Regulation for Drug Shortage Management Article 2
The reporting method and content of pharmaceutical firms in accordance with Paragraph 1 of Article 27-2 of the Act are as follows:1.Method: Report using the online platform set up by the Central Competent Health Authority. Those who reported in writing, in oral form or via e-mail should make the report again via the online platform within 24 hours.2.Content: It should include the pharmaceutical firm’s name, contact person for the report, drug item, license number, date of report, contact number, inventory, estimated time of available supply, reasons for the shortage in supply and other related information.Medical institutions or any other entities may report to the Central Competent Health Authority in accordance with the preceding provisions if they learn about a possible shortage in the supply of essential drugs.
中文原文 必要藥品短缺通報登錄及專案核准製造輸入辦法第2條
藥商依本法第二十七條之二第一項規定通報之方式及內容如下：
一、方式：應於中央衛生主管機關建構之網路平臺通報；其以書面、言詞或電子郵件通報者，應於二十四小時內，於網路平臺補正。
二、內容：應包括藥商名稱、通報連絡人、藥品品項、許可證字號、通報日期、連絡電話、庫存量、預估可供應時間、不足供應之原因及其他相關資訊。
醫療機構或其他得知必要藥品有不足供應之虞者，得準用前項規定向中央衛生主管機關通報。
一、方式：應於中央衛生主管機關建構之網路平臺通報；其以書面、言詞或電子郵件通報者，應於二十四小時內，於網路平臺補正。
二、內容：應包括藥商名稱、通報連絡人、藥品品項、許可證字號、通報日期、連絡電話、庫存量、預估可供應時間、不足供應之原因及其他相關資訊。
醫療機構或其他得知必要藥品有不足供應之虞者，得準用前項規定向中央衛生主管機關通報。