Pharmaceutical Affairs Act Article 48-17

The generic drug license holder shall market the drug within 6 months after the next day of such holder’s obtaining of said drug license and shall, within 20 days after the next day to the earliest marketing date, provide the evidence of the actual marketing date to the central competent health authority for its determination of the marketing exclusivity period granted and the commencement date and end date thereof.The marketing exclusivity period stipulated in Paragraph 1 hereof starts from the date of the actual marketing of the drug.If more than one application for the generic drug license is jointly subject to the marketing exclusivity period, the commencement date thereof shall be the date on which any of such drugs are actually first marketed.