Section D New Chemical Entity
- Product Validation
- Section A
- Section B
- Section C
- Section D
- Section E
- Section P
- Section S
- Part III
- Part IV
Specific Labelling Requirements:
- Please refer to Drug Registration Guidance Document (DRGD) Appendix 19: General Labelling Requirements, Appendix 20 : Specific Labelling Requirement
| Section | Attachment/Information |
|
D1 |
Label (Mock-up) for Immediate Container |
|
D2 |
Label (Mock-up) for Outer Carton |
|
D3 |
Proposed Package Insert |
|
D4 |
Patient Information Leaflet (PIL) (Optional)
A document defining information intended for the patien that may be supplied with a pharmaceutical product by the marketing authorization holder |