The National Agency for Food and Drug Administration and Control (NAFDAC) says there is no going back on its plan to commence enforcement of the Pharmaceutical Products (Traceability) Regulations, 2024, from 1 January, 2027, declaring that compliance will become a mandatory requirement for the grant and renewal of marketing authorisations for pharmaceutical companies.
The directive, contained in a regulatory circular, approved by the Director General of NAFDAC, Prof. Mojisola Christianah Adeyeye, outlines a phased enforcement framework that will ultimately cover all finished pharmaceutical products by 1 January, 2029. The agency said the regulations have been in full legal force since they were gazetted on 30 October, 2024, and are binding on all stakeholders across the pharmaceutical supply chain.
According to NAFDAC, implementation of the traceability regulations has already progressed in phases, beginning with narcotics and controlled substances in 2024, followed by Maternal, Newborn and Child Health (MNCH) commodities, antibiotics and antimalarial medicines in 2025. The agency said the implementation process has been supported through stakeholder engagements, issuance of guidance documents and the onboarding of regulated entities onto the NAFDAC Traceability Information System (NTIS).
The new directive applies to a broad range of stakeholders, including marketing authorisation holders, manufacturers, importers, local representatives, distributors, wholesalers, hospital and community pharmacies, healthcare institutions, procurement agencies, and both public and private healthcare facilities.
Under the directive, NAFDAC said compliance with the Pharmaceutical Products (Traceability) Regulations, 2024, will henceforth constitute a compulsory condition for obtaining new marketing authorisations as well as renewing existing ones. The agency warned that any product that fails to meet the traceability requirements within the stipulated timelines will not be eligible for regulatory approval.
To comply with the regulations, every pharmaceutical product must carry a GS1-compliant two-dimensional Data Matrix barcode containing key information, including the Global Trade Item Number (GTIN), batch or lot number, expiry date and serial number. The agency noted that these requirements are in line with Regulations 5 and 6 of the Traceability Regulations.
NAFDAC also directed that every facility involved in the manufacture, distribution or dispensing of pharmaceutical products must obtain and maintain a valid Global Location Number (GLN), with responsibility for securing and maintaining the identifier resting with the facility owner, in accordance with Regulation 11.
In addition, regulated entities are required to transmit traceability event data—including product commissioning, shipping, receiving, dispensing and other prescribed supply chain events- to the NAFDAC Traceability Information System (NTIS), as stipulated under Regulation 12. The agency said this will enable end-to-end visibility of pharmaceutical products throughout the supply chain.
The enforcement schedule provides that, from 1 January, 2027, NAFDAC will neither grant nor renew marketing authorisation for finished products containing narcotics or controlled substances unless they comply with the traceability regulations. The requirement will be extended to all finished MNCH products, antibiotics and antimalarials from 1 January, 2028, before becoming applicable to all finished pharmaceutical products from 1 January, 2029.
NAFDAC further stressed that refusal to grant or renew marketing authorisation under the directive will be without prejudice to the offences, penalties and forfeiture provisions contained in Part III of the Pharmaceutical Products (Traceability) Regulations, 2024. It added that the agency’s enforcement powers under Regulation 18 remain fully applicable to any contravention of the regulations, regardless of the implementation timelines.
As part of measures to facilitate compliance, the agency advised regulated entities to engage any NAFDAC-approved GS1-accredited traceability solution provider to support product serialisation, acquisition of Global Location Numbers and integration with the NTIS. It also disclosed that pharmacies and other dispensing points can utilise the NAFDAC Scan2Verify Mobile Application, available free on Android and iOS platforms, for product verification and dispensing-level reporting.
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