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New Applications
E-submissions
The EDQM has a secure dropbox with an restricted access. Applicants can use this dropbox to send their dossiers and QOS electronically to the EDQM. For more information, please contact us via the FAQ/ HELPDESK.
Certification Database
Search our Certification database for information on Certificates of Suitability (CEPs) granted by the EDQM.
EDQM position with regards CEP applications for biological substances
According to Resolution AP-CSP (07)1, the Certification procedure is intended for substances for which a monograph (general monograph and/or specific monograph) has been adopted by the European Pharmacopoeia Commission. The procedure does not apply for direct gene products (proteins), products obtained from human tissues, vaccines and blood products and preparations.
In the light of the discussions held at the European level concerning the definition of biological products, the EDQM has decided to exclude from the scope of the Certification procedure those products that have been classified as "other biological substances" by the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMD(h)). A list of these other biological products is available on the website of the Heads of Medicines Agencies: click HERE.
The reasoning behind this decision is that for biologicals the characterization and determination require not only a combination of physico-chemical and biological testing, but also extensive knowledge of the production process and its control.
The EDQM will therefore not accept any new application for a CEP for these biological substances.
Existing CEPs are not affected by this decision.
New procedure for the assessment of sister files
For more information on this new procedure, please click HERE.
EDQM continues to optimise the evaluation process of CEP applications
In order to optimise the process of CEP evaluation and to ensure that the official timelines are met, EDQM has decided to apply the procedure for managing the Certification scheme described in the Resolution AP CSP (07) 1 more strictly. This means that the evaluation of new dossiers is now handled in two phases: the evaluation of the original dossier and, if necessary, a single request for additional information. Based on this information, a final decision whether a CEP can be granted will be taken, following a risk-based assessment. A second request for further additional information will only be issued in exceptional cases.
Any application that does not include sufficient information after evaluation of the applicant’s response to the deficiency letter will now be definitively closed. This procedure was implemented on 1st of September 2008. More information, click HERE.
Deficiencies in Dossiers
A summary of the main deficiencies found in the dossiers for Certificates of Suitability (CEP) assessed from October to December 2007 is now available. By including the recommendations described in this summary together with the requirements listed in the guideline 'Content of the dossier for chemical purity' (PA/PH//CEP (04) 1 4R) in the submission, the applicant for a CEP can improve the quality of their dossiers and therefore limit the time taken to receive the CEP.
PA/PH/CEP (08) 11 Top deficiencies found in Applications
From October to December 2007 (Published Sept 2008)
Notice to holders of CEPs for heparin or enoxaparin
Following the adverse events observed recently in the United States of America and in Europe, and following the measures taken by European Authorities, the EDQM has published a notice to the attention of holders of CEPs for heparin or enoxaparin. More information...
Content of the Dossier
Chemical Purity and Microbiological Quality
The Quality Overall Summary (QOS) should discuss the ability of the European Pharmacopoeia monograph to control the quality of the active substance and in particular the declared potential impurities or the need for alternative methods. The purpose of the QOS is to provide the assessor with a summary of the content of the dossier.
Please refer to the 'Content of the dossier for chemical purity and microbiological quality (PA/PH/CEP 04 1 4R)' for more detailed information.
TSE Risk Assessment
An applicant can apply for a CEP for all material(s) derived from animals which are susceptible to the transmission of TSE agents, as described in general chapter 5.2.8 of the European Pharmacopoeia which is verbatim the EMEA Notes for Guidance on 'Minimising the risk of transmitting animal spongiform encephalopathy agents via medicinal products'. The certification procedure requires the presentation of a dossier as described in 'Content of a dossier for a substance for TSE risk assessment (PA/PH/CEP (06) 2)'.
Herbal Drugs and Herbal Drug Preparations
The certification procedure requires the presentation of a dossier as described in 'Content of the dossier for herbal drugs and herbal drugs preparation quality evaluation (PA/PH/CEP 026)'.
