Search https://extranet.edqm.eu/publications/Recherches_CEP.shtml Looking for a CEP?Search for a list of granted CEPs, their type, the name of the substance, the fullCEP number, the issue date and validity status)
CERTIFICATE OF SUITABILITY |
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LEGAL |
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| RESOLUTION AP-CSP (07) 1 | TERMS OF REFERENCE | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Registration Fees | Products & Services Catalogue 2011 (English/French) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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NEW SUBMISSION AND GUIDELINES |
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| NEW SUBMISSION – APPLICATION FORM | QUALITY OVERALL SUMMARY TEMPLATE | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Guidelines |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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REVISON AND RENEWALS GUIDELINES |
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| 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
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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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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NEWS |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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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