Regulations Governing Management of Manufacturing Schedule 1 and 2 Controlled Drugs Commissioned to Pharmaceutical Firms Article 3
The commissioned pharmaceutical firm must:1. Engage in a business undertaking of manufacturing pharmaceuticals.2. Obtain the permit for manufacturing the specific pharmaceutical form as defined in the contract.3. Obtain the registration license of controlled drugs under the business type of western pharmaceutical manufacturer.If the contract is terminated by the FDA according to that contract or these Regulations, the pharmaceutical firm will be disqualified for the commission of manufacturing controlled drugs for one year.
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3條
受託藥商應具備下列資格：
一、營業項目為製造西藥之藥商。
二、領有符合契約所定製造劑型之製造許可。
三、領有營業別為西藥製造業之管制藥品登記證。
經食品藥物署依委託契約解除或依本辦法終止委託契約者，一年內不具有受託製造管制藥品之資格。
一、營業項目為製造西藥之藥商。
二、領有符合契約所定製造劑型之製造許可。
三、領有營業別為西藥製造業之管制藥品登記證。
經食品藥物署依委託契約解除或依本辦法終止委託契約者，一年內不具有受託製造管制藥品之資格。