So you’ve developed an amazing new product, and you’re ready to get it out to customers in Nigeria. Fantastic! But before you start selling, you need to make sure your product meets regulations by registering with NAFDAC, Nigeria’s food and drug regulatory agency. The registration process can seem complicated, but don’t worry; we’ve got you covered.
In this guide, we’ll walk you through each step of registering your product with NAFDAC so you can get it on shelves and in front of customers as quickly and effortlessly as possible. By the time you finish reading, you’ll feel confident navigating NAFDAC’s requirements and be well on your way to launching your product in Africa’s largest market. Let’s get started!
What Is NAFDAC?
NAFDAC stands for National Agency for Food and Drug Administration and Control. It is the agency responsible for regulating and controlling the manufacture, importation, exportation, distribution, advertisement, sale and use of food, drugs, cosmetics, medical devices, bottled water, and chemicals in Nigeria.
To register a product with NAFDAC, you’ll need to submit an application with details about your company and the product you want to register. The registration process typically takes 3-18 months. Once approved, you’ll receive a NAFDAC registration number, which must appear on your product label before distributing in Nigeria.
The History of NAFDAC in Nigeria?
NAFDAC, the National Agency for Food and Drug Administration and Control, was founded in 1993 to regulate and control the manufacture, importation, exportation, distribution, advertisement, sale and use of food, drugs, cosmetics, medical devices, bottled water, and chemicals in Nigeria.
In 1993, the organization was created in Nigeria in accordance with the nation’s health and safety regulations to combat illegal and counterfeit goods. Nigeria has a problem with adulterated and fake medications. In one incident from 1989, paracetamol syrup containing diethylene glycol was responsible for the deaths of almost 150 children. Since fake pharmaceuticals were such an issue, neighboring nations like Ghana and Sierra Leone have outright forbidden the sale of drugs, food, and drink goods created in Nigeria.
NAFDAC was established as a result of a 1988 World Health Assembly decision that asked for assistance from nations in addressing the threat that fake drugs pose to the world’s health. The first executive body of NAFDAC was established in December 1992. Tanimu Saulawa presided over the council. Supporting legislation was enacted as Parliamentary Decree No. 15 of 1993 in January of that year. NAFDAC became a “parastatal of the Federal Ministry of Health” on January 1, 1994.
What are NAFDAC’s Primary Functions?
NAFDAC has many primary functions that enable it to properly regulate and control the manufacture, importation, exportation, distribution, advertisement, sale and use of food, drugs, cosmetics, medical devices, bottled water, and chemicals.
NAFDAC registers all regulated products before they can be manufactured, imported, exported, advertised, sold or distributed in Nigeria. This helps ensure safety, quality and efficacy.
Inspection and Licensing
NAFDAC routinely inspects production facilities to ensure compliance with good manufacturing practices (GMP). It also issues licenses to manufacturers, importers and distributors of regulated products.
NAFDAC analyzes product samples to verify safety, quality and efficacy before registration and also does post-marketing surveillance to monitor compliance.
NAFDAC inspects all importations of regulated products at ports of entry to prevent entry of substandard or counterfeit products.
NAFDAC evaluates the safety, quality and efficacy of regulated products through a review of documentation of clinical trials before approval and registration.
NAFDAC undertakes enforcement operations, including raids, seizures, prosecution and destruction of substandard, spurious, falsely labeled, falsified and counterfeit (SSFFC) medical products.
NAFDAC educates and informs the public on the proper use of regulated products to achieve maximum health benefits. It also warns the public against the circulation of counterfeit and substandard products.
NAFDAC cooperates with similar regulatory agencies worldwide to facilitate information exchange and adoption of best practices. It is a member of various international organizations and participates in meetings, conferences, and training programs.
Benefits of NAFDAC Registration
Registering your product with NAFDAC comes with several key benefits:
-Gain consumer confidence. NAFDAC approval reassures customers that your product meets high quality and safety standards.
-Expand your market. You can sell nationwide and export to other countries.
-Tax incentives. You may qualify for tax breaks and import duty waivers.
-Protect intellectual property. Registration helps establish ownership of your brand, invention or design.
-Avoid penalties. Selling unregistered products can lead to legal consequences like fines, product seizures or jail time.
-Improve product quality. The registration process requires you to carefully evaluate ingredients, labeling, and manufacturing practices.
-Smooth importation. Registration allows you to more easily import raw materials and finished products into Nigeria.
-Loan eligibility. Banks may require NAFDAC registration to consider you for business loans and financing.
NAFDAC registration offers companies a wealth of benefits that make the effort and expense well worthwhile. Following the proper registration procedures will help get your products on the market legally and open you up to new opportunities for growth.
NAFDAC Registration: How to Register a Product with NAFDAC
Going through NAFDAC registration shows your commitment to producing high-quality goods that meet safety standards. Although the process requires time and patience, obtaining a NAFDAC registration number is essential for any business looking to thrive in Nigeria’s consumer market.
