Pharmaceutical Affairs Act


Published: 2013-08-13

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CHAPTER I GENERAL PROVISIONS
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 Article 1 (Purpose)   print
The purpose of this Act is to prescribe matters necessary to deal with pharmaceutical affairs smoothly, thereby contributing to the improvement of the national public health.
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 Article 2 (Definitions)   print
The definitions of terms used in this Act shall be as follows: <Amended by Act No. 8643, Oct. 17, 2007; Act No. 8852, Feb. 29, 2008; Act No. 9847, Dec. 29, 2009; Act No. 9932, Jan. 18, 2010; Act No. 10788, Jun. 7, 2011; Act No. 11690, Mar. 23, 2013>
1. The term "pharmaceutical affairs" means the manufacture, dispensing, evaluation, safekeeping, importation, and sale (including presentation; hereinafter the same shall apply) of drugs and quasi-drugs, and other matters related to pharmaceutical technology;
2. The term "pharmacist" means a person who takes charge of matters concerning pharmaceutical affairs (including those concerning herb medication), other than those concerning herb drugs, and the term "herb pharmacist" means a person who takes charge of matters concerning pharmaceutical affairs related to herb drugs and preparation thereof, and both of them shall be licensed by the Minister of Health and Welfare;
3. The term "pharmacy" means a place where a pharmacist or herb pharmacist dispenses drugs [including pharmacy medication] for the purpose of presentation (including the place needed for distribution business where the founder of a pharmacy engages in drug distribution business at the same time): Provided, That dispensaries of medical institutions shall be excluded;
4. The term "drug" means any of the following:
(a) Those, other than quasi-drugs, among the articles listed in the Korean Pharmacopoeia;
(b) Articles used for the purposes of diagnosis, medical care, alleviation, treatment or prevention of diseases of human beings or animals, excluding appliances, machinery or equipment;
(c) Articles, other than appliances, machinery or equipment, used for the purpose of exerting pharmacological effects upon the structure or functions of human beings or animals;
5. The term "herb" means raw drugs picked from animals, plants, or minerals, and dried, cut, or refined without changing the original forms in most cases;
6. The term "herb medication" means a drug made by mixing herbs according to the principle of oriental medicine;
7. The term "quasi-drug" means an article designated by the Minister of Food and Drug Safety, which falls under any of the following items (excluding articles which shall be used for the purposes under subparagraph 4 (b) or (c)):
(a) Fibers, rubber products or similar products used for the purpose of treating, alleviating, or preventing human or animal diseases;
(b) Non-appliance, non-machinery or similar articles that have insignificant influences on or do not directly act upon human bodies;
(c) Preparations used for sterilization, insecticide, and uses similar thereto for the purpose of preventing infectious diseases;
8. The term "new drug" means a drug of new materials, the chemical structure or the construction of substance of which is wholly new, or a drug of composite medication containing new materials as effective ingredients, which is designated by the Minister of Food and Drug Safety;
9. The term "over-the-counter drug" means a drug that falls under any of the following items and meets the standards prescribed and announced by the Minister of Food and Drug Safety following consultation with the Minister of Health and Welfare:
(a) A drug, the misuse or the abuse of which is of little concern, and the safety and efficacy of which may be expected even when used without a prescription by a doctor or a dentist;
(b) A drug that may be used to cure a disease without doctor's or dentist's professional knowledge;
(c) A drug that has a relatively small side effect on human bodies in light of their dosage form and pharmacological action;
10. The term "prescription drug" means a drug that is not an over-the-counter drug;
11. The term "dispensing of drug" means dispensing drugs to use for the purposes of treatment, prevention, etc. of a certain disease for a specific individual in accordance with the specific directions by mixing two or more drugs or by dividing one kind of drug into certain dosages according to a specific prescription;
12. The term "medication counselling" means those falling under any of the following:
(a) Providing information on the names, directions for use and dosage, efficacy and effect, storage methods, side effects, interactions, etc. of drugs;
(b) Assisting consumers in choosing necessary drugs without passing diagnostic judgment when selling over-the-counter drugs;
13. The term "safety container or package" means a container or package designed and devised to make it difficult for children under the age of five to open;
14. The term "contract manufacturing business" means the business of manufacturing and selling drugs without owning manufacturing facilities by entrusting a drug manufacturer with the manufacture and sale of drugs which are product-licensed by the Minister of Food and Drug Safety.
15. The term "clinical trial" means a test that checks pharmacodynamic, pharmacokinetic, pharmacological, and clinical effects of drugs, etc. and investigates adverse reactions occurring on human bodies in order to prove the safety and effectiveness of the relevant drugs, etc.
16. The term "non-clinical trial" means a test conducted by using animals, plants, microorganism, a physical or chemical medium, or the composite thereof under the same conditions as those in a laboratory, so as to obtain various data on the nature or safety of test materials which influence the health of humans;
17. The term "biological equivalence test" means a medical examination using a living body conducted to prove biological equivalence, which shows that bioavailability of two pharmaceutical preparations containing the same major components is statistically equivalent.
CHAPTER II PHARMACISTS AND HERB PHARMACISTS
SECTION 1 Qualification and Licenses
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 Article 3 (Qualification and Licenses of Pharmacists)   print
(1) Any person who desires to become a pharmacist shall obtain a license from the Minister of Health and Welfare, as prescribed by Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>
(2) A license of a pharmacist under paragraph (1) shall be granted to any of the following persons: <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>
1. A person who has graduated from a college of pharmacy and received a bachelor's degree in pharmacy, and passed a national examination for pharmacists;
2. A person who has graduated from a foreign college of pharmacy, accredited by the Minister of Health and Welfare, obtained a foreign license of a pharmacist, and passed a national examination for pharmacists.
(3) Any person who has not obtained a pharmacist license shall be prohibited from using the title of "pharmacist".
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 Article 4 (Qualification and Licenses of Herb Pharmacists)   print
(1) Any person who desires to become a herb pharmacist shall obtain a license from the Minister of Health and Welfare, as prescribed by Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>
(2) A license of a herb pharmacist under paragraph (1) shall be granted to a person who has majored in herb pharmacy in a college, received a bachelor's degree in herb pharmacy, and passed a national examination for herb pharmacists.
(3) Any person who has not obtained a license of a herb pharmacist shall be prohibited from using the title of "herb pharmacist".
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 Article 5 (Grounds for Disqualification)   print
No license of pharmacist or herb pharmacist shall be given to any of the following persons: <Amended by Act No. 8643, Oct. 17, 2007; Act No. 11118, Dec. 2, 2011; Act No. 11251, Feb. 1, 2012>
1. A mental patient under subparagraph 1 of Article 3 of the Mental Health Act: Provided, That this shall not apply to a person who is recognized by a medical specialist to be suitable for taking charge of pharmaceutical affairs;
2. A person who has been adjudicated incompetent or quasi-incompetent;
3. A person addicted to narcotics, marijuana, or psychotropic drugs;
4. A person who has been sentenced to imprisonment without prison labor or a heavier penalty on charges of violating the Pharmaceutical Affairs Act, the Act on the Control of Narcotics, etc., the Act on Special Measures for the Control of Public Health Crimes, the Medical Service Act, Article 347 of the Criminal Act (limited to cases of deceiving patients or an institution or organization paying the drug expenses by demanding the drug expenses by falsity; hereinafter the same shall apply) and other statutes related to pharmaceutical affairs and for whom the sentence has yet to be terminated or exemption from its execution has yet to be made definite;
5. A person for whom three years have not elapsed since his/her license was revoked by committing the crimes under Article 347 of the Criminal Act or for whom two years have not elapsed since his/her license was revoked by violating statutes relating to pharmaceutical affairs.
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 Article 6 (Issuance and Registration of Licenses)   print
(1) When the Minister of Health and Welfare issues a pharmacist's or herb pharmacist's license, he/she shall register matters relating to the license in the relevant registry and issue the relevant license. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>
(2) If a license referred to in paragraph (1) has been lost or damaged, or the matters stated therein have been changed, a new license may be issued in lieu thereof.
