HOW TO REGISTER YOUR HERBAL MEDICINE PRODUCT WITH NAFDAC
This post is a comprehensive guide through the steps and documents require to register your herbal product with NAFDAC in Nigeria.
1. Product formulation and standardization: before you approach NAFDAC for registration you must first create a product you and the people around you have tested that its good with less side effects. You may produce and give to people to test free or with little token and follow up to get feedback from them. If the feedback is promising you need to standardized the formular by making sure you document list of ingredients and the quantity you used. Also document the methods you use for the production and time. Doing all these will help you in the future when you have a demand to produce high volume of the product and also for you to be able to give the necessary information about the product when required by NAFDAC.
2. Company registration: after you have completed step one above and you are sure that you have a promising good product next step is to register your company. NAFDAC often deal with cooperate bodies and so there is need to register your limited liability company. You can register your company through a lawyer or do it yourself from Corporate Affairs Commission website: www.cac.gov.ng. your company name certificate should come with your corporate Tax Identification Number (TIN) but if it does not come with TIN, you can visit the nearest NRS (Nigeria Revenue Service) office to get it free. You will need your TIN during the online registration process on NAPAMS (NAFDAC Automated Product Administration and Monitoring System).
3. Trade marks registration: every product in the market has a name and the particular sign or logo that is attached to it that distinguish it from other products in the market. The government institution responsible for registering trademarks in Nigeria is the Trademarks, Patents and Designs Registry, which operates under the Commercial Law Department of the Federal Ministry of Industry, Trade and Investment. Before going for trademarks ensure the name you want to use will be accepted by NAFDAC by following the NAFDAC guideline for product naming as explained under labelling below.
4. Create SOPs: Standard Operating Procedure is a technical document that covers all the steps you take from raw material to the finished products. It also covers how to document customers side effects complaints and recall process if need be. Detail elaboration on how to write these documents is beyond the scope of this guide as its often unique depending on the type of product you want to register. For example, the SOP for herbal capsule production will not be used for liquid production. Below are lists of common SOPs and records you should create prior to your NAFDAC registration process:
• 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 Batch Number Generation
• Batch Manufacturing Record (BMR)
• Batch Formulation Record (BFR)
• Organogram
5. Getting the Right Staff: you will need at least minimum of three or four staff: the quality control officer, the production manager, the cleaning officer and the managing director. The quality control officer and the production manager must possess qualification in sciences with minimum of OND.
6. Setting up production facility: one of the major costs in registering your product with NAFDAC is setting up a factory that will be acceptable by NAFDAC. You will need at least one bed room flat which you can partition into five or six compartments depending on the scale of your production. This building must stand alone, fenced with gate and situated in a place far away where there are no common sources of pollutants such as: burial ground, poultry house, saw mill, etc. the building must be planned so there will be an entry and exit door and the rooms must be planned to enable free flow of movement in the factory. The good news is that if you cannot afford to build or rent a building because of the cost, NAFDAC allow contract manufacturing. In other words, you can reach an agreement with another company that have good stand with NAFDAC to help you use their factory to register your product. You must ensure that the company reputation with NAFDAC is good by asking them if they have any approved product with NAFDAC and ensure their license has not expired. Though many companies will charge you a fee to sign such a contract with you, the advantage is that they will use their experience, equipment and staff to defend your product during NAFDAC inspection. The factory should be partition into five or six compartments as elaborated below.
7. Fitness test: your technical staff in charge of the production should carry out the following tests bi-annually and keep the record of the results:
a. sputum test
b. stool test
c. widal test
d. chest X-ray
e. urine test
8. Laboratory analysis: analyze your product in a certified laboratory and keep the report. The analysis should include: toxicological test, microbial contaminant test and physico-chemical screening.
9. Agreement with fumigation company: sign agreement with fumigation company and ensure the factory is fumigated at least once in three months.
