The National Agency for Food and Drug Administration and Control is called NAFDAC. NAFDAC is a Nigerian federal agency within the federal health agency that regulates and controls the production, import, export, distribution, distribution, sale and use of food, drugs, cosmetics, appliances health, chemicals and bottled water.
According to the law establishing the agency, it is illegal to advertise and
sell any product or item in Nigeria to the public without first registering
with NAFDAC (NAFDAC Act).
If a registered
company imports or manufactures food, medicine or foodstuffs, these products
must be registered with NAFDAC.
Primary Functions of NAFDAC
1. NAFDAC compiles the requirements, rules and guidelines for the development, import, manufacture, sale and distribution of food, medicine, medical devices, bottled water and chemicals.
2. The company handles the export of foodstuffs, medicines, medical
supplies, bottled water and chemicals from Nigeria. It also provides assurance
certificates for these products.
3. Establish
satisfactory management and comply with the specific group rules and be
authorized by the NAFDAC Council for the effective quality control of food,
medicine, cosmetics, medical equipment, water and chemicals.
4. The company
conducts research on food, medicine, cosmetics, medical devices, bottled water
and chemicals and develops a comprehensive system of assurance.
Procedures for NAFDAC Registration
NAFDAC
requirements for the manufacture or importation of food, medicine or goods into
Nigeria are different depending on whether the products are produced locally or
overseas.
Note that before
registering solid products with NAFDAC, any company involved in the production,
processing and distribution of food, imported food, pharmaceuticals, processed
foods and cosmetics will settle transactions with the Corporate Affairs
Commission (CAC).
When registering
for NAFDAC, keep the following points in mind:
1. Registration
requirements for locally produced products are different from those applicable
to imported products.
2. Each NAFDAC
registration number is linked to a single product. If you have more than one
product, you will need to get a separate registration number for that product.
Step by Step Guide to Register your Product with NAFDAC
Follow these steps to register your product with NAFDAC:
1. Obtain the NAFDAC Registration Form
The first step is to visit your nearest NAFDAC office and apply. NAFDAC Headquarters is located at Plot 2302, Olusegun Obasanjo Way, Zone 7, Wuse, Abuja, Nigeria. However, if you are not in Abuja, find their local office address in your state.
Upon arrival, purchase the NAFDAC registration form and fill it in
properly. As mentioned earlier, each type of registration can only use one
product. Therefore, if you have more than one product, you will need to buy
more than one type.
2. Submit the Registration Form
The second step
is to submit your registration and application form. Send a letter to NAFDAC
stating your intention to register your product(s). It is important to note
that your application letter should include all relevant information about your
product, such as product name, description, manufacturer name, who it is for,
etc. Send your letter to the director in charge of the district where you are
registering. Submit your registration form along with your application form and
any other required documents.
3. Submit Product Samples
You will be
asked to submit three products for review and evaluation. Once you complete
this process, you will receive a certificate of accreditation as a developer.
4. Payment
The next step is
to pay the required fee for your registration. Get the money you need in time
to avoid wasting time. The fees and tariffs to be paid are determined by the
type and type of product to be registered.
5. Get Certified
You will receive
a NAFDAC registration number and registration form for your product when you
register it.
NAFDAC Registration Procedure for Imported Goods
Foreign
companies must send samples of their products for analysis to register the
imports with NAFDAC. However, without the right to bring samples, this is not
possible. Therefore, foreign companies must first apply for permission to
export samples to Nigeria.
To do this,
NAFDAC issues special written or import permits to importers, allowing them to
bring samples of their products. In addition, the supplier must receive from
the manufacturer and other relevant companies in the country from the necessary
documents for customs clearance and delivery of samples.
NAFDAC Food Product Registration Requirements
1. Company
responsible for issuing Certificate of Incorporation (CAC)
2. NAFDAC trademark
approval test/certificate for your brand name by the Federal Department of
Commerce (if applicable)
3. Complete
certificate of inspection of the batch of products for the registration of the
manufacturer, including the name and signature of the inspector.
4. A copy of the
application submitted to the principal containing the name of the manufacturer,
brand and product(s).
1. Corporations
that issue Certificates of Incorporation (CAC)
2. Send three
samples of your goods for testing and quality control. 3. Medical product
certificate signed with authorization
4. Power of
attorney from product manufacturer, original copy (if imported)
5. Product
Registration Request Form
6. An invitation
from the manufacturer to inspect the overseas factory, including the full name
and location of the factory
7. Full copy of
NAFDAC.
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Imported Goods Registration Requirements
It should be
noted that registration for imported goods (food or medicine) includes all of
the above. There are other regulations that must be met if you want to register
imported products with NAFDAC.
A power of
attorney or a manufacturing agreement from the manufacturer authorizing the
Nigerian representative to act in their capacity in Nigeria must be attached to
the application. A power of attorney or a manufacturing contract from the
manufacturer authorizing the Nigerian representative to act in his capacity in
Nigeria must be attached to the application.
The document
must be signed by the principal or director of the company. In addition, the
power of attorney or the manufacturing contract must be notarized by a public
notary in the country where the manufacturer will be legalized.
A free sale
certificate must be issued by the health/control agency in the country of
manufacture. The certificate must include the name of the manufacturer and the
product.
A complete
inspection certificate must be included on the letterhead of the quality
control laboratory where the sample was tested or inspected, and must include
the following information:
1. Reviews of
products or articles
2. Batch number
of products production date and expiration date
3. Name, title
and signature of the examiner
4. You must keep a document that shows that the food manufacturer or drug importer has the right to sell the product in the country of origin and that the sale of the product does not violate the food laws of that country.
5. The right to bring samples
6. Letter of
invitation to inspect factories abroad
7. The NAFDAC
registration process can be difficult for Nigerian companies, which is why some
are looking for ways to cut corners. However, if you want to run a successful
business without fear, you have to do the right thing.
Timelines for Registration Processes
In Nigeria,
NAFDAC registration takes time. This is the time required to register and
obtain a NAFDAC number for food, medicine and other products.
• Registration
takes 0 days
• Paper test
lasts for 10 days
• Inspection /
house inspection takes 10 days for food and 20 days for medicine
• Laboratory
testing takes 30 days for food and 40 days for medicine
• Final approval
takes 10 days
• NAFDAC number
confirmation/transfer agreement takes 20 days
So, it takes a total of 90 days for food and 120 for medicine. The cost of registering NAFDAC products is determined by the products to be registered.
Prices vary by product
type. Some of the specific fees that an application must pay include the cost
of product registration, import permits, and inspections, if applicable.
These prices
are:
• Drug
registration costs ₦70,000.
• ₦25,000 for
medicines for orphans.
• ₦50,000 for food.
• ₦50,000 for jewelry.
• ₦40,000 for
chemicals or pesticides.
• ₦70,000 for
animal products.
• ₦30,000 for
medical devices.
• ₦40,000 for
vaccinations.
• ₦50,000 for
water.
Out of all these
expenses, international screening, which currently costs about ₦10,500, is the
most expensive; however, this cost can be avoided if the foreign manufacturing
plant already has GMP certification.
Final Thought
The information
in this article will help you apply for your NAFDAC. Apply, follow the process,
receive your NAFDAC registration number and do your business without constantly
looking over your shoulder.
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