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

VeterinaryScientific guidelines

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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

Current version

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

Adopted Reference Number: EMA/CVMP/ERA/622045/2020

English (EN) (321.86 KB - PDF)

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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)

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

English (EN) (289.13 KB - PDF)

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

Draft: consultation closed Consultation dates: to Reference Number: EMA/CVMP/ERA/622045/2020 Summary:

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.

English (EN) (331.89 KB - PDF)

Publicado pela primeira vez:
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