Regulations for Registration of Medicinal Products Article 30
For the application for drug registration of imported drugs, the regulation of testing samples, their quantity and custom clearance procedure are as follows:1.In principle, the quantities of samples of testing drugs and reference standards for custom clearance should be consistent with the quantities stated on the letter of notice issued by the central health competent authority. However, to have the packaging remain intact, the applicant may request the custom office to deliberate over the factual packaging and release one single complete package.2.Manufacturers should follow the Regulations Governing Controlled Drugs and the corresponding implementation rules in compliance with the central health competent authority for approval of the importation and exportation of controlled drugs (including the importation of active pharmaceutical ingredients of controlled drugs for trial manufacturing). This requirement also applies to drugs not classified as controlled drugs in Taiwan but an importation permit is required by the manufacturing country.The above regulations for testing samples and their quantities and custom clearance procedures are also applied to the applications of post-approval changes of imported drugs.
中文原文 藥品查驗登記審查準則第30條
申請輸入藥品查驗登記所需檢附樣品、數量與通關作業規定如下：
一、凡持中央衛生主管機關核發之通知廠商送驗書函通關，原則上以該送驗書函上載明之藥物樣品及對照標準品之數量為準。
但為顧及包裝完整性，得商請海關視實際單一完整包裝酌量放行。
二、輸出、輸入管制藥品（含試製管制藥品原料藥輸入）之相關同意文件，應依管制藥品管理條例及其施行細則之規定，向中央衛生主管機關申請。
非列屬管制藥品分級及品項，應出產國要求應申請我國輸入許可文件者，亦同。
申請輸入藥品變更登記如須送驗時，其樣品、數量與通關作業，準用前項規定。
一、凡持中央衛生主管機關核發之通知廠商送驗書函通關，原則上以該送驗書函上載明之藥物樣品及對照標準品之數量為準。
但為顧及包裝完整性，得商請海關視實際單一完整包裝酌量放行。
二、輸出、輸入管制藥品（含試製管制藥品原料藥輸入）之相關同意文件，應依管制藥品管理條例及其施行細則之規定，向中央衛生主管機關申請。
非列屬管制藥品分級及品項，應出產國要求應申請我國輸入許可文件者，亦同。
申請輸入藥品變更登記如須送驗時，其樣品、數量與通關作業，準用前項規定。