Application Forms

** Agency implements ICH Q1 and Q7 Guidelines ** ** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-6 ** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-6 ** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-6

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Application Forms

Product Registration & Regulation

Application Forms

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

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Content Current as of February 15, 2024

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NATIONAL AGENCY FOR FOOD AND DRUG ADMINISTRATION AND CONTROL (NAFDAC)

This is the Official Website of Nafdac, the Agency commissioned to protect and promote the public health by instituting an effective and efficient regulatory system that ensures only the right quality food, drugs and other regulated products are manufactured, exported, imported, advertised, distributed, sold, and used