This guide will walk you through the step by step to carry out NAFDAC registration, from gathering the documents to receiving your registration certificate.
How To Carry Out NAFDAC Registration?
If you want to sell food, drugs, or cosmetic products in Nigeria, you need to register with NAFDAC (National Agency for Food and Drug Administration and Control).
This registration ensures your products are safe and meet quality standards. Here’s a guide to help you through the process:
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Step 1: Prepare Your Documents
The first step is to gathering all the documents you’ll need:
- Company Registration Documents
- Trademark Registration
- Product Label
- Fumigation Certificate
- Food Handlers’ Certificate
- Batch Formulation
- Site Use Agreement
- Samples for Testing
- Payment Receipt
Step 2: Submit Your Application
Fill out the NAFDAC registration form, which you can get from any NAFDAC office or their online portal. Submit this form with your supporting documents and a formal application letter.
The letter should explain that you want to register your product and include details about your business and the product.
Step 3: Payment Of Fees
You’ll need to pay fees for your application.
Here’s a rough estimate:
- Food Products: The registration fee is ₦50,000.
- Drugs: The registration fee is ₦70,000.
- Cosmetics: The registration fee is ₦50,000.
- Medical Devices: The registration fee is ₦30,000.
- Veterinary Products: The registration fee is ₦70,000.
- Chemicals or Insecticides: The registration fee is ₦40,000.
- Vaccines: The registration fee is ₦40,000.
- Water: The registration fee is ₦50,000.
- Orphan Drugs: The registration fee is ₦25,000.
If you’re renewing your registration, check the latest fees on the NAFDAC website. Save your payment receipt; you’ll need it later.
Step 4: Product Inspection And Sampling
NAFDAC will schedule an inspection of your facility. They will also collect samples of your product for testing.
Step 5: Laboratory Analysis
The collected samples will be tested in a laboratory to check if your products are safe and meet NAFDAC’s regulations.
Step 6: Final Approval And Certificate Issuance
Once your product passes inspection and lab tests, NAFDAC will review your application. If everything is in order, you will receive a registration number and certificate.
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NAFDAC Registration Requirements For Different Product Categories
NAFDAC oversees a range of products, including food, drugs, cosmetics, and medical devices. Here’s a simple guide to what you need for each category:
General Requirements For All Products:
- Application Letter
- NAFDAC Application Form D-REG/001
- Certificate of Incorporation
- Trademark Registration
- Fumigation Certificate
- Product Samples
- Evidence of Payment
- Good Manufacturing Practice (GMP) Evidence
- Certificate of Analysis
Requirements By Product Category
Food Products:
- Food Handler’s Certificate: Provide medical fitness certificates for your production staff, which includes tests for sputum, stool, and hepatitis B.
- Batch Formulation: Include a detailed formula of your food product.
- Registration Fee: Approximately ₦50,000.
Drug Products:
- Certificate of Pharmaceutical Product: Provide a signed certificate showing your drug meets pharmaceutical standards.
- Comprehensive Certificate of Analysis: This should include details like batch number, manufacturing, and expiry dates.
- Registration Fee: Ranges from ₦70,000 to ₦100,000, depending on the complexity of the drug.
Cosmetic Products:
- Product Samples: Submit three labeled samples of your cosmetic product for testing.
- Evidence of Payment: The registration fee is usually around ₦50,000.
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NAFDAC Registration Timeline
The timeline for NAFDAC product registration varies depending on the type of product being registered. According to NAFDAC, the registration process takes approximately 90 days for food products and 120 days for drug products from the date of acceptance of the application. However, the detailed timeline for the NAFDAC registration process is as follows:
- Submission of Application: 0 days
- Document Verification: 10 days
- Facility Inspection and Sampling:
- Food products: 10 days
- Drug products: 20 days
- Laboratory Analysis:
- Food products: 30 days
- Drug products: 40 days
- Final Vetting: 10 days
- Approval Meeting and Issuance of NAFDAC Registration Number (Certificate of Registration): 20 days