Policy paper on traceability of medical products – WHO

Overview

This policy paper outlines the features of existing traceability systems and provides guidance on developing workable traceability regulation. In the light of the widely varying needs, capacity, and resources of Member States, the risk mitigation and sustainability strategies embedded in implementation efforts will vary. Given the range of possible implementation pathways, a set of guiding principles will assist Member States in establishing systems best suited to their needs and constraints.

For this purpose, Member States are encouraged to:

establish a suitable governance process for their traceability system based on the analysis of national specificities (e.g. regulatory environment, supply chain management), taking into account the impact of the different forms of governance on interoperability, cost, security, regulatory control and access to safe, quality medical products;
include a costing analysis as well as a sustainability mechanism in their traceability system planning to prevent costs from negatively impacting patients, government, supply chain stakeholders, and ultimately, access to medical products; and use global standards for product identification, production identification, automatic identification, and data capture and data exchange to reduce set-up and operating system costs and maximize national and international interoperability.