Risk management requirements for elemental impurities in veterinary medicinal products, including immunological veterinary medicinal products - Scientific guideline

This guideline provides recommendations on how the risk management may be conducted for elemental impurities for veterinary medicinal products (VMPs) authorised or to be authorised in the European Union in order to comply with the requirement of the European Pharmacopeia (Ph.Eur.) General Monograph 2619 for Pharmaceutical Preparations. It also provides information on the documentation expected to be included in the dossier in order to address this requirement.

Keywords: Elemental impurities, risk management, veterinary medicinal products, novel therapy products

Current version (under revision, see below)

Reflection paper on risk management requirements for elemental impurities in veterinary medicinal products

Adopted Reference Number: EMA/CVMP/QWP/153641/2018 Legal effective date: 01/01/2021

Revision 3

Draft guideline on risk management requirements for elemental impurities in veterinary medicinal products - Revision 3

Draft: consultation closed Consultation dates: 01/10/2024 to 31/01/2025 Reference Number: EMA/CVMP/426245/2023 Summary:

This guideline replaces the Reflection paper on risk management requirements for elemental impurities in veterinary medicinal products, EMA/CVMP/QWP/153641/2018 and the Implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products, EMA/CVMP/QWP/631010/2017-Rev.2.

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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

Draft: consultation closed Consultation dates: 19/12/2022 to 31/03/2023 Reference Number: EMA/CVMP/637041/2022

Revision 2

Implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products - Revision 2

Adopted Reference Number: EMA/CVMP/QWP/631010/2017 Rev.2 Legal effective date: 17/02/2020

Reflection paper on risk management requirements for elemental impurities in veterinary medicinal products

Adopted Reference Number: EMA/CVMP/QWP/153641/2018 Legal effective date: 01/01/2021

Overview of comments received on Reflection paper on risk management requirements for elemental impurities in veterinary medicinal products (EMA/CVMP/QWP/153641/2018)

Reference Number: EMA/CVMP/QWP/434956/2019

Draft reflection paper on risk management requirements for elemental impurities in veterinary medicinal products

Draft: consultation closed Consultation dates: 17/12/2018 to 31/08/2019 Reference Number: EMA/CVMP/QWP/153641/2018 Summary:

As no guidance is currently available for marketing authorisation holders, active substance, medicinal product and excipient manufacturers for veterinary medicinal products, the purpose of this reflection paper is to provide information on how such risk management may be conducted for elemental impurities in products authorised or to be authorised in the European Union. It also highlights the expectations of regulators regarding the data to be submitted in the product dossier for those risk managements/assessments. In accordance with European Pharmacopoeia General Monograph 2619, the responsibility for the conduct of the risk management rests with the medicinal product manufacturer.

Revision 1

Implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products - Revision 1

Adopted Reference Number: EMA/CVMP/QWP/631010/2017 Rev.1 Legal effective date: 27/11/2018

First version

Guideline on implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products - First version

Adopted Reference Number: EMA/CVMP/QWP/631010/2017 Legal effective date: 01/01/2018 Summary:

In order to allow time for regulators to elaborate guidance on the appropriate approach for a risk assessment for a veterinary medicinal product, the CVMP has adopted the following measured approach to the implementation of the monograph to existing veterinary products. The phased-in implementation of the risk assessment of elemental impurities in veterinary medicinal products is to be in accordance with the decision tree indicated in this document.

Overview of comments received on 'Draft guideline on implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products - First version

Reference Number: EMA/CVMP/QWP/759110/2017 Summary:

Overview of comments received on 'draft guideline on implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products’ (EMA/CVMP/QWP/631010/2017)

Draft guideline on implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products - First version

Draft: consultation closed Consultation dates: 16/10/2017 to 17/11/2017 Reference Number: EMA/CVMP/QWP/631010/2017 Summary:

In order to allow time for regulators to elaborate guidance on the appropriate approach for a risk assessment for a veterinary medicinal product, the CVMP has adopted the following measured approach to the implementation of the monograph to existing veterinary products. The phased-in implementation of the risk assessment of elemental impurities in veterinary medicinal products is to be in accordance with the decision tree indicated in this document.