Tool: Model Directive for Traceability Regulation Development

Authored on
October 23, 2020

This document is intended for use by NDRAs in the implementation of pharmaceutical labelling and packaging requirements to advance supply chain security. Implementation of serialization, verification and traceability to enhance security of the pharmaceutical supply chain is a significant endeavor. In doing so, every regulator must assess and account for local market dynamics, including local legal requirements (e.g., whether serialization will be implemented by statute, regulation, or other guidance), technological sophistication (e.g., internet connectivity in various geographic regions), trade practices (e.g., whether unit-of-use, unit-dose, or bulk packaging is used; the variety of distribution channels used), and other similar dynamics. The regulation template should be adapted to account for such market dynamics.


October 23, 2020