Pharmaceutical Affairs Act Article 48-12

For an application for a generic drug license that involves a declaration under Subparagraph 4 of Article 48-9, the applicant shall, within 20 days from the day following the receipt of notification from the central competent health authority confirming the completeness of the drug license application documents, issue a notification in writing to both the new drug license holder and the central competent health authority. If the said new drug license holder is different from the patentee or the exclusive licensee, the patentee and the exclusive licensee shall also be notified.The applicant of a generic drug license shall provide an explanation and evidence in the aforementioned notification regarding its allegation that the patent shall be revoked or that there is no patent infringement.The central competent health authority shall dismiss the application for a generic drug license if the applicant fails to issue the notification in accordance with Paragraphs 1 and 2 hereof.