Kenya’s PPB to roll out national system to track and authenticate health products

KENYA—The Pharmacy and Poisons Board (PPB) has announced plans to implement a national Authentication and Traceability System for health products and technologies (HPTs) to strengthen oversight and improve the tracking of products across the supply chain.

The initiative complies with Section 17(h) of Kenya’s Digital Health Act, 2023, which provides for a Comprehensive Integrated Health Information System to support the authentication, tracking and tracing of HPTs throughout the supply chain.

The PPB, in collaboration with the Digital Health Agency (DHA), has begun implementing the system and has engaged stakeholders through national and sector-specific sensitisation and consultation forums held from 7 to 13 July 2026.

Phased implementation

According to Dr Ahmed I. Mohamed, chief executive officer of the PPB, the system will go live on 3 August 2026.

To support a phased rollout, the Board will introduce a transition period running until 31 December 2026.

During this period, manufacturers and importers will implement authentication and traceability for locally manufactured and imported HPTs through batch-level traceability using batch numbers declared to the PPB.

From 1 January 2027, all HPTs manufactured in Kenya or imported into the country will be required to comply with the full national authentication and traceability requirements.

These requirements will include batch-level traceability and unit-level serialization in line with GS1 standards.

In preparation for the pilot and system launch, the DHA will require marketing authorization holders, manufacturers, importers and local technical representatives to submit the necessary data in accordance with the prescribed requirements.

These stakeholders must also complete system integration and other implementation activities to achieve full compliance by 1 January 2027.

The PPB and DHA will onboard wholesale dealers, distributors, retail pharmacies and other downstream supply chain actors according to the implementation timelines.

The two agencies will issue further guidance on the specific requirements for these stakeholders, while the DHA will provide detailed data specifications, submission templates and integration guidelines.

Pharmacy sector digital platforms

The PPB is also implementing Facility 360 and Practice 360 with the DHA to support the facility and health worker registries required under Section 16(e) of the Digital Health Act, 2023.

The platforms will operationalize digital registries for pharmaceutical premises, pharmacists and pharmaceutical technologists.

The PPB and DHA conducted a national stakeholder sensitization session on the platforms on 7 July 2026.

Consequently, the PPB has directed all pharmaceutical premises, pharmacists and pharmaceutical technologists to complete onboarding onto Facility 360 and Practice 360 by 31 October 2026.

Completion of the onboarding process will be a prerequisite for processing applications during the 2027 Annual Licensing Cycle.

The Board has therefore urged stakeholders to complete the process ahead of the deadline to support the timely processing of annual practice and premises licences.

Stakeholder support

The PPB and DHA will continue to provide technical support, stakeholder engagement, and implementation guidance throughout the rollout.

The agencies will also issue additional technical specifications and implementation guidelines as required.