Pharmaceutical Affairs Act Article 27-2

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.