South Korea requires serialization on the saleable unit level and the case level. Although not required by Korea Food and Drug Administration (KFDA), wholesale distributors in South Korea are asking manufacturers for aggregated shipment and data.
South Korea took the phased approach to allow manufacturers to step up their serialization effort over time. Drugs on the Essential Drug List (EDL), which consists 30% of all drugs on the Korea market, are to be serialized by January 1, 2015 and all drugs by January 1, 2016.
Manufacturers are also required to report the serialized data to the Korean Pharmaceutical Information Service (KPIS). There is lack of guideline and details around event reporting and data reconciliation. The industry is expecting such guideline to be published soon to help resolve the existing reporting issues. Watch the video to learn more about Korea serialization requirement.