Regulations for Registration of Medicinal Products Article 110

The Regulations take effect on the date of promulgation.The provisions of Article 53, Article 39 related Appendix 2, and Article 40 related Appendix 4 amended on April 6th, 2016 in this Regulation shall come into force as of July 1st, 2017; The provision of Article 92 Paragraph 3 amended on July 31th, 2017 in this Regulation shall come into force as of January 1st, 2019; The provisions of article 42 related Appendix 8, the photocopy of the API for Exportation GMP compliance certificate dated within the past 2 years, amended on September 14th , 2021 in this Regulation shall come into force as of January 1st, 2022; The provisions of Article 46, 56, 62, 64 and 70 amended on April 27th, 2023 in this Regulation shall come into force as of January 1st, 2024.
中文原文 藥品查驗登記審查準則第110條
本準則自發布日施行。
本準則中華民國一百零五年四月六日修正發布之第五十三條、第三十九條附件二及第四十條附件四,自一百零六年七月一日施行;一百零六年七月三十一日修正發布之第九十二條第三項,自一百零八年一月一日施行;一百十年九月十四日修正發布之第四十二條附件八外銷專用原料藥之近二年內查核原料藥符合藥品優良製造規範之證明影本,自一百十一年一月一日施行;一百十二年四月二十七日修正發布之第四十六條、第五十六條、第六十二條、第六十四條、第七十條,自一百十三年一月一日施行。

English translation for reference only; the Chinese text prevails. Not legal advice.