Pharmaceutical Affairs Act Article 40-3

1. For a drug that has been approved by the central competent health authority to supplement or amend the indications thereof, within 2 years after the approval of such supplements or amendments to indications, no other pharmaceutical firm may apply for registration of the same indication by citing the application data submitted by said drug license holder without such holder’s consent.2. Starting from the next day to the expiration of the period stipulated in Paragraph 1 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 3-year period after the approval of supplements or amendments to indications as stipulated in Paragraph 1 hereof. However, if the drug license holder obtaining the approval of supplements or amendments to indications conducts a domestic clinical trial regarding such supplements or amendments to indications, the central competent health authority may issue a drug license to other pharmaceutical firms only after the next day to the expiration of a 5-year period after the approval of supplements or amendments to indications.3. Paragraph 1 hereof is applicable only when an application for registration of such supplements or amendments to drug indications is filed with the central competent health authority within 2 years after such approval of indications is obtained for such drug in a foreign country.