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NAFDAC Registration: How to Register a Product With NAFDAC

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.

Product Registration

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.

Laboratory Analysis

NAFDAC analyzes product samples to verify safety, quality and efficacy before registration and also does post-marketing surveillance to monitor compliance.

Port Inspection

NAFDAC inspects all importations of regulated products at ports of entry to prevent entry of substandard or counterfeit products.

Clinical Trials

NAFDAC evaluates the safety, quality and efficacy of regulated products through a review of documentation of clinical trials before approval and registration.

Enforcement Operations

NAFDAC undertakes enforcement operations, including raids, seizures, prosecution and destruction of substandard, spurious, falsely labeled, falsified and counterfeit (SSFFC) medical products.

Public Awareness

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.

International Cooperation

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.

Email: [email protected]

Website: nafdac.gov.ng

Lagos Operational Office

Plot 1, Industrial Estate, Lagos- Oshodi Apapa Express Way, Isolo, Lagos, Nigeria

For Enquiries :

+234(0)-1-4609750

For Complaints :

+234(0)909-763-0506, +234(0)909-763-0507

[email protected]

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.

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Easy Steps On How To Get Your Food Products Registered With NAFDAC

We have been taking on food recipes and health for a while now and I feel it’s time to infuse some food business and legalities.

Food business is very important because it is the one that brings about money which is important for life.

Table of Contents

In the last decade, there has risen in Nigeria, a new wave of enterpreneurs in all fields, the standard of productions have been raised even up to world standard and the food world is not an exception.

Different creative foods and drinks have been developed and packaged which are taking over from the imported ones that has been dominating the market for many years.

However, no matter how big your ideas, food formula is, it cannot be accepted to be sold in Nigeria except it is registered under the Nigerian food and drugs agency.

HOW TO REGISTER WITH NAFDAC

The National Agency For Food and Drug Administration and Control (NAFDAC) are the regulatory body that controls the influx and efflux of food and drugs in Nigeria.

They also validate the authenticity and quality of your products either food, drinks or drugs before it can be sold publicly.

STEPS TO GETTING A NAFDAC NUMBER

1. factory check and sample collection.

Visit the NAFDAC office in your state or the one closest to you and register. Your factory is going to get a visit from the officials.

* They are going to check your Water purification plant if you are into drinks

* They are going to check your production line

* They are going to check your workers room

* They are going to check the general neatness of the place and the equipments you possess and other things they deem fit to check

After this, if they are satisfied, you will be required to submit three samples of your products for analysis and then given a certificate of recognition as a manufacturer.

2. You have to purchase a form and fill accordingly. After filling the form, you will now write an application letter to NAFDAC stating your intention to register your product.

The application must be addressed to the Director; Registration and Regulatory Affairs.

3. After both have been done. You will attach both the Registration form and the application letter together and submit.

It could takes weeks or few months but if the forms were properly filled with no mistakes, your registration would be successful.

DOCUMENTS NEEDED TO SUBMIT AT NAFDAC

1. Your certificate of inspection and Recognition after your factory was checked

2. Your certificate of incorporation by the corporate affairs commission

3. The application letter coupled with the Registration form you forwarded to the Director.

4. Certificate of sample collections with the date and signature of the analyst

5. Trade mark issuance certificate for your brand by the ministry of commerce.

Wishing you good luck as you proceed into registering your food or drink products.

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How to Register Products with NAFDAC

The National Agency for Food and Drug Administration Control, NAFDAC, requires entities that manufacture, process, pack or store foods, drugs, cosmetics and medical devices marketed in Nigeria to file registrations with the NAFDAC.

Under the NAFDAC Act, the following products are required to be registered in Nigeria:

Drug and Medical Devices
Herbals and Cosmetics
Vaccines and Biologics [Products that are made from living organisms or contain components of living organisms]

[Click on each category of product above to study the guidelines, and scope of any subcategory of your choice. They are extensive]

To initiate the registration process, you need to:

Go to https://www.napams.org/#plans to create an account, if you don’t have one
Submit all documents for registration alongside an application letter stating your intention to register a product addressed to: The Director, Registration and Regulatory Affairs, NAFDAC, Central Laboratory Complex, Oshodi, Lagos , in accordance with the issued guidelines at first instance for any of the service to be rendered by NAFDAC.
Provide NAFDAC with the relevant information and description of the facility for inspection where it relates to registration and importation of NAFDAC regulated products.
Provide samples of the products to be registered when notified by NAFDAC for laboratory analysis.
Ensure all payments are made as and when due ( download relevant guidelines, tariffs and fees) .
Ensure all documents are complete and with the appropriate description to prevent unnecessary delays.

Take Notice: In May, the Federal Government announced that new Micro Small and Medium Enterprises (MSMEs) will be able to register their products with NAFDAC at 80% discount, over the next 6 months. All MSMEs producing foods, drugs, and related consumables are eligible.

Required Documents

Your certificate of incorporation issued by the corporate affairs commission (CAC)
A signed and endorsed certificate of Pharmaceutical Product.
Submit three samples of your product for quality analysis and inspection.
Original copy of the Power of Attorney from the product manufacturer (if imported).
Completed NAFDAC application form.
The application letter for registration of the product.
Letter of invitation from manufacturer to inspect factory abroad, full names and site of plant.

The requirements for registration of imported food or drug products include all those stated above. Other terms and conditions that you would need to meet for a successful registration of imported products include:

An applicant for a manufacturer outside Nigeria must file an evidence of Power of Attorney from the manufacturer.
You must provide evidence that the manufacturer of the imported food or drug product are licensed to sell such product in the country of origin and that the sale of the product does not constitute a contravention of the food laws of that country of origin.
Permit to import samples.
A letter of Invitation to inspect the factory abroad.
The applicant must be based in Nigeria who must have a duly signed Power of Attorney from the manufacturer authorising the Nigerian representative to act in their capacity in Nigeria and with the name of the product explicitly stated

Table of Contents

Timelines for Registration

Registration of food product not more than 90 days from acceptance of application.
Registration of drug product not more than 120 days from acceptance of application.
Variation of product registration takes not more than 60 days

Compliance Directive

A client is mandated to comply with Compliance Directive (CD) within 7 days of issuance.

Note failure to comply with any CD issued by NAFDAC may be a basis for cancellation of the application and all delays of the client will not be counted within the 90 days for registration.

All Complaints or conflicts should be forwarded to the reforms unit of NAFDAC through the following address; [email protected] , [email protected] , or the nearest nafdac state offices.

Summary of Registration processes with timelines

Submission of Application – 0 days
Document Verification – 10 days
Facility Inspection/Sampling – 10 days for Food, 20 days for Drugs
Laboratory Analysis – 30 days for Food, 40 days for Drugs
Final Vetting – 10 days
Approval Meeting/Issuance of NAFDAC registration Number(Certificate of registration) – 20 days

Total number of days : 90 days for Food, 120 days for Drugs

Halima Abiola

One thought on “ how to register products with nafdac ”.

I want to register my herbal product,can someone help?

