Efficacy and target animal safety data requirements for veterinary medicinal products intended for minor uses or minor species - Scientific guideline
This document described the data requirements regarding efficacy and target animal safety for pharmaceutical veterinary medicinal products classified as minor use or minor species/limited market.
It was superseded by the following guideline on 28 January 2022:
Keywords: Target animal safety (TAS), minor uses and minor species (MUMs), veterinary medicinal product (VMP)
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Guideline on efficacy and target animal safety data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market - Revision 1 (PDF/305.33 KB)
Adopted
First published: 03/01/2017
Last updated: 03/01/2017
EMA/CVMP/EWP/117899/2004–Rev.1 -
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Overview of comments received on 'Guideline on efficacy and target animal safety data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market' (PDF/148.61 KB)
First published: 03/01/2017
Last updated: 03/01/2017
EMA/CVMP/EWP/523421/2016 -
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Draft guideline on efficacy and target animal safety data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market - Revision 1 (PDF/167.52 KB)
Draft: consultation closed
First published: 03/02/2016
Last updated: 03/02/2016
Consultation dates: 03/02/2016 to 31/07/2016
EMA/CVMP/EWP/117899/2004 Rev.1
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Guideline on efficacy and target animal safety data requirements for veterinary medicinal products intended for minor uses or minor species (PDF/77.95 KB)
Adopted
First published: 01/02/2007
Last updated: 01/02/2007
Legal effective date: 20/07/2006
EMEA/CVMP/EWP/117899/2004 -
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Overview of comments received on draft guideline efficacy and target animal safety data requirements for veterinary medicinal products intended for minor uses or minor species (PDF/63.18 KB)
First published: 20/07/2006
Last updated: 20/07/2006
EMEA/CVMP/EWP/43872/2006 -
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Draft guideline on efficacy and target animal safety data requirements for veterinary medicinal products intended for minor uses or minor species (PDF/69.53 KB)
Draft: consultation closed
First published: 18/04/2005
Last updated: 18/04/2005
EMEA/CVMP/EWP/117899/2004
- Efficacy: availability (minor uses/minor species)
- Former EMA policy on minor use / minor species (MUMS) / veterinary limited markets
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Concept paper for the revision of the guidelines on data 4 requirements for veterinary medicinal products for minor use minor species (EMEA/CVMP/IWP/123243/2006-Rev.2), (EMEA/CVMP/QWP/128710/2004), (EMEA/CVMP/SWP/66781/2005), (EMEA/CVMP/EWP/117899/2004)
- Regulation (EU) 2019/6