Europe – Revision of CEPs referring to one of the “sartan” monographs following their rapid implementation

The European Pharmacopoeia Commission has revised via a rapid implementation procedure the five “sartan” monographs (ValsartanLosartan potassiumCandesartan cilexetilOlmesartan medoximil and Irbesartan); they will enter into force on 1 April 2021 to align them with the CHMP decision on the detection, management and prevention of the presence of N-nitrosamines in “sartan medicinal products” (see EMA news item of 13 November 2020).

Given the changes in these monographs, it is considered that the currently valid CEPs referring to these monographs are already in conformity with the requirements of the monographs and therefore remain valid (i.e. there is no need to demonstrate conformity to the monographs). CEP holders of these concerned substances will therefore not be contacted by the Certification Department, as is the usual procedure following the introduction of a revised monograph…