Nigeria has just taken one of the most significant regulatory steps in Africa's pharmaceutical traceability journey.
🇳🇬 National Agency for Food and Drug Administration and Control (NAFDAC) has officially issued the Regulatory Directive for the enforcement of the Pharmaceutical Products (Traceability) Regulations, 2024, making traceability compliance a mandatory requirement for obtaining and renewing Marketing Authorizations through a phased implementation approach.
Enforcement Timeline:
📅 1 January 2027 – All finished products containing narcotics and controlled substances.
📅 1 January 2028 – All finished MNCH products, antibiotics, and antimalarial medicines.
📅 1 January 2029 – All finished pharmaceutical products.
The directive reinforces the adoption of globally recognized GS1 standards, including:
✅ GS1 DataMatrix serialization
✅ Global Location Numbers (GLNs)
✅ Reporting traceability events to the NAFDAC Traceability Information System (#NTIS)
Compliance Support
The directive also provides a clear compliance framework for industry:
🔹 Regulated entities may engage any NAFDAC-approved, GS1-accredited traceability solution provider to support compliance with the Pharmaceutical Products (Traceability) Regulations, 2024.
🔹 Pharmacies and other dispensing points can use the NAFDAC Scan2Verify Mobile Application, available free of charge on both Google Play and the Apple App Store, for product verification and dispensing-level traceability reporting.
At TraceHub, we will continue following Nigeria's implementation closely, sharing regulatory updates, technical insights, implementation guidance, and lessons learned to support manufacturers, solution providers, and regulators across Africa and beyond.
Africa's traceability ecosystem is accelerating,and #Nigeria is now one of the leading countries driving that transformation.