Certificates of Suitability to the monographs of European Pharmacopoeia[CEPs] Latest Requirements as of 2021- Critical Compliance required


Technical documentation for pharmaceutical quality of the Active Pharmaceutical Ingredients [APIs] for Formulations sold in the European market  is an integral part of the drug product dossier & and is critically reviewed by the regulators. 

The CEP is a certificate issued by the European Directorate for the Quality of Medicines (EDQM). Its role is to certify the compliance of a pharmaceutical substance or active pharmaceutical ingredient (API) with the requirements of the relevant monograph of the European Pharmacopeia and therefore the EU directives for medicines. CEP can be referenced in a Clinical Trial Application as well as in a Marketing Authorization Application instead of a Drug Master File.

Advantages of CEPs is that they  are recognised by all the member countries of the European Union and also  other Countries like Canada, Australia, New Zealand, Tunisia and Morocco,are valid for 5 years from the date of first issue and valid indefinitely following the 5-year renewal., An API manufacturer need not file an ASMF/EDMF in all the member countries involved in DCP/MRP Procedures if the manufacturer has obtained CEP for that specific API. Sending a Copy of CEP will do.Centralised evaluation of Dossier by only one agency i.e EDQM.

Of late in view of various new Regulatory & GMP guidelines & requirements, there have been several revisions to the Legislations describing the certification Procedure & Guidelines to be referred for preparing content of the Dossier to obtain a CEP have been revised to incorporate latest compliance requirements particularly wrt Nitrosamines, Heavy metals ,etc

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 Department (DCEP) of the EDQM alongwith the Registration Fee:Submissions should be sent via the “Common European Submission Platform (CESP)”. Users should first register with the CESP (cespporta.hma.eu) before sending submissions to the EDQM.
From January 2018 all submissions should be in eCTD electronic format except for substances for veterinary use (vNees is accepted) or for TSE risk From 1 January 2017 submissions should be sent via the “Common European Submission Platform (CESP)”. Users should first register with the CESP before sending submissions to the EDQM.

Samples- of substance and/or impurities need to be provided when requested by the EDQM.As of November 2021, Management of applications for new Certificates of Suitability, Requests for Revision or Renewal of Certificates of Suitability and applications using the ‘sister files’ procedure (PA/PH/CEP (13) 110, 3 R) criteria has changed following Update following implementation of new IT tool for the handling of CEP applications (changes to EDQM timelines now expressed in working days (WD).

Pharma Utility

Pharma Utility

Welcome to Pharma Utility, a magazine dedicated to news and services in the Indian pharmaceutical industry. Founded in the year 2007 by Mr. Digvijay Singh, in last 10 years we have moved leap and bound in making pharmacy knowledge available to all our partners.

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