Regulations for Approval of Specific Medicinal Products' Manufacturing or Importing as a Special Case Article 7
The manufacturing or importing of the specific medicinal products which are approved in accordance with this regulation, the applicant shall continue to conduct safety and medical efficacy assessment after the approval. The manufacturing or importing of the specific medicinal products approved in accordance with Article 3, the delivery and its sales objects should be recorded.If necessary, the central competent authority may order the applicant to submit the assessment or record of preceding paragraph within a time limit.
中文原文 特定藥物專案核准製造及輸入辦法第7條
依本辦法核准專案製造或輸入之藥品，申請者應於核准後續行安全及醫療效能之評估；其依第三條核准者，並應記錄運送及銷售對象。
中央衛生主管機關於必要時，得命申請者限期提交前項評估之報告及紀錄。
中央衛生主管機關於必要時，得命申請者限期提交前項評估之報告及紀錄。