Introducing a review and update of existing EU guidelines on residues studies to bring these into line with the VICH metabolism and residues guidelines GL46 to 49 - Scientific guideline

This concept paper reflects the need for a guideline listing all guidelines relevant to residues studies and clarifying the issues to which each relate. It shall provide additional guidance for both applicants and assessors.

Keywords: Residues of veterinary drugs in human food

Current effective version

Concept paper introducing a review and update of existing European Union guidelines on residues studies to bring these into line with the International Cooperation on Harmonisation of Technical Requirements for Registrat...

Consultation dates: 15/02/2012 to 31/05/2012Draft: consultation closedReference Number: EMA/CVMP/SWP/878228/2011Summary:

Residues studies should be performed both for the establishment of maximum residue limits and for the determination of withdrawal periods, and a number of guidance documents relating to the need for, and performance of, residues studies have been published at a European level.