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

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Document details

Download document 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
Reference number EMA/CVMP/SWP/779037/2017
Status draft: consultation open
First published 2018-01-26
Last updated 2018-01-26
Consultation start date 2018-01-26
Consultation end date 2018-02-28
Email address for submissions vet-guidelines@ema.europa.eu

Summary

In order to stimulate the development of veterinary medicines intended for minor uses or minor species (MUMS)/limited market the CVMP has developed guidelines on data requirements for MUMS/limited market veterinary medicinal products for quality, safety and efficacy for pharmaceuticals, as well as a guideline for immunologicals. The guideline that focuses on safety requirements for pharmaceuticals includes a section on extrapolation of maximum residue limits (MRLs) from major to minor species.