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Pharmaceutical Affairs Act - Article 79

Pharmaceutical Affairs Act|第 79 條|Food and Drug Administration|Act|In Force

第 八 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

Practical Impact on Consolidation/Import

本條規定查獲偽藥、禁藥、劣藥或不良醫療器材的處理方式,其中對輸入品有專門規定。查獲之偽藥或禁藥,沒入銷燬之。查獲之劣藥或不良醫療器材,如係本國製造且經檢驗後仍可改製使用者,由直轄市或縣(市)衛生主管機關派員監督原製造廠商限期改製,不能改製或屆期未改製者沒入銷燬;如係核准輸入者,應即封存,並由直轄市或縣(市)衛生主管機關責令原進口商限期退運出口,屆期未能退貨者沒入銷燬。上述規定於經依法認定為未經核准而製造、輸入之醫療器材準用之。

Content

The counterfeit drugs or prohibited drugs seized shall be confiscated and destroyed. In case the substandard drugs or defective medical devices seized are domestically manufactured and considered, after testing, to be still usable through re-modification, the municipal or county (city) competent health authority shall direct and assign an official to supervise the original manufacturer to re-modify within a time limit. Those that cannot be re-modified or have not been re-modified within the given time limit shall be confiscated and destroyed. If approved for import, they shall be placed in confinement immediately, and the municipal or county (city) competent health authority shall direct the original importer to return such products to the foreign supplier(s) within a time limit. Those which have not been returned beyond the given time limit shall be confiscated and destroyed. The provisions of the preceding paragraph shall also apply mutatis mutandis to medical devices that are legally determined to be manufactured or imported without approval.

Penalty

查獲之偽藥或禁藥,沒入銷燬之。 查獲之劣藥或不良醫療器材,如係本國製造,經檢驗後仍可改製使用者,應由直轄市或縣(市)衛生主管機關,派員監督原製造廠商限期改製;其不能改製或屆期未改製者,沒入銷燬之;如係核准輸入者,應即封存,並由直轄市或縣(市)衛生主管機關責令原進口商限期退運出口,屆期未能退貨者,沒入銷燬之。 前項規定於經依法認定為未經核准而製造、輸入之醫療器材,準用之。

FAQ

查獲的偽藥或禁藥如何處理?

依本條第一項,查獲之偽藥或禁藥,沒入銷燬之。

核准輸入的劣藥被查獲會怎麼處理?

依本條第二項,如係核准輸入者,應即封存,並由直轄市或縣(市)衛生主管機關責令原進口商限期退運出口,屆期未能退貨者,沒入銷燬之。

Related Regulations - Pharmaceutical Affairs Act

  • Pharmaceutical Affairs Act - Article 76(第 76 條)
  • Pharmaceutical Affairs Act - Article 80(第 80 條)
  • Pharmaceutical Affairs Act - Article 71(第 71 條)
  • Pharmaceutical Affairs Act - Article 71-1(第 71-1 條)
  • Pharmaceutical Affairs Act - Article 72(第 72 條)
  • Pharmaceutical Affairs Act - Article 73(第 73 條)
  • Pharmaceutical Affairs Act - Article 74(第 74 條)