Pharmaceutical Affairs Act｜第 27-3 條｜Food and Drug Administration｜Act｜In Force
第 二 章｜衛生福利部｜v1.0
Effective Date: 9999-12-31｜Last Amended: 2026-03-04
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.