Pharmaceutical Product Registration in Nigeria

Nigeria Drug Registration and Approval Process – Overview

The National Agency for Food and Drug Administration and Control (NAFDAC) is the key drug Regulatory Authority overseeing Pharmaceutical Product Registration in Nigeria.

Established under Decree No. 15 of 1993 and amended by Decree No. 19 of 1999, NAFDAC operates under the National Agency for Food and Drug Administration and Control Act Cap N1, Laws of the Federation of Nigeria (LFN), 2004. This body regulates and controls the manufacture, importation, exportation, distribution, advertisement, sale, and use of drugs in Nigeria, by implementing a rigorous NAFDAC product registration procedure to ensure compliance.

Medicinal Product Classification in Nigeria

For the NAFDAC product registration procedure, medicines in Nigeria are classified as follows:

• Prescription-only Medicines.
• Over the Counter (OTC) Medicines.

Medicinal Product Registration in Nigeria

The Pharmaceutical Regulatory Affairs in Nigeria covers a detailed process for drug registration and approval. Submitting a new Marketing Authorization Application (MAA) involves the following steps:

A) Six-Step Market Authorization Procedure

Step 1: Trademark Registration and Approval

It is mandatory to get a trademark registration done before pharmaceutical product registration in Nigeria. The Ministry of Industry Trade and Investment’s Commercial Law Department is responsible for this step, following the NAFDAC product registration requirement.

Step 2: Dossier Submission & Screening Process

The application must be submitted along with all the documentation to the NAFDAC for screening, in accordance with NAFDAC product registration guidelines.

Step 3: Import Permit and Label Vetting

An import permit is issued upon successful screening of documentation and review of supporting documents. Post this, the products are submitted for vetting, a key part of the Nigeria Drug Registration and Approval Process.

Step 4: Submission of Samples for Laboratory Analysis

After label vetting, samples are submitted for laboratory analysis.

Step 5: Product Approval Meeting

The products are presented for ‘Approval Meetings’ after the satisfactory review of the dossier, GMP of the production facility, and laboratory analysis, which are essential steps in the Drug Approval Process in Nigeria.

Step 6: Issuance of Notification

For products approved at the Annual Meeting, a notification of registration is issued. This completes the process of drug registration in Nigeria, and a compliance directive is provided to the applicant.

B) Collaborative Registration Procedure

It is an accelerated Nigeria drug registration and approval process (for pharmaceutical product registration in Nigeria) under programs such as the World Health Organization Prequalification of Medicines Program (PQP), the West African Health Organization’s joint drug product assessment procedure, and Stringent Regulatory Agencies (SRAs, facilitated by the World Health Organization) through improved information sharing.

C) Importance of a Local Entity for a Foreign Manufacturer

The NAFDAC drug registration guidelines mandate the appointment of a local agent/legal representative in Nigeria for foreign manufacturers. This representative plays a critical role in Pharmaceutical Regulatory Affairs in Nigeria, managing all communications between the manufacturer and NAFDAC to ensure compliance with local regulations and successful drug registration.

Product Maintenance & Compliance

Pharmaceutical Product Registration in Nigeria - Freyr Expertise

• Trademark Registration Process.
• End-to-end Pharmaceutical Product Registration in Nigeria.
• Authorized Local Agent Support.
• Nigeria Drug Registration and Approval.
• Manufacturing Site Approval Support.
• Import License Support.
• Regulatory Affairs Consulting.
• Pharmaceutical Dossier Preparation and Submission for the NAFDAC Registration.
• Preparation of Gap Analysis Report and Remediation Plan.
• Compilation and Submission of the Dossier to the NAFDAC.
• Faster Pharma Market Access.
• NAFDAC Product Registration.
• Query Support Management till Approval.
• Pharmaceutical Lifecycle Management Support.
• Ad-hoc Regulatory Affairs Consultation.