Specific regulations concerning the registration of certain products in Africa: registration of cosmetics in Nigeria with the national agency for food and drug administration control (NAFDAC)

Some products are subject to certain requirements before they are placed on the market in some countries.

In Nigeria, NAFDAC is the authority charged with the regulation and control of the importation, exportation, manufacture, advertisement, distribution, sale and use of certain products. The scope of its authority is broad and the products under its jurisdiction are drugs, cosmetics, medical devices, still (table) water and chemicals. Upon registration, a unique registration number is issued and inscribed on a product and it serves as a mode of confirming that the product has been approved and registered by NAFDAC for manufacture, sales and consumption in Nigeria.

Indeed, no product shall be manufactured, imported, exported, advertised, sold or distributed in Nigeria unless it has been registered in accordance with the provisions of the National Agency for Food and Drug Administration and Control Act, Cap N1 LFN, 2004.

It should be noted however that to have access to the largest market in Africa, this extra step is worth it…!

We will now focus on and briefly summarize the regulatory requirements for COSMETIC products in Nigeria:

• Regarding the applicant:

An application for registration of a cosmetic product in Nigeria should be made by the manufacturer. However, if the manufacturer is established outside Nigeria, it should be represented in Nigeria by a duly registered company or indigenous individual (local agent) with facilities to recall the product when necessary.

• Procedural requirements:

The registration process at NAFDAC is carried out in five (5) main stages:

STEP 1: The Application and Documentation

The essence of this step is to ensure the origin and composition of products by well-defined and authenticated administrative certificates. An online application form is required to be purchased at the cost of €1, completed and submitted alongside a written application for registration by the applicant. Other documents such as

• the certificate of registration of the trade mark (a Letter of Acceptance may be accepted in the alternative),
• the manufacturing contract or Power of Attorney,
• the certificate of analysis,
• certificate of manufacture or free sale,
• a notarized declaration in the country of origin,
• certificate of business incorporation in Nigeria,
• letter of invitation for Good Manufacturing Practice (GMP) inspection and label or artwork of the product

will be requested for submission.

This step remains the longest in the procedure.

STEP 2: Obtaining the Import Permit

After satisfactory documentation, the import permit (i.e. the authorization to import samples for registration) must be obtained by the local agent in Nigeria from the Registration & Regulatory Affairs Directorate upon payment of the applicable fee of €36.

However, this import permit concerns the importation of limited samples for analysis only.

STEP 3: Product Vetting

This step is carried out by the local agent in Nigeria. After the import permit is issued, a well labeled sample of the product, certificate of analysis, 2 labels/artworks samples and receipt of payment for the import permit are submitted to NAFDAC for product vetting.

STEP 4: Laboratory Analysis

After satisfactory vetting of product labels, laboratory samples must be submitted to the NAFDAC Cosmetic Unit. Documents such as proof of payment of the total Registration Fee of €2,816.20 (application form- €1, import permit- €36, processing fee- €2,419.20, product licensing- €360) inclusive of VAT, certificate of analysis of the product and evidence of submission for product vetting must be submitted to begin the laboratory analysis.

STEP 5: Product approval meeting

After successful documentation, satisfactory GMP inspection of the product facility and satisfactory laboratory analysis, products sought to be registered are submitted for deliberations at series of Approval Meetings.

Upon being satisfied, NAFDAC will issue a notification of registration and will assign a unique registration number to the product approved at the meetings.

• Time frame:

The processing time for obtaining NAFDAC registration may take between 6 and 12 months, depending on the level of compliance with all the requirements and the volume of pending products on the queue for laboratory testing.

• Validity of registration

The NAFDAC registration is usually valid for a period of 5 years and must be renewed at the cost of €1,701 (inclusive of VAT) in order to maintain the registration.

IMPORTANT NOTICE:

There is information that these costs will be increased very soon.

INLEX AFRICA with its Intellectual Property lawyers are available to provide you with further information and assist you in all your efforts in Nigeria and before NAFDAC.