EDQM: Implementation of the 11th Edition of Ph. Eur. – Notification for CEP Holders
The EDQM informs that the 11th Edition of the European Pharmacopoeia (Ph. Eur.) is now available. Holders of Certificates of suitability to the monographs of the Ph. Eur. (CEPs) are invited to update their applications according to the revised monographs that will be implemented on 1 January 2023, and to follow the instructions that the EDQM provides.
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.
The EDQM also lists the substances covered by a CEP and for which a revised monograph will be implemented on 1 January 2023. They differentiate two categories A and B.
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.
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