Risk management requirements for elemental impurities in veterinary medicinal products, including immunological veterinary medicinal products - Scientific guideline
Table of contents
Concept paper on a guideline on risk management requirements for elemental impurities in veterinary medicinal products, including immunological veterinary medicinal products.
Keywords: Elemental impurities, risk management, veterinary medicinal products, immunological veterinary medicinal products.
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Concept paper on a guideline on risk management requirements for elemental impurities in veterinary medicinal products, including immunological veterinary medicinal products (PDF/149.41 KB)
Draft: consultation closed
First published: 19/12/2022
Consultation dates: 19/12/2022 to 31/03/2023
EMA/CVMP/637041/2022 -
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Implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products - Revision 2 (PDF/144.97 KB)
Adopted
First published: 17/02/2020
Legal effective date: 17/02/2020
EMA/CVMP/QWP/631010/2017 Rev.2 -
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Reflection paper on risk management requirements for elemental impurities in veterinary medicinal products (PDF/146.24 KB)
Adopted
First published: 17/02/2020
Legal effective date: 01/01/2021
EMA/CVMP/QWP/153641/2018
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Implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products - Revision 2 (PDF/144.97 KB)
Adopted
First published: 17/02/2020
Legal effective date: 17/02/2020
EMA/CVMP/QWP/631010/2017 Rev.2 -
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Overview of comments received on Reflection paper on risk management requirements for elemental impurities in veterinary medicinal products (EMA/CVMP/QWP/153641/2018) (PDF/115.48 KB)
First published: 17/02/2020
EMA/CVMP/QWP/434956/2019 -
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Draft reflection paper on risk management requirements for elemental impurities in veterinary medicinal products (PDF/147.5 KB)
Draft: consultation closed
First published: 17/12/2018
Consultation dates: 17/12/2018 to 31/08/2019
EMA/CVMP/QWP/153641/2018
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Guideline on implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products - First version (PDF/89.1 KB)
Adopted
First published: 13/12/2017
Last updated: 13/12/2017
Legal effective date: 01/01/2018
EMA/CVMP/QWP/631010/2017 -
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Overview of comments received on 'Draft guideline on implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products - First version (PDF/167.04 KB)
First published: 13/12/2017
Last updated: 13/12/2017
EMA/CVMP/QWP/759110/2017 -
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Draft guideline on implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products - First version (PDF/88.9 KB)
Draft: consultation closed
First published: 16/10/2017
Last updated: 16/10/2017
Consultation dates: 16/10/2017 to 17/11/2017
EMA/CVMP/QWP/631010/2017