(3) No license shall be lent to a third party.
(4) Matters necessary for registration of a pharmacist's or herb pharmacist's license and issuance thereof shall be prescribed by Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>
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 Article 7 (Reporting by Pharmacists or Herb Pharmacists)   print
Each pharmacist or herb pharmacist shall file a report on matters with the Minister of Health and Welfare as prescribed by Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 10788, Jun. 7, 2011>
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 Article 8 (National Examinations for Pharmacists or Herb Pharmacists)   print
(1) National examinations for pharmacists or herb pharmacists shall be conducted by the Minister of Health and Welfare at least once a year. <Amended by Act No. 88562, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>
(2) The Minister of Health and Welfare may commission relevant specialized institutions recognized as competent to administer national examinations for pharmacists or herb pharmacists referred to in paragraph (1), as prescribed by Presidential Decree. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>
(3) The Minister of Health and Welfare may, when he/she commissions specialized institutions to administer national examinations under paragraph (2), subsidize necessary expenses. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>
(4) Matters necessary for national examinations for pharmacists or herb pharmacists shall be prescribed by Presidential Decree.
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 Article 9 (Restrictions on Application for Examination)   print
No person falling under subparagraphs 1 through 3 of Article 5 shall apply for the national examination for pharmacists or herb pharmacists.
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 Article 10 (Cheating of Examinees)   print
(1) Any person who has cheated in a national examination for pharmacists or herb pharmacists shall be suspended from taking the examination, and where the fact of cheating is found after a candidate has passed the examination, the pass shall be nullified.
(2) The Minister of Health and Welfare may disallow persons falling under paragraph (1) to apply for a national examination for pharmacists or herb pharmacists, for two years. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>
SECTION 2 Pharmaceutical Association and Oriental Pharmacy Association
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 Article 11 (Pharmaceutical Association)   print
(1) Pharmacists shall establish the Korean Pharmaceutical Association (hereinafter referred to as the "Pharmaceutical Association"), as prescribed by Presidential Decree, to research pharmaceutical affairs, establish pharmacists' ethics, promote the pharmacists' interests and elevate their quality.
(2) The Pharmaceutical Association shall be a juristic person.
(3) When the Pharmaceutical Association is established, pharmacists shall naturally become its members.
(4) The provisions of the Civil Act relating to the corporate juridical person, in addition to those of this Act, shall apply mutatis mutandis to the Pharmaceutical Association.
(5) The Pharmaceutical Association shall establish the Ethics Committee in order to deliberate on and resolve requests for the disposition of qualification suspension under Article 79-2. <Newly Inserted by Act No. 10788, Jun. 7, 2011>
(6) Matters necessary for the organization and operation of the Ethics Committee shall be prescribed by Presidential Decree. <Newly Inserted by Act No. 10788, Jun. 7, 2011>
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 Article 12 (Oriental Pharmacy Association)   print
(1) Herb pharmacists shall establish the Association of Korea Oriental Pharmacy (hereinafter referred to as the "Oriental Pharmacy Association"), as prescribed by Presidential Decree, to research pharmaceutical affairs in connection with herb and herb medication, establish herb pharmacists' ethics, promote the herb pharmacists' interests and elevate their quality.
(2) The Oriental Pharmacy Association shall be a juridical person.
(3) When the Oriental Pharmacy Association is established, herb pharmacists shall naturally become its members.
(4) The provisions of the Civil Act concerning a corporate juridical person, in addition to those as provided for in this Act, shall apply mutatis mutandis to the Oriental Pharmacy Association.
(5) The Oriental Pharmacy Association shall establish the Ethics Committee in order to deliberate on and resolve requests for the disposition of qualification suspension under Article 79-2. <Newly Inserted by Act No. 10788, Jun. 7, 2011>
(6) Matters necessary for the organization and operation, etc. of the Ethics Committee shall be prescribed by Presidential Decree. <Newly Inserted by Act No. 10788, Jun. 7, 2011>
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 Article 13 (Authorization, etc.)   print
(1) When the Pharmaceutical Association or Oriental Pharmacy Association is established, the articles of association and other necessary documents shall be submitted to the Minister of Health and Welfare and authorization from him/her shall be obtained, as prescribed by Presidential Decree. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>
(2) Matters to be stated in the articles of association by the Pharmaceutical Association or by the Oriental Pharmacy Association shall be prescribed by Presidential Decree.
(3) If the Pharmaceutical Association or Oriental Pharmacy Association intends to amend its articles of association, it shall obtain authorization therefor from the Minister of Health and Welfare. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>
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 Article 14 (Chapters, etc. of the Pharmaceutical Association and the Oriental Pharmacy Association)   print
(1) The Pharmaceutical Association or the Oriental Pharmacy Association shall establish its chapters in the Special Metropolitan City, Metropolitan Cities, Dos, and Special Self-Governing Province (hereinafter referred to as "City/Do"), and may establish branches in the Gus of the Special Metropolitan City and Metropolitan Cities, Sis (referring to an administrative-Si in cases of the Special Self-Governing Province; hereinafter the same shall apply) and Guns. <Amended by Act No. 10788, Jun. 7, 2011>
(2) When the Pharmaceutical Association or the Oriental Pharmacy Association has established its chapters and branches, it shall, without delay, file a report thereon with the Special Metropolitan City Mayor, Metropolitan City Mayors, Do Governors, or Governor of the Special Self-Governing Province (hereinafter referred to as "Mayor/Do Governor").
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 Article 15 (Training and Education)   print
(1) The Minister of Health and Welfare may order pharmacists and herb pharmacists to undergo training and education for the improvement of their quality. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>
(2) Matters necessary for training and education under paragraph (1) shall be prescribed by Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>
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 Article 16 (Duties of Cooperation and Entrustment)   print
(1) The Pharmaceutical Association or Oriental Pharmacy Association shall comply with a request for cooperation of the Minister of Health and Welfare concerning projects for the improvement of national public health, pharmaceutical affairs, and pharmacists' or herb pharmacists' ethics. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>
(2) The Minister of Health and Welfare may entrust some of matters concerning pharmaceutical affairs and pharmacists' or herb pharmacists' ethics to the Pharmaceutical Association or Oriental Pharmacy Association, as prescribed by Presidential Decree. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>
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 Article 17 (Subsidization of Expenses)   print
When the Minister of Health and Welfare deems that programs of the Pharmaceutical Association or Oriental Pharmacy Association are necessary for the improvement of national public health, or when he/she has ordered or entrusted such Association to conduct training for pharmacists or herb pharmacists, investigation and research, he/she may fully or partially subsidize necessary expenses. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>
CHAPTER III PHARMACEUTICAL AFFAIRS COUNCIL
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 Article 18 (Central Pharmaceutical Affairs Council)   print
(1) A Central Pharmaceutical Affairs Council shall be established under the control of the Minister of Food and Drug Safety in order to respond inquiries from the Minister of Health and Welfare and the Minister of Food and Drug Safety when requested. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
(2) Matters necessary for the organization and operation of the Central Pharmaceutical Affairs Council and other necessary matters shall be prescribed by Presidential Decree.
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 Article 19 Deleted. <by Act No. 10512, Mar. 30, 2011>   print
CHAPTER IV PHARMACIES AND DISPENSING DRUGS
SECTION 1 Pharmacies
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 Article 20 (Registration for Establishment of Pharmacies)   print
(1) No person, other than a pharmacist or herb pharmacist, shall establish a pharmacy.
(2) Any person who intends to establish a pharmacy shall file for registration for establishment with the head of a Si/Gun/Gu (referring to the head of an autonomous Gu; hereinafter the same shall apply), as prescribed by Ordinance of the Ministry of Health and Welfare. The same shall apply to any amendment to registered matters. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>
(3) Any person who intends to file for registration under paragraph (2) shall install necessary facilities in conformity with standards for facilities prescribed by Presidential Decree.
