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Jun 4, 2015

EU vs US: What are the New Track and Trace Requirements?

The European Commission and the FDA are fighting 
counterfeit medicines through traceability 
requirements in the pharmaceutical supply chain.
by Wolfgang Schmitt
Director Operations
CONCEPT HEIDELBERG GmbH 


In 2011, the European Commission published Directive 2011/62/EC, the so-called Falsified Medicines Directive (or FMD).One goal was the fight against counterfeit medicines through serialization and verification. In 2014 the technical characteristics of these key ideas were defined, the unique identifier (UI), delivering the possibility of verification of the authenticity of single folding boxes. The unique identifier contains information on the:


  • Manufacturer product code
  • Serial Number
  • National reimbursement number, if present
  • Batch Number
  • Expiry Date

The 2D barcode (data matrix) has been set as carrier of this unique identifier, a decision which did not come unexpected but rather late. The composition, format and carrier of this unique identifier will be fully harmonized across the EU.

Medicine authenticity will be guaranteed by an end-to-end verification system supported by risk-based verifications by wholesale distributors. Medicines will be systematically verified before being dispensed to patients. With the end-to-end scanning process of the data matrix, the authenticity of each packaging is automatically verified via a protected centralized database. If identical numbers are found or if a number cannot be found in the database, an alarm will be triggered immediately. The repository containing the unique identifiers will be set up and managed by the stakeholders. National competent authorities will be able to access and supervise the database.

As this new requirement will become active in 2018, it is time to start defining strategies for both technical implementation and change control strategy.

With the Drug Supply Chain Security Act (DSCSA) and the related implementation plan, new requirements were defined in the USA which aim to improve the traceability of prescription drugs within the supply chain. 
This article is related to the Whitepaper: Managing Change Control to Comply with FDA and EU Regulations.To get the full details, please download your free copy.

The DSCSA is focusing more on each step in the supply chain, tracking the different stages on the way to the pharmacist.

On the FDA website, a graphic represents a summary of planned implementation time frames for the Drug Supply Chain Security Act over a 10-year period. The major phases are:
  • Lot-Level traceability and verification
Starting January 1 2015 for manufacturers, wholesalers and re-packagers; and July 1, 2015 for pharmacy (hospitals and retail): changes of ownership of a batch must be tracked.
  • Unique Serialization
From 2017 – 2019, single packages of drug products have to be marked with serialisation numbers and bar codes.
  • Serialized Item-Level Traceability
From 2023, information must be provided to allow supply chain partners to trace the transaction history back to the initial manufacturer or re-packager.  

The Drug Supply Chain Security Act Implementation Plan will be updated as appropriate.


The European Compliance Academy (ECA), recognizing this need for further professional knowledge development, intend to support the pharmaceutical industry inside and outside Europe in understanding the new European approach and legal framework in this respect and have set up a Conference on The new GDP and Track & Trace regulations in Europe on 14-15 July 2015 in Jersey City, NJ (New York City Metro Area): http://www.gmp-compliance.org/eseminar_9170_The-new-GDP-and-Track---Trace-Regulations-in-Europe.html

Have you begun implementing track and trace at your workplace?  Has it been a smooth transition for you? Share your experiences below!



Wolfgang Schmitt studied pharmacy at the University in Heidelberg, Germany and the School of Pharmacy in London, U.K. He also holds a degree in total quality management from the University of Kaiserslautern, Germany.  

After functions in the community pharmacy, he started in 1999 in the GMP-Coordination (R&D) of the former Knoll AG in Ludwigshafen, Germany (later Abbott). Subsequently he was head of quality management at SOLIQS (Abbott’s global Drug Delivery Business Unit).

From 2005-2006 he was an associate director and Qualified Person at Abbott’s Global Pharmaceutical Research and Development Quality Assurance, responsible for the GMP/GLP-Compliance. In July 2006 he joined CONCEPT HEIDELBERG as
project manager where he is now Director Operations. Email him at w.schmitt@concept-heidelberg.de.






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