National Agency for Food and Drug Administration and Control (NAFDAC) is the key drug Regulatory Authority for regulating drugs 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 applications:
- Prescription-only medicines
- Over the Counter (OTC) medicines
Medicinal Product Registration
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 before registering a medicinal product in Nigeria. Ministry of Industry Trade and Investment’s Commercial Law Department Trademarks, Patents and Designs Registry is responsible to register the trademark in Nigeria.
Step 2: Dossier Submission & Screening Process
The application should 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. And then, 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 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 is issued to the applicant and a compliance directive is issued for products that are not approved.
B) Collaborative Registration Procedure
It is the accelerated registration procedure for drug products that are registered 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 World Health Organization) through improved information sharing.
C) Importance of Local Entity for a Foreign Manufacturer
NAFDAC mandates the appointment of a local agent/legal representative in Nigeria for foreign manufacturers. Local agent/legal representative is responsible for all the communications between manufacturer and the NAFDAC.
Product Maintenance & Compliance
Validity of Registration Certificate
Post Approval Changes (Variations)
The certificate of registration is valid for 5 years.
The renewal application should be submitted thirty (30) days before the expiration of the existing registration certificate.
Any change of registered medicine should be sent to the NAFDAC with relevant documents.
- Trademark Registration
- End-to-end Pharmaceutical Product Registration
- Authorized Local Agent Support
- Manufacturing Site Approval Support
- Import License Support
- Pharmaceutical Dossier Preparation and Submission to the NAFDAC
- Preparation of Gap Analysis Report and Remediation Plan
- Compilation and Submission of the Dossier to the NAFDAC
- Query Support Management till Approval
- Pharmaceutical Lifecycle Management Support
- Ad-hoc Regulatory Affairs Consultation