The European Pharmacopoeia (Ph. Eur.) general monograph Pharmaceutical preparations (2619) requires manufacturers of products outside the scope of general chapter 5.20 to control the levels of elemental impurities in products using the principles of risk management. As of 1 January 2021, this applies to veterinary medicinal products, and new marketing authorisation applications submitted in the European Union for veterinary medicinal products must comply with specific risk assessment requirements for the control of elemental impurities.
In this context, to provide suitable information on elemental impurities to manufacturers of veterinary medicinal products via Certificates of Suitability to the Monographs of the Ph. Eur. (CEPs), the European Directorate for the Quality of Medicines & HealthCare (EDQM) is asking CEP holders for substances for veterinary use only to submit risk assessments and to propose suitable controls for elemental impurities using the principles of risk management as part of their CEP applications. This concerns new CEP applications, CEP renewals and requests for revision where changes related to elemental impurities are introduced into the manufacturing process for substances for veterinary use only, which are submitted to the EDQM as of 1 February 2021.
The EDQM policy on elemental impurities will be revised shortly to reflect this situation and to introduce further clarifications.