Serialisation Regulations in the EU and USA (single user digital version)

Feb 2020
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This chapter is reprinted and available individually from Good Distribution Practice: A Handbook for Healthcare Manufacturers and Suppliers, Volume 1 edited by Siegfried Schmitt, a text that collects in one place invaluable and comprehensive regulatory, manufacturing and distribution guidance and reference.

"The only way to be able to protect patients from substandard and falsified medical products is that each and every part of the manufacturing and supply chain is aware of its own influence on the quality of a medicinal product ... by preventing any negative influence of the quality, efficacy or safety ... and assuring that the medicinal product stays within the legal supply chain."

From the text Foreword by Lea Joos, Government of Upper Bavaria

Get current by reading this reprint and the additional 25 other timely and informative chapters to be found in Good Distribution Practice: A Handbook for Healthcare Manufacturers and Suppliers, Volumes 1 and 2, edited by Siegfried Schmitt. Description details, a complete Table of Contents and details about purchase of the two volume set will be found at: and

Available to download. Prior to purchase please view the download instructions and Terms of Usage
Format: PDF (1 file 784 KB)

Table of Contents

Table of Contents:

  • Background on Serialisation
  • Falsified Medicines Directive
  • Drug Supply Chain Security Act
  • Risk to Public
  • Cost to Industry of Counterfeit Drugs
  • How it Works
  • Implementation
  • Difficulties/Challenges
  • Benefits
  • Penalties for Non-Compliance
  • Conclusion
  • References

About the Authors

About the Author

Daniel Kavanagh is a Regulatory Affairs Professional from Dublin, Ireland who holds a Bachelor of Science (honours) in Pharmaceutical Science. He has over 6 years' experience in the pharmaceutical industry where he has worked in various roles in Quality Control, Quality Assurance and Regulatory Affairs. He currently works as a Regulatory Affairs Specialist for MSD with a focus on Chemistry, Manufacturing and Controls for the European, African, Eastern European and Middle East Regions