Regulations for Drug Recall Article 11
The drug manufacturers or importers, with respect to the recall procedure under Class I and Class II, shall produce a proposal of recall operation based on the template referred to in Subparagraph 3 of Article 9 herein and submit to the municipal or county(city) competent health authority and central competent health authority within 3 days since the date of the public notice or since the date determined pursuant to laws, and the competent health authority may request for correction.The proposal referred to in the preceding paragraph shall include the following:1. Name, address, and phone number of the drug manufacturer or importer.2. Name, specifications, and permit license number of the drug.3. Batch number, serial number or any other identification information or number of the drugs;4. The total quantity, sales quantity, and inventory quantity of the drugs manufactured domestically or imported.5. Name, address, and their individual sales quantity of the medical care institutions, pharmacies, and pharmaceutical firms which are domestic distributors.6. Name of the export country, name, address and individual sales quantity of the target distributor from the domestic drug manufacturer for export.7. The reason of recall and the hazard it may cause.8. The scheduled date for recall completion.9. The methods, contents, and other related measures proposed to be adopted as indicated in the notification to the medical care institutions, pharmacies, and pharmaceutical firms which are the direct distributors.
中文原文 藥物回收處理辦法第11條
藥品製造或輸入業者對於第一級及第二級藥品回收作業，應自公告或依法認定之日起三日內，依第九條第三款範本製作計畫書，報所在地直轄市、縣（市）衛生主管機關及中央衛生主管機關；各級主管機關得要求其更正。
前項計畫書，應包括下列事項：
一、藥品製造或輸入業者之名稱、地址及電話。
二、藥品之品名、規格及藥品許可證字號。
三、藥品之批號、序號，或其他識別資料、編號。
四、藥品於國內製造或輸入之總量、銷售數量及庫存量。
五、藥品於國內銷售之醫療機構、藥局及藥商之名稱、地址及其個別之銷售數量。
六、國內製造藥品輸出者，其輸出之國別、對象名稱與地址及各別銷售數量。
七、回收之原因及其可能產生之危害。
八、預定完成回收之日期。
九、通知該藥品直接銷售之醫療機構、藥局及藥商之方式與內容及其他擬採取之相關措施。
前項計畫書，應包括下列事項：
一、藥品製造或輸入業者之名稱、地址及電話。
二、藥品之品名、規格及藥品許可證字號。
三、藥品之批號、序號，或其他識別資料、編號。
四、藥品於國內製造或輸入之總量、銷售數量及庫存量。
五、藥品於國內銷售之醫療機構、藥局及藥商之名稱、地址及其個別之銷售數量。
六、國內製造藥品輸出者，其輸出之國別、對象名稱與地址及各別銷售數量。
七、回收之原因及其可能產生之危害。
八、預定完成回收之日期。
九、通知該藥品直接銷售之醫療機構、藥局及藥商之方式與內容及其他擬採取之相關措施。