Requirements for NAFDAC product Registration in Nigeria

The National Agency for Food and Drug Administration and Control (NAFDAC) is the key body in Nigeria regulating the registration of drugs, medical devices, food supplements, and cosmetic products.

For a manufacturer seeking to successfully carry out a product registration in Nigeria, the under-listed documents formed part of documents required for the registration of product at the National Agency for Food and Drugs Administration and Control (NAFDAC);

  1. Power of Attorney or Contract Manufacturing Agreement– the Power of Attorney is usually issued by the manufacturer of the product in favour of their local agent stating the name of the product and authority to register the product at NAFDAC. The power of attorney may be signed by the Managing Director of the company, or General Manager, or Chairman or President of the manufacturing company and notarized in the country where the product was manufactured. In the case of Contract Manufacturing Agreement, it must be signed by parties to the agreement and notarized in the country of manufacture.
  1. Certificate of incorporation of the applicant (local agent) -this is the evidence of registration at the Corporate Affairs Commission (CAC), Abuja-Nigeria.
  1. Certificate of trademark registration of the brand name in the name of the manufacturer/owner of the product. This registration is done at the Trademarks Registry, Abuja-Nigeria. Where the certificate of registration has not been obtained at the time of submitting the documents, evidence of the trademark application (Acknowledgement and Acceptance Forms) may be used.
  1. Certificate of manufacture and free of sale – this document shall indicate the name of manufacturer and the product to be registered. It must be authenticated by the Nigerian Embassy in the country of manufacture.
  • Comprehensive Certificate of product analysis – this document is issued by the manufacturer of the product. The name of the product, name and designation of the analyst must be indicated on the face of the document. It should also be authenticated by the Nigerian Embassy in the country of manufacture.
  • An application letter by the local agent for Import Permit in respect of the product.
  • All the documents listed above will be accompanied with a duly completed Registration Form.

The original documents and 2 set of photocopies of each of the documents listed above shall be submitted to the appropriate department in NAFDAC for assessment. If the documents are considered sufficient for the registration, the applicant may proceed to obtain an Import Permit from the Drug Registration Division on payment of the official fee. Please note that this permit allows the applicant to import only samples of product needed for the registration process.

As soon as the applicant obtains the Import Permit, the Agency will request for the under-listed for product vetting.

  • A letter of invitation addressed to NAFDAC for inspection of the manufacturer’s factory abroad;
  • A copy of the import permit and receipt of payment;
  • Certificate of analysis of the product;
  • 3 labeled samples of the product.

An acknowledgement paper will be issued to the applicant upon receipt of the vetting samples.

Finally, laboratory analysis will be conducted on the product. The applicant will be required to make necessary payment covering the official fee of the product registration, acknowledgement of receipt of vetting samples and the product samples for laboratory analysis. This will be followed by the issuance of the registration certificate.

Timelines

According to NAFDAC, registration of food product is not more than 90 days from the date of acceptance of application. While the registration of drug product is not more than 120 days from acceptance of application, the variation of product registration takes not more than 60 days.

By Adeola Oyinlade & Co

Note: The content of this article is anticipated to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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