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

Current effective version

PDF icon Revision 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
Description

This document defined 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.

It was superseded by the following guideline on 28 January 2022:


Document history

Revision 3

Current version

PDF icon Adopted guideline

 

PDF icon Overview of comments

 

PDF icon Draft guideline

Published: 20/04/2017

 

Published: 20/04/2017

 

Published: 03/02/2016

Revision 2

 

PDF icon Adopted guideline

 

PDF icon Overview of comments

 

PDF icon Draft guideline

Published: 23/04/2010

 

Published: 12/07/2007

 

Published: 16/03/2009

Revision 1

PDF icon Draft guideline

 

PDF icon Explanatory note

Published: 25/07/2008

 

Published: 01/07/2006


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