NAFDAC REQUIREMENTS FOR PRODUCT REGISTRATION

NAFDAC REQUIREMENTS FOR PRODUCT REGISTRATION

The National Agency for Food and Drug Administration and Control (NAFDAC) was established to thwart the creation of illicit and fake products which are detrimental to the health and well-being of Nigerians. This body is also responsible for regulating the exportation, importation, manufacture and the registration products such as drugs, chemicals, consumable goods, cosmetics, biological, and medical services which were produced in or outside Nigeria.

The NAFDAC Requirements for production or importation of food, drugs or consumable goods in Nigeria is dependent on whether such items are produced locally or abroad.  The Federal Government of Nigeria has put in place registration procedure that must be completed and complied with by any manufacturer, importer, exporter, and sellers of food and drugs product.

It is unlawful to promote and market any product or consumable goods in Nigeria to the general public without a due registration with the NAFDAC according to the law establishing the Agency (NAFDAC Act). Where a company is registered for the purpose of importing or manufacturing food or drugs or consumable products, such products must be registered with NAFDAC.

It is mandatory that any company involved in the production, manufacturing and distribution of food, imported foods, drugs, export of semi-processed food and cosmetics must incorporate a company with the Corporate Affairs Commission (CAC) before registering its company product with NAFDAC.

The registration of locally made NAFDAC Regulated Products is slightly different from the registration process for imported goods. Where a company produces different products it will be required to register each of them separately in order to obtain the NAFDAC registration numbers for each of the product.

REQUIREMENTS FOR REGISTERING LOCALLY PRODUCED PRODUCTS

So many products are regulated by NAFDAC, the requirements and documents to be submitted to the agency for registration of locally made products can be categorized into food and drug group of products. Consequently, the documents required to be submitted for registration will depend on whether the product falls into the food or the drug category.

However, irrespective of the product to be registered, NAFDAC would only issue a registration number and certificate after the product has passed the quality and standard test carried out by the agency.

Documents required for registration

  • Certificate of incorporation of the company
  • The certificate of inspection or recognition issued by NAFDAC
  • Original copy of Power of Attorney from the product manufacturer (if imported)
  • Comprehensive certificate of analysis of the batch of product submitted for registration from the manufacturer stating the name and signature of the analysis.
  • Trademark approval for brand name issued by the Federal Ministry of Interior.
  • Application forwarded to the Director stating the name of the manufacturer, brand name and product.
  • A signed and endorsed certificate of Pharmaceutical Product (applicable to drugs).
  • Completed NAFDAC application form
  • Letter of invitation from the manufacturer to inspect factory abroad, full names and site of plant (where applicable).
  • Three samples of product for quality analysis and inspection.

REQUIREMENTS FOR FOREIGN PRODUCED ITEMS OR PRODUCTS

As earlier stated, the requirements for registration of imported food or drug products is similar to that of locally made products. As such all the requirements stated above for locally produced items are applicable to foreign imported products.

In addition to the above listed requirements, the following requirements must also be provided for.

  • Notarized Declaration: This is required to be type-filled and notarized by a Notary Public here in Nigeria.
  • Power of Attorney or Contract Manufacturing Agreement: This is required to be submitted from the manufacturer authorizing the Nigerian representative to act in their capacity in Nigeria. The Director or President of the Company must sign this document. The document must state the names of the products to be registered. It also states ownership of brand names/Trademark. The power of attorney or contract manufacturing agreement is to be notarized by the Notary public in the country of manufacture.
  • Certificate of Free Sale: This is obtained and issued from a relevant health and regulatory body in the manufacturer’s country indicating the name of the Manufacturer and products to be registered. It is also to be authenticated by the Nigerian Embassy in the country of origin. In countries where no Nigerian Embassy or High Commission exists, any other Embassy or High Commission of any Commonwealth or West African country can authenticate the document.
  • Comprehensive Certificate of Analysis: The Certificate of analysis must be presented on a letter headed paper of the quality control laboratory where the sample was tested or evaluated and it should contain the following information;
  • The brand name of the product
  • The batch number of the product
  • The manufacturing and expiry dates
  • The name, designation and signature of the analyst
  • Application letter for Import Permit by the applicant (i.e. Local Agent).
  • Duly completed Registration Form online.
  • Coloured Artwork or Label of the product and leaflet insert of the product.
  • Evidence of GMP inspection by NAFDAC.
  • GMP Invitation letter: a letter of invitation to inspect the factory abroad shall be written by the manufacturer and shall state the following:
  • Manufacturer Information: Name of the Company, full location address of the factory, email address and current phone no. & fax no, the name of contact person overseas, telephone no, email address. Name of airport closest to the location and guide map illustrating the shortest land/air route to the factory overseas
  • Local Agent Information: Name of the company, full location address and functional telephone no, fax no. & email address. Name(s) of product(s) for registration, name & mobile phone no. of contact person in Nigeria
  • Upon satisfactory documentation, obtain import permit to import samples for registration, shall be obtained from the Respective units after payment. The product(s) to be registered must also be brought in samples for sample vetting by the agency upon registration and the following documents are required for the sample vetting.
  • A copy of the import permit and receipt of payment for import permit
  • Comprehensive Certificate of Analysis of the product.
  • One (1) well labeled vetting samples of the product(s) and two(2) labels/artworks
  • The next step for registration is the Laboratory Analysis which takes place upon satisfactory documentation, vetting of samples and payment. The laboratory samples are to be submitted at the respective units.

It is also important to know that products can be registered with NAFDAC without obtaining the NAFDAC Registration Number.  For NAFDAC registration of foreign products without the acquisition of NAFDAC registration number, the following shall be required:

  • A Warehouse must be present for NAFDAC inspection
  • Listing Certificate
  • Permit to import
  • Technical officer needed especially in the Science field, with the Passport photograph of the Technical Officer
  • Certificate of Incorporation with the Corporate Affairs Commission
  • Local Purchase Order and
  • Material Safety Data Sheet

In conclusion, NAFDAC issues a registration number or certificate of registration after the product has passed the quality and standard test carried out by the agency. After a successful product registration, the importer can start to import the products in large quantity in Nigeria.  Every imported product must be properly labeled to avoid unnecessary delay in the course of importation. After a successful product registration the product will be generally accepted in the market and the producer will have more confidence in doing business in Nigeria

BY: RESOLUTION LAW FIRM

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