Obtaining NAFDAC registration and certification is essential for businesses in Nigeria involved in manufacturing, importing, exporting, or distributing consumable products such as food, drugs, cosmetics, chemicals, and medical devices.
This certification ensures compliance with safety and quality standards set by the National Agency for Food and Drug Administration and Control (NAFDAC), safeguarding public health.
Without NAFDAC approval, businesses face legal consequences, including fines, product confiscation, recalls, closures, or severe reputational harm.
This certification is vital for maintaining consumer trust, ensuring market access, and promoting sustainable growth within the industry.
Compliance with NAFDAC regulations is not only a legal requirement but also crucial for long-term business success and credibility in the market.
Requirements for the registration
For micro-scale businesses, the first step in obtaining NAFDAC registration is ensuring your business is registered with the Corporate Affairs Commission (CAC). The required documents include:
- Site Use Agreement (if applicable)
- Trademark approval
- A vetting sample
- Three product labels
- Fumigation certificate
- Proof of payment for registration
- Medical fitness certificates for production staff, including health tests like sputum, stool, urine, Widal, and Hepatitis B.
For small-scale businesses, the requirements expand to include:
- Standard Operating Procedures (SOPs) for key production processes like quality assurance, equipment cleaning, and packaging material handling.
- Certificates of analysis for raw materials and finished products.
- Health certificates for production staff.
All documents must be uploaded to NAFDAC’s e-registration portal to complete the application process. By ensuring compliance with these steps, businesses can meet the necessary regulations for product safety and quality.
Registration procedures
- Obtaining the registration form and guidelines
- 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.
2. Submission of Documents
- Ensure you submit the aforementioned documents along with a completed registration form.
- Before making payments, request a payment advice from the NAFDAC desk officer to determine fees. Payments can then be made via Remita and receipts collected from the NAFDAC Accounts Department.
- Schedule a convenient date for your facility inspection, where samples will be taken for laboratory analysis, provided your Good Manufacturing Practices (GMP) and Good Hygiene Practices (GHP) are satisfactory.
- Once inspection and laboratory results meet NAFDAC standards, your product will be approved, and you will be notified to collect your registration certificate. This process typically takes about 90 working days from start to finish.
- Ensure your product label includes:
- Product name, net weight/volume, and batch number
- Manufacturing and best-before dates
- Space for the NAFDAC registration number
- Allergy cautions (if applicable)
- Storage conditions, list of ingredients, and manufacturer’s details
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.
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