(4) The Mayor/Do Governor may set standards for registration for establishing a pharmacy, respectively by regulations of the relevant City/Do in compliance with the standards prescribed by Presidential Decree.
(5) In any of the following cases, registration for establishment of a pharmacy shall be rejected:
1. Where a person whose registration for establishment of a pharmacy has been revoked pursuant to Article 76 intends to file a registration again before the lapse of six months;
2. Where a pharmacy is to be established in a place located within facilities or premises of a medical institution;
3. Where a pharmacy is established by dividing, altering or repairing some of facilities or sites of a medical institution;
4. Where a pathway, such as an exclusive corridor, a flight of stairs, an elevator or a footbridge, is in place or to be constructed between a pharmacy and a medical institution.
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 Article 21 (Duties to Manage Pharmacies)   print
(1) A pharmacist or herb pharmacist may establish only one pharmacy.
(2) Any pharmacy founder shall manage the pharmacy in person: Provided, That where a pharmacy founder is unable to manage the pharmacy, he/she shall designate a pharmacist or a herb pharmacist who manages such pharmacy on his/her behalf.
(3) Each pharmacist or herb pharmacist who manages a pharmacy shall observe the following matters necessary for managing such pharmacy: <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 10788, Jun. 7, 2011; Act No. 11690, Mar. 23, 2013>
1. He/she shall manage his/her pharmacy and drugs in a manner not inflicting harm to health and sanitation and not reducing the efficacy of drugs;
2. He/she shall thoroughly oversee his/her employees in order to prevent any sanitary incident;
3. He/she shall keep any goods feared to incur any sanitary danger off from his/her pharmacy;
4. He/she shall take necessary safety measures in cases where any side effect, etc. occurs in connection with the use of drugs, etc.;
5. He/she shall observe other matters which correspond to the provisions of subparagraphs 1 through 4 and are prescribed by Ordinance of the Ministry of Health and Welfare following consultation with the Minister of Food and Drug Safety as deemed necessary to manage the facilities and drugs of pharmacies in a manner not inflicting harm to health and sanitation.
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 Article 22 (Reporting on Discontinuation, etc. of Business)   print
Where a pharmacy founder discontinues business of his/her pharmacy, or suspends such business or resumes the suspended business, he/she shall file a report thereon with the head of a Si/Gun/Gu having jurisdiction over his/her pharmacy within seven days from the date of discontinuation, suspension or resumption, as prescribed by Ordinance of the Ministry of Health and Welfare: Provided, That the same shall not apply where the period of suspension of business is less than one month. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>
SECTION 2 Dispensing Drugs
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 Article 23 (Dispensing Drugs)   print
(1) No person, other than pharmacists or herb pharmacists, may dispense drugs, and pharmacists or herb pharmacists shall dispense drugs within their licensed area: Provided, That students who major in pharmacy at college may dispense drugs within the limits prescribed by Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>
(2) A pharmacist or herb pharmacist shall dispense drugs at a pharmacy or a dispensary of a medical institution (including a dispensary installed in the Korea Orphan Drug Center pursuant to the latter part of Article 92 (1) 2): Provided, That this shall not apply where he/she has obtained approval from the head of a Si/Gun/Gu.
(3) Any doctor or dentist shall be entitled to prescribe prescription drugs and over-the-counter drugs and any pharmacist shall be entitled to dispense prescription drugs and over-the-counter drugs according to the prescriptions issued by doctors or dentists: Provided, That a pharmacist may dispense drugs without prescriptions issued by a doctor or dentist in any of the following cases: <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9847, Dec. 29, 2009; Act No. 9932, Jan. 18, 2010>
1. Where he/she dispenses drugs in an area where no medical institution exists;
2. Where he/she dispenses drugs for the purpose of disaster relief because medical institutions become virtually nonexistent in times of a natural disaster;
3. Where he/she sells oral vaccines to prevent spread of an infectious disease after the Minister of Health and Welfare recognizes such infectious disease has broken out or is feared to break out widely;
4. Where he/she dispenses drugs for community service activities.
(4) Notwithstanding the provisions of paragraph (1), a doctor or dentist may directly dispense drugs, in any of the following cases: <Amended by Act Nos. 8723 & 8728, Dec. 21, 2007; Act No. 8852, Feb. 29, 2008; Act No. 9819, Nov. 2, 2008; Act No. 9847, Dec. 29, 2009; Act No. 9932, Jan. 18, 2010; Act No. 10512, Mar. 30, 2011; Act No. 11251, Feb. 1, 2012>
1. Where he/she dispenses drugs in an area where no pharmacy exists;
2. Where he/she dispenses drugs for the purpose of disaster relief because pharmacies become virtually nonexistent in times of a natural disaster;
3. Where he/she dispenses drugs for an emergency patient or a mental patient suffering from schizophrenia, a manic-depressive insanity, etc. who is feared to harm himself/herself or third persons;
4. Where he/she dispenses drugs for an in-patient, a patient suffering from a Type 1 infectious disease under the Infectious Disease Control and Prevention Act or a person admitted to a social welfare facility under the Social Welfare Services Act (where a person does not board and lodge in such social welfare facility, it shall be limited only to the dispensing of drugs during a period for which he/she utilizes such facility);
5. Where he/she gives injections;
6. Where he/she administers medication, including vaccines to prevent infectious diseases, drugs for medical examinations, and other drugs prescribed by Ordinance of the Ministry of Health and Welfare;
7. Where he/she, while serving in a public health center or its branch office under the Regional Public Health Act, dispenses drugs for patients, as performance of his/her duties (excluding ambulatory care services for residents within the jurisdiction of a public health center and a public health branch office designated by the Minister of Health and Welfare);
8. Where he/she dispenses drugs for veterans with disability ratings 1 through 3 under the Act on the Honorable Treatment and Support of Persons, etc. of Distinguished Services to the State and its Enforcement Decree, persons with disability ratings 1 through 4 among those wounded in the May 18 Democratization Movement under the Act on the Honorable Treatment of Persons of Distinguished Service to the May 18 Democratization Movement, persons with severe disabilities under the Act on Assistance, etc. to Patients from Actual or Potential Aftereffects of Defoliants and its Enforcement Decree, persons with disability ratings 1 and 2 under the Act on Welfare of Persons with Disabilities and its Enforcement Decree, disabled persons equivalent thereto, and patients suffering from Parkinson's disease or Hansen's disease;
9. Where he/she dispenses drugs for the treatment of persons having undergone the surgery of internal organ transplant and the treatment of patients suffering from AIDS;
10. Where he/she dispenses drugs for the active service persons in the course of discharging a military duty, riot police officers, security guards of any correctional institution, and other persons who are held in correctional institutions under the Administration and Treatment of Correctional Institution Inmates Act and the Act on the Execution of Criminal Penalties in the Armed Forces and the Treatment of Military Prison Inmates, protected juvenile accommodation facilities under the Act on the Treatment of Protected Juveniles, Etc., and internment facilities under the Immigration Control Act;
11. Where he/she administers medication of drugs for the treatment of tuberculosis under the Tuberculosis Prevention Act (limited to public health centers, public health branches and subsidiary hospitals of the Korean National Tuberculosis Association);
12. Where he/she dispenses drugs for community service activities;
13. Where he/she is prohibited from disclosing prescriptions for the sake of the confidentiality of information related to the national security;
14. Other cases prescribed by Presidential Decree.
(5) The scope of an area where no medical institution or pharmacy exists, as referred to in paragraph (3) 1 or (4) 1, shall be determined by the Minister of Health and Welfare. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010 >
(6) When a herb pharmacist dispenses any herb drug, he/she shall comply with the prescription of a herb doctor: Provided, That where he/she dispenses it according to the category of herb drug prescriptions or by a dispensing method determined by the Minister of Health and Welfare, he/she may dispense it without prescription of a herb doctor. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>
(7) Any pharmacist engaging in dispensing drugs at a dispensary of a medical institution shall be prohibited from dispensing any drug for a patient to whom a prescription is issued under Article 18 of the Medical Service Act.
