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

Revision of the European Pharmacopoeia General Monograph 2619 for Pharmaceutical Products which comes into effect in January 2018, requires manufacturers of products outside the scope of the General Chapter 5.20 to control the levels of elemental impurities in the products using the principles of risk management.

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.

*In view of the temporary suspension of guideline work from 1 November 2018, as part of the Agency’s business continuity plan, the deadline for implementation of risk assessment requirements has been extended to allow the preparation of adequate guidance.

Keywords: elemental impurities, risk assessment, European Pharmacopoeia

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