Regulations on Management of Medicament Samples and Gifts Article 2
For a medicament that meets one of the requirements of the following subparagraphs, an application may be made to have it declared a medicament sample:I. The pharmaceutical firm is applying for registration or improvement of manufacturing technology purposes.II. Due to business needs, the pharmaceutical firm, academic research or trial institute, contract research organization, medical academic group or teaching hospital is applying for solely research or trial purposes.III. A specialized teaching hospital or teaching hospital at or above the regional level is applying for purposes of diagnosis and treatment of patients with critical or catastrophic illness.IV. A patient applying for personal uses, certified by a medical institution. However, medical devices that should be operated by a physician or professional are excluded.V. A medical device company applying for specific exhibitions or demonstration purposes.VI. A pharmaceutical firm applying for educational promotion purposes, given that the medicament has been issued a license in accordance with the stipulations of the Act.VII. An application for purposes of public safety or public health or due to major disasters.
中文原文 藥物樣品贈品管理辦法第2條
藥物符合下列各款規定之一者，得申請為藥物樣品：
一、藥商申請供查驗登記或改進製造技術之用者。
二、藥商、學術研究或試驗機構、試驗委託機構、醫藥學術團體或教學醫院，因業務需要，申請專供研究、試驗之用者。
三、專科教學醫院或區域級以上教學醫院申請供診治危急或重大病患之用者。
四、病患經醫療機構出具證明申請供自用者。
但應由醫師或專業人員操作之醫療器材除外。
五、醫療器材藥商申請供特定展覽或示範之醫療器材。
六、藥商申請依本法規定已核發許可證之藥物供教育宣導之用者。
七、申請供公共安全或公共衛生或重大災害之用者。
一、藥商申請供查驗登記或改進製造技術之用者。
二、藥商、學術研究或試驗機構、試驗委託機構、醫藥學術團體或教學醫院，因業務需要，申請專供研究、試驗之用者。
三、專科教學醫院或區域級以上教學醫院申請供診治危急或重大病患之用者。
四、病患經醫療機構出具證明申請供自用者。
但應由醫師或專業人員操作之醫療器材除外。
五、醫療器材藥商申請供特定展覽或示範之醫療器材。
六、藥商申請依本法規定已核發許可證之藥物供教育宣導之用者。
七、申請供公共安全或公共衛生或重大災害之用者。