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 Article 24 (Duties and Observances)   print
(1) No pharmacist or herb pharmacist engaging in dispensing drugs at a pharmacy, shall refuse any request for dispensing drugs, without just cause.
(2) Any pharmacy founder (including persons working for the relevant pharmacy; hereafter the same shall apply in this Article) and any medical institution founder (including persons working for the relevant medical institution; hereafter the same shall apply in this Article) shall be prohibited from engaging in any of the following collusive acts:
1. The act, performed by any pharmacy founder, of wholly or partially exempting any person carrying a medical prescription issued by a specific medical institution from paying drug expenses;
2. The act, performed by any pharmacy founder, of offering money, articles, favors, labor, entertainment and other economic interest in return for medical prescriptions arranged by a specific medical institution founder in favor of him/her;
3. The act, performed by any medical institution founder, of directing or inducing any person carrying its medical prescription to get drugs dispensed at a specific pharmacy (excluding the act of introducing in full the names, locations, etc. of pharmacies in the relevant area at the request of any patient);
4. The act, performed by any doctor or dentist, of repeatedly prescribing other drugs identical in composition to drugs that are included in the list of prescription drugs offered by the branches of the Medical Association or the branches of the Dental Association to the branches of the Pharmaceutical Association under Article 25 (2) (the same shall apply to any pharmacist who repeatedly dispenses the relevant drugs according to the relevant medical prescription);
5. Any other act similar to that referred to in subparagraphs 1 through 4 and prescribed by Presidential Decree as having the potential of collusion.
(3) Where a pharmacist or herb pharmacist working at a dispensary of a medical institution under Article 23 (2) dispenses drugs, he/she shall observe matters prescribed by Ordinance of the Ministry of Health and Welfare following consultation with the Minister of Food and Drug Safety. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
(4) Where a pharmacist dispenses drugs for any patient, he/she shall give the dosage instructions to the relevant patient.
(5) The Minister of Health and Welfare may take necessary measures for pharmacists to faithfully offer patients the medication counseling referred to in paragraph (4) by allowing them to dispense a proper number of medical prescriptions. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>
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 Article 25 (Preparation, etc. of List of Prescription Drugs)   print
(1) Any medical institution founder shall submit a list of drugs that the relevant medical institution intends to prescribe to the branch of the Medical Association or the branch of the Dental Association (hereinafter referred to as the "branch of the Medical Association, etc."), which has been established pursuant to Article 28 (5) of the Medical Service Act, of the Si/Gun/Gu where such medical institution is located.
(2) The branch of the Medical Association, etc. shall provide the branch of the Pharmaceutical Association of the relevant Si/Gun/Gu with a regional list of prescription drugs, the items of which are appropriately selected from the list of prescription drugs of each medical institution pursuant to paragraph (1) and a list of prescription drugs of each medical institution which are selected from the regional list of prescription drugs.
(3) The branch of the Pharmaceutical Association shall, upon receiving the regional list of prescription drugs and the list of prescription drugs of each medical institution from the branch of the Medical Association, etc. under paragraph (2), inform pharmacy founders in the relevant area of such lists and require them to secure relevant drugs.
(4) In the event that a pharmacy founder finds it difficult to secure drugs according to the list of prescription drugs under paragraph (2) and that it becomes necessary to adjust the number of items, the branch of the Medical Association, etc. and the branch of the Pharmaceutical Association may adjust it through consultations. The same shall apply where the numbers of items are added or altered.
(5) Where the branch of the Medical Association, etc. intends to alter or add the list of prescription drugs referred to in paragraph (2), it shall inform the branch of the Pharmaceutical Association thereof 30 days in advance.
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 Article 26 (Modification and Revision of Prescriptions)   print
(1) No pharmacist or herb pharmacist shall dispense drugs by modifying or revising prescriptions without the consent of the doctor, dentist, herb doctor or veterinarian who has issued the prescriptions.
(2) Where a name, quantity, directions, dose, etc. of any of drugs written in a prescription is suspected to fall under any of the following subparagraphs, a pharmacist or herb pharmacist shall not dispense the drug unless he/she has confirmed any suspect points by telephone and fax or by telephone and e-mail with the doctor, dentist, herb doctor, or veterinarian who has issued the prescription: <Amended by Act No. 8558, Jul. 27, 2007; Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11141, Dec. 31, 2011; Act No. 11690, Mar. 23, 2013>
1. Where a drug, the product license or product notification of which is revoked by the Minister of Food and Drug Safety due to any defect in terms of safety and effectiveness of the drug, is written in the prescription;
2. Where it is impracticable to confirm a product name of a drug or names of ingredient thereof;
3. Where a drug, any of the ingredients of which has been announced by the Minister of Food and Drug Safety to be banned from use in combination or from use for a specific age bracket in accordance with the criteria for medical care benefits prescribed by Ordinance of the Ministry of Health and Welfare pursuant to Article 41 (2) of the National Health Insurance Act, is written in the prescription.
(3) Detailed matters, such as the method of and procedures for revising and modifying prescriptions under paragraph (1), shall be prescribed by Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 8852. Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>
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 Article 27 (Dispensing Substitute Drugs)   print
(1) When a pharmacist intends to dispense a drug by substituting the drug in a prescription slip issued by a doctor or dentist with a drug of the same ingredients, content and dosage form, he/she shall obtain prior consent of the doctor or dentist who has issued the prescription slip.
(2) Notwithstanding paragraph (1), a pharmacist may dispense a substitute drug without obtaining prior consent of the doctor or dentist who has issued the prescription slip where it falls under any of the following subparagraphs: <Amended by Act No. 11690, Mar. 23, 2013>
1. Where the pharmacist dispenses a substitute drug which has been recognized by the Minister of Food and Drug Safety as having biological equivalence (including drugs that prove their biological equivalence through a medical experiment using no living body because of the needlessness to conduct a medical experiment using a living body or of the impossibility to do so): Provided, That where the doctor or dentist has indicated in the prescription slip that dispensing a substitute drug is not permissible, and has written in detail the clinical reasons, etc. therefor, such product shall be excluded;
2. Where the pharmacist dispenses a substitute drug with the same prescription dosage, which has been manufactured by the same drug manufacturer who also manufactures the drug stated in the prescription slip, and which is different in content but is of the same ingredients and dosage form: Provided, That dispensing such substitute drug shall be limited only in cases where a substitute over-the-counter drug is dispensed in place of an over-the-counter drug and a substitute prescription drug is dispensed in place of a prescription drug;
3. Where the pharmacist dispenses a substitute drug, with the same ingredients, content, and dosage form as the drug stated in the prescription slip, which is included in the regional list of prescription drugs of the pharmacy concerned where a drug, which is stated in the prescription slip issued by a medical institution located in a region other than the Si/Gun/Gu in which the pharmacy is located, is not included in the regional list of prescription drugs of the pharmacy concerned, and for which it is difficult to obtain prior consent of the doctor or dentist who has issued the prescription slip due to any unavoidable reasons.
(3) Where a pharmacist dispenses a substitute drug instead of the drug prescribed in a prescription slip under paragraph (1) or (2), he/she shall notify the person carrying such prescription slip of the detail of such substitute drug that has been dispensed.
(4) Where a pharmacist dispenses a substitute drug instead of the drug prescribed in a prescription slip under paragraph (2), he/she shall notify the doctor or dentist who has issued such prescription slip of the details of such substitute drug that has been dispensed within one day from the date of dispensing (within three days if any unavoidable reasons exist): Provided, That the same shall not apply where the pharmacist dispenses such substitute drug after obtaining prior consent of the doctor or dentist who has issued the prescription slip thereof.
(5) Where any pharmacist dispenses a substitute drug instead of a drug prescribed in a prescription slip without prior consent of the doctor or dentist who has issued such prescription slip, such doctor or dentist shall not be held responsible for any drug accident caused by such substitute drug.
(6) Necessary matters concerning methods of and procedures for obtaining consent and giving notification, etc. under paragraphs (1) and (4) shall be prescribed by Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>
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 Article 28 (Indication and Recording of Drugs Dispensed)   print
(1) A pharmacist or herb pharmacist shall indicate the relevant patient's name, directions, and dosage mentioned in the pertinent prescription slip and other matters prescribed by Ordinance of the Ministry of Health and Welfare on the containers or packages of drugs dispensed for sale. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>
(2) When a pharmacist or herb pharmacist has dispensed drugs, he/she shall indicate in the prescription slip, the date of dispensing and other matters prescribed by Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>
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 Article 29 (Preservation of Prescriptions)   print
A pharmacist or herb pharmacist shall keep prescriptions by which he/she has dispensed drugs at his/her pharmacy, for two years from the date of dispensing.
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 Article 30 (Records of Dispensing)   print
(1) Where a pharmacist dispenses drugs (including cases where he/she dispenses drugs without a prescription in accordance with the proviso to Article 23 (3), with the exception of its subparagraphs, and each subparagraph of the said Article; hereafter the same shall apply in this Article) at his/her pharmacy, he/she shall enter the personal information of a patient, dispensing date, the names of prescribed drugs and the days of taking drugs, details of dispensing, details of medication counselling and other matters prescribed by Ordinance of the Ministry of Health and Welfare in his/her dispensing records (including electronic records) and preserve such dispensing records for five years. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 10512, Mar. 30, 2011>
(2) Where any patient, his/her spouse, his/her lineal ascendant or descendant, or his/her spouse's lineal ascendant (an agent designated by such patient where none of his/her spouse, his/her lineal ascendant or descendant and his/her spouse's lineal ascendant exists) requests a perusal of dispensing records preserved under paragraph (1), an issuance of a copy of such dispensing records and a confirmation of details of such dispensing records, etc., he/she shall comply with such request.
CHAPTER V MANUFACTURE, IMPORTATION, ETC. OF DRUGS, ETC.
SECTION 1 Manufacturing Business of Drugs, etc.
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 Article 31 (Permission for Manufacturing Business, etc.)   print
(1) A person who intends to manufacture drugs for business purposes shall obtain permission from the Minister of Food and Drug Safety, as prescribed by Ordinance of the Prime Minister, after being equipped with necessary facilities meeting the standards for facilities prescribed by Presidential Decree. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
(2) Where a manufacturer under paragraph (1) intends to sell drugs manufactured (including cases of entrusting another manufacturer with manufacture), he/she shall obtain a license of a drug he/she intends to manufacture and sell by product (hereinafter referred to as "product license") from the Minister of Food and Drug Safety or file notification of a drug he/she intends to manufacture and sell by product (hereinafter referred to as "product notification"), as prescribed by Ordinance of the Prime Minister. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
(3) Where a person, other than a manufacturer under paragraph (1), intends to entrust a manufacturer with manufacture and sale of a drug which has been successfully completed clinical trials after having obtained approval for a protocol of clinical trials pursuant to Article 34 (1) and sell it, he/she shall submit a report on contract manufacturing business to the Minister of Food and Drug Safety and obtain a license by product, as prescribed by Ordinance of the Prime Minister. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
(4) A person who intends to manufacture quasi-drugs for business purposes shall file a report on manufacturing business with the Minister of Food and Drug Safety after being equipped with necessary facilities meeting the standards for facilities prescribed by Presidential Decree, and obtain a product license or file product notification. <Amended by Act No. 11690, Mar. 23, 2013>
(5) A person who has obtained a product license or filed product notification pursuant to paragraphs (2) and (3) (hereinafter referred to as "person who has obtained a product license") may establish a business office, as prescribed by Ordinance of the Prime Minister. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
(6) Notwithstanding paragraphs (1) through (4), permission for manufacturing business, a product license, or product notification may be omitted with regard to drugs or quasi-drugs prescribed by Ordinance of the Prime Minister, such as drugs for clinical trials under Article 34 (hereinafter referred to as "drugs, etc."). <Newly Inserted by Act. No. 10512, Mar. 30, 2011; Act No. 11690, Mar. 23, 2013>
(7) Notwithstanding paragraphs (2) through (4), a product or an item, in which a drug, etc. and a medical device are combined together or complexly made and which has been licensed or notified pursuant to the Medical Devices Act because its major function is that of a medial device, shall be deemed to have been product-licensed or product notified pursuant to paragraphs (2) through (4). <Newly Inserted by Act. No. 10512, Mar. 30, 2011>
(8) No person falling under any of the following subparagraphs may obtain permission for nor file a report on the business of manufacturing drugs, etc. or the business of contract manufacturing: <Amended by Act. No. 10512, Mar. 30, 2011>
1. A person falling under any subparagraph of Article 5;
2. A person in whose case one year has not passed since the revocation of permission for manufacturing business or the closure of a contract manufacturing business office or a factory pursuant to Article 76;
3. A person who was declared bankrupt and has not been reinstated.
(9) Where a person intends to change any of the matters prescribed by Ordinance of the Prime Minister among matters licensed or notified under paragraphs (1) through (4), he/she shall obtain permission to change or file a report on the change, as prescribed by Ordinance of the Prime Minister. <Amended by Act No. 8852, Feb. 29, 2008; Act. No. 10512, Mar. 30, 2011; Act No. 11690, Mar. 23, 2013>
(10) If an item subject to a product license or product notification pursuant to paragraphs (2) and (3), is a new drug or a drug designated by the Minister of Food and Drug Safety, the following documents related to its safety and effectiveness shall be submitted as prescribed by Ordinance of the Prime Minister: Provided, That subparagraph 2 shall be excluded, where drug substances have been registered pursuant to Article 31-2: <Amended by Act No. 8852, Feb. 29, 2008; Act. No. 10512, Mar. 30, 2011; Act No. 11690, Mar. 23, 2013>
1. Test results and relevant data;
2. Data on drug substances;
3. Relevant documents;
4. Other necessary data.
(11) When granting permission for, or filing a report on, the business of manufacturing drugs, etc. and contract manufacturing business, or granting licenses, or filing notification, of products under paragraphs (1) through (4) and (9), necessary matters concerning the subject matter of permission, report, license or notification, standards therefor, conditions therefor, management thereof, etc. shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 8852, Feb. 29, 2008; <Amended by Act. No. 10512, Mar. 30, 2011; Act No. 11690, Mar. 23, 2013>
[This Article Wholly Amended by Act No. 8643, Oct. 17, 2007]
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 Article 31-2 (Registration, etc. of Drug Substances)   print
(1) A person who intends to manufacture and sell a drug substance of a new drug or a drug substance which is determined and publicly notified by the Minister of Food and Drug Safety may file a registration for the matters prescribed by Ordinance of the Prime Minister, such as its components, name and manufacturing method, with the Minister of Food and Drug Safety, as prescribed by Ordinance of the Prime Minister. <Amended by Act No. 11690, Mar. 23, 2013>
(2) The Minister of Food and Drug Safety shall examine whether the matters of registration under paragraph (1) satisfy the criteria prescribed by Ordinance of the Prime Minister, inform the relevant applicant of the examination results, record the details of examination in the drug substance register, and keep the register. In such cases, he/she shall publicly notify the matters prescribed by Ordinance of the Prime Minister, such as the components and manufacturer of the relevant drug substance. <Amended by Act No. 11690, Mar. 23, 2013>
(3) A person, who intends to change important matters prescribed by Ordinance of the Prime Minister among the matters registered pursuant to paragraphs (1) and (2), shall file a registration for such change with the Minister of Food and Drug Safety: Provided, That a person who intends to change any other matters shall report thereon. <Amended by Act No. 11690, Mar. 23, 2013>
(4) Drug substances registered pursuant to paragraphs (1) through (3) shall be deemed to have been product-licensed or product-notified under Article 31 (2).
