The standards are established in accordance with Article 58 of the Act Governing Food Safety and Sanitation, the second Paragraph of Article 104-2 of the Pharmaceutical Affairs Act, the second Paragraph of Article 76 of the Medical Devices Act, Article 30 of the Cosmetic Hygiene and Safety Act, and Article 10 of the Charges and Fees Act.

Contents of the standards are laid down in the Appendix.

• Appendix.pdf

On grounds for humane or relief purposes, biological preparations in the D numbering section of the Appendix that donated for use by international organizations, countries or pharmaceutical corporations can be exempted from all fees upon approvalby the central competent authorities.

The standards come into forceon the date of promulgation.