Compliance of authorised equine influenza vaccines with OIE requirements - Scientific guideline

This document provides guidance on the data requirements to support changes to the strain composition of authorised, equine influenza vaccines in line with recommendations from the Office International des Épizooties (OIE) Expert Surveillance Panel on Equine Influenza Vaccine Composition.

Keywords: Equine influenza, vaccines, data requirements, the Office International des Épizooties (OIE), recommendations

Current effective version

Guideline on data requirements for changes to the strain composition of authorised equine influenza vaccines in line with World Organisation for Animal Health (OIE) recommendations

Adopted Reference Number: EMA/CVMP/IWP/97961/2013 Summary:

This document provides guidance on the data requirements to support changes to the strain composition of authorised, equine influenza vaccines in line with recommendations from the Office International des à‰pizooties (OIE) Expert Surveillance Panel on Equine Influenza Vaccine Composition.

Document history - First version

Guideline on data requirements for changes to the strain composition of authorised equine influenza vaccines in line with World Organisation for Animal Health (OIE) recommendations

Adopted Reference Number: EMA/CVMP/IWP/97961/2013 Summary:

This document provides guidance on the data requirements to support changes to the strain composition of authorised, equine influenza vaccines in line with recommendations from the Office International des à‰pizooties (OIE) Expert Surveillance Panel on Equine Influenza Vaccine Composition.

Overview of comments received on 'Guideline on the compliance of authorised equine influenza vaccines with World Organisation for Animal Health (OIE) requirements'

Reference Number: EMA/CVMP/IWP/36240/2014 Summary:

Overview of comments received on 'Guideline on the compliance of authorised equine influenza vaccines with OIE requirements' - CVMP/IWP/97961/2013

Draft guideline on the compliance of authorised equine influenza vaccines with World Organisation for Animal Health requirements

Draft: consultation closed Consultation dates: 11/04/2013 to 30/04/2013 Reference Number: EMA/CVMP/IWP/97961/2013

Concept paper on the need of revision of the note for guidance: Harmonisation of requirements for equine influenza vaccines – Specific requirements for substitution or addition of a strain or strains

Draft: consultation closed Consultation dates: 16/03/2012 to 31/05/2012 Reference Number: EMA/CVMP/IWP/4199/2012 Summary:

The purpose of this note for guidance is to outline situations and requirements where substitution or addition of one or more strains of the influenza A/equine 1 virus (H7N7) and/or influenza A/equine 2 virus (H3N8) subtypes of an equine influenza vaccine is necessary due to antigenic drift associated with the gene coding for the haemagglutinin (i.e. the major surface protein of influenza A strains).

Document history - Superseded document

Note for guidance: Harmonisation of requirements for equine influenza vaccines: Specific requirements for substitution or addition of a strain or strains

Adopted Reference Number: EMEA/CVMP/112/98-FINAL Legal effective date: 01/12/1998