Regulations for Approval of Specific Medicinal Products' Manufacturing or Importing as a Special Case Article 8
The specific medicinal products’ manufacturing or importing which are approved in accordance with this regulation, with any of the following circumstances, shall be deemed with a doubt of safety or medical efficacy as prescribed in subparagraph 3 Paragraph 2 of Article 48-2 of the Act, the central competent authority may annual the approval:1. Additional conditions are not implemented.2. Applicant did not submit the assessment and record within the time limit of the preceding article, or failed to make corrections within the deadline after the submission.
中文原文 特定藥物專案核准製造及輸入辦法第8條
依本辦法核准專案製造或輸入之藥品，有下列各款情形之一者，視為本法第四十八條之二第二項第三款有安全或醫療效能疑慮，中央衛生主管機關得廢止其核准：
一、未依核准之附款執行。
二、申請人未於前條限期內提交評估報告及紀錄，或提交後未依限完成補正。
一、未依核准之附款執行。
二、申請人未於前條限期內提交評估報告及紀錄，或提交後未依限完成補正。