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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 implements a strict procedure for assessment of CEP applications.

The evaluation of new applications is handled with three rounds of assessment. A policy document describes this policy and provides clarification on the potential outcomes of assessment and subsequent activities. Applications lacking sufficient information after evaluation of the applicant's response to a maximum of 2 EDQM deficiency letters are definitively closed.

Management of applications for new CEPs and applications for revision/renewal of CEPs (PA/PH/CEP (13) 110 1R, January 2017)

 

 

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).

From 1 January 2017 submissions should be sent via 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 are available here: User guide (PA/PH/CEP (13) 67, 2R)

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

"Guidance for electronic submissions for Certificates of Suitability (CEP) applications", PA/PH/CEP (09) 108, 4R

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