EU vs US: what are the new Track and Trace Requirements?

Recommendation

13/14 December 2023
Berlin, Germany

Root Cause Analysis
A CAPA Workshop on Successful Failure Investigation

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 serialisation 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 harmonised 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 centralised 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 at improving the traceability of prescription drugs within the supply chain.

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 timeframes 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.
• Serialised 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.