NAFDAC

NAFDAC is an abbreviation for National Agency For Food and Drug Administration and Control. Their major responsibility to regulate and control the manufacture, importation, exportation, distribution, advertisement, sale and use of Food, Drugs, Cosmetics, Medical Devices, Packaged Water, Chemicals and Detergents (collectively known as regulated products).

There are three broad categories of products that can e registered with NAFDAC namely; food, cosmetics and drugs. It is mandatory to register any packaged product that falls under any of these categories.

To register a product with NAFDAC, it is imperative to thoroughly review the applicable guidelines for the product and fulfill all associated requirements and conditions. Subsequently, you should adhere to the following procedure:

1. Prepare and submit the application form along with all required supporting documents.
2. Make the assessed payment.
3. The submitted documents undergo verification, and a date for the facility inspection is scheduled.
4. Conduct the facility inspection and sample the products, followed by laboratory analysis.
5. Final vetting and approval meetings ensue.
6. Upon successful completion, the NAFDAC Registration Number and certificate of registration are issued.

For NAFDAC approval, the required documents are:

1. Evidence of Registration with CAC (Business Name and/or Incorporation)
2. Site Use Agreement (if applicable)
3. Evidence of Trademark Approval (optional for micro-scale)
4. Product Sample and Labels
5. Fumigation Certificate
6. Payment Receipt for Product Registration
7. Food Handler’s/Medical Fitness Certificates for Production Staff (various health tests)
8. SOPs for Production, Distribution/Recall, Quality Assurance, Equipment Cleaning, Packaging Materials Receiving, Personal Hygiene, Environmental Cleaning (for small-scale)
9. Water Analysis (if applicable), List of Raw Materials and Sources
10. Certificate of Analysis for Raw Materials and Finished Products (optional for micro-scale)
11. Certificate of Pharmaceutical Product (for drug products)
12. Power of Attorney from Manufacturer (if imported)
13. Manufacturer’s Invitation for Factory Inspection Abroad (if applicable)
14. Permit to Import Samples (for imported products)
15. Certificate of Free Sale (for imported products)

Before approaching NAFDAC for product registration, consider these steps:

1. Register your business with the Corporate Affairs Commission (CAC).
2. Obtain trademark registration, if applicable (optional for micro-scale enterprises).
3. Design and prepare your product label/packaging according to relevant regulations.
4. Ensure your personnel meet NAFDAC’s educational, experience, sanitation, hygiene, and medical test requirements.
5. Confirm that your facility and equipment comply with NAFDAC’s standards.
6. Assure the quality and standard of all raw or packaging materials.

The timeline is usually within ninety (120) working days for food products and 150 working days for drug products but may exceed this stipulated time.

Yes, you have to register. NAFDAC categorizes enterprises into micro-scale, small-scale and large-scale enterprises.

Yes. In order to register the product, you must first get approval from NAFDAC to import into Nigeria. You must also be armed with the necessary documents to register the imported products.

Yes, the certificate has to be renewed after 5 years.

Micro scale enterprise is a business employing no more than five (5) individuals. It should possess a facility or building designed specifically or adapted to meet the minimum requirement of having a designated standard room not directly exposed to potential sources of contamination. However, certain products fall outside the scope of registration for such enterprises. These include meat and meat products (except dried), poultry and poultry products, fish and fish products (except dried), milk and dairy products, packaged cooked rice, beans, or fresh vegetables, baked potatoes, beverages, and packaged water while

Small scale is an enterprise with 1 to 10 employees. Its building can be purpose built or adapted. It must also have adequate space, capacity and equipment for its intended product (s) for registration.