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Homepage / Certification of Pharmaceutical Substances / Revisions & Renewals

Revisions & Renewals

Each time a revised or renewed CEP is granted, the Holder of the CEP shall give a copy of the CEP to all their customers to allow them to update MA for medicinal products referring to it. The list of valid CEPs is available on this site (see under Databases) and is updated daily.

New system for Revision/Renewal of certificates

To be in line with the revision of the EU Regulation on Variations to marketing applications, the system for revision/renewal of CEPs will change for all requests for revision received from 1st March 2010.
As a consequence, the following documents have been revised:

• Guideline on revision/renewal of certificates of suitability to the monographs of the European Pharmacopoeia (PA/PH/CEP (04) 2, 4R, December 2009)
• Procedures for management of revisions/renewals of certificates of suitability to the monographs of the European Pharmacopoeia (PA/PH/Exp. CEP/T (04) 18, 2R, December 2009)
• Application form for revision/renewal

The changes are related to procedural aspects as well as to the classification of changes. As previously, changes are categorised as notifications, minor changes or major changes, with the following modifications:

• Notifications are split in immediate notifications and "annual" notifications.
• Unclassified changes are now minor by default. Some minor changes of the former guideline have also been downgraded to notifications. For unclassified variations, an applicant will also have the possibility to request for confirmation of the type of revision through the EDQM HelpDesk.
• Major changes are now listed.

The possibility of grouping variations affecting several CEP applications has been introduced and the concept of consolidated revision has been deleted. The deadlines and fees have been modified. Click HERE for the updates fees.

 

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, please 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.

Revisions

Content of the Dossier

The holder of a CEP must inform the EDQM of any change(s) in the information provided in the certification dossier. Changes or revisions are classified into three categories: notifications, minor changes and major changes, depending on the potential impact of the change on the quality of the final substance.
These three categories correspond to those described in the European regulation on variations 2003/1084/EC and 2003/1085/EC as amended.
Please refer to the 'Guideline on requirements for revision/renewal of certificates: PA/PH/CEP (04) 2 4R', which describes the classification of the changes, the conditions to be met and the documentation to be provided for each type of revision of certificate. The document 'Procedures for management of revisions/renewals of certificates: PA/PH/Exp CEP/T (04) 18 2R' describes the operating procedures for the handling of revisions, fee and timetables.

 

Submitting a Revision 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 holder of a CEP must inform the EDQM of any change(s) by sending all the necessary documents demonstrating that the conditions laid down in the present guideline are met. An applicant should send the following documentation to the EDQM:

• a completed application form including the fee form, and
• a single copy of a dossier (preferably in English).

 

Applications to the EDQM consist of a justification of the change and documentation in support of the request as described in PA/PH/CEP (04) 2 4R. For any particular scheme, please contact EDQM prior submitting an application.

The revision application is sent to the Certification Division of the EDQM. It is validated or rejected and then 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.

Renewals

Content of the Dossier

A CEP is valid for 5 years from the date of first issuing and is renewed only once. This is consistent with the requirements for a marketing authorisation (MA) stipulated in the revised Directives 2001/82/EC and 2001/83/EC. Once renewed, the CEP is valid for an unlimited period unless it is decided by the EDQM and upon justified grounds, to request one additional renewal (as forseen by Directives 2004/27/EC and 2004/28/EC).
This policy applies to all CEPs for which the date of renewal is from 1 January 2006. For those CEPs which have already been renewed, a new renewal is not necessary provided the dossier is in compliance with the current legislation. The document 'Procedures for management of revisions/renewals of certificates: PA/PH/Exp CEP/T (04) 18 2R' describes the operating procedures for the handling of renewals.

 

Submitting a Renewal 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 request for renewal should be submitted 6 months before the expiry date. Any requests sent later may lead to a gap between the expiry date of the certificate and the approval of the request for renewal, during which no valid certificate would be available. Holders have no longer the possibility to include major changes to the content of the dossier at the time of the renewal. Only minor updates of the dossier will therefore be accepted and assessed for renewal.
Provisional certificates are granted at expiry date if the request is not yet approved. They avoid a gap between expiry date and the granting of the renewed CEP. For more information, click HERE.

 

Suspension or cancellation of a Certificate of Suitability

The EDQM explains its policy on the suspension or withdrawal of a certification of suitability. A document describing the scope, the decision making process as well as the resulting actions is now available. More information...

 

Compliance with the current regulation

The CEP holder should check that their dossier is in compliance with current legal requirements and update it if necessary, taking in account the following requirements:
- For a CEP referring to the chemical purity
The general chapter 5.10 'Control of impurities in substances for pharmaceutical use' should be used and the specification of the final substance should include appropriate limits for impurities in compliance with the general monograph 2034, 'Substances for pharmaceutical use'.
Should the dossier refer to a monograph, which includes a non-quantitative test for related substances (such as TLC), and which is therefore not in compliance with the requirements of the 'General monograph 2034', the dossier should be updated with another, suitable quantitative method for related substances. This method should be properly validated with regards to the impurity profile of the substance.
- For a CEP referring to TSE risk
Compliance with the current, revised general chapter 5.2.8 'Minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary products' should be verified.

Treatment of variations related to replacement of acetonitrile in the route of synthesis / analytical methods

As a consequence of the global shortage of acetonitrile, companies are seeking to use alternative solvents or analytical methods to minimise the impact of this shortage. Certificates holders are reminded that such changes will require the submission of variation applications together with appropriate supporting data. The Certification of Substances Division will assess any resulting revision of CEP applications as a fast-track procedure (within 1 month of receipt), provided no other changes are included in the request for revision.