NAFDAC APPROVAL PROCESS
The National Agency for Food Drug and Administration Control (NAFDAC) is responsible for controlling, maintaining the distribution of transportation, advertisement, exportation, importation, manufacture and the registration of the categories of products such as drugs, chemicals, consumable goods, cosmetics, biological, and medical services.
The NAFDAC Requirements for production or importation of food, drugs or consumable goods in Nigeria depend on whether such items are produced locally or abroad.
Under the law establishing the Agency (NAFDAC Act), it is unlawful to market any drugs or consumable goods in Nigeria to the public without a due registration with the NAFDAC. If any company is set up in Nigeria for the purpose of the importation or manufacturing of food or drugs or consumable products, all the products produced by such a company must be registered with the NAFDAC.
A company involved in the production, manufacturing and distribution of food, imported foods, drugs, export of semi-processed food and cosmetics must register and establish 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 that of imported goods.
REQUIREMENTS FOR LOCALLY PRODUCED ITEMS OR PRODUCTS
The documents to be submitted to the agency for registration of locally made categorized into food and drug group of products. The documents to be submitted will depend on if the product falls into the food or drug category.
- Certificate of incorporation issued by the corporate affairs commission
- The certificate of inspection issued by NAFDAC
- Original copy of Power of Attorney from the product manufacturer (if imported)
- A 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 a brand name.
- Application forwarded to the Director stating the name of the manufacturer, brand name and product.
- Completed NAFDAC application form
- Three samples of product for quality analysis and inspection.
REQUIREMENTS FOR FOREIGN PRODUCED ITEMS OR PRODUCTS
For manufacturers of foreign products looking to import into Nigeria, the NAFDAC Registration Number must be acquired. The requirements for registration of imported food or drug products include all the requirements stated above for locally produced items. Generally, the requirements to be met for registration of imported or foreign products with NAFDAC include the followings:
- Notarized Declaration: this is to be type-filled and notarized by a Notary Public here in Nigeria.
- Power of Attorney or Contract Manufacturing Agreement: an applicant must submit power of attorney or contract manufacturing agreement 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 or imported into Nigeria. It must also states the ownership of brand names/trademark of the product. The power of attorney or contract manufacturing agreement is to be notarized by the Notary public in the country of the manufacturer.
- Certificate of Free Sale: a relevant health/regulatory body in the manufacturer’s country indicating the name of the Manufacturer and products to be registered issues this document. 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;
- The analysis of the product or goods
- The batch number of the product
- The manufacturing and expiry dates
- The name, designation and signature of the analyst
- Certificate of Business Incorporation of the Importing Company with the Corporate Affairs Commission in Nigeria.
- Certificate of Registration of Brand Name with the trademark registry
- Application letter for Import Permit by the applicant (i.e. Local Agent).
- Duly completed Registration Form online.
- Coloured Artwork/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’s Information: Name of the company, full location address and functional telephone no, fax no. & email address. Name(s) of the product(s) for registration, name & mobile phone no. of the contact person in Nigeria
Upon satisfactory documentation, 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 the import permit
- Certificate of Analysis of the product.
- One (1) well-labelled 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.
In our previous write-ups, we explained the procedure to obtain an importation permit and approval.
Finally, 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
- The 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 would only give 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. Every imported product must be properly labelled to avoid unnecessary delay in the course of importation.
By Corporate & Commercial Law Department at Resolution Law Firm
Resolution Law Firm’s Corporate & Commercial Law Department assist and offer advisory to both local and foreign manufacturers in processing NAFDAC approvals. You can contact us using the below details: