Regulations Governing Accreditation and Outsourced Accreditation Management of Drugs Testing Institutions Article 10
In the event of changes in any of the items enumerated under Subparagraphs 1 to 3 of Paragraph 1 of Article 8, the testing institution shall, within the following periods, submit an application for changes to the central competent health authority:1. Change of laboratory address: application shall be filed within 30 days of event.2. Change of the basis of testing methods: application shall be filed within 90 days of event.3. Change of test scope due to amendments of the dosage limitation of abnormal substance contained in Chinese medicine and Concentrated Chinese Medicinal Preparations: application shall be filed within 90 days of the effective date.4. Change of the title of the testing institution, the title of the laboratory, the name of the laboratory head or the report signatory: application shall be filed within 90 days of event.For the applications specified above, the central competent health authority, when necessary, may conduct on-site review.
中文原文 藥物檢驗機構認證及委託認證管理辦法第10條
第八條第一項第一款至第三款所定事項變更時，檢驗機構應於下列規定期間內，向中央衛生主管機關申請變更：
一、實驗室地址變更：自事實發生之日起三十日。
二、檢驗方法之依據變更：自事實發生之日起九十日。
三、中藥材及中藥濃縮製劑含異常物質限量基準修正致檢驗範圍變更：自生效之日起九十日。
四、檢驗機構名稱、實驗室名稱、實驗室負責人或報告簽署人變更：自事實發生之日起九十日。
前項申請，必要時，中央衛生主管機關得進行實地查核。
一、實驗室地址變更：自事實發生之日起三十日。
二、檢驗方法之依據變更：自事實發生之日起九十日。
三、中藥材及中藥濃縮製劑含異常物質限量基準修正致檢驗範圍變更：自生效之日起九十日。
四、檢驗機構名稱、實驗室名稱、實驗室負責人或報告簽署人變更：自事實發生之日起九十日。
前項申請，必要時，中央衛生主管機關得進行實地查核。