When enrolling with NAFDAC, keep the following in mind: Locally produced goods are subject to a different registration requirement than imported goods. A single product is registered under each NAFDAC registration number. You will need a different registration number for each product if you have more than one.
NAFDAC Registration Requirements For Food Products
To register a food product with NAFDAC, you’ll need to provide some important documentation.
- Certificate of Incorporation obtained from the Corporate Affairs Commission (CAC)
- Certificate of inspection/recognition issued by NAFDAC
- Trademark approval for your brand name by the Federal Ministry of Commerce (where it is applicable)
- Comprehensive Certificate of analysis of the batch of the product for registration from the manufacturer stating the name and signature of the analyst
- The name of the manufacturer, the brand name, and the product(s) should be listed on an application form sent to the director.
NAFDAC Registration Requirements For Imported Goods
To register imported goods with NAFDAC, you’ll need to provide the following:
- A Power of Attorney or a contract manufacturing agreement with the manufacturer must be submitted by the applicant if they want the Nigerian representative to be able to represent them in Nigeria. The director or president of the business must sign the document. Additionally, a notary public in the nation where the manufacturer is located must notarize the Power of Attorney or the contract manufacturing agreement.
- A certificate of free sale must be issued by a relevant health/regulatory body in the manufacturer’s country. The certificate must indicate the name of the manufacturer and the product.
- A comprehensive certificate of analysis must be presented on a letter headed paper of the quality control laboratory where the sample was tested or evaluated, and it should contain the analysis of the product or goods, the batch number of the product, manufacturing and expiry dates, name, designation, and signature of the analyst.
- You must show proof that the manufacturer of the imported food or drug product has the necessary authorization to sell it in the country of origin and that the sale of the product does not violate the local food regulations in that country.
- Permit to import samples.
- A letter of invitation to inspect the factory abroad
- Certificate of Analysis of the products.
- Local Purchase Order
- Material Safety Data Sheet.
Complying with these registration requirements and having all your documentation in order will facilitate a smooth registration process with NAFDAC for your imported goods. But be aware the entire process can take 3 to 6 months or more to complete, depending on the product type. So start early!
NAFDAC Registration Requirements For Drug
To register a product with NAFDAC, you’ll need to gather some important documentation and information, such as:
- Certificate of incorporation issued by the Corporate Affairs Commission (CAC)
- You must submit three samples of your product for quality analysis and inspection
- A signed and endorsed certificate of pharmaceutical product
- The Original copy of the Power of Attorney from the product manufacturer (if imported)
- The application letter for registration of the product
- A letter of invitation from the manufacturer to inspect the factory abroad with full names and site of the plant
- A completed NAFDAC application form
Steps to Register Your Product With NAFDAC
To register your product with NAFDAC, follow these steps:
Step 1: Obtain the NAFDAC Registration Form
The first step is to make your request known at the NAFDAC office by visiting the closest one to you. Their Headquarters is at Plot 2302, Olusegun Obasanjo Way, Zone 7, Wuse, Abuja.
Find the address of their zonal office in your state of residence. Once there, purchase and fill out the NAFDAC registration form properly. Note that each registration form can only be used for one product, as was previously stated. Therefore, you will need to acquire more than one form if you have many products.
Step 2: Submit Your Registration & Application Form
Your intention to register your product(s) should be stated in a letter sent to NAFDAC. Keep in mind that your letter of application should include all pertinent details about your product, like its name, description, maker, intended audience, etc. Your letter should be addressed to the zone director for the organization you are registering with. Along with your application letter and other necessary documents, submit your registration form.
Additionally, give NAFDAC pertinent data and a description of your facility for an accurate examination. Even though this stage can be extremely tedious, the work is always worthwhile.
Step 3: Submit Samples Of Your Product(s)
You would then receive a notification asking you to send three samples of your goods for inspection and analysis. You will be given a certificate of recognition as a manufacturer as soon as you finish this stage.
Step 4: Make the Necessary Payments
Pay the appropriate fees for your registration. You must pay the required fees on time to avoid delays. Depending on the kind and class of the product you are registering, different fees and taxes apply.
Step 5: Certificate Collection
You will receive a NAFDAC registration number and a certificate of registration for your product after it has been registered.
NAFDAC Registration Procedure For Imported Goods
The foreign business must send samples of its product for analysis in order to register imported items with NAFDAC. However, without formal authorization to bring in the samples, this is not possible. Therefore, the foreign business must first request permission to import samples into Nigeria.
To do this, NAFDAC grants specific written authorizations or import permits to importers, allowing them to bring samples of their goods into the country. The manufacturer and other pertinent organizations in the country of origin must also provide the importer with the paperwork necessary for the clearance and delivery of the samples.
Going through the proper NAFDAC registration process for imported goods ensures your products meet all regulatory standards to be legally sold in the Nigerian marketplace. While the requirements may seem extensive, NAFDAC aims to protect public health by ensuring only safe, high-quality products are available for consumption in Nigeria.
