Regulations on Management of Medicament Samples and Gifts Article 6
The quantity of medicament samples applied for is limited to the actual amount required. However, for medical device samples for which application is made for purposes of technical improvement, specific exhibitions or demonstration, then except in special circumstances, the quantity is limited to one device (piece) of one model.For applications made in accordance with Article 2, Subparagraph 4, in addition to the stipulations of the preceding paragraph, they shall also comply with the following stipulations:I. Prescription drugs may not exceed a reasonable prescription amount.II. Over-the-counter drugs may not be re-applied for within six months. Except for special needs, which should be applied to the central health competent authority for approval, the quantity each time may not exceed 12 bottles, 12 cream tubes or a total quantity of 1,200 pills.III. Medical devices or instruments are limited to one device per model; and the quantity of consumables or sanitary materials may not exceed six months' usage.
中文原文 藥物樣品贈品管理辦法第6條
藥物樣品申請數量，以實際需要量為限。
但申請供改進技術、特定展覽或示範之醫療器材樣品，除特殊情形外，同一型號以一部（個）為限。
依第二條第四款規定申請者，除準用前項規定外，並應符合下列各款規定：
一、處方藥品不得超過處方箋之合理用量。
二、非處方藥品於六個月內不得重複申請。
除特殊需要，應申請中央衛生主管機關核准外，每次數量不得超過十二瓶或軟管類十二支或總量一千二百顆。
三、醫療器材儀器同一型號以一部為限，屬耗材或衛生材料類者，不得超過六個月用量。
但申請供改進技術、特定展覽或示範之醫療器材樣品，除特殊情形外，同一型號以一部（個）為限。
依第二條第四款規定申請者，除準用前項規定外，並應符合下列各款規定：
一、處方藥品不得超過處方箋之合理用量。
二、非處方藥品於六個月內不得重複申請。
除特殊需要，應申請中央衛生主管機關核准外，每次數量不得超過十二瓶或軟管類十二支或總量一千二百顆。
三、醫療器材儀器同一型號以一部為限，屬耗材或衛生材料類者，不得超過六個月用量。