What Nigerian importers need to know about registering imported medicines with NAFDAC — documentation, timelines and how to prepare a smooth submission.
Nigeria is one of the largest pharmaceutical markets in Africa, and the National Agency for Food and Drug Administration and Control (NAFDAC) regulates the registration of imported medicines. Here is what importers should know when sourcing from India.
Why registration matters
No medicine can be legally imported and distributed in Nigeria without NAFDAC registration. Planning registration early avoids costly delays at the port and protects your business.
Key documents you will need
- Certificate of Pharmaceutical Product (COPP) from the country of origin
- Manufacturing license and WHO-GMP certificate of the manufacturing facility
- Certificate of Analysis (COA) and finished product specifications
- Product dossier, generally in CTD format
- Samples and reference standards for laboratory analysis
- Labeling and artwork compliant with NAFDAC requirements
Typical steps
- Appoint a local representative / importer of record.
- Compile and submit the product dossier to NAFDAC.
- Facility inspection or documentary GMP assessment.
- Laboratory analysis of submitted samples.
- Review and issuance of the registration certificate.
How a supplier can help
A well-prepared exporter provides a complete, review-ready dossier and all supporting certificates, which significantly reduces back-and-forth and speeds approval. Explore what we can supply to the Nigerian market.
Get support with your submission
We supply WHO-GMP certified generics with full documentation for NAFDAC. Contact our export team to discuss your product list.
Need a supplier for this market?
Tuli Enterprise supplies WHO-GMP certified generics and nutraceuticals worldwide with full registration and export documentation.
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