How to Become NAFDAC Registration Agent | Full Guide

Food and drug manufacturing is a good venture but one needs to be acquainted with the steps involved in setting it up in terms of getting registered with CAC and getting NAFDAC registration.

An entrepreneur in Nigeria, who intends to upscale and sell goods that fall under the registrable products of NAFDAC, must begin the process as a matter of urgency.

Becoming an NAFDAC registration agent is one of the best ways to assist businesses in ensuring that their products are up to regulatory standards. With NAFDAC in charge of the safety of food, drugs, and other consumables in Nigeria, the demand for knowledgeable agents is high.

In this writing, we will guide you on how to become a NAFDAC registration agent whether you are a professional or simply curious about the process.

What is NAFDAC?

NAFDAC is an abbreviation for the National Agency for Food and Drug Administration and Control. This Nigerian government agency was tasked with the responsibility of regulating and controlling the production, importation, exportation, advertisement, distribution, sale, and use of food, drugs, cosmetics, medical devices, chemicals, and packaged water.

Established in 1993, NAFDAC ensures that consumable products in Nigeria are safe for human use. The agency plays a critical role in maintaining public health. Its tasks include the inspection of production facilities, testing the quality of products, and approving products before they reach consumers.

Without NAFDAC, it would be quite difficult to ascertain whether or not products sold in Nigeria are safe and meet international standards.

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NAFDAC Requirements for Food Products Registration

Before a food product is registered with NAFDAC, certain requirements must be met. This will ensure that the product is safe enough for consumption and also meets the set standards by the agency.

The following are the requirements for food products registration with NAFDAC:

1. Business Registration: Your business must be registered with the Corporate Affairs Commission (CAC). This is the first step in proving your company is legitimate.

2. Comprehensive Product Information: NAFDAC will need details about your food product, including its name, ingredients, and intended use.

3. Labeling: The product’s label must include the brand name, list of ingredients, net weight, manufacturer’s name, and address. All labels must be clear, legible, and truthful.

4. Certificate of Analysis: The lab analysis report of the product for nutritional content and safety.

5. Facility Inspection: For local production, NAFDAC will inspect the facility for hygienic and safety concerns.

6. Application Form and Fees: Filled application form with NAFDAC and payment of the stipulated registration fee.

7. Sample Submission: Samples of the food product shall be submitted for laboratory testing at NAFDAC.

Once all these are in place, NAFDAC will consider the application. If the product passes inspection and testing, you’ll receive a NAFDAC registration number, allowing you to sell the product legally.

NAFDAC Procedure for Registration of Products

STEP 1: Submission of documents

Submission of the fully completed Registration form. This should be accompanied by the following:

Submit evidence of registration with Cooperate Affairs Commission (CAC)
Business Name and Incorporation
Site use Agreement (Where applicable)
Evidence of Trademark approval. We advise that you get these document as it helps to protect the product/ or business name.

Three labels

Fumigation certificate

Copy of Receipt of payment for production inspection, Laboratory Analysis

Food handlers’ certificate/ medical fitness certificate for production staff.

Step 2: Inspection Booking

In booking for your facility inspection, you are given the privilege to pick the most convenient date for your inspection.

Step 3: Sampling products

Samples of products are collected during facility inspection and sent to the laboratory for analysis.

Note: Samples are taken when GMP/GHP is satisfactory.

Step 4: Product Approval

The products are scheduled for approval upon satisfactory manufacturing practice (GMP) and laboratory report.

Step 5: Collection of Certificate

The company is informed to collect their certificate

What are the documents required for NAFDAC Registration?

