AUTHOR OF THIS BLOG

DR ANTHONY MELVIN CRASTO, WORLDDRUGTRACKER

CEP

 
SERCH CEP
str1
EXAMPLE PROPOFOL
Substance
Number
Substance Certificate Holder Certificate Number Issue
Date
Status End date Type
1558 Propofol Sochinaz SA Vionnaz CH   R0-CEP 2003-076 – Rev 01 07/12/2004 Expired 26/04/2009 Chemical
1558 Propofol Themis Medicare Ltd. Vapi IN   R0-CEP 2004-218 – Rev 00 13/10/2005 Withdrawn by Holder 18/12/2008 Chemical
1558 Propofol PORTON FINE CHEMICALS LTD. Chongqing CN   R1-CEP 2001-188 – Rev 03 09/07/2014 Withdrawn by Holder 28/05/2018 Chemical
1558 Propofol F.I.S. – FABBRICA ITALIANA SINTETICI S.P.A. Montecchio Maggiore IT   R1-CEP 2004-313 – Rev 01 01/03/2017 Valid Chemical
1558 Propofol SI GROUP, INC. Schenectady US   R1-CEP 2002-229 – Rev 02 17/08/2017 Valid Chemical
1558 Propofol Neuland Laboratories Limited Hyderabad IN   R1-CEP 2013-202 – Rev 00 20/02/2019 Valid Chemical
1558 Propofol Code number 22270 BACHEM S.A. Vionnaz CH   R1-CEP 2005-003 – Rev 03 03/12/2019 Valid Chemical
1558 Propofol HARMAN FINOCHEM LIMITED Mumbai IN   R0-CEP 2015-347 – Rev 02 02/11/2020 Valid Chemical
1558 Propofol EMCURE PHARMACEUTICALS LIMITED Pune IN   R0-CEP 2020-203 – Rev 00 05/01/2021 Valid Chemical
1558 Propofol CURIA ITALY S.R.L. Origgio IT   R1-CEP 2001-267 – Rev 04 11/08/2021 Valid Chemical
What is the Full form of abbreviation, CEP?
Certificate of Suitability to the monographs of the European Pharmacopoeia (or) Certificate of suitability of monographs of the European Pharmacopoeia (or) Certification of suitability of European Pharmacopoeia monographs
It is also informally referred to as Certificate of Suitability (COS)
What is a CEP?
It is the certificate which is issued by Certification of Substances Division of European Directorate for the Quality of Medicines (EDQM), when the manufacturer of a substance provides proof that the quality of the substance is suitably controlled by the relevant monographs of the European Pharmacopoeia.
For which substances, applications for the grant of CEPs can be submitted?
Applications for the grant of CEPs can be submitted to EDQM if monograph (general monograph and/or specific monograph) has been adopted by the European Pharmacopoeia for the following-
  • Organic or inorganic substances (active or excipients), manufactured or extracted.
  • Sterile Active Substances
  • Substances produced by fermentation as indirect gene products, which are metabolites of microorganisms, irrespective of whether or not the microorganisms have been modified by traditional procedures or r-DNA technology
  • Products with risk of transmitting agents of animal spongiform encephalopathies (TSE)
  • Herbal Drugs and Herbal Drug Preparations
For which substances CEP is not granted?
  • Direct gene products (proteins)
  • Products obtained from human tissues
  • Vaccines
  • Blood products and preparations.
What are the Legislations which describe certification Procedure?
Directives 2001/82/EC and 2001/83/EC, as amended, of the European Council and of the Parliament.

Guidelines to be referred for preparing Dossier to obtain a CEP 

Content of the Dossier for Chemical Purity and Microbiological Quality (PA/PH/CEP 04 1 4R)

Note: Click on the hyperlinks in blue for application form and template of QOS to download them.
Online Database of Approved CEPs
Link to Online Databases of Approved CEPs
Registration Fees 
Registration fees for various New CEP Applications  Deficiencies
 Link to top 10 deficiencies in New Applications for grant of CEPs Recognition of CEPs- CEPs are recognised by all the member countries of the European Union and also   other Countries like Canada, Australia, New Zealand, Tunisia and Morocco.
 
Advantages of CEPs-
  •  It is valid for 5 Years.
  • 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.

