Safety and residue data requirements for the establishment of maximum residue limits in minor species - Scientific guideline

This draft guideline defines the acceptable data requirements for maximum residue limit (MRL) applications for pharmacologically active substances intended for use in minor species that will apply under the Veterinary Medicines Regulation (Regulation (EU) 2019/6).

The Regulation became applicable on 28 January 2022.

This guideline will replace the Guideline on safety and residue data requirements for veterinary medicinal products intended for minor uses or minor species/ limited market (EMEA/CVMP/SWP/66781/2005-Rev.2).

Keywords: maximum residue limits, minor species, safety data, residue data, veterinary medicinal products

Draft guideline

Draft guideline on safety and residue data requirements for the establishment of Maximum Residue Limits in minor species

Consultation dates: 25/02/2021 to 15/05/2021Draft: consultation closedReference Number: EMA/CVMP/345236/2020Summary:

This draft guideline defines the acceptable data requirements for maximum residue limit (MRL) applications for pharmacologically active substances intended for use in minor species that will apply under the Veterinary Medicines Regulation (Regulation (EU) 2019/6).

The Regulation becomes applicable on 28 January 2022.

This guideline will replace the Guideline on safety and residue data requirements for veterinary medicinal products intended for minor uses or minor species/ limited market (EMEA/CVMP/SWP/66781/2005-Rev.2).