Policy on veterinary medicines for minor use, minor species / limited market revised
The European Medicines Agency has revised the operation of its minor-use-minor-species (MUMS) / limited-market policy for veterinary medicines to direct its assistance to those medicines most deserving of public support and to clarify the criteria used for the classification of medicines.
The MUMS policy was introduced in September 2009 to stimulate the development of new veterinary medicines for minor species and for rare diseases in major species that would otherwise not be developed under current market conditions.
Under this policy, two types of assistance are provided for veterinary medicines that are classified as intended for MUMS/limited market: reduced data requirements and financial incentives.
Following an analysis of the requests received and incentives granted so far, the Agency has limited access to financial incentives offered under this policy to medicines indicated for food-producing species. The Agency considers that these medicines have the potential to be of most benefit to animal or public health. This change has been effective since 1 September 2013 following endorsement by the Agency's Management Board. Reduced data requirements continue to apply to medicines for food-producing species and those for companion animals, since the cost of studies required to generate data is a major disincentive to the development of medicines for limited markets.
In addition, the criteria for classification as MUMS have been refined in light of the experience gained with the objective of providing greater clarity and predictability to potential applicants with regard to the classification of the medicines and the support they can obtain.
The updated policy has been separated out into a policy document and a separate guidance document for applicants. This guidance document describes the operation of the updated policy, including the procedure and the steps to be followed by the applicant and the Agency when dealing with a request for classification.
Comments are invited on the revised guidance by 24 October 2014 using the form provided.