Quality Templates:

• Quality overall summary – product dossier (QOS-PD)
• Quality information summary (QIS)

Bioequivalence Template:

• Bioequivalence Trial Information Form (BTIF)
• Biowaiver Application Form (BAF):
  • NAFDAC BCS Biowaiver Template
  • NAFDAC Additional Strength Biowaiver Template

Labelling Templates:

• Patient information leaflet (PIL)– Template
• Summary Product Characteristics (SmPC) Template

Administrative Templates:

• Letter of Access for CEP
• Letter of Access for APIMF

Overseas Good Manufacturing Practice (GMP):

• Risk Categorization Of Foreign Manufacturing Facilities