(5) Except as provided for in paragraphs (1) through (3), matters necessary for registering drug substances, filing a registering for change thereto, reporting changes thereto, giving public notice of registered drug substances, and similar matters shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 11690, Mar. 23, 2013>
[This Article Newly Inserted by Act No. 10512, Mar. 30, 2011]
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 Article 31-3 (Patent Lists of Drugs)   print
(1) If a person who has obtained a product license pursuant to Article 31 (2) or (3) desires to have the matters prescribed by Ordinance of the Prime Minister, such as an owner of a patent right, duration, and the extent of the patent of the product-licensed drug, (hereinafter referred to as "patent information") registered in the patent list for drugs (hereinafter referred to as "patent list"), he/she shall file an application for registration with the Minister of Food and Drug Safety. <Amended by Act No. 11690, Mar. 23, 2013>
(2) If the patent of a drug, the registration of which was applied for pursuant to paragraph (1) satisfies the subject matter and standards determined by Ordinance of the Prime Minister, the Minister of Food and Drug Safety shall register the patent information of the relevant drug in the patent list. <Amended by Act No. 11690, Mar. 23, 2013>
(3) If a person who has obtained a product license of the drug registered in the patent list pursuant to paragraph (2) (hereinafter referred to as "registered drug") desires to change the patent information registered in the patent list, he/she shall file an application for change registration with the Minister of Food and Drug Safety. <Amended by Act No. 11690, Mar. 23, 2013>
(4) The Minister of Food and Drug Safety shall ascertain the details of the application for change registration under paragraph (3), and if the details are deemed appropriate, he/she shall change the patent information registered in the patent list. <Amended by Act No. 11690, Mar. 23, 2013>
(5) Where the patent on the registered drug fails to meet the subject matter and standards referred to in paragraph (2), the Minister of Food and Drug Safety may delete from the patent list or change the patent information on the registered drug by his/her authority. In such cases, the Minister of Food and Drug Safety shall hear, in advance, opinions of a person who has obtained a product license of the relevant registered drug. <Amended by Act No. 11690, Mar. 23, 2013>
(6) If the Minister of Food and Drug Safety has registered the patent information on drugs in the patent list, or deleted or changed the patent information on registered drugs, he/she shall post the details on the Internet website. <Amended by Act No. 11690, Mar. 23, 2013>
(7) Except as provided for in paragraphs (1) through (6), matters on the registration in the patent list, deletion and change of the registered patent information, and the methods of and procedures for giving public notice of the patent list and other necessary matters shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 11690, Mar. 23, 2013>
[This Article Newly Inserted by Act No. 11118, Dec. 2, 2011]
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 Article 31-4 (Notification of Application for Product License)   print
(1) A person who has filed an application for a product license under Article 31 (2) or (3) based on the data on the safety and effectiveness of the registered drugs shall notify the persons who have obtained product licenses of the registered drugs and the holders of the patent rights (hereinafter referred to as "patent right holder, etc.") of matters prescribed by Ordinance of the Prime Minister, such as the fact that he/she has filed such application: Provided, That the same shall not apply to any of the following cases: <Amended by Act No. 11690, Mar. 23, 2013>
1. Where the duration of the patent of a registered drug expires;
2. Where an application for a product license is filed to sell the relevant drug after the duration of the patent of a registered drug expires;
3. Where the holder of the patent right, etc. of a registered drug has agreed to the omission of notification;
4. Where the Patent Tribunal's trial decision or a court judgement exists that the patent of a registered drug is invalid, or that a drug subject to an application for a product license is not included in the scope of the right to the patent of the registered drug;
5. Cases corresponding to those falling under subparagraphs 1 through 4 which are prescribed by Ordinance of the Prime Minister.
(2) Matters necessary for the period, methods, and procedures of giving notice under paragraph (1) and other matters shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 11690, Mar. 23, 2013>
[This Article Newly Inserted by Act No. 11118, Dec. 2, 2011]
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 Article 31-5 (Renewal of Product Licenses of Drugs and Similar Matters)   print
(1) The period of validity of a product license or product notification under Article 31 (2) and (3) shall be five years: Provided, That the period of validity thereof shall not apply to any of the following drugs: <Amended by Act No. 11690, Mar. 23, 2013>
1. Drug substances;
2. Drugs for export which are produced only for the purpose of export;
3. Other drugs prescribed by Ordinance of the Prime Minister, which correspond to those prescribed in subparagraphs 1 and 2.
(2) Notwithstanding paragraph (1), the period of validity of a product license of the drug subject to re-examination under Article 32 shall commence after the period of re-examination of the relevant drug expires.
(3) If a person who has obtained a product license intends to sell the relevant drug continuously after the expiration of the period of validity prescribed in paragraph (1) or (2), he/she shall obtain a renewed product license from, or file renewed product notification with, the Minister of Food and Drug Safety before the period of validity expires. <Amended by Act No. 11690, Mar. 23, 2013>
(4) Where any serious problem is considered to exist in the safety or effectiveness of drugs, where no data necessary for the renewal under paragraph (3) are submitted, or where other similar cases occur, the Minister of Food and Drug Safety may choose not to renew the product license or product notification of the relevant drugs. <Amended by Act No. 11690, Mar. 23, 2013>
(5) The product license or product notification of a drug shall not be renewable in accordance with paragraph (3), if a person who has obtained the product license or filed public notification fails to manufacture the relevant drug during the period of validity prescribed in paragraph (1): Provided, That the same shall not apply to the drug that has not been manufactured due to any of unavoidable causes as prescribed by Ordinance of the Prime Minister. <Amended by Act No. 11690, Mar. 23, 2013>
(6) Necessary matters concerning the method of calculating the period of validity under paragraphs (1) and (2) and the standards, methods and procedures for the renewal of a product license or product notification under paragraphs (3) and (4) shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 11690, Mar. 23, 2013>
[This Article Newly Inserted by Act No. 11421, May 14, 2012]
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 Article 32 (Re-Examination of New Drugs, etc.)   print
(1) Drugs referred to in Article 31 (10), among those which are product-licensed under Article 31 (2) and (3), shall undergo a re-examination by the Minister of Food and Drug Safety, within three months after the date on which four to six years have passed depending on items from the date on which the product licenses have been granted. <Amended by Act No. 8643, Oct. 17, 2007; Act No. 10512, Mar. 30, 2011; Act No. 11690, Mar. 23, 2013>
(2) Necessary matters concerning method, procedure, timing, etc. for re-examination referred to in paragraph (1) shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
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 Article 33 (Re-Evaluation of Drugs)   print
(1) The Minister of Food and Drug Safety may reevaluate drugs, for which examination of their safety and effectiveness by efficacy or ingredient or the verification of drug equivalence are deemed necessary, among drugs which are product-licensed or product-notified pursuant to Article 31 (2) and (3). <Amended by Act No. 8643, Oct. 17, 2007; Act No. 11690, Mar. 23, 2013>
(2) Matters necessary for method, procedure, etc. for reevaluation referred to in paragraph (1) shall be determined by the Minister of Food and Drug Safety. <Amended by Act No. 11690, Mar. 23, 2013>
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 Article 34 (Approval, etc. for Protocols of Clinical Trials, etc.)   print
(1) Any person who intends to conduct a clinical trial or a biological equivalence test using drugs, etc. shall prepare a protocol thereof and obtain approval from the Minister of Food and Drug Safety. The same shall apply to a revision to the approved protocol of the clinical trial or biological equivalence test. <Amended by Act No. 11690, Mar. 23, 2013>
(2) Notwithstanding paragraph (1), approval under paragraph (1) may be omitted for the clinical trials and biological equivalence tests prescribed by Ordinance of the Prime Minister (hereinafter referred to as "clinical trials, etc."), such as a trial or test aimed at examining clinical effects of drugs, etc. in distribution and investigating whether any adverse event occurs within the conditions that such drugs are product-licensed or product-notified. <Amended by Act No. 11690, Mar. 23, 2013>
(3) Any person who intends to conduct a clinical trial under paragraph (1) shall observe the following matters: <Amended by Act No. 11690, Mar. 23, 2013>
1. A clinical trial shall be conducted at a clinical trial institution or a biological equivalence test institution designated under Article 34-2 (1): Provided, That the same shall not apply to clinical trials, etc. prescribed by Ordinance of the Prime Minister in which participation by a medical institution, other than by a clinical trial institution or a biological equivalence test institution, is deemed necessary considering the characteristics of the clinical trials, etc;
2. A person who is under the custody of any of the group care facilities prescribed by Ordinance of the Prime Minister, such as social welfare facilities, (hereafter referred to as "inmate" in this subparagraph) shall not be selected as a test subject of a clinical trial, etc.: Provided, That an inmate may be selected as a test subject of a clinical trial, etc. where it is inevitable to select an inmate as a test subject of a clinical trial, etc. in light of the characteristics of the clinical trial, etc. and where such selection meets the criteria prescribed by Ordinance of the Prime Minister.
