- within Food, Drugs, Healthcare and Life Sciences topic(s)
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What is NAFDAC and what does it do?
NAFDAC stands for the National Agency for Food and Drug Administration and Control. It is the government agency in Nigeria responsible for regulating and controlling the manufacture, importation, exportation, distribution, advertisement, sale, and use of food, drugs, cosmetics, vaccines, medical devices, packaged water, chemicals, and detergents (collectively known as regulated products).
What products do I need a NAFDAC license for before I import or sell?
You must have a NAFDAC license before selling or importing regulated products such as food, drugs, cosmetics, vaccines, medical devices, chemicals, and packaged water.
Are there any products exempted from NAFDAC registration?
Only products directly regulated by NAFDAC need to be registered with NAFDAC. As such, every product not regulated by NAFDAC is exempted from NAFDAC registration.
Can I import food products into Nigeria without a NAFDAC license?
No, you cannot import food products in large quantities for sale into Nigeria without a NAFDAC license. All imported food products must be registered and approved by NAFDAC before shipment.
What happens if I sell unregistered products in Nigeria?
Selling unregistered products without NAFDAC registration is a violation of NAFDAC regulations and a disregard for public safety, and this attracts fines of up to N500,000.
How Can I Register a Food Product with NAFDAC in Nigeria?
To register your food product with NAFDAC, you should take the following simple steps:
- Write an application letter with your company's letterhead to the appropriate NAFDAC Directorate. For foreign manufacturers without a registered Nigerian company, appoint a local Nigerian company as your agent.
- Purchase and complete the application form on the NAFDAC product registration website.
- Submit the application form online, along with the required documents for vetting.
- After a successful documentation review and inspection of the manufacturing facility, submit samples of the products for laboratory analysis.
- The products are thereafter presented at an approval meeting, and a certificate is issued for a successful registration.
Can Home-Produced Foods be Registered with NAFDAC?
Yes, home-produced foods can be registered with NAFDAC. For registration, they are regarded as a micro/kitchen or cottage production scale.
How do I check if a product is registered with NAFDAC?
To check if a product is registered with NAFDAC, follow these steps:
- Visit the NAFDAC product registration website at https://registration.nafdac.gov.ng/
- Click on "Verify Products"
- Enter the NAFDAC registration number of the product. If the product is registered with NAFDAC, the details (including the product name, the product category, the name of the manufacturer, the approved and expiry dates, and the product's active ingredients) are displayed as the result.
What are the requirements for product registration in Nigeria?
The requirements for NAFDAC registration are as follows:
- Completed online application form.
- Evidence of business or company registration with the Corporate Affairs Commission.
- Evidence of trademark or brand name registration with the Ministry of Trade and Investment.
- Notarised Declaration.
- Product Labels/Artworks.
- Product Samples for laboratory analysis
- Good Manufacturing Practice (GMP) Certificate issued by NAFDAC.
- Power of Attorney, if applying on behalf of a manufacturer outside Nigeria.
- Contract Manufacturing Agreement, if applicable.
- Certificate of Free Sale, for imported products.
- Certificate of Analysis of the Products
- Evidence of payment to NAFDAC
See our blog for more information on specific products.
What happens if my documentation is incomplete?
If your documents for product registration with NAFDAC are incomplete or inaccurate, the registration process will be delayed.
What is the cost of registering a food product in Nigeria?
Depending on the scale of production, the government fee for registering a food product with NAFDAC is between ₦ 60,000 to ₦145,000. If the food products are imported, the cost is between 12,000USD to 13,000USD. This fee covers the cost for registration, facility inspection, laboratory analysis, and the GMP Certificate.
How Long Does it Take to Register a Product with NAFDAC?
The timeline for product registration with NAFDAC is 120 working days, provided that all documents are submitted timely and in the correct formats.
How Long Does It Take to Register Imported Products With NAFDAC?
