Quality data requirements for applications for veterinary medicinal products other than biologicals intended for limited markets - Scientific guideline
Table of contents
The guideline defines acceptable data requirements for the demonstration of quality of veterinary medicinal products other than biologicals classified as limited markets in line with Article 4(29) of Regulation (EU) 2019/6.
Keywords: availability, limited market, classification, Article 4, Article 8, Article 23, Annex II, Regulation (EU) 2019/6, non-biological veterinary medicinal products, quality, data requirements
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Guideline on quality data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market (PDF/302.05 KB)
Adopted
First published: 03/01/2017
Last updated: 03/01/2017
Legal effective date: 01/07/2017
EMA/CVMP/QWP/128710/2004-Rev.1 -
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Overview of comments received on ‘Guideline on quality data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market’ (PDF/148.57 KB)
First published: 03/01/2017
Last updated: 03/01/2017
EMA/CVMP/QWP/472725/2016 -
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Draft guideline on quality data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market (PDF/165.86 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/128710/2004 Rev.1 -
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Note regarding CVMP guidelines on data requirements for veterinary medicinal products intended for minor uses or minor species - Revision 1 (PDF/41.66 KB)
Adopted
First published: 01/07/2006
Last updated: 01/07/2006
Legal effective date: 01/02/2007
EMEA/CVMP/133672/2005-Rev.1 -
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Guideline on quality data requirements for veterinary medicinal products intended for minor uses or minor species (PDF/51.43 KB)
Adopted
First published: 20/07/2006
Last updated: 20/07/2006
Legal effective date: 01/02/2007
EMEA/CVMP/QWP/128710/2004 -
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Overview of comments received on guideline on quality data requirements for veterinary medicinal products intended for minor uses or minor species (PDF/34.91 KB)
First published: 20/07/2006
Last updated: 20/07/2006
EMEA/CVMP/QWP/50314/2006