Steps to follow in getting a NAFDAC registration for your business in 2024

Many entrepreneurs shy away from starting food or drug businesses due to the perceived difficulty of NAFDAC registration, while others attempt to bypass the process by cutting corners. 

Obtaining a NAFDAC registration and certification is crucial for businesses in Nigeria that manufacture, import, export, or distribute food, drugs, cosmetics, chemicals, and medical devices.  

Without this certification, businesses risk legal penalties, product confiscation, product recalls, closures or reputational damage, which can severely affect their operations and growth. As such, businesses involved in the production or handling of consumable goods must comply with NAFDAC regulations to ensure consumer protection and maintain industry credibility. 

The process can seem daunting, but it is often a lack of clear direction that makes it appear more challenging than it truly is. This article provides the essential steps you need to follow to navigate the registration process smoothly. 

For micro-scale businesses, you must first ensure your business is registered with the Corporate Affairs Commission (CAC). Additional required documents include a Site Use Agreement (if applicable), trademark approval, a vetting sample, three product labels, a fumigation certificate, and proof of payment for registration. You’ll also need to submit food handlers’ or medical fitness certificates for your production staff, covering essential health tests like sputum, stool, urine, Widal, and Hepatitis B. 

For small-scale businesses, along with the documents listed above, you will need to submit Standard Operating Procedures (SOPs) for various production aspects such as quality assurance, equipment cleaning, and packaging material handling. You’ll also need certificates of analysis for raw materials and finished products, as well as the health certificates for production staff. These documents must be uploaded to NAFDAC’s e-registration portal to complete the application process. 

You can access the registration form and guidelines online via the NAFDAC website: https://nafdac.gov.ng/our-services/msme/. Alternatively, the form can be collected from any NAFDAC State Office nationwide. 

By following these steps, businesses can successfully navigate the NAFDAC registration process, ensuring that their products are safe, compliant, and ready for the Nigerian market. 

In addition to the registration steps, businesses should also be aware of the ancillary fees associated with NAFDAC certification, which vary based on the product category and services required. 

Ancillary fees 

For product variants 

Clinical trial fees 

Understanding these fees helps businesses budget effectively for their NAFDAC registration and compliance. Click here for more details. 

The National Agency for Food and Drug Administration and Control (NAFDAC) was created in response to a growing public health crisis in Nigeria.  

Nigeria was flooded with fake drugs and substandard products, leading neighboring countries like Ghana and Sierra Leone to ban Nigerian-made goods. In 1990, 109 children tragically died after consuming paracetamol syrup contaminated with diethylene glycol, a toxic substance. 

To tackle these issues, NAFDAC was officially established in October 1992. Its mandate is to regulate and control the importation, manufacture, distribution, and sale of food, drugs, cosmetics, and other consumables, ensuring they are safe for public consumption. 

The process for obtaining NAFDAC registration typically begins with the submission of the application, which occurs immediately. Document verification follows, taking about 10 days. For food products, facility inspection and sampling are completed within 10 days, while for drugs requires 20 days.  

Laboratory analysis takes approximately 30 days for food and 40 days for drugs. Afterward, a final vetting process occurs over the next 10 days. Finally, the approval meeting and issuance of the NAFDAC registration number take about 20 days. Overall, the registration process spans 90 days for food products and 120 days for drugs.