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How To Register Regulated Product With NAFDAC

When starting a business in Nigeria, there are several considerations you have to make. One of which is registering your regulated product With NAFDAC – The National Agency For Food And Drug Administration And Control.

 

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NAFDAC is one of the bodies in charge of regulated product registration in Nigeria. It covers both locally manufactured and imported products. However, it’s not the only body approved by government for the registration of products in the country. There’s also SON – Standard Organization of Nigeria.

But NAFDAC covers just food and drug related products. Anything that Nigerians are meant to consume falls within the purview of NAFDAC. While SON covers those products that falls outside of food and drugs.

For an entrepreneur, you need to register your regulated food and drug products with NAFDAC to avoid falling into the wrong side of the law. That would also help build consumer confidence on your product.

Why Register Your Product?

NAFDAC registration is about certifying the product and approving it for consumption and sale, while a registration number is issued to notify the public or help in verifying the authenticity of the product being consumed.

A registered product gains consumers confidence, meets all regulatory conditions and helps promoters avoids battles with the laws of the land. Any responsible business entity knows that registering their products with the appropriate authorities is an important business decision.

Moreover, you need to know how NAFDAC operates to enable you register your products without hitches. The process is not difficult but sometimes can drag for a while before your product would be approved fit for consumption.

What Are Regulated Products?

According to a Science Direct bookon An Overview of FDA Regulated Products, a product is considered regulated if a government authority determines when and how the product is allowed to be commercialized.

Although, regulated products differ by countries and territories. What may be regulated in the United States for example, may not be regulated in Nigeria. Countries regulate their products based on their own unique market challenges.

Also, a product may have been regulated in the past but later withdrawn from regulated list of products.

 

Register regulated product With NAFDAC
Some regulated products in Nigeria

Products To Register With NAFDAC

Based on the definition of regulated product above, you can site some classes of regulated products to fall within these categories. In the United States, the FDA separates products into specific categories:

  • Food
  • Dietary supplements
  • Cosmetics
  • Drugs
  • Biologics
  • Medical devices
  • Veterinary products
  • And tobacco

The same applies to NAFDAC in Nigeria. Water also falls within the food category. These products are regulated due to the grave implication if their are adulterated or subsatndardly produced.

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I also feel to give some few examples of previously registered products by NAFDAC to help you fully understand the Nigerian regulatory environment. I picked products from different categories, and in no particular order:

  • Revup (water, yoghurt, and juice)
  • Infini Clear (cream, soap and lotion)
  • De-Zack Water 50Cl Sachet
  • Flexi Joint Capsules And Cream
  • A1 Pat Life Water
  • Brave Herbal Capsules
  • GINO magic pepper and onion tomato seasoning mix (MILD)
  • MR CHEF seasoning
  • FAMKO sweetened yoghurt

You can search and find any NAFDAC registered products on this website link.

Who Can Register Product With NAFDAC

In case you are wondering if your business qualify to register a product With NAFDAC, let me clarify those classes of businesses that can approach NAFDAC for product registration. Below are the categories of entrepreneurs that can register a product With NAFDAC.

  1. Manufacturer
  2. Distributor
  3. Marketer

These three classes of entrepreneurs deals directly with products, and your business have to fall within any of these three to register a product With NAFDAC. Although, it’s not like NAFDAC has restriction on classes of business as a condition. It’s even because you cannot have the right over a product unless you fall within these three classes of entrepreneur, especially as a manufacturer.

A retailer only has exclusive retail rights. It’s only a manufacturer, distributor or marketer that can have an exclusive product right in a market. That’s why NAFDAC demands that only among these classes of entrepreneurs can register a product with the commission.

NAFDAC Registration Process

The process of registrating a regulated product With NAFDAC has been further simplified. It used to be solely by visiting any of the following NAFDAC offices in Nigeria.

  • NAFDAC Central Laboratory Complex, 3/4 Oshodi ? Apapa Expressway, Oshodi ? Lagos.

This office is where registration and regulatory affairs, legal process, inspections, food Laboratory tests, narcotics and controlled substances are handled.

  • NAFDAC Central Drug and Vaccines Laboratory (CDVL), Edmund Crescent, Yaba, Lagos

This office is in charge of drug laboratory tests and ports Inspection jobs.

