Nigerian products registration process with NAFDAC.

Before you think about registering local products with NAFDAC, you should have a production facility, with adequate production equipments, with adequate number of rooms, and water treatment plant if you use water for your production, though it is compulsory for compulsory for drugs, both human and veterinary.

The next thing is to get the required documents for the process.

Documents required to start registration process with NAFDAC:

  1.       Certificate of incorporation

  2.       Trade mark registration certificate

  3.       Certificate of analysis of the finished product, raw materials and treated water for production.

  4.       Samples of the products label

  5.       Letter of employment and acceptance of key staffs

  6.       Credentials of key staffs

  7.       Annual license of superintendent pharmacist/ veterinary doctor

  8.       Current premises license by veterinary council of Nigeria and or pharmacist council of Nigeria
  9.       Site master plan of premises

  10.   Vetting product samples

  11.   Certificate of fumigation of the facility.

  12.   Retainer-ship agreement with the fumigation company

  13.   Medical fitness certificate/food handlers test cert with the following parameter tested;

a.       Sputum test

b.      Urine test

c.       Stool test

d.      Chest X-ray

e.      Widal test

f.        Hepatitis B

  14.   Retainer-ship agreement with the hospital

  15.   Dossier of the product (drugs, pesticides and fertilizers) in accordance with the agency approved        format.

  16.   Standard operating procedures (SOPs)

a.       Production

b.      Quality control

c.       Cleaning and maintenance

d.      Product recall and distribution.

e.      And others.

  17.   List of production and quality control equipment

  18.   List of raw materials

  19.   Batch formulation of each product

  20.   Duly completed registration form (online)

  21.   Copy of receipt of payment

  22.   Organogram of the company

  23.   Geological survey of borehole water

  24.   Expired license (for renewals only).

These documents are mandatory for registration process to continue, i.e, they must be provided. for questions or you need to be cleared about any of the documents mentioned above call 08024577934 or send a message to nzebekaconsult@gmail.com.

  you can get the detailed soft copy of the guideline for different regulated product for FREE. Just send your email address, name the type of products (food cosmetics, medical device, drugs etc), to nzebekaconsult@gmail.com. 

Or u can walk into any NAFDAC office and get it. IT’S FREE. Don’t let anybody deceive you or demand money for it.