list of products regulated by NAFDAC

A simple explanation that gives insight to the products regulated by the National Agency for Food and Drug Administration and Control, NAFDAC, is that every products used On and In the body, and on any animal and plants (which still comes back to our body because we consume products from animals and plants) is NAFDAC's business. such products relates to our 'health  and safety'. This translates to NAFDAC's Mission "safeguarding the Health of the Nation!!!".

NAFDAC also regulates the importation and use of chemicals in Nigeria.

Here is a list of such products:

1. Food products.

2. Drugs; including prescription and over the counter drugs.

3. Vaccines

4. Medical devices

5. Cosmetics

6. Animal and Veterinary; animal food and feed as well as veterinary medicines and vaccines.

7. Alcoholic and non-alcoholic beverages

8. Water

9. Pesticides

10. Fertilizers

easy steps to register locally manufactured products with NAFDAC. (SUBMIT DOCUMENST AND BOOK FOR PRODUCTION INSPECTION)

Easy steps to register locally manufactured products with NAFDAC.

By now you should know which documents to provide for the registration of your products with NAFDAC to obtain your NAFDAC license. click here for information on the documents required for registration with NAFDAC.

STEPS:

1. Submit the documents, originals with a duplicated set of the documents, to the appropriate department,  after submission, you can then get a Payment Advice (PA) which gives a breakdown of what you will pay for.

2. You will then generate and RRR number from Remita website (www.remita.net),

using the RRR number, got to any commercial bank and make payment. You can also pay online. (contact 08024577934 or nzebekaconsult@gmail.com for more information).

3. Change your bank teller and remita reciept to NAFDAC reciept.

4. Submit a copy to the unit/department concerned with the registration of your product type.

5.Apply for production inspection and book a date when the inspection team will come and inspect your factory. (contact 08024577934 or nzebekaconsult@gmail.com for more information). 

6. Get ready to produce on that day because they will have to see your production line (observe how you produce form start to finish) on the day of inspection. 

7. The inspectors will draw samples from what you produced that day and send to NAFDAC laboratory for comprehensive analysis of the product(s). 

8. Your lab result from NAFDAC may come out satisfactory or unsatisfactory.

9. If unsatisfactory, then you will pay for another lab analysis and another batch of your product will be reanalyzed. 

10. If satisfactory, then your products will be scheduled for approval meetings. (about three approval meetings). this takes approximately 3 weeks to a month. 

11. Every other thing being OK, the product(s) will then get Notification for NAFDAC license number. 

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.

imported products registration with NAFDAC

TWO CATEGORIES OF PRODUCTS ARE REGISTERED WITH NAFDAC, THEY ARE;

• 
  
•        Locally manufactured products (made in Nigeria) 
•        Imported products

IMPORTED PRODUCTS:

DOCUMENTATION-

This is the first step to take in registration. You have to get the right documents and get the right information that should be on the documents. Any mistake or wrong information will jeopardize the whole thing. And time is essential in the registration process with NAFDAC. To avoid going back and forth and wasting time.

You need the following documents:

HUMAN DRUGS/ VETERINARY DRUGS:

    1.       The power of attorney or contract manufacturing agreement,

    2.       Certificate of pharmaceutical products (COPP)/ certificate of manufacture and      frees sales

    3.       Certificate of good manufacturing practice (GMP)

    4.       Certificate if manufacture/manufacturing license.

    5.       Certificate of incorporation

    6.       Trade mark certificate

 7.    Pharmacy license and premises

 8.    Notarized declaration
9.  Duly completed registration form (online)

10.   Invitation letter for GMP inspection, issued by the manufacturer

11.   Art work and samples of the products.

12.   Application letter stating purpose.

FOOD/ANIMAL FEED:

1.       The power of attorney or contract manufacturing agreement,

2.       Certificate of manufacture/frees sales

3.       Certificate of analysis of the product

4.       Certificate of incorporation

5.       Trade mark certificate

6.       Notarized declaration

7.       Duly completed registration form (online)

8.       Invitation letter for GMP inspection, issued by the manufacturer

9.       Vetting art work and samples of the products.

10.   Application letter stating purpose.

COSMETICS:

1.       The power of attorney or contract manufacturing agreement,

2.       Certificate of manufacture and frees sales

3.       Certificate of incorporation

4.       Trade mark certificate

5.       Notarized declaration

6.       Duly completed registration form (online)

7.       Invitation letter for GMP inspection, issued by the manufacturer

8.       Vetting art work and samples of the products.

9.       Application letter stating purpose.

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.

Any questions?, ask away, my email address is nzebekaconsult@gmail.com. Typical replies within one hour.