  • NAFDAC Enforcement Directorate. Ahmadu Bello Way (Behind Nigerian Air Force Camp by Legico B/stop), Victoria Island – Lagos.

While this office sole responsibility is the enforcement of all NAFDAC laws.

To begin the registration process, you start with the purchase of the relevant registration application form from the NAFDAC office closest to you and pick up the applicable guidelines. This guidelines gives you proper directives on how to make your applications with the support documents required. Also read how to register a business in Nigeria.

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How To Begin Registration Process

It’s takes about three months to complete NAFDAC product registration process, if all requirements are met at stipulated times. There are processes to follow when registering a regulated product. NAFDAC has laid out rules to guide applicants. Let me list each process for you:

  • Application Letter And Document Submission
  • Registration description of intent
  • Samples for laboratory analysis
  • Payments for category of registration

The first step is to submit letter of application with all required documents. Your letter of application gives NAFDAC information about your request for registration, and your documents helps them to understand who is making the application. But you have to ensure all the documents are complete, with the appropriate description so you won’t encounter any delays in the process.

The next step in your registration process is the description of your intent. This includes the purpose of your registration, and the product description itself. You are letting NAFDAC know what you want to register, what it does and your reason for registration.

Then, you submit your samples for testing. Here are the requirements to bear in mind when submitting your samples for laboratory analysis.

  1. Make your labelling clear, accurate and informative
  2. And your label must carry the following details:
  • The brand name
  • The name and address of manufacturer, distributor, marketer
  • The provision or slot for NAFDAC Registration number
  • The batch number to be tested, manufacturing and expiry date
  • The net content
  • The complete list of ingredients
  • Any product warnings that consumers should be aware of

And finally, you pay your registration fees according to your registration category.

NAFDAC Application Fees

It’s equally important to know how much it cost to get the NAFDAC number in Nigeria? The number is a symbolic representation of the product that it has been approved by NAFDAC.

So, registering your product With NAFDAC is not only to prove the quality and authenticity of it but also to get NAFDAC seal of approval, which is the NAFDAC number. And these fees are charged in two variants.

Register regulated product With NAFDAC
Infini clear product range

Since Nigeria imports a lot of products, NAFDAC also classified the registration fees into two. One class is for imported products, while the other one is approved for locally made products.

For imported products, NAFDAC charges as much as N200,000 plus VAT to register any imported product to be sold in Nigeria. These products that are not manufactured in Nigeria are made to pay more than those manufactured in the country.

While the locally manufactured products gets a lower fee of just N50,000 plus value added tax (VAT).

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What’s NAFDAC Registration Number?

When you register a product With NAFDAC you will be issued with a registration number. This number is what NAFDAC uses to identify your product and it equally gives consumers a sense of confidence that your product is under the purview of the regulatory authority of NAFDAC.

NAFDAC issues this number as a final approval for each product that has successfully undergoes its rigorous examinations under its quality and health considerations.

Each registered product is issued a unique identification number to help NAFDAC monitor and control the quality of such product. While these efforts are meant to curb fake and substandard products, it doesn’t completely eliminates it from the market.

Unscrupulous importers and manufacturers also explore the porous nature and the inadequacies of NAFDAC to exploit consumers by using either fake or unapproved registration number on their products to deceive buyers.

Apart from the issue of registration number, NAFDAC also issues product certificate after registration. But this certificate is not issued immediately. It takes about a maximum of six months after the product approval date. So, it can be issued anytime within the six months period after registration.

Conclusion

Inasmuch as you can process NAFDAC registration yourself, it’s usually helpful to seek the services of a consultant. It helps to simplify things for you and make it work faster. An experienced consultant knows the process better and understand NAFDAC modus operandi better than you who is doing it for the first time.

Since China dominates Nigerians import destination, NAFDAC also has a Chinese office, which enables Chinese products to be registered right there in china before being imported into Nigeria. This option may be suitable for you, but try and check the cost implications compared with registering in Nigeria before choosing this option.

Finally, any product you want to sell in Nigeria, find out first if it requires registration. If it’s not a product under the NAFDAC purview, it would be under the Standard Organization of Nigeria (SON). Avoid importing or selling unregistered products in Nigeria.

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