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

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.

Current version

Concept paper on a guideline on risk management requirements for elemental impurities in veterinary medicinal products, including immunological veterinary medicinal products

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

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

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

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

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

Revision 3

Concept paper on a guideline on risk management requirements for elemental impurities in veterinary medicinal products, including immunological veterinary medicinal products

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

Revision 2

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

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

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

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

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

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

First version

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

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

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/759110/2017Summary:

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

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

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.