If you’re looking to register pharmaceutical products in Nigeria, understanding the process and requirements can seem daunting. However, with a clear step-by-step approach, you can navigate the registration process more easily. Here’s a simplified guide to help pharmaceutical manufacturers get their products approved by the National Agency for Food and Drug Administration and Control (NAFDAC).

1. What is NAFDAC?

The National Agency for Food and Drug Administration and Control (NAFDAC) is the Nigerian regulatory body responsible for ensuring the safety and efficacy of pharmaceuticals, food, and other consumables. No pharmaceutical product can be manufactured, imported, or sold in Nigeria without NAFDAC approval.

2. Who Needs to Register?

• Local Manufacturers: If you’re producing pharmaceuticals within Nigeria, you must obtain NAFDAC registration before manufacturing or selling your products.
• Foreign Manufacturers: If you’re based outside Nigeria, you’ll need a local representative in Nigeria to handle the registration process for you. This representative must be authorized with a notarized Power of Attorney from the manufacturer.

3. Key Steps for Registration

1. Prepare Required Documents
   • Manufacturer’s Certificate: Proof of licensing from the country of origin.
   • Certificate of Free Sale: Confirmation that your product is legally sold in the country of origin.
   • Power of Attorney: For foreign manufacturers, this must be notarized and authenticated by the Nigerian Embassy.
2. Complete the Application Form
   • Obtain FORM D-REG/001 from NAFDAC.
   • Fill in details about the product, including:
     • Generic and brand names
     • Strength and dosage
     • Indications and usage
3. Submit Your Application
   • Submit the completed form and documents to NAFDAC.
   • Pay the application fee of ₦500 per product.
4. Prepare Product Dossiers
   • Provide five hard copies of the product dossier, which includes comprehensive product information and labeling details.

4. Product Requirements

• For Local Products: Ensure your manufacturing facility is inspected and recognized by NAFDAC.
• For Imported Products:
  • Must be registered in the country of origin.
  • Must comply with drug laws in the country of origin.
  • Must be authenticated by the Nigerian Embassy.

5. Labeling Requirements

Labels must be clear and include:

• Product Name: Both brand and generic names.
• Manufacturer’s Address.
• Batch Number, Manufacture Date, and Expiry Date.
• Dosage Instructions and Warnings.
• Active Ingredients per dose.

Labels in foreign languages must have an English translation.

6. Fees and Costs

• Application Form Fee: ₦500 per product.
• Registration Fees:
  • ₦250,000 for prescription drugs.
  • ₦1,000,000 for over-the-counter (OTC) drugs.

7. Post-Registration Information

• Validity: The registration is valid for five years.
• Advertising: Requires a separate approval from NAFDAC.
• Compliance: Follow all post-registration requirements to avoid issues with your registration.