Understanding what NAFDAC does
The National Agency for Food and Drug Administration and Control (NAFDAC) regulates and controls the importation, exportation, manufacture, advertisement, distribution, sale and use of food, drugs, cosmetics, medical devices, packaged water, chemicals and detergents in Nigeria. These are collectively known as regulated products.
The agency was officially established in October 1992, with its enabling law being Decree No. 15 of 1993, as amended by Decree No. 19 of 1999, and now the National Agency for Food and Drug Administration and Control Act, Cap N1, Laws of the Federation of Nigeria 2004.
A lot of people think NAFDAC only deals with fake drugs. While it is true that much of NAFDAC’s effort goes into combating counterfeit drugs, that is far from all it does. In this article, we discuss the powers and functions of NAFDAC.
People often speak of “the NAFDAC Act” as if it were a single statute covering everything. It is not. Cap N1 establishes the agency and sets out its functions. The rules on registering and controlling products sit in two separate laws — the Food and Drugs Act, Cap F32, and the Food, Drug and Related Products (Registration, etc.) Act, Cap F33. Criminal penalties for counterfeit drugs and unwholesome foods sit in a third, the Counterfeit and Fake Drugs and Unwholesome Processed Foods (Miscellaneous Provisions) Act, Cap C34.
Functions and powers of NAFDAC
1. Regulation and control
NAFDAC regulates and controls the import, export, manufacture, advertisement, distribution, sale and use of food, drugs, cosmetics, medical devices, packaged water, chemicals and detergents.
2. Specifications, testing and compliance
NAFDAC designates specifications for maintaining the quality of regulated products and their raw materials, and sets standards for the production processes used in factories and other establishments.
3. Investigations and inspections
NAFDAC ensures that the standards it sets are adhered to, through inspections and investigations into the activities of relevant individuals, companies and premises.
In exercising this function, a NAFDAC officer may, in the course of duty, at any reasonable time and on production of a certificate of designation, enter — in some cases forcefully — any premises where the officer reasonably believes that the manufacture, preparation, preservation, packaging, storage or sale of a regulated product is taking place. On entering, the officer may examine and take samples of the product, and examine, seize or detain records relevant to the investigation.
4. Guidelines and registration
NAFDAC issues the guidelines governing the registration of regulated products in Nigeria, and no regulated product may lawfully be manufactured, imported, sold or distributed in Nigeria until it has been registered.
Applications are made through the NAFDAC Automated Product Administration and Monitoring System (NAPAMS) portal. The process includes inspection of the production facility. Once an applicant meets the standards set, NAFDAC issues a Certificate of Registration, valid for 5 years and renewable for further 5-year periods.
One point that catches importers out: a foreign manufacturer cannot apply to NAFDAC directly. Foreign manufacturers must register through a local representative — a Nigerian person or entity — and the certificate is issued in that representative’s name. Choose that representative carefully, because the registration sits with them.
Note also that NAFDAC is not necessarily your only regulator. Depending on your product, the Standards Organisation of Nigeria may set applicable standards, the Pharmacists Council of Nigeria may regulate your premises, and state or local health authorities will handle food handler permits and premises inspections.
5. Research and development
Beyond regulation, NAFDAC undertakes and coordinates research programmes on the storage, adulteration, distribution and rational use of regulated products in Nigeria, and compiles and publishes the resulting data.
6. Enforcement and prosecution
NAFDAC enforces its mandate through seizure, detention, product recall, closure of premises and, where appropriate, criminal prosecution under the relevant statutes. If you are facing an enforcement action, get advice early — the powers of seizure and closure bite quickly, and the procedural requirements around designation, sampling and detention are the ones most worth scrutinising.
Checking whether a product is genuine
If you simply want to know whether a product on a shelf is properly registered, you do not need a lawyer. NAFDAC publishes registration information and operates verification tools, accessible through its website at nafdac.gov.ng. A registration number printed on a pack means very little on its own — verifying it against NAFDAC’s own records is what counts.
Why NAFDAC approval matters beyond Nigeria
NAFDAC holds WHO Maturity Level 3 (ML3) status as a national regulatory authority. That designation signals that Nigeria’s regulatory system meets international benchmarks, and it makes NAFDAC approval far more meaningful to overseas regulators and buyers than it once was.
If you would like to know more about NAFDAC and its work, visit nafdac.gov.ng, where the agency publishes its current guidelines by product category.
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We hope you have found this information helpful. Please note that this information is provided for general informational purposes only and is not intended to be legal advice. No lawyer-client relationship is formed nor should any such relationship be implied. This answer is not intended to substitute for the advice of a qualified lawyer. If you require legal advice, please consult with a qualified lawyer.