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New EDQM IT tool for the management of CEP activities – Impact for CEP applicants and CEP holders

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Certification of suitability (CEP)
Procedure of certification (general)
News
24 September 2021
Strasbourg, France

From the beginning of October 2021, the CEP Department (DCEP) of the European Directorate for the Quality of Medicines & HealthCare (EDQM) will use a new IT application for the management of its activities. The implementation of this tool will entail certain changes in the way the EDQM communicates with applicants for Certificates of Suitability to the European Pharmacopoeia monographs (CEPs) and CEP holders.

  • Communication with companies in the frame of their CEP applications will be streamlined, and e-mails or automatic notifications will be sent instead of letters in an increasing number of situations, such as reminders and acknowledgements of receipt of responses to deficiency letters and requests for revisions. Companies are therefore strongly advised to provide the DCEP with the name and valid e-mail address of a suitable contact person and to inform the DCEP whenever there are changes to this information.
  • A new tool will be used to ensure that documents related to CEP applications are shared securely. Applicants will no longer receive documents via e-mail but via the “EDQM DCEP Sharing tool”. Documents will be made available for download for 60 days maximum and will be deleted from the tool afterwards. Designated contact persons will receive a notification from the EDQM DCEP Sharing tool informing them of the automatic creation of their accounts and usernames and inviting them to choose a password. As indicated above, it is highly recommended to inform the DCEP immediately of any changes concerning the name or e-mail of the contact person.
  • The EDQM Database of Certificates of Suitability (CERTIFICATION Database) will display in real time the reasons why any CEPs are no longer valid (e.g. in case of suspension, withdrawal or expiry).

The implementation of this new IT tool may slow down CEP activities during the initial introductory phase.

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