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.
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.
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.
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.
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”.
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.
How To Register With NAFDAC
Step One: Get NAFDAC Registration Form
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.
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.
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.
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
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
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.
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).
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
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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