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Pharma Serialization in Kenya: National Traceability to Become Mandatory by 2027

Pharma Serialization Kenia

Kenya is rapidly advancing the digitalization of its pharmaceutical supply chain. With the introduction of a national track-and-trace system, healthcare products will become traceable throughout the entire supply chain. For pharmaceutical companies, this means that requirements regarding data exchange, product verification, and pharmaserialization in Kenya will become increasingly important over the coming months.

Regulation: National Track and Trace System (NTTS)
Competent Authorities: Digital Health Agency (DHA) and Pharmacy and Poisons Board (PPB)
Code Type: GS1 DataMatrix
Aggregation: SSCC for cases and pallets
Transition Period: Until December 31, 2026
Serialization Requirement: Effective January 1, 2027

National Traceability System for Healthcare Products

The new serialization requirements in Kenya are based on the Digital Health Act 2023. Under this legislation, a national traceability system for healthcare products is being introduced. The Digital Health Agency (DHA) is responsible for operating the system, while the Pharmacy and Poisons Board (PPB) oversees its regulatory implementation.

The objective of the system is to identify and remove counterfeit, substandard, and illegally distributed products from the supply chain more efficiently. Product data will be centrally captured and electronically tracked throughout the supply chain.

Serialization Implementation Timeline in Kenya

The current implementation schedule represents a significant acceleration compared to the originally communicated rollout plan. In June 2025, the Pharmacy and Poisons Board (PPB) presented a phased implementation approach during an event organized by the Kenya Association of Pharmaceutical Industry (KAPI).

According to this original plan, implementation would begin with batch-level traceability. This first phase was expected to take between 12 and 48 months. Between months 48 and 72, serialization requirements would gradually be introduced for high-risk products. Full serialization of all affected products was not planned until between 72 and 120 months after the start of the program.

Under this original approach, complete serialization would only have been achieved several years after the system’s introduction. On August 18, 2026, mandatory serialization at the unit-pack level was announced. The start date of January 1, 2027, therefore represents a significant acceleration of the original schedule. As a result, manufacturers, marketing authorization holders, and importers now face a much shorter timeframe for technical and organizational implementation.

DateMilestone
2023Digital Health Act enters into force, providing the legal basis for the national traceability system
2025Publication of a multi-year implementation roadmap
August 3, 2026Launch of the National Track and Trace System
August to December 2026Transition period with batch-level data reporting
January 1, 2027Mandatory item-level serialization enters into force

Product Labeling Requirements

According to the published technical specifications, each saleable unit must be marked with a GS1 DataMatrix code containing the following information:

  • GTIN
  • Serial Number
  • Batch/Lot Number
  • Expiration Date

This ensures that every individual product pack receives a unique identity that can be tracked throughout the supply chain.

In addition to item-level identification, aggregation requirements have also been defined. Shipping cases and pallets must be identified using a Serial Shipping Container Code (SSCC)

The relationship between individual packs, cases, and pallets must be maintained to enable full traceability down to the unit level.

Central Data Repository and Verification

The data generated through pharmaceutical serialization in Kenya will be stored in a centralized database. Companies may submit the required data directly or use specialized service providers like tracekey to fulfill these obligations.

The system also includes product verification capabilities. By scanning the DataMatrix code, stakeholders will be able to confirm a product’s authenticity. Products that cannot be successfully verified may not be dispensed to patients. Verification procedures are also planned for imported products.

Which Companies Are Affected?

The requirements apply particularly to:

  • Marketing Authorization Holders (MAHs)
  • Manufacturers
  • Contract Manufacturing Organizations (CMOs)
  • Importers
  • Local representatives of foreign companies

Companies without a local presence in Kenya must comply with the requirements through their local partners or marketing authorization holders.

What Should Companies Do Now?

With mandatory item-level serialization scheduled to begin in early 2027, the remaining implementation window is relatively short. Companies should therefore begin preparations by:

  • Identifying affected products
  • Obtaining and managing the required GS1 identification numbers
  • Updating packaging artwork and production lines to accommodate GS1 DataMatrix codes
  • Implementing aggregation processes
  • Defining responsibilities for data reporting
  • Preparing the technical connection to the national traceability system

Kenya is emerging as one of Africa’s most dynamic markets for pharmaceutical traceability. With the implementation of the National Track and Trace System and the introduction of mandatory serialization on January 1, 2027, extensive new requirements will apply to manufacturers and marketing authorization holders. Companies supplying medicines to Kenya or manufacturing products for the Kenyan market should use the remaining transition period to ensure that their serialization and data management processes are fully prepared for the upcoming regulations.

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