the pandemic dossier during the inter-pandemic period, followed by a fast track approval of the pandemic vaccine, based on submission of a pandemic variation. It has been superseded by the guideline on influenza vaccines - quality module.

Keywords: Submission and procedural requirements, influenza vaccines

Current effective version

Guideline on submission of marketing authorisation applications for pandemic influenza vaccines through the centralised procedure - Superseded

Adopted Reference Number: EMEA/CPMP/VEG/4986/03 Legal effective date: 30/04/2004