EDQM: Supplement 11.8 to the European Pharmacopoeia available

The Supplement 11.8 to the European Pharmacopoeia (Ph.Eur.) is now available. All CEP holders (Certificate of Suitability of Monographs of the European Pharmacopoeia - holder) are required to adapt their specifications and thus the respective CEPs to comply with the new monographs by July 01, 2025.

All substances that are subject to the implementation of the amended or updated monographs are listed in a table. Along with the names of the substances, the classifications (Case A or Case B) are also included. A distinction is made as follows:

Case A

The specifications of the substances belonging to this classification must be revised.

If the relevant specification does not contain the addition "current version of the monograph", notification of the new specification is required with the next application for a CEP update. If this passage is included, the monograph can be implemented without submission with the next amendment of the CEP.

Case B

Monographs belonging to this category must always be reported to the EDQM.

The updated dossier, which shows that the new data of the revised monographs have been implemented, must be submitted within 3 months. CEP holders are obliged to update modules 1 and 3 and to provide corresponding explanatory information. After receiving the new data, the EDQM will review it and then inform the CEP holder of the results of this assessment. A reissuing of the CEP is not ruled out.

The list of categorized substances and further information on supplement 11.8 to the European Pharmacopoeia (Ph.Eur.) can be viewed on the EDQM website.