Pharmaceutical Affairs Act Article 78
In addition to the actions to be taken under other relevant provisions of this Act, the following disciplinary actions shall be taken when any counterfeit drugs, substandard drugs, prohibited drugs, or defective medical devices are found during any inspection or testing:1. For any firm that manufactures or imports counterfeit drugs or prohibited drugs or that engages in imposture by using another party’s permit licenses, the original issuing authority shall revoke their entire medicament licenses, pharmaceutical firm business permits, and medicament manufacture licenses, and all or part of the items for which the company, business, or factory is registered.2. For any firm that sells or displays with intent to sell counterfeit drugs or prohibited drugs, the municipality or county (or city) competent health authority shall publicly announce the name, address, and the responsible person of the firm or the business, the name of the drugs involved, and the details of the violation. In the event of any further violation, its business operations may be suspended.3. For any firm that manufactures, imports, sells, or displays with intent to sell substandard drugs or defective medical devices, the municipality or county (or city) competent health authority shall publicly announce the name, address, and the responsible person of the firm or the business, the name of the drugs involved and the details of the violation. In the case of a serious violation or repeated violation, each respective medicament license or medicament manufacture license may be revoked, and its business operations may be suspended.The provisions of the preceding paragraph shall apply mutatis mutandis to medical devices that are manufactured or imported without approval.
中文原文 藥事法第78條
經稽查或檢驗為偽藥、劣藥、禁藥及不良醫療器材，除依本法有關規定處理外，並應為下列處分：
一、製造或輸入偽藥、禁藥及頂替使用許可證者，應由原核准機關，廢止其全部藥物許可證、藥商許可執照、藥物製造許可及公司、商業、工廠之全部或部分登記事項。
二、販賣或意圖販賣而陳列偽藥、禁藥者，由直轄市或縣（市）衛生主管機關，公告其公司或商號之名稱、地址、負責人姓名、藥品名稱及違反情節；再次違反者，得停止其營業。
三、製造、輸入、販賣或意圖販賣而陳列劣藥、不良醫療器材者，由直轄市或縣（市）衛生主管機關，公告其公司或商號之名稱、地址、負責人姓名、藥物名稱及違反情節；其情節重大或再次違反者，得廢止其各該藥物許可證、藥物製造許可及停止其營業。
前項規定，於未經核准而製造、輸入之醫療器材，準用之。
一、製造或輸入偽藥、禁藥及頂替使用許可證者，應由原核准機關，廢止其全部藥物許可證、藥商許可執照、藥物製造許可及公司、商業、工廠之全部或部分登記事項。
二、販賣或意圖販賣而陳列偽藥、禁藥者，由直轄市或縣（市）衛生主管機關，公告其公司或商號之名稱、地址、負責人姓名、藥品名稱及違反情節；再次違反者，得停止其營業。
三、製造、輸入、販賣或意圖販賣而陳列劣藥、不良醫療器材者，由直轄市或縣（市）衛生主管機關，公告其公司或商號之名稱、地址、負責人姓名、藥物名稱及違反情節；其情節重大或再次違反者，得廢止其各該藥物許可證、藥物製造許可及停止其營業。
前項規定，於未經核准而製造、輸入之醫療器材，準用之。