22/23 February 2024
In most cases, the processing of a new application for a Certificate of Suitability (CEP) or an application for the revision of an existing CEP by the EDQM is a multi-stage process and the Authority has to require further information from the API manufacturer in order to make an appropriate evaluation of the dossier. To clarify its approach, the EDQM published a Policy this year in March which describes each single phase for the assessment of applications and the respective deadlines. The document is entitled "The Policy of Two Rounds of Evaluation for Applications for Certificates of Suitability and Requests for Revision" (PA/PH/CEP (13) 110).
As already indicated in the title of the document, the EDQM restricts the processing of CEP applications to 2 phases:
Thanks to this approach and the rigorous application of deadlines, the Authority has optimised and accelerated the processing procedure. Applicants for new CEPs have 6 months to provide additional documents required to clarify open points; for applications regarding the revision of a CEP they have 1 month. If these deadlines are not met, the assessment of the respective dossier will be stopped and the related procedure will be closed. In exceptional cases only the 2-phase procedure may be extended to a third one where the authority will request additional information from the applicant.
The Policy describes various scenarios depending on the different types of lacking information. The deadlines set for submitting additional documents are also respectively different.
For all CEP applicants, the document contains essential data about the certification process of APIs which are indispensable to a successful application procedure.