This document provides a comprehensive framework for the implementation of Authentication and Traceability (A&T) standards for Health Products and Technologies (HPTs) in Kenya. It aims to safeguard patient safety, ensure product integrity, and secure the medical supply chain from falsified and substandard products.
The standard applies to all stakeholders involved in the supply chain of regulated medical products—from manufacturers to pharmacists—including importers, distributors, wholesalers, healthcare providers, and A&T service providers. It covers therapeutic and non-therapeutic products, such as: Oral and non-oral medications, Herbal medicines, Medical devices and diagnostics, Cosmetic products with medical claims.
Pharmaceutical preparations and products of subheadings 3006.10.10 to 3006.93.00 (HS code(s): 3006); Pharmaceutics (ICS code(s): 11.120)
