Statutes of the Republic of Korea

No. 16250
Promulgation Date 2019-01-15
Ministry of Health and Welfare

ALL

CHAPTER I GENERAL PROVISIONS

Article 1 (Purpose)

Article 2 (Definitions)

CHAPTER II PHARMACISTS AND ORIENTAL MEDICINE PHARMACISTS

Section 1 Qualification and Licenses

Article 3 (Qualification and Licenses of Pharmacists)

Article 4 (Qualification and Licenses of Oriental Medicine Pharmacists)

Article 5 (Grounds for Disqualification)

Article 6 (Issuance and Registration of Licenses)

Article 7 (Notification by Pharmacists or Oriental Medicine Pharmacists)

Article 8 (National Examinations for Pharmacist License and Oriental Medicine Pharmacist License)

Article 9 (Restrictions on Application for Examination)

Article 10 (Cheating of Examinees)

Section 2 The Pharmaceutical Association and the Oriental Pharmacy Association

Article 11 (The Pharmaceutical Association)

Article 12 (The Oriental Pharmacy Association)

Article 13 (Authorization)

Article 14 (Chapters of the Pharmaceutical Association and the Oriental Pharmacy Association)

Article 15 (Training and Education)

Article 16 (Duties of Cooperation and Entrustment)

Article 17 (Subsidization)

CHAPTER III PHARMACEUTICAL AFFAIRS ADVISORY　COMMITTEE

Article 18 (The Central Pharmaceutical Affairs Advisory Committee)

Article 19 Deleted.

CHAPTER IV PHARMACIES AND DISPENSATION OF DRUGS

Section 1 Pharmacies

Article 20 (Registration for Establishment of Pharmacies)

Article 21 (Duties to Manage Pharmacies)

Article 21-2 (Succession to Status of Pharmacy Founders)

Article 22 (Notification of Business Closure)

Section 2 Dispensation of Drugs

Article 23 (Dispensation of Drugs)

Article 23-2 (Checking Drug Information)

Article 23-3 (Establishment and Operation of Information System for Safe Use of Drugs)

Article 24 (Duties and Matters to Be Observed)

Article 25 (Preparation of List of Prescription Drugs)

Article 26 (Modification and Revision of Prescriptions)

Article 27 (Dispensation of Substitute Drugs)

Article 28 (Indication and Recording of Drugs Dispensed)

Article 29 (Retainment of Prescriptions)

Article 30 (Records of Dispensation)

CHAPTER V MANUFACTURING AND IMPORT OF DRUGS

Section 1 Manufacturing Business of Drugs

Article 31 (Permission for Manufacturing Business)

Article 31-2 (Registration of Drug Substances)

Articles 31-3 and 31-4 Deleted.

Article 31-5 (Renewal of Permission by Item of Drugs)

Article 32 (Re-Review of New Drugs)

Article 33 (Re-Evaluation of Drugs)

Article 34 (Approval for Clinical Trial Protocols)

Article 34-2 (Designation of Institution Conducting Clinical Trials)

Article 34-3 (Designation of Institutions Conducting Non-Clinical Studies)

Article 34-4 (Education for Persons Engaged in Clinical Trials)

Article 35 (Conditional Permission)

Article 35-2 (Preliminary Examination of Permission by Item of Drugs)

Article 36 (Manufacturing Managers of Drugs)

Article 37 (Duty to Manage Manufacturing of Drugs)

Article 37-2 (Education for Manufacturing Managers)

Article 37-3 (Post-Marketing Safety Management of Drugs)

Article 37-4 (Education for Safety Managers)

Article 38 (Duties of Production Management of Drugs and Reporting Thereof)

Article 38-2 (Drug Identification Mark)

Article 39 (Recall of Hazardous Drugs)

Article 40 (Notification of Business Closure)

Article 41 (Preparation of Pharmacy Medication)

Section 2 Permission for Import of Drugs

Article 42 (Permission for Import of Drugs)

Article 43 (International Trade in Endangered Species of Wild Fauna and Flora)

Section 3 Distribution Business of Drugs

Article 44 (Distribution of Drugs)

Article 44-2 (Registration of Distributors of Safe and Readily Available Drugs)

Article 44-3 (Education for Distributors of Safe and Readily Available Drugs)

Article 44-4 (Matters to Be Observed by Distributors of Safe and Readily Available Drugs)

Article 44-5 (Application Mutatis Mutandis)

Article 45 (Permission for Drug Distribution Business)

Article 46 (Grounds for Disqualification of Permission for Herb Druggists or Drug Wholesalers)

Article 47 (Order in Distribution of Drugs)

Article 47-2 (Submission of Expense Report on Details of Providing Economic Benefits)

Article 47-3 (Designation and Operation of Korea Pharmaceutical Information Service)

Article 48 (Prohibition of Distribution of Unsealed Drugs)

Article 49 (Restrictions on Products for Distribution by Drug Sellers)

Article 50 (Distribution of Drugs)

CHAPTER V-2 REGISTRATION OF DRUG PATENT AND PREVENTION OF DISTRIBUTION

Section 1 Registration of Drug Patent

Article 50-2 (Registration of Drug Patent)

Article 50-3 (Modification of Registered Information)

Section 2 Informing of Application for Permission by Item and Prohibition of Distribution

Article 50-4 (Informing of Application for Permission by Item)

Article 50-5 (Application for Prohibition of Distribution)

Article 50-6 (Prohibition of Distribution)

Section 3 Permission for Preferential Distribution of Items

Article 50-7 (Application for Permission for Preferential Distribution of Items)

Article 50-8 (Permission for Preferential Distribution of Items)

Article 50-9 (Prohibition of Distribution of Same Drugs)

Article 50-10 (Extinction of Effect of Prohibition of Distribution of Same Drug)

Section 4 Impact Assessment

Article 50-11 (Impact Assessment)

Article 50-12 (Management of Listed Drugs)

CHAPTER VI HANDLING OF DRUGS

Section 1 Standards and Verification

Article 51 (The Korean Pharmacopoeia)

Article 52 (Standards for Drugs)

Article 52-2 (Fact-Finding Surveys and Research on Safe Use of Drugs by Specific Groups)

Article 53 (Drugs under National Lot Release)

Article 54 (Radiopharmaceuticals)

Article 55 (Addictive and Habit-Forming Drugs)

Section 2 Handling of Drugs

Article 56 (Labeling on Drug Containers)

Article 57 (Labeling on Outside Packages)

Article 58 (Labeling on Package Inserts)

Article 59 (Precautions in Indications)

Article 60 (Information Prohibited from Labeling)

Article 61 (Prohibition of Distribution)

Article 61-2 (Prohibition against Arranging and Advertising Illegal Distribution of Drugs)

Article 62 (Prohibition of Manufacturing)

Article 63 (Sealing)

Article 64 (Safety Containers or Packages)

Section 3 Quasi-Drugs

Article 65 (Labeling on Containers of Quasi-Drugs)

Article 65-2 (Labeling on Outside Packages)

Article 65-3 (Labeling on Package Inserts)

Article 65-4 (Precautions in Indications)

Article 66 (Application Mutatis Mutandis)

Section 4 Pharmaceutical Organizations

Article 67 (Organization)

Section 5 Advertisement of Drugs

Article 68 (Prohibition of Exaggerated Advertisement)

Article 68-2 (Deliberation on Advertisement)

Section 6 The Korea Institute of Drug Safety and Risk Management

Article 68-3 (Establishment)

Article 68-4 (Projects)

Article 68-5 (Financial Resources for Operation)

Article 68-6 (Submission of Business Plans)

Article 68-7 (Requests for Provision of Data)

Article 68-8 (Reporting Side Effects)

Article 68-9 (Duty of Confidentiality)

Article 68-10 (Prohibition against Use of Similar Names)

Article 68-11 (Establishment of Deliberative Council on Side Effects of Drugs)

Article 68-12 (Drug Epidemiological Investigators)

CHAPTER VII SUPERVISION

Article 69 (Reporting and Inspections)

Article 69-2 (Informing Relevant Agencies)

Article 69-3 (Reporting Matters of Agreement)

Article 69-4 (Corrective Order)

Article 69-5 (On-Site Inspections at Overseas Manufacturing Factories)

Article 70 (Order to Commence Business)

Article 71 (Order of Destruction)

Article 72 (Announcement of Recall of Drugs)

Article 73 (Inspection Orders and Test and Inspection Institutions)

Articles 73-2 and 73-3 Deleted.

Article 74 (Order for Improvement)

Article 75 (Order to Replace Managers)

Article 75-2 (Corrective Orders)

Article 76 (Revocation of Permission and Suspension of Business)

Article 76-2 (Revocation of Designation of Institutions Conducting Clinical Trials)

Article 76-3 (Revocation of Registration of Distributors of Safe and Readily Available Drugs)

Article 77 (Hearings)

Article 78 (Pharmaceutical Inspectors)

Article 79 (Revocation of Pharmacist or Oriental Medicine Pharmacist Licenses)

Article 79-2 (Requests for Disposition of Revocation of License or Suspension of Qualifications by the Pharmaceutical Association and the Oriental Pharmacy Association)

Article 80 (Renewal of License, Permit, and Certificate of Registration)

Article 81 (Disposition of Penalty Surcharges Imposed in Lieu of Disposition of Business Suspension)

Article 81-2 (Imposition of Penalty Surcharges for Manufacturing of Harmful Drugs)

Article 82 (Fees)

Article 82-2 (Registration Fees)

CHAPTER VIII SUPPLEMENTARY PROVISIONS

Article 83 (Subsidization from National Treasury)

Article 83-2 (Training of Professional Personnel)

Article 83-3 (Establishing Stable Supply Base of National Essential Drugs)

Article 83-4 (Comprehensive Drug Safety Management Plans)

Article 83-5 (Establishment and Operation of Integrated Drug Information System)

Article 84 (Delegation and Entrustment of Authority)

Article 85 (Special Cases concerning Animal Drugs)

Article 85-2 (Special Cases concerning Prophylactic Drugs and Therapeutic Drugs in Cases of National Emergencies)

Article 85-3 (Special Cases concerning Ginseng Varieties under the Ginseng Industry Act)

Article 85-4 (Special Cases concerning Obligation to Preserve and Retain Records)

Article 86 (Projects for Relief of Injury from Side Effects of Drugs)

Article 86-2 (Charges for Relief of Injury from Side Effects of Drugs)

Article 86-3 (Benefits for Relief of Injury from Side Effects of Drugs)

Article 86-4 (Procedures for Relief of Injury from Side Effects of Drugs, etc.)

Article 86-5 (Determination to Cease Payment of Benefits for Relief of Injury, and Collection of Unjust Enrichment)

Article 86-6 (Investigation of Injury from Side Effects)

Article 86-7 (Protection of Rights to Benefits for Relief of Injury)

Article 86-8 (Exemption from Public Dues)

Article 87 (Prohibition of Divulgence of Confidential Information)

Article 87-2 (Prohibition against Use of Similar Names)

Article 88 (Protection of Data Submitted)

Article 89 (Succession to Status of Manufacturers)

Article 89-2 (Succession to Effects of Dispositions of Administrative Sanctions)

Article 90 (Monetary Awards)

Article 91 (Establishment of the Korea Orphan and Essential Drug Center)

Article 92 (Projects of the Center)

Article 92-2 (Legal Fiction as Public Officials for Purposes of Penalty Provisions)

Article 92-3 (Re-Examination of Regulation)

CHAPTER IX PENALTY PROVISIONS

Article 93 (Penalty Provisions)

Article 94 (Penalty Provisions)

Article 94-2 Deleted.

Article 95 (Penalty Provisions)

Article 95-2 (Penalty Provisions)

Article 96 (Penalty Provisions)

Article 97 (Joint Penalty Provisions)

Article 97-2 (Administrative Fines)

Article 98 (Administrative Fines)

ADDENDA

ADDENDA <Act No. 8558, Jul. 27, 2007>

ADDENDA <Act No. 8643, Oct. 17, 2007>

ADDENDA <Act No. 8723, Dec. 21, 2007>

ADDENDA <Act No. 8728, Dec. 21, 2007>

ADDENDA <Act No. 8852, Feb. 29, 2008>

ADDENDUM <Act No. 9123, Jun. 13, 2008>

ADDENDA <Act No. 9819, Nov. 2, 2009>

ADDENDA <Act No. 9847, Dec. 29, 2009>

ADDENDA <Act No. 9932, Jan. 18, 2010>

ADDENDUM <Act No. 10324, May 27, 2010>

ADDENDA <Act No. 10512, Mar. 30, 2011>

ADDENDA <Act No. 10788, Jun. 7, 2011>

ADDENDA <Act No. 10888, Jul. 21, 2011>

ADDENDUM <Act No. 11118, Dec. 2, 2011>

ADDENDA <Act No. 11141, Dec. 31, 2011>

ADDENDA <Act No. 11251, Feb. 1, 2012>

ADDENDA <Act No. 11421, May 14, 2012>

ADDENDA <Act No. 11690, Mar. 23, 2013>

ADDENDA <Act No. 11985, Jul. 30, 2013>

ADDENDA <Act No. 11998, Aug. 6, 2013>

ADDENDA <Act No. 12074, Aug. 13, 2013>

ADDENDA <Act No. 12450, Mar. 18, 2014>

ADDENDA <Act No. 13114, Jan. 28, 2015>

ADDENDA <Act No. 13219, Mar. 13, 2015>

ADDENDUM <Act No. 13320, May 18, 2015>

ADDENDA <Act No. 13331, May 18, 2015>

ADDENDA <Act No. 13367, Jun. 22, 2015>

ADDENDA <Act No. 13425, Jul. 24, 2015>

ADDENDA <Act No. 13598, Dec. 22, 2015>

ADDENDA <Act No. 13655, Dec. 29, 2015>

ADDENDA <Act No. 14084, Mar. 22, 2016>

ADDENDA <Act No. 14170, May 29, 2016>

ADDENDA <Act No. 14328, Dec. 2, 2016>

ADDENDUM <Act No. 14560, Feb. 8, 2017>

ADDENDA <Act No. 14839, Jul. 26, 2017>

ADDENDA <Act No. 14926, Oct. 24, 2017>

ADDENDA <Act No. 15534, Mar. 27, 2018>

ADDENDA <Act No. 15709, Jun. 12, 2018>

ADDENDA <Act No. 15891, Dec. 11, 2018>

ADDENDA <Act No. 16250, Jan. 15, 2019>