NAFDAC Permit

NAFDAC is the body responsible for regulation and control of the manufacture, production, importation, exportation, distribution, advertisement, sale and use of certain products in Nigeria. As long as you intend to put up these products for the consumption of the general public, you must register with NAFDAC.

There are two broad categories of products that can be registered with NAFDAC namely; food and drug. However, includes different kinds of foods, drugs, cosmetics, chemicals, medical devices, packaged water (sachet and bottled) and so on.  

In order to register a product with NAFDAC, you must first critically examine the guidelines applicable to the product and fulfill all requirements and conditions attached. Afterwards, you may go online to: https://www.nafdac.gov.ng/our-services/msme/ micro or small-scale enterprises environment and click e-Registration for Registration form and Guidelines. 

However, the procedure is as follows; 

• You prepare and submit your application form together with all supporting documents. 
• You make payment as assessed.
• The documents are verified and a date for inspection of facility is fixed. 
• The inspection of the facility/ sampling of products is done, followed by laboratory analysis of the product. 
• Final vetting and approval meeting follow.
• Then the NAFDAC Registration Number and certificate of registration is issued.

The documents include: 

• Evidence of Registration with Corporate Affairs Commission (CAC) (Business Name and/ or incorporation) 
• Site use Agreement (Where applicable)
• Evidence of Trademark approval (optional for micro scale enterprise)
• One vetting Sample and three labels  
• Fumigation certificate 
• Copy of Receipt of Payment for production registration  
• Food handler’s certificate / medical fitness certificate for production staff, this should include the following: Sputum test, stool test, Urinary test, Widal test, Hepatitis B test.
• SOPs for production, distribution /Recall, Quality assurance, Cleaning of equipment, receiving of packaging materials, Personal Hygiene, and for cleaning of the environment (for small-scale enterprises)
• Water analysis (where applicable) List of raw material and their source(s)
• Certificate of analysis of raw materials (optional for micro scale)
• Certificate of analysis of finished products (optional for micro scale)
• A signed and endorsed certificate of Pharmaceutical Product (for drug products)
• Original copy of the Power of Attorney from the product manufacturer (if imported).
• Letter of invitation from manufacturer to inspect factory abroad, full names and site of plant (where applicable)
• Permit to import samples (for imported products)
• Certificate of Free Sale (for imported products)

The following include the necessary steps to take before approaching NAFDAC for registration of a product:

Ensure that your business has been duly registered with Corporate Affairs Commission (CAC)

Ensure that you have your trademark registration (but this is optional for micro-scale enterprises) 

Design and prepare your product label/packaging material according to the relevant regulations.

Ensure that your personnel have and meet the NAFDAC requirements with respect to education, experience, good sanitation and hygiene habits as well as medical tests.

Ensure that your building or facility and equipment meet the required standards.

Ensure that all raw or packaging materials are of good quality and standard.

Yes, you have to register. NAFDAC categorizes enterprises into micro-scale, small-scale and large-scale enterprises. 

A foreign company or manufacturer can only register his products through a Nigerian applicant or agent duly authorized by the foreigner to act on his behalf.