References-

CERTIFICATE OF SUITABILITY
 click for files

LEGAL

RESOLUTION AP-CSP (07) 1 TERMS OF REFERENCE
Registration Fees Products & Services Catalogue 2011 (English/French)

NEW SUBMISSION AND GUIDELINES

NEW SUBMISSION – APPLICATION FORM QUALITY OVERALL SUMMARY TEMPLATE

Guidelines

Content of the Dossier for Chemical Purity and Microbiological Quality (PA/PH/CEP 04 1 4R) Content of the Dossier for a Substance for TSE Risk Assessment (PA/PH/CEP (06) 2)
Content of the Dossier for Herbal Drugs and Herbal Drug Preparation Quality Evaluation Certificates of Suitability for Sterile Active Substances (PA/PH/Exp. CEP/T (06) 13, 1R)
Clarification on the Acceptability of CEP Applications for Sterile Grade Material (PA/PH/CEP (08) 60, November 2008) Explanatory note: Updated EDQM procedures related to Paper and Electronic Submissions for CEP applications (PA/PH/CEP (09) 109, 1R
Guidance for Submission of Electronic Documentation for Applications for Certificates of Suitability (CEPs): Revised Procedures (PA/PH/CEP (09) 108 Top Deficiencies Found During First Assessment of New Applications From October to December 2009, PA/PH/CEP (10) 65
New Procedure for the Assessment of Sister Files, PA/PH/CEP (09) 141 Note for the Applicants: Procedure for Validation of New Applications, PA/PH/Exp. CEP/T (08) 37
The EDQM‘s Position on CEPApplications for Biological Substances

REVISON AND RENEWALS GUIDELINES

REVISION APPLICATION FORM RENEWALS APPLICATION FORM
Guideline on Requirements for Revision/Renewal of Certificates of Suitability to the European Pharmacopoeia Monographs, PA/PH/CEP (04) 2 4R  Explanatory Note: Updated EDQM Procedures related to Paper and Electronic Submissions for CEP Applications PA/PH/CEP (09) 109, 1R
Guidance for Submission of Electronic Documentation for Applications for Certificates of Suitability (CEPs): Revised Procedures PA/PH/CEP (09) 108, 1R Procedures for Management of Revisions/Renewals of Certificates of Suitability to the European Pharmacopoeia Monograph, PA/PH/Exp CEP/T (04) 18 2R

NEWS

Note concerning the assessment of stability data within the Certification procedure Packaging information within the Certification procedure
Note concerning CEPs for gelatin and impact of the revised EU Note for Guidance on the TSE risk GPS/DUNS information to be mentioned in the application forms
Refusal of information from third parties in reply to EDQM‘s request for information Update of monographs regarding limit for unspecified impurities            – List of monographs
Changes to Submitted Documentation No Longer Accepted During the Assessment Phase Change in Contact Details: Notify the EDQM
EDQM Policy ‘Suspension or Cancellation of a Certificate of Suitability’ PA/PH/CEP (08) 17, R2 The report on the international APIinspection pilot programme

 https://www.edqm.eu/en/certificate-suitability-new-applications

Certificate of Suitability: 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 Department (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 Certificates of Suitability, Requests for Revision or Renewal of Certificates of Suitability and applications using the ‘sister files’ procedure, December 2021


Sister files

The sister files procedure is intended to facilitate the submission of similar dossiers within the Certification Procedure, and to allow applicants benefit from a fast-track procedure and harmonised assessments.

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 (for example, to cover an alternative manufacturing process, manufacturing site or an alternative grade).

This new application can be submitted as a “sister file”, provided that the conditions listed in the guideline are fulfilled.

A specific application form should be used for the submission of a sister file.

These applications are managed as described in the document 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, December 2021).


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 January 2018 all submissions should be in eCTD electronic format except submissions for substances for veterinary use (vNees is accepted) or for TSE risk (DF is accepted).

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.

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, 5R

Important information

CEP holders are obliged to inform all their customers for each CEP revision, suspension, withdrawal or negative outcome of an EDQM inspection.


Find a guideline

Please go to Certification Policy documents & Guidelines for a list of all of our guidelines.


Looking for a CEP?

Search for a list of granted CEPs, their type, the name of the substance, the full CEP number, the issue date and validity status, using the Certification Database (updated daily).
Search the Certification Database (CEP)


More information about Fees


Samples

Applicants commit to provide samples of substance and/or impurities when requested by the EDQM.

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