Interpretation of Article 72 of Regulation (EU) 2019/6 - Environmental safety documentation and environmental risk assessment of certain veterinary medicinal products - Scientific guideline

This reflection paper has been developed to aid the procedure for the harmonisation of the summary of product characteristics (SPC) according to Articles 69-71 of Regulation (EU) 2019/6 with regards to environmental risk assessment.

Keywords: Environmental risk assessment, generic veterinary medicinal product, SPC harmonisation

Current version

Adopted reflection paper on the interpretation of Article 72 of Regulation (EU) 2019/6 - Environmental safety documentation and environmental risk assessment of certain veterinary medicinal products

AdoptedReference Number: EMA/CVMP/ERA/245311/2021

Document history

Overview of comments received on the "Reflection paper on the interpretation of Article 72 of Regulation (EU) 2019/6" (EMA/CVMP/ERA/245311/2021)

Reference Number: EMA/CVMP/ERA/56761/2022

Draft reflection paper on the interpretation of Article 72 of Regulation (EU) 2019/6 - Environmental safety documentation and environmental risk assessment of certain veterinary medicinal products

Consultation dates: 15/10/2021 to 31/01/2022Draft: consultation closedReference Number: EMA/CVMP/ERA/245311/2021