Maximum Residue Limits Q&A: Introduction

This section on pre-submission guidance addresses a number of questions which prospective users of the MRL application procedures may have. It provides an overview of the European Medicines Agency position on issues which are typically encountered during the pre-submission phase.

If an applicant intends to submit an MRL application and needs to obtain information on a certain topic, they can consult the Questions and Answer section. Clicking on the question will direct the user to the answer. We trust that the information linked to the question will answer most queries.

However, since each application is unique, the Agency is available for assistance and clarification of any additional questions in writing or in a pre-submission meeting. If you would like to arrange a pre-submission meeting, please send an e-mail, fax or letter to the Agency, using the contact details below.

In your request, you should indicate details of the intended application, such as:

  • substance
  • species
  • full application / extension / modification / extrapolation
  • preferred dates for pre-submission meeting
  • names and affiliation of participants
    as well as any specific questions you would like to address.

For queries in the pre-submission phase, or to arrange a pre-submission meeting with the Agency, please contact:

Isaura Duarte
Head of Animal and Public Health
Phone: +44 (0)20 74 18 84 57
Fax: +44 (0)20 74 18 84 47
vet.applications@ema.europa.eu

Please note:

The procedure for the establishment of MRLs is laid down in Regulation (EC) No 470/2009.

Detailed guidance on the establishment of MRLs is available in Volume 8 of "The rules governing medicinal products in the European Union”: Maximum residue limits guidelines (MRL).

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