How To Register A Product In Nigeria With The National Agency For Food And Drug Administration And Control

The National Agency for Food and Drug Administration and Control (NAFDAC) is the agency responsible for regulating and granting permits for the exportation, importation, manufacture, and the registration of products such as drugs, chemicals, consumable goods, cosmetics, biological, and medical services which are produced in or outside Nigeria.

Companies involved in the exportation, importation, manufacture, and distribution of products such as drugs, chemicals, consumable goods, cosmetics, biological, and medical services in or outside Nigeria are required to register such product with NAFDAC after incorporation with the Corporate Affairs Commission (CAC).

Requirements for Registering a Product with NAFDAC

1. A formal written application for product registration directed to the Director (Registration and Regulatory Affairs) stating the name of the manufacturer, brand name, and product.
2. Fill the prescribed NAFDAC Application Form
3. Evidence of payment of prescribed fees.
4. Certificate of Incorporation of the company
5. The certificate of inspection issued by NAFDAC
6. Certificate of fumigation
7. Original copy of Power of Attorney from the product manufacturer (if imported)
8. Trademark registration in Nigeria for brand name
9. A signed and endorsed certificate of Pharmaceutical Product (applicable to drugs only).
10. Letter of invitation from the manufacturer to inspect the factory abroad, full names, and site of a plant (where applicable).
11. Pack of product samples for quality analysis and inspection.
12. Comprehensive Certificate of Analysis which must be on a letter headed paper of the quality control laboratory where the sample was tested or evaluated and it should contain the following information:
    a. The brand name of the product
    b. The batch number of the product
    c. The manufacturing and expiry dates
    d. The name, designation, and signature of the analyst
13. Application letter for Import Permit by the applicant (i.e. locally registered company).
14. Evidence of warehouse acquisition (where applicable)
15. Coloured Artwork or Label of the product and leaflet insert of the product.
16. Manufacturer Information such as Name of the Company, full location address of the factory, email address, and current phone no. & fax no, the name of contact person overseas, telephone no, email address. Name of airport closest to the location and guide map illustrating the shortest land/air route to the factory overseas (where applicable)
17. Local Agent Information: Name of the locally registered company that will take immigration responsibility; full location address and functional telephone number & email address (where applicable)
    

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