This post contained the Requirements for NAFDAC Products Registering, and the Cost for Registering Products with NAFDAC.
INTRODUCTION
The National Agency for Food and Drug Administration and Control (NAFDAC) is the agency responsible for regulating and granting permits for the exportation, importation, manufacture, and the registration of products such as drugs, chemicals, consumable goods, cosmetics, biological, and medical services which are produced in or outside Nigeria. Any company involved in the production, manufacturing, and distribution of food, imported foods, drugs, the export of semi-processed food and cosmetics must incorporate a company with the Corporate Affairs Commission (CAC) before registering its company product with NAFDAC.
WHAT IS NAFDAC?
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. NAFDAC is the body responsible for regulation and control of the manufacture, production, importation, exportation, distribution, advertisement, sale and use of certain products in Nigeria. As long as you intend to put up these products for the consumption of the general public, you must register with NAFDAC.
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The registration process for the grant of NAFDAC permit comes in two stages, these stages are;
- Application for NAFDAC permit to bring in samples for products manufactured outside Nigeria. For this kind of application, NAFDAC grants special written authorization to importers to bring in samples of the products into Nigeria.
- Application for registration of products locally manufactured or imported.
The registration of locally made products is slightly different from the registration process for imported goods. Where a company produces different products, it will be required to register each of them separately to obtain the NAFDAC registration numbers for each of the products.
REQUIREMENTS FOR REGISTERING PRODUCTS WITH NAFDAC
Consequently, the documents required to be submitted for registration will depend on whether the product falls into the food or the drug category. Irrespective of the product to be registered, NAFDAC would only issue a registration number and certificate after the product has passed the quality and standard test carried out by the agency.
The general requirements for the NAFDAC’s registration of products include the followings:
- A formal written application for product registration directed to the Director (Registration and Regulatory Affairs) stating the name of the manufacturer, brand name, and product.
- Fill the prescribed NAFDAC Application Form D-REG/001.
- Evidence of payment of prescribed fees.
- Certificate of Incorporation of the company
- The certificate of inspection or recognition issued by NAFDAC
- Original copy of Power of Attorney from the product manufacturer (if imported)
- Trademark registered in Nigeria for brand name
- A signed and endorsed certificate of Pharmaceutical Product (applicable to drugs only).
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- Letter of invitation from the manufacturer to inspect the factory abroad, full names, and site of a plant (where applicable).
- Pack of product samples for quality analysis and inspection.
- Notarized 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.
- Certificate of Free Sale obtained and issued from relevant health and regulatory body in the manufacturer’s country indicating the name of the Manufacturer and products to be registered. It is also to be authenticated by the Nigerian Embassy in the country of origin. In countries where no Nigerian Embassy or High Commission exists, any other Embassy or High Commission of any Commonwealth or West African country can authenticate the document.
- Comprehensive Certificate of Analysis: The 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 (i.e. locally registered company).
- Evidence of warehouse acquisition (where applicable)
- Colored Artwork or Label of the product and leaflet insert of the product.
- Evidence of GMP inspection.
- Manufacturer Information: Name of the Company, full location address of the factory, email address, and current phone no. & fax no, the name of contact person overseas, telephone no, email address. Name of airport closest to the location and guide map illustrating the shortest land/air route to the factory overseas
- Local Agent Information: Name of the locally registered company that will take immigration responsibility; full location address and functional telephone number & email address.
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It is also important to note that some goods can be registered with NAFDAC without obtaining the NAFDAC Registration Number. For NAFDAC registration of foreign goods without the acquisition of the NAFDAC registration number, an import permit must be obtained. The following are required for the process of NAFDAC Import Permit;
- Application for an import permit with the payment of prescribed fees.
- A warehouse must be present for NAFDAC inspection.
- The technical officer needed especially in the Science field, 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.
Cost for Registering Products with NAFDAC.
The costs for NAFDAC product registration are usually dependent on specific products to be registered. There are various prices for categories of products. Some of the specific costs an applicant is required to pay to include the cost for product registration itself, import permit and inspection where applicable. Among all these costs, the cost of the foreign inspection, which currently costs at about $10,500 is the most exorbitant, however, such cost may be waived if the foreign manufacturing company has an existing GMP Certification.
CONCLUSION.
NAFDAC issues a unique registration number or certificate of registration after a product has passed the quality and standard test carried out by the agency and subsequently registered. After a successful product registration, the importer can start to import the products in large quantities into Nigeria. Every imported product must be properly labeled to avoid unnecessary delays in the course of importation. After a successful product registration, it will be valid for a term of five years, which is subject to renewal.