In this article, we discussed the NAFDAC registration requirements for food, we explained the term NAFDAC and furthermore the application requirements.
WHAT IS NAFDAC?
The National Agency for Food and Drug Administration and Control (NAFDAC) is a Nigerian federal agency under the Federal Ministry of Health that is responsible for regulating and controlling the manufacture, importation, exportation, advertisement, distribution, sale, and use of food, drugs, cosmetics, medical devices, chemicals, and packaged water.
ABOUT NAFDAC
The National Agency for Food and Drug Administration and Control (NAFDAC), was established by Decree 15 of 1993 to regulate and control the manufacture, importation, exportation, distribution, advertisement, sale and use of food, drugs, cosmetics, chemicals, medical devices and packaged water.
NAFDAC was inspired by a 1988 World Health Assembly resolution requesting countries’ help in combatting the global health threat posed by counterfeit pharmaceuticals, and amidst growing concerns about the growing problem of fake and poorly-regulated drugs in Nigeria.
APPLICATIONS FOR NAFDAC REGISTRATION REQUIREMENTS FOR FOOD
A manufacturer who intends to register a food or related product in Nigeria shall first have the factory inspected by the Establishment Inspection Directorate of NAFDAC and be assigned a Certificate of Recognition as a manufacturer before an application to register the product can be made.
Food in this context includes supplements processed for addition to animal and poultry feeds.
(a) The applicant should purchase and fill the prescribed application form. A separate application form shall be submitted for each food product.
(b) Written application for food registration shall be made to the Director (Registration and Regulatory Affairs), stating the name of the manufacturer, the generic name of product, brand name (where applicable)
DOCUMENTATION:
Documents required for submission for food registration are:
- Evidence of pre-production inspection/ Certificate of Recognition issued by NAFDAC.
- Evidence of Trade mark approval for brand name from Federal Ministry of Commerce (where applicable).
- Certificate of Incorporation of the company issued by the Corporate Affairs Commission.
- Comprehensive Certificate of analysis of the batch of the product submitted for registration from the manufacturer stating name and signature of the analyst.
PRODUCT:
Three vetting samples shall be submitted upon satisfactory Pre- Registration inspection.
READ:NMDPRA Permits, Costs and Requirements
LABELLING:
- Labeling shall be informative, clear and accurate.
- Minimum requirements on the package label in accordance with food labeling regulations shall be:
(a) Name of food (brand name) (where applicable).
(b) Name and location address of the manufacturer, distributor, packer or advertiser.
(c) Provision for NAFDAC Registration Number on product label or listing number.
(d) Batch No., Manufacturing date and Expiry date.
(e) Net content.
(f) A complete list of ingredients.
(g) Adequate warnings (where necessary)
- Where a brand name is used, the type of product should also be stated
- Any food product whose name or package label bears close resemblance to an already registered product or is likely to be mistaken for such registered product, shall not be considered for registration.
- Any food product which is labeled in a foreign language shall not be considered for registration unless an English translation is included on the label.
- Failure to comply with these requirements may result in the disqualification of the application or lead to considerable delays in processing of registration time.
- A successful application attracts a Certificate of Registration with a validity period of 5 (five) years whereas products with Listing status have a validity of 2(two) years.
8.) The time line for product registration from submission of samples up to issuance of registration number is sixty (60) work days. However, this depends on satisfactory compliance by the applicant.
TARRIFF:
All payments to the Agency should be in Bank Draft payable to National Agency for Food and Drug Administration and Control (NAFDAC)
1 Food – Fifty thousand naira (N 50, 000:00) + 5% VAT.
2 Water in sachet Thirty thousand naira (N30, 000:00) + 5% VAT.
3 Water in bottle Fifty thousand naira (N50, 000:00) + 5% VAT.