Europe – Implementation of the European Pharmacopoeia Supplement 10.7 – Notification for CEP holders

Supplement 10.7 of the European Pharmacopoeia (Ph. Eur.) is now available. Holders of Certificates of suitability to the monographs of the Ph. Eur. (CEPs) are invited to update their applications according to the revised monographs that will be implemented on 1 April 2022, and to follow the instructions given below.

The table at the end of this announcement provides a list of substances covered by a CEP and for which a revised monograph will be implemented on 1 April 2022 in Supplement 10.7 of the Ph. Eur.

According to Directives 2001/83/EC and 2001/82/EC, as amended, it is the responsibility of the manufacturer to comply with the current version of a Ph. Eur. monograph, and therefore to update the specification when a revised monograph is issued. In addition, the European Directorate for the Quality of Medicines and HealthCare (EDQM) ensures that CEPs refer to the most recent version of a Ph. Eur. monograph at any time…