Concept paper for the revision of scientific guidelines on limited market for veterinary medicinal products

This document announces the revision of the guidelines on reduced data requirements for veterinary limited markets, considering the new legal basis of Regulation (EU) 2019/6.

Keywords: Limited Market, Minor Uses Minor Species, MUMS, New Veterinary Regulation

Current version

Concept paper for the revision of scientific guidelines on limited market for veterinary medicinal products

Draft: consultation closedConsultation dates: 21/11/2019 to 31/01/2020Reference Number: EMA/CVMP/539861/2019Summary:

This document announces the revision of the guidelines on reduced data requirements for veterinary limited markets, considering the new legal basis of Regulation (EU) 2019/6.