Veterinary limited markets

The Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) introduced a specific authorisation route for medicines intended for veterinary limited markets in the European Union (EU) when it became applicable on 28 January 2022. 

The Regulation aims to further stimulate the development of veterinary medicines for small markets, in order to increase the availability of treatments for serious or life-threatening animal diseases and unmet veterinary medical needs.

It enables EMA's Committee for Veterinary Medicinal Products (CVMP) to recommend granting a marketing authorisation for such medicines based on less comprehensive data than normally required, where the benefit for animal or public health  of placing the medicine on the market is greater than the risk of having less data on the medicine.

The benefits for applicants comprise reduced data requirements and enhanced regulatory assistance. 

Criteria and conditions

For a medicine to be eligible for a limited market authorisation and benefit from reduced data requirements, it must meet the following two criteria:

  • it must be intended for a limited market (Art 4(29) of the Regulation). In this context, this means one of the following:
    • it is intended for the treatment or prevention of diseases that occur infrequently or in limited geographical areas; 
    • it is intended for animal species other than cattle, sheep for meat production, pigs, chickens, dogs and cats.
  • the benefit of its availability on the market to animal or public health is greater than the risk inherent in the fact that less than usual data is provided (Art 23 of Regulation).

Limited market authorisations are valid for five years and are renewable every five years thereafter.

EMA will provide further guidance on flexibility on data requirements for applicants whose product only meets the criterion on being intended for a limited market. 

More information:

Guidance on reduced data requirements

Requesting a limited market classification / confirmation of eligibility

Before submitting an application for a limited market authorisation, it is advisable to request that the CVMP confirm a product meets the above eligibility criteria.  

The CVMP will:

  • classify the product as intended for a limited market (in accordance with Art 4(29)) – known as a limited market classification;
  • confirm that the product is eligible for a marketing authorisation for a limited market (in accordance with Art 23) – known as a confirmation of eligibility.

A CVMP limited market classification and confirmation of eligibility is valid for five years. Applicants can request a renewal by submitting the necessary supporting evidence every five years thereafter.

Applicants should submit their request via Eudralink to using the following form:

Applicants should submit their request at least 30 calendar days prior to the CVMP meeting when they wish their request to be considered. For more information on CVMP meeting dates, see CVMP Meetings.

Applicants can provide further supporting 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

Applicants and marketing authorisation holders being levied a fee by EMA for the first time should contact EMA's accounts team to request a customer account number.

EMA publishes a summary table of the CVMP's classifications and confirmations of eligibility on this website:

Fees and fee reductions

Applicants and marketing authorisation holders being levied a fee by EMA for the first time should contact EMA's accounts team to request a customer account number.

Applicants and marketing authorisation holders requiring a purchase order number or similar references on their invoice are encouraged to issue a standing (blanket) purchase order covering all marketing authorisation and/or pharmacovigilance fees levied by the Agency for a given period, and to provide such reference to the Agency’s accounts receivable service at

For more information, please visit:

Information on the fees EMA charges for limited market applications is available on:

EMA encourages eligible applicants to obtain an SME status, in order to benefit from financial and administrative assistance for SMEs. For more information, see Supporting SMEs.


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