Product Registration & RegulationHow to register NAFDAC regulated Products


The following are required from the Applicants

  1. Submit all documents for registration and application letter in accordance with the issued guidelines at first instance for any of the service to be rendered by NAFDAC.
  2. Provide NAFDAC with the relevant information and description of the facility for inspection where it relates to registration and importation of NAFDAC regulated products.
  3. Provide samples of the products to be registered when notified by NAFDAC for laboratory analysis.
  4. Ensure all payments are made as at when due (See relevant guidelines and tariffs and fees).
  5. Ensure all documents are complete and with the appropriate description to prevent unnecessary delays.

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Timelines

  1. Registration of food product not more than 90 days from acceptance of application.
  2. Registration of drug product not more than 120 days from acceptance of application.
  3. Variation of product registration takes not more than 60 days

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Compliance Directive

A client is mandated to comply with Compliance Directive (CD) within 7 days of issuance.

Note failure to comply with any CD issued by NAFDAC may be a basis for cancellation of the application and all delays of the client will not be counted within the 90 days for registration.

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Complaints:

All Complaints or conflicts should be forwarded to the reforms unit of NAFDAC through the following address; nafdac@nafdac.gov.ng, complaints@nafdac.gov.ng, or the nearest nafdac state offices (see attached details).

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Summary of Registration processes with timelines

  1. Submission of Application – 0 days
  2. Document Verification – 10 days
  3. Facility Inspection/Sampling – 10 days for Food, 20 days for Drugs
  4. Laboratory Analysis – 30 days for Food, 40 days for Drugs
  5. Final Vetting – 10 days
  6. Approval Meeting/Issuance of NAFDAC registration Number(Certificate of registration) – 20 days

Total number of days: 90 days for Food, 120 days for Drugs