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
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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 (PDF/147.45 KB)
Adopted
First published: 19/11/2014
Last updated: 19/11/2014
EMA/CVMP/IWP/97961/2013 -
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Overview of comments received on 'Guideline on the compliance of authorised equine influenza vaccines with World Organisation for Animal Health (OIE) requirements' (PDF/264.34 KB)
First published: 19/11/2014
Last updated: 19/11/2014
EMA/CVMP/IWP/36240/2014 -
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Draft guideline on the compliance of authorised equine influenza vaccines with World Organisation for Animal Health requirements (PDF/169.7 KB)
Draft: consultation closed
First published: 25/04/2013
Last updated: 25/04/2013
Consultation dates: 11/04/2013 to 30/04/2013
EMA/CVMP/IWP/97961/2013 -
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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 (PDF/116.84 KB)
Draft: consultation closed
First published: 16/03/2012
Last updated: 16/03/2012
Consultation dates: 16/03/2012 to 31/05/2012
EMA/CVMP/IWP/4199/2012