Pharmaceutical Affairs Act Article 6-1

Dealers and manufacturers of drugs categorized and announced by the central competent health authority shall establish their own traceability system for tracing the source and tracking the flow of the drugs according to their industry modes.The central competent health authority shall establish the traceability report system in the preceding paragraph; the business in the preceding paragraph shall use electronic methods to declare the information to the traceability report system. The electronic declaration method shall be prescribed by the central competent health authority.Regulations governing the establishment of the traceability report system mentioned in the preceding paragraph, items that should be recorded, inspections, and other matters requiring compliance shall be established by the central competent health authority.