Sequence Number Four digit sequence number matching the sequence folder being submitted. Example: 0000 Related Sequence Number The related sequence number is used to group sequences within an eSubmission. This will allow easy sequences associated with a particular regulatory activity among the multiple activities submitted during the lifecycle of the eSubmission. The four (4)-digit related sequence no. for each regulatory activity is the of the initial sequence of that regulatory activity. Therefore, all sequences that belong to a specific regulatory activity should contain the same four (4)-digit number in the related sequence no field. Related Sequence Sequence Sequence Sequence Type Description 0000 0000 A: Initial Pharmaceutics Application - New Chemical Entity 0001 0000 J: Response to Supplementary Request for Information Information Date: 0002 0000 J: Response to Supplementary Request for Information Information Date: 0003 0000 J: Response to Supplementary Request for Information Information Date: 0004 0004 F: Variation - Initial Major Variation Variation (MaV) 0005 0005 H: Periodic Initial Safety Update Report Report 0006 0006 F: Variation - Initial Minor Variation Variation (MiV-PA)
Sequence Number Four digit sequence number matching the sequence folder being submitted. Example: 0000 Related Sequence Number The related sequence number is used to group sequences within an eSubmission. This will allow easy sequences associated with a particular regulatory activity among the multiple activities submitted during the lifecycle of the eSubmission. The four (4)-digit related sequence no. for each regulatory activity is the of the initial sequence of that regulatory activity. Therefore, all sequences that belong to a specific regulatory activity should contain the same four (4)-digit number in the related sequence no field. Sequence Related Sequence Sequence Type Sequence Description 0000 0000 A: Pharmaceutics - New Chemical Entity Initial Application 0001 0000 J: Supplementary Information Response to Request for Information Date: 0002 0000 J: Supplementary Information Response to Request for Information Date: 0003 0000 J: Supplementary Information Response to Request for Information Date: 0004 0004 F: Variation - Major Variation (MaV) Initial Variation 0005 0005 H: Periodic Safety Update Report Initial Report 0006 0006 F: Variation - Minor Variation (MiV-PA) Initial Variation
20180209891095870.docx