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New Applications

Submit A New Application

To obtain a Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP), applicants must send in electronic format the following documentation to the Certification of Substances Division (DCEP) of the EDQM:

  • a completed application form which includes your invoicing details
  • a dossier in CTD format written in one of the two official languages of the Council of Europe (preferably in English),
  • a single copy of the Quality Overall Summary (QOS).

Upon receipt, the application is validated and listed for assessment. After assessment, the EDQM may send queries to the applicant. When they are resolved, the EDQM sends the applicant a CEP, which is valid for 5 years from the date of first issue and valid indefinitely following the 5-year renewal.

To ensure the official timelines are met, the EDQM applies strictly the procedure for assessment described in the Resolution AP CSP (07) 1.

The evaluation of new applications is handled in two phases and a document has been prepared which describes the policy relative to two rounds of assessment and provides clarification on the potential outcomes of assessment and subsequent activities. This does not change the current situation which is that applications lacking sufficient information after evaluation of the applicant's response to the EDQM deficiency letter are definitively closed. A second request for additional information is issued in exceptional cases only.

 

Content of the Dossier

Detailed information on what an application should contain is described in the documents below. Refer to the document relevant to your application.

You should also read the:

Clarification on the Acceptability of CEP Applications for Sterile Grade Material (PA/PH/CEP (08) 60, 1R, July 2016)

 

Submission Format

From June 2016 the EDQM does not accept paper applications anymore. All submissions should be in electronic format (PDF, NeeS, VNeeS and eCTD).

The primary route of electronic submissions is through the “Common European Submission Platform (CESP)”. Users should first register with the CESP (https://cespportal.hma.eu/) before sending submissions to the EDQM.

Instructions for submitting electronic documents using the CESP platform is available here:

It is still possible to send CEP submissions via the EDQM dropbox.

Please read the "Guidance for electronic submissions for Certificates of Suitability (CEP) applications"

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