Quality & Compliance
Safety & Vigilance
26 june 2023
The “CEP 2.0” (the new name for the CEP of the future) is a “new-look” CEP. Its new look will offer greater transparency of the information conveyed to CEP users without increasing the regulatory burden.
The process to redesign CEPs started in late 2020 with a public consultation, followed by a second, more targeted one in 2022. Based on the feedback received during these discussions, the Certification Steering Committee decided on the future design of CEPs. This impacts CEP applicants, holders and users of CEPs.
The implementation process of the revised Certificates of Suitability to the EU Pharmacopeia (CEP 2.0) is marking a new step, as announced by the European Directorate for the Quality of Medicines & HealthCare (EDQM).
CEP 2.0 will majorly impact all users; therefore, a stepwise approach is a must for its implementation. As a part of the implementation of CEP 2.0, as of 1st June 2023, the changes to the content of CEP applications will be implemented, and the use of updated application forms will be mandatory. Using the EMA SPOR/OMS Organisation (Org) and Location (Loc) ID will become mandatory for all sites listed in the application form.
With its new look, CEP will become an electronic document with a digital signature. It will be downloadable as a pdf or printed by CEP holders to share with their customers for inclusion in Marketing Authorisation Applications (MAA). EDQM will deliver no paper copy.
Find below the table listing a few updates in CEP 2.0 Layout:
|Changes in Layout||Current CEP||CEP 2.0|
|CEP numbering||Rx-CEP YEAR-xxx-Rev xx||CEP-YEAR-xxx-Rev-xx
(The increment due to renewal is no longer part of the number)
|Company details||Name and address||Name, address and EMA SPOR/OMS Organisation (Org) and Location (Loc) ID|
|Declaration of access||Declaration of access box||No declaration of access box in the CEP document|
|Technical information||Additional controls for impurities or solvents||Specification as per section 3.2.S.4.1 and the additional methods as approved during the assessment of the CEP dossier.|
|Use of water in the last steps of the process||The quality of water used in the last steps of the synthesis of the substance|
To smoothen the implementation of CEP 2.0, the Coexistence of “New look” CEP, “Old look” CEP and “Hybrid look,” CEP will remain for some time. This will ensure an appropriate balance between updating the existing CEPs to the “new look” CEP and the burden generated for the holders / the EDQM / the other users. Let’s have an overview of the layout and implementation of “New look” CEP, “Old look” CEP and “Hybrid look” CEP.
|Type of CEP||Old look||Hybrid look||New look|
|Layout||Current layout CEPs||These CEPs will have the new numbering, SPOR/OMS ORG_ID and LOC_ID, the declaration of access removed, and an e-signature issued as an electronic document.||These CEPs will have the new numbering, SPOR/OMS ORG_ID and LOC_ID, the declaration of access removed, an e-signature along with the specifications (3.2.S.4.1) and additional methods appended and are issued as an electronic document.|
|Implementation remarks||No CEP will be granted with the “old look” after implementing CEP 2.0. CEPs granted before this date will still be valid until they get revised.
|The “hybrid look” CEP will be granted after the revision of existing dossiers when there is no impact on the information reported on the CEP.||The “New Look” CEP will be granted for any new CEP and a renewal.
During the initial implementation phase of CEP 2.0, the CEP holders will not be pushed to switch to the “new look” CEP for their existing CEPs except at renewal, after which the specification of the substance will be appended to the CEP. There will, however, be a special type of CEP revision request to switch to the “new look” CEP for the convenience of CEP holders.
Implementing CEP 2.0 will also impact the content of the CEP dossier and CEP assessment process.
Some changes will be introduced regarding the content of the CEP dossier and associated assessment as listed below:
The new features of the public CEP database would be:
With the new look, “CEP 2.0” will bring greater transparency within the information shared. It will widen the regulatory acceptance of CEPs through proposed changes in the content and assessment of CEPs.
For CEP applicants and CEP holders, it is important to understand proposed changes in the layout and quality of CEP and to implement them via required changes in their submissions. To ensure that their applications are processed smoothly, applicants have to meet the new expectations regarding CEP dossiers.
During the transition period, applicants/ CEP holders face challenges getting the right information and correctly strategising their submissions. In such a situation, one can contact PLG to get solutions to challenges faced during the implementation of CEP 2.0. PLG can help evaluate the impact of CEP 2.0 implementation on currently approved CEPs and new CEP applications. Our services can support getting approval for your CEP in line with CEP 2.0 with a new look and assessment. PLG experts know how to facilitate the creation of SPOR/OMS LOC/ORG ID/LOCATION ID. Our experts ensure end-to-end support for CEP procedures (new applications, revisions, renewals), such as preparation and review of CEP dossiers, regulatory submission, publishing and post-approval management.
Contact us to find out how PLG can provide tailored support to help you implement CEP 2.0.
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