Minor use / minor species and limited markets

The European Medicines Agency (EMA) has put in place a policy to improve the availability of veterinary medicines for the treatment of minor animal species and uncommon diseases in major animal species. The aim is to stimulate development of new medicines which would otherwise not be developed in the current market conditions, for the benefit of animal welfare, animal health and in some cases, public health. 

EMA's support for limited veterinary markets is governed by its minor use / minor species (MUMS) / limited market policy:

Any medicine can receive MUMS / limited market classification irrespective of the intended authorisation route.

The benefits for applicants comprise reduced data requirements for applications, greater level of assistance and in certain circumstances, financial incentives.

    Defining MUMS and limited markets

    Minor use medicines are intended for use in major species (cattle, sheep, pigs, chickens, salmon, cats and dogs) for the treatment of diseases that occur infrequently or occur in limited geographical areas.

    Minor species are all animals that are not one of the major species.

    Limited market for a veterinary medicine is a market that is limited in size.

    Incentives

    All MUMS / limited market products benefit from:

    EMA encourages eligible applicants to register as an SME, in order to benefit from financial and administrative assistance from EMA. For more information, see Supporting SMEs.

    In addition, products indicated for food producing species where no alternative product is authorised benefit from financial incentives for certain procedures, as described in the table below.

     

    ProcedureFee reduction
    Scientific advice100% fee exemption
    Establishment / extension of MRL
    • 50% fee reduction for a new active substance for which no MRL is established
    • 50% fee reduction for extension of an existing MRL to a minor species where there is a need to assess new data
    • 100% fee exemption for extending an existing MRL
    • 100% fee exemption in the event of failure of validation
    Centralised marketing authorisations
    • 50% fee reduction for marketing authorisation applications
    • 75% fee reduction for annual maintenance fees
    • 100% fee exemption in the event of failure of validation
    • Fee deferral until the outcome of marketing authorisation application (for registered micro, small and medium-sized enterprises (SMEs) only)

    Please note that a centralised application that concerns more than one target species, only one of which is MUMS, does not benefit from fee reductions.

    For more information on fees, see Fees payable to EMA.

    Guidelines on reduced data requirements

    Applicants for medicines classified for MUMS / limited market benefit from reduced data requirements for marketing authorisation. EMA has published guidance covering the following areas:

    EMA's CVMP is currently revising its scientific guidelines on reduced data requirements for veterinary limited markets, in line with the requirements of the new veterinary medicines legislation. For more information, see:

    Procedural guidance for applicants

    EMA provides guidance to applicants on requesting MUMS / limited market classifications:

    Annual reports

    EMA publishes an annual report on the activities carried out under the MUMS / limited market scheme, including requests for MUMS / limited market classification, incentives provided and support to applicants in determining data requirements.

    10-year report

    MUMS 10 year report coverEMA's PDF icon10-year report on the operation of its MUMS / limited market policy provides an overview of the activities carried out under the scheme between September 2009 and December 2019.

    It shows that the policy has been successful in increasing the availability of veterinary medicines.

    In this period, EMA's Committee for Medicinal Products for Veterinary Use (CVMP) reviewed 272 requests for classification.

    For previous reports, see:

    Public information on MUMS / limited market classifications

    EMA publishes a list of the CVMP classifications on MUMS /limited market and decisions on financial incentives, which is updated twice a year:

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