Minor uses / minor species and limited markets

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The European Medicines Agency (EMA) has developed 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.

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. 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 June 2013 to restrict the fee incentives to products indicated for food-producing species only. 

The annual reports on the functioning of the policy and its uptake by applicants can be found below: 

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.

Requesting MUMS classification

Guidance in the form of a question and answer document is available for applicants seeking to access incentives for MUMS/limited market products:

Applicants need to submit their request for classification to the Committee for Medicinal Products for Veterinary Use (CVMP) using the following submission form:

The CVMP will assess the application in line with the following guidance and classify the product (species/indication):

Below is a list of the CVMP classifications on MUMS and financial incentives:

Development guidelines for MUMS

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:

 

 

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