Gartner Research

An Assessment of Global Regulations Across the Healthcare Value Chain Requiring Product Authentication and/or Verification With Serialization

Published: 05 February 2020

ID: G00418303

Analyst(s): Andrew Stevens

Summary

Supply chain leaders in the life science industry and healthcare value chain can use this assessment of the global regulatory momentum to fully comprehend the requirements and modes of execution for product authentication and/or verification with serialization.

Table Of Contents

Analysis

  • Definitions of Counterfeit and Fake Medicines or Products
  • The Business and Regulatory Need for Product Authentication and Verification With Serialization Models
  • Data and Coding Building Blocks That Shape Global Regulations
    • Batch Coding
    • Serialization (and Serial Numbers)
    • Product Authentication and/or Verification (With Serialization)
    • Track and Trace (With Serialization)
  • Regulatory Outlook
    • Product Authentication and/or Verification With Serialization Regulation Origins
  • Decision Making and Challenges for Deployments of Product Authentication and/or Verification With Serialization as Part of Compliance Mandates
  • Recommendations

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