Pharmaceutical Affairs Act Article 48-19

For any settlement agreement or other agreement involving the manufacture, sales, and marketing exclusivity period of drug related to the regulations under this Chapter executed between the applicant for a new drug license, the new drug license holder, the applicant for a generic drug license, the generic drug license holder, and the patentee or exclusive licensee of a drug patent, within 20 days after the next day to the occurrence of such matter, both parties shall notify the central competent health authority, and if reverse payment interest agreement is involved, shall also notify the Fair Trade Commission.The method and content of the notification stipulated in Paragraph 1 hereof, as well as other matters, shall be abided by in this regard and shall be promulgated by the central competent health authority jointly with the Fair Trade Commission.If the central competent health authority considers that the agreement notified under Paragraph 1 hereof is likely to violate the Fair Trade Act, it may notify the Fair Trade Commission.