EDQM - Sister File Procedure

 

Sister File Procedure

 

The sister file procedure is intended to facilitate the submission of similar dossiers within the Certification procedure, and to allow applicants benefit from a fast-track procedure and harmonised assessments. An applicant who has been granted a certificate of suitability (CEP) may wish to apply for a second CEP for the same substance, either because the specifications of the final substance obtained with an alternative process cannot be covered by the  existing CEP or because the applicant wishes to have separate CEPs for different conditions of preparation or qualities (for example, to cover an alternative manufacturing site or an alternative grade).

This new application can be submitted as a “sister file”,

Note: Sterile and TSE applications are outside the scope of this procedure.

 Conditions:

• The original application should already have been approved by EDQM and the CEP granted
• The manufacturer should be the same for both applications
• Differences described in the new dossier compared to the already granted CEP can be classified and hence treated as a revision.

Documentation:

• New application according to the current procedures
• Reference to the already approved dossier and explanation of differences
• A comparative table of the affected dossier sections for both the approved and the new application
• A subtitle for the CEP of the sister application, in order to differentiate both CEPs.