Legal Status & Background

Background

The certification procedure was established in 1994 and was in the beginning restricted to the control of the chemical purity of pharmaceutical substances. In 1999, the procedure was extended to include products with risk of transmissible spongiform encephalopathy (TSE), thus enabling their certification on the basis of the new monograph on 'Products with risk of transmitting agents of animal spongiform encephalopathies (1483)' and the associated general chapter 5.2.8 (verbatim reproduction of the text of the CPMP/ CVMP guideline on minimising TSE risk).  The procedure was further revised in 2002 to allow control of herbal drugs and herbal drug preparations.

Legal Status

Under the official procedure described in Resolution AP-CSP (07) 1 and Directives 2001/83/EC, 2001/82/EC and 2003/63/EC as amended of the European Union, manufacturers or suppliers of active substances or excipients (organic or inorganic, obtained by synthesis, extraction or fermentation), any product with transmissible spongiform encephalopathy (TSE) risk, or herbal products used in the production or preparation of pharmaceutical products can apply for a certificate concerning:

• the evaluation of the suitability of the monograph for the control of the chemical purity and microbiological quality of their substance; or,
• the evaluation of the reduction of TSE risk according to the general monograph; or,
  
• both of the above; or,
  
• the evaluation of the suitability of the monograph for the control of herbal drugs and herbal drugs preparations.
  

This procedure is aimed at facilitating and simplifying exchanges between the partners to ensure that the quality of substances is guaranteed and that these substances comply with the European Pharmacopoeia and therefore the requirements of EU directives for medicines.

International recognition

(20/03/07) To mark several years of cooperation and collaboration the EDQM and the Health Products and Food Branch (HPFB) of Health Canada signed a Memorandum of Understanding. More information....

The CEP Procedure

Who can apply? What are CEPs used for?

Manufacturers (or the duly authorised representatives of these manufacturers) of the products mentioned above, can apply for a CEP, regardless of their geographical location.

A CEP can be used by the manufacturers of pharmaceutical products in their marketing authorisation applications (MAA) to demonstrate the compliance of the substance used with the monographs of the European Pharmacopoeia and Directives 2001/83/EC and 2001/82/EC.

CEPs are recognised by all signatory states of the European Pharmacopoeia Convention and by the European Union. Other countries have also chosen to recognise them, e.g. Canada, Australia, New Zealand, Tunisia and Morocco.

How to check the validity of a CEP?

The list of CEP granted is updated daily in the Certification Database. Information is given concerning name of substance, full CEP number, issue date of current CEP, status and type. For more information click HERE.