Quick and Easy Guide to NAFDAC Product Registration in Nigeria
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Welcome to Wigmore Trading! We are here to assist you every step of the way in registering your food and drug products with NAFDAC. This concise guide will walk you through the process and highlight how Wigmore Trading can represent you in Nigeria.
Steps to Register Your Products
- Power of Attorney or Contract Manufacturing Agreement
- Requirement: Evidence of Power of Attorney from the manufacturer outside Nigeria.
- Details:
- Issued and signed by an authorized company officer.
- States product names and authority to register with NAFDAC.
- Notarized and valid for at least five (5) years.
- Wigmore Trading Assistance: We can help you prepare and notarize this document locally.
- Certificate of Manufacture and Free Sale
- Requirement: Certificate indicating the manufacturer is licensed and the product is legally sold in the country of origin.
- Details:
- Issued by relevant Health/Regulatory body.
- Authenticated by the Nigerian Embassy or a Commonwealth/ECOWAS country.
- Wigmore Trading Assistance: We can facilitate the authentication process.
- Comprehensive Certificate of Analysis
- Requirement: Certificate from a Quality Control Laboratory.
- Details:
- Includes brand name, batch number, manufacturing and expiry dates, and analyst’s signature.
- Wigmore Trading Assistance: We can coordinate with laboratories to ensure compliance.
- Evidence of Business Incorporation
- Requirement: Proof of business incorporation with the Corporate Affairs Commission in Nigeria.
- Wigmore Trading Assistance: If you don’t have a local company, we can represent you.
- Registration of Brand Name
- Requirement: Evidence of brand name registration with the Trademark Registry.
- Wigmore Trading Assistance: We can manage the trademark registration process.
- Valid GMP Certificate
- Requirement: Good Manufacturing Practice (GMP) certificate from the National Regulatory Authority (NRA).
- Wigmore Trading Assistance: We assist in obtaining and verifying this certificate.
- Valid Inspection Report
- Requirement: Inspection report supporting the GMP certificate.
- Wigmore Trading Assistance: We facilitate the inspection process with NAFDAC.
- Letter of Invitation for GMP Inspection
- Requirement: Invitation letter for NAFDAC to inspect the factory.
- Details:
- Includes manufacturer and local agent information, and product details.
- Wigmore Trading Assistance: We can draft and submit this letter.
Additional Costs and Fees
- GMP Inspection Fee:
- $10,998 for a three-year valid facility inspection.
- Processing Fee:
- $1,350 per product.
- Import Permit:
- $125 per product.
- Application Form:
- N2,500 per product.
- Notarized Declaration:
- N20,000 by a Notary Public in Nigeria.
- Service Charges:
- N500,000 for product registration and GMP application.
- VAT: 7.5%.
Process Overview and Timelines
- Submission of Application
- Complete document submission.
- Document Verification
- 10 days for verification.
- Facility Inspection/Sampling
- 10 days for food, 20 days for drugs.
- Laboratory Analysis
- 30 days for food, 40 days for drugs.
- Final Vetting
- 10 days.
- Approval Meeting/Issuance of NAFDAC Registration Number
- 20 days.
Total Timeline:
- Food Products: 90 days.
- Drug Products: 120 days.
For detailed guidelines, visit the NAFDAC website (NAFDAC) (NAFDAC) (NAFDAC).
How Wigmore Trading Can Assist
- Representation: We can act as your local agent in Nigeria, handling all necessary documentation and processes.
- Documentation: Assistance with preparation, notarization, and submission of all required documents.
- Authentication: Facilitation of certificate authentication by relevant authorities.
- Inspection Coordination: Arranging and managing GMP inspections with NAFDAC.
- Trademark Registration: Handling the registration of brand names with the Trademark Registry.
- Consultation: Providing detailed cost estimates and guidance through the registration process.
Contact Wigmore Trading today to streamline your NAFDAC registration process and ensure compliance with all regulatory requirements.
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