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Nigeria
QUALITY GUIDELINES FOR THE REGISTRATION OF PHARMACEUTICAL PRODUCTS FOR HUMAN USE IN NIGERIA
This module provides all the administrative and product-specific information required for pharmaceutical product registration in Nigeria under NAFDAC. It ensures applicants present complete, standardized dossiers in line with the Common Technical Document (CTD) format while addressing local requirements. The contents include:
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Cover letter and completed application form
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Comprehensive product information (active ingredient(s), strength, dosage form, packaging)
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Applicant and manufacturer details
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Labeling, packaging, and Patient Information Leaflet (PIL)
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Evidence of compliance with Nigerian laws, including GMP certification and fees payment
Unlike CTD Modules 2–5, this section is country-specific and designed to capture Nigeria’s regulatory expectations.
Use Cases
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Pharmaceutical Companies: Ensure applications are complete and aligned with NAFDAC’s expectations before submission.
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Regulatory Authorities: Use as a reference checklist for dossier completeness and compliance verification.
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Legal & Compliance Teams: Verify that product submissions meet both local and international standards.
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Academia & Researchers: Provide a framework for teaching regulatory science and dossier preparation.
Key takeaways you'll learn
