Challenges and Opportunities for the Traceability of (Biological) Medicinal Products

Drug Saf. 2018 Oct;41(10):911-918. doi: 10.1007/s40264-018-0678-7.


This article provides an overview of the current situation regarding the traceability of medicinal products, with a focus on drug safety and biologics. Limited traceability of biologics, in particular with regard to the batch number, is associated with incomplete recording of exposure information in clinical practice. The current pharmaceutical barcode standards in the EU do not support the automatic recording of dynamic product information, such as batch numbers and expiry dates, by means of electronic barcode scanning in clinical practice. New barcode requirements, such as the 2D DataMatrix with encoded batch numbers and expiry dates, provided on both the primary and the secondary package, can facilitate routine barcode scanning at all points in the supply chain in different healthcare settings. To build a full track-and-trace system for medicines with electronic capture of relevant exposure information, alignment with other topics, such as the Falsified Medicines Directive and initiatives to reduce medication errors, is needed to increase the buy-in from all stakeholders and to solve multiple issues with a joint effort.

MeSH terms

  • Biological Products / adverse effects
  • Biological Products / standards*
  • Counterfeit Drugs / supply & distribution
  • Drug Labeling / standards
  • Drug Packaging / standards
  • Electronic Data Processing*
  • Humans
  • Medication Errors / prevention & control*


  • Biological Products
  • Counterfeit Drugs