Gartner Research

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

Published: 22 March 2016

ID: G00295588

Analyst(s): Andrew Stevens


Published compliance timelines for safety features on packaging, as part of the European Stakeholder Model, have given fresh momentum to manufacturers for planning and execution.

Table Of Contents


  • Introduction
  • "Safety Features" Delegated Act, October 2015 (Directive 2001/83/EC)
  • Suggested Next Steps
  • Expected Aggregation and Reporting for Manufacturers
    • An Example of Aggregation
  • Near-Term Outlook — Ongoing Developments in the ESM
  • Suggested Next Steps
  • Falsified Medicines Directive
  • European Stakeholder Model
  • European Medicines Verification Systems

Appendix 1 — The European Stakeholder Model Industry Association's 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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