The current EDQM policy PA/PH/CEP (09) 141, 2R, “Guidance on applications for “sister files””, has guided the sister file procedure for CEPs for many years. Experience gathered over time indicates that there may be discrepancies in the understanding of the procedure and the EDQM has noted that certain CEP applications are being submitted under the sister file procedure even though their characteristics would more appropriately classify them as new applications.
This observation highlights the need to ensure that the sister file procedure is applied according to the established policy and used strictly within its intended scope.
To reinforce clarity, avoid misclassifications and ensure consistency, the EDQM will implement the following measures:
- Stricter screening of requests for sister file applications at reception
All requests for sister file applications will undergo stricter content validation with the aim of confirming full alignment with the established criteria and ensuring that the appropriate assessment pathway is selected. Hence, applications that do not fully meet the requirements will be reclassified as new applications.
- The EDQM will revise the “Guidance on applications for “sister files" in 2026.
The updated version will provide guidance with enhanced clarity on eligibility criteria, further limiting the scope for interpretation.
These measures will support consistent decisions, ensuring equal treatment of all applicants within the CEP certification framework.
The stricter screening of sister file applications as highlighted above is scheduled to begin on 1 February.