Safety and residue data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market
Description: This document defined the acceptable data requirements for safety and residues documentation for veterinary medicinal products intended for minor uses or minor species.
It was superseded by the following guideline on 28 January 2022:
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/449.15 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
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Adopted guideline on safety and residue data requirements for the establishment of Maximum Residue Limits in minor species - Rev.2 (PDF/271 KB)
Adopted
First published: 25/03/2022
Legal effective date: 01/10/2022
EMA/CVMP/345236/2020 -
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Overview of comments received on ‘Guideline on safety and residue data requirements for the establishment of Maximum Residue Limits in minor species’ (EMA/CVMP/345236/2020) - Revision 2 (PDF/264.82 KB)
First published: 25/03/2022
EMA/CVMP/148042/2021 -
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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/464.52 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
- Former EMA policy on minor use / minor species (MUMS) / veterinary limited markets
Concept paper for the revision of the guidelines on data 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
- Directive 2009/9/EC
- Regulation (EC) No 470/2009
- Commission Regulation 2018/782