Update on the Ph. Eur. policy on elemental impurities – Monographs on substances for veterinary use only

Since 1 January 2021, new marketing authorisation applications for such products submitted in the European Union must comply with these requirements and all veterinary medicinal products will have to comply by January 2023. The European Pharmacopoeia is proposing to delete the cross-references to the test for Heavy Metals (HMs, general chapter 2.4.8) in the 16 monographs on substances “for veterinary use only”.
_{May 5, 2021}