Safety and residue data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market
Description: This document defines the acceptable data requirements for safety and residues documentation for veterinary medicinal products intended for minor uses or minor species.
Keywords: Minor uses/minor species (MUMS), data requirements
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Guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market (PDF/296.11 KB)
Adopted
First published: 03/01/2017
Last updated: 03/01/2017
Legal effective date: 01/07/2017
EMA/CVMP/SWP/66781/2005–Rev.1 -
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Overview of comments received on 'Guideline on safety and residue data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market' (PDF/242.92 KB)
First published: 03/01/2017
Last updated: 03/01/2017
EMA/CVMP/SWP/523387/2016 -
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Draft guideline on safety and residue data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market (PDF/388.07 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/QWP/66781/2005 Rev.1
Document history
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Draft guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market - Revision 2 (PDF/330.74 KB)
Draft: consultation closed
First published: 18/12/2018
Consultation dates: 18/12/2018 to 31/08/2019
EMA/CVMP/SWP/66781/2005 Rev. 2 -
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Overview of comments received on “Revised guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market” EMA/CVMP/SWP/66781/2005–Rev.2 (PDF/337.31 KB)
First published: 25/02/2021
EMA/CVMP/57188/2020 -
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Concept paper for the revision of the guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market (PDF/84.91 KB)
Draft: consultation closed
First published: 26/01/2018
Last updated: 26/01/2018
Consultation dates: 26/01/2018 to 28/02/2018
EMA/CVMP/SWP/779037/2017
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Guideline on safety and residue data requirements for veterinary medicinal products intended for minor uses or minor species (PDF/116.41 KB)
Adopted
First published: 20/07/2006
Last updated: 20/07/2006
Legal effective date: 01/02/2007
EMEA/CVMP/SWP/66781/2005 -
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Overview of comments received on draft guideline safety and residue data requirements for veterinary medicinal products intended for minor uses or minor species (PDF/124.72 KB)
First published: 20/07/2006
Last updated: 20/07/2006
EMEA/CVMP/SWP/401874/2005
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)- Directive 2001/82/EC
- Directive 2009/9/EC
- Regulation (EC) No 470/2009
- Commission Regulation 2018/782