NAFDAC Product Registration Guide

Some time ago, we brought you an article on a product that has attained near-elixir status and that product is CBD oil (you can click here if you haven’t read it and you should read it, we promise it’ll be worth your while). We received a lot of positive feedback which made it clear that many of us would love to get involved in the importation and sale of premium quality CBD oil.

nafdac logo

Now, you would recall that in that post, we said something about getting your CBD oil registered with the appropriate regulatory bodies (and that body for Nigerians is NAFDAC) as it’ll give you all the audacity, temerity, surety, certainty, and every other ‘-ty’ word out there that connotes confidence, you need to import and sell your CBD oil and gain massive chunks of market shares – because a larger market share is one way to improve those precious profit margins after all.

It’s no secret that we want you to be successful – even the emails from our CEO always end with “May you always be profitable” – and seeing as that’s our goal, we’ve decided to bring you a guide on how to go about registering your CBD oil and other such products with NAFDAC. Now before we go any further, why don’t we take a brief look at the body called NAFDAC so that we’re on more familiar footings with the organization, its origins and the reason for its existence; here we go!

nafdac lagos office

NAFDAC is the acronym for the National Agency for Food and Drug Administration and Control. It’s the body tasked with the regulation and control of all the processes involved in the production, importation, exportation and promotion of food, drugs, medical devices, chemicals, cosmetics and packaged water in Nigeria. NAFDAC was officially established in the year 1992 and since that time, its vision has been the safeguarding of public health. It took upon itself the responsibility of ensuring that only food, drugs and regulated products of the right quality are made, imported, distributed, advertised, sold and used in Nigeria. It carries out these functions through its offices and laboratories located in all six geo-political zones of the country.

To prove that it’s no barking dog, NAFDAC has prompted the arrest, interrogation, investigation and arraignment of many who have tried to cleverly evade due process by counterfeiting NAFADC regulated products, forging documents, purchasing and distributing substandard products and a host of other activities that go against the watchdog’s guidelines and regulations.

channels tv news of nafdac arrest

We know that we’re always on your case, encouraging you to grow, to take advantage of opportunities we inform you about through our mails and Facebook posts. However, we do not want that to be at the expense of your reputation and freedom neither do we wish to jeopardize our credibility as a brand and as a business. Having reiterated our commitment to you and given you a brief description of NAFDAC and its functions, let’s see what it takes to get one’s product registered with the organization.

Before we go any further, we’ll like to say that only businesses registered with the Corporate Affairs Commission can register products with the agency. NAFDAC’s product registration process differs slightly for imported products as opposed to locally produced ones. Generally, product registration is a process that involves:

NAFDAC Product Registration Documentation

A number of documents will be required by NAFDAC during the registration process. Some of these documents include:

Power of Attorney (POA)

A POA, as it relates to the topic at hand, is a legal document granting one person or an entity – in this case, you or your business, the Nigerian representative – the authority or power to act in the capacity or on the behalf of the manufacturer in Nigeria. The manufacturer issues this and the president or director of the company must sign it. It must also bear the notarization of the Notary Public in the country of origin. This, as you may have already guessed, is for imported products.

Certificate of Manufacture and Free Sale

This is a legal document that shows or proves that the product is manufactured and freely sold in the country of origin. It is issued by the relevant regulatory body in the country of origin and authenticated by the Nigerian Embassy in that country (which in our case is China). It is another document for imported products.

Certificate of Business Incorporation

The Corporate Affairs Commission (CAC) issues this upon successful application and registration of your business or company with the commission. It’s required by NAFDAC for both imported and locally produced products.

Evidence of Trademark Registration

This is a document that shows that your company’s or brand’s trademark has been approved and is recognized by the trademark registry. It’ll also be required of the foreign company whose products you’re importing.

Comprehensive Certificate of Analysis

This is a document that proves the quality of the batch of products to be registered. It must be presented on a letter headed paper of the laboratory where samples of the product were tested. It should contain, among other things, the result of the analysis; name, office and signature of the analyst and the product’s batch number. It applies to locally manufactured and imported products.