10. Geological survey of borehole: for liquid herbs you will need to dig a borehole of at least 150ft or tap water and install a water treatment plant to get a clean drinkable water that you can use for the production.
FACTORY LAYOUT
a. Cloak Room: the cloak room is often close to the entrance of the factory. It’s the first room to encounter when you enter the factory where you sanitize your hands and change your street wears to the factory wears. The floor of the cloak room must be neatly covered with tiles and the walls cemented and painted with washing hand basin and running tap water provided. Below is the list of items to install in the cloak room:
i. Hanger: a wardrobe or hanger should be provided in the cloak room to hang the lab clothes and other street wears you bring to the factory.
ii. Lab coat: the white lab coat to be used during production activities is usually store in the cloakroom before and after use
iii. First aid box: the first aid box should contain necessary items like: cotton wool, methylated spirit, scissors, paracetamol, adhesive tape, hand gloves.
iv. Shoe rack/shelves: provide shoe rack or shelve in the cloakroom to store shoes and other personal protective equipment (PPE) and detergents like liquid soap, hand gloves, facemask, nurse cap and hand sanitizer
v. Hand dryer: get a small hand dryer machine and mount on the wall to dry the hand after washing with liquid soap. The use of towel to dry hands is not allowed because it possess high contamination risk.
vi. Provide good illumination and ventilation in this room but do not install AC or fan.
b. Raw material/Bulk Room: the raw material room also called bulk room is the room where you store your raw material that you often use for the production. For example, an herbal company can store the dry herbs in sacks in the raw material room pending production. Ensure the floor of the room is neatly covered with tiles and the walls painted with oil paint. Screen the door and the windows with net. Below are lists of items to provide in the raw material room
i. Plastic pallets: lay plastic pallets on the floor and store your raw materials which you have packed in sacks or air-tight container on the pallets. This is to avoid keeping your raw materials directly on the floor as it may increase risk of contamination
ii. Record book: provide record book to keep record of all incoming and outgoing raw materials
iii. Ventilation/illumination: provide good ventilation and lighting in this room but do not install AC or fan. Ensure all the windows and door is screened with net to avoid entrance of pests and rodents.
iv. Weighing equipment: provide weighing scale in the bulk room for weighing of incoming and outgoing stock.
c. Production room: the production room is where all the final manufacturing activities is carried out like encapsulation, tea bagging, extraction, powder bagging, and all packaging activities is carried out. It’s one of the most vital rooms in the factory that requires high level of sanitation and hygiene to avoid any form of contamination in your final products. The floor of the production room must be covered with tiles and the walls should be tilled to the window level. The remaining walls that is not tiled should be neatly painted with oil paints including the ceiling, there should be entrance and exit doors in the production room. All the doors and windows must be screened with nets. you are advised to use aluminum windows and doors to make it easy for proper cleaning. The use of wooden or iron doors is not preferable. Below are some of the items you will need to install in the production room:
i. Production tables: for manual production of capsules, tea and powder bagging you will need a quality stainless tables to work on. The stainless stable is not compulsory if your production activities does not require it.
ii. Utensils: all utensils like basin, spoons, spatula and containers to be used in production room should be stainless
iii. Weighing machine: provide digital weighing scale in the production room to quantify all your raw materials before and after production. For example, powders to be used for encapsulation need to be weighed before and the capsules also weighed after production
iv. Record book: it’s important to have a book to keep record of all your production activities for future reference. NAFADAC officials will also like to see it when they come for routine check up
v. Air conditioner/Extractor fans: AC should be installed in the production room to make the room convenience for your staff and also to regulate the temperature of the room. However, if your production activities involve high heat or excessive dust generation, it’s better to install big extractor fans and humidifier rather than AC.
vi. Equipment: basic equipment like encapsulating machine, tea bagging machine, extraction machine, sealing machines should be provided in the production room. For a small-scale producer, you may start with manual or semi-automatic machines with lower cost
vii. Storage shelves: you will not want to litter your tools around as the production room is one of the busiest rooms in the factory to free space for movement you can provide a wooden storage shelve to keep some of your small production equipment.
