How To Easily Register A Product With Nafdac: Costs And Requirements

Registering a product with the National Agency for Food and Drug Administration and Control (NAFDAC) is crucial for businesses in Nigeria dealing with food, drugs, cosmetics, medical devices, and chemicals. This process ensures that products meet the regulatory standards for safety, efficacy, and quality before they are allowed in the Nigerian market. Below is a comprehensive guide to registering a product with NAFDAC, including the costs, procedures, and requirements.

Steps to Register a Product with NAFDAC

1. Prepare Necessary Documentation

The first step involves gathering all the required documents. These include:

• Certificate of Incorporation from the Corporate Affairs Commission (CAC)
• Comprehensive Certificate of Analysis for the product
• Labeling Information (product name, ingredients, usage instructions, etc.)
• Product Samples for testing and analysis
• If applicable, Power of Attorney from the manufacturer (for imported goods)
• Trademark Registration of the product name
• Evidence of Warehouse Acquisition for inspection
• Product Artwork and any inserts for packaging

For imported products, you will also need a local representative in Nigeria who will be responsible for liaising with NAFDAC.

2. Application Submission

Submit your application either online or at a NAFDAC office. The application must include the necessary forms, documents, and product samples. You must also pay the relevant registration fees, which vary depending on the product type and whether it is locally produced or imported.

• Food products: ₦3,000,000 – ₦5,000,000
• Drugs and Pharmaceuticals: ₦5,000,000 – ₦10,000,000
• Cosmetics: ₦2,000,000 – ₦4,000,000

Medical devices: ₦5,000,000 – ₦7,000,000.

3. Inspection and Laboratory Testing

NAFDAC will conduct an evaluation, which includes laboratory testing to ensure that the product meets all safety and quality standards. For locally manufactured products, NAFDAC will also inspect the factory to ensure it complies with Good Manufacturing Practices (GMP). For imported products, the manufacturer’s facilities may also be inspected.

4. Approval or Rejection

Once NAFDAC has reviewed your application and the product has passed the tests and inspections, they will issue a NAFDAC Registration Number. This number must be printed on the product packaging as proof of regulatory approval. If the application is rejected, NAFDAC will provide feedback, and you can make the necessary corrections.

5. Waiting Period

The approval time varies based on the product category:

• Food and Beverages: 3-6 months
• Drugs and Pharmaceuticals: 6-12 months
• Cosmetics: 2-4 months
• Medical Devices: 3-6 months.

6. Post-Market Surveillance

After approval, NAFDAC conducts ongoing surveillance to ensure that products in the market maintain the required standards. Products also need to be re-registered after five years to continue being legally sold.

Costs of Registering a Product with NAFDAC

The fees depend on the type of product you are registering. Local products typically incur lower costs than imported products. However, fees can vary depending on whether you are registering food items, pharmaceuticals, or cosmetics, as detailed earlier. Additionally, there are costs associated with laboratory tests, factory inspections, and administrative fees.

Key Requirements for NAFDAC Registration

To successfully register a product, you will need the following:

• Certificate of Incorporation: Proof that your business is legally registered in Nigeria with the CAC.
• Comprehensive Certificate of Analysis: A technical document detailing the quality of the product.
• Labeling and Packaging: The packaging must meet NAFDAC’s standards, with clear labeling of ingredients, usage instructions, and storage conditions.
• Product Samples: These are submitted for laboratory analysis and quality testing.
• Local Representative: For foreign manufacturers, appointing a local agent is a requirement.

Conclusion

The NAFDAC registration process can be time-consuming and costly, but it is a mandatory step for any business looking to enter Nigeria’s regulated industries. Preparation and accurate documentation are essential to avoid delays. Businesses are encouraged to consult with NAFDAC experts or agents to facilitate the process and ensure compliance with all requirements. Post-registration, ongoing compliance with NAFDAC standards is necessary to maintain product certification.

By following the right steps, your product can gain access to the Nigerian market, enhancing your business's growth potential while ensuring that public health and safety standards are upheld