Pharmaceutical Affairs Act Enforcement Rules Article 15
Matters relating to the "amendment of registration" that shall be carried out in accordance with Article 27, paragraph 1 of the Act include amendments to the content of a pharmaceutical firm's registration and the voluntary suspension, resumption, or termination of business.To carry out amendment of registration, a pharmaceutical firm must apply to the competent health authority that originally approved its registration within 15 days from the date of occurrence of a change in any matter requiring amendment of registration under the preceding paragraph.
中文原文 藥事法施行細則第15條
本法第二十七條第一項所稱應辦理變更登記之事項，包括藥商登記事項之變更及自行停業、復業或歇業。
前項應辦理變更登記事項，藥商應自事實發生之日起十五日內，向原核准登記之衛生主管機關申請辦理變更登記。
前項應辦理變更登記事項，藥商應自事實發生之日起十五日內，向原核准登記之衛生主管機關申請辦理變更登記。