CEP

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?

Resolution AP-CSP (07) 1 on the 'Certification of Suitability to the Monographs of the European Pharmacopoeia (Revised Version)' (Adopted by the Public Health Committee (CD-P-SP) on 21/02/2007)

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)

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) 

Note :  
1. Each of the above guideline corresponds to individual type of substances. For example, the first Guideline is to be referred for preparing dossier to obtain a CEP for an API.

2. Each of the above guideline is to be referred in conjunction with Resolution AP-CSP (07) 1 on the 'Certification of Suitability to the Monographs of the European Pharmacopoeia (Revised Version)

Application form and template for QOS 
Link for Downloading Application form and template of QOS.

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-

 1.http://www.edqm.eu/site/Background-Legal-Framework-77.html

 2. http://www.edqm.eu/site/New-Applications-29.html#

Keywords: CEP, EDQM,  Resolution AP-CSP (07) 1, Directives 2001/82/EC and 2001/83/EC.