The EU Falsified Medicines Directive (FMD) goes into ef- fect in February 2019, incorporating a variety of initiatives aimed at protecting both patient safety and product integrity as medicines move through the pharmaceutical supply chain.
While at first glance, the EU FMD may look relatively straightforward, especially when compared to other global track and
trace regulations, in reality the EU directive is much more diverse
than it appears. Implementing solutions to serialize products,
manage product serialization and master data, and connect to
the EU Hub to share and manage information across the product lifecycle requires more preparation than some manufacturers
may be expecting.
This article provides an overview of the EU FMD and shares
key serialization considerations for pharmaceutical companies
that produce and distribute medicines for the European markets
through the knowledge TraceLink and its customers have gained
from early pilot programs.
THE EU FMD
The EU FMD introduces tough new rules to improve the protec-
tion of public health, bringing a new pan-European approach to
ensure the safety of medicines. Essentially, the goal is to create a
European Medicines Verification System with point-of-dispense
verification for most prescription medicines and selected high-
risk over-the-counter (OTC) products. This will be achieved
through unique identity encoding and the application of serial-
ization onto every packaging unit.
The EU FMD covers three regulatory areas:
1. Serialization. Applying a unique identity at the secondary
sales pack level;
2. Compliance reporting. Preparing and reporting master
data, serialization data and status information to the European Hub; and
3.Verification. Implementing point-of-dispense verification
that also includes risk-based verification for other members
of the supply chain.
EUROPEAN MEDICINES VERIFICATION SYSTEM
Serialization requires the sharing of high-level information between a complex web of stakeholders in the supply chain. Manufacturers that supply products to the EU will be required to exchange information with their supply network and report data
about a product’s serialization identity to the national repositories through the EU Hub.
The EU FMD
Regulatory requirements and key considerations for implementation
Brian Daleiden, VP of Industry Marketing, TraceLink
Caitlin Czulada, Manager, Technical Services, TraceLink