Part I, Section D : Label (Mock-Up) for Immediate Container, Outer Carton and Proposed Package Insert & PIL
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 |
