The National Agency for Food and Drug Administration and Control (NAFDAC) regulates and controls the manufacture, importation, exportation, distribution, advertisement, sale and use of food, drugs, cosmetics, medical devices, chemicals and packaged water in Nigeria.
If you plan to sell a health product, especially a herbal one, you need to understand how NAFDAC registration works. This guide explains what NAFDAC does, why registration matters, the steps to take before you apply, how to set up your factory, and what your label must contain.
What Does NAFDAC Do?
NAFDAC’s key functions include:
- Product regulation: NAFDAC regulates food, drugs, cosmetics, medical devices, chemicals and detergents to make sure they meet quality and safety standards.
- Registration: The agency registers regulated products to make sure they are safe for consumption or use.
- Inspection: NAFDAC inspects factories and imported products to maintain quality control.
- Safety alerts: The agency issues alerts about fake, counterfeit or substandard products in circulation, such as warnings on counterfeit drugs or food products.
- Investigation and enforcement: NAFDAC investigates and takes action against the production and sale of prohibited or fake goods.
Benefits of Selling NAFDAC-Registered Products
- Legal compliance: Registration gives you official legal approval to manufacture, import, export and distribute regulated products in Nigeria.
- Consumer trust and brand value: A NAFDAC registration number signals quality and safety, because it confirms the product has gone through laboratory analysis and facility inspection.
- Market access: Most reputable supermarkets, pharmacy chains and distributors in Nigeria require a valid NAFDAC number before they will stock or sell a product.
- Export authorization: A NAFDAC registration number is mandatory for exporting regulated Nigerian-made goods.
- Protection against counterfeiting: Registered products are added to the agency’s database, which makes it easier to identify and act against substandard or falsified versions.
- Advertising permissions: A registered product can apply for the separate advertising permits that are required before any public promotion.
- Easier trade transactions: Registered products are integrated into the National Single Window for Trade, which streamlines customs clearance and documents such as Form M.
- MSME support: Small businesses can use specialized MSME registration schemes that offer reduced documentation and faster processing, typically 90 working days.
Risks of Selling Unregistered Health Products
- Arrest and prosecution: Sellers, distributors and manufacturers can be arrested and prosecuted by NAFDAC.
- Fines and financial loss: Selling unregistered products can attract heavy fines, and regulatory actions can involve large investigative fees and high-value seizures.
- Confiscation and destruction of goods: NAFDAC routinely raids markets and seizes unregistered products, which can mean a total loss of inventory.
- Sealing of premises: Shops and warehouses found selling such products are sealed, which shuts down the business.
- Severe health risks to consumers: Unregistered products, particularly herbal medicines, may contain harmful contaminants or toxic substances.
- Ineffectiveness and worsening disease: Unregistered products often lack efficacy, which can lead to treatment failure and a worsening condition.
- Unsafe herbal claims: Many unregistered herbal remedies are sold with false claims of curing all diseases, which can mislead consumers into delaying proper medical treatment.
- Business and reputation damage: Selling unsafe products destroys public trust and causes long-term damage to the manufacturer and the vendor.
- No legal protection: Because the business is operating illegally, sellers have no recourse if products are seized or if suppliers scam them.
- Fueling antimicrobial resistance: Substandard, unregistered products contribute to drug resistance, which makes infections harder to treat nationwide.
Steps to Take Before You Start Product Registration
1. Product Formulation and Standardization
Before you approach NAFDAC, create a product that you and the people around you have tested and found to be good, with minimal side effects. You can produce samples, give them to people free or for a small token, and follow up to collect feedback.
If the feedback is promising, standardize your formula. Document the list of ingredients and the quantity of each, as well as the production methods and the time they take. This helps when demand grows and you need to produce in high volume, and it lets you give NAFDAC the information it asks for.
2. Company Registration
Once you are confident in your product, register your company. NAFDAC usually deals with corporate bodies, so you need a registered limited liability company. You can register through a lawyer or do it yourself on the Corporate Affairs Commission website (www.cac.gov.ng).
Your certificate should come with a corporate Tax Identification Number (TIN). If it does not, you can get one free at the nearest Nigeria Revenue Service (NRS) office. You will need the TIN during online registration on NAPAMS (NAFDAC Automated Product Administration and Monitoring System).
3. Trademark Registration
Every product in the market has a name and a sign or logo that distinguishes it from others. In Nigeria, trademarks are registered by the Trademarks, Patents and Designs Registry, which operates under the Commercial Law Department of the Federal Ministry of Industry, Trade and Investment.
Before you apply, make sure the name you want will be accepted by NAFDAC by following its product naming guidelines (see the labelling section below).
4. Create Your SOPs
A Standard Operating Procedure (SOP) is a technical document that covers every step from raw material to finished product. It also covers how to record customers’ side-effect complaints and how to run a recall if needed.