It takes 6-7months to register an imported product with NAFDAC.
Can I register a product with NAFDAC online?
Yes, the procedure for registration of any product with NAFDAC begins with purchasing and filling out the application form online. However, some of the procedures, like submitting samples for laboratory analysis, will have to be done physically at the nearest NAFDAC Laboratories closest to you.
Can one application cover multiple products?
No. Each product is to be applied for registration separately.
Can foreign companies register products with NAFDAC?
Foreign companies and manufacturers cannot register their products using their company name. A foreign company or manufacturer looking to register its product with NAFDAC must appoint a local agent (a registered Nigerian company) to register the product using its brand name.
Can a distributor apply for NAFDAC registration on behalf of a foreign manufacturer?
Yes, a distributor (registered business) can apply for NAFDAC registration on behalf of a foreign manufacturer.
How Many Product Samples Does NAFDAC Require?
The number of samples required for product registration with NAFDAC depends on the sizes and packaging of the products. See the NAFDAC Sampling Guide for more information.
Is Product Testing Conducted Abroad Acceptable to NAFDAC?
No. Product or laboratory testing of product samples conducted abroad is acceptable for product registration with NAFDAC. NAFDAC will conduct its own laboratory analysis of the product during registration.
What is the cost for registering a cosmetic product with NAFDAC in Nigeria?
Depending on the production scale, the government fee for registering a cosmetic product with NAFDAC is between ₦ 65,000 to ₦ 210,000. If the cosmetic products are imported, the cost is between 13,000USD to 14,000USD. Note that this cost is inclusive of registration fee, laboratory analysis, facility inspection, application forms, and GMP Certificate.
What is the difference between NAFDAC registration and NAFDAC listing?
NAFDAC registration is the process of registering a NAFDAC-regulated product and obtaining a NAFDAC registration number. NAFDAC Global listing scheme, on the other hand, was introduced in 2003 to allow for the importation of specific NAFDAC-regulated products (food and cosmetics items) subject to meeting established conditions or requirements. This scheme is only open to particular entities operating in Nigeria with established retail outlets, where applicable, such as supermarket operators, fast food chains, restaurants, hotels, embassies, and international organizations
Do I need a NAFDAC license for my restaurant?
Yes, you need a Good House Practice (GHP) Certificate issued by NAFDAC for your fast food or restaurant business. A GHP Certificate is issued by NAFDAC following NAFDAC's inspection of the production or manufacturing facility of your restaurant.
Are Frozen Foods Subject to NAFDAC Registration?
Yes, frozen foods are subject to NAFDAC registration.
Can food supplements be classified under food registration?
No. Food supplements are registered as dietary supplements with the Drug Registration Directorate at NAFDAC.
Do I Need NAFDAC Approval to Sell Locally Made Snacks or Drinks?
Yes, NAFDAC approval is required to sell locally made snacks or drinks since the products are for sale. See our article on how to register biscuits with NAFDAC.
Are Herbal Medicines Subject to NAFDAC Registration?
Yes, herbal medicines are subject to NAFDAC registration if they are to be sold, exported, distributed, or imported to Nigeria.
Do I need WHO GMP certification for drug registration?
No, you do not need a WHO GMP Certification for drug registration with NAFDAC.
Can Foreign Herbal Medicine be Registered With NAFDAC?
Yes, foreign herbal medicines can be registered with NAFDAC.
What documents are required for imported drug registration in Nigeria?
In addition to the requirements for product registration with NAFDAC, the technical documents for imported drug registration with NAFDAC include:
- Certificate of Pharmaceutical Product (COPP-WHO Format)
- Manufacturer's certificate issued by the relevant health/regulatory authority in the country of manufacture.
- Two Copies of the dossiers for each drug product.
- Evidence of a valid Premises Retention License for the facility.
- The Current Good Manufacturing Practice Certificate issued by the relevant regulatory authority in the country of manufacture and authenticated at the Nigerian Embassy.
