The European Directorate for the Quality of Medicines (EDQM) has explained the implications of new sartan monographs for the holders of a currently valid Certification of Suitability (CEP).
Last month, EDQM said monographs for five sartan medicines, which were rapidly revised considering the risk of contamination with N-nitrosamines, will take effect 1 April. However, EDQM’s February update lacked details of how the revised monographs will affect suppliers of valsartan, losartan potassium, irbesartan, candesartan cilexetil and olmesartan medoxomil.
EDQM shared more information this week, stating that “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.”
While there is no need for CEP holders to demonstrate conformity to the monographs, EDQM said they may choose to revise their control strategies for nitrosamine impurities in light of the updated information. CEP holders that change their strategies should request a minor revision....[EDQM]