Manage your CEPs in eCTD format easily, quickly and with guaranteed compliance.

CEP in eCTD

Are you looking for the best solution to submit your Certification of Suitability to the Monographs of the European Pharmacopoeia Applications (CEP) in eCTD format? cune-eCTD is built to help you prepare and submit your CEPs. A secure and easy to use solution that can get you started today. And our global Client Success team guarantees 100% eCTD compliance for your first CEP submission!

eCTD submission software

Submit Your Certification of Suitability (CEP)

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Will you be ready to submit your Certification of Suitability to the Monographs of the European Pharmacopoeia (CEPs) in the eCTD format by the 1st January 2020? According to the European Directorate for the Quality of Medicines & HealthCare (EDQM) – the organisation responsible for the procedure of CEP –  submissions for CEP must be in the eCTD format beginning the 1st of January 2020.

The mandate applies to:

  • Notifications, revisions, renewals & new applications
  • EDQM will no longer accept NeeS Submissions for notifications, revisions and renewal application
  • Exceptions applies to TSE only submissions, where PDF continues to be a standard format accepted.

About CEP submission

CEP or Certification of Suitability to the Monographs of the European Pharmacopoeia is the certification confirming  that pharmaceutical substances or active pharmaceutical ingredients (API) are produced according to the monographs of the European Parliament.

Scope of the CEP:

  • “Chemical” or herbal” CEP – substances described in monographs: active substances, excipients, herbal drugs/herbal preparations
  • “TSE” CEP – products with risk of TSE (SM, intermediates, reagents)

CEP application:

CEP application in eCTD format contains 3 modules:

  • Module 1 – Application form and a dossier in eCTD format written in one of two official languages of Council of Europe (preferably in English)
  • Module 2 – Quality Overall Summary
  • Module 3 – Baseline. Holds the information of previous submissions.
    • Mandatory for the following circumstances:
      • switch from a paper to an eCTD
      • switch from a pdf/NeeS to an eCTD
    • Recommended for a renewal, a revision or a notification

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.

CEP application is open to any manufacturer regardless of region they are based at. CEPs are accepted in 36 Member States of the European Pharmacopoeia Convention + EU, Canada, Australia, Singapore, South Africa, etc.

If a company which has been granted a certificate of suitability (CEP) may wish to apply for another CEP for the same substance, either when it is not possible to apply for a revision of the initial CEP or when the company wishes to have separate CEPs for different conditions of preparation or qualities, they can submit a new application as a “sister file”. This new application should fulfill the conditions listed in the guideline for sister files.

Inform your colleagues – download our informational sheets!

For more information, please follow EDQM news page  or refer to the electronic submission for CEP road map.