European Medicines Agency revises MUMS / limited-market policy
The European Medicines Agency has published a public statement revising the operation of the minor-use-minor-species (MUMS) / limited-market policy (MUMS policy) for veterinary medicines. In future, only products indicated for food-producing species will be eligible for fee incentives. This revision was endorsed by the Agency’s Management Board at its meeting on 13 June 2013.
The development of a policy and procedures to assist applicants with submitting applications for products for limited markets is intended to stimulate development of new veterinary medicines for minor species and for rare diseases in major species that would otherwise not be developed in the current market conditions. Since its introduction in October 2010, this policy has been highly successful in terms of increasing interest from the animal-health industry in submitting applications for MUMS products, with over 70 products classified so far.
The veterinary community recognises that the availability of medicines is most restricted in terms of products indicated for MUMS in food-producing species, whereas the situation is less acute with respect to products for companion animals.
In light of the experience gained and against the backdrop of scarcity of financial and human resources, the Agency identified the need to refine the criteria by which products are classified as ‘MUMS’ and ‘limited market’, to ensure that the limited resources available are directed to those products most deserving of public support which would otherwise not be developed.
The Agency has decided that the criteria for classification as MUMS will remain unchanged. The Agency will continue to accept requests for classification of products as MUMS for both food-producing species and companion animals and, if classification is confirmed, the MUMS data requirements in accordance with the Committee for Medicinal Products for Veterinary Use (CVMP) MUMS guidelines will apply.
However, in future, only products indicated for food-producing species will be accepted for classification by CVMP as also indicated for a ‘limited market’ and thereby eligible for fee incentives.
The MUMS policy and Agency guidance documents for companies requesting classification as MUMS / limited markets will be updated to reflect this amendment to the criteria for eligibility for financial incentives.