EMA: Concept paper for the revision of the guidelines on data requirements for veterinary medicinal products for minor use minor species

The European Medicines Agency, together with the European medicines regulatory network, aims to facilitate the access of products indicated for minor use minor species (MUMS) / limited market to the market, as part of measures to promote the availability of veterinary medicines. One of the measures initiated by the Committee for Medicinal Products for Veterinary Use was to review dossier requirements for veterinary medicinal products intended for minor uses or MUMS and, if possible, to establish standards for demonstration of quality, safety and efficacy for these.