What is CEP?
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In the following you can read on the Certificate of suitability of Monographs of the European Pharmacopoeia ( CEP ).
A manufacturer of a substance can provide proof that the quality of the substance is suitably controlled by the relevant monographs of the European Pharmacopoeia by a CEP granted by the Certification Secretariat of the European Directorate for the Quality of Medicines ( EDQM ). The CEP confirms that pharmaceutical substances or active pharmaceutical ingredients ( API ) are produced according to the monographs of the EP. The CEP bridges between European Pharmacopoeia monographs and the need to prepare a file for licensing and thus it also bridges between industry and health authorities.
Who needs it?
Manufacturers or suppliers needing or wanting to apply for a marketing authorization for:
- active substances or excipients to control the chemical purity and microbiological quality of their substance,
- products with TSE risk to evaluate the reduction of TSE risk according to the general monograph,
- herbal products used in the production or preparations of pharmaceutical products to be evaluated according to the suitability of the monograph for the control of herbal drugs and herbal drugs preparations.
The CEP is 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.
Advantages of the CEP
What can you do with a CEP ?
- Used for marketing authorization applications.
- To demonstrate the compliance of the substance used with the monographs of the European Pharmacopoeia and Directives 2001/83/EC and 2001/82/EC.
- Recognized by all registration authority within the states of the European Pharmacopoeia Convention and by the European Union.
- Recognized by the following countries and institutions:
- New Zealand,- Tunisia and Morocco.
Where to check who has already an CEP ?
Website of the EDQM – 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.
How to apply and fees
- Applications are submitted in electronic versions (e- CDT ) to the EDQM
- More information, please read guidance for submission
- Following documentation is required:
- a complete application form including the fee form,
- a single copy of a dossier in CTD format,- a copy of the Quality Overall Summary
- for chemical purity and microbiological
quality evaluation: detailed information on the manufacturing method of the substance and the impurities that are associated with it,- for TSE evaluation: Information on the source of animals and tissues used, manufacturing method, traceability and quality system in force.
- for new single applications about 3000 $,
- for revision of a existing CED 500 $ (simple notification).
How does the process of Evaluation by the EDQM work?
- Application is sent to the Certification Division of the EDQM ,
- it is validated and listed for assessment,
- EDQM may send queries to the applicant,
- when the queries have been resolved EDQM sends the applicant the CEP .
Advices to avoid queries please see here .
To complete this quality evaluation, EDQM has initiated in 1999 an inspection programme for manufacturing sites covered by a certificate ( CEP ), which is now running according to the EU Commission mandate given to EDQM for application of Directive 2001/83/EC and 2001/82/EC, as amended. The program checks compliance with current Good Manufacturing Practices ( GMP ) and the CEP application dossier (and any updates) at the manufacturing/distribution sites. Inspections are carried out as team inspections by official inspectors from the competent supervisory authorities. The company is charged for the inspection.
- In the case of major/critical deficiencies notices during the inspection,
- the corresponding CEP’s may be suspended (Annex 7), – the suspension is reported on the EDQM ’s website and all the authorities concerned, necessary action regarding related marketing authorization(s) (MA) is taken, – the holder has to inform all their customer(s), – suspension ends only when the company takes satisfactory corrective actions and the implementation, – corrective actions is confirmed by a re-inspection.
How to maintenain the CEP ?
The document PA/PH/ExpCep/T (04) 18 2R’ describes the operating procedures for the handling of renewals, revisions and changes, fees and timetables. The holder of a CEP must inform the EDQM of any change(s) in the information provided in the certification dossier by sending all the necessary documents. A CEP is valid for 5 years from the date of first issuing. CEP is renewed only once and then valid for an unlimited period unless it is decided by the EDQM and upon justified grounds, to request one additional renewal. This policy applies to all CEP’s for which the date of renewal is from 1 January 2006. For those CEP’s, which have already been renewed, a new renewal is not necessary provided the dossier is in compliance with the current legislation . Under certain circumstances the certificate can be suspended or cancelled as outlined here