How to Register Your Products with NAFDAC in Nigeria and Costs: A Comprehensive Guide

The National Agency for Food and Drug Administration and Control (NAFDAC) is responsible for ensuring the safety, quality, and efficacy of products in Nigeria, including food, drugs, cosmetics, and medical devices. Registering your product with NAFDAC is crucial if you want to legally manufacture, import, distribute, or sell products in Nigeria. This guide outlines the step-by-step process to register your products with NAFDAC and the associated costs, requirements, and timeline.

Types of Products Regulated by NAFDAC

NAFDAC oversees the registration of the following product categories:

• Food products
• Drugs (both prescription and over-the-counter)
• Cosmetics
• Medical devices
• Water
• Chemicals or pesticides
• Veterinary products

Each category may have specific requirements, but the general process of registration remains similar across all categories.

Step-by-Step Process for Registering Products with NAFDAC

Step 1: Business Incorporation

Before you can register your products with NAFDAC, you must ensure that your company is registered with the Corporate Affairs Commission (CAC) in Nigeria. This is mandatory as only incorporated entities can apply for NAFDAC product registration.

Also See: How to Register Your Business with CAC in Nigeria (2024)

Step 2: Application for Registration

You will need to write an official letter of application to NAFDAC. This letter should be addressed to the Director, Registration and Regulatory Affairs at NAFDAC, including details such as:

• The name of the product
• The brand name
• The manufacturer’s name
• Your company’s details (for locally manufactured products)

The application must be accompanied by the completed NAFDAC application form (Form D-REG/001) and proof of payment for the registration fees.

Step 3: Submission of Documentation

You’ll need to submit essential documents that demonstrate the safety and quality of your product. These documents vary slightly depending on whether the product is locally manufactured or imported, but typically include:

• Certificate of Incorporation of your company
• Certificate of Free Sale from the country of origin (for imported products)
• Comprehensive Certificate of Analysis (from the manufacturer’s quality control laboratory)
• Power of Attorney or a Contract Manufacturing Agreement (for imported goods)
• Trademark registration for your brand name.

Step 4: Payment of Fees

NAFDAC charges fees based on the type of product you are registering. Here’s a breakdown of some typical registration fees:

• Food products: ₦50,000
• Drugs: ₦70,000
• Cosmetics: ₦50,000
• Veterinary products: ₦70,000
• Medical devices: ₦30,000
• Water: ₦50,000.

Additional costs may arise depending on whether NAFDAC will need to conduct an international inspection for imported products, which can cost around ₦10,500.

Step 5: Inspection and Evaluation

Once your application is submitted, NAFDAC will evaluate your documents. This process may involve an inspection of your manufacturing facility, particularly for locally made products. For imported products, NAFDAC may request a factory inspection in the country of origin.

Additionally, you will need to submit samples of your product for laboratory analysis, where NAFDAC will test the product to ensure it meets safety and quality standards.

Step 6: Product Approval and Issuance of NAFDAC Number

After completing all evaluations and inspections, NAFDAC will assign your product a unique NAFDAC registration number. This number signifies that your product is approved for sale and distribution in Nigeria. The entire process can take between 90 to 120 days, depending on the complexity of the product.

Requirements for Imported Goods

For imported products, the registration process includes some additional steps. You’ll need to provide:

• A Power of Attorney that authorizes your local representative to act on behalf of the foreign manufacturer.
• A Certificate of Free Sale from the relevant regulatory body in the country of origin, authenticated by the Nigerian Embassy.
• A Comprehensive Certificate of Analysis from the manufacturer’s laboratory.

Timeline for NAFDAC Product Registration

The NAFDAC registration process typically takes 90 to 120 days to complete. This timeline includes:

1. Document verification (10 days)
2. Facility inspection and sampling (10-20 days)
3. Laboratory analysis (30-40 days, depending on the product type)
4. Final vetting (10 days)
5. Approval meeting and issuance of NAFDAC number (20 days).

Delays may occur if documentation is incomplete, or if additional inspections are required.

Cost Breakdown for NAFDAC Registration

The total cost of registering a product with NAFDAC varies depending on the type of product and whether it is locally produced or imported. Here’s a general cost estimate:

• Registration fees: ₦30,000 to ₦70,000 depending on the product category.
• Inspection fees: ₦10,500 (for international inspections, waived if the manufacturer has GMP certification).
• Other costs: These include packaging inspections, import permits, and laboratory analysis fees.

Challenges and Solutions in NAFDAC Registration

Registering products with NAFDAC can be challenging, especially for first-time applicants. Common issues include:

1. Complex Documentation: Applicants may find it difficult to gather and submit the required documents. To resolve this, create a checklist and consider hiring a consultant.
2. Regulatory Updates: NAFDAC’s regulations can change, so it’s essential to stay informed by regularly checking their website and attending relevant workshops.
3. Delays: Processing times may vary due to unforeseen delays. Maintaining constant communication with NAFDAC officials and ensuring all documents are in order can help speed up the process.

Conclusion

Registering your products with NAFDAC is a necessary step for any business looking to manufacture, import, or sell consumable goods in Nigeria. While the process may seem tedious, following the steps outlined above will help ensure that your products meet regulatory standards and are approved for sale in the Nigerian market. Proper preparation, including submitting the correct documentation and understanding the associated costs, is key to navigating the registration process smoothly.

For more details on NAFDAC product registration, you can visit their official website or consult with legal experts who specialize in regulatory compliance.

Frequently Asked Questions