Regulations Governing the Trace and Track System for Medicinal Products Article 2
The “Trace and Track System” stated in the Act 6.1.1 refers to distributors and manufacturers with the medicinal products which categorized and announced by the central competent health authority (hereinafter referred to as medicinal products), shall establish their own information system for tracing the source and tracking the flow of the medicinal products according to manufacturing, import, sale or export process and establish the information system and management measures.The “Trace and Track System” stated in the Act 6.1.2 refers to the system established by central competent health authority in order to manage the system stated in the preceding paragraph.
中文原文 藥品追溯或追蹤系統申報及管理辦法第2條
本法第六條之一第一項所稱追溯或追蹤系統，指經中央衛生主管機關公告類別之藥品（以下稱藥品），其販賣業者或製造業者為追溯藥品來源或追蹤藥品流向，就其製造、輸入、販賣或輸出過程，所建立之資訊及管理系統。
本法第六條之一第二項所稱追溯或追蹤申報系統，指中央衛生主管機關為管理前項系統所建立之系統。
本法第六條之一第二項所稱追溯或追蹤申報系統，指中央衛生主管機關為管理前項系統所建立之系統。