Regulations for the Issuance and Administration of Controlled Drugs Prescription Licenses and Registration licenses Article 13

When there is any change to any of the items recorded on the controlled drug registration license, then in accordance with Article 16, paragraph 3 of the Act, within 15 days from the date of occurrence of the change, a Controlled Drug Registration License Amendment Registration Application, the documents in Article 10, subparagraphs 2 to 4, and the original copy of the original controlled drug registration license shall be submitted to the FDA to carry out amendment registration.When applying for registration of a change to the responsible person or a controlled drug manager, the status of thecontrolled drug record book entries shall be reported, and the controlled drug inventory and balance data shall be submitted therewith.