How To Obtain NAFDAC Approval For Your Company [Complete Registration Guide]

Obtaining NAFDAC approval for your company is as important as registering the business. Companies that produce food items, packaged water, drugs etc ought to register with NAFDAC as long as it is situated in Nigeria.

Brief introduction on what NAFDAC stands for

The National Agency For Food and Drug Administration and Control (NAFDAC) is a federal agency set up to control and regulate the manufacture, importation, exportation, distribution and consumption of consumable products in the country.  Founded in 1993, the agency has since been vibrant in the fight against the illegal production of drugs, food, cosmetics products, chemicals, medical devices and other consumable products including packaged water. They also stand to fight against the misuse of these items.

The agency performs inspection and carryout all necessary tests to ensure that products that are produced or imported into the country are suitable for use.
Companies that do not meet the requirement of NAFDAC are shutdown and products are discarded as well as banned from use. To prevent this ill treatment from befalling your business, you should proceed as quickly as possible to obtain NAFDAC approval for your business. Another reason you should get registered with NAFDAC is the authenticity of your product. Health concerned citizens can never purchase, recommend or administer your products without the NAFDAC registration number clearly inscribed on the pack. NAFDAC registration of your product ensures customers about the safety of the product.

Steps involved in getting NAFDAC approval

It is disheartening to discover that some manufacturers falsely accredit their products as NAFDAC approved without any authorization from the agency. Hopefully, someday they will all be caught and apprehended.
So, in this article I shall be sharing with you all the procedures and important documents needed for your company to get approved by NAFDAC. The registration process can be an uphill task and time consuming but I hope and believe that this guide will be helpful to you and put you through all the steps involved.

NOTE: if your company produces different products, you must register each product and not as a whole.

To commence registration for either food products or drugs, you must first apply.

How can you apply to get NAFDAC approval?

Write an application letter for the registration of the product (be it food or drug) to

The Director,
Registration and Regulatory Affairs (R & R) Directorate,
Ground Floor,
NAFDAC Office Complex,
Isolo Industrial Estate,
Oshodi-Apapa Express Way,
Isolo,
Lagos State.

In full details, write the product name, brand name and the name of the manufacturer(s). if you company deals on imported products, state it and ensure to attach a copy or two of all documents and licenses pertaining to the imported product.

Purchase and fill an application form for product registration gotten from http://registration.nafdac.gov.ng.
Submission of documents is dependent on the type of product you manufacture. Basically, the required documents for NAFDAC registration depend on the product being food or drug.

Required documents for NAFDAC registration of food products and packaged water

Submit the application form and letter at any NAFDAC office nearest to you. The forms should be submitted along side with two copies of the following documents:
1. Certificate of incorporation.
2. Proof of payment to the agency.
3. Manufacturing Agreement as it applies to the business.
4. Proof of trademark done in the name of the owner of the brand name.
5. Good Manufacturing Practice (GMP) certificate for your product.
6. Accurate and informative Product Label.
7. Certificate of analysis of the product with full details of the brand name, batch number, expiry and production dates, signature and name of analyst.

Required documents for NAFDAC registration of drugs

Obtaining NAFDAC approval for drugs is quite different from that of food products and packaged water. But firstly, the application forms will be submitted alongside documents which I am about to enumerate to you. You should also submit atleast 3 samples of your product for test and other experimental analysis.
1. Certificate of incorporation
2. Proof of payment to the agency.
3. Manufacturing Agreement as it applies to the business.
4. Proof of trademark done in the name of the owner of the brand name.
5. Valid certificate or license for pharmaceutical products.
6. Valid Premises Retention License issued for the company.
7. Proof of membership to PMG-MAN.
8. Good Manufacturing Practice (GMP) certificate for your product.
9. Accurate and informative Product Label.
10 Certificate of analysis of the product with full details of the brand name, batch number, expiry and production dates, signature and name of analyst together with Product Dossiers. The product dossiers should be in 3 different softcopy document formats; Compact Disc, Portable Document Format and Common Technical Document format.

Guidelines for NAFDAC approved drug label

Despite the attractive label designed for your drug, NAFDAC still has laid down guidelines or requirements for the drug label. If the label does not contain the following information, your drug will not be approved.
1. Accurate and informative product label with full details of the general and brand name,
Name and address of the manufacturer
2. Space for NAFDAC registration number
3. Batch number
4. Manufacturing and expiry date
5. Drug prescription and description (Dosage form, strength per dose, indications, frequency, route, conditions of administration, Dosage regimen on the package)
6. Information leaflet for patient
7. Product’s net content
8. Ingredients contained per dose
9. Caution and storage conditions.

Inspection of the company’s facility

The facility is inspected from time to time usually without the notice of the owner to see if it meets up to the standard required by NAFDAC. Ensure to give a full description of your company to avoid being disapproved or queried. Bribery should not be an option if you make use of substandard materials and equipments in the production, processing, storage and even transportation of your products. You might be disqualified and in most cases, arrested. Instead work on improving the facility before applying for NAFDAC licensing of the company.

Experimental and Quality Analysis of your product by NAFDAC

For any product you produce, you will submit at least three samples of the product to NAFDAC. The agency then performs all necessary laboratory tests to ensure the quality of the product is as required. Remember that will also submit the product’s test results from your company so make sure you do not falsify the information.

Conclusion: How To Obtain NAFDAC Approval For Your Company [Complete Registration Guide]

It only takes about 90 and 120 days for the registration of food and drug products respectively. After completion of the requirements stipulated by NAFDAC, a product approval meeting will be held amongst the agency officials concerning your product. Once your product is approved, you shall be issued a notification of registration.

Ensure to get NAFDAC registration of your product as quickly as possible unless you want to start on a very small scale where you do not need any form of publicity for your business. Most importantly, produce quality products and never relent simply because your product has already been approved by the agency. By doing so you are endangering the lives of innocent people.

For more information on NAFDAC registration proceedure, visit https://www.nafdac.gov.ng/our-services/product-registrationevaluation/
Or better still you can go to NAFDAC's official website @ www.nafdac.gov.ng.