NAFDAC Registration 2023 Application Requirement and Procedure
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NAFDAC Registration 2024 Application Requirement And Procedure

NAFDAC Registration 2024 – The National Agency for Food and Drug Administration and Control (NAFDAC), is the agency responsible for regulating and granting permission for manufacturing, exporting, importing, and the registration of products such as drugs, chemicals, consumable goods, cosmetics, pharmaceuticals, medical equipment, biological, and medical services which are produced, distributed and consumed within or outside the country, Nigeria.

Therefore, any firm, or industry that is into the production, manufacturing, and distribution of consumable goods or commodities, whether imported or produced within the country, must register with the Corporate Affairs Commission (CAC), in order to have a legal ground for operation. It is after this, that you can proceed with the registration of your product with The National Agency for Food and Drug Administration and Control (NAFDAC).

 NAFDAC Registration 2023 Application Requirement and Procedure

Overview of NAFDAC

The National Agency for Food and Drug Administration and Control, (NAFDAC), was founded under Decree No. 15 of the 1993 constitution as amended by Decree No. 19 of 1999, and presently the National Agency for Food and Drug Administration and Control Act CAP N1 laws of the Federal Republic of Nigeria, 2004.

 NAFDAC headquarters is located at Federal Capital Territory, Plot 2032, Olusegun Obasanjo Way, Zone 7, Wuse, Abuja, Nigeria. The agency is spearheaded by the Director General, Professor Mojisola Christiana Adeyeye, who is assisted by deputy Directors and heads of departments of the agency, who help to manage and oversee the overall affairs of the NAFDAC,

under the following directorates:

  • Directorate of Registration and Regulatory Affairs
  • Directorate of Food Service and Applied Nutrition
  • Directorate of Drug Evaluation and Research
  • Directorate of Chemical Evaluation and Research
  • Directorate of Narcotics and Controlled Substances
  • Directorate of Veterinary Medicines and Allied Products
  • Directorate of Ports Inspectorate
  • Pharmacovigilance and post-marketing Surveillance
  • Directorate of Laboratory Services
  • Directorate of Planning Research and Statistics
  • Directorate of Investigation and Enforcement
  • Directorate of Administration and Human Resources Management
  • Directorate of Finance and Accounts.

NAFDAC Vision, Mission, and Core Values

The NAFDAC’s vision is to safeguard public health.  The agency also has the mission of achieving the aforementioned vision, by seeing to it that only the right quality and standard of drugs, consumable goods, and other regulated products are manufactured, imported, distributed, advertised, sold, bought, and utilized in Nigeria.

NAFDAC Registration 2024 Application Requirement and Procedure

Stages of NAFDAC Registration

The registration of locally produced products is not the same as the process of registration for imported goods. Again if you manufacture more than one product, each of them will have a different NAFDAC registration number. The registration process for the NAFDAC permit comes in two stages;

  • Application for NAFDAC permits to bring in samples of products manufactured outside Nigeria. This type of application is only for importers, for NAFDAC grants permission to bring in samples of the products into Nigeria.
  • Application for registration of products locally manufactured or produced in Nigeria.

NAFDAC Application Procedures

Before the registration starts formally, you have to do the following:

  • The NAFDAC application/registration form

Firstly, you have to obtain the NAFDAC registration or application form, from the NAFDAC office close to you.

  • Registration form submission

After you have obtained the application/registration form, you will have to fill it out according to the instructions stipulated in the form. Remember to read the form carefully, to avoid mistakes, and be careful too while filling it.

  • Submission of product samples

When you are done filling out the form, submit it to the appropriate person in the right office.

  • Make payment

After submitting the registration form, you have to pay the necessary fees required by the agency for the registration of products.

  • Collection of certificates

The next thing that follows is the payment you have to make to the agency, you will be issued the NAFDAC registration number and certificates for the products.

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Products Registration Requirements with NAFDAC

To register your products with NAFDAC, the documents required to be submitted depend on the category your product falls into, it is either the food or the drug category. 

