Minor uses / minor species and limited markets
The European Medicines Agency (EMA) has implemented a policy to address the lack of veterinary medicines for the treatment of minor animal species and uncommon diseases in major animal species. The minor use/minor species (MUMS)/limited market policy is intended to assist applicants with developing and submitting applications for products for limited markets in order to stimulate development of new medicines which would otherwise not be developed in the current market conditions.
United Kingdom’s (UK) withdrawal from the EU
EMA has published important information to help users of the centralised procedure prepare for the expected consequences of 'Brexit', including their obligations related to establishment within the European Economic Area (EEA). For more information, see UK’s withdrawal from the EU.
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.
Lack of investment to meet data requirements and establish maximum residue limits (MRLs) for small volume, low sale products led to a lower availability of veterinary medicines. For more information, see Position paper on availability of veterinary medicines.
This prompted the Agency to develop a policy on classification and incentives for veterinary medicines indicated for MUMS/limited market, which was introduced in September 2009 and revised in December 2014. Since September 2013, financial incentives are restricted to products indicated for food-producing species only.
- Revised policy for classification and incentives for veterinary medicinal products indicated for minor use minor species (MUMS)/limited market
The type of assistance provided to applicants for products indicated for MUMS/limited market includes reduced data requirements and fee reductions or waivers for applications.
Guidance in the form of a question and answer document is available for applicants seeking to access incentives for MUMS/limited market indications:
Applicants need to submit their request for classification to the Committee for Medicinal Products for Veterinary Use (CVMP) using the following submission form:
- Request to the CVMP to classify a veterinary medicinal product as minor use minor species (MUMS)/intended for use in a limited market .
- Guidance on the classification of veterinary medicinal products indicated for minor use minor species (MUMS) / limited market
EMA publishes a list of the CVMP classifications on MUMS and decision on financial incentives, which is updated twice a year:
The Agency 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.
- 9th annual veterinary report- Minor use / minor species and limited markets (2018)
- 8th annual report veterinary - Minor use / Minor species an limited market (2017)
- 7th annual report veterinary - Minor use / Minor species and limited market (2016)
- 6th annual report veterinary - Minor use / minor species and limited market (2015)
- 5th annual report veterinary - Minor use / minor species and limited market (2014)
- 4th annual report veterinary - Minor use / minor species and limited market (2013)
- 3rd annual report veterinary - Minor use / minor species and limited market (2012)
- 2nd annual report veterinary - Minor use / minor species and limited market (2010 - 2011)
Update: On 21 November 2019, the Committee for Medicinal Products for Veterinary Use (CVMP) CVMP launched a revision of its scientific guidelines on reduced data requirements for veterinary limited markets, in line with the requirements of the new veterinary medicines legislation. The resulting concept paper is available for public consultation until 31 January 2020.
The Agency has published guidelines on data requirements for veterinary medicines intended for MUMS/limited markets as classified by the CVMP to help applicants prepare marketing authorisation applications for veterinary medicines.
The guidance covers the following areas: