No. 20138
Promulgation Date 2024-01-23
Ministry of Food and Drug Safety
ALL
CHAPTER I GENERAL PROVISIONS
Article 1 (Purpose)
Article 2 (Responsibilities)
Article 3 (Definitions)
CHAPTER II BUSINESS
Article 4 (Business Types and Facility Standards)
Article 5 (Permission for Business)
Article 6 (Reporting on Business)
Article 7 (Reporting on Manufacturing Items)
Article 8 Deleted.
Article 9 (Restrictions on Permission for Business)
Article 10 (Obligations of Business Entities)
Article 10-2 (Report on Adverse Events)
Article 10-3 (Subscription to Insurance)
Article 11 (Succession of Business)
Article 12 (Quality Control Managers)
Article 12-2 (Order to Replace Quality Control Manager)
Article 12-3 (Customized Health Functional Food Managers)
Article 13 (Education)
CHAPTER III STANDARDS AND SPECIFICATIONS
Article 14 (Standards and Specifications)
Article 15 (Recognition of Raw Materials)
Article 15-2 (Reassessment)
Article 16 Deleted.
Article 16-2 Deleted.
Article 17 Deleted.
Article 17-2 (Labeling of Genetically Modified Health Functional Foods)
Article 18 Deleted.
Article 19 (Codes of Health Functional Foods)
CHAPTER IV INSPECTIONS
Article 20 (Visit, Inspections, and Collection)
Article 20-2 (Requests by Consumers for Hygiene Inspection)
Article 21 (Obligation of Self-Quality Inspection)
Article 21-2 (Obligations to Inspect and Confirm Materials)
Article 21-3 (Order of Inspection)
CHAPTER V REGULATIONS FOR GOOD MANUFACTURING PRACTICE
Article 22 (Regulations for Good Manufacturing Practice)
Article 22-2 (Registration Standards for Tracking Management of Records on health functional foods)
CHAPTER VI PROHIBITION AGAINST SALE
Article 23 (Prohibition against Sale of Harmful Health Functional Foods)
Article 24 (Prohibition against Sale of Health Functional Foods which Violate Standards and Specifications)
Article 25 Deleted.
Article 26 Deleted.
CHAPTER VII HEALTH FUNCTIONAL FOODS DELIBERATION COMMITTEE AND ESTABLISHMENT OF ORGANIZATIONS
Article 27 (Health Functional Foods Deliberation Committee)
Article 28 (Establishment of Organizations)
CHAPTER VIII ADMINISTRATIVE SANCTIONS, INCLUDING CORRECTIVE ORDERS AND REVOCATION OF PERMISSION
Article 29 (Corrective Orders)
Article 30 (Dispositions of Discarding)
Article 31 (Orders to Repair Facilities)
Article 32 (Revocation of Permission for Business)
Article 33 (Suspension of Manufacturing Specific Products)
Article 34 (Succession to Effects of Administrative Sanctions)
Article 35 (Measures for Closure)
Article 36 (Hearings)
Article 37 (Imposition of Penalty Surcharges in Lieu of Suspension of Business)
Article 37-2 (Imposition of Penalty Surcharges for Sale of Harmful Health Functional Foods)
Article 37-3 (Publication of Violations)
CHAPTER IX SUPPLEMENTARY RULES
Article 38 (Relationship to Other Statutes)
Article 39 (State Subsidies)
Article 40 (Payment of Monetary Rewards)
Article 41 (Delegation and Entrustment of Authority)
Article 42 (Service Charges)
Article 42-2 Deleted.
CHAPTER X PENALTY PROVISIONS
Article 43 (Penalty Provisions)
Article 44 (Penalty Provisions)
Article 45 (Penalty Provisions)
Article 46 (Joint Penalty Provisions)
Article 47 (Administrative Fines)
Article 48 (Special Exemption to Application of Provisions on Administrative Fines)
ADDENDA <Act No. 6727, Aug. 26, 2002>
ADDENDUM <Act No. 7211, Mar. 22, 2004>
ADDENDA <Act No. 7428, Mar. 31, 2005>
ADDENDUM <Act No. 8033, Oct. 4, 2006>
ADDENDA <Act No. 8365, Apr. 11, 2007>
ADDENDA <Act No. 8852, Feb. 29, 2008>
ADDENDUM <Act No. 8941, Mar. 21, 2008>
ADDENDA <Act No. 9932, Jan. 18, 2010>
ADDENDA <Act No. 10128, Mar. 17, 2010>
ADDENDA <Act No. 10219, Mar. 31, 2010>
ADDENDUM <Act No. 11508, Oct. 22, 2012>
ADDENDA <Act No. 11690, Mar. 23, 2013>
ADDENDA <Act No. 11985, Jul. 30, 2013>
ADDENDUM <Act No. 12106, Aug. 13, 2013>
ADDENDUM <Act No. 12389, Jan. 28, 2014>
ADDENDA <Act No. 12669, May 21, 2014>
ADDENDA <Act No. 13201, Feb. 3, 2015>
ADDENDA <Act No. 13330, May 18, 2015>
ADDENDA <Act No. 14018, Feb. 3, 2016>
ADDENDA <Act No. 14476, Dec. 27, 2016>
ADDENDA <Act No. 15480, Mar. 13, 2018>
ADDENDUM <Act No. 15706, Jun. 12, 2018>
ADDENDA <Act No. 15938, Dec. 11, 2018>
ADDENDA <Act No. 16295, Jan. 15, 2019>
ADDENDUM <Act No. 16715, Dec. 3, 2019>
ADDENDA <Act No. 17091, Mar. 24, 2020>
ADDENDA <Act No. 18359, Jul. 27, 2021>
ADDENDA <Act No. 18445, Aug. 17, 2021>
ADDENDUM <Act No. 19914, Jan. 2, 2024>
ADDENDA <Presidential Decree No. 20138, Jan. 23, 2024>