Requesting a minor use / minor species (MUMS) / limited market classification
The European Medicines Agency (EMA) provides guidance to applicants requesting minor use / minor species (MUMS) / limited market classifications.
EMA's Committee for Medicinal products for Veterinary Use (CVMP) is responsible for evaluating requests for MUMS / limited market classifications.
Any medicine can receive MUMS / limited market classification irrespective of the intended authorisation route.
For general information on EMA's MUMS / limited market policy, see Minor use / minor species and limited markets.
MUMS / limited market classification according to EMA's MUMS / limited market policy will cease to apply once the Veterinary Medicines Regulation (Regulation (EU) 2019/6) becomes applicable on 28 January 2022, as the Regulation contains new legal provisions on veterinary medicines intended for limited markets.
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 aims to provide guidance on the new legal and procedural framework in 2021 to help potential applicants and holders of MUMS / limited market classifications decide on any actions to take.
Applicants can provide further supportive evidence.
EMA can advise applicants on what information to provide in the request in writing or as part of a pre-submission meeting. To request pre-submission advice, applicants should write to email@example.com.
Questions and answers
The CVMP assesses requests and classifies products in line with the following guidance:
- Guidance on the classification of veterinary medicinal products indicated for minor use minor species (MUMS) / limited market
- target species (major or minor);
- prevalence of the condition in the EU including geographical distribution (minor use);
- potential market size and return on investment (limited market);
- use in food-producing animals (financial incentives);
- current or alternative therapies available.
In straightforward cases, the CVMP classifies the product during its plenary meeting.
In complex cases, the CVMP may appoint one of it members to examine the request in depth and to provide a recommendation to the committee. In such cases, the applicant may need to supply further information. The CVMP usually reaches a decision within one month of the initial plenary meeting but it may take longer if the applicant needs to supply further information.
Applicants may ask for a re-examination of a decision on classification in writing within 60 days of receipt of the notification letter.
The timetable for a re-examination is similar to that of an initial request.
If the transfer only affects the sponsor / owner of the classification, the current owner of the classification should inform EMA in writing to firstname.lastname@example.org, including:
- the MUMS outcome letter document reference number;
- confirmation that the sponsor/applicant (owner) is the only aspect or characteristic of the product that changes as a result of the transfer.
If any other aspect or characteristic of the product changes, the current owner should contact EMA to clarify whether the current classification still applies to the product and if any further action is required.
Before requesting a re-classification, classification owners should consider whether:
- there is an ongoing need for the classification;
- there have been any changes to the data in the original application.
Applicants should include in the re-classification request:
- any changes in the epidemiological / disease / disorder status relevant to the product indication;
- whether or not alternative products have been authorised for the condition concerned since the date of last classification;
- a report on sales volume data / number of treated animals as reported in periodic safety update reports for authorised products or a report on a current state of development of the product (i.e. what studies have been done).
Re-classifications for minor species without financial incentives benefit from a simplified procedure and require only a confirmation of an ongoing need for the classification.
EMA advises applicants to submit re-classification requests well in advance of the expiry of the classification.
Questions and answers
EMA does not charge a fee for evaluating a request for a MUMS / limited market classification or any related advice it provides.
Certain MUMS / limited market products may also benefit from fee incentives for other EMA procedures.