Pharmaceutical Affairs Act Article 48-20

The provisions under Articles 48-9 through 48-15 hereof related to the application for a generic drug license shall apply mutatis mutandis to the new drugs not having a new ingredient.The provisions related to the stay of drug license issuance and the marketing exclusivity period under Articles 48-13 to 48-18 are not applicable to the application for a generic drug license set forth in Article 48-12 if the following circumstances are met:1. The patent(s) registered under an approved new drug is still valid and is a patent for medical use under Subparagraph 3, Paragraph 2 of Article 48-3.2. The applicant of a generic drug license excludes the indication corresponding to the patent for medical use referred to in Subparagraph 1 hereof and declares that the generic drug does not infringe the said patent.The exclusion of indication, declaration, and other matters shall be abided by in this regard as stipulated in Paragraph 2 hereof shall be promulgated by the central competent health authority.