Submitting a maximum residue limit application

The European Medicines Agency (EMA) makes available guidance on how to prepare and submit a maximum residue limits (MRLs) application.

The maximum residue limit (MRL) is the highest concentration of residue accepted by the European Union (EU) in a food product obtained from an animal that has received a veterinary medicine. 

Applicants need to submit an application to EMA for:

• establishing an MRL for a new pharmacologically active substance;
• extending an existing MRL to a new animal species.

EMA charges a fee for MRL applications.

It may grant a total or partial fee exemption for veterinary medicinal products classified as eligible for authorisation according to Article 23 of Regulation (EU) 2019/6, i.e. applications for limited markets.

For more information, see:

• Maximum residue limits (MRL)

Pre-submission guidance

Applicants must submit the MRL application at least 6 months before the marketing authorisation application.

At least 6 months before the intended submission of the MRL application, applicants need to notify EMA in writing of the following:

• Name of the substance
• Intended use (indication)
• Target species
• Intended target submission date

If the company has a valid micro, small and medium-sized enterprise (SME) status or a classification as eligible for authorisation according to Article 23 of Regulation (EU) 2019/6, they should include this information in the notification.

The data requirements and dossier structure are laid down in the Commission Implementing Regulation (EU) 2017/12.

For more information, see:

• Applying for SME status
• Commission Implementing Regulation (EU) 2017/12

How to get more guidance

Applicants can request the clarification on specific issues and / or a pre-submission meeting via Service Now. They can do so by selecting Veterinary Regulatory > Pre-Submission-Vet Requests. 

For pre-submission meetings, they should include details of the intended application, such as:

• substance and species;
• nature of the application, i.e. full application / extension / modification;
• preferred dates for pre-submission meeting;
• names and affiliation of participants;
• specific questions for discussion.

EMA provides more pre-submission guidance in the form of questions and answers.

Submission of the application

Applicants should use the MRL application form and consult the recommended submission dates for submitting an application.

Applicants need to submit their application through the eSubmission Gateway / Web Client portal.

For more information and guidance on registration with the system, see the Veterinary eSubmission website.

The submission procedure is defined in Article 8 of Regulation (EC) 470/2009 and further described in Commission Implementing Regulation (EU) 2017/12.

For information on the practical aspects of how to submit the application and its evaluation, see the standard operating procedure available below:

Application form for the establishment of maximum-residue-limits for an active substance to be used in veterinary medicinal products in accordance with Regulation (EC) No. 470/2009

Recommended submission dates for veterinary medicinal products

Adopted Reference Number: EMA/7507/2026

Standard operating procedure for evaluation procedure for applications and requests for the establishment or review of Maximum Residue Limits (MRLs)

Adopted Reference Number: SOP/V/4150 Legal effective date: 05/05/2017 Summary:

This SOP serves to describe the procedure for the establishment or review of maximum residue limits (MRLs) incl. re-examination, where applicable. It does not describe the processing of requests for inclusion of a substance in the so-called “out of scope” list.

Page update history

An update log is available to show the date and summary of changes to this webpage. It does not include updates to linked documents or minor edits like typos or broken link fixes.

The tracking of updates begins in April 2026.

See update history

8 April 2026

Page first published. Content transferred from the Maximum residue limits (MRL) page.