Requirements for an authorisation under exceptional circumstances for vaccines for use in birds against avian influenza

This document aims to provide guidance to manufacturers on the minimum data requirements for authorisation of avian influenza vaccines for emergency use under Article 26 of Directive 2001/82/EC, as amended, and Article 39(7) of Regulation 726/2004.

Keywords: Birds, avian influenza virus, differentiation of infection from vaccination (DIVA), emergency use, preventive use

Current effective version

Guideline on requirements for an authorisation under exceptional circumstances for vaccines for use in birds against avian influenza

Adopted Reference Number: EMEA/CVMP/IWP/222624/2006 Legal effective date: 01/11/2007

Document history

Guideline on requirements for an authorisation under exceptional circumstances for vaccines for use in birds against avian influenza

Adopted Reference Number: EMEA/CVMP/IWP/222624/2006 Legal effective date: 01/11/2007

Overview of comments received on guideline on requirements for an authorisation under exceptional circumstances for vaccines for use in birds against avian influenza EMEA/CVMP/IWP/222624/2006

Reference Number: EMEA/146160/2007

Concept paper on requirements for vaccines for use in birds against avian influenza virus

Reference Number: EMEA/CVMP/86063/2006-CON.

Reflection paper: Minimum data requirements for an authorisation under exceptional circumstances for vaccines for emergency use in birds against H5 and/or H7 highly pathogenic avian influenza virus

Adopted Reference Number: EMEA/CVMP/IWP/46853/2006