After the product has passed the quality and standard test carried out by the agency, NAFDAC will only issue a registration number and certificate to you, notwithstanding the product to be registered. However, the general requirements for the NAFDAC’s registration of products:

  • Company Registration Documents
  • Trademark
  • Fumigation Certificate
  • A written application for product registration, to the Director of Registration and Regulatory Affairs, stating the name of the manufacturer, the brand name, and the product.
  • Fill out the prescribed NAFDAC Application Form D-REG/001.
  • Evidence of payment of prescribed fees.
  • The Certificate of Incorporation of the company
  • The certificate of Inspection or recognition issued by NAFDAC
  • Original copy of Power of Attorney sent by the product manufacturer
  • Trademark registered in Nigeria for brand name
  • Duly signed and endorsed certificate of Pharmaceutical Product (for drugs only).
  • Letter of invitation from the manufacturer for factory inspection abroad, full names, and site of a plant
  • A pack of product samples for quality inspection, and analysis
  • Notary Declaration of a well-executed power of attorney from the product manufacturer, which is well-type-filled and notarized by a Notary Public here in Nigeria.
  • Certificate of Free Sale issued by the relevant health and regulatory body in the manufacturer’s country showing the name of the Manufacturer and products to be registered. Must be authenticated by the Nigerian Embassy of that country. In countries where no High Commission or Nigerian Embassy are not, other Embassy or High Commission of any Commonwealth or West African country can authenticate the document.
  • A Comprehensive Certificate of Analysis, and must be presented on a letter headed paper of the quality control laboratory where the sample was tested, and it should carry information like:
  • The brand name of the product
  • The batch number of the product
  • The manufacturing and expiry dates
  • The name, and signature of the analyst
  • Application letter for Import Permit by the applicant, for the locally registered factory.
  • Evidence of warehouse acquisition (where applicable)
  • Label of the product, with a leaflet inside the product.
  • Evidence of GMP inspection.
  • Manufacturer Information: Name, location/address, email, phone number, and fax number, of the factory abroad. The name of contact persons, telephone no, and email address. Name of airport closest to the location and guide map illustrating the shortest land/air route to the factory abroad.
  • Local Agent Information: Name of the locally registered factory taking the immigration obligations; a functional phone number, location, and email addresses.

Note that some goods can be registered with NAFDAC but the NAFDAC Registration Number not be issued. For NAFDAC registration of imported goods without the acquisition of the NAFDAC registration number, an import permit must be obtained. 

The Requirements for the Process of the NAFDAC Import Permit include:

  • Application for an import permit, showing fees paid
  • A warehouse for NAFDAC inspection.
  • A technical officer in the Science field, with the passport photograph
  • Certificate of Incorporation of the Corporate Affairs Commission for the local factory.
  • Certificate of Analysis of the products.
  • Local Purchase Order.
  • Material Safety Data Sheet.

NOTE: Remember your registration application will take you about 60 days before it can be registered.

FAQS

 

Why do I need to register with NAFDAC?

In Nigeria, NAFDAC is the body responsible for regulation and control of the manufactured consumable products, whether imported or not, since the products for the consumption of the general public, you must register with NAFDAC.

Do I need to register imported products also?

Yes. you have to register the product so that you can have approval from NAFDAC to import your goods.  Other necessary documents may be required too.

How long does it take to get the NAFDAC number?

the time spans ninety (90) working days for food products to be approved.

Conclusion

now, if you want to know the requirements and procedures for registering your products with the NAFDAC, we have taken the time to provide every piece of information you may require to register your products with the agency.

After your products have passed the quality and standard test conducted by the agency and your products are subsequently registered, NAFDAC will issue a unique registration number or certificate of registration. Those who importer can start their important. After your products have been registered successfully, they will be valid for just a term of five years, which is subject to renewal.

Amos Nya
Amos Nya is a Digital (SEO) Content Developer at LegitSchoolInfo.com. Legit School Info is a team of Resource academicians and Consultants led by John Akpan. However, If you need personal assistance on this topic, kindly contact us.

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