Pharmaceutical Affairs Act Article 92-1

If the new drug license holder fails to reply within the period of time prescribed in Paragraph 3, Article 48-7, and after being ordered by the central competent health authority to reply within a prescribed period of time, still fails to reply within such period, shall be imposed with a fine of not less than NT$30,000 but no more than five NT$500,000 by the central competent health authority.Any failure to issue a notification in accordance with the method and content of notification as stipulated in the regulations promulgated pursuant to Paragraph 1 or 2 of Article 48-19 shall be imposed with a fine of not less than NT$30,000 but no more thanNT$2,000,000 by the central competent health authority.