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.
- Revised policy for classification and incentives for veterinary medicinal products indicated for minor use minor species (MUMS)/limited market
- European Medicines Agency amends minor-use-minor-species / limited-market policy
- Position paper regarding availability of products for minor uses and minor species (MUMS) published in 2004 was the precursor to the policy for classification and incentives for veterinary medicines indicated for MUMS/limited market.
The annual reports on the functioning of the policy and its uptake by applicants can be found below:
- 7th annual report veterinary – Minor uses / minor species and limited market (2016)
- 6th annual report veterinary - Minor uses / minor species and limited market (2015)
- 5th annual report veterinary - Minor uses / minor species and limited market (2014)
- 4th annual report veterinary - Minor uses / minor species and limited market (2013)
- 3rd annual report veterinary - Minor uses / minor species and limited market
- 2nd annual report veterinary - Minor uses / minor species and 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.
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:
- Request to the CVMP to classify a veterinary medicinal product as minor use minor species (MUMS)/intended for use in a limited market.
The CVMP will assess the application in line with the following guidance and classify the product (species/indication):
- Guidance on the classification of veterinary medicinal products indicated for minor use minor species (MUMS) / limited market
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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