The documents required for NAFDAC Registration include:

Company Registration Documents
Trademark
Product Label
Fumigation Certificate
Food Handler’s certificate / Medical Fitness Certificate for Production staff, this should include the following: Sputum test, stool test, Urinary test, Widal test, Hepatitis B test.
Batch Formulation.
Site use Agreement (Where applicable)
One vetting Sample and three labels
Copy of Receipt of Payment for production registration
SOPs for production, distribution /Recall, Quality assurance, Cleaning of equipment, receiving of packaging materials, Personal Hygiene, Water analysis (where applicable), and for cleaning of the environment (for small-scale enterprises)
List of raw materials and their source(s)
Certificate of analysis of raw materials (optional for micro-scale)
Certificate of analysis of finished products (optional for micro-scale)
A signed and endorsed certificate of Pharmaceutical Product (for drug products)
Original copy of the Power of Attorney from the product manufacturer (if imported).
Letter of invitation from the manufacturer to inspect the factory abroad, full names, and site of the plant (where applicable)
Permit to import samples (for imported products)
Certificate of Free Sale (for imported products)

How Much Is the Fee for NAFDAC Registration?

The cost of registering a product with NAFDAC varies depending on the type of product, whether it is imported or locally manufactured, and the size of the business applying for registration. As of now, NAFDAC charges in categories:

1. Small and Medium Enterprises: Lower fees are applied to encourage local manufacturers and small businesses. The cost typically ranges from ₦15,000 to ₦50,000 for local products.

2. Imported Products: The registration fees are higher for imported products, and this ranges from ₦100,000 to ₦150,000 per product.

3. Fast Track Services: Where the companies want faster processing, extra charges apply.

Please note that such fees may not cover associated costs like laboratory testing, facility inspections, and consultancy services. Always check the updates on the NAFDAC portal or its customer care.

How to Get NAFDAC Certification

To get a product certified by NAFDAC, there is a systematic process to be followed that guarantees that the products you are selling meet their set standards. Here are the steps:

1. Prepare all the required documents: Gather all the necessary documents, including your certificate of registration from CAC, a full description of your product, a Certificate of Analysis, and your facility’s GMP certificate.

2. Fill out the NAFDAC Application Form: Access the application form for product registration from the website or any nearest office of NAFDAC and fill it out accordingly.

3. Pay the Registration Fee: After knowing your product category, pay for the required registration fees. Most times, online payment options are available.

4. Submit Product Samples: Provide samples of your product for laboratory analysis. NAFDAC will test the product to verify its quality and safety.

5. Undergo Facility Inspection: If your product is manufactured in the country, NAFDAC will inspect your production facility to ascertain whether it meets the required hygiene and safety standards.

6. Wait for Approval: When your product has passed all the tests, NAFDAC will issue a registration number and certification. This certifies that your product is safe for sale in Nigeria.

How Long Does NAFDAC Registration Take?

NAFDAC registration would normally take about 2-6 months, depending on the kind of product and whether one’s application is complete or not.

Factors which control the timeline include the followings:

Completeness of Documentation: Delay would be experienced if documentation was incomplete or incorrect.
Laboratory Testing: If there will be a lot of tests on your product, processing it may take longer.
Facility Inspection: If your manufacturing facility doesn’t meet the NAFDAC standards during the first inspection, you will have to improve them, which can extend the timeline.
Type of Service: Choosing fast-track services will reduce the processing time by a significant margin.

To avoid delays, ensure your application is accurate and complete before submission. You may also remain in close contact with NAFDAC officials to be informed about the progress of your application.

How to Become a NAFDAC Registration Agent

Becoming a NAFDAC registration agent is a great career path if you want to help businesses navigate the regulatory process. Here’s how to get started:

1. Understand NAFDAC Regulations: Familiarize yourself with NAFDAC’s guidelines, requirements, and processes for registering different products. This knowledge is crucial for assisting your clients effectively.

2. Acquire Relevant Skills and Certifications: Although there is no required certification to be a NAFDAC registration agent, a background in regulatory affairs, business administration, or food and drug management is helpful. You are also at liberty to attend NAFDAC workshops and training sessions to improve your knowledge.

3. Registration of Business: You have to register your consultancy business with the Corporate Affairs Commission, CAC, being a registration agent. This lends credence to your operations and makes you lawfully acceptable.

4. Networking with NAFDAC Officials: Networking with NAFDAC personnel helps in getting acquainted with the agency’s processes and can ensure speed in resolving issues.

