2018.8.22
Fang-Wei Lin
Since incidences of drug abuse in Taiwan have increased rapidly in Taiwan, the Taiwan Food and Drug Administration (hereinafter, the “TFDA”) promulgated Articles 3, 4-1, 11, and 22 of the Regulations for the Inspection and Examination of Imported Medicaments (hereinafter, the “Regulations”) as amended on August 22, 2018 to prevent narcotics raw materials from being falsely imported as active pharmaceutical ingredients with the amendments highlighted below:
For starter, to prevent narcotics raw materials from being falsely imported as active pharmaceutical ingredients and to enhance import control and the accuracy of customs clearance information, the TFDA amended Article 4-1 of the Regulations to conduct border control over the import of active pharmaceutical ingredients by specifically stipulating the spot check method for the active pharmaceutical ingredients under Chapters 28 and 29 of the ROC Import and Export Commodity Classification Table. In addition to spot check quantities under Subparagraph 1 of this article, the method of examination for the spot check is also stipulated as follows. In case of a spot check, rapid examination will be conducted by using rapid examination instruments on the borders. If an item is found to be narcotics as determined by the examination, this item will be referred to relevant agencies for investigation. If goods cannot be determined on borders by rapid examination instruments, all goods shall be sealed on the spot and the operator shall issue an affidavit, provide a storage location that meets applicable requirements and assume the responsibility for the custody of the goods before the party obligated to submit the goods for examination notifies the TFDA to send personnel to conduct an examination in the location. If the examination is passed, the TFDA will issue an import permit. If the examination as well as a re-examination is not passed, the party obligated to submit the goods for examination shall return or destroy the goods.
In addition, to carry out prevention and traceability mechanisms for narcotics, a party obligated to submit goods for examination shall prepare relevant documents and apply to the TFDA for examination. According to Article 3 of the Regulations as amended, the documents that shall be prepared for application for an import permit for active pharmaceutical ingredients shall not be limited to the copy of an import license for pharmaceuticals. Instead, import certificates issued by the competent authority may also be used.