How To Do NAFDAC Registration Successfully

How To Do NAFDAC Registration Successfully

Are you looking to bring your food, drug, or cosmetic product to the Nigerian market? NAFDAC registration is a paramount step in assuring product safety and compliance. Let’s guide you through the process, from the requirements to securing your registration certificate.

NAFDAC Registration Requirements

The National Agency for Food and Drug Administration and Control (NAFDAC) in Nigeria has specific requirements for product registration, which vary based on whether the products are locally manufactured or imported. Here’s a comprehensive overview of the requirements:

General Requirements

Formal Application: A written application directed to the Director of Registration and Regulatory Affairs, detailing the manufacturer’s name, brand name, and product.
NAFDAC Application Form D-REG/001: This must be filled out correctly.
Payment Evidence: Proof of payment for the prescribed registration fees.
Certificate of Incorporation: Issued by the Corporate Affairs Commission (CAC).
Inspection Certificate: A certificate of inspection or recognition from NAFDAC.
Power of Attorney: An original copy from the product manufacturer (if imported).
Trademark Registration: Evidence of trademark registration in Nigeria for the brand name.
Pharmaceutical Product Certificate: Required for drug registrations.
Factory Inspection Letter: An invitation letter from the manufacturer for factory inspection abroad, if applicable.
Product Samples: A pack of product samples for quality analysis and inspection.
Certificate of Free Sale: Issued by relevant health authorities in the manufacturer’s country, authenticated by the Nigerian Embassy.
Comprehensive Certificate of Analysis: Must include details like brand name, batch number, manufacturing and expiry dates, and analyst’s signature.
Local Agent Information: Details of a locally registered company responsible for immigration matters.

Requirements Based On Product Type

For Locally Manufactured Products:

Comprehensive Certificate of Analysis from the manufacturer.
Three samples of the product for quality testing4.

For Imported Products:

In addition to the general requirements, imported products must also include:

Import Permit Application with payment evidence.
Warehouse details for NAFDAC inspection.
Local Purchase Order and Material Safety Data Sheet

How To Register A Product With NAFDAC?

Registering a product with the National Agency for Food and Drug Administration and Control (NAFDAC) is essential if you plan to sell food, drugs, or cosmetics in Nigeria. Here’s a simple, step-by-step guide to help you through the process:

Step 1: Determine Product Classification

Before you begin, you need to classify your product. Is it a food item, drug, or cosmetic? This classification will help you understand the specific requirements you need to meet. NAFDAC has different guidelines for each type, so correctly identifying your product is the first key step.

Step 2: Prepare Your Documents

Once you know your product type, you need to prepare the required documents.

This includes:

NAFDAC Application Form (D-REG/001): You can download this form from the NAFDAC website or get it from one of their offices.
Certificate of Incorporation from the Corporate Affairs Commission (CAC): This shows that your business is legally registered in Nigeria.
Proof of Payment: You’ll need to pay registration fees, and proof of this payment must be included.
Power of Attorney: If your product is imported, you’ll need a Power of Attorney from the manufacturer, allowing you to handle the registration process in Nigeria.

Step 3: Engage An Authorized Regulatory Consultant (ARC)

Hiring an Authorized Regulatory Consultant (ARC) can make the process easier than you think. These professionals are familiar with NAFDAC’s procedures and can guide you through every step, ensuring you meet all the requirements.

Step 4: Submit Your Application

With your documents ready, submit your application to NAFDAC. This step also requires you to submit product samples for laboratory analysis. NAFDAC will test your product to ensure it meets safety and quality standards.

Step 5: Wait For Verification

NAFDAC will review your documents and conduct thorough laboratory tests on the product samples you provided. In some cases, NAFDAC may also schedule an inspection of your manufacturing facility to ensure it complies with Good Manufacturing Practices (GMP).

Once NAFDAC verifies that everything is in order, you’ll be issued a Certificate of Registration. This certificate allows you to legally sell your product in Nigeria.

That being said, the registration process takes 90 to 120 days, depending on the product type and how complete your application is.

NAFDAC Registration Fees

Here’s a table that shows the product registration costs for various categories:

No	Product Category	Registration Fee (₦)	Details
1	Food Products	50,000	Includes processing and registration certificate.
2	Drugs	70,000	Breakdown: 50,000 processing + 20,000 certificate.
3	Cosmetics	50,000	Same as food products; includes a processing fee.
4	Medical Devices	30,000	Processing fee included in this amount.
5	Veterinary Products	70,000	Breakdown: 50,000 processing + 20,000 certificate.
6	Chemicals/Pesticides	40,000	Processing fee included in this amount.
7	Vaccines/Biologicals	40,000	Includes processing and registration certificate.
8	Water (Bottled)	50,000	Same as food products; includes a processing fee.
9	Orphan Drugs	25,000	Lower fee due to limited market access.

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