5. Market Your Services: Use social media, word-of-mouth, and partnerships with business groups to promote your services. Highlight your knowledge of NAFDAC procedures to attract clients.

6. Stay Updated: NAFDAC regulations can change, so it’s important to stay informed about any updates or amendments to the agency’s processes.

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Can I Sell My Products Without a NAFDAC Number?

No, it is not possible to sell your products legally in Nigeria without a NAFDAC number. A NAFDAC number is a unique registration code assigned to approve products upon passing the agency’s stringent quality and safety evaluations.

Selling products without a NAFDAC number is illegal and may lead to:

1. Product Seizure: NAFDAC officials are empowered to seize unregistered products during inspections.

2. Fines and Penalties: Businesses found selling unregistered products can be fined and also suffer other legal penalties.

3. Loss of Consumer Trust: Nigerian consumers are mostly skeptical about purchasing products without a visible NAFDAC number. Without it, your product may struggle to gain market acceptance.

To avoid these risks, ensure your products are registered and display their NAFDAC number prominently on the packaging.

How Do I Check If My NAFDAC Number Is Valid?

To verify the validity of a NAFDAC number, follow these steps:

1. Use the NAFDAC Verification Portal:

Visit the official NAFDAC website.
Navigate to the verification section and enter the NAFDAC registration number on your product.

2. Send a Text Message:

NAFDAC offers a text verification service. Simply send the NAFDAC number via SMS to the shortcode provided on their website. You’ll receive a confirmation message if the number is valid.

3. Contact NAFDAC Directly:

If you cannot verify either online or through text, contact NAFDAC’s customer service or go to their office. Provide them with the NAFDAC number and product details for verification.

4. Check the Product Label:

Genuine NAFDAC numbers are usually supported by legible and coherent labeling. Badly printed or missing details on the product label could mean that it is either a counterfeit or unregistered product.

This means regularly checking the NAFDAC number will ensure that you are selling or buying approved products and will protect consumers from counterfeit products.

How Do I Renew My NAFDAC License?

Renewal of the NAFDAC license is important to maintain the legal presence of your product in the market. Here’s how to renew it:

1. Expiry Date Verification:

Verify the date of expiration on your current license. NAFDAC usually calls for renewal applications a few months prior to the date of expiration.

2. Log in to the NAFDAC E-Registration Portal:

If you had registered your product online, log in to your account on the NAFDAC portal. Navigate to the renewal section to begin the process.

3. Provide Updated Information:

Update any changes to your business or product, such as new packaging, address, or ingredients. Ensure all documents, such as the Certificate of Analysis, are current.

4. Pay the Renewal Fee:

Pay the renewal fee as stipulated through the provided payment channels. The fees depend on the type of product and the size of the business.

5. Submit Samples (If Required):

In some cases, NAFDAC may request new samples of your product for laboratory re-evaluation.

6. Schedule a Facility Inspection:

If there have been significant changes to your production process or facility, NAFDAC may inspect the premises again to ensure compliance.

7. Receive Your Renewed License:

Once all the requirements are satisfied, NAFDAC will grant you a renewed license to continue selling your product legally.

Start early to avoid delays in renewal, and update your business documentation. Being proactive means your product is always up to date with NAFDAC’s requirements.

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FAQs

Does NAFDAC register drugs?

It has the responsibility for registration of human and veterinary drugs & vaccines, biologics, medical devices, cosmetics, household products, and agrochemicals.

What products require NAFDAC number?

drugs, chemicals, consumable goods, cosmetics

How do I report a product to NAFDAC?

For Complaints:

+234(0)909-763-0506.
+2349097630507.
reforms@nafdac.gov.ng.

Conclusion

The NAFDAC registration agent has to know in full the process and requirements of the agency. Knowing what NAFDAC is, its roles, and other important things, will make it easier for you as a NAFDAC registration agent to assist business owners through the process.

Becoming a NAFDAC registration agent might be considered as one’s contribution to ensure public health and safety in Nigeria.