Conduct of efficacy studies for intramammary products for use in cattle - Scientific guideline
This document provides guidance on the conduct of efficacy studies and their evaluation for veterinary medicinal products that are administered via the teat canal to cattle.
Keywords: Intramammary preparations, milk, udder, mastitis, somatic cell counts, veterinary medicinal product (VMP)
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Guideline on the conduct of efficacy studies for intramammary products for use in cattle (PDF/215.33 KB)
Adopted
First published: 26/01/2017
Last updated: 26/01/2017
Legal effective date: 01/08/2017
EMA/CVMP/344/1999-Rev.2 -
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Overview of comments received on Guideline on the conduct of efficacy studies for intramammary products for use in cattle (EMA/CVMP/344/1999-Rev.2) (PDF/176.87 KB)
First published: 26/01/2017
Last updated: 26/01/2017
EMA/CVMP/EWP/444475/2016 -
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Draft guideline on the conduct of efficacy studies for intramammary products for use in cattle (PDF/228.51 KB)
Draft: consultation closed
First published: 26/02/2016
Last updated: 26/02/2016
Consultation dates: 26/02/2016 to 31/05/2016
CVMP/344/1999 Rev. 2 -
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Overview of comments received on guideline on the conduct of efficacy studies for intramammary products for use in cattle (PDF/188.97 KB)
First published: 26/02/2016
Last updated: 26/02/2016
EMA/CVMP/EWP/335976/2014 -
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Draft guideline on the conduct of efficacy studies for intramammary products for use in cattle (PDF/185.77 KB)
Draft: consultation closed
First published: 18/10/2013
Last updated: 18/10/2013
Consultation dates: 18/10/2013 to 30/04/2014
EMEA/CVMP/EWP/141272/2011 -
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Concept paper for the revision of the guideline on the conduct of efficacy studies for intramammary products for use in cattle (PDF/68.74 KB)
Draft: consultation closed
First published: 27/09/2010
Last updated: 27/09/2010
Consultation dates: 15/09/2010 to 31/12/2010
EMA/CVMP/EWP/87114/2010