You may be wondering what it takes to register a product with NAFDAC and obtain a NAFDAC registration number, or you may be wondering how NAFDAC works. If that’s the case, I hope you’ll find this piece useful after taking a few minutes out of your busy schedule to read it.
The National Agency for Food and Drug Administration and Control (NAFDAC) is a Nigerian government agency under the Federal Ministry of Health that is mandated by Decree 15 of 1993, as amended by Decree 19 of 1999 Constitution, and the NAFDAC Act Cap N1 Laws of Nigeria, 2004, to regulate and control the importation, production, exportation, sales, advertisement, distribution, and use of food, drugs, and other products.
If you want to start a food and drug business, you should think about how to register it with NAFDAC. Otherwise, you risk being shut down by the Agency. Manufacturers frequently refuse to register their products due to the lengthy processes involved.
In Nigeria, the agency is particularly well-known for aggressively combating counterfeit drugs. To register a product with NAFDAC, you must go through some steps. As a result, this article will walk you through the steps of registering a product with NAFDAC.
For people in the know, NAFDAC categorizes products registration into 2 categories: Drugs and food. Drugs classified are vaccines, pesticides and chemicals, veterinary products, supplements, etc.
Both products locally manufactured and the ones manufactured locally have to meet certain conditions before they will be approved by NAFDAC.
If it is an imported product, the importer must initiate the process and the importer must have a company registered with Corporate Affairs Commission.
The applicant must be based in Nigeria who must have a duly signed Power of Attorney from the manufacturer authorizing the Nigerian representative to act in their capacity in Nigeria and with the name of the product explicitly stated.
The requirement you must meet or provide to register a product in NAFDAC include:
- Submit Certificate of Incorporation of the company from Corporate Affairs Commissions
- About 3 packs of sample
- Original copy of the Power of Attorney from the product manufacturer (if imported)
- Certificate of manufacture
- Completed NAFDAC application form
- The application letter for registration of the product
- Duly signed Certificate of Pharmaceutical Product
- Premises Registration License from Pharmacists Council of Nigeria
- Letter of invitation from manufacturer o inspect factory abroad, full names and location of plant
- Certificate of Registration of brand name with trademark registry
Food: (Manufactured in Nigeria)
- Application form and forward to the Director, stating the name of manufacturer, brand name, and product (s)
- Comprehensive Certificate of analysis of the batch of the product submitted for registration from the manufacturer stating name and signature of the analyst
- Trade mark approval for brand name from Federal Ministry of Commerce (where applicable)
- Pre-production inspection/ Certificate of Recognition issued by NAFDAC
- Certificate of Incorporation of the company issued by the CAC
(Imported Food Items)
- An application for registration of a food product
- An applicant for a manufacturer outside Nigeria must file an evidence of Power of Attorney from the manufacturer
- The applicant must submit to the office of the Director of NAFDAC, a written application, stating name of the manufacturer, the product names
- The original manufacturer must show evidence that they are licensed to manufacture food for sale 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
- Certificate of Incorporation of the representative company issued by the Corporate Affairs commission in Nigeria
- Trade mark registration (from the Federal Ministry of Commerce in Nigeria) evidence.
- Certificate of Analysis of the batch of product to be registered.
- Permit to import samples
- A letter of Invitation to inspect the factory abroad
Terms and conditions apply, and other requirements may apply. All applications and product samples should be forwarded to NAFDAC office in Lagos for inspection, analysis and subsequent approval. Note that to register a product in NAFDAC, you must meet the requirements above.
All payments to the Agency shall be in bank draft in favour of National Agency for Food and Drug Administration and Control. The conditions are stated bellow:
Imported food products
Food Registration Form Two hundred and fifty Naira per Food product plus 5% VAT
Also for local food products:
Food – Fifty thousand naira plus 5% VAT (Value Added Tax).
1 Water in sachet: Thirty thousand naira plus 5% VAT.
2 Water in bottle: Fifty thousand naira plus 5% VAT
For Imported Drug Products:
Processing fee of two hundred and fifty thousand naira plus 5% VAT per product for Prescription Only Medicines (POM) as well as one million naira plus 5% VAT by bank draft in favour of the Agency
Also for locally Manufactured Drug Products:
(i) Drug – Seventy thousand naira plus 5% VAT per product, covering processing, analysis and license
(ii) Traditional Medicines – Traditional medicine can be categorized as follows:
Small Scale Industry -Ten thousand naira plus 5% VAT.
Large Scale Industry – Forty thousand naira plus 5% VAT
Medium Scale Industry – Twenty thousand naira plus 5% VAT
(iii) Cosmetics: – Fifty thousand naira plus 5% VAT
(iv) Phytomedicines – Seventy thousand naira plus 5% VAT
(iv) Nutraceuticals – Seventy thousand naira plus 5% VAT
After application approval, NAFDAC issues an applicant a NAFDAC Registration Number. Note that these tariffs are levied on applicants to enable NAFDAC properly test all the products in the lab (clinical trials) which lasts roughly 7 months (depending on the products in question).
These trials are conducted to ensure that the products are fit for consumption. To register a product in NAFDAC, be it food or drugs, you must meet the requirements, and the entire process of registration takes a maximum of 3 months and you will be issued with a certificate 6 months after registration.
Also, before choosing a name for products, do well to write to NAFDAC to find out if such name is still available for use.
From the foregoing, it is obvious that product registration is a rigorous and costly process especially for entrants; perhaps this explains why many importers and local manufacturers of food product(s) and drugs often fake NAFDAC Registration Numbers and use them to market their products.
This is a punishable offence under NAFDAC Act, and the Agency has gone further to provide a phone number to consumers to confirm whether drugs are genuine or not.
This is known as Mobile Authentication Service (MAS) to stop the circulation of counterfeit drugs in Nigeria. To achieve this, just scratch the panel on the drug pack and send the PIN on it to 38353.
In a few seconds, you will receive a text message informing you whether it is genuine or not. All confirmatory text messages to the line are toll-free.
In conclusion, despite the seemingly difficult processes involved in a bid to register a product in NAFDAC, I advise you register your product(s) so that you don’t run the risk of having your facility shut down, your products being seized and burnt by the agency, ban of products on Nigerian markets, your arrest and detention of your product distributors, disgrace and destruction of the reputation of your company.
Why should I register my product?
The consequences of not registering products in NAFDAC have been outlined earlier and the points below are reasons why you should register your product in NAFDAC:
• It is a constitutional requirement for all food/drugs manufacturers and importers in Nigeria
• Giving customers assurance that your products are fit for consumption
• Increased sales
• Customer loyalty and brand trust
• Good corporate image