Do you Know about Sister File??

Sister File: There are cases when a manufacturer has been granted a CEP for a substance and where they apply for a second CEP for the same substance to cover an alternative process, generally because the existing one cannot cover the new process/conditions. Any differences compared to the approved CEP from a content point of view could be considered as revisions. These applications will be called sister files.

Since the original dossier has already been approved, it is proposed to treat sister dossiers with a fast track procedure and focus the evaluation on the variations compared to the approved CEP dossier. 

This is applicable typically in case of changes of solvents used in the final purifications steps or processes carried out in two sites belonging to the same company, if the company wants to have both situations covered by CEPs.

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

Further Information: Sister File