How to register your product with NAFDAC as a foreinger; Steps for Registration
To know how to register your product with NAFDAC as a foreigner, the following registration process should be followed:
- Appoint a Local Agent: Since you cannot personally make the application for registration, it is expected that you appoint a local Agent to make the application on your behalf. It is advised that you appoint a lawyer to act on your behalf because a lawyer is vested and equipped with the knowledge of the law and rudiments of the procedure of registration. This Agent will serve as the Nigerian representative for your product. You must provide them with a Power of Attorney notarized in your country of manufacture. This document must be signed by a top executive of your company and explicitly state the names of the products to be registered.
- Submit an Application: Your local agent will submit an application letter to the NAFDAC Director-General. The application must be accompanied by all required documents.
- Required Documents: The specific documents vary by product type (e.g., food, drug, cosmetic), but generally include:
- Power of Attorney appointing the local agent
- Certificate of Product/Certificate of Manufacture and/or Free Sale from a relevant health/regulatory body in your country of manufacture.
- Manufacture license to show that the manufacturer is licensed to manufacture the products in its country of origin.
- Certificate of Good Manufacturing Practice (GMP) from the regulatory body in your country.
- Certificate of Analysis for the product, provided by a quality control laboratory.
- Evidence of Registration of Trademark ]showing that an application has been made to register the trademark in Nigeria in the name of the manufacturer.
- Certificate of Incorporation of the local agent’s company with the Corporate Affairs Commission (CAC) in Nigeria or certificate of Incorporation of your Company in Nigeria.
- NAFDAC Processes: After document submission, NAFDAC undertakes several processes:
- Document Verification: NAFDAC reviews all submitted documents for completeness and accuracy.
- Import Permit : When an application has been successfully submitted and all supporting documents reviewed, an import permit is issued by NAFDAC for the importation of the samples of the product. The imported of the sample is to enable NAFDAC conduct laboratory analysis on the product.
- Laboratory Analysis: The imported samples are submitted to NAFDAC laboratory for evaluation. The submission of the samples is accompanied with payment receipt of the official application and processing fee, certificate of analysis and a copy of the import permit.
- Facility Inspection: NAFDAC officials may conduct an inspection of your manufacturing facility abroad to ensure it complies with GMP standards. Foreign companies are subject to international inspection fees for this, though in practice, the visit does not always take place.
- Approval and Certification: If your application, documents, and inspection results are satisfactory, the NAFDAC committee will issue a unique NAFDAC registration number and a Certificate of Product Registration. This certificate is typically valid for five years and can be renewed.
The above are the steps on how to register your product with NAFDAC as a foreigner.
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