How to Register an Imported Drug or Pharmaceutical Product with NAFDAC in Nigeria

Introduction

All pharmaceutical products must be registered with NAFDAC before they can be manufactured, imported, exported, advertised, sold, distributed, or used in Nigeria. Registration must be in accordance with the NAFDAC Act, related legislation, and the applicable guidelines.

The NAFDAC registration process guarantees that all drug products, whether for human or veterinary use, meet stringent regulations and are safe for consumption in Nigeria. This Article outlines the steps to successfully register your products with NAFDAC.

 

Step 1: Complete the NAFDAC Online Registration Form

To initiate the registration process, the applicant shall purchase, fill out, and print the online registration form available on the NAFDAC website and ensure that the following required information:

1. Manufacturer Information: Company name, Factory address, contact details and Airport proximity (for imported products)
2. Company Tax Identification Number (for Nigerian companies)
3. Applicant Details: Qualifications, Job title and Warehouse address
4. Drug Product Information: Product specifics, Number of drug products and Key staff involved

Please Note:

– Each drug product requires a separate registration form.

– For imported drugs, a dossier of the product must be submitted for preliminary screening.

 

Step 2: Gather Required Documents

Compile the following documents to support your application:

1. Address the application letter to: The Director-General, NAFDAC BUT Attention: The Director, Drugs Registration and Regulatory Affairs Directorate (This ensures that your application reaches the correct department and personnel within NAFDAC, facilitating a smoother registration process)

 

2. Certificate of Incorporation: Obtained from the Corporate Affairs Commission in Nigeria.

 

3. Power of Attorney (POA): Notarized in the country of manufacture for foreign companies, confirming brand ownership.

 

4. Trademark Certificate: Registered under Class 5 for pharmaceuticals, covering the drug’s brand name or trademark.

 

5. Superintendent Pharmacist License: This is required for both human and veterinary drugs.

 

6. Current Good Manufacturing Practice (GMP) Certificate: Mandatory for local production lines.

 

7. Product Label Artwork: Must adhere to NAFDAC’s labeling requirements.

 

Step 3: Facility Inspection and Compliance Assessment

NAFDAC will conduct a facility inspection to ensure compliance with Good Manufacturing Practice (GMP) standards. Applicants must provide advance notice and submit details, including the factory’s address and product information.

 

Step 4: Label Review and Approval

NAFDAC will review product labels to ensure they meet regulatory standards. Once approved, a permit will be issued for importing registration samples, applicable to imported drugs.

 

Step 5: Laboratory Testing and Quality Verification

Submit product samples along with evidence of payment of processing fee, Certificate of Analysis and a copy of permit to import registration samples for laboratory testing. This step verifies the product’s quality and ensures safety standards are met.

 

Step 6: Final Registration Approval and Certificate Issuance

After successful document review, facility inspection, and laboratory testing, NAFDAC’s Food and Drug Registration Committee (FDRC) will issue a unique registration number and a Certificate of Product Registration. This Certification enables importers to bring their products into Nigeria in large quantities. To avoid importation delays, it is essential that all imported products are properly labeled.

The Certificate of Registration is valid for five years and is renewable upon expiration.

 

NAFDAC Labeling Requirements for Drug Products

Drug product labels must be in English and include the following essential information:

1. Product Name: Both brand and generic names.
2. Manufacturer Information: Name and Full address.
3. NAFDAC Registration Number: To be included once issued.
4. Batch, Manufacturing, and Expiry Dates
5. Dosage and Usage Instructions: For Over the Counter (OTC) drugs.
6. Patient Information Leaflet (PIL)
7. Prescribing Information: For prescription-only medicines.
8. Net Content and Active Ingredients
9. Warnings and Storage Conditions: Critical for ensuring safety
10. Veterinary Drug Withdrawal Period.

 

Clinical Trials for New Drugs

For new drugs, NAFDAC mandates clinical trials to demonstrate safety and efficacy. Clinical Trials are therefore, necessary for testing or studying a drug or medical device to see if it is a safe and effective treatment for people, usually following clinical research. NAFDAC has strict rules that govern how clinical trials are conducted. These rules are designed to ensure the safety of those who participate.

What Documents are Needed for Clinical Trials in Nigeria?

