Overview of product registration and other incidental matters at NAFDAC – Frequently Asked Questions.

WHAT IS NAFDAC?

NAFDAC refers to the National Agency for Food and Drug Administration and Control, the government regulatory agency charged with regulating and controlling the manufacture, importation, exportation, distribution, advertisement, sale and use of food, drugs and related products (“Regulated Products”).

WHAT PRODUCTS NEED TO BE REGISTERED WITH NAFDAC?

“Regulated Products” include foods, drugs, cosmetics, medical devices, packaged water, chemicals, detergents. All Regulated Products, must be registered with NAFDAC before they can be bought, manufactured, sold and distributed into the Nigerian market.

CAN A FOREIGN MANUFACTURER OF ANY OF THE REGULATED PRODUCTS APPLY DIRECTLY TO NAFDAC FOR THE REGISTRATION OF ITS PRODUCTS?

No, it cannot. Foreign Manufacturers (“FMs”) are required to register their products through local representatives – Nigerian entities/persons, in whose name the product registration certificates will be issued. FMs usually achieve this through any of the following options:

(a) Incorporation of local subsidiaries in Nigeria for the purpose of registering their products with the NAFDAC;

(b) Appointment of an existing Nigerian company (such as their local distributors) as their local representatives in Nigeria; or

(c) Engaging a custodial services company to hold the product registrations on their behalf. This option is usually adopted by FMs who prefer not to appoint their local distributors as their local representative and also do not want to go through the rigors of incorporating a company in Nigeria solely for the purpose of holding their product registrations. The services rendered by the custodial services company will include holding the NAFDAC registrations in its own name and issuing Letters of No Objections to enable the FM’s distributors import the registered products into the Nigerian market.

HOW LONG IS THE NAFDAC PRODUCT REGISTRATION PROCESS?

The registration process can be completed within 90 working days from the date of acceptance of the application for food products, and 120 working days for drug products.

This is, however, subject to delays often attributable to delays in providing requested information or documents, objections or bureaucratic bottlenecks that often arise in the course of the registration. Therefore, the process typically takes longer in practice.

WHAT DOCUMENTS ARE REQUIRED FOR REGISTRATION?

The application for product registration is made through the NAFDAC Automated Product Administration and Monitoring System (NAPAMS) portal. The following documents are required for registration:

• Completed application form;

• Application letter addressed to the Director-General of NAFDAC and directed to the appropriate directorate within NAFDAC, based on the nature of the product;

• Certificate of Registration (or Notice of Acceptance) or Renewal Certificate (where applicable) of the brand name/trade mark with the Nigerian Trade Marks Registry;

• Invitation letter written by the manufacturer addressed to NAFDAC, requesting for the inspection of the manufacturer’s factory;

• Means of Identification/Certificate of Incorporation or registration of the applicant;

• Samples of the labels of each product (which must comply with NAFDAC’s labelling requirements), and must contain relevant information such as the list of ingredients, batch number of the products issued by NAFDAC, date marking instructions etc;

• Evidence to support any special labeling claims regarding the character, quality and safety of the product (where applicable);

• A declaration to be made before a notary public by the applicant confirming that the information and documents submitted to NAFDAC are authentic;

• Adequate number of samples of the product; and

• Evidence of payment of the prescribed fees.

Where the products to be registered are imported, the following additional documents will be required:

• Power of attorney (“PoA”) granted to a Nigerian representative or an agreement between the manufacturer and the Nigerian agent empowering the Nigerian agent to register the product(s) in Nigeria;

• Certificate of Manufacture and Free Sale;

• Comprehensive Certificate of Analysis of the product;

• Certificate of Incorporation of the Nigerian agent/representative with the Corporate Affairs Commission;

• Application letter for Import Permit by the Nigerian agent/representative (where applicable);

• A declaration to be made before a notary public by the Nigerian agent/representative in Nigeria confirming that the information and documents submitted to NAFDAC are authentic.

Documents listed above are based on the current regulatory requirements and may change without prior notice, based on NAFDAC Regulations or the nature of the product to be registered.

WHAT IS THE PROCEDURE FOR PRODUCT REGISTRATION?

The procedure entails the following stages:

• Submission of Application;

• Document Verification;

• Facility Inspection/Sampling;

• Laboratory Analysis;

• Final Vetting;

• Approval Meeting; and

• Issuance of NAFDAC Registration Number/ Certificate of Registration.

CAN YOU GIVE THE ESTIMATED COSTS FOR PRODUCT REGISTRATION?

The estimated costs for product registration would be dependent on the type of products to be registered (for example, food, drinks drugs, medical devices etc.) and are contained in NAFDAC’s Tariff schedules, which can be found on the agency’s official website.

HOW LONG IS A NAFDAC PRODUCT REGISTRATION CERTIFICATE VALID FOR?

5 (Five) years, renewable for subsequent periods of 5 (Five) years each.

HOW DO I TRANSFER OWNERSHIP OF PRODUCT LICENCE/REGISTRATION?

A transfer of a product licence or registration typically happens in one of two situations:

• Change of Local Representative: For a foreign manufacturer, this may occur where there is a change of its local representative.

• Assignment of Product or Change of Licence Holder: This may happen where the product is sold or transferred to a third party or where the licence holder undergoes a name change or restructuring.

In the case of the former, the foreign manufacturer shall apply to NAFDAC for the change of its local representative and the appointment of a new one. This is discussed in more details below.

If the transfer results from the assignment of the product to a third party or a change in the name or restructuring of the licence holder, a formal application may be submitted to NAFDAC. The application should include the following supporting documents:

• Resolution of the Board of Directors of the holder of the product licence approving the change of name of the company, or sale of the product;

• Copy of Product Registration Certificate;

• Evidence of assignment of the trademark (where applicable);

• Newspaper publication; and

• Old and newly issued certificates of incorporation (in the case of a change of name)

WHAT DO I DO IF I TERMINATE RELATIONSHIP WITH MY LOCAL REPRESENTATIVE?

A foreign manufacturer/product owner that has terminated its relationship with its local representative, must appoint a new one and thereafter, notify NAFDAC of the change of local representative.

This process involves writing a letter to NAFDAC to notify it of the revocation of the PoA granted to the previous local representative and introducing the new local representative. The letter should be accompanied by the following supporting documents:

• A written and notarised instrument from the manufacturer/owner of the product officially revoking the PoA issued to the initial representative;

• Notarised PoA appointing the new agent/representative; and

• Copy of Product Registration Certificate;

AFTER REGISTRATION, CAN I CHANGE THE PRODUCT LABEL?

Yes, you can. However, any change in the product label of a registered product will require notification to NAFDAC, which will entail the submission of the revised labelling information to NAFDAC to ensure compliance with its labelling requirements.

 This is an abridged version of the article. You can read the article in full on the author’s website.

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