The sister file procedure is intended to facilitate the submission of similar dossiers within the Certification Procedure, and to allow applicants to benefit from a fast-track procedure and harmonised assessments.
A company which has been granted a certificate of suitability (CEP) may wish to apply for another CEP for the same substance. This may be because it is not possible to apply for a revision of the initial CEP or when the company wishes to have separate CEPs for different conditions of preparation or qualities (for example, to cover an alternative manufacturing process, manufacturing site or an alternative grade).
This new application can be submitted as a “sister file”, provided that the conditions listed in the guideline PA/PH/CEP (09) 141, are fulfilled.
Holders of a Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP) should send, in electronic format, the following documentation to the Certification of Substances Department (DCEP) of the EDQM:
- a completed specific application form, which includes invoicing details and a comparative table of the differences between the existing CEP and the new application for a sister file,
- a complete dossier in eCTD format,
- A risk assessment relating to the potential for nitrosamine impurities in the substance should be submitted for the sister file application.
These applications are managed as described in the guidance PA/PH/CEP (09) 141 and PA/PH/CEP (13) 110.
Search for a list of granted CEPs, their type, the name of the substance, the full CEP number, the issue date and validity status, using the Certification Database (updated daily).
Applicants commit to provide samples of substance and/or impurities when requested by the EDQM.