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

Summary

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

Analysis

  • 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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