How Long Does NAFDAC Registration Take?
The NAFDAC registration process typically takes between 3 to 18 months to complete, depending on the type of product. In most cases, it takes 90 days. As an applicant, the actual timelines are mostly outside of your control once you submit your application. However, there are a few things you can do to help speed up the process:
Make sure your application is comprehensive and error-free. Double-check that you have included all necessary forms, documents and information before submitting. Incomplete or inaccurate applications will delay processing times.
Respond promptly to any requests for additional information. NAFDAC may follow up with queries or ask for clarification on certain points. Provide a quick turnaround to keep your application moving forward.
Use a regulatory consultant. Experienced consultants are familiar with the NAFDAC registration procedure and timelines. They can ensure the proper preparation and submission of your application to minimize potential delays. Hiring a consultant may allow for faster approval.
Monitor the status of your application and follow up periodically. While waiting, check in with NAFDAC to confirm they have everything needed and see if there are any outstanding requests on their end. Politely following up shows your enthusiasm and can help prevent your application from getting lost in the process.
Although the NAFDAC approval timeline can vary significantly based on many factors, taking the proper steps will increase your chances of obtaining registration for your product as efficiently as possible. With patience and persistence, you’ll have NAFDAC approval before you know it!
Summary of Registration processes with timelines
To register a product with NAFDAC, here’s a quick summary of the key steps and timelines to expect:
- Submission of Application– 0 days
- Verification of documents– 10 days
- Facility Inspection/Sampling– 10days for Food, 20days for Drugs
- Laboratory Analysis– 30 days for Food, 40 days for Drugs
- Final Vetting– 10 days
- Approval Meeting/Issuance of NAFDAC registration number– 20 days
Total number of days: 90 days for Food and 120 days for Drugs
With some patience and perseverance, you’ll have your NAFDAC registration certificate in hand, allowing you to legally market your product in Nigeria.
How much does NAFDAC Registration Cost?
To register a product with NAFDAC, you’ll need to pay the required fees for your application. Costs vary depending on the type of product. Some of the factors that determine the cost include:
- Product category: Food, drugs, medical devices, etc. Drugs and medical devices tend to cost more.
- Product source: Locally made or imported. Imported products usually have higher fees.
- Shelf life of the product: Products with a longer shelf life may have higher fees.
- Number of product variants: Fees are charged per product, so more variants mean higher total fees.
- Type of evaluation required: More complex products need more rigorous evaluation, increasing the fees.
The prices are as follows:
- The registration of drugs cost ₦70,000.
- orphan drugs cost ₦25,000
- Food Products registration cost ₦50,000
- Cosmetic Products cost ₦50,000
- Chemicals or Insecticides cost ₦40,000
- Veterinary products cost ₦70,000
- Medical devices cost ₦30,000
- Vaccines cost ₦40,000
- Water Registration cost ₦50,000
The international inspection, which currently costs around $10,500, is the most expensive of all of these expenses; however, if the overseas manufacturing business already has a GMP certification, this cost may be avoided.
In addition to the product registration fees, you’ll need to budget for other costs like facility inspection, product testing, and label vetting.
NAFDAC Contact Informations
NAFDAC’s corporate headquarters
- Plot 2032, Olusegun Obasanjo Way, Wuse Zone 7, Abuja, Nigeria.
Lagos Operational Office
- Plot 1, Industrial Estate, Lagos- Oshodi Apapa Express Way, Isolo, Lagos, Nigeria
Frequently Asked Questions
Here are some of the most asked questions about NAFDAC registration:
Do I need a lawyer for NAFDAC registration?
No, you do not need a lawyer to register a product with NAFDAC. The registration process is designed to be handled directly by manufacturers and applicants. However, hiring a consultant familiar with the process can help make the process smoother.
Does NAFDAC registration expire?
Yes, NAFDAC registrations must be renewed every 5 years, depending on the product category. Manufacturers are required to pay a renewal fee and, in some cases, go through a re-evaluation process to maintain an active product registration. Lapsed registrations will require going through the initial registration process again.
Can I register a product myself, or do I need a consultant?
You can register a product with NAFDAC yourself, but the process can be complicated. Many companies choose to hire a regulatory consultant to guide them through the steps and ensure the application is completed properly. Consultants have experience registering many products and can help avoid delays or rejections. They are familiar with NAFDAC’s requirements and procedures. For new companies, a consultant is highly recommended.
So there you have it, the step-by-step process for registering a product with NAFDAC. While it can seem complicated, if you follow the guidelines and have all your documents in order, you’ll be well on your way to getting your product approved.
The key is starting early and not leaving things to the last minute. Once you have that approval certificate in hand, you’ll have the green light to start manufacturing and distributing your product to customers all over Nigeria. Not only will you have the peace of mind of operating legally, but you’ll open up your business to new opportunities.