Pharmaceutical Affairs Act Article 80

If any of the following circumstances apply to any medicament, its manufacturer or importer shall immediately notify medical care institutions, pharmacies, and pharmaceutical firms and, within a prescribed time limit, shall recall the medicament in question from the market and dispose of it together with its stock of the medicament pursuant to the relevant provisions of this Act:I. Where the medicament has been granted a license but is subsequently prohibited by public announcement from being manufactured or imported.II. Where the drug has duly been deemed counterfeit, substandard, or prohibited in accordance with the law.III. Where the medical device has duly been deemed defective or has been manufactured or imported without approval in accordance with the law.IV. Medicaments produced by a medicament manufacturing factory are found, after inspection, to be damaging or likely to damage the life, body, or health of users.V. Where an application for extension of a medicament manufacture or import license previously granted has not been filed, or its approval has been denied.VI. Other medicaments whose recall has been publicly announced by the central competent health authority.Medical care institutions, pharmacies, and pharmaceutical firms shall cooperate with manufacturers or importers in recalling the medicaments set forth in the subparagraphs of the preceding paragraph.Regulations governing recalled medicaments under the provision of the first paragraph, such as classification, method of handling, recalling, and other matters to be complied with shall be prescribed by the central competent health and welfare authority.