Pharmaceutical Affairs Act｜第 92 條｜Food and Drug Administration｜Act｜In Force
第 九 章｜衛生福利部 / 食品藥物管理署｜v107.01.31
Effective Date: 9999-12-31｜Last Amended: 2026-03-04
本條對違反藥事法多項規定者處3萬至200萬元罰鍰，並可公布藥廠藥商名單、限期改善、停止製造輸入。藥品（含成藥、處方藥、部分保健製劑）的輸入須經查驗登記並由合格藥商辦理，個人集運代購藥品極易觸法，務必先確認品項是否屬藥品管理範圍。
Any violator of the provisions of Article 6-1, Paragraph 1, Article 27, Paragraphs 1 and 3, Article 29, Article 31, Article 36, Article 37, Paragraphs 2 and 3, Article 39, Paragraph 1, Article 40, Paragraph 1, Article 44, Article 45-1, Article 46, Article 49, Article 50, Paragraph 1, Articles 51 through 53, Article 53-1 Paragraph 1, Article 55 Paragraph 1, Article 57 Paragraphs 1, 2, and 4, Article 57-1, Article 58, Article 59, Article 60, Article 64, Article 71, Paragraph 1, Article 72, Article 74, or Article 75, shall be issued a fine of not less than NT$30,000 but not more than NT$2,000,000. In the case of any violation of the provisions of Article 59 or dispensing or supplying strongly poisonous drugs in violation of the provisions of Article 60, Paragraph 1, either the person responsible for managing the drugs or the production supervisor of the drugs shall also be issued the fines set forth in the preceding paragraph. Any violator of the provisions of Article 53-1 Paragraph 1, Article 57, Paragraph 2 or 4 shall be penalized pursuant to Paragraph 1 of this Article. The central competent health authority may publicly announce the name of the medicament factory or pharmaceutical firm and order them to make rectification within a prescribed time period, and during the time period for such rectification, may suspend, in whole or in part, their manufacturing, wholesaling, import, export, and business operations. If rectification is not made within the prescribed time period, the central competent health authority may deny approval for an extension of the validity of the medicament license previously granted and will not process any other new application for other medicaments from the given factory or firm in the case of severe violation, and the central competent health authority may revoke all or part of the medicaments manufacture or distribution license. A violator of any provision of Article 66, Paragraph 1 or 2, Article 67, or Article 68 shall be issued a fine of not less than NT$ 200,000 but not more than NT$ 5,000,000.
違反第六條之一第一項、第二十七條第一項、第三項、第二十九條、第三十一條、第三十六條、第三十七條第二項、第三項、第三十九條第一項、第四十條第一項、第四十四條、第四十五條之一、第四十六條、第四十九條、第五十條第一項、第五十一條至第五十三條、第五十三條之一第一項、第五十五條第一項、第五十七條第一項、第二項、第四項、第五十七條之一、第五十八條、第五十九條、第六十條、第六十四條、第七十一條第一項、第七十二條、第七十四條、第七十五條規定之一者，處新臺幣三萬元以上二百萬元以下罰鍰。 違反第五十九條規定，或調劑、供應毒劇藥品違反第六十條第一項規定者，對其藥品管理人、監製人，亦處以前項之罰鍰。 違反第五十三條之一第一項、第五十七條第二項或第四項規定者，除依第一項規定處罰外，中央衛生主管機關得公布藥廠或藥商名單，並令其限期改善，改善期間得停止其一部或全部製造、批發、輸入、輸出及營業；屆期未改善者，不准展延其藥物許可證，且不受理該藥廠或藥商其他藥物之新申請案件；其情節重大者，並得廢止其一部或全部之藥物製造許可或西藥運銷許可。 違反第六十六條第一項、第二項、第六十七條、第六十八條規定之一者，處新臺幣二十萬元以上五百萬元以下罰鍰。
藥事法第92條：藥品、藥商多項違規的3萬至200萬元罰鍰規定——提醒集運勿擅自輸入藥品。
藥品輸入須經查驗登記並由合格藥商辦理，個人自用進口有嚴格數量與品項限制，商業輸入未經許可可處3萬至200萬元罰鍰。代購處方藥、來路不明藥品風險極高，不建議透過一般集運進口。