Pharmaceutical products traceability master data guideline, version 002

Abstract

Ethiopia has made great strides to improve access to safe, quality and efficacious pharmaceutical products to the public. The EFDA is responsible for ensuring the safety, quality and efficacy of pharmaceutical products circulating in the market. The availability of substandard and falsified (SF), and illegally circulating medicine with unknown sources negatively impacts patient safety. In addition, the inefficient recall system, and lack of visibility in pharmaceutical products movement among the pharmaceutical supply chain actors and within organizations, hinders the supply chain from functioning efficiently. This has forced the government to implement a system that ensures traceability of pharmaceutical products that spans from manufacturer to end-users.