The National Agency for Food and Drug Administration and Control (NAFDAC) regulates the production and importation of food and drug-related products in Nigeria, and you cannot conduct business in the country without first registering with the agency (NAFDAC). Because of the widely perceived strictness of the NAFDAC registration process, many people shy away from getting involved in the food or drug industry or look for ways to cut corners.
Despite this, a large number of companies have been successful in obtaining NAFDAC approval for their products. For many people, the process is made difficult by a lack of adequate information, which is common. In this article, you will learn everything you need to know about starting and completing your registration with NAFDAC, including how to register online.
Generally speaking, NAFDAC permits are divided into two categories: foods and drugs. Because of this, if your manufactured or imported goods fall into either of these categories, you must register with NAFDAC immediately.
Remember that food and drug manufacturers must first register with the Corporate Affairs Commission (CAC) before registering their products with the National Agency for Food and Drug Administration and Control (NAFDAC).
To ensure the safety of Nigerian citizens, every manufacturer, exporter, importer, and trader of drugs and food-related products must adhere to the registration requirements established by the National Agency for Food and Drug Administration and Control (NAFDAC).
History of NAFDAC
The National Agency for Food and Drug Administration and Control (NAFDAC) is a federal Government agency which reports to the Federal Ministry of Health, and it is responsible for food and drug regulation. Nigeria’s Food and Drug Administration (FDA) is the body in charge of regulating the importation, manufacture, exportation, distribution, sale, and use of food and drugs as well as cosmetics, medical devices, chemicals, and packaged water in the country.
The use of paracetamol syrup that contained diethylene glycol resulted in the death of more than 150 children in 1989. Because of the prevalence of counterfeit drugs in Nigeria at the time, neighboring countries such as Sierra Leone and Ghana prohibited the sale of foods, pharmaceuticals, and beverage products originating from the country of origin.
The existence of NAFDAC was a result of this problem. The National Agency for Food and Drug Administration and Control’s mission is to ensure that all imported or locally produced food and drugs are safe for consumption.
The first governing council of the NAFDAC was established in December 1992. Tanimu Saulawa served as the council’s chairman. National Agency for Food and Drug Administration and Control (NAFDAC) was officially established in 1994 as a “parastatal of the Federal Ministry of Health.”
Procedures for Registration with the NAFDAC
When registering with NAFDAC, keep the following points in mind:
- The registration requirement for locally produced products differs from the requirement for imported products, as explained below.
- NAFDAC registration numbers are unique to a single product and can only be used once. If you have more than one product, each product will require its own registration number, which you will obtain from the government.
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How to Register with the National Association of Food and Drug Administrators (NAFDAC)
1. Obtain a NAFDAC Registration Form.
The first step is to go to the NAFDAC office that is most convenient for you and make your request known. NAFDAC’s headquarters are located at Plot 2302, Olusegun Obasanjo way, Zone 7, Wuse, Abuja, Nigeria, and are accessible by car or on foot.
If you are not in Abuja, however, you should look up the address of their zonal office in your state. Once you’ve arrived, you’ll need to purchase and complete the NAFDAC registration form as instructed.
In accordance with the previous statement, each registration form can only be used for a single product. As a result, if you have multiple products, you will need to purchase multiple forms.
2. Submission of your Registration and Application Form
Write a letter to NAFDAC expressing your desire to have your product registered with the organization (s). Take note that your letter of application should include all pertinent information about your product, including the product name, description, manufacturer’s name, who the product is intended for, and so forth.
Your letter should be addressed to the director in charge of the zone in which you are registering. Submit your registration form along with your application letter and any other documents that may be required.
Additionally, you must provide NAFDAC with pertinent information and a description of your facility in order for them to conduct a proper inspection. This stage can be time-consuming, but the results are always worth the effort.
3. Send in samples of your products.
Following that, you would be notified that three samples of your product would be required for inspection and analysis. Following completion of this stage, you will receive a certificate of recognition as a manufacturer from the appropriate authority.
