Thursday, 8 March 2012

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

4 comments:

  1. CEP=Certificate (acc. to) European Pharmacopoeia i.e having a COS (Certificate of Suitability) issued by EDQM (European Directorate of Quality of Medicines).
    Scope - all the substances under the monographs of EP.
    It is mandatory all the suppliers from countries not belonging to EU to have a COS in order to sell in the territory of EU incl. Bulgaria (regulated by BDA).

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  2. This comment has been removed by the author.

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