Serialisation officially stated as a mandatory requirement

摘要

In early February the European Commission published the Delegated Acts on safety features in the Official Journal of the European Union, supplementing Directive 2001/83/EC (Falsified Medicines Directive). This publication effectively marks the start of a three-year implementation period for all EU member states. The deadline for implementation of the Delegated Acts is February 2019. Not all pharmaceutical manufacturers had followed the Delegated Act closely. However, some did because they have been warned to implement serialisation into their production due to other national demands seen in markets such as Turkey, China or Korea. Soon one can only sell prescription drugs when produced and marked in compliance with Directive 2001/83/EC. The US Government is also expected to announce its demands and regulations for the traceability of medicine in the North America.