4. Make the Payments That Are Required
In order to complete your registration, you must make the required payment first. Make the required payment on time in order to avoid any delays. The fees and tariffs that must be paid are determined by the type and category of product that you are attempting to register.
5. Obtaining the Certificate of Achievement
Upon successful registration of your product, you will be provided with a NAFDAC registration number and certificate of registration for the product.
How long does it take to become a member of NAFDAC?
- It takes no more than 90 days after an application is accepted before a food product can be registered with the FDA.
- The registration of pharmaceutical products takes no more than 120 days from the date of acceptance of the application.
- The process of changing a product registration takes no longer than 60 days.
Processes for registering that have deadlines
- Application submission is due in 0 days.
- 10 days are required for document verification.
- Inspection and sampling of facilities – 10 days for food, 20 days for drugs
- For food, the analysis takes 30 days; for drugs, the analysis takes 40 days.
- Final Examination – 10 days
- NAFDAC registration number will be issued after the approval meeting and within 20 days of the meeting.
- The total number of days is 90 days for food and 120 days for pharmaceuticals.
The Registration of Imported Goods with the National Agency for Food and Drug Administration and Control
In order to register imported goods with NAFDAC, the foreign company must send samples of their product to the agency for testing and evaluation. However, this is not possible without the proper approval to bring in the samples in the first instance. As a result, the foreign company must submit an application for approval before bringing samples into Nigeria.
To accomplish this, NAFDAC issues specially written authorizations or import permits to importers, allowing them to bring samples of their products into the country. Apart from that, the importer must obtain all necessary documents from the manufacturer as well as from other relevant authorities in the country of origin in order to complete the clearance and delivery of samples.
Registration Requirements for Food Products with the National Association of Food and Drug Administrators
- The Certificate of Incorporation was obtained from the Corporations and Business Regulation Commission (CAC)
- NAFDAC has issued a certificate of inspection/recognition to a company.
- The Federal Ministry of Commerce has granted trademark approval for your company’s brand name (where applicable)
- A comprehensive Certificate of Analysis of the Batch of Product for Registration from the manufacturer, which includes the analyst’s name and signature, is required for product registration.
- A completed application form is forwarded to the Director, along with the name of the manufacturer, brand name, and product description (s).
NAFDAC Registration Requirements for Pharmaceutical Manufacturers
- The Corporate Affairs Commission issues a certificate of incorporation to a business (CAC)
- Send three samples of your product to be analyzed and inspected for quality control.
- A certificate of a pharmaceutical product that has been signed and endorsed
- Authentication of the product manufacturer’s Power of Attorney (if imported)
- The letter of application for the product’s registration with the FDA.
- Letter of invitation from a manufacturer to inspect a factory abroad, including the manufacturer’s full name and the location of the plant.
- NAFDAC application form that has been completed
Importer Requirements for Registration of Imported Goods
It is important to note that the registration requirement for imported products (food or drugs) includes all of the items listed above as well. There are additional requirements that must be met if you want to register imported products with NAFDAC in addition to the ones listed above.
Power of Attorney or contract manufacturing agreement from the manufacturer authorizing the Nigerian representative to act in their capacity must be submitted by an applicant in order for them to be considered.
An official signature from the Director or President of a company is required on this document. The Power of Attorney or the contract manufacturing agreement, in addition, must be notarized by a notary public in the country in which the manufacturer is located.
It is necessary to obtain a certificate of free sale from the appropriate health or regulatory authority in the country of manufacture. The certificate must include the manufacturer’s name as well as the product’s identification number.
This certificate of analysis should be presented on letterhead from the quality control laboratory where the sample was tested or evaluated and should include the following information:
Analysis of a product or a collection of goods
– The batch number of the product – The dates of manufacture and expiration of the product
– The analyst’s name, designation, and signature are included.
The manufacturer of the imported food or drug product must demonstrate that they are authorized to sell the product in the country of origin and that the sale of the product does not constitute a violation of the food laws of the country of origin in which the product was manufactured.
Permission to bring in samples
A letter of invitation to visit the factory in another country.
