This article is about how to register your products with the National Agency for Food and Drug Administration and Control (NAFDAC) this 2021. NAFDAC is the regulatory agency that is responsible for granting permits for the import and export, manufacture, and registration of food and drug products such as chemicals, consumable goods, cosmetics, biological, and medical equipment, etc., that are produced within or outside the shores of Nigeria.
Many businesses that produce, manufacture and distribute food, imported foods, semi-processed foods, drugs, and cosmetic products are required to incorporate their companies with the Corporate Affairs Commission (CAC) before they register their products with the National Agency for Food and Drug Administration and Control (NAFDAC). Registering your products with NAFDAC are of two different types, and they include the following:
- Application to NAFDAC for the permission to bring in samples of food and/or drug products manufactured outside Nigeria. NAFDAC gives special written permit to importers so that they can bring in samples of the products into Nigeria for this type of application.
- Application to NAFDAC for the registration of food and/or drug products that are locally manufactured or imported.
It is important to note that for the second type of registration, what is obtainable for locally made products is a bit different from the registration process for imported goods. Also take note that if a company produces different products, they will be mandated to register each of these products separately from each other in order to obtain the NAFDAC registration numbers for the different products.
REQUIREMENTS FOR OBTAINING NAFDAC NUMBER FOR YOUR PRODUCTS IN NIGERIA
If you want to register your products with NAFDAC in order to obtain their unique NAFDAC number in Nigeria today, be informed that the documents you are to provide for the registration of your products largely depend on whether they fall into the food or drug category. Kindly note that NAFDAC has the final say on whether or not to issue you a registration number and certificate for your product. Once your product passes their quality and standard test, you will surely be given your registration number.
With that said, the following are the requirements for the registration of your food and drug products with NAFDAC:
- An official written application letter for the registration of your product(s) addressed to the Director, Registration and Regulatory Affairs, NAFDAC stating the name of the manufacturer, brand name, and product.
- Fill out the authorised NAFDAC Application Form D-REG/001.
- Provide proof of payment of specified fees.
- Provide the Certificate of Incorporation of your company
- Provide the certificate of inspection or recognition issued by NAFDAC
- If the product is imported, you are to provide the original copy of Power of Attorney from the product manufacturer
- Provide the trademark registered in Nigeria for your brand name
- If your products are drugs only, you are to provide a signed and endorsed certificate of the pharmaceutical product.
- Where applicable, you are to provide a letter of invitation from the manufacturer to inspect the factory abroad, full names, and site of a plant.
- Provide a pack of your product samples for quality analysis and inspection.
- Provide a signed and sealed declaration of a duly executed power of attorney from the product manufacturer, which is required to be type-filled and notarized by a Notary Public here in Nigeria.
- Also required is a Certificate of Free Sale that is to be obtained and issued from a relevant health and regulatory body in the manufacturer’s country showing the Manufacturer’s name and product(s) to be registered. This certificate must be authenticated by the Nigerian Embassy in the country of origin. In countries where there are no Nigerian Embassies or High Commissions, any other Embassy or High Commission of any Commonwealth or West African country can authenticate this document.
- Provide a Comprehensive Certificate of Analysis. This Certificate of analysis must be presented on a letter headed paper of the quality control laboratory where the sample was tested or evaluated and it should contain the following information: The brand name of the product, the batch number of the product, the manufacturing and expiry dates, the name, designation, and signature of the analyst.
- Application letter for Import Permit by the applicant (this applies for a locally registered company).
- Evidence of warehouse acquisition (where applicable)
- Coloured Artwork or Label of the product and leaflet insert of the product.
- Evidence of Good Manufacturing Practices (GMP) inspection.
- Manufacturer Information which includes the name of the company, contact details of the factory which must capture the address, email address, current phone number and fax number, the name of contact person overseas, telephone number, email address, etc. Also important is the Name of the airport closest to the location and guide map illustrating the shortest land/air route to the factory overseas.
- Local Agent Information such as the name of the locally registered company that will take immigration responsibility; full location address, functional telephone number, and email address.
You should be aware that NAFDAC can register some goods without assigning to them a Registration Number. If you want to register foreign goods without the acquisition of NAFDAC registration number, you will be required to obtain an import from the agency. The requirements for obtaining an import permit from NAFDAC include the following:
- Application for an import permit with the payment of specified fees.
- A neat warehouse for NAFDAC inspection.
- A Technical Officer with background knowledge in the field of science with the passport photograph of the Technical Officer.
- Certificate of Incorporation of the local company with the Corporate Affairs Commission.
- Certificate of Analysis of the products.
- Local Purchase Order.
- Material Safety Data Sheet.
You can also check out the NAFDAC official website for more information on how to register your products with the agency.