Back CEP 2.0: implementation date

EDQM Strasbourg, France 19/07/2023
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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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