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[13] 申請「病人隨身攜帶管制藥品入境出境中華民國證明書」之規定
| 發布日期:2023-09-21 | 更新日期:2024-04-15 發布單位:管制藥品組

申請「病人隨身攜帶管制藥品入境出境中華民國聲明書STATEMENT FOR PATIENTS CARRYING CONTROLLED DRUGS INTO OR OUT OF THE REPUBLIC OF CHINA」規定

一、申請該證明書手續及應檢附文件為:

(1)填寫「病人隨身攜帶管制藥品入境出境中華民國聲明書STATEMENT FOR PATIENTS CARRYING CONTROLLED DRUGS INTO OR OUT OF THE REPUBLIC OF CHINA」,此聲明書可由本署網站>便民服務>下載專區>管制藥品相關表單下載。

(2)醫師診斷證明書正本,載明病人之病名、治療經過及必須使用管制藥品理由及每日服用量等。

(3)病人之護照影本。

(4)實際攜帶管制藥品之數量,請填寫正確清楚,併檢附擬攜帶管制藥品之標籤或仿單影本(或記載有擬攜帶管制藥品之品名、成分、含量、包裝規格、製造廠名等之相關英文資料),以供核對。

二、請將上述文件資料寄送本署,本類申請案件無需繳納費用,本署收件辦理約需7工作天,核發後立即寄送(請提供正確清楚之收件地址)。

三、申請文件請郵寄:

衛生福利部食品藥物管理署

地址:115021臺北市南港區研究院路一段130109

Food and Drug Administration, Ministry of Health and Welfare

No. 109, Ln. 130, Sec. 1, Academia Rd., Nangang Dist., Taipei City 115021, Taiwan (R.O.C.)
 

lease follow the procedures to get a permit.

a. Fill out Application Form and prepare the needed document:

1Fill out “STATEMENT FOR PATIENTS CARRYING CONTROLLED DRUGS INTO OR OUT OF THE REPUBLIC OF CHINA”. This can be downloaded from the website of FDA.

2Diagnostic Statement issued by licensed physician with patient’s name, therapeutic history, controlled drugs prescribed, and daily dosage.

3Photocopy of patient’s passport and travel document.

4Please clearly and correctly list actual volume of controlled drugs to be carried into Taiwan. Please attach photocopy of label or instruction of the said drug (with drug’s name, ingredient, concentration, packing information, manufacturer’s name, --etc in English) for verification.

b. Please send all the above said material/document to FDA by post mail. The application is free of charge but it will take 7 working days for processing the permit. Once the permit is issued, we will send the permit out to you. Please make sure a clear and correct mailing address is provided.

c. Mailing address of FDA is:

Food and Drug Administration, Ministry of Health and Welfare

No. 109, Ln. 130, Sec. 1, Academia Rd., Nangang Dist., Taipei City 115021, Taiwan (R.O.C.)