Minor uses / minor species and limited markets

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This page includes information on the European Medicines Agency's minor-use-minor-species (MUMS) / limited-market policy.

This policy is intended to assist applicants with submitting applications for products for limited markets, to stimulate development of new veterinary medicines for minor species and for rare diseases in major species which would otherwise not be developed in the current market conditions.

The policy was first introduced in October 2010 and has been successful in terms of increasing interest from the animal-health industry in submitting applications for MUMS products.

In June 2013, the Agency revised the policy, so that only products indicated for food-producing species will be eligible for fee incentives in the future.

Scientific guidance documents on this topic can be found in the relevant section under scientific guidance.

Table of contents


General

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Document(s) Language Status First published Last updated Effective Date
Concept paper for the revision of the guidelines on data requirements for veterinary medicinal products for minor use minor species (English only) draft: consultation open 18/11/2014    
Revised policy for classification and incentives for veterinary medicinal products indicated for minor use minor species (MUMS) / limited market (English only) adopted 16/09/2014 13/01/2015 18/12/2014
Guidance on the classification of veterinary medicinal products indicated for minor use minor species (MUMS) / limited market (English only) adopted 22/12/2014    
Draft guidance on the classification of veterinary medicinal products indicated for minor use minor species (MUMS) / limited market (English only) draft: consultation closed 16/09/2014    
European Medicines Agency amends minor-use-minor-species / limited-market policy (English only) adopted 18/06/2013    
Template of the request to the CVMP to classify a veterinary medicinal product as minor use minor species (MUMS) / intended for use in a limited market (English only)   30/10/2013 12/11/2015  
European Medicines Agency guidance for companies requesting classification as minor uses minor species / limited markets (English only) adopted 01/07/2009 16/04/2014 01/07/2009
Position paper regarding availability of products for minor uses and minor species (MUMS) (English only) adopted 14/07/2004   14/07/2004
Position paper regarding availability of veterinary medicinal products - extrapolation of maximum residue limits (English only) adopted 10/12/2003   10/12/2003
Update of the position paper on availability of veterinary medicines agreed on 21 June 2000 (English only) adopted 21/06/2000   21/06/2000
Update of the position paper on availability of veterinary medicines agreed on 9 February 2000 (English only) adopted 09/02/2000   09/02/2000
Update of the position paper on availability of veterinary medicines agreed on 14 October 1999 (English only) adopted 14/10/1999   14/10/1999
Position paper on availability of veterinary medicines agreed on 17 March 1999 (English only) adopted 17/03/1999   17/03/1999
Availability of medicines (English only)   20/01/1999   20/01/1999

European Task Force on Availability

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