10/10/2014

How to Get Approval for NAFDAC Of Nigeria

No comments


The National Agency for Food and Drug Administration and Control (NAFDAC), was establish by decree N0 15 of 1993 (as amended), now Act CAP. N1, Laws of Federaltion of Nigeria (LFN) 2004, to control and regulate the manufacture, importation, exportation, distribution, advertisement, sale and use of food, drugs cosmetics medical devices and packaged water including all drinks (referred to as regulated products).

In accordance with the enabling laws, NAFDAC is authorised to:
  • Regulate and control the importation, exportation, manufacture, advertisement, distribution, sale and use of regulated products.
  • Conduct appropriate tests and ensure compliance with standard specifications.
  • Undertake appropriate investigation of the production premises and raw materials of regulated products.
  • Compile standard specifications, regulations, regulation and guidelines for the production, importation, exportation, sale and distribution of regulated products
  • Control the exportation and issue quality certification of regulated products intended for export.
  • Establish and maintain relevant laboratories for the performance of its functions.
  • Ensure that the use of narcotic drugs and psychotropic substances are limited to medical and scientific use only.
  • Undertake the registration of food, drugs, medical devices, bottled/sachet water and chemicals.
  • Undertake inspection of imported regulated product.
  • Pronounce on the quality and safety of regulated products after analysis.

Therefore, if you have not gotten an approval for that product you are manufacturing or marketing in Nigeria its better you go and register quickly to avoid  NAFDAC sealing up your factory and also blacklist your product from being sold in the country. Just think of the effort, time and money you have invested into your business, it must not go down the drain!





To start the registration of your product with NAFDAC, below are the requirements you must meet before you get approval and get certificate of compliance.

NAFDAC Registration Requirement for Drugs, Cosmetic and Food products



Obtain a registration from [D-REG/001] from any NAFDAC offices in Nigeria or still you can download it from their website. www.nafdac.gov.ng


Fill the registration form and write an application letter. NB: Your application letter should contain the name of the product.

The completed registration form and letter of application for each product should be returned to NAFDAC registration center with the following items
  • Five copies of writen report for the product.
  • Three packets of produc samples (drugs, cosmetic or food)
  • Name and copies of the current license of your company’s supervisor/production pharmacist/chemist
  • The registration license you obtained from pharmacists coucil of Nigeria (PCN) that allows you to license obtained from relevant professional bodies.
  • Pay registration fees at NAFDAC designated bank.
Below are the registration fees at NAFDAC for various products:

  •  Pharmaceutical drugs produced in Nigeria cost N25,000 to N70,000
  • Pesticides/chemicals cost =N40,000
  • Cosmetics cost =N40,000
  • Sachet water cost =N50,000
  • Bottled water cost =N40,000
  • Herbal drugs cost =N10,000 to N20,000
       4. To quicken the approval of your products, you will need to fix a date and invite NAFDAC officials to come and inpect your factory/production facilities.
With the above information, I’m quite sure you must have discovered the importance of obatining NAFDAC approval for your product and how to go about the registration with ease.

Cheers!!

No comments :

Post a Comment

Use the comment box to make your views, your contribution is kindly appreciated. Urge not to SPAM! Your comment will not be published if noticed as SPAM!! Thanks!!!