Whether a product is manufactured in Nigeria or the product is imported from a foreign manufacturer, some products have to go through certain regulatory approvals and registration before the product can be sold legally in Nigeria. The most important registration is done through the National Agency for Food and Drug Administration and Control (NAFDAC).
NAFDAC is a Nigerian federal agency under the Nigerian Federal Ministry of Health that is responsible for regulating and controlling the manufacture, importation, exportation, advertisement, distribution, sale and use of food, drugs, cosmetics, medical devices, chemicals and packaged water. Once the product for sale falls under any of these categories, it will have to be certified by NAFDAC.
If you are looking to introduce a new product to the Nigerian market and you decide either to work with a local distributor or incorporate a business for the sale of your product, then here are the steps needed for product registration with NAFDAC.
Inspection (For Products Manufactured in Nigeria)
If you are manufacturing the product in Nigeria, then the first step is an inspection of your production facility. The inspection is to verify that your facility meets the minimum good manufacturing practice (GMP) requirements. This ensures that the facilities, equipment and controls to be used in the manufacturing, processing and packing of products meet quality standards. Once inspection is commpleted you will be assigned a Certificate of Recognition as a manufacturer.
Here are the guidelines for the establishment of manufacturing plants for food and drugs.
Power of Attorney (For Imported Goods)
If the product being reigstered is manufactured outside Nigeria, then the registration process has to be carried out by a registered company or individual with facilities to effect a recall of the product in Nigeria when necessary. The representative must file an evidence of Power of Attorney from the manufacturer which authorizes the representative to speak for its principal on all matters relating to the latter’s specialties. The original Power of Attorney should be notarized by a Notary Public in the country of origin and submitted to NAFDAC. There are also some products imported into the country that have to be certified by the Standards Organization of Nigeria. Here is a list of those products.
Application & Documentation
Fill out the prescribed NAFDAC application form for your product. A separate application form is required for each product being registered. The application would state the name of the manufacturer, the generic name of product and the brand name (where applicable).
The documentation to complement the application includes the following:
- Certificate of Incorporation of the company (or representative company, in the case of imported goods) issued by the Corporate Affairs commission in Nigeria.
- Evidence of Trade mark registration from the Federal Ministry of Commerce in Nigeria.
- Comprehensive Certificate of Analysis of the batch of product to be registered.
The extra documents required below depend on whether the product is manufcatured inside or outside Nigeria.
For products manufatured in Nigeria:
1. Evidence of pre-production inspection/Certificate of Recognition issued by NAFDAC.
For Imported goods:
1. Power of attorney as stated above.
2. Permit to import samples.
3. A letter of invitation to inspect the factory abroad.
4. Certificate of Manufacture and Free Sale – This is evidence that the manufacturer is licensed to legally manufacture the product for sale in the country of origin. This is issued by the Competent Authority of the country of manufacture, and authenticated by the Nigerian Mission in that country.
Samples & Labeling
Submit three vetting samples of your product to NAFDAC for inspection. Include clear, informative and accurate labels on your products with the following minimum requirements:
- Name of product (brand name) where applicable and generic name.
- Name and full location address of the manufacturer (distributor, packer or advsertiser).
- Provision for NAFDAC Registration Number on product label or listing number.
- Batch No., Manufacturing date and Expiry date.
- Dosage form & strength
- Net content of product.
- Adequate warnings where necessary.
- Indications, frequency, route, conditions of administration (for pharmaceutical products).
- Dosage regimen on the package (for pharmaceutical products).
- Leaflet insert, if prescription product and hospital packs (for pharmaceutical products).
- Quantitative listing of all the active ingredients per unit dose (for pharmaceutical products).
The time line for product registration from submission of samples up to issuance of registration number is 60 to 100 work days, depending on the type of product and the level of compliance by the applicant.
A successful application attracts a Certificate of Registration with a validity period of five (5) years.
Interested in more detailed guidelines for each category of products that has to be registered with NAFDAC in Nigeria? Click on the category below that you want to learn more about.