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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.

    Implementation of the Veterinary Medicines Regulation

    The?Veterinary Medicines Regulation?(Regulation (EU) 2019/6)?contains?new legal provisions on veterinary medicines intended for limited markets. These will provide?a?solid legal basis for the authorisation?of these medicines in the EU.

    This aims to further stimulate the development of innovative veterinary medicines for small markets, in order to increase the availability of treatments for serious or life-threatening animal diseases and unmet veterinary medical needs.

    MUMS / limited market classification according to EMA's MUMS / limited market policy?will cease to apply once the Regulation?becomes applicable on 28 January 2022.

    If the holder of a MUMS / limited market classification applies for?a marketing authorisation?after 28 January 2022,?the responsible regulatory body will need to reconsider the product's eligibility?for limited markets applications under Article 23 of the Regulation.

    EMA is?providing?guidance on the new legal and procedural framework?to help potential applicants and holders of MUMS / limited market classifications decide on any actions to take.?

    Update: The eligibility criteria?and guidelines?on reduced?data requirements?that will apply under the Regulation?are available for public consultation:

    These guidelines?will supersede the currently applicable guidelines under EMA's MUMS / limited market policy?on 28 January 2022.

    Stakeholders should send their comments to?vet-guidelines@ema.europa.eu?by 15 May 2021 using the form linked within the guidelines.?

    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

    Applicants for medicines classified as?MUMS / limited market?under EMA's MUMS / limited market policy benefit from reduced data requirements for marketing authorisation. Guidance is available in?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 Veterinary Medicines Regulation?(Regulation (EU) 2019/6). For more information, see:

    Procedural guidance for applicants

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

    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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