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:
- Revised policy for classification and incentives for veterinary medicinal products indicated for minor use minor species (MUMS) / limited market
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.
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.?
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.
All MUMS / limited market products benefit from:
- reduced data requirements as specified in the relevant CVMP guidelines. The extent of reduction depends on the nature of the product and the indication;
- a greater level of advice and assistance, including for pre-submission meetings for centralised?marketing authorisation applications, scientific advice or establishing or extending a maximum residue limit (MRL).
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.
|Scientific advice||100% fee exemption|
|Establishment / extension of MRL|
|Centralised marketing authorisations|
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.
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:
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.
- 11th annual report -?MUMS and limited market (2020)
- 10-year report -?MUMS and limited market (2009-2019)
- 9th annual report - MUMS and limited market?(2018)
- 8th annual report?- MUMS and limited market (2017)
- 7th annual report - MUMS and limited market (2016)
- 6th annual report - MUMS and limited market (2015)
- 5th annual report?- MUMS and limited market (2014)
- 4th annual report - MUMS and limited market (2013)
- 3rd annual report?- MUMS and limited market (2012)
- 2nd annual report?- MUMS and limited market (2010-2011)
EMA publishes a list of the CVMP classifications on MUMS /limited market and decisions on financial incentives, which is updated twice a year: