How To Register A Product With NAFDAC: Cost & Steps

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). 

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

1. NAFDAC compiles consistent requirements, legislation, and directions for the development, importation, manufacturing, sale, and distribution of food, medicines, medical devices, bottled water, and chemicals. 
2. 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.
3. 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
4. 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:

1. The registration requirements for locally manufactured goods differ from those for imported goods. 
2. 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. 

4. PAYMENT

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

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

NAFDAC DRUG REGISTRATION REQUIREMENTS 

1. The Corporate Affairs Commission issues a certificate of incorporation (CAC) 
2. Send three samples of your goods for quality testing and inspection. 
3. A pharmaceutical product certificate that has been signed and authorized
4. Power of Attorney from the product’s maker, original copy (if imported) 
5. The letter of application for product registration 
6. Letter of invitation from the manufacturer to inspect the factory abroad, including full names and the location of the plant 
7. 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.

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:

1. The product’s or items’ analysis 
2. The batch number of the product Manufacturing and expiry dates 
3.  The analyst’s name, designation, and signature 
4. 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. 
5. Permission to bring in samples 
6. A letter of invitation to inspect the factory in another country 
7. 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. 

CONCLUSION

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.