Revisions & Renewals
Submit a Revision Application
Holders of a Certificate of Suitability to the monographs of the European Pharmacopoeia (CEPs) must inform the EDQM of any change(s) to the information provided in the initial application.
Applicants should send the following documentation to the Certification of Substances Division (DCEP) of the EDQM:
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a completed application form, which includes your invoicing details and
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data supporting the request for revision
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update of the relevant section(s) of the dossier.
Submit a Renewal Application
Requests for renewal should be submitted 6 months before a certificate's expiry date. Requests sent later may lead to a gap between the expiry date and the approval of the renewal request. Provisional certificates can be granted if a request has not yet been approved.
Once renewed, CEPs are valid for an unlimited period unless decided by the EDQM upon justified grounds to request one additional renewal (as foreseen by Directives 2004/27/EC and 2004/28/EC of the European Council and of the Parliament) and provided that your dossier is in compliance with current legal requirements.
This applies to all CEPs for which the renewal date is from 1 January 2006. For CEPs which were renewed prior to this date, a further renewal is not necessary provided that your dossier is in compliance with current legal requirements.
Applicants should send the following documentation to the Certification of Substances Division (DCEP) of the EDQM:
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a completed application form, which includes your invoicing details and
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a single copy of the updated technical documentation in CTD format,
OR
a declaration that no changes have been made since the last certificate was granted.
If an application is submitted, which includes changes made since the last certificate was granted, it should include an exhaustive list of those changes as well as supportive data.
CEP holders no longer have the possibility to include major changes to the content of the dossier. Only minor changes are accepted and assessed.
CEP holders should check that their manufacturing methods are in compliance with current legal requirements, and, if necessary, they should update the information provided in their application. If there are major changes, CEP holders should submit a revision rather than a renewal application.
Content of an Application
In accordance with the current European regulation on variations to marketing applications, changes are classified into three categories: notifications, minor changes and major changes.
The classification of changes, the conditions to be met and the documentation to be provided for each type of certificate have been revised and are described in detail in the:
Guideline on Requirements for Revision/Renewal of Certificates of Suitability to the European Pharmacopoeia Monographs, PA/PH/CEP (04) 2 4R
Help on Submission of Notifications, Revisions and Renewals
Arising from the frequent issues occurring in submissions of notifications, revisions and renewals of dossiers for certificates of suitability to the monographs of the European Pharmacopoeia (CEPs), a guide has been established to help applicants when compiling their documentation. It describes several key points to be considered for the administrative and technical aspects of submissions.
Download "Guidance on frequent changes to applications for Certificates of Suitability (CEPs)"
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. Please read the:
Explanatory Note: Updated EDQM Procedures related to Paper and Electronic Submissions for CEP Applications PA/PH/CEP (09) 109, 1R
And
CEP holders are obliged to inform all their customers for each CEP revision, suspension, withdrawal or negative outcome of an EDQM inspection.
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News
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Cases of falsification of data in the context of the CEP procedure
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Note concerning the assessment of stability data within the Certification procedure
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Note concerning CEPs for gelatin and impact of the revised EU Note for Guidance on the TSE risk
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GPS/DUNS information to be mentioned in the application forms
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Refusal of information from third parties in reply to EDQM's request for information
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Products & Services
Search for a list of granted CEPs, their type, the name of the substance, the full CEP number, the issue date and validity status, using the Certification Database (updated daily).
For more information about fees:
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Samples
Applicants commit to provide samples of substance and/or impurities when requested by the EDQM.
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Additional Information
Access for existing clients
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F67081 Strasbourg, France
Tel. +33 (0)3 88 41 30 30
Fax +33 (0)3 88 41 27 71
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