CEP 2.0 – A “new-look” CEP is here

The European Directorate for the Quality of Medicines & HealthCare (EDQM) are currently implementing a “new-look” CEP (Certificate of Suitability). This is following a public consultation with stakeholders which in turn led to the launch of the project CEP 2.0.

The aim of the project was to provide greater transparency and reduce the regulatory burden.

The EDQM has outlined 9 specific areas (listed below) which will be affected by the implementation of CEP 2.0:

  • Area 1: CEPs and information reported
  • Area 2: Changes regarding assessment of CEP applications
  • Area 3: On-line public certification database
  • Area 4: Authorities database
  • Area 5: Fostering information sharing between CEP holders & MAH
  • Area 6: Reduction of revisions of CEPs
  • Area 7: Impact of changes and their implementation
  • Area 8: Trainings for CEP holders and CEP users
  • Area 9: Revising documents available on the EDQM website

Further details about each area is provided on the EDQM website here, under the heading ‘CEP 2.0 – What will change?’.

The layout of the “new look” CEP  will be similar to the current one but the main changes to the information that will be reported on CEPs going forward are:

  • Numbering system will no longer include renewal number at the start i.e. R0 CEP YEAR-123-Rev 05
  • The CEP holder’s name and address & all sites listed on CEP will now include the EMA SPOR/OMS Organisation (Org) and Location (Loc) ID.
  • Information reported on the CEP for chemical purity, Herbal Drug/Herbal Drug preparations and related to the quality of the substance will be revised, for example:
    The approved specification (as in the section 3.2.S.4.1) and certain analytical methods, will be appended to the CEP
  • The quality of water (i.e. purified water, distilled etc) used in the last steps of synthesis will be reported on CEP.
  • No declaration of access box will be in the CEP document anymore (will be replaced by a letter of access from the CEP holder).
  • Also, it will be issued as an electronic document with a digital signature (No more paper copies).

The implemention of CEP 2.0 started on 1st of September 2023.
There will now be a coexistence of “new look”, “hybrid look” and “old look” CEPs for some time:

  • From 1st 2023, “new look” CEPs (as outlined above) are being issued for new CEPs granted and following renewal procedures.
  • A “hybrid look” CEP will be granted after a revision of an existing CEP when the content of the CEP is impacted, but the company’s specifications will not be appended to the CEP (since this may require additional assessment not linked to the request for revision). The “hybrid look” CEP will have the new numbering, SPOR/OMS Loc ID, the declaration of access removed and will be issued as an electronic document with an e-signature.
  • “Old look” CEPs will continue to be valid until they need to be revised.

A training webinar is presented on the EDQM website.

The webinar is for CEP applicants, holders and users, including manufacturers and competent authorities. The webinar provides an overview of the changes and outlines the revised evalution procedures (new applications, revisions, renewals) for CEP applicants and CEP holders.

The EDQM website also includes responses to a list of Frequently Asked Questions (FOA).

If you need assistance with anything CEP related, get in touch with us at info@eureg.ie

Written by

Claire Brown

Claire Brown 1