EDQM continues to optimise the evaluation process of CEP applications

In order to optimise the process of CEP evaluation and to ensure that the official timelines are met, EDQM has decided to apply the procedure for managing the Certification scheme described in the Resolution AP CSP (07) 1 more strictly. This means that the evaluation of new dossiers is now handled in two phases: the evaluation of the original dossier and, if necessary, a single request for additional information. Based on this information, a final decision whether a CEP can be granted will be taken, following a risk-based assessment. A second request for further additional information will only be issued in exceptional cases.

Any application that does not include sufficient information after evaluation of the applicant’s response to the deficiency letter will now be definitively closed. This procedure was implemented on 1st September 2008.

Moreover, EDQM reserves the right to terminate the procedure of evaluation of an application if the applicant does not provide the required information in the specified period of time mentioned in the deficiency letter or if the information is inadequate to complete the evaluation process.

Furthermore, EDQM will continue applying the validation policy put in place in 2007. This means that new applications will be validated at receipt only if formally complete. No application will be evaluated prior to successful validation.  Any time needed to complete the application prior to successful validation will not be considered as assessment time.

In the event of any disagreement between the applicant and EDQM, the resolution foresees the possibility for the applicant to requesting a hearing.

Furthermore, at any stage of the process, the applicants can request Technical Advice.