Enforcement Rules for the Controlled Drugs Act Article 9

A person who applies to the FDA for an import permit for Schedule 1 and 2 controlled drugs in accordance with Article 19 Paragraph 1 of this Act shall prepare an application with the following documents enclosed:1. The copy of the drug import and manufacture permit license issued by the Central Health authority, or the documents relating to the permitted medical and educational research project. However, if the copies of licenses and documents have been sent to and retained by the FDA, need not to be enclosed.2. The records of the increase and decrease of stocks for the month prior to the date of application pertaining to the applied controlled drugs sought to be imported. However, records reported in accordance with Article 26 need not be enclosed.