For businesses in Nigeria, the NAFDAC registration process can be time-consuming, which is why some companies look for ways to save money by cutting corners. Nonetheless, if you want to run a successful business without fear, you must take the necessary precautions.
The information provided in this article will assist you in completing your NAFDAC application. Make that application, see it through to completion, obtain your NAFDAC registration number, and get back to business without constantly looking over your shoulder.
Frequently Asked Questions on NAFDAC
1. WHAT IS THE DURATION OF THE REGISTRATION PROCESS?
If all requirements are met on time and in full, the time frame is three months.
2. HOW DO I GET STARTED WITH THE REGISTRATION PROCESS?
You begin by purchasing the appropriate registration application form from the NAFDAC office that is most convenient for you, as well as picking up the necessary guidelines.
3. WHERE IS THE NAFDAC REGISTRATION OFFICE LOCATED IN LAGOS
(a) NAFDAC Central Laboratory Complex
3/4 Oshodi? Apapa Expressway, Oshodi in Lagos.
(for Registration and Regulatory Affairs Directorate, Legal Unit, Establishment Inspection Directorate, Food Laboratory, Narcotics, and Controlled Substances Directorate).
(b) NAFDAC Central Drug and Vaccines Laboratory (CDVL)
Edmund Crescent, Yaba in Lagos (for Drug Laboratory and Ports Inspection Directorate).
(c) NAFDAC Enforcement Directorate.
Ahmadu Bello Way (Behind Nigerian Air Force Camp by Legico B/stop), Victoria Island – Lagos.
4. WHO SHOULD I CONTACT IF I HAVE A COMPLAINT?
Dial 01-4748627 or 01-4772452 to speak with the Director (Registration and Regulatory Affairs).
5. WHAT IS THE WEBSITE AND E-MAIL ADDRESS OF THE NAFDAC?
E-mail: [email protected]
6. HOW LONG WILL IT TAKE FOR MY FOOD PRODUCT TO BE REGISTERED?
The registration of food products takes a maximum of three (3) months if all of the necessary documents and other requirements as specified in the food registration guidelines are received and found to be in compliance.
7. DO VARIANTS OF IMPORTED FOOD PRODUCTS HAVE A DIFFERENT REGISTRATION TARIFF THAN THEIR STANDARD VERSION?
YES, registration of food variants, such as flavor, color, and so on, is subject to reduced tariff charges (concessionary tariff charges).
8. How long will it take for my PRODUCT REGISTRATION CERTIFICATE to be completed and ready to use?
To be ready for use, product registration certificates must be received no later than six(6) months after the date of approval.
9. CAN I CONDUCT TEST MARKETING FOR MY PRODUCT BEFORE I REGISTER IT WITH THE DEA?
No, it is not permitted to conduct food product testing or marketing.
10. IN RESPECT OF THE LITTERING OF THE ENVIRONMENT BY EMPTY SACHET PACKAGING, WHAT IS THE AGENCY DOING?
While the agency ensures that the sachet packaging bears the logo and inscription are properly disposed of, proper waste disposal is the responsibility of the Ministry of Environment at the state and local government levels.
11. Is it not possible for people to simply enter a NAFDAC number that does not exist on their own?
They do, in fact. However, they are fictitious numbers. And they have also stated that they will obtain a NAFDAC Registration Number in the near future. However, this is not the case.
12. HOW DO I KNOW IF THE NAFDAC NO. IS GENUINE?
Check the NAFDAC website, the NAFDAC green pages, and the NAFDAC offices in all of the states of the Federation for confirmation.
13. WHERE CAN I FIND A LIST OF THE PRODUCTS THAT HAVE BEEN REGISTERED?
The Nigerian Gazette, the NAFDAC green pages, the NAFDAC website, as well as NAFDAC offices throughout the country.
14. IN THE EVENT THAT SOMEONE TRYS TO MAKE A FAKE NAFDAC REGULATED PRODUCT, WHERE DO I GO TO REPORT THE NEFARIOUS ACTIVITY?
