Enforcement Rules for the Controlled Drugs Act Article 16

A person who applies to the FDA for the permit for manufacturing Schedule 3 and 4 controlled drugs in accordance with Article 20 of this Act shall prepare the application with the following documents enclosed:1. The copies of drug manufacture permit license issued by the Central Health or Agricultural Administration, of the approved medical research projects or permission documents for developing drugs. However, one who has sent the copies of the documents mentioned above to the FDA for reference need not to enclose them.2. The records of increase and decrease of stocks for the month prior to the date of application pertaining to the applied controlled drugs sought to be manufactured. However, records reported in accordance with Article 26 need not be enclosed.The permit for manufacturing controlled drugs mentioned in the preceding Paragraph shall not be reused. The given time limit of manufacturing shall not exceed three months after the issuance date.