Enforcement Rules of the Rare Diseases and Orphan Drugs Act Article 5
The report stipulated in Article 7 of the Act shall be submitted within a month from the day of discovery.
中文原文 罕見疾病防治及藥物法施行細則第5條
本法第七條規定之報告，應自發現之日起一個月內為之。
English translation for reference only; the Chinese text prevails. Not legal advice.