Regulations for Registration of Medicinal Products Article 26
In situations where fees have not been paid, application forms not submitted, data insufficient or other matters not in accordance with the Regulations, the applicant should take corrective actions before the deadline specified by the central health competent authority. A two-month period is given for correction.If the applicant is not able to meet the deadline, a written statement should be submitted to support the application of an extension. The extended deadline is one month after the expiry date of the original correction period. Only one extension will be allowed.If the applicant fails to make correction within the original or the extended deadline, then the central health competent authority can reject the application based on the currently available information.
中文原文 藥品查驗登記審查準則第26條
申請案件如未依規定繳納費用、未填具申請書表、未備齊資料或有其他不符本準則規定之情形而得補正時，申請人應依中央衛生主管機關通知之期限內補正。
補正期限為二個月。
申請人如未能於期限內補正者，得於補正期滿前，以書面敘明理由申請延期；其延期期限，自補正期滿翌日起算一個月，且延期以一次為限。
申請人如未於期限內補正或延期一個月後仍逾期未補正者，中央衛生主管機關得依現有資料逕為審查核駁。
補正期限為二個月。
申請人如未能於期限內補正者，得於補正期滿前，以書面敘明理由申請延期；其延期期限，自補正期滿翌日起算一個月，且延期以一次為限。
申請人如未於期限內補正或延期一個月後仍逾期未補正者，中央衛生主管機關得依現有資料逕為審查核駁。