Pharmaceutical Affairs Act｜第 40-2 條｜Food and Drug Administration｜Act｜In Force
第 四 章｜衛生福利部 / 食品藥物管理署｜v107.01.31
Effective Date: 9999-12-31｜Last Amended: 2026-03-04
1. Upon the issuance of a new drug license, the central competent health authority shall publish the patent numbers or file numbers that have already been disclosed to the public as submitted by the applicant. 2. Within 3 years after the issuance of a new drug license for a new molecular entity, no other pharmaceutical firm may apply for registration of the same drug by citing the application data submitted by said drug license holder without such holder’s consent. 3. Starting from the next day to the expiration of the period stipulated in Paragraph 2 hereof, other pharmaceutical firms may apply for registration of drugs in accordance with this Act and relevant regulations; for those in compliance with relevant regulations, the central competent health authority may issue a drug license only after the next day to the expiration of a 5-year period after the issuance of said new drug license for the new molecular entity as stipulated in Paragraph 2 hereof. 4. Paragraph 2 hereof is applicable only when an application for registration of a drug containing a new molecular entity is filed with the central competent health authority within 3 years after marketing approval is obtained for such drug in a foreign country.