Pharmaceutical Affairs Act Article 48-16

The application for a generic drug license in accordance with Subparagraph 4 of Article 48-9 with application documents duly prepared at the earliest shall be granted a 12-month period of marketing exclusivity; the central competent health authority shall not issue other drug licenses to other applicants for a generic drug license before the expiration of the aforementioned period.For the aforementioned application for a generic drug license with documents duly prepared under Subparagraph 4 of Article 48-9, upon the occurrence of vacancy due to any of the following matters, the vacancy will be fulfilled by the subsequent applicant with application documents duly prepared:1. During the period of drug license examination, the declaration under Subparagraph 4 of Article 48-9 is amended.2. The earliest applicant fails to obtain notification from the central competent health authority that the examination of the application for a generic drug license has been completed within 12 months after the next day to the date that all the application documents are duly prepared.3. Any matter as stipulated in Paragraph 4 of Article 48-13 occurs.If more than one application for a generic drug license in compliance with the requirements regarding the earliest duly prepared application documents is filed on the same date, such applications are jointly subject to the 12-month period of marketing exclusivity.