Which specific international mandate, enforced by the European Union, drove the implementation of unique product identifiers across Europe for pharmaceuticals?
Answer
Falsified Medicines Directive (FMD)
While the United States pursued drug traceability through acts like the DSCSA, the European Union implemented its own comprehensive measures. The Falsified Medicines Directive (FMD) stands out as the key European mandate that spurred the requirement for unique product identifiers across the European pharmaceutical supply chain. This international harmonization effort paralleled US developments and forced manufacturers operating globally to develop systems capable of meeting strict package-level authentication and tracing standards within the EU market.
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