EDQM: Supplement 11.2 of the European Pharmacopoeia available

Recommendation

23-25 April 2024
Barcelona, Spain

Global Registration and Life Cycle Management for APIs

Supplement 11.2 of the European Pharmacopoeia (Ph.Eur.) is now available. This supplemental edition lists several updated monographs that will be implemented on 01 July 2023. All CEP holders (Certificate of Suitability of Monographs of the European Pharmacopoeia holders) are encouraged to align their specifications and thus the respective CEPs to the new monographs.

As we already informed about with the publication of version 11 of the European Pharmacopoeia, this may result in the need to update the corresponding dossier and report it to the EDQM (European Directorate for the Quality of Medicines & HealthCare).

For this purpose, the revisions of the monographs were 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 must be revised. If the respective specification does not include the phrase "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 may be implemented without submission with the next CEP amendment.

Case B

Monographs that fall into this category require notification to EDQM in all cases. The updated dossier showing that the new data of the revised monographs have been adopted must be submitted within 3 months. CEP holders are encouraged to update Module 1 and 3 and provide explanatory information accordingly. Upon receipt of the new data, EDQM will review it within 3 months and then inform the CEP holder of the results of this review. This does not preclude reissuance of the CEP.

The list of categorized monographs and further information on the European Pharmacopoeia (Ph.Eur.) Supplement 11.2 can be found on the EDQM website.