Application of the regulation

In accordance with Article 22 of the Pharmaceutical Affairs Act, consent of the Administration shall be obtained before drugs may be imported. For travelers bringing drugs into Taiwan, Article 2, Subparagraph 4; Article 4; Article 6; and Article 14 of the Regulations on Management of Medicament Samples and Gifts apply. In addition to filling out the Application for Import Certificate (as attached), the following materials shall be attached:

I. A copy of your passport(ID)

II. Customs claim paper (not required, if you apply before the products be sent)

III. Doctor's prescription

IV. Assurance Statement of Drug Application for Personal Use

V. Application Form . ( Application for import certificate )

VI. Your medicine (drug) products instructions (an instruction leaflet accompanying medicine sold).

Where the sample applied for is a prescription drug or medical device, the diagnosis certificate and prescription issued by a domestic medical institution or the diagnosis certificate and prescription issued by the original foreign medical institution recognized by the central health competent authority shall also be submitted.

In addition to the materials prescribed in the preceding two paragraphs, the Administration may request that the applicant submit the product-related information and Certificate for Foreign Government issued by the country of origin of the medicament for review.

Thus, when applying, fill out the application form and attach a photocopy of the applicant's ID card or passport, a photocopy of the customs bill of lading, a package insert (including product ingredients) or instructions, and an original copy of affidavit of personal use, and send them along with the Application to No. 161-2, Kunyang Street, Nangang District, Taipei City 11561 Food and Drug Administration, Ministry of Health and Welfare. The Administration will process the application as soon as possible after receipt.

The Administration will send the Import Certificate to the correspondence address provided by the applicant so that the applicant can use it for Customs clearance.