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In general anything that has to do with ingestion into the human body for consumption has been mandated to be regulated by NAFDAC.
The sole aim and purpose of this agency is to make sure Fake products are not being exposed into the nations borders.
What is NAFDAC ?
NAFDAC stands for National Agency for Food and Drugs Commission, it is an agency commissioned under the Federal Government of Nigeria to regulate consumable food, drugs, cosmetics, veterinary products and drinks in the country.
How To Register Your Product With Nafdac
If you are a Nigerian and you aspire to launch any product that deals with ingestion into the human body here in Nigeria, you need the approval of NAFDAC in order to expand production and reach otherwise if caught in the process you might be prosecuted and sent to Jail.
Registration requirements for locally manufactured good are slightly different form that of imported goods.
If your company produces different products you will need to register each of them separately. For example If your company is involved in the production of Sausage Roll, Meat Pie and Carbonated Drinks, NAFDAC mandates that you register all separately and obtain a NAFDAC registration number for each.
Below are the procedures required in getting a NAFDAC approval for your Company
1. Visit the Nearest NAFDAC Office in your Location.
Visit the closest zonal office of NAFDAC to get your production factory inspected, which means you must have a fully constructed factory . When you complete this stage you would be required to submit all samples of your product for analysis then a certificate of manufacturing is issued to you.
2. Obtain a NAFDAC registration Form.
Purchase a registration form from NAFDAC from any zonal office close to you and fill it appropriately. Remember that each form can only be used for a single product so if you have more than products you would need to obtain as many forms as possible.
3. Write an application Form To the Agency.
You would also be mandated to write an application form to the nearest NAFDAC agency stating your intention to register a product. The application should give details of the product name (general name), brand name, and the name of the manufacturer. Address your application to the following:
Registration and Regulatory Affairs
Central Laboratory Complex
After the above make sure to Submit the application together with your completed registration form and attach the required documents.
After a successful registration you will be offered a certificate of registration and finally NAFDAC registration number for the each and every product you submit.
For more info, you can visit their official website to learn more www.nafdac.gov.ng and you could send an email of inquiry to the agency at: firstname.lastname@example.org
Frequently Asked Questions.
Here are the frequently asked question you might have in mind.
1. How long is the registration process?
Three months – six months if all requirements are met as and when due.
2. How do I begin the process of registration?
You begin with the purchase of the relevant registration application form from the NAFDAC office closest to you and pick up the applicable guidelines.
3. Where is the NAFDAC registration Office?
In Lagos, with the following addresses.
(a) NAFDAC Central Laboratory Complex
3/4 Oshodi ? Apapa Expressway, Oshodi ? 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 ? 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 are the complaint officers ?
Call the Director (Registration and Regulatory Affairs) on 01-4748627, 01- 4772452
5. What is NAFDAC?s website and e-mail address?
6. Are there any concession in registration Tarfff for variants of imported Food products ?
.YES, registration of food variants e.g. flavour, colour, e.t.c. have concessionary tariff charges
7. How Long will it take for my product registration certificate to be ready ?
Product registration certificates takes a maximum of six(6) months after the date of approval to be ready.
8. Can I do a test Marketing of my products before registration ?
No test marketing of products are allowed before registration
9 .Can people not just put nafdac number that does not exist on their own?
Yes they do. But they are fake numbers. And they also claim they are going to secure NAFDAC Registration Number very soon. But this is not true.
10. How do I know the genuine nafdac no.?
Cross check from NAFDAC website, NAFDAC green pages and from NAFDAC offices in all the states of the Federation.
11. Where can I find the list of registered products?
Gazzette, NAFDAC green pages and NAFDAC website, also NAFDAC offices in Nigeria.
12. Where do I report any nefarious activity when people are trying to fake nafdac regulated product?
Report to any NAFDAC office and Enforcement Directorate in Lagos. Call NAFDAC hotlines.
13. Can I register my product myself without knowing anybody in nafdac or going through an agent?
14. How do I know that the name I want to use for registration of my product will be accepted by nafdac?
Write formally to NAFDAC for clearance of Name which can hold for 2 weeks only.
15. When is the product likely to come out of the laboratory?
16. Why can’t our product which is an international product be accepted as sold all over the world ?.
Because products must comply with the labeling regulations developed to meet the needs of Nigeria.
17. How and where are clinical trials conducted?
Clinical trials are conducted in accordance with good clinical practice (GCP) and are conducted in research institutions.
18. What are the requirements to conduct clinical trials in nigeria?
The requirements for clinical trials can be obtained from our website: www.nafdacnigeria.gov.ng.
19. Are clinical trials directly supervised by nafdac?
20. Do foreign drugs get subjected to clinical trials before they are allowed for use in the country?
Yes. Particularly if the drug does not have adequate and well documented use in black population or it has some race specific properties or its efficacy, safety and usefulness needs to be proven in our population.
21. Nafdac choose investigators to conduct clinical trials?
No. Sponsors and applicants are responsible for the choice of their trial investigators.
22. How many study sites are clinical trials are supposed to be conducted?
At least two centers.
23.How long does it take to conduct clinical trials?
It depends on t a number of factors, some of which are:
? The design of the trial.
? The nature of the investigational product.
? The investigational product.
? The rate of recruitment of trial participants, etc.
24. How many people are supposed to participate in clinical trials?
The number of participants to be involved in a study depends on the phase of the study (I, II, III or IV) and the trial design.
25. How much does it take to conduct clinical trial in nigeria?
The applicant need to pay NAFDAC N200, 000.00 plus 5% VAT for imported products and N50, 000.00 plus 5%VAT for local and herbal products. Other monetary expenses related to the conduct of the trial are handled between the sponsors and the investigators.
26. How many drugs are currently undergoing clinical trials now?
27. List of banned food colours and / or additives.
This is in accordance with Codex, EU, and FDA list of Banned Colours and / or food additives. This is usually downloaded On www.codexalimentarius.net, www.fda.gov , and www.eu.net .
28. Codex list of food contaminants and maximum limit in different categories of foods
This is in accordance with Codex, EU, and USFDA position on maximum limit of contaminants in foods. However, in some cases it depends on country?s position as some external factors can contribute to high values of contaminants in foods. These values can be downloaded on the websites given above.
Getting your products registered and recognized by NAFDAC sometimes can be very humiliating sometimes, but i appeal to the business owners in question to be patient.
However, after a successful product registration your product will be trusted and accepted in the market and you will have more confidence in doing business in Nigeria it only takes about three months and thereafter you will be a free registered manufacturer in Nigeria.
Click the link to visit the official website below