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Product Registration & Regulation

The following are required from the Applicants

Submit all documents for registration and application letter in accordance with the issued guidelines at first instance for any of the service to be rendered by NAFDAC.
Provide NAFDAC with the relevant information and description of the facility for inspection where it relates to registration and importation of NAFDAC regulated products.
Provide samples of the products to be registered when notified by NAFDAC for laboratory analysis.
Ensure all payments are made as at when due ( See relevant guidelines and tariffs and fees ).
Ensure all documents are complete and with the appropriate description to prevent unnecessary delays.
Registration of food product not more than 90 days from acceptance of the application.
Registration of drug product not more than 120 days from acceptance of the application.
Variation of product registration takes not more than 60 days

Compliance Directive

A client is mandated to comply with Compliance Directive (CD) within 7 days of issuance.

Note failure to comply with any CD issued by NAFDAC may be a basis for cancellation of the application and all delays of the client will not be counted within the 90 days for registration.

Complaints:

All Complaints or conflicts should be forwarded to the reforms unit of NAFDAC through the following address; [email protected] , [email protected], or the nearest nafdac state offices (see attached details).

Summary of Registration processes with timelines

Submission of Application – 0 days
Document Verification – 10 days
Facility Inspection/Sampling – 10 days for Food, 20 days for Drugs
Laboratory Analysis – 30 days for Food, 40 days for Drugs
Final Vetting – 10 days
Approval Meeting/Issuance of NAFDAC Registration Number(Certificate of registration) – 20 days

Total number of days : 90 days for Food, 120 days for Drugs

Product Registration

Company Name:
Non-Govenmental
Date of Incorporation: Date Format: MM slash DD slash YYYY

Company Contact Information

Address Street Address Address Line 2 City State / Province / Region ZIP / Postal Code Afghanistan Åland Islands Albania Algeria American Samoa Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia Bonaire, Sint Eustatius and Saba Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darrussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos Islands Colombia Comoros Congo, Democratic Republic of the Congo, Republic of the Cook Islands Costa Rica Côte d'Ivoire Croatia Cuba Curaçao Cyprus Czech Republic Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Eswatini (Swaziland) Ethiopia Falkland Islands Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard and McDonald Islands Holy See Honduras Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati Kuwait Kyrgyzstan Lao People's Democratic Republic Latvia Lebanon Lesotho Liberia Libya Liechtenstein Lithuania Luxembourg Macau Macedonia Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Martinique Mauritania Mauritius Mayotte Mexico Micronesia Moldova Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island North Korea Northern Mariana Islands Norway Oman Pakistan Palau Palestine, State of Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Poland Portugal Puerto Rico Qatar Réunion Romania Russia Rwanda Saint Barthélemy Saint Helena Saint Kitts and Nevis Saint Lucia Saint Martin Saint Pierre and Miquelon Saint Vincent and the Grenadines Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Sint Maarten Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia South Korea South Sudan Spain Sri Lanka Sudan Suriname Svalbard and Jan Mayen Islands Sweden Switzerland Syria Taiwan Tajikistan Tanzania Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu Uganda Ukraine United Arab Emirates United Kingdom United States Uruguay US Minor Outlying Islands Uzbekistan Vanuatu Venezuela Vietnam Virgin Islands, British Virgin Islands, U.S. Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe Country
Company Phone
Contact Phone
Company Email
Contact Email

Applicant Information

Name Representative First Name Representative Middle Name Representative Last Name
Confirmation Password

Applicant Documentation

Certificate Of Incorporation: Accepted file types: pdf.
Pharmacist's License to Practise or Receipt of Payment for Renewal: Accepted file types: pdf. Drug Only
Current Premises License: Accepted file types: pdf. Drug Only
Pharmacist's License to Practise or Receipt of Payment for Renewal Expiry Date: Accepted file types: pdf.
Current Premises License Expiry Date: Accepted file types: pdf.

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How To Process Your NAFDAC And Get A NAFDAC Registration Number In Nigeria

Entrepreneurs.ng
May 22, 2020

If your business involves the production or importation of food and drug-related products, you cannot run such business in Nigeria without properly registering with the National Agency for Food and Drug Administration and Control (NAFDAC). Due to the assumed stringent procedure of NAFDAC registration, many run away from involving in any food or drug business or look for ways to cut corners.

See Also: Benefits Of Registering Your Business With Corporate Affairs Commission (CAC)

Howbeit, many companies have been able to successfully get NAFDAC’s approval for their products. Usually, it is a lack of adequate information that makes the process rigorous for many people. In this article, you will get the necessary information you need to begin and complete your registration with NAFDAC.

Start Your Business in 30 Days Even If You Don't Have An Idea

Basically, NAFDAC permits cover two categories: Foods and Drugs. Therefore, if manufactured or imported goods fall within these two categories, registration with NAFDAC is mandatory.

Also, note that the foods or drugs companies must first register with the Corporate Affairs Commission (CAC) before registering their products with NAFDAC.

To ensure the safety of Nigerian citizens, every manufacturer , exporter , importer , or trader of drug and food-related products must comply with the registration requirements set down by NAFDAC.

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The Evolution Of NAFDAC

The National Agency for Food and Drug Administration and Control (NAFDAC) is a federal agency under the Federal Ministry of Health. It is the body responsible for regulating the importation, manufacture, exportation, distribution, sale, and use of food, drugs, cosmetics, medical devices, chemicals, and packaged water in Nigeria.

In 1989, over 150 children died as a result of paracetamol syrup containing diethylene glycol. At the time, the issue of fake drugs was rampant in Nigeria such that neighbouring countries such as Sierra Leone and Ghana banned the sale of foods, drugs and beverages products made in Nigeria.

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This problem led to the establishment of NAFDAC. The aim of NAFDAC is to ensure that all imported or locally produced food and drugs are safe for consumption.

In December 1992, NAFDAC’s first governing council was formed. The council was headed by Tanimu Saulawa. In 1994, NAFDAC was officially established as a “parastatal of the Federal Ministry of Health”.

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NAFDAC Registration Procedures

Note the following when registering with NAFDAC

The registration requirement for locally produced products is different from that of imported products.
Each NAFDAC registration number is for a single product. If you have more than one product, you will have to get a separate registration number for the product.

See Also: How To Get Tax Identification Number (TIN) And Open A Bank Account For Your Business

How To Register With NAFDAC

Step one: get nafdac registration form.

Go from idea to starting your business in 30 days

The first step is to go to the nearest NAFDAC’s office to you to make your request known. NAFDAC’s headquarters is located at Plot 2302, Olusegun Obasanjo way, Zone 7, Wuse, Abuja, Nigeria.

However, if you are not in Abuja, find the address of their zonal office in your state. Once you get there, purchase the NAFDAC registration form and fill it appropriately.

As said earlier, each registration form can only be used for a single product. So, if you have more than one product, you’ll need to purchase more than one form.

See Also: Taxes: Different Taxes In Nigeria And How To Pay Your Tax

Step Two: Submit Your Registration And Application Form

Write an application letter to NAFDAC stating your intention to register your product(s). Note that your letter of application should contain all relevant information about your product: product name, product description, manufacturer’s name, who the product is for, etc.

Address your letter to the director in charge of the zone you are registering with. Submit your registration form alongside your application letter and other required documents.

Also, provide NAFDAC with relevant information and a description of your facility for proper inspection. This stage may be quite tedious but it’s always worth the effort.

See Also: How To Start A Successful Supermarket Business In Nigeria

Step Three: Submit Samples Of Your Products

Thereafter, you would be notified to submit three samples of your product for inspection and analysis. As soon as you complete this stage, a certificate of recognition as a manufacturer would be issued to you.

Step Four: Make Necessary Payments

The next step is to make necessary payment for your registration. To avoid delays, make the required payment on time. The fees and tarriffs to be paid depend on the type and category of product you are registering.

See Also: How To Start A Successful Bakery Business In Nigeria

Step Five: Certificate Collection

After your product is registered, you will be given a NAFDAC registration number and certificate of registration for the product.

How Long Does NAFDAC Registration Takes?

Registration of food products takes not more than 90 days from after acceptance of the application
Drug products registration takes not more than 120 days from acceptance of the application
Variation of product registration takes not more than 60 days

See Also: How To Start Printing Business In Nigeria

Registration Processes With Timelines

Submission of Application – 0 days
Verification of documents – 10days
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 – 20days

Total number of days: 90 days for Food, 120 days for Drugs

See Also: How To Start Bottled Water Or Pure Water Business In Nigeria

Procedure For Registering Imported Goods With NAFDAC

To register imported goods with NAFDAC, the foreign company needs to send samples of their product for analysis. But, this is not possible without proper approval to bring in the samples. Hence, the foreign company must first apply for approval to bring in samples to Nigeria.

To do this, NAFDAC issues special written authorization or import permit to enable importers to bring in the samples of their products. In addition, the importer must also obtain the documents required for the clearing and delivery of the samples from the manufacturer and other relevant bodies in the country of origin.

See Also: How To Start An E-Commerce Business In Nigeria

NAFDAC Registration Requirements For Food Products

Certificate of Incorporation obtained from the Corporate Affairs Commission (CAC)
Certificate of inspection/recognition issued by NAFDAC
Trademark approval for your brand name by Federal Ministry of Commerce (where applicable)
Comprehensive Certificate of analysis of the batch of the product for registration from the manufacturer stating the name and signature of the analyst
Application form forwarded to the Director stating the name of the manufacturer, brand name, and product(s).

See Also: How To Start A Cleaning Service Company In Nigeria

NAFDAC Registration Requirements For Drug

Certificate of incorporation issued by the Corporate Affairs Commission (CAC)
Submit three samples of your product for quality analysis and inspection
A signed and endorsed certificate of pharmaceutical product
Original copy of Power of Attorney from the product manufacturer (if imported)
The application letter for registration of the product
Letter of invitation from manufacturer to inspect factory abroad with full names and site of the plant
Completed NAFDAC application form

See Also: How To Start A Poultry Farming Business In Nigeria

Registration Requirements For Imported Goods

Note that the registration requirement for imported products (food or drugs) includes all the above mentioned. In addition to those, there are other conditions you must also meet if you want to register imported products with NAFDAC.

An applicant must submit Power of Attorney or contract manufacturing agreement from the manufacturer authorizing the Nigerian representative to act in their capacity in Nigeria. The document must be signed by the Director or President of the company. Also, the Power of Attorney or the contract manufacturing agreement must be notarized by the notary public in the country of the manufacturer.
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 following: – 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 provide evidence that the manufacturer of the imported food or drug product are licensed to sell such product in the country of origin and that the sale of the product does not constitute a contravention of the food laws of that country of origin.
Permit to import samples
A letter of invitation to inspect the factory abroad

The NAFDAC registration process can be hard for businesses in Nigeria, which is why some businesses look for ways to cut corners. But, if you want to run a sustainable business without fear, it’s important that you do the right things.

The information in this article will guide you in applying for your NAFDAC. Go ahead and make that application, endure the process, get your NAFDAC registration number, and run your business without always looking over your shoulders.

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How To Register A Product With NAFDAC: Cost & Steps

by Mfonobong Daniel

The National Agency for Food and Drug Administration and Control is abbreviated as NAFDAC. NAFDAC is a Nigerian federal body within the Federal Ministry of Health that regulates and controls the manufacture, importation, exportation, advertisement, distribution, sale, and usage of food, pharmaceuticals, cosmetics, medical equipment, chemicals, and packaged water.

According to the statute creating the Agency, it is illegal to advertise and market any product or consumable items in Nigeria to the general public without first registering with NAFDAC (NAFDAC Act).

TABLE OF CONTENTS

If a corporation is registered to import or manufacture food, pharmaceuticals, or consumable products, those products must be registered with NAFDAC.

NAFDAC’S PRIMARY FUNCTIONS

NAFDAC compiles consistent requirements, legislation, and directions for the development, importation, manufacturing, sale, and distribution of food, medicines, medical devices, bottled water, and chemicals.
The Agency regulates the export of food, medicines, medical gadgets, bottled water, and chemicals from Nigeria. It also gives quality assurance certificates for these commodities.
Conducting satisfactory checks and adhering to uniform rules defined and authorized by the NAFDAC Council for successful quality control of food, pharmaceuticals, cosmetics, medical equipment, bottled liquids, and chemicals
The Agency performs audits of imported foods, medicines, cosmetics, medical devices, bottled water, and chemicals as well as developing a comprehensive program for quality assurance.

PROCEDURES FOR NAFDAC REGISTRATION

The NAFDAC requirements for the production or importation of food, pharmaceuticals, or consumable goods in Nigeria vary depending on whether such commodities are manufactured locally or overseas.

Note that before registering a firm product with NAFDAC, any company involved in the manufacture, processing, and distribution of food, imported foods, pharmaceuticals, semi-processed food, and cosmetics must establish a company with the Corporate Affairs Commission (CAC).

When enrolling with NAFDAC, keep the following in mind:

The registration requirements for locally manufactured goods differ from those for imported goods.
Each NAFDAC registration number is associated with a specific product. If you have more than one product, you will have to receive a separate registration number for the product.

Follow these steps to get your products registered with NAFDAC:

1. OBTAIN THE NAFDAC REGISTRATION FORM

The initial step is to go to the NAFDAC office closest to you and make your request. The headquarters of NAFDAC are located at Plot 2302, Olusegun Obasanjo Way, Zone 7, Wuse, Abuja, Nigeria.

If you are not in Abuja, however, find the address of their zonal office in your state. When you arrive, purchase the NAFDAC registration form and fill it out correctly.

As previously stated, each registration form can only be used for one product. As a result, if you have more than one product, you will need to buy more than one form.

2. SUBMIT THE REGISTRATION FORM

The second step is to submit your registration and application form. Send a letter to NAFDAC declaring your purpose to register your product (s). It is important to note that your letter of application should include all pertinent information about your product, such as the product name, description, manufacturer’s name, who the product is for, and so on.

Send your letter to the director in charge of the zone where you are registering. Submit your registration form together with your application letter and any other documentation required.

3. SUBMIT PRODUCT SAMPLES

You will be asked to submit three samples of your product for examination and analysis. As soon as you finish this stage, you will be awarded a certificate of recognition as a manufacturer.

The next step is to make the required payment for your registration. Make the required money on time to avoid delays. The fees and tariffs to be paid are determined by the type and category of product being registered.

5. OBTAIN CERTIFICATE

You will be granted a NAFDAC registration number and a certificate of registration for your product when it has been registered.

NAFDAC REGISTRATION PROCEDURE FOR IMPORTED GOODS

The foreign company must send samples of their product for analysis in order to register imported items with NAFDAC. However, without formal authority to bring in the samples, this is not possible. As a result, the foreign enterprise must first request permission to transport samples into Nigeria.

To do this, NAFDAC offers a special written license or import permit to importers, allowing them to bring in samples of their products. Furthermore, the importer must receive from the manufacturer and other necessary organizations in the country of origin the papers required for the clearance and delivery of the samples.

NAFDAC FOOD PRODUCT REGISTRATION REQUIREMENTS

The Corporate Affairs Commission issues a certificate of incorporation (CAC)
NAFDAC inspection/recognition certificate Trademark approval for your brand name by the Federal Ministry of Commerce (where applicable)
A comprehensive certificate of analysis of the batch of goods for registration from the manufacturer, including the analyst’s name and signature
Application form delivered to the Director containing the manufacturer’s, brand’s, and product’s names (s).

NAFDAC DRUG REGISTRATION REQUIREMENTS

Send three samples of your goods for quality testing and inspection.
A pharmaceutical product certificate that has been signed and authorized
Power of Attorney from the product’s maker, original copy (if imported)
The letter of application for product registration
Letter of invitation from the manufacturer to inspect the factory abroad, including full names and the location of the plant
NAFDAC application form completed

IMPORTED GOODS REGISTRATION REQUIREMENTS

It should be noted that the registration requirement for imported products (food or medications) encompasses all of the above. There are additional standards that must be met if you want to register imported products with NAFDAC.

A Power of Attorney or contract manufacturing agreement from the manufacturer authorizing the Nigerian representative to act in their capacity in Nigeria must be submitted by the application.

The paper must be signed by the company’s Director or President. In addition, the Power of Attorney or the contract manufacturing agreement must be notarized by a notary public in the manufacturer’s nation.

A free sale certificate must be given by an appropriate health / regulatory organization in the manufacturer’s country. The certificate must include the manufacturer’s and product’s names.

A thorough certificate of analysis must be submitted on the letterhead of the quality control laboratory where the sample was tested or appraised, and it must include the following information:

The product’s or items’ analysis
The batch number of the product Manufacturing and expiry dates
The analyst’s name, designation, and signature
You must submit documentation that the maker of the imported food or drug product is licensed to sell such product in the country of origin and that the sale of the product does not violate that country’s food laws.
Permission to bring in samples
A letter of invitation to inspect the factory in another country
The NAFDAC registration process can be difficult for Nigerian firms, which is why some look for methods to cut corners. However, if you want to manage a successful business without fear, you must do the correct things.

TIMELINES FOR REGISTRATION PROCESSES

In Nigeria, completing NAFDAC registration takes time.

This is the amount of time required to register and get a NAFDAC number for food, pharmaceuticals, and other products.

Application submission takes 0 days
Document verification takes 10 days
Inspection/sampling of facilities takes 10 days for food and 20 days for drugs
Laboratory testing takes 30 days for food and 40 days for drugs
final vetting takes 10 days
Meeting of Approval/Issuance of NAFDAC Registration Number takes 20 days

So, it takes a total number of days 90 for food and 120 for drugs.

The cost of NAFDAC product registration is often determined by the individual products to be registered. Prices vary according to product category. Some of the specific charges that an application must pay include the cost of product registration, import permit, and inspection, if applicable.

The prices are as follows:

The registration of drugs costs ₦70,000.
₦25,000 for orphan drugs.
₦50,000 for food.
₦50,000 for cosmetics.
₦40,000 for chemicals or insecticides.
₦70,000 for veterinary products.
₦30,000 for medical devices.
₦40,000 for vaccines.
₦50,000 for water.

Among all of these expenditures, the international inspection, which presently costs around ₦10,500, is the most expensive; however, this cost may be avoided if the overseas manufacturing company already has a GMP certification.

This article’s information will assist you in applying for your NAFDAC. Make the application, go through the process, receive your NAFDAC registration number, and conduct your business without constantly looking over your shoulder.

Mfonobong Daniel

Daniel is an Editor on Nigerian Infopedia who craves for writing, researching and also watching soccer.

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NAFDAC REQUIREMENTS FOR PRODUCT REGISTRATION

NAFDAC APPROVAL PROCESS

The National Agency for Food Drug and Administration Control (NAFDAC) is responsible for controlling, maintaining the distribution of transportation, advertisement, exportation, importation, manufacture, and the registration of the categories of products such as drugs, chemicals, consumable goods, cosmetics, biological, and medical services.

The NAFDAC Requirements for production or importation of food, drugs, or consumable goods in Nigeria depend on whether such items are produced locally or abroad.

Under the law establishing the Agency (NAFDAC Act), it is unlawful to market any drugs or consumable goods in Nigeria to the public without a due registration with the NAFDAC . If any company is set up in Nigeria for the purpose of the importation or manufacturing of food or drugs or consumable products, all the products produced by such a company must be registered with the NAFDAC.

A company involved in the production, manufacturing, and distribution of food, imported foods, drugs, the export of semi-processed food and cosmetics must register and establish a company with the Corporate Affairs Commission (CAC) before registering its company product with NAFDAC.

The registration of Locally Made NAFDAC Regulated Products is slightly different from that of imported goods.

REQUIREMENTS FOR LOCALLY PRODUCED ITEMS OR PRODUCTS

The documents to be submitted to the agency for registration of locally made categorized into food and drug group of products. The documents to be submitted will depend on if the product falls into the food or drug category.

Certificate of incorporation issued by the corporate affairs commission
The certificate of inspection issued by NAFDAC
Original copy of Power of Attorney from the product manufacturer (if imported)
A comprehensive certificate of analysis of the batch of product submitted for registration from the manufacturer stating the name and signature of the analysis.
Trademark approval for a brand name.
Application forwarded to the Director stating the name of the manufacturer, brand name, and product.
Completed NAFDAC application form
Three samples of products for quality analysis and inspection.

REQUIREMENTS FOR FOREIGN PRODUCED ITEMS OR PRODUCTS

For manufacturers of foreign products looking to import into Nigeria, the NAFDAC Registration Number must be acquired. The requirements for registration of imported food or drug products include all the requirements stated above for locally produced items. Generally, the requirements to be met for registration of imported or foreign products with NAFDAC include the followings:

Notarized Declaration: this is to be type-filled and notarized by a Notary Public here in Nigeria.
Power of Attorney or Contract Manufacturing Agreement: an applicant must submit a power of attorney or contract manufacturing agreement from the manufacturer authorizing the Nigerian representative to act in their capacity in Nigeria. The Director or President of the Company must sign this document. The document must state the names of the products to be registered or imported into Nigeria. It must also state the ownership of the brand names/trademark of the product. The power of attorney or contract manufacturing agreement is to be notarized by the Notary public in the country of the manufacturer.
Certificate of Free Sale : a relevant health/regulatory body in the manufacturer’s country indicating the name of the Manufacturer and products to be registered issues this document. It is also to be authenticated by the Nigerian Embassy in the country of origin. In countries where no Nigerian Embassy or High Commission exists, any other Embassy or High Commission of any Commonwealth or West African country can authenticate the document.
The analysis of the product or goods
The batch number of the product
The manufacturing and expiry dates
The name, designation, and signature of the analyst
Certificate of Business Incorporation of the Importing Company with the Corporate Affairs Commission in Nigeria.
Certificate of Registration of Brand Name with the trademark registry
Application letter for Import Permit by the applicant (i.e. Local Agent).
Duly completed Registration Form online.
Coloured Artwork/Label of the product and leaflet insert of the product.
Evidence of GMP inspection by NAFDAC.
Manufacturer Information: Name of the Company, full location address of the factory, email address and current phone no. & fax no, the name of contact person overseas, telephone no, email address. Name of airport closest to the location and guide map illustrating the shortest land/air route to the factory overseas
Local Agent’s Information: Name of the company, full location address and functional telephone no, fax no. & email address. Name(s) of the product(s) for registration, name & mobile phone no. of the contact person in Nigeria

Upon satisfactory documentation, import permit to import samples for registration shall be obtained from the respective units after payment. The product(s) to be registered must also be brought in samples for sample vetting by the agency upon registration and the following documents are required for the sample vetting.

A copy of the import permit and receipt of payment for the import permit
Certificate of Analysis of the product.
One (1) well-labeled vetting samples of the product(s) and two(2) labels/artworks

The next step for registration is the Laboratory Analysis which takes place upon satisfactory documentation, vetting of samples, and payment. The laboratory samples are to be submitted at the respective units.

In our previous write-ups, we explained the procedure to obtain an importation permit and approval.

Finally, for NAFDAC registration of foreign products without the acquisition of NAFDAC registration number, the following shall be required:

A Warehouse must be present for NAFDAC inspection
Listing Certificate
Permit to import
The technical officer needed especially in the Science field, with the Passport photograph of the Technical Officer
Certificate of Incorporation with the Corporate Affairs Commission
Local Purchase Order and
Material Safety Data Sheet

In conclusion, NAFDAC would only give a registration number or certificate of registration after the product has passed the quality and standard test carried out by the agency. After a successful product registration, the importer can start to import the products in large quantities. Every imported product must be properly labeled to avoid unnecessary delays in the course of importation.

By Corporate & Commercial Law Department at Resolution Law Firm

Getting Help:

Resolution Law Firm’s Corporate & Commercial Law Department assist and offer advisory to both local and foreign manufacturers in processing NAFDAC approvals. You can contact us using the below details:

Email: [email protected]

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Nigeria: Overview Of NAFDAC Product Registration Process

The National Agency for Food and Drug Administration and Control (NAFDAC) is the agency responsible for regulating and granting permits for the exportation, importation, manufacture, and the registration of products such as drugs, chemicals, consumable goods, cosmetics, biological, and medical services which are produced in or outside Nigeria.

Any company involved in the production, manufacturing, and distribution of food, imported foods, drugs, the export of semi-processed food and cosmetics must incorporate a company with the Corporate Affairs Commission (CAC) before registering its company product with NAFDAC.

The registration process for the grant of NAFDAC permit comes in two stages, these stages are;

Application for NAFDAC permit to bring in samples for products manufactured outside Nigeria. For this kind of application, NAFDAC grants special written authorization to importers to bring in samples of the products into Nigeria.
Application for registration of products locally manufactured or imported.

The registration of locally made products is slightly different from the registration process for imported goods. Where a company produces different products it will be required to register each of them separately to obtain the NAFDAC registration numbers for each of the products.

Requirements for Registering Products with NAFDAC

Consequently, the documents required to be submitted for registration will depend on whether the product falls into the food or the drug category. Irrespective of the product to be registered, NAFDAC would only issue a registration number and certificate after the product has passed the quality and standard test carried out by the agency.

The general requirements for the NAFDAC's registration of products include the followings:

A formal written application for product registration directed to the Director (Registration and Regulatory Affairs) stating the name of the manufacturer, brand name, and product.
Fill the prescribed NAFDAC Application Form D-REG/001.
Evidence of payment of prescribed fees.
Certificate of Incorporation of the company
The certificate of inspection or recognition issued by NAFDAC
Original copy of Power of Attorney from the product manufacturer (if imported)
Trademark registered in Nigeria for brand name
A signed and endorsed certificate of Pharmaceutical Product (applicable to drugs only).
Letter of invitation from the manufacturer to inspect the factory abroad, full names, and site of a plant (where applicable).
Pack of product samples for quality analysis and inspection.
Notarized Declaration of a duly executed power of attorney from the product manufacturer, which is required to be type-filled and notarized by a Notary Public here in Nigeria.
Certificate of Free Sale obtained and issued from relevant health and regulatory body in the manufacturer's country indicating the name of the Manufacturer and products to be registered. It is also to be authenticated by the Nigerian Embassy in the country of origin. In countries where no Nigerian Embassy or High Commission exists, any other Embassy or High Commission of any Commonwealth or West African country can authenticate the document.
Comprehensive Certificate of Analysis: The 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 following information;
The brand name of the product
The batch number of the product
The manufacturing and expiry dates
The name, designation, and signature of the analyst
Application letter for Import Permit by the applicant (i.e. locally registered company).
Evidence of warehouse acquisition (where applicable)
Coloured Artwork or Label of the product and leaflet insert of the product.
Evidence of GMP inspection.
Manufacturer Information: Name of the Company, full location address of the factory, email address, and current phone no. & fax no, the name of contact person overseas, telephone no, email address. Name of airport closest to the location and guide map illustrating the shortest land/air route to the factory overseas
Local Agent Information: Name of the locally registered company that will take immigration responsibility; full location address and functional telephone number & email address.

It is also important to note that some goods can be registered with NAFDAC without obtaining the NAFDAC Registration Number. For NAFDAC registration of foreign goods without the acquisition of the NAFDAC registration number, an import permit must be obtained. The following are required for the process of NAFDAC Import Permit;

Application for an import permit with the payment of prescribed fees.
A warehouse must be present for NAFDAC inspection.
The technical officer needed especially in the Science field, with the passport photograph of the Technical Officer.
Certificate of Incorporation of the local company with the Corporate Affairs Commission.
Certificate of Analysis of the products.
Local Purchase Order.
Material Safety Data Sheet.

Cost for Registering Products with NAFDAC

The costs for NAFDAC product registration are usually dependant on specific products to be registered. There are various prices for categories of products. Some of the specific costs an applicant is required to pay to include the cost for product registration itself, import permit and inspection where applicable. Among all these costs, the cost of the foreign inspection, which currently costs at about $10,500 is the most exorbitant, however, such cost may be waived if the foreign manufacturing company has an existing GMP Certification.

In conclusion, NAFDAC issues a unique registration number or certificate of registration after a product has passed the quality and standard test carried out by the agency and subsequently registered. After a successful product registration, the importer can start to import the products in large quantities into Nigeria. Every imported product must be properly labeled to avoid unnecessary delays in the course of importation. After a successful product registration, it will be valid for a term of five years, which is subject to renewal.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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REGISTRATION OF PROCESSED BREAD PRODUCTS WITH NAFDAC IN NIGERIA

Legal News & Articles

BY SAM ELEANYA

The manufacture, importation, exportation, advertisement, sale or distribution of any processed food – which includes bread – in Nigeria is prohibited except after its registration with the National Agency for Food and Drug Administration and Control, NAFDAC. Such a process is regulated under the Food, Drugs and Related Products (Registration, Etc.)Act Cap F33, LFN, 2004 as well as other Regulations and Guidelines made pursuant thereto – by NAFDAC. Import of samples of processed bread for laboratory tests or for the purpose of registration in Nigeria also requires a prior NAFDAC issued certificate.

Currently existing Regulations and Guidelines published by NAFDAC which are relevant to processed bread’s production, importation, exportation, advertisement, sale or distribution in Nigeria fall under two categories: the specific and the general. The first category include Guidelines for Registration of Bread; Guidelines for Inspection & Requirements for Bread Manufacturing; and the Pre-Packaged Food, Water and Ice (Labeling) Regulations. Other relevant NAFDAC regulations which apply generally to food or related products include Food Additives Regulation 2005, Food Fortification Regulation 2005, Food Fortification with Vitamin A Regulations 2005, Non-Nutritive Sweeteners in Food Products Regulations 2005, and the Processed Food Registration Regulations 2005.

BREAD REGISTRATION: THE NAFDAC PROCESS IN BRIEF

Registration of a bread product with NAFDAC involves the following steps.

A. THE APPLICATION

This covers:

1. Application to NAFDAC through “The Director, Food Safety and Applied Nutrition Directorate, NAFDAC, Lagos)

2. Submission of all relevant documents for registration in accordance with the issued guidelines;

3. Provision of relevant information and description of the bread making and other connected facilities for inspection by NAFDAC designated agents;

4. Provision of samples of the products to be registered when notified by NAFDAC for laboratory analysis.

5. Payment of prescribed tariffs and assessment.

Note that Supermarkets operating bakeries as part of their operations may apply to utilize a single NAFDAC registration number per bread variant for all their outlets Nationwide. This will also be applicable to bakeries with a chain of outlets for bread with the same variant but application for inspection and listing approval has to be done for each outlet separately.

B. VETTING OF APPLICATION DOCUMENTS AND PAYMENT

The main purpose of this step is to ensure adequacy of applicant’s compliance with the application process. Secondarily, it enables the proper assessment of sum payable by the applicant under the process – including the Payment Advice for inspection and laboratory analysis.

According to Section 13.0 of the NAFDAC Guidelines for Registration of Bread mandates that a processed bread product shall only be registered with NAFDAC “upon factory recognition” following inspection and after submission of the relevant documents. A combined reading of the Guidelines for Registration of Bread and S.2 of the Guidelines for Inspection & Requirements for Bread Manufacturing outlines the following:

COMPULSORY DOCUMENTS

· An application for production inspection on applicant company’s letter head addressed to the Director Food Safety and Applied Nutrition Directorate (FSAN) submitted through the NAFDAC Office Complex, Isolo Lagos or any state office of NAFDAC. Importantly, the letter should include company’s“exact factory location address (not P. O. Box) and functional email address and telephone number(s).

· Bread Label/Packaging material (art work could be presented)

· Evidence of payment of assessed fees to the Agency;

· Evidence of business registration or incorporation [CAC Certificates of Business Name registration or Company incorporation (including a registered trustees or nonprofit organisation)]

· Evidence of Registration of Trade Mark with the Trade Registry in the Ministry of Industry, Trade and Investment (done in the name of the owner of the Trade Mark or Brand name as the case may be)

· Contract Manufacturing Agreement (where applicable)

· the Standard Operating Procedures (SOP) Index for production, recall, distribution, cleaning of equipment and environment which will be reviewed during inspection of facilities),

· List of equipment,

· Company organogram,

· Certificate of Food Handlers test for production staff (which should include tests for Sputum, Hepatitis B, Widal, Stool and Urinary Test),

· Current fumigation Certificate (carried out quarterly)

· Any other relevant document

OPTIONAL DOCUMENTS

· Certificate of analysis of raw material

· Certificate of analysis of finished product.

Failure to respond promptly to queries or enquiries raised by NAFDAC on the application (within 15 working days) will automatically lead to the closure of the Application.

MINIMUM PAYMENT OR TARIFF

Under section 17 of the NAFDAC Guidelines for Registration of Bread, the following tariffs currently apply:

· Registration of bread- 31,500

· Renewal Inspection – 15, 500

· Bromate in Bread – 50,000

Laboratory analysis for the purpose of renewal of registration is pegged at 50% of the original tariff. 5% VAT is charged on all statutory fees.

Under the Treasury Single Account, TSA system, an applicant will need to visit www.remita.net to generate a Remita invoice and print out a copy; make the assessed payment in the invoice to any nearest commercial bank; and visit the NAFDAC Accounts Office to collect official receipt (evidence) of payment.

C. INSPECTION

Upon satisfactory application and vetting, an inspection is scheduled and subsequently conducted by the FSAN Directorate. During the inspection, an applicant is expected to ensure that the Master Baker (Production Manager) is present for the inspection and that two sets of documents are submitted during the inspection.

Where an inspection is found to be unsatisfactory, a Compliance Directive is issued and communicated to the company. Failure to respond to concerns raised by NAFDAC on the application or inspection, will automatically lead to delay in further processing of the application.

Once registered, a Certificate issued by NAFDAC shall be valid for the period of 5 years (unless suspended or cancelled pursuant to section xxx of the |Act) and can be renewed as provided for under S. 2(4) of the Act.

REQUIREMENTS FOR BREAD MANUFACTURING FACILITY

D. REGISTRATION TIMELINES

1. Registration of food product not more than 90 days from acceptance of application.

2. Variation of product registration takes not more than 60 days

Note that failure to comply with any Compliance Directive, CD issued by NAFDAC may be a basis for cancellation of the application and all delays of the client will not be counted within the 90 days for registration.

SUMMARY OF TIMELINES FOR SPECIFIC REGISTRATION PROCESSES

1. Submission of Application – 0 days

2. Document Verification – 10 days

3. Facility Inspection/Sampling – 10 days for

4. Laboratory Analysis – 30 days

5. Final Vetting – 10 days

6. Approval Meeting/Issuance of NAFDAC registration Number (Certificate of registration) – 20 days

Total number of days: 90 days for Food, 120 days for Drugs

[SAM ELEANYA is Principal Strategist at Tree & Trees JusticeMedia Group facilitators of LawNigeria, Tree & Trees LP; 3PLR [Policy, Practice and Publishing Law Reports, and Standards and Enterprise Development Center]

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NAFDAC

Food and drugs approval in nigeria.

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In order to market some products, they must be submitted to a process of administrative authorization. This process exists to safeguard the public health, ensuring the quality of products as drugs, food, cosmetics, chemicals, biologicals, and medical devices.

In Nigeria, The National Agency for Food and Drug Administration and Control (NAFDAC), which is a Nigerian federal agency under the Federal Ministry of Health, is responsible for regulating and controlling the manufacture, importation, exportation, advertisement, distribution of the products above-mentioned.

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How is the food and drugs approval process carried out?

Inventa guarantees you a comprehensive consulting service throughout the food and drugs approval process. This service involves a careful analysis of your product, frequent state-of-play updates after consultations with public authorities, and reports indicating any adjustments needed to ensure your business is perfectly in line with the legal framework.

The service will help prevent and reduce the risk of problems that may affect the validity of your products on the market and in various other areas.

Integrated Service

Application.

It is necessary a written application letter addressed to the Director of NAFDAC. The application should state the names of the manufacturer and the product(s). The form(s) should be duly completed, signed and submitted with all the mandatory documents.

Vetting of documents and issuance of import permit

The mandatory documents are analyzed by officials of the Legal Department of NAFDAC to ensure compliance with guidelines.

Submission of Vetting Samples

Following the vetting of the documents, some samples of the products to be registered are vetted, to confirm that the product labeling/packaging comply with NAFDAC requirements.

Laboratory Analysis

Additional samples of the product (a number to be determined by the NAFDAC on the relevant import permit), to be shipped to Nigeria on the basis of the import permit would be required at this stage. The lab analysis will be conducted on these additional samples, with a view to ensuring that the ingredients in, and components of the products are not injurious to human health.

Approval Committee

The reports of the laboratory analysis as well as the on-site factory inspection are forwarded to the NAFDAC Approval Committees for Approval.

Payment Advice

If the reports are satisfactory, and the product is approved, the Approval fee falls due for payment.

Allocation of Registration Number

A NAFDAC Registration Number is thereafter allotted to the product. The applicant may then deal in the products pending the issuance of the Certificate/License.

Issuance of NAFDAC Certificate/License

If successful, it will be issued a Certificate/License to operate in the country.

This process, dedicated to the approval of food and drugs, is always supported by the guarantee of complete confidentiality and transparency every step of the way.

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Nigeria - Apply or Get Certificate of Registration from NAFDAC

1 Procedure
2 Required Documents
3 Office Locations & Contacts
4 Eligibility
7 Documents to Use
8 Sample Documents
9 Processing Time
10 Related Videos
11 Instructions
12 Required Information
13 Need for the Document
14 Information which might help
15 Other uses of the Document/Certificate
16 External Links

Procedure [ edit ]

Apply In-Person:

To apply for Certificate of Registration from NAFDAC in person, the applicant has to make an application at the National Agency for Food and Drug Administration and Control.
The applicant will have to prepare an application letter as a request for the Certificate of Registration from NAFDAC, addressed to the Director-General of National Agency for Food and Drug Administration and Control.
Make sure that you have all the documents listed in the “Required documents” section of this page.
Attach all the required documents with the application letter, and then submit it at the NAFDAC Office in Lagos or any nearest NAFDAC office.
The contact link of NAFDAC can be found below: contact link
Address details of regional offices can be found in the following link: regional offices addresses
After submission, the application and accompanying documents are subsequently reviewed and verified.
Upon satisfactory assessment of the application, the agency proceeds to process the Certificate. Once the document is ready, the applicant is notified via email or phone.
Then, the applicant can visit the office and collect the Certificate.

Apply Online

To apply for a Certificate of Registration online, the applicant must visit the following link: e-license application link
If you have registered with the Nigeria Single Window Trade Portal, you can enter the user credentials in the fields provided and click “Login” button.
Otherwise, the person who wants to obtain a registration must contact/visit the Federal Inland Revenue Services office where he/she obtained the TIN and provide one valid email and mobile number, together with other company's identification details as per FIRS requirement.
After that, he/she can visit the following link and make the registration: apply online .
You will have to just enter TIN number, Email ID, text image in the respective fields and click “Validate” button.
Follow the instructions and complete the registration, then the applicant must be proceeding to apply for and obtain the certificate of analysis.
Visit the following link e-license application link and enter the user details in the respective fields, then click “Login” button.
NAFDAC e-License main page will be displayed. Default page is for new permits. For digitization of certificates/permits, please click ‘Permit/Certificate Enrolment’ option on the left side.
Start completing the tabs one-by-one by entering the required details and making the appropriate selections by following the on-screen instructions.
After successfully completing all the tabs, click “Submit” button to submit the application form. Click “Yes” button in the dialogue that appears.
Click “ok” button in the next tab. An email notification is immediately sent to your registered email address.
On submission, the application and other documents will be forwarded for examination and verification processes.
In the portal, you can find a tab named Support information tab provides a general status of application and Application Progress Indicator shows the current status of your application at NAFDAC.
Where there is a query on an application, an email notification is immediately sent to your registered email address.
Respond to queries raised, by using the ‘search’ function and ‘Support information’ tab. Make the appropriate changes by following the on-screen instructions and update the application.
Onceall the information is found sufficient, the application will be approved and the officials will proceed to take required steps to issue the certificate.
When the document is ready to be downloaded, a “print view” button will appear in the portal on the top of your application. Click that to download your certificate.

Required Documents [ edit ]

Application letter
Valid proof of Identification
Receipt of Acknowledgement for the application
Tax Identification Number
Proof of payment (if any)
Any supporting document (as instructed)

Office Locations & Contacts [ edit ]

National Agency for Food and Drugs Administration and Control - Head Office Address: Plot 2032, Olusegun, Obasanjo Way, br> Zone 7, Wuse, Abuja, Nigeria. Tel: 0700-1-NAFDAC (0700-1-623322), +234(0)-1-4609750 Tel: 0800-1-NAFDAC (0800-1-623322) +234(0)909-763-0506, +234(0)909-763-0507 Email: [email protected] Website: Link NAFDAC Regional Contacts: Link

Eligibility [ edit ]

Any kind of NAFDAC registration pursuant in Nigeria, who needs to obtain a registration certificate, can apply.
The applicant should have registered with the Federal Inland Revenue Services and possess a Tax Identification Number.

Fees [ edit ]

Validity [ edit ], documents to use [ edit ], sample documents [ edit ], processing time [ edit ], related videos [ edit ], instructions [ edit ], required information [ edit ].

Company Name and Type
Registration Certificate Number
Incorporation Date
Company physical and mailing address
Contact number and email address
Applicant names
Application number
Card details

Need for the Document [ edit ]

No product shall be manufactured, imported, exported, advertised, sold, distributed or used in Nigeria unless it has been registered in accordance with the provisions of NAFDAC Act.

