EDQM: European Pharmacopoeia Version 11 published

Recommendation

23-25 April 2024
Barcelona, Spain

Global Registration and Life Cycle Management for APIs

The 11th version of the European Pharmacopoeia (Ph.Eur.) is now available. The latest edition comprises some updated monographs which will be implemented on 01 January 2023. All CEP holders (Certificate of Suitability of Monographs of the European Pharmacopoeia - holders) are required to align their specifications and thus the respective CEPs with the new monographs. This may result in the associated dossier having to be updated and reported to the EDQM (European Directorate for the Quality of Medicines & HealthCare). For this purpose, the revisions of the monographs have been divided into two categories and presented in a list available on the EDQM website.

Case A

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

If the respective specification does not include the addition "current version of the monograph", notification of the new specification is required with the next CEP update request.
If this passage is included, the monograph can be implemented without updating the specification.

Case B

Monographs belonging to this category require notification to the EDQM in any case.
The updated dossier showing that the new data of the revised monographs have been adopted must be submitted within three months. CEP holders are encouraged to update Module 1 and 3 and provide explanatory information accordingly. After receipt of the new data, the EDQM will check it within three months and then inform the CEP holder of the results of this evaluation. Revision of CEPs is not excluded.

Please see the list of categorised monographs and further information on the 11th version of the European Pharmacopoeia (Ph.Eur.) on the EDQM website.