Sterile Substances
An applicant can apply for a CEP for a sterile active ingredient. The certification procedure requires the presentation of a dossier as described in 'Certificates of suitability for sterile active substances (PA/PH/Exp. CEP/T (06) 13, 1R)'. This applies also for CEPs which have already been granted with the subtitle "sterile" and for which the validation of the sterilisation process has not yet been assessed. An additional fee will be applied in all cases and the manufacturing site will be inspected before or after granting of the CEP (at the latest 18 months after granting the CEP).
Clarification on the acceptability of CEP applications for sterile material
An application for a sterile substance can only be accepted if the sterilisation step is an integral part of the manufacture of the material as performed by the manufacturer. Certificates for sterile materials, which have already been issued and where this requirement is not met will continue to be valid, but any new application which does not satisfy this requirement will not be accepted. For more information, click HERE.
Submitting a New Application
Applicants are encouraged to submit electronic versions of their applications. This will allow a better and more efficient management of the applications. For more information, please click HERE.
The applicant should send the following documentation to the EDQM:
- a complete application form (preferably in English) including the fee form,
- a single copy of a dossier in CTD format, and
- a single copy of the Quality Overall Summary (QOS) in Word format.
For CEP on chemical purity and microbiological quality evaluation, detailed information on the manufacturing method of the substance and the impurities that are associated with it so that the reference to the corresponding European Pharmacopoeia monograph can be validated.
For CEP on TSE evaluation, information on the source of animals and tissues used, manufacturing method, traceability and quality system in force.
The application is sent to the Certification Division of the EDQM. It is validated and listed for assessment. After it is assessed, the EDQM may send queries to the applicant. When the queries have been resolved, the EDQM sends the applicant a CEP.
Revised EDQM procedures related to paper and electronic submissions for CEP applications
Applicants are encouraged to submit electronic versions of their applications. This will allow a better and more efficient management of the applications. For more information, click HERE.
Clarification on electronic submissions
In line with the implementation of eCTD submissions at the level of national competent authorities, the EDQM announced at the beginning of August its readiness for accepting electronic submissions in the format of eCTD or NeeS dossiers, and published a revised procedure and some requirements.
It should be stressed that e-CTDs prepared in compliance with the ICH guidance and specifications are fully acceptable for EDQM; these are the preferred specifications which manufacturers should follow when preparing their electronic dossiers.
The EDQM revised procedure for electronic submissions was published to serve as guidance to those companies who would not yet be ready to implement the ICH specifications and who would still wish to apply electronically to obtain a certificate of suitability. Such companies are asked to apply the guidance described in the revised procedure.
More information, click HERE.
Note for the applicants: Procedure for validation of new applications
This document presents the measures taken for the validation of new applications for a CEP that were put in place in 2007 and how to avoid the blockage of an application at receipt. More information ...
New policy for mentioning manufacturing sites on CEPs
The policy concerning the manufacturing sites mentioned on the CEPs was changed in 2007 and applies to new and revised CEPs. For more information about this policy click HERE.
Fees
Fees should be paid AFTER the application has been submitted and upon receipt of the invoice sent by EDQM. In any case, the applicant should fill in the form for invoicing details included in the application form, to allow EDQM to establish the invoice. Payment should be made using this invoice only.
Certification Registration Fees
Providing Samples
The Certification Division wishes to announce that its policy concerning samples will change from 1st July 2008. Instead of providing samples for every new ‘chemical’ or ‘herbal drug/herbal drug preparation’ application for a Certificate of Suitability, a commitment to provide samples of the substance and/or its impurities when requested by the EDQM should be provided.
Additional Information and Downloads
PA/PH/Exp.CEP/T (06) 13, 1R Certificates of Suitability for Sterile Active Substances (Chinese)
PA/PH/CEP (06) 2 Content of the Dossier for a Substance for TSE Risk Assessment (Chinese)
PA/PH/Exp. CEP/T (08) 37 Note for the applicants: Procedure for validation of new applications
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