行政程序法: 依法通報時間之計算

 藥物不良反應之通報, 對廠商很重要的就是時效性(timeline), 也就是法規所規定的當知悉不良反應後15天內要通報.

 

這裡指的15天內的起始計算, 知悉日不在計算時間內, 故也就是Day 0. 而次日才算是day 1.

 

法源依據(藥品安全監視訓練之釋疑):

 

行政程序法

第 八 節 期日與期間

第 48 條

n  期間以時計算者，即時起算。

n  期間以日、星期、月或年計算者，其始日不計算在內。但法律規定即日起算者，不在此限。

n  期間不以星期、月或年之始日起算者，以最後之星期、月或年與起算日相當日之前一日為期間之末日。但以月或年定期間，而於最後之月無相當日者，以其月之末日為期間之末日。

n  期間之末日為星期日、國定假日或其他休息日者，以該日之次日為期間之末日；期間之末日為星期六者，以其次星期一上午為期間末日。

n  期間涉及人民之處罰或其他不利行政處分者，其始日不計時刻以一日論；其末日為星期日、國定假日或其他休息日者，照計。但依第二項、第四項規定計算，對人民有利者，不在此限。

 

Administrative Procedure Act

Section 8 Dates and Periods

Article 48

n   A period fixed by hours shall commence immediately.

n   Where a period is fixed by days, weeks, months or years, the first day does not count for the purpose of calculation, unless it is prescribed by law that the period shall commence as of the immediate day.

n   If a period does not run from the beginning day of a week, month or year, it ends with the expiration of the day preceding the day of the last week, month or year which corresponds to that on which it began to run; provided that, if a period is fixed by months or years and there is no corresponding day in the last month, the period ends with the expiration of the last day of the last month.

n   If the last day of a period falls on Sunday, national holiday or any other holiday, the day following that day shall take its place, and if the last day of a period falls on Saturday, its last day shall be the Monday morning of the following week.

n   If a period has to do with any punishment to be imposed upon or any adverse administrative disposition to be rendered against a person, the beginning day shall be the whole day thereof regardless of any hour of the day; and if the last day falls on Sunday, national holiday or any other holiday, it shall ends on that day, unless it is more advantageous to the person if calculated in the manner set forth in paragraphs 2 and 3 hereof.