Regulations for the Inspection and Examination of Imported Medicaments Article 7
For the Chinese medicine materials required for inspection by the competent authority, the obligatory inspection applicants shall submit the following documents to the inspection authority to carry out the inspection:1. An application form for inspection.2. A copy of Chinese medicines pharmaceutical firms permit license.3. A copy of application for import declaration.4. A certificate of examination issued by the laboratories approved by central health competent authority, Chinese medicine manufacturers in compliance with Pharmaceutical Good Manufacturing Practice Regulations, or related competent authority from the country of origin.5. Necessary documents required by the competent authority.The application of the preceding paragraph can be submitted electronically.Chinese medicine materials that conform to one of the following situations can be exempted from inspection:1. Products to be imported are issued with a certificate of examination by the government of the country of origin who has signed an inspection waiver reciprocity agreement with the government of the Republic of China.2. The samples are permitted to import by the central competent health authority for the certificate of inspection pursuant to the fourth sub-paragraph of the first paragraph.3. A special permit from central competent health authority granted for national emergency situation or to improve the public welfare.
中文原文 輸入藥物邊境抽查檢驗辦法第7條
輸入經公告應施查驗之中藥材，應由報驗義務人檢具下列文件，向查驗機關申請查驗：
一、查驗申請書。
二、中藥商許可執照影本。
三、進口報單影本。
四、中央衛生主管機關公告認可之檢驗實驗室，或符合藥物優良製造準則之藥廠，或出口國主管機關所出具之檢驗證明。
五、其他經中央衛生主管機關公告之文件。
前項申請，得以電子方式為之。
第一項之中藥材有下列情形之一，免予查驗：
一、經互惠免驗優待輸出國主管機關發給檢驗合格證明者。
二、為取得第一項第四款之文件，而經中央衛生主管機關核准輸入之樣品者。
三、其他為因應國家緊急情況，或增進公益，經中央衛生主管機關專案核准免查驗者。
一、查驗申請書。
二、中藥商許可執照影本。
三、進口報單影本。
四、中央衛生主管機關公告認可之檢驗實驗室，或符合藥物優良製造準則之藥廠，或出口國主管機關所出具之檢驗證明。
五、其他經中央衛生主管機關公告之文件。
前項申請，得以電子方式為之。
第一項之中藥材有下列情形之一，免予查驗：
一、經互惠免驗優待輸出國主管機關發給檢驗合格證明者。
二、為取得第一項第四款之文件，而經中央衛生主管機關核准輸入之樣品者。
三、其他為因應國家緊急情況，或增進公益，經中央衛生主管機關專案核准免查驗者。