Human Biobank Management Act Article 23

Violations of Article 4, Paragraph 1 hereof by establishing any Biobank without an approval from the Competent Authority shall be subject to a fine of no less than two million New Taiwan Dollars (NT$ 2,000,000) and no more than ten million New Taiwan Dollars (NT$ 10,000,000). Any and all biological specimens and other data and information stored in such a Biobank shall be destroyed. However, in the event that the qualification and condition requirements for the establishment set for in Article 4, paragraph 2 hereof are met and that other relevant procedures may be supplemented or corrected, the violator may be first ordered to make such supplement or correction within a prescribed deadline.Violations of Article 14, Paragraph 1 hereof or Article 14, Paragraph 3 by failing to submit a follow-up plan to the competent authority for a prior approval with regard to of any future cessation of Biobank operation within the time specified; or by failing to comply with the approved follow-up plan shall be subject to a fine of no less than two million New Taiwan Dollars (NT$ 2,000,000) and no more than ten million New Taiwan Dollars (NT$ 10,000,000).Violations of Article 15, Paragraph 1 or Paragraph 2 by failing to apply to the Competent Authority for approval shall be subject a fine of no less than two million New Taiwan Dollars (NT$ 2,000,000) and no more than ten million New Taiwan Dollars (NT$ 10,000,000). Any exported biological specimens and related data and information shall be immediately destroyed.Violations of Article 30 by failing to destroy any biological specimens and related data and information as required by law shall be subject to a fine of no less than two million New Taiwan Dollars (NT$ 2,000,000) and no more than ten million New Taiwan Dollars (NT$ 10,000,000).Where the circumstances set forth in the preceding four paragraphs constitute a serious offense, the Competent Authority may also revoke the establishment permit of the violator.