EDQM: Implementation of the 11th Edition of Ph. Eur.

The EDQM informs that the 11th Edition of the European Pharmacopoeia (Ph. Eur.) is now available.

The latest version comprises some updated monographs which will be implemented on 1 January 2023.

Holders of Certificates of suitability to the monographs of the Ph. Eur. (CEPs) are required to align their applications and thus the respective CEPs according to the revised monographs.

Responsibility

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 & HealthCare (EDQM) ensures that CEPs always reference the latest version of the pharmacopoeia.

Besides the web notice, EDQM will contact CEP holders to provide more details on how to proceed. However, it remains the responsibility of the CEP holder to comply with the requirements of the monograph and, if necessary, to update their respective applications no later than the implementation date of the revised monograph, regardless of whether they have been contacted by EDQM.

The EDQM listed the substances covered by a CEP and for which a revised monograph will be implemented on January 1, 2023, classifying them into two categories, A and B, based on the required information

Case A:

The specification of the substance should be updated according to the revised monograph. The updated specification should be included in the next request for revision that is submitted to the EDQM.

Case B:

This case concerns amendments to the monograph which require the submission of data to the EDQM. An updated dossier demonstrating that the substance complies with the requirements of the revised monograph should be provided within three months of the EDQM contacting the CEP holder.

Where the required information has already been submitted in the approved dossier, a self-declaration is considered to be sufficient.

Source: EDQM Newsroom