Interpretation of Article 72 of Regulation (EU) 2019/6 - Environmental safety documentation and environmental risk assessment of certain veterinary medicinal products - Scientific guideline
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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
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Overview of comments received on the "Reflection paper on the interpretation of Article 72 of Regulation (EU) 2019/6" (EMA/CVMP/ERA/245311/2021) (PDF/193.08 KB)
First published: 25/03/2022
EMA/CVMP/ERA/56761/2022 -
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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 (PDF/388.26 KB)
Draft: consultation closed
First published: 15/10/2021
Consultation dates: 15/10/2021 to 31/01/2022
EMA/CVMP/ERA/245311/2021