Pharmaceutical Affairs Act｜第 27-2 條｜Food and Drug Administration｜Act｜In Force
第 二 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
本條規範必要藥品的供應穩定機制，適用對象為持有中央衛生主管機關公告為必要藥品許可證之藥商。該藥商應就許可證藥品之製造、輸入及供應情形定期申報；有無法繼續製造、輸入或不足供應之虞時，應至少於六個月前通報中央衛生主管機關；因天災或其他不可歸責之事由而未及通報者，應自事實發生之次日起三十日內通報。
Pharmaceutical firms holding drug licenses that were announced as essential drugs by the central competent health authority shall regularly report to the central competent health authority the status of manufacture, import, and supply of such drugs covered by the drug licenses. Where a pharmaceutical firm referred to in the preceding paragraph anticipates that it will be unable to continue manufacturing or importing the drug, or that the supply of such drug may become insufficient, it shall notify the central competent health authority at least six months in advance. Where prior notification cannot be made within the preceding period due to natural disasters or other causes not attributable to the pharmaceutical firm, such notification shall be made within thirty days since the occurrence of such event. The reporting method, content, scope, and period referred to in the first paragraph, as well as the notification method, content, and other related matters referred to in the preceding paragraph, shall be prescribed by the central competent health authority.
依本條第一項，藥商持有經中央衛生主管機關公告為必要藥品之許可證者，應就該許可證藥品之製造、輸入及供應情形，定期向中央衛生主管機關申報。
依本條第二項，應至少於六個月前向中央衛生主管機關通報；因天災或其他不可歸責之事由而未及通報者，應自事實發生之次日起三十日內通報。