The European Directorate for the Quality of Medicines & HealthCare (EDQM) is pleased to announce that the CEP 2.0 will be implemented on 1 September 2023. From that date onwards, new dossier applications and renewal applications will receive a CEP 2.0, whereas revision applications will receive a Hybrid CEP if the content of the CEP has been impacted.
It should be noted that due to major IT system updates, the effective roll-out date might be delayed by a few days.
CEP holders will receive their CEP only as a document to be downloaded from the DCEP sharing tool. The validity of CEPs can be checked on the certification database.
Also, as of September, CEP holders having a valid CEP can apply for a switch to CEP 2.0 via a minor revision (to be mentioned in the cover letter) and with a dossier updated according to the CEP 2.0 requirements.
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