Interpretation of Article 18(7) of Regulation (EU) 2019/6 - Scientific guideline

This reflection paper has been developed to provide guidance on when an environmental risk assessment can be requested by competent authorities in the frame of marketing authorisation applications for generic veterinary medicinal products.

Keywords: Generic veterinary medicinal product, environmental risk assessment, new veterinary regulation

Current version

Reflection paper on the interpretation of Article 18(7) of Regulation (EU) 2019/6

AdoptedReference Number: EMA/CVMP/ERA/622045/2020

Overview of comments received on the Reflection paper on the interpretation of Article 18(7) of Regulation (EU) 2019/6 (EMA/CVMP/ERA/622045/2020)

Reference Number: EMA/CVMP/ERA/768241/2021

Draft reflection paper on the interpretation of Article 18(7) of Regulation (EU) 2019/6

Consultation dates: 17/09/2021 to 17/12/2021Draft: consultation closedReference Number: EMA/CVMP/ERA/622045/2020Summary:

This reflection paper has been developed to provide guidance on when an environmental risk assessment can be requested by competent authorities in the frame of marketing authorisation applications for generic veterinary medicinal products.