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1. Definition and Regulatory Authority

A NAFDAC number is an official registration number issued by the National Agency for Food and Drug Administration and Control (NAFDAC) in Nigeria. NAFDAC is the Regulatory body responsible for overseeing and controlling the importation, exportation, manufacture, advertisement, distribution, sale, and use of food, drugs, cosmetics, medical devices, chemicals, and packaged water in Nigeria.

2. Purpose of the NAFDAC Number

  • This unique number is assigned to approved Regulatory products—such as pharmaceuticals, food, cosmetics, and other consumables—after they have passed safety, quality, and efficacy checks
  • The presence of a NAFDAC Number on a product label indicates that the item has been registered and certified safe for sale and use in Nigeria by the national Regulatory authority. It is a key tool in combating the circulation of fake, substandard, or unapproved products within Nigeria.
  • The number assures consumers and healthcare professionals that the product is legally approved for sale, distribution, or use in the country.
  • Only products with a valid NAFDAC Number are permitted for importation, sale, or distribution in Nigeria.

3. Structure and Appearance

  • The NAFDAC number typically appears as “NAFDAC REG. NO.: xxxxxxx” or a similar format (e.g., “NAFDAC No.: xxxxxxxxxx”).
  • It is printed clearly on the primary and/or secondary packaging of registered regulated products.

4. Regulatory Requirements

  • All regulated products (including pharmaceuticals, foods, cosmetics, household items, medical devices and chemicals) sold, imported, or distributed in Nigeria must bear a valid NAFDAC number.
  • Products without a NAFDAC number are deemed to be unregistered, illegal, and subject to seizure, recall, or destruction by Regulatory inspectors.
  • For imported products, the NAFDAC number is typically required on shipping documents, product packaging, and advertising or promotional materials.

5. Registration Process

  • To obtain a NAFDAC number, a manufacturer, importer, or distributor must follow the NAFDAC registration process, which involves submission of application forms, documentation (including Certificate of Analysis, Certificate of Manufacture, GMP certificates, etc.), sample evaluation, and compliance assessment.
  • Upon successful evaluation and satisfaction of all requirements, NAFDAC assigns a unique registration number to the approved product.
  • Following are the summarized key steps for application of the NAFDAC Number:

i. Facility Pre-Inspection
 NAFDAC will inspect your manufacturing or processing facility before production to ensure compliance with Good Manufacturing Practices (GMP).

ii. Submission of Application
 Submit a formal application (online or at NAFDAC offices) for registration. The application must include:

  • Completed application form
  • Valid company registration documents
  • Relevant business permits
  • Importers: Power of Attorney from the manufacturer
  • Product samples and labels
  • Evidence of payment of application and inspection fees

iii. Product Assessment and Laboratory Evaluation
 NAFDAC carries out laboratory analysis of product samples for safety, quality, and efficacy.

iv. Facility Registration and Documentation Review
 NAFDAC reviews the facility and supporting documents. There may be a risk assessment or audit visit.

v. Final Approval and Issuance of NAFDAC Number
 If the product passes all evaluations and facility is compliant, NAFDAC will issue a Registration Certificate with a unique NAFDAC Number

6. Verification and Enforcement

  • The NAFDAC number can be checked by consumers and Regulatory officials through the NAFDAC Product Authentication Service, website, or official communication channels.
  • Displaying counterfeit or fake NAFDAC numbers is a criminal offence under Nigerian law.

Key Points to Remember:

  • The NAFDAC number is a mandatory Regulatory mark for product compliance in Nigeria.
  • It ensures the product has passed mandatory health, safety, and efficacy checks.
  • Products found without a NAFDAC number are subject to removal from the market and may carry legal penalties.

Conclusion 

Securing a valid NAFDAC number is essential for lawful market access and brand credibility in Nigeria’s regulated sectors.

Nigeria Drug Registration and Approval Process requires strong Regulatory understanding and precise execution. With deep expertise in African Regulatory frameworks, Freyr Solutions supports global companies in navigating NAFDAC registration requirements seamlessly—from dossier preparation to product approval—ensuring faster compliance and market entry. Contact us to get started.