Registration of Imported Products with NAFDAC in Nigeria

Introduction

A pre-requisite for the importation, marketing, distribution and sales of foods, drugs, chemicals, cosmetics and medical devices manufactured or produced abroad is registration with the National Agency for Food and Drugs Administration and Control (NAFDAC) in Nigeria. Failure to register with NAFDAC before importing, marketing or distributing any regulated products manufactured or produced abroad would attract enforcement actions from NAFDAC.

In this article, we discuss the requirements and processes of registering imported products with NAFDAC.

Requirements for Registering Imported products with NAFDAC

There are minimum requirements to be met before any imported products can be registered with NAFDAC. These requirements include the following:

1. Certificate of Company Incorporation: An applicant who wishes to register a product with NAFDAC is required to submit evidence of company incorporation obtained from the Corporate Affairs Commission (CAC). The applicant may register its own local company with CAC or appoint a local agent for the registration process in which case the applicant’s or local agent’s company information and documents would be submitted to NAFDAC for the registration process.
2. Evidence of Trademark Registration: Trademark registration certificate or acceptance letter issued in the name of the manufacturer by the Nigerian Trademark Registry must be submitted to NAFDAC. Read our previous article on The Procedure for the Registration of Trademarks in Nigeria
3. Power of Attorney or Contract Manufacturing Agreement: Where a local agent applies as applicant on behalf of a foreign manufacturer, a power of attorney issued by the manufacturer is required to be submitted to NAFDAC. The power of attorney must be signed by either the Managing Director, General Manager, Chairman or President of the manufacturer. However, where the applicant wishes to register the products directly without appointing a local agent in Nigeria, it is required to provide a Contract Manufacturing Agreement.
4. Certificate of Manufacture and Free Sale: This document indicates that the manufacturer is licensed to manufacture the products and the sale of the product does not contravene the laws of the country of manufacture. For drugs, a Certificate of Pharmaceutical Product which shows that the sale of the product does not contravene the drugs law of the country of manufacture is required.
5. Comprehensive Certificate of Analysis: The certificate is issued by a quality control laboratory that tested or evaluated samples of the product to be registered with NAFDAC. It must indicate the brand name and batch number of the products and must be signed by a laboratory analyst who tested or evaluated the samples.
6. Annual License to Practice: An applicant registering a drug is to provide the annual license to practice issued by the Pharmacist Council of Nigeria to the Superintendent Pharmacist for human or veterinary drugs.
7. Labels or artworks: Labels and artworks which must contain a space for registration number, batch number, date of manufacture and expiry, etc. must be submitted to NAFDAC.
8. Letter of Invitation for Good Manufacturing Practice: The letter which is addressed to NAFDAC by the manufacturer invites NAFDAC officials to visit and inspect the factory of the manufacturer abroad for Good Manufacturing Practice.

Registration Processes with NAFDAC

1. Application to NAFDAC for Registration: Application form is purchased from NAFDAC and completed with all the information required for the registration of the product. An application letter to register the product is addressed to the NAFDAC supported with all the required documents for the product to be registered including the duly completed application form.
2. Import Permit: NAFDAC issues import permit for the product upon the satisfactory review of the application for registration and the documents in support. The import permit enables the applicant to import a specify number of the products as samples to be subject to laboratory analysis by NAFDAC.
3. Laboratory Analysis: The imported samples of the product are submitted to NAFDAC for laboratory analysis. Documents to be submitted together with the imported samples include certificate of analysis, a copy of import permit and evidence of payment of application and processing fee.
4. Factory Inspection: NAFDAC officials visit the factory of the manufacturer abroad to inspect it for Good Manufacturing Practice (GMP) upon the payment of inspection fees and in furtherance of the letter of invitation provided to NAFDAC.
5. Product Registration Approval: The application for registration of the product is approved where NAFDAC is satisfied with the applicant’s documentations and GMP of the manufacturing facility. Upon approval, a certificate of registration is issued to the applicant. The registration is valid for 5 years and subject to renewal every 5 years.

Conclusion

An applicant who wishes to register imported products in Nigeria is required to apply to NAFDAC for the registration of the products through its local company incorporated with CAC in Nigeria or apply through a local agent. The application for registration submitted to NAFDAC is required to be accompanied with required documents and payment of official fees. NAFDAC reviews the application and approves the registration where the applicant satisfies the registration requirements.