Former EMA policy on minor use / minor species  (MUMS) / limited markets

Between 2011 and 2022, the European Medicines Agency (EMA) had a policy on minor use / minor species  (MUMS) / limited markets, to support the availability of veterinary medicines for the treatment of minor animal species and uncommon diseases in major animal species.

The limited market provisions of the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) superseded EMA's former MUMS / limited market policy on 28 January 2022. For more information and guidance on the current framework, see Veterinary limited markets.

The former MUMS / limited market policy is available below: 

Revised policy for classification and incentives for veterinary medicinal products indicated for minor use minor species (MUMS) / limited market

AdoptedLegal effective date: 18/12/2014Reference Number: EMA/308411/2014

Also on this topic

• Classifications as minor-use-minor-species and limited-market according to former EMA policy

Superseded scientific guidelines

Applicants for medicines classified as MUMS / limited market under EMA's MUMS / limited market policy benefited from reduced data requirements for marketing authorisation in the following areas, for which superseded scientific guidelines are available:

• Quality
• Safety and residues
• Efficacy
• Immunologicals

Annual reports

EMA published annual reports on the activities carried out under its MUMS / limited market policy. These include requests for MUMS / limited market classification, incentives provided and support to applicants in determining data requirements.

Minor uses and minor species (MUMS)/limited market scheme for veterinary medicinal products - 12th annual report

AdoptedReference Number: EMA/573681/2021

Minor use or minor species (MUMS)/limited market scheme for veterinary medicinal products - 11th annual report (2020)

AdoptedReference Number: EMA/553359/2020

10-year annual report on MUMS/limited market scheme for veterinary medicines

Minor use or minor species (MUMS)/limited market scheme for veterinary medicinal products - 9th annual report (2018)

Reference Number: EMA/713390/2018

Minor use or minor species (MUMS)/limited market scheme for veterinary medicinal products - 8th annual report (2017)

AdoptedReference Number: EMA/795802/2017

Minor use or minor species (MUMS)/limited market scheme for veterinary medicinal products - 7th annual report (2016)

AdoptedReference Number: EMA/868034/2016

Minor use or minor species (MUMS)/limited market scheme for veterinary medicinal products - 6th annual report (2015)

Reference Number: EMA/57157/2016Summary:

2015 annual report on EudraVigilance for the European Parliament, the Council and the Commission Reporting period: 1 January to 31 December 2015

Minor use or minor species (MUMS)/limited market scheme for veterinary medicinal products - 5th annual report (2014)

Reference Number: EMA/47723/2015Summary:

The European Medicines Agency (the Agency) implemented the Policy for Classification and Incentives for Veterinary Medicinal Products indicated for Minor Use Minor Species (MUMS)/limited market on 1 September 2009 and updated it in July 2013 and in December 2014 following a review process.

Minor use or minor species (MUMS)/limited market scheme for veterinary medicinal products - 4th annual report (2013)

AdoptedReference Number: EMA/14945/2014Summary:

Fourth annual report veterinary - Minor uses / minor species and limited market

Minor use or minor species (MUMS)/limited market scheme for veterinary medicinal products - 3rd annual report (2012)

Reference Number: EMA/MB/114227/2013

Minor uses and minor species (MUMS)/limited market scheme for veterinary medicinal products - 2nd annual report (2010-2011)

AdoptedReference Number: EMA/680110/2011Summary:

This second annual report covers the activities from 1 September 2010 - 31 August 2011 where 26 separate requests were classified by the CVMP under this policy. This is a 30% increase on the 20 requests classified in the last year.