Regulations for Approval of Specific Medicinal Products' Manufacturing or Importing as a Special Case Article 6
The medicinal products approved in accordance with Article 3, in the case that changes have to be made to an approved item, the changes must be approved before execution.
中文原文 特定藥物專案核准製造及輸入辦法第6條
依第三條核准之藥品，其核准事項有變更必要者，應經核准，始得為之。