Data requirements for immunological veterinary medicinal products intended for minor use or minor species

Current effective version

PDF iconRevision 3 - Adopted guideline

Reference numberEMEA/CVMP/IWP/123243/2006 Rev. 3
Published20/04/2017
Effective from01/11/2017
KeywordsImmunological veterinary medicinal products (IVMPs), minor use, minor species, limited markets
DescriptionThis document defines acceptable data requirements for the demonstration of quality, safety and efficacy for immunological veterinary medicinal products (IVMPs) intended for minor use. It applies to new applications for authorisation, line extensions and variations of IVMPs, defined as minor use immunological veterinary medicinal products.


Document history

Revision 3

Current version

PDF iconAdopted guideline

PDF iconOverview of comments

PDF iconDraft guideline

Published: 20/04/2017

Published: 20/04/2017

Published: 03/02/2016

Revision 2

PDF iconAdopted guideline


PDF iconOverview of comments


PDF iconDraft guideline

Published: 23/04/2010


Published: 12/07/2007


Published: 16/03/2009

Revision 1

PDF iconDraft guideline


PDF iconExplanatory note

Published: 25/07/2008


Published: 01/07/2006


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