Submission format and electronic submission
Applicants should send their documentation in electronic format only to the Certification of Substances Department (DCEP) of the EDQM.
All submissions should be in eCTD format except submissions for substances for veterinary use (vNees is accepted) or for TSE risk (PDF is accepted). Submissions should be sent via the “Common European Submission Platform (CESP)”.
Users should first register with the CESP before sending submissions to the EDQM.
Instructions for submitting electronic documents using the CESP platform are available here:
EDQM DCEP sharing tool
Instructions for using the EDQM DCEP sharing tool to ensure the secure sharing of EDQM documents between the EDQM Certification of Substances Department (DCEP) and CEP holders or applicants during the CEP lifecycle.
Search for a list of granted CEPs, their type, the name of the substance, the full CEP number, the issue date and validity status, using the Certification Database (updated daily).
Applicants commit to provide samples of substance and/or impurities when requested by the EDQM.