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

This guideline defines the acceptable data requirements for maximum residue limit (MRL) applications for pharmacologically active substances intended for use in minor species.

Paragraph I.8 of Annex I to Commission Regulation (EU) 2018/782 establishing the methodological principles for the risk assessment and risk management recommendations referred to in Regulation (EC) 470/2009 mentions the possibility of reduced data requirements for MRL applications for a substance for use in minor species. 

Minor species in context of MRLs are defined in Art 2 of Commission Regulation (EU) 2017/880 laying down rules on the use of a maximum residue limit established for a pharmacologically active substance in a particular foodstuff for another foodstuff derived from the same species and a maximum residue limit established for a pharmacologically active substance in one or more species for other species, in accordance with Regulation (EC) No 470/2009.

This guideline replaced the MRL sections of 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). 

This former guideline was addressing both MRL procedures and marketing authorisation procedures. However, the application of the Veterinary Medicines Regulation (Regulation (EU) 2019/6) on 28 January 2022 generated a difference of legal basis and terminology between MRL procedures and marketing authorisation procedures. 

Consequently, the former guideline was split into one guideline on safety and residue data requirements for the establishment of maximum residue limits in minor species, and one guideline on 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 (EMA/CVMP/345237/2020).

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

Current effective version

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

Adopted Reference Number: EMA/CVMP/345236/2020 Legal effective date: 01/10/2022

First version

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

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

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).

Overview of comments received on ‘Guideline on safety and residue data requirements for the establishment of Maximum Residue Limits in minor species’ (EMA/CVMP/345236/2020)

Reference Number: EMA/CVMP/148042/2021