Guideline on the evaluation of the benefit-risk balance of veterinary medicinal products

This guideline was developed to facilitate the methodology for benefit-risk evaluations of the different pre-and post-authorisation applications of veterinary medicinal products, to provide a systematic approach, hence improving the consistency and transparency of decisions taken at CVMP level. In light of the implementation of Regulation (EU) 2019/6 and experience gained over the years, the CVMP has revised the guideline.

Keywords: benefit-risk, risk assessment, benefit

Current version - revision 1

Guideline on the evaluation of the benefit-risk balance of veterinary medicinal products

Consultation dates: 15/12/2023 to 30/06/2024 Reference Number: EMA/CVMP/248499/2007 – Rev.1

Document history

Overview of comments received on Guideline on the evaluation of the benefit-risk balance of veterinary medicinal products (EMA/CVMP/307496/2024 – Rev.1)

Reference Number: EMA/CVMP/307496/2024

Concept paper on the revision of the CVMP Recommendation on the evaluation of the benefit-risk balance of veterinary medicinal products (EMEA/CVMP/248499/2007)

Draft: consultation closed Consultation dates: 12/11/2021 to 28/02/2022 Reference Number: EMA/CVMP/299406/2021

Recommendation on the evaluation of the benefit-risk balance of veterinary medicinal products

Adopted Reference Number: EMEA/CVMP/248499/2007 Legal effective date: 01/11/2009

Overview of comments received on the draft recommendation on the evaluation of the benefit-risk balance of veterinary medicinal products

Reference Number: EMEA/CVMP/66531/2009