Requirements for food and drug registration in Nigeria REQUIREMENTS FOR FOOD AND DRUG REGISTRATION IN NIGERIA: HOW TO REGISTER WITH NAFDAC The Lex Artifex Law Office has introduced the F&D Helpdesk to assist individuals and companies involved in the manufacturing, distribution, exportation, and importation of regulated food and drugs in meeting the requirements set by Nigeria’s National Agency for Food and Drug Administration and Control (“NAFDAC”). This publication gives a snapshot of the regulatory requirements for food and drug registration in Nigeria. THE REQUIREMENTS FOR FOOD AND DRUG REGISTRATION IN NIGERIA: The following are required: Application letter in accordance with the NAFDAC guidelines Information and description of the food and drug facility for inspection Samples of the food and drug products to be registered for laboratory analysis. Payments of prescribed fees All documents are to be completed with the appropriate description to prevent unnecessary delays. TIMELINES FOR FOOD AND DRUG REGISTRATION IN NIGERIA Registration of food product takes about 90 days from the date of acceptance of the application. Registration of drug product takes about 120 days from the date acceptance of the application. Variation of product registration takes not more than 60 days A BREAKDOWN OF THE REGISTRATION PROCESSES TIMELINES FOR FOOD AND DRUG REGISTRATION IN NIGERIA Submission of Application – 0 days Document Verification – 10 days Facility Inspection/Sampling – 10 days for Food, 20 days for Drugs Laboratory Analysis – 30 days for Food, 40 days for Drugs Final Vetting – 10 days Approval Meeting/Issuance of NAFDAC registration Number (Certificate of registration) – 20 days Total number of days: 90 days for Food, 120 days for Drugs COMPLIANCE DIRECTIVE It is mandatory for an applicant to comply with the Compliance Directive (“CD”) within 7 days of issuance. Failure to comply with any Compliance Directive 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. ABOUT LEX ARTIFEX LLP Lex Artifex LLP is the window for manufacturers, exporters, and distributors of regulated food and drug products seeking licensing in Nigeria and seeking access to the Nigerian market. We are a one-stop shop for legal compliance and due diligence services in Nigeria. We provide clients with legal guidance through every step of the trade process and beyond. To learn more about the Lex Artifex LLP's F&D Helpdesk and how we can help you with food and drug registration with NAFDAC in Nigeria, please email: lexartifexllp@lexartifexllp.com; call +234.803.979.5959.

Requirements for food and drug registration in Nigeria

REQUIREMENTS FOR FOOD AND DRUG REGISTRATION IN NIGERIA: HOW TO REGISTER WITH NAFDAC

The Lex Artifex Law Office has introduced the F&D Helpdesk to assist individuals and companies involved in the manufacturing, distribution, exportation, and importation of regulated food and drugs in meeting the requirements set by Nigeria’s National Agency for Food and Drug Administration and Control (“NAFDAC”). This publication gives a snapshot of the regulatory requirements for food and drug registration in Nigeria.

THE REQUIREMENTS FOR FOOD AND DRUG REGISTRATION IN NIGERIA:

The following are required:
  • An application letter
  • Information and description of the food and drug facility for inspection
  • Samples of the food and drug products to be registered for laboratory analysis.
  • Payments of prescribed fees
  • All documents are to be completed with the appropriate description to prevent unnecessary delays.

COST OF REGISTRATION WITH NAFDAC

For information on the applicable tariffs and the cost of products registration with NAFDAC in Nigeria, contact us with the description or image of the specific product(s) sought to be registered, and we will send the cost estimates to you. Email at lexartifexllp@lexartifexllp.com, WhatsApp +234 803 979 5959.

TIMELINES FOR FOOD AND DRUG REGISTRATION IN NIGERIA

  • Registration of food product takes about 90 days from the date of acceptance of the application.
  • Registration of drug product takes about 120 days from the date acceptance of the application.
  • Variation of product registration takes not more than 60 days

A BREAKDOWN OF THE REGISTRATION PROCESSES TIMELINES FOR FOOD AND DRUG REGISTRATION IN NIGERIA

  • Submission of Application – 0 days
  • Document Verification – 10 days
  • Facility Inspection/Sampling – 10 days for Food, 20 days for Drugs
  • Laboratory Analysis – 30 days for Food, 40 days for Drugs
  • Final Vetting – 10 days
  • Approval Meeting/Issuance of NAFDAC registration Number (Certificate of registration) – 20 days
  • Total number of days: 90 days for Food, 120 days for Drugs

COMPLIANCE DIRECTIVE

  • It is mandatory for an applicant to comply with the Compliance Directive (“CD”) within 7 days of issuance.
  • Failure to comply with any Compliance Directive 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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The foregoing provides only an overview and does not in any way constitute legal advice. Readers are advised to obtain specific professional guidance.

ABOUT LEX ARTIFEX LLP

Lex Artifex LLP, a business and commercial law firm in Nigeria, is the window for manufacturers, exporters, and distributors of regulated food and drug products seeking licensing in Nigeria and seeking access to the Nigerian market. We are a one-stop shop for legal compliance and due diligence services in Nigeria. We provide clients with legal guidance through every step of the trade process and beyond.
To learn more about the Lex Artifex LLP’s F&D Helpdesk and how we can help you with food and drug registration with NAFDAC in Nigeria, please email: lexartifexllp@lexartifexllp.com; call +234.803.979.5959.