Drug Injury Relief Act Article 3

The terms used in this Act are defined as follows:I. Drug injury: Death, disability, or severe illness caused by an adverse drug reaction.II. Legal drug: A drug that has obtained a drug license issued by the competent authority, or that has received special approval pursuant to Paragraph 1 of Article 27-3 or Subparagraph 2 of Paragraph 1 of Article 48-2 of the Pharmaceutical Affairs Act, and is manufactured, imported, or sold in accordance with the law.III. Proper use: The use of a drug in accordance with the instructions provided by medical professionals or the labeling of the drug.IV. Adverse reaction: A harmful effect associated with the use of a specific drug.V. Disability: A condition meeting the disability categories and severity classifications defined under the People with Disabilities Rights Protection Act, excluding conditions caused by psychological factors.VI. Severe Illness: An illness announced by the competent authority with reference to the scope of the Major Illness and Injury under the National Health Insurance system and the serious adverse reactions listed in the Regulations for Reporting Serious Adverse Reactions of Medicaments.
中文原文 藥害救濟法第3條
本法用詞定義如下:
一、藥害:指因藥物不良反應致死亡、障礙或嚴重疾病。
二、合法藥物:指領有主管機關核發藥物許可證,或依藥事法第二十七條之三第一項、第四十八條之二第一項第二款規定取得專案核准,依法製造、輸入或販賣之藥物。
三、正當使用:指依醫藥專業人員之指示或藥物標示而為藥物之使用。
四、不良反應:指因使用藥物,對人體所產生之有害反應。
五、障礙:指符合身心障礙者權益保障法相關規定所定身心障礙類別、程度分級者。
但不包括因心理因素所導致之情形。
六、嚴重疾病:指主管機關參照全民健康保險重大傷病範圍及藥物不良反應通報規定所列嚴重不良反應公告之疾病。

English translation for reference only; the Chinese text prevails. Not legal advice.