Interpretation of Article 18(7) of Regulation (EU) 2019/6 - Scientific guideline
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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
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Reflection paper on the interpretation of Article 18(7) of Regulation (EU) 2019/6 (PDF/321.86 KB)
Adopted
First published: 25/02/2022
EMA/CVMP/ERA/622045/2020 -
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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) (PDF/289.13 KB)
First published: 25/02/2022
EMA/CVMP/ERA/768241/2021 -
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Draft reflection paper on the interpretation of Article 18(7) of Regulation (EU) 2019/6 (PDF/331.89 KB)
Draft: consultation closed
First published: 17/09/2021
Consultation dates: 17/09/2021 to 17/12/2021
EMA/CVMP/ERA/622045/2020