No. 7635
Promulgation Date 2005-07-29
Ministry of Health and Welfare
ALL
CHAPTER I GENERAL PROVISIONS
Article 1 (Purpose)
Article 2 (Definitions)
CHAPTER II PHARMACIST AND HERB PHARMACIST
Section 1 Qualifications and Licenses
Article 3 (Qualifications and Licenses for Pharmacist)
Article 3-2 (Qualification and License for Herb Pharmacist)
Article 4 (Disqualification, etc.)
Article 5 (Issuance and Registration of License)
Article 6 (Report of Pharmacist or Herb Pharmacist)
Article 7 (National Examination for Pharmacists or Herb Pharmacists)
Article 8 (Restrictions on Application for Examination)
Article 9 Deleted.
Article 10 (Cheating of Examinee)
Section 2 Pharmacists' Association and Herb Pharmacists' Association
Article 11 (Pharmacists' Association)
Article 11-2 (Herb Pharmacists' Association)
Article 12 (Approval)
Article 12-2 (Chapter, etc. of Pharmacists' Association and Herb Pharmacists' Association)
Article 13 Deleted.
Article 13-2 (Training and Education)
Article 13-3 (Duty of Cooperation and Entrustment)
Article 13-4 (Support of Expenses)
CHAPTER III PHARMACEUTICAL AFFAIRS COUNCIL
Article 14 (Central Pharmaceutical Affairs Council)
Article 15 (Local Pharmaceutical Affairs Council)
CHAPTER IV PHARMACY AND PREPARATION OF MEDICINES SECTION 1 Pharmacy
Article 16 (Registration of Opening of Pharmacy)
Articles 17 and 18 Deleted.
Article 19 (Duty to Manage Pharmacy)
Article 20 (Report on Discontinuation of Business, etc.)
Section 2 Preparation of Medicines
Article 21 (Preparation of Medicines)
Article 22 (Duty and Matters to be Observed)
Article 22-2 (Compilation of Table of Prescription Medicines)
Article 23 (Modification and Revision of Prescriptions)
Article 23-2 (Preparation of Alternative Medicines)
Article 24 (Description of Prepared Medicines)
Article 25 (Preservation of Prescriptions)
Article 25-2 (Preparation Records)
CHAPTER V MANUFACTURE, IMPORT OF MEDICINES, ETC.
Section 1 Manufacture of Medicines, etc.
Article 26 (License, etc. for Manufacturing Industry)
Article 26-2 (Re-examination of New Medicines)
Article 26-3 (Reevaluation of Medicines)
Article 26-4 (Approval of Clinical Demonstration Plan, etc.)
Article 27 (Conditional License)
Article 28 Deleted.
Article 29 (Administrator of Manufacturing Medicines, etc.)
Article 30 (Duty of Supervising Manufacture of Medicines, etc.)
Article 31 (Duty of Production Management of Medicines, etc. and Report Thereof)
Article 32 (Report on Discontinuance of Business)
Article 32-2 Deleted.
Article 33 (Making of Dispensary Preparations)
Section 2 Import Permission, etc. of Medicines, etc.
Article 34 (Permission, etc. on Import of Medicines, etc.)
Article 34-2 (International Trade, etc. in Endangered Species of Wild Fauna and Flora)
Section 3 Sales of Medicines, etc.
Article 35 (License for Sales of Medicines)
Article 36 (Sales of Medicines)
Article 37 (Criteria for Granting License for Sale of Medicines)
Article 38 (Order of Sale of Medicines)
Article 39 (Ban on Opening and Selling)
Article 40 (Restrictions on Sale Items by Medicine Distributor)
Article 41 (Sales of Medicines)
Article 42 Deleted.
CHAPTER VI HANDLING OF MEDICINES, ETC.
Section 1 Criteria and Approval
Article 43 (Korean Pharmacopoeia)
Article 44 (Criteria for Medicines, etc.)
Article 45 (State-authorized Medicines)
Article 45-2 (Radioactive Medicines)
Article 45-3 (Toxic and Habit-forming Medicines)
Section 2 Deleted.
Articles 46 through 49 Deleted.
Section 3 Handling of Medicines
Article 50 (Matters to be Stated on Containers)
Article 51 (Matters to be Stated on Outside Packages)
Article 52 (Matters to be Stated on Appended Notes)
Article 53 (Precautions in Statement)
Article 54 (Matters not to be Stated)
Article 55 (Ban of Sales, etc.)
Article 56 (Ban of Manufacturing, etc.)
Article 57 (Sealing)
Article 57-2 (Safety Container and Package, etc.)
Section 4 Non-pharmaceutical Drugs
Article 58 (Matters to be Stated on Containers, etc.)
Article 59 (Mutatis Mutandis Application)
Section 5 Deleted.
Articles 60 and 61 Deleted.
Section 6 Pharmaceutical Organization
Article 62 (Organization)
Section 7 Advertisement of Medicines, etc.
Article 63 (Ban of Exaggerated Advertisement)
CHAPTER VII SUPERVISION
Article 64 (Report and Inspection, etc.)
Article 64-2 (Order to Commence Business, etc.)
Article 65 (Order, etc. of Abolition)
Article 66 (Order of Inspection)
Article 67 (Repair Order)
Article 68 (Order to Change Manager, etc.)
Article 69 (Cancellation of License and Suspension of Business)
Article 69-2 (Hearings)
Article 70 (Pharmaceutical Inspector)
Article 71 (Cancellation, etc. of Pharmacist's or Herb Pharmacist's License)
Article 71-2 (Renewal of License, Permit and Registration)
Article 71-3 (Disposition of Penalty)
Article 72 (Fees)
CHAPTER VIII SUPPLEMENTARY PROVISIONS
Article 72-2 (Subsidy from National Treasury)
Articles 72-3 and 72-4 Deleted.
Article 72-5 (Delegation of Authority)
Article 72-6 (Special Cases on Animal's Medicines, etc.)
Article 72-7 (Projects for Relief of Injury from Side Effects of Medicines)
Article 72-8 (Ban on Secret Leakage)
Article 72-9 (Protection of Material Furnished)
Article 72-10 (Succession of Status of Manufacturer)
Article 72-11 (Bounty)
Article 72-12 (Creation of Korea Orphan Drug Center)
Article 72-13 (Work of Center)
Article 73 Deleted.
CHAPTER IX PENAL PROVISIONS
Article 74 (Penal Provisions)
Article 75 (Penal Provisions)
Article 76 (Penal Provisions)
Article 77 (Penal Provisions)
Article 78 (Penal Provisions)
Article 79 (Fine for Negligence)
ADDENDA
ADDENDA<Act No. 1694, Apr. 3, 1965>
ADDENDA<Act No. 1910, Mar. 3, 1967>
ADDENDA<Act No. 2279, Jan. 13, 1971>
ADDENDUM<Act No. 2611, Mar. 13, 1973>
ADDENDA<Act No. 2861, Dec. 31, 1975>
ADDENDA<Act No. 3441, Apr. 13, 1981>
ADDENDA<Act No. 3825, May 10, 1986>
ADDENDA<Act No. 4268, Dec. 27, 1990>
ADDENDA<Act No. 4486, Dec. 31, 1991>
ADDENDA<Act No. 4731, Jan. 7, 1994>
ADDENDUM<Act No. 4852, Dec. 31, 1994>
ADDENDA<Act No. 4852, Dec. 6, 1995>
ADDENDA<Act No. 5101, Dec. 29, 1995>
ADDENDA<Act No. 5153, Aug. 8, 1996>
ADDENDA<Act No. 5453, Dec. 13, 1997>
ADDENDUM<Act No. 5454, Dec. 13, 1997>
ADDENDA<Act No. 5529, Feb. 28, 1998>
ADDENDA<Act No. 5959, Mar. 31, 1999>
ADDENDA<Act No. 5982, May 24, 1999>
ADDENDA<Act No. 6025, Sep. 7, 1999>
ADDENDA<Act No. 6153, Jan. 12, 2000>
ADDENDUM<Act No. 6272, Aug. 5, 2000>
ADDENDA<Act No. 6400, Jan. 29, 2001>
ADDENDA<Act No. 6511, Aug. 14, 2001>
ADDENDA<Act No. 6611, Jan. 14, 2002>
ADDENDA<Act No. 6685, Mar. 30, 2002>
ADDENDA<Act No. 6844, Dec. 30, 2002>
ADDENDA<Act No. 6909, May 29, 2003>
ADDENDUM<Act No. 6982, Sep. 29, 2003>
ADDENDA<Act No. 7148, Jan. 29, 2004>
ADDENDA<Act No. 7376, Jan. 27, 2005>
ADDENDA<Act No. 7635, Jul. 29, 2005>