Guideline for CEP Revisions published for Comment

At the beginning of December 2025, the draft of the 8th revision of the 'GUIDELINE ON REQUIREMENTS FOR REVISION/RENEWAL OF CERTIFICATES OF SUITABILITY TO THE EUROPEAN PHARMACOPOEIA MONOGRAPHS' was published on the EDQM website in the 'Newsroom Certificate of suitability' section. This draft (dated October 2025) is now available for public comment in the 'Consultation space' section until 16 January 2026. Comments and remarks can be submitted here.

According to the document's change history, the new draft contains changes based on the following three points:

• Adjustments due to the new EU Variations Regulations
• Changes due to the new EU regulations for veterinary medicinal products
• Updates due to the current CEP process

The updated table of contents is listed below:

1 Introduction
2 Classification of Changes
3 Documentation to be provided
4 List of Changes
  4.I Administrative Changes
  4.II Quality Changes
   4.II.1 Manufacture
   4.II.2 Control of the starting materials/reagents/intermediates/final substance
   4.II.3 Container closure system
   4.II.4 Stability
   4.II.5 Design space and Post-Approval Change Management Protocols
  4.III Changes to TSE CEPs
  4.IV Use of CEP in an application for another CEP
5 Renewal
6 Transfer of holdership
7 Substances for veterinary use only

This shows that the title of subchapter 4.II.2 has been slightly changed. In the previous version of the guideline, it was still called 'Control of the final substance'. The updated guideline includes starting materials, intermediates and reagents. The title of subchapter 4.III has also been slightly changed and is no longer called 'TSE changes' but has been clarified to 'Changes to TSE CEPs'. Chapter 7, 'Substances for veterinary use only', has been added entirely new.

The revised draft 'GUIDELINE ON REQUIREMENTS FOR REVISION/RENEWAL OF CERTIFICATES OF SUITABILITY TO THE EUROPEAN PHARMACOPOEIA MONOGRAPHS' can be found in the 'Newsroom Certificate of suitability' or in the 'Consultation space' section of the EDQM website.