Regulations for the Patent Linkage of Drugs Article 10

The Central Competent Health Authority shall, with reference to the provisions in Item 4 of Article 48-9 in the Act regarding the application for a generic drug permit license, formally respond to the applicant whether the application is duly prepared. If the application is duly prepared, the authority shall publicize the date when the application is duly completed in the Registration System.For more than one application for drug permit license of generic drugs that have the same reference new drug, the Central Competent Health Authority shall, as stated in the preceding Paragraph, formally respond, and also prioritize the formal responses in order of the dates of the receipt of the applications. If the applications are received on the same date, the authority shall formally respond on the same date.