- Information on the Manufacturer and your Local Agent
Is Clinical Trial Data Required for New Drug Registration?
Yes, clinical trial data contained in the dossier are required for new drug registration with NAFDAC.
What is bioequivalence testing, and is it required?
A bioequivalence testing/study is a requirement for a generic drug to prove it is interchangeable with a reference (innovator) drug in Nigeria. It is required for the registration of a drug product with NAFDAC.
What is the Cost of Registering a Drug Product in Nigeria?
The cost depends on the production, the category of medicine, and whether it is a foreign or a locally made drug product. If the drug products are locally made, the cost is between N100,000 to N N250,000. If the products are imported, the cost is between 14,000 USD and 15,000 USD. These include the cost for registration or processing, facility inspection, laboratory analysis, etc.
Can I Register Traditional/Native Medicines with NAFDAC in Nigeria?
Yes, you can register traditional/native medicines with NAFDAC. To do so, you have to brand the products and obtain approval from NAFDAC before sale. Native medicines are regarded as herbal medicines for registration purposes with NAFDAC.
What are the labeling requirements for pharmaceutical products?
Generally, the labels should be in English, and include the brand and generic name, manufacturer's full address, NAFDAC registration number, batch number, manufacturing and expiry dates, dosage form and strength, and net content. Pharmaceutical product labels should also include warnings and avoid names or designs that resemble already registered products. See our article on NAFDAC Labelling Requirement for specific details.
What Is the Validity of NAFDAC Drug Registration?
The validity of NAFDAC registration for a drug or pharmaceutical product with NAFDAC is 5 years. After this period, you must apply for renewal to continue selling the product legally.
What is a NAFDAC Good Manufacturing Practice (GMP) Certificate?
A NAFDAC GMP Certificate is issued following an inspection of the manufacturing facility and confirms that the facility meets NAFDAC's required quality and safety standards. It is mandatory for all regulated product registrations, and it is valid for three (3) years.
Do I Need a Clinical Evaluation for A Category I Software as A Medical Device (SaMD) Before Registration with NAFDAC?
Yes, you need to have conducted a clinical evaluation for any category of SaMD before registration with NAFDAC. Clinical evaluation for registration of a SaMD with NAFDAC is a set of ongoing activities conducted in the assessment and analysis of a SaMD's clinical safety, effectiveness, and performance as intended by the manufacturer in the SaMD's definition statement.
Do I Always Need NAFDAC To Inspect My Facility Before I Register A New Product?
No, if the manufacturing facility has been inspected during the registration process of a previous product, and you want to register a different product, you will only need the GMP certificate (which should still be valid) issued previously to register the new product.
How Often Does NAFDAC Inspect Manufacturing Facilities?
Generally, NAFDAC inspects manufacturing facilities 3 years after the first inspection carried out during or after the registration process of the product. However, for foreign facilities, depending on the risk categorization (as either high or low) of the facility, NAFDAC inspection can be up to twice or thrice every year.
How do I renew my NAFDAC license for my products?
To renew your NAFDAC license, you need to initiate the renewal process within 90 days before expiry, pay the renewal fees, and undergo inspection as may be required.
Do I need to pay renewal fees after expiration?
Yes. If your product has expired and you fail to renew as and when due, you will be required to pay the renewal fees as well as a penalty for late renewal.
Do I Need NAFDAC Registration for Exported Products?
Yes, all NAFDAC-regulated products are to be registered before they can be legally exported for sale abroad, except for the products that are for personal use.
How long is the validity of the NAFDAC import permit?
A NAFDAC import permit is valid for one (1) year, during which you have to import only samples of the product for registration.
How do I amend product labels after registration?
To amend product labels after registration, apply through the NAPAMS, upload the amended label along with other necessary documents, and pay the required fees. NAFDAC will review and approve the application if the changes comply with the relevant labeling regulations.
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