3. Details of a clinical trial, etc. and details of and procedures, etc. for an indemnity for any health damage that may be inflicted on a test subject during the clinical trial, etc. shall be explained to the test subject of the clinical trial, etc. and consent of the test subject shall be obtained;
4. Drugs, etc. which were manufactured, or imported after being manufactured, in appropriate manufacturing facilities prescribed by Ordinance of the Prime Minister shall be used;
(4) No drugs, etc. which were manufactured or imported after being manufactured for the purpose of clinical trials, etc. shall be used for any purpose other than for clinical trials, etc.: Provided, That where the Minister of Food and Drug Safety has granted approval, the drugs, etc. for medical treatment of any of the following persons can be used for any purpose other than for clinical trials, etc., as prescribed by Ordinance of the Prime Minister and in such cases, paragraph (3) 3 shall apply mutatis mutandis: <Amended by Act No. 11690, Mar. 23, 2013>
1. A patient with a serious life-threatening disease, such as terminal cancer or AIDS;
2. An emergency patient prescribed by Ordinance of the Prime Minister, such as a patient whose life is being threatened and a patient without alternative means of treatment.
(5) Where a clinical trial, etc. on pharmaceutical preparations, blood pharmaceutical preparations, gene remedial agents, cell remedial agents, etc., which contain questionable composition in light of safety or effectiveness, is deemed or feared to harm the public interest or health and sanitation, the Minister of Food and Drug Safety may place limits on such clinical trial, etc. which is subject to approval under paragraph (1). <Amended by Act No. 11690, Mar. 23, 2013>
(6) Where any clinical trial, etc., approved under the former part and latter part of paragraph (1), is conducted in violation of the approved matters, or gives rise to serious safety and ethical issues, the Minister of Food and Drug Safety may issue an order to halt conducing the clinical trial, etc., to stop using drugs, etc. for the clinical trial, etc., to recall or abandon such drugs, etc., or to take other necessary measures. <Amended by Act No. 11690, Mar. 23, 2013>
(7) Matters necessary for approval for protocols of clinical trials, etc. under paragraph (1), matters to be included in the protocols, the details of the consent of a test subject of a clinical trial, etc. and the timing and methods thereof under paragraph (3) 3, standards for a clinical trial, etc., and other necessary matters shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 11690, Mar. 23, 2013>
[This Article Wholly Amended by Act No. 10788, Jun. 7, 2011]
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 Article 34-2 (Designation, etc. of Clinical Trial Institutions, etc.)   print
(1) The Minister of Food and Drug Safety shall designate an institution which shall conduct clinical trials under Article 34 (limited to medical institutions designated under the Medical Service Act; hereinafter referred to as a “clinical trial institution”) and an institution which shall conduct biological equivalence tests under Article 34 (hereinafter referred to as a "biological equivalence test institution"). <Amended by Act No. 11690, Mar. 23, 2013>
(2) A person who intends to be designated as a clinical trial institution or biological equivalence test institution pursuant to paragraph (1) shall have necessary facilities, professional personnel, and equipment and devices.
(3) Where a clinical trial institution or biological equivalence test institution designated pursuant to paragraph (1) has conducted a clinical trial, etc., it shall comply with matters prescribed by Ordinance of the Prime Minister, such as preparing and issuing clinical trial results or biological equivalence test results and keeping records on such a clinical trial, etc. <Amended by Act No. 11690, Mar. 23, 2013>
(4) Except as provided for in paragraphs (1) through (3), matters necessary for the designation requirements, procedures, methods, operation, and management of clinical trial institutions or biological equivalence test institutions and other matters shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 11690, Mar. 23, 2013>
[This Article Newly Inserted by Act No. 10788, Jun. 7, 2011]
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 Article 34-3 (Designation, etc. of Non-Clinical Trial Institutions)   print
(1) The Minister of Food and Drug Safety shall designate an institution which shall conduct non-clinical trials determined and publicly notified by the Minister of Food and Drug Safety on test subjects other than humans with regard to the safety and effectiveness of drugs, etc. (hereinafter referred to as "non-clinical trial institution"). <Amended by Act No. 11690, Mar. 23, 2013>
(2) A person who intends to be designated as a non-clinical trial institution pursuant to paragraph (1) shall have facilities, professional personnel, and equipment and devices necessary for non-clinical trials referred to in paragraph (1).
(3) When a non-clinical trial institution has conducted a non-clinical trial under paragraph (1), it shall comply with the matters prescribed by Ordinance of the Prime Minister, such as preparing and issuing non-clinical trial results and keeping records on such a non-clinical trial, etc. <Amended by Act No. 11690, Mar. 23, 2013>
(4) Except as provided for in paragraphs (1) through (3), matters necessary for the designation requirements, procedures, methods, operation, and management of non-clinical trial institutions and other matters shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 11690, Mar. 23, 2013>
[This Article Newly Inserted by Act No. 10788, Jun. 7, 2011]
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 Article 35 (Conditional Permission)   print
(1) In granting permission under Article 31 (1) and (2), the Minister of Food and Drug Safety may grant permission for the business of manufacturing drugs or items prescribed by Ordinance of the Prime Minister, on condition that the facilities referred to in Article 31 (1) be installed within a fixed period. <Amended by Act No. 8643, Oct. 17, 2007; Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
(2) If a person who has obtained permission under paragraph (1) fails to be equipped with proper facilities without justifiable grounds within the period under paragraph (1), the Minister of Food and Drug Safety shall revoke such permission. <Amended by Act No. 11690, Mar. 23, 2013>
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 Article 35-2 (Preliminary Examination of Product Licenses of Drugs, etc.)   print
(1) A person who intends to obtain product licenses, or file product notification, of drugs, etc. pursuant to Article 31 and a person who intends to conduct a clinical trial, etc. pursuant to Article 34 may request, in advance, the Minister of Food and Drug Safety to examine standards for preparing documents necessary for licenses, notification, approval, etc. <Amended by Act No. 11690, Mar. 23, 2013>
(2) Upon receiving a request under paragraph (1), the Minister of Food and Drug Safety shall confirm such request and inform the applicant of examination results in writing. <Amended by Act No. 11690, Mar. 23, 2013>
(3) In cases of permission, report, approval, etc. referred to in Articles 31 and 34, the Minister of Food and Drug Safety shall take into consideration the examination results referred to in paragraph (2). <Amended by Act No. 11690, Mar. 23, 2013>
(4) Matters necessary for preliminary examination under paragraph (1), such as the subject matter, scope, procedures and methods shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 11690, Mar. 23, 2013>
[This Article Newly Inserted by Act No. 10788, Jun. 7, 2011]
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 Article 36 (Manufacturing Supervisors of drugs, etc.)   print
(1) A manufacturer of drugs or quasi-drugs (excluding a quasi-drug manufacturer who manufactures only items falling under subparagraph 7 (a) of Article 2) shall assign the necessary number of pharmacists or herb pharmacists to each of his/her production facilities and entrust them with supervision over manufacturing affairs, as prescribed by Ordinance of the Prime Minister: Provided, That in cases of the biological preparation manufacturing industry, he/she may entrust a doctor or technician with bacteriological knowledge, approved by the Minister of Food and Drug Safety, with supervision over the manufacturing affairs thereof. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
(2) A quasi-drug manufacturer who manufactures only items falling under subparagraph 7 (a) of Article 2 shall assign technicians approved by the Minister of Food and Drug Safety to each of his/her production facilities and entrust them with supervision over manufacturing affairs: Provided, That where the manufacturer himself/ herself is a technician approved by the Minister of Food and Drug Safety, and supervises manufacturing affairs at his/her production facility, he/she may choose not to assign an additional technician to such production facility. <Amended by Act No. 11690, Mar. 23, 2013>
(3) Where a manufacturer of drugs, etc. intends to assign a person who supervises manufacturing affairs of drugs, etc. (hereinafter referred to as "manufacturing supervisor") pursuant to paragraph (1) or (2), he/she shall report to the Minister of Food and Drug Safety, as prescribed by Ordinance of the Prime Minister. <Newly Inserted by Act No. 10788, Jun. 7, 2011; Act No. 11690, Mar. 23, 2013>
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 Article 37 (Duty to Supervise Manufacturing Drugs, etc.)   print
(1) A manufacturing supervisor shall comply with the matters prescribed by Ordinance of the Prime Minister with regard to guidance and supervision of employees engaging in the affairs of manufacturing drugs, etc., quality control, management of manufacturing facilities, and other matters concerning manufacturing supervision. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
(2) No manufacturing supervisor shall engage in business, other than manufacture-supervising duties for the relevant production facility.
