Description - Figure 8 - Consultation Document - Draft Guidance Document: Preparation of Drug Regulatory Activities in Electronic Common Technical Document (eCTD)

Figure 8 is a graphic representation of the inner and outer label leaf elements. For draft inner and outer label leaf elements provided for the first time the operation attribute should be “new”. For the leaf element provided with all other sequence numbers, the operation attribute should be “replace”.  For final inner and outer label leaf elements provided for the first time with the Drug Notification Form (DNF) the operation attribute should be “new”. For the leaf element provided with all subsequent DNF, the operation attribute should be “replace”.
Regulatory Activity A (new drug submission): Document (operation attribute) is Seq 0000 Initial Leaf A3 (N), current view is A0;
Regulatory Activity A (new drug submission): Document (operation attribute) is Seq 0001 Response to clarifax Leaf A1 (R), current view is A1;
Regulatory Activity A (new drug submission): Document (operation attribute) is Seq 0002 Drug Notification Form Leaf B2 (N), current view is A1+B2;
Regulatory Activity B (supplemental to a new drug submission): Document (operation attribute) is Seq 0003 initial Leaf A3 (R), current view is A3+B2;
Regulatory Activity B (supplemental to a new drug submission): Document (operation attribute) is Seq 0004 initial Leaf A4 (R), current view is A4+B2;
Regulatory Activity B (supplemental to a new drug submission): Document (operation attribute) is Seq 0005 Drug Notification Form Leaf B5 (R), current view is A4+B5;
Regulatory Activity B (supplemental to a new drug submission): Document (operation attribute) is Seq 0006 response to clarifax Leaf A6 (R), current view is A6+B5;
Regulatory Activity B (supplemental to a new drug submission): Document (operation attribute) is Seq 0007 drug notification form Leaf B7 (R), current view is A6+B7;
Note: Each draft label should be submitted as a separate file (for example: inner label, outer label, box label, blister label etc.). Each final label should also be submitted as a separate file.