Part 1, Section D : Label (Mock-Up) for Immediate Container, Outer Carton and Proposed Package Insert & PIL
Please refer:
- Drug Registration Guidance Document (DRGD) - Appendix 9: Labeling Requirement
| Section | Attachment/Information |
|
D1 |
Label (Mock-up) for Immediate Container Appendix 9: 9.1.1 LABEL (MOCK-UP) FOR IMMEDIATE CONTAINER AND OUTER CARTON |
|
D2 |
Label (Mock-up) for Outer Carton Appendix 9: 9.1.1 LABEL (MOCK-UP) FOR IMMEDIATE CONTAINER AND OUTER CARTON |
|
D3 |
Proposed Package Insert |
|
D4 |
Patient Information Leaflet (PIL) / RisalahMaklumat Ubat Pesakit (RiMUP) |
|
D5 |
Label (Mock-up) for Diluent |
