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This research surveys several countries’ regulations regarding “serialization” of pharmaceutical products and whether these regulations apply to free medicinal product samples. The attached reports explore the specific “track and trace” or “serialization” laws and regulations in the European Union, Japan, and Turkey. While technical aspects of serialization differ across jurisdictions, one widely used benchmark for legislation is the voluntary GS1 standards, and specifically the Global Trade Item Number (GTIN). Globally, it is estimated that 70 countries have based their regulatory requirements for traceability of pharmaceuticals on these standards.

Comparative Summary

European Union



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Global Legal Research Directorate Staff
September 2019

Last Updated: 12/30/2020