What You Need to Know About Registering a Drug or Pharmaceutical Product with NAFDAC

Are you looking to import or manufacture drugs and pharmaceutical products for sale in Nigeria? As a critical legal and regulatory compliance step, all drug products—whether human or veterinary—must be registered with the National Agency for Food and Drug Administration and Control (NAFDAC).

Registration helps to ensure compliance with safety, efficacy, and quality standards essential to protect public health.

This guide explains the registration process, requirements, costs, and the best approach to a successful and timely application.

Step-by-Step Guide to Registering Drugs/Pharmaceutical Products with NAFDAC

Step 1: Complete the Online Registration Form Begin by purchasing, completing, and printing the NAFDAC online registration form, available on the agency’s website. The form requires detailed information, including:

• Manufacturer Information: Company name, factory address, contact details, and airport proximity if the product is imported.
• Company’s Tax Identification Number: For Nigerian companies.
• Applicant Details: Includes qualifications, job title, and warehouse address.
• Drug Product Information: Specifics of the product, number of drug products, and key staff involved.

Each drug product requires a separate registration form, and for imported drugs, a dossier of the product must be submitted for preliminary screening.

Step 2: Prepare Required Documentation Compile the following documents to include with your application:

• Application Letter: Addressed to NAFDAC’s Director-General.
• Certificate of Incorporation: Issued by Nigeria’s Corporate Affairs Commission.
• Power of Attorney (PoA): For foreign manufacturers, PoA must be notarised in the country of manufacture and confirm brand ownership.
• Trademark Certificate: For the drug’s brand name or trademark, registered under Class 5 for pharmaceuticals.
• Superintendent Pharmacist License: For human and veterinary drugs.
• Good Manufacturing Practice (GMP) Certificate: Essential for local production lines.
• Product Label Artwork: Must comply with NAFDAC’s labeling requirements.

Step 3: Facility Inspection Following an invitation from the applicant, NAFDAC conducts a facility inspection to assess compliance with GMP standards. Details like the factory’s full address and product information must be submitted in advance.

Step 4: Label Vetting NAFDAC will review your product labels to ensure they meet the required standards. Following approval, a permit will be issued for importing registration samples, applicable to imported drugs.

Step 5: Laboratory Analysis Submit product samples along with a Certificate of Analysis for testing. This step verifies the product’s quality and ensures safety standards.

Step 6: Final Approval and Registration Certificate After successful document review, inspection, and laboratory analysis, NAFDAC’s Food and Drug Registration Committee (FDRC) will issue a Certificate of Product Registration. This certificate is valid for five years and is renewable.

NAFDAC Labeling Requirements

Drug product labels must be in English and should include:

• Product Name: Both brand and generic names.
• Manufacturer Information: Full address.
• NAFDAC Registration Number: Once issued.
• Dosage and Strength: Clear dosage instructions.
• Warnings and Storage Conditions: Essential for product safety.

Clinical Trials for New Drugs

For new drugs, NAFDAC requires clinical trials to demonstrate safety and effectiveness. Key documents include:

• Clinical Trial Application Form (CTAF)
• Study Protocol: Detailed plan of the trial.
• Informed Consent Form (ICF): To obtain participant consent.

Cost Summary for NAFDAC Registration

Below is a cost summary chart for NAFDAC’s product registration fees and other charges.