This document details procedures and standards for manufacturing and licensing health functional foods, covering business applications, facility requirements, and compliance with the Health Functional Food Act.
Key updates, effective March 19, 2025, require applicants to submit detailed documentation—including product descriptions, manufacturing methods, and facility layouts—to the Regional Food and Drug Safety Office.
Changes to licenses or reported matters must be submitted using specific forms such as Appendix 5 and Appendix 8, while business closures must be reported within one month using Appendix 14. Manufacturers must also submit product manufacturing reports in the Appendix 15 format.
Region: Asia
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