A detailed explanation of how to write each document is beyond the scope of this guide, because SOPs differ by product. For example, the SOP for herbal capsule production cannot be used for a liquid product. These are the common SOPs and records to prepare before registration:
- SOP for production
- SOP for cleaning and maintenance
- SOP for quality control
- SOP for harvesting and drying
- SOP for recall
- SOP for line clearance
- SOP for batch number generation
- Batch Manufacturing Record (BMR)
- Batch Formulation Record (BFR)
- Organogram
5. Get the Right Staff
You will need at least three or four staff: a quality control officer, a production manager, a cleaning officer and a managing director. The quality control officer and the production manager must hold a science qualification of at least an OND.
6. Set Up Your Production Facility
Setting up a factory that NAFDAC will accept is one of the biggest costs of registration. You will need at least a one-bedroom flat that can be partitioned into five or six compartments, depending on your scale of production.
The building must stand alone, be fenced with a gate, and be located far from common sources of pollution such as burial grounds, poultry houses and sawmills. It must have an entry door and an exit door, and the rooms must be planned so people and materials can move freely through the factory.
Contract manufacturing is an option. If you cannot afford to build or rent a building, NAFDAC allows contract manufacturing. This means you agree with another company in good standing with NAFDAC to use its factory to register your product. Check the company’s reputation by asking whether it has approved NAFDAC products and confirming that its license has not expired.
Many companies charge a fee for this arrangement. The advantage is that they bring their experience, equipment and staff to defend your product during NAFDAC inspection.
7. Fitness Tests
The technical staff in charge of production should take the following tests every six months and keep the results on record:
- Sputum test
- Stool test
- Widal test
- Chest X-ray
- Urine test
8. Laboratory Analysis
Have your product analyzed in a certified laboratory and keep the report. The analysis should include a toxicological test, a microbial contaminant test and physico-chemical screening.
9. Fumigation Agreement
Sign an agreement with a fumigation company and make sure the factory is fumigated at least once every three months.
10. Geological Survey of Borehole
For liquid herbal products, you will need to dig a borehole of at least 150ft, or use tap water, and install a water treatment plant to produce clean, drinkable water for production.
Factory Layout for NAFDAC Registration
The factory should be divided into five compulsory compartments, with two optional ones depending on your product.
a. Cloak Room
The cloak room is usually near the entrance and is the first room you enter. This is where you sanitize your hands and change from street wear into factory wear. The floor must be tiled, the walls cemented and painted, and there must be a hand-washing basin with running water.
Items to install:
- Hanger or wardrobe for lab clothes and the street wear you bring to the factory.
- Lab coats: white lab coats for production, stored in the cloak room before and after use.
- First aid box containing items such as cotton wool, methylated spirit, scissors, paracetamol, adhesive tape and hand gloves.
- Shoe rack or shelves for shoes and personal protective equipment (PPE) such as liquid soap, hand gloves, face masks, nurse caps and hand sanitizer.
- Hand dryer: mount a small hand dryer on the wall for drying hands after washing with liquid soap. Towels are not allowed because they carry a high contamination risk.
- Lighting and ventilation: provide good illumination and ventilation, but do not install an AC or fan.
b. Raw Material (Bulk) Room
This is where you store the raw materials used in production. A herbal company, for example, can store dry herbs in sacks here until production. The floor should be tiled and the walls painted with oil paint. Screen the doors and windows with nets.
Items to provide:
- Plastic pallets to hold raw materials packed in sacks or airtight containers, so nothing sits directly on the floor.
- Record book for all incoming and outgoing raw materials.
- Ventilation and lighting, with no AC or fan. Screen all windows and doors with nets to keep out pests and rodents.
- Weighing scale for incoming and outgoing stock.
c. Production Room
This is where the final manufacturing activities take place, such as encapsulation, tea bagging, extraction, powder bagging and packaging. It is one of the most important rooms in the factory and needs a high level of sanitation and hygiene to prevent contamination.
The floor must be tiled, and the walls should be tiled up to window level. The rest of the walls and the ceiling should be neatly painted with oil paint. Provide an entrance and an exit door. Screen all doors and windows with nets. Aluminum windows and doors are advised because they are easy to clean. Wooden or iron doors are not preferable.
Items to install:
- Production tables: quality stainless steel tables for manual production of capsules, tea and powder bagging. These are not compulsory if your production does not require them.
- Utensils: basins, spoons, spatulas and containers should be stainless steel.
- Digital weighing scale to measure raw materials before and after production. For example, powders for encapsulation are weighed before, and the finished capsules are weighed after.
- Record book for all production activities. NAFDAC officials will want to see it during routine checks.
- Air conditioner or extractor fans: install an AC to keep the room comfortable and regulate temperature. If your production involves high heat or a lot of dust, install large extractor fans and a humidifier instead.
- Equipment such as an encapsulating machine, tea bagging machine, extraction machine and sealing machine. Small-scale producers can start with lower-cost manual or semi-automatic machines.
- Storage shelves to keep small tools off the work area and free up space in this busy room.
- Adequate lighting and ventilation.
d. Packaging Material Room
This room stores packaging materials such as PET bottles, stickers and cartons used for tertiary packaging. The floor should be tiled and the walls painted with oil paint. Doors and windows should be screened with self-closing nets. Preferably, use aluminum doors and windows laminated in a dark colour so the room is dark when they are closed.