viii. Provide adequate in this room
d. Packaging material room: the packaging material room is the room where you store your packaging materials like your pet bottles, stickers and all cartons used for tertiary packaging. The floor of this room should be neatly tiled and the walls painted with oil paint, the door and the window should be screened with self-closing nets. The window and door should be preferably aluminum and laminated with dark colour to make the entire room look dark when both door and window are closed. Provide items below in the packaging material room:
i. Plastic pallets: lay plastic pallets on the floor and store all your packaging material on it. For your labelling materials you can put them in a plastic container with cover and put it on the pallets.
ii. Ultraviolet light: install UV light in the packaging material room to help sterilize the packaging containers before production. Ensure you close the window and door, expose the packaging materials and switch on the UV light for about 30 minutes before use. The UV light is dangerous to the skin and eye, do not enter the room while the light is on.
e. Finished product room: the finished product room is the room where you store all your finished packaged products ready to be moved to your shop or market. like every other room you should ensure good ventilation in this room and screen the door and the window with nets. Provide storage shelves in this room for light products or lay plastic pallets on the floor to store heavy products depending on the type of your finished products. Ensure all the products are properly labelled.
NOTE: Above are the compulsory five room compartments you must create when trying to set up your factory for NAFDAC registration. However, depending on the type of products you are registering and your level of production, you may need to create additional compartments below:
f. Milling Room: for companies dealing with herbal medicine, you will need to create a room where you will keep the milling engine and carry out all your milling activities. If you are not the one responsible for milling and you source your milled herbal powder from a vendor, ensure the vendor’s environment is clean and certified by NAFDAC. During documentation NAFDAC will require the details of the vendor where you buy your raw material from.
g. Drying Room: for herbal companies that harvest and process herbs fresh, you need to create a room where you will keep your electric stainless drying machine that will be drying the herbs. The dryer should have a temperature control knob and a thermometer to be able to monitor the temperature during drying process.
LABELLING GUIDELINES
NAFDAC has strict guidelines for labelling of health products which does not allow the manufacturer to lay any ambiguous claims that is not back up by any scientific evidence. Products registered under listing which the NAFDAC registration number often end with letter L cannot lay a curative claim but management. For example, you can not say your infection product “cures urinary tract infection” under listing registration but say to “manage urinary tract infection” or to “boost body immunity against urinary tract infection”. Most manufacturers are not happy with this and often complain that after passing through the rigorous process of registration why is NAFDAC restricting them from laying the curative claim on their labels? The reason is that your product has not passed through full registration process which requires clinical trial to confirm the efficacy of the product. Clinical trial is carried out in collaboration with the NAFDAC and a government hospital where the manufacturer will provide enough quantity of the products free to be used by a medical doctor to treat patients with such health condition. The doctor will follow-up with the patient to confirm if the product is effective. All these information is required to be submitted to NAFDAC for them to give the product full registration which expires in five years. Listing on the other hand often expires in two years. NAFDAC only ensures the safety of the product to be sure its not harmful when consumed and give you the license to sell your product which is renewable every two years. Most of the pharmaceutical drugs and herbal supplements in the market today only pass-through listing as the clinical trial requirement for full registration requires huge capital and time to achieve it.
The list below is the necessary information that should be on your labelling sticker, carton and inner leaflet:
I. Product name: write the trademark name of the product and input the logo in the design as specified on the trademark acceptance certificate. Indicate under the product name if its capsule, tea, mixture or powder
II. Specify the quantity: indicate the quantity of the herbal material in the bottle. For example, if it’s packed as a capsule and you have 60 capsules in the bottle you should indicate “60 capsules”. If it’s a powder and you have 70g in the bottle you should write 70g below the name.
