Further Regulations within the CEP Procedure: Changes in Contact Persons and Complaints Procedure

With the publication of two new guidelines, the EDQM has tackled further loopholes in the current rules with regard to the CEP procedure.
The public document entitled "Changes in contact details to be notified to EDQM" (PA/PH/CEP (10) 86 1R)" includes provisions on how to proceed when the data of the contact person have changed with whom the EDQM communicates within the CEP procedure or when a personnel change has taken place. In that case, the applicant or the holder of the CEP has two possibilities to update the details of the contact person:

  • Notification of the new data in the table 2.2 of the CEP application form. This option is applicable when the complete application form has to be submitted anyway, e.g. during an application for revision or renewal of an existing CEP.
  • Notification of the new data via the form developed for this purpose. This procedure has to be used when no full application form is required, e.g. during an ongoing procedure.

The EDQM strongly recommends keeping the contact data up-to-date within the lifecycle of a CEP as the interruption of the communication flow and delays in response deadlines may lead to the closure of an ongoing procedure or to the cancellation of a CEP.

The second document entitled "Complaints Procedure" /PA/PH/CEP (15) 19 describes how an applicant should proceed in the context of a complaint procedure with EDQM's CEP department, the "European Directorate for the Quality of Medicines & Healthcare's Certification Division" (DCEP). When the applicant or holder of a CEP would like to denounce a quality defect regarding the service of the DCEP within the CEP procedure, he or she should send a complaint in writing to the responsible contact person of the DCEP within a 3-month deadline after the service has been brought. After 2 days, the complainant will receive an acknowledgement of receipt and after 10 days a proposed solution from the EDQM. If a complaint is deemed unfounded by the EDQM, the CEP holder will receive a notification also within 10 days and the procedure will be closed.

The complaints procedure has to be distinguished from a hearing. This path can also be followed in contentious cases; however it is part of the decision process within the CEP procedure and is subject to other regulations described in the document "Suspension or withdrawal of a certificate of suitability, closure of an application" (PA/PH/CEP (08) 17, R4).

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