PHARMACEUTICAL AFFAIRS ACT
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 (Reporting by Pharmacists or Oriental Medicine Pharmacists)
Article 8 (National Examinations for Pharmacist Licenses or Oriental Medicine Pharmacist Licenses)
Article 9 (Restrictions on Application for Examination)
Article 10 (Cheating of Examinees)
SECTION 2 Pharmaceutical Association and Oriental Pharmacy Association
Article 11 (Pharmaceutical Association)
Article 12 (Oriental Pharmacy Association)
Article 13 (Authorization, etc.)
Article 14 (Chapters, etc. of the Pharmaceutical Association and the Oriental Pharmacy Association)
Article 15 (Training and Education)
Article 16 (Duties of Cooperation and Entrustment)
Article 17 (Subsidization of Expenses)
CHAPTER III PHARMACEUTICAL AFFAIRS COUNCIL
Article 18 (Central Pharmaceutical Affairs Council)
Article 19 Deleted.
CHAPTER IV PHARMACIES AND DISPENSING DRUGS
SECTION 1 Pharmacies
Article 20 (Registration for Establishment of Pharmacies)
Article 21 (Duties to Manage Pharmacies)
Article 22 (Reporting on Discontinuation, etc. of Business)
SECTION 2 Dispensing Drugs
Article 23 (Dispensing 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, etc. of List of Prescription Drugs)
Article 26 (Modification and Revision of Prescriptions)
Article 27 (Dispensing Substitute Drugs)
Article 28 (Indication and Recording of Drugs Dispensed)
Article 29 (Preservation of Prescriptions)
Article 30 (Records of Dispensing)
CHAPTER V MANUFACTURE, IMPORTATION, ETC. OF DRUGS, ETC.
SECTION 1 Manufacturing Business of Drugs, etc.
Article 31 (Permission for Manufacturing Business, etc.)
Article 31-2 (Registration, etc. of Drug Substances)
Articles 31-3 and 31-4 Deleted.
Article 31-5 (Renewal of Marketing Approval, etc. of Drugs)
Article 32 (Re-Examination of New Drugs, etc.)
Article 33 (Re-Evaluation of Drugs)
Article 34 (Approval, etc. for Protocols of Clinical Trials, etc.)
Article 34-2 (Designation, etc. of Institutes for Clinical Trials, etc.)
Article 34-3 (Designation, etc. of Non-Clinical Trial Institutes)
Article 34-4 (Education of Persons Conducting Clinical Trials, etc.)
Article 35 (Conditional Permission)
Article 35-2 (Preliminary Examination of Marketing Approval of Drugs, etc.)
Article 36 (Supervisors of Drug Manufacturing, etc.)
Article 37 (Duty to Supervise Manufacturing Drugs, etc.)
Article 37-2 (Education for Manufacturing Supervisors, etc.)
Article 37-2 (Education for Manufacturing Supervisors, etc.)
Article 37-3 (Post-Marketing Safety Control of Drugs)
Article 37-4 (Education of Safety Control Managers)
Article 37-4 (Education of Safety Control Managers)
Article 38 (Production Control of Drugs, etc. and Reporting thereof)
Article 38-2 (Drug Identification Mark)
Article 39 (Recall of Hazardous Drugs, etc.)
Article 40 (Reports on Discontinuance, etc. of Business)
Article 40 (Reports on Discontinuance, etc. of Business)
Article 41 (Manufacturing Pharmacy Medication)
SECTION 2 Permission, etc. for Importation of Drugs, etc.
Article 42 (Permission, etc. for Importation of Drugs, etc.)
Article 43 (International Trade, etc. in Endangered Species of Wild Fauna and Flora)
SECTION 3 Distribution Business of Drugs, etc.
Article 44 (Distribution of Drugs)
Article 44-2 (Registration of Sellers of Safe and Readily Available Drugs)
Article 44-3 (Education for Sellers of Safe and Readily Available Drugs)
Article 44-4 (Matters to be Observed by Sellers of Safe and Readily Available Drugs)
Article 44-5 (Application Mutatis Mutandis)
Article 45 (Licenses of Drug Distribution Business)
Article 46 (Grounds for Disqualification of Licenses of Herb Druggists or Drug Wholesalers)
Article 47 (Order in Distribution of Drugs, etc.)
Article 47-2 (Submission, etc. of Expense Report on Details of Providing Economic Interests, etc.)
Article 47-3 (Designation and Operation of Korea Pharmaceutical Information Service)
Article 48 (Prohibition of Sale of Unsealed Drugs)
Article 49 (Restrictions on Products for Sale by Drug Sellers)
Article 50 (Distribution of Drugs)
CHAPTER V-II REGISTRATION OF DRUG PATENT AND PREVENTION OF MARKETING, ETC.
SECTION 1 Registration of Drug Patent
Article 50-2 (Registration of Drug Patent)
Article 50-3 (Change, Etc. of Registered Information)
SECTION 2 Notice of Application for Marketing Approval and Prevention of Marketing, Etc.
Article 50-4 (Notice of Application for Marketing Approval, etc.)
Article 50-5 (Application for Prevention of Marketing)
Article 50-6 (Marketing Prevention, Etc.)
SECTION 3 Exclusive Marketing Approval
Article 50-7 (Application for Exclusive Marketing Approval)
Article 50-8 (Exclusive Marketing Approval)
Article 50-9 (Marketing Prevention, Etc. of Same Drugs, Etc.)
Article 50-10 (Extinction of Effect of Marketing Prevention of Same Drug, Etc.)
SECTION 4 Impact Assessment, Etc.
Article 50-11 (Impact Assessment)
Article 50-12 (Management, etc. of Listed Drugs)
CHAPTER VI HANDLING OF DRUGS, ETC.
SECTION 1 Standards and Product Testing
Article 51 (Korean Pharmacopoeia)
Article 52 (Standards for Drugs, etc.)
Article 52-2 (Surveys, Research, etc. on Actual Status of 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 (Labelling of Drug Containers, etc.)
Article 56 (Labelling of Drug Containers, etc.)
Article 57 (Labelling of Outside Packages)
Article 58 (Information in Package Inserts)
Article 59 (Precautions in Indications)
Article 60 (Information Prohibited from being Indicated)
Article 61 (Prohibition of Distribution, etc.)
Article 62 (Prohibition of Manufacturing, etc.)
Article 63 (Sealing)
Article 64 (Safety Containers or Packages, etc.)
SECTION 3 Quasi-Drugs
Article 65 (Labelling of Containers, etc. of Quasi-Drugs)
Article 65 (Labelling of Containers, etc. of Quasi-Drugs)
Article 65-2 (Precautions in Indications)
Article 66 (Application Mutatis Mutandis)
SECTION 4 Pharmaceutical Organizations
Article 67 (Organization)
SECTION 5 Advertisement of Drugs, etc.
Article 68 (Prohibition of Exaggerated Advertisement, etc.)
Article 68-2 (Deliberation of Advertisement)
SECTION 6 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, etc. of Business Plans)
Article 68-7 (Requests for Provision of Data)
Article 68-8 (Reporting Side Effects, etc.)
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, Inspection, etc.)
Article 69-2 (Notification to Relevant Institution)
Article 69-3 (Reporting on Matters of Agreement)
Article 69-4 (Correction Order)
Article 70 (Order, etc. to Commence Business)
Article 71 (Order, etc. of Abandonment)
Article 72 (Announcement of Recall, etc. of Drugs, etc.)
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 Change Managers, etc.)
Article 76 (Revocation of Permission, Suspension of Business, etc.)
Article 76-2 (Revocation, etc. of Designation)
Article 76-3 (Revocation of Registration of Sellers of Safe and Readily Available Drugs)
Article 77 (Hearings)
Article 78 (Pharmaceutical Inspectors)
Article 79 (Revocation, etc. of Pharmacist's or Oriental Medicine Pharmacist's Licenses)
Article 79-2 (Pharmaceutical Association and Oriental Pharmacy Association's
Article 80 (Renewal of Certificates of License, Permission, Registration, etc.)
Article 81 (Disposition of Penalty Surcharges)
Article 82 (Fees)
Article 82-2 (Registration Fees)
CHAPTER VIII SUPPLEMENTARY PROVISIONS
Article 83 (Subsidization from National Treasury)
Article 83-2 (Training of Professionals)
Article 83-3 (Establishing Stable Supply Base of National Essential Drugs)
Article 84 (Delegation and Entrustment of Authority)
Article 85 (Exceptions to Drugs, etc. for Animals)
Article 85-2 (Exceptions to Prophylactic Drugs and Therapeutic Drugs in Cases of National Emergencies, etc.)
Article 85-3 (Exceptions to Ginseng Varieties under Ginseng Industry Act)
Article 86 (Projects for Relief of Harm from Side Effects of Drugs)
Article 86-2 (Charges for Relief of Harm Resulting from Side Effects of Drugs)
Article 86-3 (Benefits for Relief of Harm from Side Effects of Drugs)
Article 86-4 (Procedures for Relief of Harm from Side Effects of Drugs, etc.)
Article 86-5 (Determination to Cease Payment of Benefits for Relief of Harm, Collection of Unfair Gains, etc.)
Article 86-6 (Inspection of Harm from Side Effects, etc.)
Article 86-7 (Protection of Rights to Benefits for Relief of Harm)
Article 86-8 (Exemption from Public Dues, etc.)
Article 87 (Preventing Leakage of Confidential Information)
Article 87-2 (Prohibition against Use of Similar Names)
Article 88 (Protection of Materials Submitted)
Article 89 (Succession to Status, etc. of Manufacturers, etc.)
Article 89-2 (Succession to Effects of Dispositions of Administrative Sanctions)
Article 90 (Bounty)
Article 91 (Establishment of Korea Orphan and Essential Drug Center)
Article 92 (Projects of Center)
Article 92-2 (Inspectors to be Deemed Public Officials in Applying Penal Provisions)
Article 92-3 (Review 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)
Article 98 (Administrative Fines)