Regulations Governing Management of Manufacturing Schedule 1 and 2 Controlled Drugs Commissioned to Pharmaceutical Firms Article 2
Where the Taiwan Food and Drug Administration (hereinafter referred to as the “FDA”) commission a pharmaceutical firm to manufacture any controlled drug pursuant to Paragraph 1, Article 4 of the Act, the parties shall enter into a contract in which the parties shall specify the items commissioned for manufacturing, rights and obligations, dispute resolution, and other provisions.Upon the execution of the foregoing contract, the commissioned pharmaceutical firm shall obtain the consent of the FDA before it starts manufacturing the controlled drugs.
中文原文 藥商受託製造第一級及第二級管制藥品管理辦法第2條
衛生福利部食品藥物管理署（以下稱食品藥物署）依本條例第四條第一項規定，委託藥商製造管制藥品時，應訂定委託契約，載明委託製造項目、相關權利義務、爭議處理及其他相關事項。
受託藥商依前項規定簽訂契約後，應於製造管制藥品前，報食品藥物署同意後，始得製造。
受託藥商依前項規定簽訂契約後，應於製造管制藥品前，報食品藥物署同意後，始得製造。