Gartner Research

Assessment of Track-and-Trace and Serialization Legislation for Life Science Companies, Europe

Published: 22 July 2015

ID: G00276669

Analyst(s): Andrew Stevens


Full implementation of European serialization mandates is expected by 4Q18. Recent stand-alone EU guidelines for managing active substances present additional challenges for supply chain stakeholders who are responsible for meeting full product compliance across end-to-end supply chains.

Table Of Contents


  • Introduction
  • 2015 Developments
  • Parallel and Stand-Alone Laws, and Mandates
  • Suggested Next Steps
  • Falsified Medicines Directive
  • European Stakeholder Model
  • European Medicines Verification Systems

Appendix 1 — The European Stakeholder Model Industry Associations Governing Stakeholders

Appendix 2 — Definitions for Counterfeit Medicines and Falsified Medicines

Appendix 3 — European Stakeholder Model Key Datasets

Appendix 4 — Harmonization of National Coding Regimes

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