Enforcement Rules for the Controlled Drugs Act Article 26
When reporting the records maintained for controlled drugs in accordance with Article 28 Paragraph 2 of this Act, the western medicine or veterinary medicine manufacturer and sellers shall report the records for the previous month to the local health administration and the FDA prior to the 20th of every month (institutions has no transaction record are included), and the records shall record the following items for each individual drug batch by batch :1.The name of the reporting institutions, controlled drugs registration license number, address, telephone number, the person in charge, the name of the controlled drugs manager, reporting date, the time period of the reported records, with the official seal, the seal of person in charge, the seal and signature of the controlled drugs manager impressed.2. The name of the drug, the ingredient and contained amount of controlled drugs, drug permit license number, schedule, batch number, minimal unit and the name of the manufacturer.3. The inventory amount of the previous time period.4. The records of the increase and decrease of stocks of the current time period, the content of that shall be identical to the maintained records.5. The inventory amount of the current time period.The reporting mentioned in the preceding Paragraph may be done via electronic means. The format and specification of such medium shall be announced to the public by the Central Health authority.
中文原文 管制藥品管理條例施行細則第26條
西藥或動物用藥品製造業者及販賣業者依本條例第二十八條第二項規定申報管制藥品簿冊登載情形者，應於每月二十日前就其前一個月簿冊登載情形，依藥品品項逐批載明下列事項，向所在地、銷售地衛生主管機關及食品藥物署申報；於該期間無任何管制藥品收入、支出或結存者，亦同：
一、申報者之名稱、管制藥品登記證字號、地址、電話號碼、負責人、管制藥品管理人、申報日期及申報資料期間，並加蓋印信戳記、負責人印章及管制藥品管理人之簽章。
二、品名、管制藥品成分、含量、許可證字號、級別、批號、最小單位及製造廠名稱。
三、上期結存數量。
四、本期收入及支出資料，其內容並應與簿冊登載者相同。
五、本期結存數量。
前項申報得以電子方式為之；其媒體形式及規格，由中央衛生主管機關公告之。
一、申報者之名稱、管制藥品登記證字號、地址、電話號碼、負責人、管制藥品管理人、申報日期及申報資料期間，並加蓋印信戳記、負責人印章及管制藥品管理人之簽章。
二、品名、管制藥品成分、含量、許可證字號、級別、批號、最小單位及製造廠名稱。
三、上期結存數量。
四、本期收入及支出資料，其內容並應與簿冊登載者相同。
五、本期結存數量。
前項申報得以電子方式為之；其媒體形式及規格，由中央衛生主管機關公告之。