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Search for a list of granted CEPs, their type, the name of the substance, the fullCEP number, the issue date and validity status)

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Substance
Number
Substance Certificate Holder Certificate Number Issue
Date
Status End date Type
1270 Terconazole Janssen Pharmaceutica NV BE 2340 Beerse   R0-CEP 2000-219-Rev 02 16/11/2004 WITHDRAWN BY HOLDER 31/07/06 Chemistry
Detailed view of Terconazolum.

Status In use
Monograph Number 01270
English Name Terconazole
French Name Terconazole
Latin Name Terconazolum
Pinyin Name
Chinese Name
Pharmeuropa
Published in English Supplement 7.3
Published in French Supplement 7.3
Chromatogram Not available
Additional information Not available
History View history
Interchangeable (ICH_Q4B) NO
International Harmonisation
chapter 5.8
NO
Reference standards
Available since Cat. No. Name Batch No. Unit Quantity Price
K0600000 Ketoconazole 2 150 mg 79 EUR
T0060000 Terconazole 2 250 mg 79 EUR
Trade Names
To be used in test(s) Brand Name
Related substances column used: hypersil BDS
CEP
Substance
Number
Substance Certificate Holder Certificate Number Issue
Date
Status End date Type
1270 Terconazole Janssen Pharmaceutica NV BE 2340 Beerse   R0-CEP 2000-219-Rev 02 16/11/2004 WITHDRAWN BY HOLDER 31/07/06 Chemistry

Submit A New Application

To obtain a Certificate of Suitability to the monographs of the European Pharmacopoia (CEP), applicants must send the following documentation to the Certification of Substances Division (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), and submitted preferably in electronic format

  • a single copy of the NEW: 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 applies strictly the procedure for assessment described in the Resolution AP CSP (07) 1.

The evaluation of new applications is handled in two phases and a document has been prepared which describes the policy relative to two rounds of assessment and provides clarification on the potential outcomes of assessment and subsequent activities. This does not change the current situation which is that applications lacking sufficient information after evaluation of the applicant’s response to the EDQMdeficiency letter are definitively closed. A second request for additional information is issued in exceptional cases only.

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, November 2008)

A document is now available to provide clarification on the use of a CEPfor a starting material in an application for a CEP.

Submission Format

Paper or Electronic

Applicants are encouraged to submit electronic versions of their applications. Additionally, there are new requirements for paper submissions. This allows us to manage the applications more efficiently.

The EDQM is now accepting CEP submissions (request for new CEP, request for revision/renewal/notification, responses to request for additional information, data related to EDQM inspections) through the Common European Submission Platform “CESP”. Users can register for a CESP account on the Heads of Medicines Agencies website

Instructions for submitting electronic documents using the CESP platform is available here:

It is still possible to send CEP submissions via the EDQM dropbox.

Please read the Guidance for electronic and paper submissions for Certificates of Suitability (CEP) applications, PA/PH/CEP (09) 108, 2R

CERTIFICATE OF SUITABILITY

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

……….

What is CEP?

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.

Described in Resolution AP CSP 1 and Directives 2001/83/EC, 2001/82/EC

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

  • full confidentiality of the submitted data,
  • centralized evaluation by the EDQM,
  • recognized by all Member States of the European Pharmacopoeia Convention (36 countries) as well as by other countries,
  • easing of the management of applications for marketing authorization (MAA) for medicinal products in these countries,
  • simplifies the approbation of a medicinal product compared to the active substance master file (ASMF) or European drug master file (EDMF).

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:
    – US (FDA),
    – Canada (HPFB),
    – Australia (TGA),
    – New Zealand,
    – Tunisia and Morocco.
  • Simplifies the trading with pharmaceutical substances and ingredients.

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
  • Additional information:
    – 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.
  • Fees are paid after the application has been submitted and upon receipt of the invoice sent by EDQM.
  • Fees are listed here:
    – 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.

Inspections

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

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