1. Clinical Trial Application Form (CTAF): This must be filled and submitted online and is available on the NAFDAC website.
2. Study Protocol showing the detailed plan of the clinical trial.
3. Informed Consent Form (ICF): A document that explains the trial to participants and obtains their consent.
4. Patient Information Leaflet (PIL): Information for participants about the study.
5. Investigator’s Brochure (IB): Contains relevant clinical and non-clinical data on the investigational product.
6. Evidence of Agreement: Between the sponsor and the investigator.
7. Ethics Committee Approval: From accredited institutions and a list of committee members.
8. Investigator’s Curriculum Vitae (CV) and evidence of Good Clinical Practice (GCP) training.
9. Insurance Cover: For participants.
10. Data Safety Monitoring Board (DSMB) details and financial disclosures.

 

Step 7

Following a successful laboratory analysis of the products, the Food and Drug Registration Committee (FDRC) will review the dossier, GMP inspection results, and laboratory analysis. Upon approval, an electronic Certificate of Product Registration or Listing is issued. A Certificate of Product Registration is valid for 5 years and renewable subsequently.

 

How Much Does It Cost to Register Drugs or Pharmaceutical Products in Nigeria?

Below is a breakdown of the government Charges applicable for product registration:

1. Facility Inspection (Per Line for Local Facilities) –
2. Pre-Production: Small Scale N50,000.00
3. Pre-Production: Medium/Large Scale N70,000.00
4. Production: Medium/Large Scale (Renewable yearly) N170,000.00

Per Site for Foreign — $10,989.01

1. Port Inspections
2. Donated Drugs – N37,500.00
3. Registered Orphan Drugs/Antiretrovirals/ Vaccines – N13,500.00
4. Registered Over the Counter Drugs – N148,500.00
5. Registered Prescription Only Medicines – N40,000
6. Application Form – N2500.00
7. Clinical Trials
8. Application Fee
9. Industry Sponsored/Locally-developed IMP – N250,000.00
10. Industry Sponsored/Imported IMP — $1923.00
11. Academic Trials (Individual Self-Funded/local) – N50,000.00

(Institutional Grant Aided) – N300,000.00

1. Extension of Study (Locally Developed IMP) – N350,000.00

(Imported IMP) – $2,747.25

(Academic Trials) – N20,000.00

1. Inspections
2. Institutional Grant Aided (Academic Trials) – N300,000.00
3. Additional Site (Locally developed IMP) – N150,000.00

(Imported IMP) — $415.00

(Academic Trials) – N150,000.0

 

NAFDAC Registration: Essential Steps and Recommendations

To ensure a successful NAFDAC registration, keep the following key takeaways and actions in mind:

1. Accuracy Matters: Ensure all submitted documents are up-to-date, accurate, and meet NAFDAC’s standards.
2. Plan Ahead: Factor in NAFDAC’s estimated 6–12-month registration timeline.
3. Clinical Trials: Allocate an additional 2-3 months for clinical trial approvals for new drugs.
4. Compliance is Key: Avoid common misconceptions, such as assuming local facilities are exempt from inspections or neglecting label standards.

By following these guidelines and adhering to NAFDAC’s requirements, you can successfully register your pharmaceutical product and enter the Nigerian market.

Key Takeaways and Actions for NAFDAC Registration

Registering a pharmaceutical product with NAFDAC requires careful planning and adherence to regulations. To ensure a smooth process, consider the following recommendations:

1. Ensure Document Accuracy: Verify that all submitted documents are up-to-date, accurate, and meet NAFDAC’s standards.
2. Plan for Timely Application: Factor in NAFDAC’s estimated 6-12 month registration timeline.
3. Allow Time for Clinical Trials: For new drugs, allocate an additional 2-3 months for clinical trial approvals.

 

Common Misconceptions to Avoid

1. Local Facility Exemption: All manufacturers, local or foreign, are subject to NAFDAC’s facility inspections.
2. Neglecting Label Standards: Ensure drug labels meet NAFDAC’s strict requirements, including accurate product information and storage instructions.

 

CONCLUSION

By following these guidelines and adhering to NAFDAC’s requirements, you can successfully register your pharmaceutical product and enter the Nigerian market.

 

Note: The content of this article is anticipated to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstance.

 

By Deborah Ogedengbe for Adeola Oyinlade & Co.

 

Adeola Oyinlade & Co. is a leading Corporate and Commercial full-service law firm in Nigeria offering advisory services to both local and foreign clients on products registration with NAFDAC in Nigeria.

 

To see our service offerings, please contact us at [email protected] or visit www.adeolaoyinlade.com

 

Mobile: +234 803 826 7683 / +234 802 686 0247