Pharmaceutical Affairs Act Article 27-3
Where the central competent health authority becomes aware that a drug with a drug license may face a risk of insufficient supply, it may post such circumstance on a public website and may grant special approval for the manufacture or import of such drug or its substitute drugs, not subject to Article 39.In response to emergencies or events that have a significant impact on public health, the central competent health authority may impose restrictions on the scope, duration, quantity, recipients, methods, or other restrictive measures on supply of the drugs referred to in the preceding paragraph, including those with a drug license or those approved for manufacture or import as a special case.The registration procedures referred to in the first paragraph, the application eligibility, review procedures, review criteria, revocation of approvals, and other matters to be complied with in regarding to the approval as a special case shall be prescribed by the central competent health authority.
中文原文 藥事法第27-3條
中央衛生主管機關於知悉具有藥品許可證之藥品有供應不足之虞時，得將該情形登錄於公開網站，並得專案核准該藥品或其替代藥品之製造或輸入，不受第三十九條規定之限制。
中央衛生主管機關為因應緊急或重大影響公共衛生事件，得就前項具有藥品許可證之藥品或專案核准製造、輸入之藥品，限制其供應之範圍、期間、數量、對象、方式或為其他限制措施。
第一項登錄作業、專案核准之申請條件、審查程序、審查基準、核准之廢止及其他應遵行事項之辦法，由中央衛生主管機關定之。
中央衛生主管機關為因應緊急或重大影響公共衛生事件，得就前項具有藥品許可證之藥品或專案核准製造、輸入之藥品，限制其供應之範圍、期間、數量、對象、方式或為其他限制措施。
第一項登錄作業、專案核准之申請條件、審查程序、審查基準、核准之廢止及其他應遵行事項之辦法，由中央衛生主管機關定之。