In Lagos, you can file a complaint with any NAFDAC office or the Enforcement Directorate. Call one of the NAFDAC helplines.
15. IS IT POSSIBLE FOR ME TO REGISTER MY PRODUCT ON MY OWN WITHOUT KNOWING ANYONE AT NAFDAC OR WITHOUT USING AN AGENT?
16. DO I HAVE CONFIDENCE THAT THE NAME I WANT TO USE FOR PRODUCT REGISTRATION WILL BE ACCEPTED BY NAFDAC?
Write formally to NAFDAC for clearance of the name, which can only be held for a maximum of two weeks.
17. WHEN CAN WE EXPECT THE PRODUCT TO COMMENCE ITS USE IN THE REAL WORLD?
6 to 8 weeks
18. WHY CAN’T our product, which is an international product, be accepted as a legitimate product for sale all over the world?
Because products must adhere to labeling regulations that were developed specifically to meet the needs of Nigerian consumers.
19. IN WHAT MANNER AND WHERE DO CLINICAL TRIALS TAKE PLACE?
Clinical trials are carried out in accordance with good clinical practice (GCP) and are carried out in research facilities.
20. ARE THERE ANY SPECIFIC REQUIREMENTS FOR CONDUCTING CLINICAL TESTS IN NIGERIA?
The requirements for clinical trials can be found on our website, www.nafdacnigeria.gov.ng. If you have any questions, please contact us.
21. Is NAFDAC directly involved in the oversight of clinical trials?
22. DO FOREIGN DRUGS HAVE TO BE SUBJECTED TO CLINICAL TESTING BEFORE THEY CAN BE USED IN THE NATIONAL HEALTH CARE SYSTEM?
Yes. Particularly if the drug does not have a sufficient and well-documented history of use in the black population, or if it possesses some race-specific characteristics, or if its efficacy, safety, and usefulness in our population must be demonstrated.
23. DO THE NAFDAC SELECT THE INVESTIGATORS WHO WILL CONDUCT CLINICAL TESTS?
No. The selection of trial investigators is the responsibility of both the sponsors and the applicants.
24. HOW MANY STUDY SITES ARE CLINICAL TRIALS SUPPOSED TO BE CONDUCTED, AND HOW LONG WILL THEY LAST?
There are at least two centers.
25. What is the average length of time it takes to conduct clinical trials?
Several factors influence the outcome of a clinical trial, including the trial’s design, the nature of the investigational product, the investigatory product, and the rate at which trial participants are recruited.
26. WHEN IT COMES TO CLINICAL TRIAL PARTICIPANTS, HOW MANY PEOPLE ARE SUPPOSED TO TAKE PART?
The number of participants who will be involved in a study is determined by the study’s phase (I, II, III, or IV) and the design of the experiment.
27. WHEN IT COMES TO CONDUCTING CLINICAL TRIALS IN NIGERIA, WHAT DO YOU NEED?
For imported products, the applicant must pay NAFDAC a sum of NAFDAC 200,000.00 plus 5 percent VAT, and for local and herbal products, the applicant must pay NAFDAC a sum of NAFDAC 50,000.00 plus 5 percent VAT. Other monetary expenses incurred during the course of the trial are handled between the sponsors and the investigators in a collaborative fashion.
28. DO YOU KNOW HOW MANY PHARMACOLOGICAL STUDIES ARE CONTINUALLY BEING CONDUCTED?
There are five products.
29. List of food colorings and additives that are prohibited.
This is in accordance with the Codex, European Union, and Food and Drug Administration lists of prohibited colors and/or food additives. This is usually available for download from websites such as www.codexalimentarius.net, www.fda.gov, and www.eunet.
30. FOOD CONTAMINANTS AND MAXIMUM LIMITS IN DIFFERENT CATEGORIES OF FOODS FROM THE CODEX
This is in accordance with the Codex, European Union, and United States Food and Drug Administration positions on the maximum allowable level of contaminants in foods. However, in some instances, it is dependent on the country. Positioned as a result of the fact that some external factors can contribute to high levels of contaminants in food. These values are available for download from the websites listed above.