NAFDAC registration | NAFDAC approval process

NAFDAC REGISTRATION | NAFDAC APPROVAL PROCESS

The National Agency for Food and Drug Administration and Control (“NAFDAC”) regulates a wide range of products in Nigeria including the manufacture, importation, exportation, advertisement, distribution, and sale of food, dietary supplements, drugs, cosmetics, medical devices, chemicals, wine, alcoholic beverages, and drinks. NAFDAC uses different measures to make sure the quality of products marketed in Nigeria. NAFDAC registration requirements for each product category are different.

NAFDAC registration or NAFDAC approval is required for food products and is a mandatory requirement for food establishments.

All Medical devices require NAFDAC registration in Nigeria.

NAFDAC approval is a mandatory requirement for drugs, NAFDAC approves drug products only after strict evaluation of documents, test results, clinical studies, protocol, and site inspection.

NAFDAC approval for cosmetic products is mandatory in Nigeria.

HOW TO GET NAFDAC REGISTRATION | NAFDAC APPROVAL IN NIGERIA

The following documents are needed for product registration with NAFDAC:

  1. Certificate of Manufacture and Free Sale– Must be issued by a relevant health/regulatory body in the country of manufacture. It must indicate the name of the manufacturer and products registered. This document needs to be authenticated in the country of origin;
  2. 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/evaluated and should have the following information: A. the brand name of the product; B. the batch number of the product; C. the manufacturing and expiry dates; D. the name, designation, and signature of the analyst.
  3. Declaration of Conformity;
  4. Validation/performance evaluation /Clinical Evaluation Report;
  5. Colored Artwork / the Label of the Product;
  6. The Dossier;
  7. Letter of Invitation for Good Manufacturing Practice Inspection. – This letter to inspect the factory abroad shall be written by the manufacturer and shall state the following:
    A. The Manufacturer’s Information: Name of company, full location address of factory (not administrative office address), e-mail, and current phone number. Details (name, phone number, and email) of contact person overseas.
    B. The Local Agent Information:
    C. Names(s) of product(s) for registration.
  8. The Product Images;
  9. Evidence of trademark registration in Nigeria.

 

NAFDAC Registration and Licensing of Food Products in Nigeria

The National Agency for Food and Drug Administration and Control (“NAFDAC”) is responsible for assuring that food sold in Nigeria is safe, wholesome, and properly labeled. This applies to food produced domestically, as well as food from foreign countries. Food products must be licensed with NAFDAC before being imported, exported, or distributed in Nigeria. NAFDAC officials may visit and check local and foreign manufacturing facilities to ensure adherence with Good Manufacturing Practices (GMP). The registration helps NAFDAC with information on the origin and distribution of food products and thereby aid in the detection and quick response to actual or potential threats to the food supply in Nigeria.

NAFDAC Certification of Drug Products in Nigeria

To get NAFDAC certification, drug manufacturers must conduct lab, animal, and human clinical testing and submit their data to NAFDAC. NAFDAC will then review the data and may certify the drug if the agency determines that the benefits of the drug outweigh the risks for the intended use. Marketing a drug that has no NAFDAC registration is prohibited under the extant Regulation.

NAFDAC Approval of Medical Devices in Nigeria

Manufacturers of medical devices must demonstrate to NAFDAC that a subject device provides reasonable assurance of safety and effectiveness. Foreign manufacturing facilities may be inspected by NAFDAC for Good Manufacturing Practices (GMP) before a medical device may be certified.

NAFDAC Registration of Cosmetics in Nigeria

NAFDAC registration for cosmetics is mandatory in Nigeria. Manufacturers are required to register their products with NAFDAC. The information provided by the registration allows NAFDAC to know the current ingredients being used in cosmetic products, the frequency of their use, the types of cosmetic products on the market, and the companies that are manufacturing the products. It is the manufacturer’s responsibility to assure that its cosmetic products and ingredients are safe and properly labeled, in full compliance with the NAFDAC regulations.

 

Every foreign manufacturer or exporter must have a NAFDAC Agent in Nigeria who acts as the domestic communications representative for that manufacturer or exporter. A NAFDAC registration number and a NAFDAC registration certificate or a permit are issued for each product registered with NAFDAC.

 

Industrial Renaissance Ltd. helps foreign manufacturers and exporters with product registration, licensing, and certification in Nigeria.

For enquiries on NAFDAC registration in Nigeria, contact a member of our team for assistance; call or WhatsApp +234 803 979 5959, or email at trade@indusren.com.