Kenya is proposing a phased implementation consisting of three phases:

First phase (12-48 months) aimed at establishing basic visibility and record capabilities for tracking products, including data capturing and a central batch repository

Second phase (48-72 months) focused on unique level traceability with serialized numbers for high-risk health products and event-based reporting

Third phase (72-120 months) that will implement universal serialization and advanced analytics, including AI for data-driven regulation.

Technical notes

• All blister packs and sachets sold directly as such to consumers: unique identifier must be printed directly on the blister pack or sachet

• All bottle or vial products sold directly as such to consumers: unique identifier must be printed directly on bottle or vial

• Aggregation of serialized secondary packages into a serialized tertiary package (case) and then onto a serialized pallet. Aggregation data are shown in the table below.

• Patients: Patients can verify their dispensed medicines using a mobile app linked to the central database.

• Oral medications (pills, capsules, syrups, drops, dissolvable, sprays, inhalants)
• Non-oral medications (transdermal, submucosal, subcutaneous, intramuscular, intravenous, intraspinal)
• Topical medications (ointments, drops, patches)
• Suppositories (vaginal, rectal)
• Herbal products (ayurvedic, homeopathic)
• Medical Devices and Invitro Diagnostics
• Cosmetic products with medical claims

• https://kapikenya.org/introduction-to-serialization-track-and-trace/
• https://tinyurl.com/yte5fbkt

No deadlines specified