Application

Written application (on your company’s letter headed paper) addressed to the director of the NAFDAC office in your business location. It should contain the manufacturer’s name, generic name e.g. CBD Oil and brand name e.g. Spreadit CBD Oil (that’s if you already have a brand name for your CBD oil or if you’ll be retaining the name of the manufacturer). This of course applies to both groups of products.

Online Registration

You’ll also be required to purchase and fill an online registration form at http://registration.nafdac.gov.ng/ which will be one of the documents you’ll be submitting. When you arrive at the site, click on “NAFDAC CLIENT” icon to be taken to a page with the registration form. This for both imported and home-made products. Information you’ll need here include TIN (Tax Identification Number), RC Number, company incorporation details, company contact details etc.

Application Letter for Import Permit

This applies to imported goods. The applicant sends it to NAFDAC.

GMP Invitation Letter

This one is for importers. The manufacturer writes it, inviting NAFDAC to inspect their facilities. It’ll contain the company’s name, address, email, phone number, name of overseas contact person, name of its nearest airport and guide map showing air/land route to the factory. It’ll also contain name and contact details of the representative company in Nigeria as well as that of its contact person.

Certificate of Inspection

Labeling

NAFDAC inspects the labels of your product to ensure that the information they contain is clear and accurate. It should contain the name of the product, name and address of the manufacturer, packer, distributor, importer, exporter or vendor. There should also be provision for the NAFDAC registration number, batch number, dates of manufacture and expiry, ingredients and net content.

NAFDAC Inspection

Inspection of your facility (for locally produced goods) and/or manufacturer’s facility (for imported goods) will be carried out based on the Good Manufacturing Practice (GMP). If NAFDAC is pleased with what it sees, it’ll issue a certificate of inspection or a certificate of recognition to the inspected.

Product Approval Committee Meetings

A 3-tier product approval meeting will be held to consider your documents, lab reports, product labels, GMP inspection reports and so on. Upon successful and satisfactory conclusion of these investigations, a NAFDAC registration number will be assigned and you can then proceed to sell your product anywhere in Nigeria. For advertising through conventional media i.e. you’ll need a separate application and approval for an Advertising Permit.

picture showing nafdac approval

So that’s the rundown of what you’re to expect during the NAFDAC registration process. It usually takes about 120 days from the day of submission of your application to the issuance of the NAFDAC registration number.  The next paragraph is a practical guide on how to go about the registration process. You’ll recognize some of the words or concepts you’ll be seeing here from what you’ve read in earlier paragraphs.

Step 1: Visit the NAFDAC office in your state (it has an office in every state and here’s a link to the addresses of those offices in each state). A file containing documents and instructions will be given to you. You’re to follow those descriptions in preparation for the next step.

Step 2: NAFDAC will inspect your location and this may take a while. A certificate of inspection or recognition will bw given to you after the inspection. You’ll need to provide all the necessary information and description of the oversea facility for inspection if you’re seeking to register and import regulated products.

Step 3: Purchase and correctly fill the registration form. We’ve already provided the link for that but just in case scrolling back there would be too much of a hassle, here it is again: http://registration.nafdac.gov.ng/

Step 4: Submit application form and other relevant documents on time and in accordance with issued guidelines

Step 5: NAFDAC will request product samples to be analysed in its laboratory

N.B:

  • Making timely payments and filling out forms correctly will prevent unnecessary delays.
  • Photocopy all documents.
  • Certificate of registration is valid only for a period of 5 years.

Having said all these, we’d like you to know that register imported products without acquiring NAFDAC registration numbers. To do so, you’d need the following:

  • Import permit
  • Listing Certificate
  • A warehouse to be inspected by NAFDAC
  • A technical officer with training in the sciences and his/her passport photograph
  • Local Purchase Order
  • Material Safety Data Sheet
  • Certificate of Incorporation with CAC
power point slide showing nafdac's promise of committment

As we draw the curtain on this post, it’s important to note that products that passed NAFDAC’s standard and quality tests will be issued a certificate of registration or registration number. Upon successful product registration, you can now proceed to import as many products (or bottles of CBD Oil –let’s not forget the product that inspired this post) as you want. Ensuring your products are labeled correctly will help you avoid unnecessary importation delays.

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