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

• a completed application form;
• a dossier in CTD format written in English* (Modules 1, 2 (QOS) & 3);
• Content of the dossier for chemical purity and microbiological quality, PA/PH/CEP (04) 1, 7R.

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 a CEP to the applicant.

To ensure the official timelines are met, the EDQM implements a strict assessment procedure for CEP applications.

The evaluation of new applications is handled with three rounds of assessment. A document describes this policy and provides clarification on the potential outcomes of assessment. 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 Certificates of Suitability, Requests for Revision or Renewal of Certificates of Suitability and applications using the ‘sister files’ procedure, November 2021

Applications which are out of the scope of the Certification procedure are rejected at receipt. This concerns applications for:

• Substances that are not included in Ph. Eur.
• Biologicals
• Human tissues derivatives, blood derivatives, vaccines
• Substances which do not comply with the “Definition” section of the monograph, if applicable
• Medicinal products

*Alternatively in French, the other official language of the Council of Europe