Pharmaceutical Affairs Act Article 48-22

The details of the following should be promulgated by the central competent health authority: the method and content of submission of the patent information, the amendment and deletion thereof, the listing and publication of the patent information as stipulated in Articles 48-4 to 48-8; the declaration made by the applicant for a generic drug license as stipulated in Article 48-9; the method and content of the written notification made by the applicant for the generic drug license as stipulated in Article 48-12; the method and content of the notification relating to completion of the examination procedures of an application for a generic drug license by the central competent health authority as stipulated in Article 48-15; the commencement and termination of the marketing exclusivity period as stipulated in Articles 48-16 to 48-18; other matters that shall be abided by.