Pharmaceutical Product Registration in Nigeria

Pharmaceutical Product Registration in Nigeria - Overview

The National Agency for Food and Drug Administration and Control (NAFDAC) is the key drug Regulatory Authority for regulating and Pharmaceutical Product Registration in Nigeria. The Agency was established by Decree No. 15 of 1993, as amended by Decree No. 19 of 1999. Now, the National Agency for Food and Drug Administration and Control Act Cap N1 Laws of the Federation of Nigeria (LFN), 2004, is responsible for regulating and controlling the manufacture, importation, exportation, distribution, advertisement, sale, and use of drugs.

Medicinal Product Classification in Nigeria

Medicines are broadly subdivided into the following categories for the submission of pharmaceutical product registration in Nigeria:

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

Medicinal Product Registration in Nigeria

The process of submitting a new Marketing Authorization Application (MAA) consists of the following phases:

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 Trademarks, Patents, and Designs Registry is responsible for registering trademarks in Nigeria.

Step 2: Dossier Submission & Screening Process

The application must be submitted along with all the documentation to the NAFDAC for screening.

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.

Step 4: Submission of Samples for Laboratory Analysis

Laboratory samples are submitted after the successful vetting of product labels.

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.

Step 6: Issuance of Notification

For products approved at the Annual Meeting, notification of registration or listing will be issued to the applicant, and a compliance directive will be issued for Nigeria drug registration and approval products.

B) Collaborative Registration Procedure

It is an accelerated Nigeria drug registration and approval procedure for pharmaceutical product registration in Nigeria under 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. The local agent/legal representative is responsible for all communications between the manufacturer and the NAFDAC.

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.