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. 

Updated 14 November 2025:
'Criteria and conditions', 'Scientific guidelines', 'Requesting a limited market classification eligibility for Article 23', 'Fees and fee reductions' sections

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 the Regulation).

More information:

• Questions and answers on classification of a product as intended for a limited market according to Article 4(29) and/or eligibility for authorisation according to Article 23 (Applications for limited markets)

This Q&A provides guidance on the above-mentioned key criteria and addresses aspects not covered by the European Commission Notice: Guidance to Applicants - Veterinary Medicinal Products (Corrigendum, C/2024/90009).

The document also replaces the reflection paper on classification of a product as intended for a limited market according to Article 4(29) and/or eligibility for authorisation according to Article 23 (EMA/CVMP/235292/2020).

Scientific guidelines

Products intended for limited markets according to Art 4(29) and eligible for authorisation under Art 23 of Regulation (EU) 2019/6

Applicants for limited market authorisations under Article 23 of the Veterinary Medicinal Products Regulation benefit from reduced data requirements.

Final guidance is available in the following areas:

• Safety and residue data requirements for applications for non-immunological veterinary medicinal products intended for limited markets submitted under Article 23 of Regulation (EU) 2019/6 - Scientific guideline
• Data requirements for applications for immunological veterinary medicinal products intended for limited markets submitted under Article 23 of Regulation (EU) 2019/6 - Scientific guideline
• Efficacy and target animal safety data requirements for applications for non-immunological veterinary medicinal products intended for limited markets submitted under Article 23 of the Regulation (EU) 2019/6

EMA's CVMP agreed the final guidelines following a public consultation. 

Products intended for limited markets according to Art 4(29), but not eligible for authorisation under Art 23 of Regulation (EU) 2019/6

Guidance is available in the following areas:

• Safety and efficacy data requirements for applications for immunological VMPs intended for limited markets but not eligible for authorisation under Art 23 of Reg (EU) 2019-6 - Scientific guideline
• Safety and residue data requirements for applications for non-immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6 - Scientific guideline
• Efficacy and target animal safety data requirements for applications for non-immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6 - Scientific guideline

Quality data requirements for products intended for limited markets according to Art 4(29)

Guidance is available in the following areas:

• Quality data requirements for applications for biological veterinary medicinal products intended for limited markets - Scientific guideline
• Quality data requirements for applications for veterinary medicinal products other than biologicals intended for limited markets - Scientific guideline

Requesting a limited market classification / eligibility for Article 23

Before submitting an application for a limited market authorisation, it is advisable to request that the CVMP confirm a product meets the 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;
• check that the product is eligible for a marketing authorisation for a limited market (in accordance with Art 23).

It should be noted that such classification would be provisional and valid as of the date of the decision. If the circumstances, taken into account at the time of the classification, change at any time before the MA is granted (e.g. alternative veterinary medicinal products for the same species and indication for use receive marketing authorisation through a comprehensive dossier) the product may no longer be considered eligible for authorisation according to Article 23. It will be the responsibility of the applicant to monitor the situation and to justify the eligibility for Article 23 at the time of marketing authorisation application and during the authorisation procedure.

Applicants should submit their request via Eudralink to [e-mail] using the following form:

Request to the CVMP for classification of a veterinary medicinal product as intended for a limited market according to Article 4(29) and for eligibility for authorisation according to Article 23 (Applications for limited markets)

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.

EMA can advise applicants on what information to provide in the request either in writing or via a virtual meeting, if necessary. For more information, or in case of any questions, applicants can contact [e-mail] 

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

Fees and fee reductions

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

Applicants 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 [e-mail].

For more information, please visit:

• How to pay

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

•  Fees payable to the European Medicines Agency.

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.