Quality Templates:
| SN | Quality Templates |
|---|---|
| 1 | Quality overall summary – product dossier (QOS-PD) |
| 2 | Quality information summary (QIS) |
Bioequivalence Templates:
| SN | Bioequivalence Template |
|---|---|
| 1 | Bioequivalence Trial Information Form (BTIF) |
| 2 | NAFDAC BCS Biowaiver Template |
| 3 | NAFDAC Additional Strength Biowaiver Template |
Labelling Templates:
| SN | Labelling Templates |
|---|---|
| 1 | Patient information leaflet (PIL)– Template |
| 2 | Summary Product Characteristics (SmPC) Template |
Administrative Templates:
| SN | Administrative Templates |
|---|---|
| 1 | Letter of Access for CEP |
| 2 | Letter of Access for APIMF |
Overseas Good Manufacturing Practice (GMP):
| SN | Overseas Good Manufacturing Practice (GMP) |
|---|---|
| 1 | Risk Categorization Of Foreign Manufacturing Facilities |
