New EMA Guidance: Risk Management for Elemental Impurities in Veterinary Medicinal Products

On 20 February 2026, the European Medicines Agency (EMA) published two key documents outlining the risk management of elemental impurities in veterinary medicinal products. The new requirements will come into effect on 1 September 2026.

Implementation of submission of risk assessments to control elemental impurities required by the European Pharmacopeia in immunological veterinary medicinal products

This document introduces a phased plan for submitting risk assessments regarding elemental impurities in immunological veterinary medicinal products (VMPs), detailing the relevant timelines and obligations for both new and existing products. These requirements are set out in European Pharmacopoeia General Monograph 2619.

Guideline on risk management requirements for elemental impurities in veterinary medicinal products

The Guideline details on how marketing authorization holders and applicants should conduct and document risk management for elemental impurities in veterinary medicinal products intended for approval or already approved within the European Union. The purpose of the guideline is to ensure alignment with the requirements of the European Pharmacopoeia (Ph. Eur.) General Monograph 2619 for Pharmaceutical Preparations.

This guideline replaces the following previous EMA documents: 

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