Information which might help [ edit ]

Other uses of the document/certificate [ edit ], external links [ edit ], others [ edit ], navigation menu, personal tools.

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NAFDAC product registration guidelines

Knowledge documents to get you started

These guidelines are to enable applicants obtain detailed provisions of how to undertake their requested service from NAFDAC.

The guidance documents are categorized based on product type and do provide detailed information on: Application, Facility Inspection, Documentation, Labelling, Tariff (Fees) and Timelines.

Reference: Guidelines – NAFDAC

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Application Letter NDLEA Self

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COMMENTS

Application Forms
Application Forms. Guidance Documents to get you started. These guidelines are to enable applicants obtain detailed provisions of how to undertake their requested service from NAFDAC. The guidance documents are categorized based on product type and do provide detailed information on: Application, Facility Inspection, Documentation, Labelling ...
NAFDAC Registration: How to Register a Product With NAFDAC
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.
PDF Guidelines for Registration of Food Products & Packaged Water ...
accordance with the provisions of NAFDAC Act CAP N1 (LFN) 2004, other related Legislations and the accompanying guidelines. 2. Application 2.1. A written application for registration of food products and packaged water produced in Nigeria should be made on the company's letter-head to the Director-General (NAFDAC),
Easy Steps On How To Get Your Food Products Registered With NAFDAC
After filling the form, you will now write an application letter to NAFDAC stating your intention to register your product. The application must be addressed to the Director; Registration and Regulatory Affairs. 3. After both have been done. You will attach both the Registration form and the application letter together and submit.
How to Register Products with NAFDAC
A signed and endorsed certificate of Pharmaceutical Product. Submit three samples of your product for quality analysis and inspection. Original copy of the Power of Attorney from the product manufacturer (if imported). Completed NAFDAC application form. The application letter for registration of the product.
Product Registration
Product Registration & Regulation. The following are required from the Applicants. Submit all documents for registration and application letter in accordance with the issued guidelines at first instance for any of the service to be rendered by NAFDAC. Provide NAFDAC with the relevant information and description of the facility for inspection ...
How To Process NAFDAC Registration Number
Step One: Get NAFDAC Registration Form. Go from idea to starting your business in 30 days. The first step is to go to the nearest NAFDAC's office to you to make your request known. NAFDAC's headquarters is located at Plot 2302, Olusegun Obasanjo way, Zone 7, Wuse, Abuja, Nigeria.
PDF NAFDAC eLICENSE APPLICATION USER MANUAL (Traders)
National Agency for Food and Drug Administration and Control (NAFDAC) eLicense Application automates the NAFDAC e-permit/certificate application, e-permit/certificate renewal, request for additional quantity and permit enrolment processes. This documented procedure describes on how Traders will use NAFDAC eLicense Application for the following: a.
How To Register A Product With NAFDAC: Cost & Steps
1. OBTAIN THE NAFDAC REGISTRATION FORM. The initial step is to go to the NAFDAC office closest to you and make your request. The headquarters of NAFDAC are located at Plot 2302, Olusegun Obasanjo Way, Zone 7, Wuse, Abuja, Nigeria. If you are not in Abuja, however, find the address of their zonal office in your state.
PDF NAFDAC e-License Application User Manual for Certificate/Permit Enrolment
NAFDAC e-License Application User Manual for Certificate/Permit Enrolment 15 Enter the H.S. code. Note that when entering the HS code, the system will display the list of HS codes which will contain the same value. Use the scrollbar to move up and down the list to select the relevant HS code from dropdown list.
How to register a product with NAFDAC
Submit all documents for registration and application letter in accordance with the issued guidelines at first instance for any of the service to be rendered by NAFDAC. ... [email protected], [email protected], or the nearest NAFDAC state offices (see attached details). Summary of Registration processes with timelines. Submission of Application ...
Nafdac Requirements for Product Registration
Certificate of Registration of Brand Name with the trademark registry. Application letter for Import Permit by the applicant (i.e. Local Agent). Duly completed Registration Form online. Coloured Artwork/Label of the product and leaflet insert of the product. Evidence of GMP inspection by NAFDAC.
Nigeria: Overview Of NAFDAC Product Registration Process
The general requirements for the NAFDAC's registration of products include the followings: A formal written application for product registration directed to the Director (Registration and Regulatory Affairs) stating the name of the manufacturer, brand name, and product. Fill the prescribed NAFDAC Application Form D-REG/001.
Registration of Processed Bread Products With Nafdac in Nigeria
· An application for production inspection on applicant company's letter head addressed to the Director Food Safety and Applied Nutrition Directorate (FSAN) submitted through the NAFDAC Office Complex, Isolo Lagos or any state office of NAFDAC. Importantly, the letter should include company's"exact factory location address (not P. O. Box ...
PDF Examining Nafdac Guidelines for The Importation and Manufacturing of
Documents required for an application for the importation of medical devices include the following: An application letter on the applicant's letterhead. A registration form for product registration. This form is to be printed from the NAFDAC website, and separate forms are required for multiple products.
PDF National Agency for Food & Drug Administration & Control (NAFDAC) Drug
Application Letter for Renewal of Product Licence 2.1. An application for renewal should be initiated not later than 30 calendar days to the date of expiration of the current/valid Licence. 2.2. An application for the renewal of all drug products should be submitted and processed on the NAFDAC Automated Product Administration and Monitoring
NAFDAC
Application. It is necessary a written application letter addressed to the Director of NAFDAC. The application should state the names of the manufacturer and the product(s). The form(s) should be duly completed, signed and submitted with all the mandatory documents.
Nigeria
The applicant will have to prepare an application letter as a request for the Certificate of Registration from NAFDAC, addressed to the Director-General of National Agency for Food and Drug Administration and Control. Make sure that you have all the documents listed in the "Required documents" section of this page.
NAFDAC product registration guidelines
The guidance documents are categorized based on product type and do provide detailed information on: Application, Facility Inspection, Documentation, Labelling, Tariff (Fees) and Timelines. NAFDAC Good Cold Chain Management For Vaccines & Biopharm. Products Guidelines 2021. Reference:
PDF National Agency for Food and Drug Administration and Control Ports
1.4 NAFDAC will not issue any certificate to export product that has already left the shores of the country. 2. DOCUMENTATION Applicants intending to export Food, Cosmetics, Drugs and Medical Devices shall submit the following: 2.1 An application letter by the company written on company's letter head addressed to the: Director-General,
(PDF) Application Letter NDLEA Self
2007 •. Victoria Nwogu. This report reviews the impact of anti-trafficking measures on human rights in 8 countries: Australia, Bosnia and Herzegovina, Brazil, India, Nigeria, Thailand, the United Kingdom and the United States. Each country chapter provides an overview of human trafficking, the current legal framework concerning all aspects of ...
Micro, Small & Medium Enterprises (MSME)
Below are the definitions of MSMEs in terms of personnel: Micro Enterprise (1-9 Personnel) Small Enterprise (10-49 Personnel) Medium Enterprises (50-199) However, an applicant in the micro category may only apply for registration of 1-5 different products and can qualify for the Micro palliative separately for each product.

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