0In April 2026, the Pharmacy Council of Nigeria (PCN) and the Federal Ministry of Health and Social Welfare achieved a landmark milestone.
The Electronic Pharmacy Regulations 2026 were gazetted into law, replacing the country’s 2021 Online Pharmacy Regulations with a comprehensive, modernized framework for the fast-growing digital pharmacy sector. For patients, pharmacists, digital health entrepreneurs, and the broader ecosystem working to expand access to medicines in Nigeria, this is a significant milestone.
What changed, and why it matters
The PCN has long recognized the 2021 Regulations had some notable shortcomings. First, they failed to recognize electronic pharmacy aggregator platforms as an e-pharmacy type. Second, they required electronic pharmacies to have a physical location for registration; an obstacle for digital-first businesses. Third, they had no provisions for a centralized architecture to govern data flows within the e-pharmacy ecosystem. Fourth, the dispensing guidelines were unclear, effectively preventing certain essential health products from being distributed through electronic pharmacy channels. Fifth, the regulations broadly required electronic pharmacies and aggregators to comply with all applicable ICT laws without defining which ones, thus creating vague compliance obligations.
The changes in the 2026 Regulations address these shortcomings and together represent a broader architectural shift: from a flat regulatory model to a layered, platform-governed ecosystem. We highlight 5 central changes that address these shortcomings:
1. Establishment of 2 categories of e-pharmacy operators, recognizing digital pharmacy aggregators for the first time: 1) Electronic Pharmaceutical Service Providers (EPSPs) that own and operate online pharmacies, directly selling, dispensing, and delivering pharmaceutical products to consumers via digital channels; and 2) Electronic Pharmacy Aggregators (EPAs) are third-party platforms that provide technology infrastructure to connect multiple EPSPs with consumers, without owning the products, with activities restricted to managing and maintaining the platform. Aggregators are formally regulated for the first time, giving them defined legal standing and a clear registration pathway.
2. Reconfiguration, not elimination, of physical premises requirements for registering EPSPs. Flexible registration pathways now accommodate operators with or without existing premises and/or online infrastructure. These include options to register via partnership with a licensed physical pharmacy or a service-level agreement with an aggregator platform. In all cases, a Superintendent Pharmacist – linked to a licensed physical premises – must oversee registration and remains accountable for pharmaceutical service delivery.
3. Establishment of a National Electronic Pharmacy Platform (NEPP) as the central hub through which all e-pharmacy transactions must be processed, with all EPSPs and aggregators required to integrate. NEPP is not merely a coordination layer; it functions as a regulatory rail for transactions, prescription verification, and end-to-end traceability, and is the mechanism through which platform-level data governance becomes operational.
4. Clarification of what health products can legitimately be distributed through digital channels. Prescription-Only Medicines with OTC waivers such as oral contraceptives and family planning drugs authorized for self-administration like DMPA-SC are specifically referenced. The key shift, however, is not just naming these products; it is the removal of regulatory ambiguity that had been preventing digital channels from serving as meaningful distribution points for high-impact self-care products.
Limits on quantities that can be dispensed are now explicit: EPSPs must dispense in line with the treating physician’s prescription, with documented medical justification required for any increases. The Regulations also introduce consumer return rights for expired products or those with signs of tampering, backed by a broader strengthening of the Patients’ Bill of Rights.
5. Finally, sharpening of data protection requirements and creation of a centralized data governance framework. By aligning explicitly with Nigeria’s Data Protection Act and with NEPP acting as a central transaction node, the data governance framework is extended from company-level to the platform/ecosystem-level.
A longer journey, and a broader vision
While earlier reform efforts helped shape parts of the regulatory direction, the 2026 Regulations go significantly further in formalizing the ecosystem. This represents a shift from policy intent to enforceable system architecture. The PCN’s Strategic Implementation Plan maps the road ahead, with the ambition of a fully integrated pharmaceutical system that improves access, reduces substandard medicines, and enables data-driven public health decision-making across Nigeria.
Salient has been learning from and with the PCN on this journey. In 2022 we launched a regulatory learning group with 13 countries to share regulatory frameworks for direct-to-consumer health commodities. We also supported in early conceptualization of a centralized platform model for verification and traceability and helped PCN study Ghana’s platform for Nigeria’s NEPP goals.
In 2023, we were honored to assist PCN in conducting a structured review and revision of the 2021 Online Pharmacy Regulations, addressing key gaps including the absence of a framework for aggregators, ambiguities around digital prescribing and telemedicine-enabled dispensing. Several of these elements are now reflected and further developed in the 2026 Regulations. Dr. Elijah Mohammed provided regulatory technical guidance, while Prof. Cheluchi Onyemelukwe and Health Ethics & Law Consulting offered legal support.
Translating a draft regulation into gazetted law required sustained leadership, stakeholder engagement, and institutional will by the PCN and its partners. Our heartfelt congratulations to PCN Registrar/CEO, Pharm. Ibrahim Babashehu Ahmed, FPSN and the teams who brought this to life.
Salient Advisory works with governments, regulators, and development partners on health policy, regulatory strategy, and digital health across Africa. On this journey we learned and collaborated with Dr. Romuald Mbwasi, Dr. Elijah Mohammed, Dr. Placide Tapsoba, Prof. Cheluchi Onyemelukwe, Health Ethics & Law Consulting, Dr. Mojisola Odeku and Rodio Diallo of the Gates Foundation, and other partners.
Read more about our work in advancing regulations for online pharmacies across Africa here, here, and here.