III. Storage condition: specify the storage condition that must be adhere to maintain the shelve life of the product. You can use this phrase: “store in a cool dry place below 300C and away from direct sunlight”.
IV. Indication: this is the statement of the function of the product. As said earlier do not lay claim of cure but management. For bacterial infection product you may write: “for the management of bacterial infection”
V. Composition: this the list of the ingredients you use to manufacture the product. Write out all the ingredients and the quantity
VI. Dosage: specify how to use the product. Specify dosage for adult and children 12-17 years should use lower dose than adult.
VII. Manufacturing date: state the date you produce the product
VIII. Expiry date: write the expiry date usually two years for herbal powder, teas and capsules. Liquid products may not stay long unless they are well preserved.
IX. Batch number: batch numbers often contain numbers and letters that enable manufacturers to track a particular batch of production. This is valuable incase of any complaint in the market you can track the batch record. You should specify how you want to create your batch number in the batch number generation SOP and stick to it. It also helps to make you identity fake adulteration of your product. For example, if your product name is Basuta Herbal Capsule and you produce the batch in December 2026, your batch number can be written like this: BHC/DEC/26/01. First are the three initials of the product name in capital letter, second is the three letters of the month it was produced in capital letter, third is the last two digit of the year it was produced and last, is the first batch in the month. So, if you have more batches of production in the same month you will add ….02,03,04, etc. this illustration is an example if you like you can create your own rules but ensure the important date marking information is included.
X. Net weight: net weight is the total weight of the content in the bottle. For example, if you package 70g of your herbal powder in a bottle your net weight is 70g. Do not add the weight of the container. If your package is in liquid form you should use net content in ml instead of net wight which is often measure in mass unit.
XI. Caution: indicate the category of people that can not use the herbs due to their age or condition. This caution “Not recommended for pregnant women, breast feeding mothers and children below 12 years old” is often recommended by NAFDAC.
XII. Manufacturer’s information: write your company name, address and phone number on the labels.
XIII. NAFDAC Registration Number: its compulsory to write the NAFDAC REG. No. on all your labels. If it’s a new product that have not been registered you should write: “NAFDAC REG. NO.” and leave it blank. If your product has not been registered by NAFDAC it’s an offense to put fake number on it. Note that each product will have its own separate numbers. As a manufacturer you can not use the NAFDAC number for product A on product B.
NAFDAC ONLINE PRODUCT REGISTERATION ON NAPAMS
After ensuring that all the necessary documents above are ready visit NAPAMS (Nafdac Automated Product Administration and Monitoring System) online at https://registration.nafdac.gov.ng/Home/Login . Register with your TIN, RC number and create login password . On your dashboard click on registration form and fill all the required information. Ensure you have pictures and scan copies of all your documents above as you will be asked to upload the documents at the end of the registration process. After submitting the application a payment invoice will be generated for you to make the necessary payment. After successful application and payment it will take some weeks or months for NAFDAC officials to contact you for a schedule physical inspection in your factory. During this inspection period they will request for all the original copies of the documents you have submitted for sighting and photocopies of the documents will be collected for filling if you are a new client.
CONTRACT MANUFACTURING
At Olason Herbal Nig Ltd, we accept contract manufacturing to help you use our factory and experience staff to register your products with NAFDAC. Our facility is approved by NAFDAC and is well equiped with the latest machineries for herbal medicine production and packaging. For contract manufacturing we will provide most of the documents you need above. You will only submit photocopies of your company certificate, trademark acceptance certificate, the product and your company letter headed paper. Every other steps above will be taken by us to ensure fast registration of your product. we produce you own your brand.
ABOUT THE BLOGGER
Mr. Olajide Yusuf is a blogger and a botanist with inherited family background of traditional medicinal practice. He is very familiar with most medicinal plants of Nigeria and their uses. He pioneer creation of many herbal formulas which has been registered with NAFDAC. He is the Co-founder of Olason Herbal Nig Ltd with over 20 years of experience in herbal medicine practice.Â