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NAFDAC Product Registration 2021 Guidelines

In this article, I’ll be explaining the guidelines involved in registering your products with the National Agency for Food and Drug Administration and Control (NAFDAC). 

As you should know already, NAFDAC is the regulatory agency in charge of issuing permits for the import and export, manufacture, and registration of food and medicine products that are produced in or outside of Nigeria’s borders. 

This includes products like chemicals, consumable goods, cosmetics, biological, and medical equipment, among other things. If you produce any of the following and you’ll like to register with NAFDAC, read on: 

Before registering their products with the National Agency for Food and Drug Administration and Control, ensure that you have first incorporated with the Corporate Affairs Commission (CAC). There are two methods for registering your products with NAFDAC, and they are as follows: 

  • Application to NAFDAC for approval to bring in samples of food and/or drug goods made outside of Nigeria. Importers are granted a special written permit by NAFDAC to bring samples of their products into Nigeria for this type of application. 
  • Application to NAFDAC for registration of locally manufactured or imported food and/or medicine goods. 

It’s worth noting that the second form of registration available for locally manufactured goods differs slightly from the registration process for imported goods. Also keep in mind that if a company manufactures many products, it will be required to register each of them separately to receive NAFDAC registration numbers for the various products. 

What are the requirements for NAFDAC registration?

For NAFDAC registration to get a unique NAFDAC number in Nigeria today, the documentation you’ll need to supply will mostly rely on whether the products are food or drugs. You will almost certainly be awarded your registration number if your product passes their quality and standard tests. 

The following are the prerequisites for NAFDAC registration of food and drug products: 

  • A formal written application letter to the Director, Registration and Regulatory Affairs, NAFDAC, describing the manufacturer’s name, brand name, and product. 
  • NAFDAC Application Form D-REG/001
  • Fees payment receipt 
  • Provide your company’s Certificate of Incorporation
  • NAFDAC’s certificate of inspection or recognition 
  • Original copy of the product manufacturer’s Power of Attorney for imported goods
  • Trademark registration number for your brand name in Nigeria if necessary 
  • Signed and endorsed pharmaceutical product certificate for drug products 
  • Sample pack of your product for quality testing and inspection. 
  • Signed and sealed declaration from the product manufacturer of a duly executed power of attorney, which must be typed and notarized by a Notary Public in Nigeria. 
  • A Certificate of Free Sale from a relevant health and regulatory organization in the manufacturer’s country. This should show the manufacturer’s name and the products to be registered. The Nigerian Embassy in the country of origin must authenticate this certificate. Any other Embassy or High Commission of any Commonwealth or West African country can validate this document in countries where there are no Nigerian Embassies or High Commissions. 
  • A comprehensive certificate of analysis. This Certificate of Analysis must be delivered on the quality control laboratory’s letterhead paper, and it must include the following information: The product’s brand name, batch number, manufacturing and expiration dates, as well as the analyst’s name, designation, and signature. 
  • The applicant’s letter of application for an import permit for a locally registered companies 
  • Evidence of a warehouse purchase 
  • The product’s colored artwork or label, as well as the product’s booklet insert. 
  • Proof of Good Manufacturing Practices (GMP). 
  • The name of the company, the factory’s contact information, including the address, email address, current phone number, and fax number, the name of the overseas contact person, telephone number, and email address, and so on. The name of the nearest airport and a guidance map depicting the shortest land/air route to the factory overseas are also important. 
  • Information about the local agent, including the name of the locally registered company that will handle immigration matters, as well as the full address, phone number, and email address. 

You should know that NAFDAC has the authority to register some goods without granting them a Registration Number. You will need to secure an import from the agency if you want to register imported items without obtaining a NAFDAC registration number. The following are the prerequisites for getting an import permit from NAFDAC: 

  • Application form for an import permission 
  • Payment of the required fees. 
  • A clean warehouse for inspection 
  • A Technical Officer with background science expertise 
  • The local company’s certificate of incorporation with the Corporate Affairs Commission. 
  • Certificate of Analysis
  • Safety Data Sheet (SDS)
  • Purchase Order 

Can I sell my products without NAFDAC number?

It is prohibited to sell to the general public products that do not have a NAFDAC registration number. Every producer or maker of items in Nigeria must identify and register their products with NAFDAC, otherwise they would face penalties. 

NAFDAC launched a strong anti-fake and substandard product campaign, raising public awareness about false and substandard items. NAFDAC introduced registration numbers as a means of verifying quality items as part of their endeavour to bring sanity to the system. 

How much does NAFDAC registration cost?

The cost of NAFDAC registration differs. It mainly depends on the type of product and scale of business of the manufacturer. You can check this official NAFADAC document to see the different prices available. 

Bottom Line

That’s all the basic information about NAFDAC product registration that you should know. Ensure that you provide all documents and pay all fees that apply to your type of product.