Regulations for Registration of Medicinal Products Article 84
If an applicant for the registration of imported Chinese medicines is required to apply for Chinese medicine samples before proceeding with drug testing in accordance with the preceding article, the applicant shall carry out customs clearance according to the quantity of the Chinese medicine samples, raw materials, and reference standards stated on the drug testing notice set forth in Paragraph 1 of Article 82 in addition to proceeding with drug testing in accordance with the preceding article. However, to ensure that the packaging remains intact, the applicant may request the customs office to release the medicines in a single complete package if the quantity of a single package of imported medicines exceeds the quantity required for testing.The regulations of the preceding paragraph shall apply mutatis mutandis to the samples, their quantity, and the customs clearance procedures for the testing required for the application for post-approval changes of imported Chinese medicines.
中文原文 藥品查驗登記審查準則第84條
申請輸入中藥查驗登記，依前條規定送驗前須申請中藥樣品者，除依前條規定辦理送驗外，應依第八十二條第一項送驗通知所載之中藥樣品、原藥材及對照標準品之數量，辦理通關。
但輸入之單一包裝數量逾檢驗所需數量者，為顧及包裝完整性，得商請海關以單一完整包裝酌量放行。
申請輸入中藥變更登記須送驗時，其樣品、數量與通關作業，準用前項規定。
但輸入之單一包裝數量逾檢驗所需數量者，為顧及包裝完整性，得商請海關以單一完整包裝酌量放行。
申請輸入中藥變更登記須送驗時，其樣品、數量與通關作業，準用前項規定。