The National Agency for Food and Drug Administration and Control (NAFDAC) has introduced a new regulatory directive making compliance with the Pharmaceutical Products (Traceability) Regulations, 2024 a mandatory requirement for the grant and renewal of Marketing Authorisation, marking a significant milestone in Nigeria's efforts to strengthen medicine safety, improve supply chain transparency, and eliminate counterfeit pharmaceuticals.
The National Agency for Food and Drug Administration and Control (NAFDAC) has officially announced the enforcement of its Regulatory Directive on the Pharmaceutical Products (Traceability) Regulations, 2024, making traceability compliance a compulsory condition for the grant and renewal of Marketing Authorisation (MA) for pharmaceutical products in Nigeria. The directive, referenced NAFDAC-RDCL-042-00, became effective on 13 July 2026 and establishes a new regulatory framework aimed at ensuring that pharmaceutical products can be tracked throughout the supply chain from manufacturing to dispensing.
According to the Agency, the Pharmaceutical Products (Traceability) Regulations, 2024 were enacted on 16 October 2024 and published in the Federal Republic of Nigeria Official Gazette on 30 October 2024, making them legally binding on all stakeholders within the pharmaceutical sector. Since then, implementation has progressed in phases, beginning with narcotics and controlled substances before expanding to maternal, newborn and child health (MNCH) commodities, antibiotics, and antimalarial medicines. The latest directive now elevates compliance from a regulatory expectation to a mandatory requirement for market access.
Comprehensive Requirements Across the Pharmaceutical Supply Chain
The directive applies to Marketing Authorisation Holders (MAHs), manufacturers, importers, local representatives, distributors, wholesalers, hospital pharmacies, community pharmacies, healthcare institutions, procurement agencies, and both public and private healthcare facilities. By extending traceability obligations across the entire pharmaceutical value chain, NAFDAC aims to establish a transparent and accountable medicine distribution system capable of identifying and preventing the circulation of counterfeit, falsified, and substandard medicines.
To achieve this objective, every pharmaceutical product must carry a GS1-compliant two-dimensional Data Matrix barcode containing the Global Trade Item Number (GTIN), batch or lot number, expiry date, and a unique serial number. These identifiers will enable every medicine pack to be uniquely authenticated and monitored throughout its lifecycle, significantly improving product verification and recall efficiency while enhancing patient safety.
In addition, every facility involved in manufacturing, distributing, or dispensing pharmaceutical products must obtain and maintain a valid Global Location Number (GLN). Regulated entities are also required to transmit traceability event data—including commissioning, shipping, receiving, dispensing, and other prescribed activities—to the NAFDAC Traceability Information System (NTIS), allowing the Agency to maintain end-to-end visibility of pharmaceutical products circulating within the Nigerian market.
Phased Enforcement and Industry Readiness
NAFDAC has adopted a phased enforcement strategy to provide stakeholders with sufficient time to implement the required systems. Beginning on 1 January 2027, compliance will become mandatory for all finished products containing narcotics and controlled substances. The requirement will expand on 1 January 2028 to include all finished Maternal, Newborn and Child Health (MNCH) products, including antibiotics and antimalarial medicines. From 1 January 2029, every finished pharmaceutical product marketed in Nigeria must fully comply with the traceability requirements before it can receive a new Marketing Authorisation or qualify for renewal.
The Agency emphasized that failure to comply with the directive will result in the refusal of applications for the grant or renewal of Marketing Authorisation without prejudice to additional enforcement measures provided under the Pharmaceutical Products (Traceability) Regulations, 2024. Offending entities may also be subject to penalties, forfeiture provisions, and other enforcement actions available under the Regulations.
To facilitate implementation, NAFDAC has encouraged regulated entities to engage NAFDAC-approved GS1-accredited traceability solution providers for technical support. Pharmacies and other dispensing outlets are also advised to utilize the NAFDAC Scan2Verify Mobile Application, available free of charge on both Android and iOS platforms, to verify medicines and report dispensing activities. Furthermore, the Agency has urged stakeholders to begin or conclude their compliance programmes immediately, noting that adequate time is required for product serialization, acquisition of Global Location Numbers, and onboarding onto the NAFDAC Traceability Information System.
Approved by the Director-General of NAFDAC, Prof. (Mrs.) Mojisola Christianah Adeyeye, and signed on 20 July 2026, the directive represents one of the most significant regulatory reforms in Nigeria's pharmaceutical industry in recent years. By making traceability compliance a prerequisite for Marketing Authorisation, NAFDAC is reinforcing its commitment to protecting public health, improving medicine quality assurance, strengthening supply chain integrity, and ensuring that patients across Nigeria have access to safe, authentic, and high-quality pharmaceutical products.
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