EDQM: Addendum 11.5 to the European Pharmacopoeia available

Recommendation

17/18 September 2024

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Supplement 11.5 to the European Pharmacopoeia (Ph.Eur.) is now available and will be implemented on 1 July 2024. All CEP holders (Certificate of Suitability of Monographs of the European Pharmacopoeia - holder) are required to harmonise their specifications and thus the respective CEPs with the new monographs.

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

Case A

The specifications of the substances belonging to this classification must be revised.
If the respective specification does not contain the addition "current version of the monograph", a notification of the new specification is required with the next application for 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 adopted, must be submitted within 3 months. CEP holders are required to update modules 1 and 3 and to provide corresponding explanatory information. After receiving the new data, the EDQM will check it and then inform the CEP holder of the results of this check. A reissue of the CEP is not excluded.

The list of categorised substances and further information on Addendum 11.5 to the European Pharmacopoeia (Ph.Eur.) can be found on the EDQM website.