The EDQM has published a press release about the evaluation process of CEP applications. In order to ensure that the official timelines are met, EDQM has decided to apply the procedure for managing the Certication sheme more strictly. "This means that the evaluation of new dossiers will be 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 be definitively closed. This procedure was implemented on 1st of September 2008.
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." The revised document dated June 2008 can be found here.
EDQM News and General Information (www.edqm.eu)
On behalf of the European Compliance Academy (ECA)