This post is going to be on how to register a product with NAFDAC, or how to get NAFDAC registration number for your product; either way, you are right.
For the purpose of clarity; I am going to quickly run through the meaning of NAFDAC, and its functions. The National Agency for Food and Drugs Administration and Control (NAFDAC) is a Nigerian government agency under the Federal Ministry of Health; this body 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, etc.
That is why you need a NAFDAC registration number if you intend selling products related to foods and drugs; this is important to avert the risk of being shut down by the Agency. Most times, manufacturers do not wish to register their products because of the rigorous processes involved. However, it’s going to save you a lot of stress if done on time.
So, in today’s post, I will give you the step-by-step procedures on how to register a product with NAFDAC.
NAFDAC Registration Requirements
NAFDAC categorizes products registration into 2 categories: Drugs and foods. Drugs classified are vaccines, pesticides and chemicals, veterinary products, supplements, etc. while foods are all we already know.
However, NAFDAC registration is required for both local and foreign manufactured drugs and foods. Which means they both must meet certain conditions before they will be approved by NAFDAC.
In the case where the products are imported, 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, and must have a duly signed Power of Attorney from the manufacturer authorizing the Nigerian representative to act in their capacity in Nigeria 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 samples
- 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 the manufacturer to 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
(v) 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 with NAFDAC, be it food or drug, 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. So, that you have to prolong the registration process.