Items to provide:
- Plastic pallets for all packaging materials. Labelling materials can go in a covered plastic container on the pallets.
- Ultraviolet (UV) light to sterilize packaging containers before production. Close the windows and door, expose the packaging materials and switch on the UV light for about 30 minutes before use. UV light is dangerous to skin and eyes, so do not enter the room while it is on.
e. Finished Product Room
This room stores your finished, packaged products that are ready to move to your shop or market. Ensure good ventilation and screen the door and windows with nets. Use storage shelves for light products, or lay plastic pallets on the floor for heavy ones. Make sure all products are properly labelled.
Optional Rooms
Depending on your product and scale of production, you may need extra compartments:
- f. Milling room: herbal companies need a room for the milling engine and all milling activity. If you buy milled herbal powder from a vendor instead, make sure the vendor’s environment is clean and certified by NAFDAC. During documentation, NAFDAC will ask for details of the vendor you buy raw material from.
- g. Drying room: herbal companies that harvest and process fresh herbs need a room for an electric stainless steel dryer. The dryer should have a temperature control knob and a thermometer so you can monitor temperature during drying.
Listing vs Full Registration
NAFDAC has strict labelling guidelines for health products. It does not allow manufacturers to make ambiguous claims that are not backed by scientific evidence.
Listing. Products registered under listing usually have a NAFDAC registration number ending in the letter “L”. These products cannot make curative claims, only management claims. For example, you cannot say your product “cures urinary tract infection”, but you can say it helps to “manage urinary tract infection” or to “boost body immunity against urinary tract infection”. Listing expires after two years and is renewable every two years. NAFDAC’s role here is to confirm the product is safe and not harmful when consumed.
Full registration. Many manufacturers complain that after the rigorous registration process they still cannot make curative claims. The reason is that listing does not include the full process, which requires a clinical trial to confirm efficacy.
The clinical trial is carried out in collaboration with NAFDAC and a government hospital. The manufacturer provides enough of the product free of charge for a medical doctor to use in treating patients with the relevant condition. The doctor follows up with the patients to confirm whether the product works. All this information is submitted to NAFDAC, which can then grant full registration. Full registration expires after five years.
Most pharmaceutical drugs and herbal supplements in the market today go through listing only, because the clinical trial requirement for full registration demands a lot of capital and time.
NAFDAC Labelling Guidelines
Your sticker, carton and inner leaflet should carry the following information:
- Product name: the trademark name and logo exactly as specified on the trademark acceptance certificate. State under the name whether it is a capsule, tea, mixture or powder.
- Quantity: the amount of herbal material in the bottle, for example “60 capsules” or “70g”.
- Storage condition: the conditions needed to maintain shelf life. You can use: “Store in a cool dry place below 30°C and away from direct sunlight.”
- Indication: the function of the product. Do not claim a cure, only management. For a bacterial infection product you may write: “For the management of bacterial infection.”
- Composition: all the ingredients used, with the quantity of each.
- Dosage: how to use the product, with separate dosage for adults and for children aged 12 to 17, who should take a lower dose than adults.
- Manufacturing date: the date the product was produced.
- Expiry date: usually two years for herbal powders, teas and capsules. Liquid products may not last as long unless well preserved.
- Batch number: a code of numbers and letters that lets you trace a particular batch of production. This helps if there is a complaint in the market, and it also helps you identify fake or adulterated copies of your product. Define how you generate batch numbers in your batch number generation SOP and stick to it. For example, for Basuta Herbal Capsule produced in December 2026, the batch number could be BHC/DEC/26/01: the three initials of the product name, the first three letters of the month, the last two digits of the year, and the batch number for that month (01, 02, 03 and so on). You can create your own rules, but always include the date marking information.
- Net weight: the total weight of the content in the bottle, excluding the container. If you pack 70g of herbal powder, the net weight is 70g. For liquid products, use net content in ml instead.
- Caution: the groups who should not use the product. NAFDAC often recommends: “Not recommended for pregnant women, breastfeeding mothers and children below 12 years old.”
- Manufacturer’s information: your company name, address and phone number.
- NAFDAC registration number: compulsory on all labels. If your product is not yet registered, write “NAFDAC REG. NO.” and leave it blank. Putting a fake number on an unregistered product is an offence. Each product has its own number, so you cannot use the number for Product A on Product B.
Frequently Asked Questions
What is the difference between NAFDAC listing and full registration?
Listing confirms safety, allows management claims only, and lasts two years. Full registration requires a clinical trial, allows efficacy claims, and lasts five years.
Can I use another company’s factory to register my product?
Yes. NAFDAC allows contract manufacturing. Confirm that the company has approved NAFDAC products and a valid license.
What qualifications must key staff have?
The quality control officer and production manager must hold a science qualification of at least an OND.
Is NAFDAC registration mandatory for herbal products?
Yes. Selling unregistered products can lead to arrest, fines, seizure of goods and the sealing of your premises.
Conclusion
NAFDAC registration takes planning, money and patience, but it protects your customers, your business and your brand. Start by standardizing your formula, register your company and trademark, prepare your SOPs and staff, and build or contract a compliant facility. Then label your product correctly and apply through NAPAMS.