(3) No manufacturer of drugs, etc. or person who has obtained a product license shall interfere with the supervisory affairs of a manufacturing supervisor, nor refuse, without justifiable grounds, any request from a manufacturing supervisor on matters necessary for carrying out his/her duties. <Amended by Act No. 8643, Oct. 17, 2007>
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 Article 37-2 (Education for Manufacturing Supervisors, etc.)   print
(1) A manufacturing supervisor shall receive education on securing of safety and effectiveness, manufacturing, and quality control of drugs, etc. on a regular basis.
(2) If necessary to prevent harm to public health, the Minister of Food and Drug Safety may order a manufacturing supervisor to receive education referred to in paragraph (1). <Amended by Act No. 11690, Mar. 23, 2013>
(3) A manufacturing supervisor (where the alteration of a manufacturing supervisor was reported pursuant to subparagraph 3 of Article 40, such altered manufacturing supervisor shall be included) shall receive education referred to in paragraph (1) within three months: Provided, That the same shall not apply to a person who has received the same education within two years before he/she becomes a manufacturing supervisor.
(4) In order to provide education referred to in paragraphs (1) through (3), the Minister of Food and Drug Safety may designate and publicly notify a relevant professional organization or an institution as an education institution. <Amended by Act No. 11690, Mar. 23, 2013>
(5) Except as provided for in paragraphs (1) through (4), matters necessary for educating manufacturing supervisors, such as curricula, timing, method, procedures and fees of education, and matters necessary for designating an education institution shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 11690, Mar. 23, 2013>
[This Article Newly Inserted by Act No. 10788, Jun. 7, 2011]
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 Article 37-3 (Post Marketing Safety Control of Drugs)   print
(1) A person who has obtained a product license shall employ a doctor, pharmacist, or herb pharmacist to perform affairs of post marketing safety control, such as re-examination of new drugs, etc., re-evaluation of drugs, and reporting side effects, as prescribed by Ordinance of the Prime Minister. <Amended by Act No. 11251, Feb. 1, 2012; Act No. 11690, Mar. 23, 2013>
(2) A person who performs affairs of safety control under paragraph (1) (hereinafter referred to as a "safety control manager") shall comply with the matters prescribed by Ordinance of the Prime Minister regarding the safety control of drugs under distribution. <Amended by Act No. 11690, Mar. 23, 2013>
[This Article Newly Inserted by Act No. 8643, Oct. 17, 2007]
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 Article 38 (Production Control of Drugs, etc. and Reporting thereof)   print
(1) A manufacturer of drugs, etc. or a person who has obtained a product license of a drug shall comply with the matters prescribed by Ordinance of the Prime Minister with respect to the manufacture and quality control (including self-test) of drugs, etc. and other production control thereof. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 10788, Jun. 7, 2011; Act No. 11690, Mar. 23, 2013>
(2) A person who has obtained a product license of a drug or a quasi-drug manufacturer shall report the production performance, etc. of drugs, etc. to the Minister of Food and Drug Safety or the president of the Korea Pharmaceutical Information Service under Article 47-2 (1), as prescribed by Ordinance of the Prime Minister. <Amended by Act No. 8643, Oct. 17, 2007; Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
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 Article 39 (Recall of Hazardous Drugs, etc.)   print
(1) When a person prescribed by Ordinance of the Prime Minister, among those who have obtained product licenses of drugs, quasi-drug manufacturers, or importers and distributors of drugs, etc., pharmacy founders, medical institution founders, and other persons eligible to sell or deal with drugs pursuant to this Act or other Acts, becomes aware of that the drugs, etc. have a problem in terms of the safety and efficacy, in violation of Article 53 (1), 61 (including cases to which relevant provisions apply mutatis mutandis in Article 66), or 62 (including cases to which relevant provisions apply mutatis mutandis in Article 66), he/she shall promptly recall the drugs, etc. in distribution or take necessary measures for recall. In such cases, persons who have obtained product licenses of drugs, quasi-drug manufacturers, or importers of drugs, etc. shall report a recall plan to the Minister of Food and Drug Safety in advance. <Amended by Act No. 8643, Oct. 17, 2007; Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
(2) The Minister of Food and Drug Safety, Mayors/Do Governors or heads of Sis/Guns/Gus may release or lift the administrative dispositions granted pursuant to Article 76 to persons who have obtained product licenses of drugs, manufacturers of quasi-drugs or importers of drugs, etc., pharmacy founders and drug distributors who conscientiously perform the recall or measures necessary for the recall in accordance with paragraph (1), as prescribed by Ordinance of the Prime Minister. <Amended by Act No. 8643, Oct. 17, 2007; Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
(3) Matters necessary for the ranking of harms and standards for appraisal thereof necessary for the recall of drugs, etc., recall plans, procedures for recall and abandonment and follow-up steps of recalled drugs, etc. in accordance with paragraph (1) shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 10788, Jun. 7, 2011; Act No. 11690, Mar. 23, 2013>
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 Article 40 (Reports on Discontinuance, etc. of Business)   print
Where a manufacturer of drugs, etc. or a person who has obtained a product license falls under any of the following subparagraphs, he/she shall report such fact to the Minister of Food and Drug Safety within 20 days: Provided, That the same shall not apply where the period of suspension of business is under one month: <Amended by Act No. 11690, Mar. 23, 2013>
1. Where a factory or a contract manufacturing business office is closed down or its operation is temporarily suspended;
2. Where a factory or a contract manufacturing business office, the operation of which is temporarily suspended, resumes its operation;
3. Where a manufacturing supervisor, a safety control manager, and other matters prescribed by Ordinance of the Prime Minister have been changed.
[This Article Wholly Amended by Act No. 8643, Oct. 17, 2007]
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 Article 41 (Manufacturing Pharmacy Medication)   print
(1) When pharmacy founders intend to manufacture pharmacy medications or dispensaries of medical institutions designated by the Minister of Health and Welfare intend to manufacture medications, they shall report the relevant items to the head of a Si/Gun/Gu, as prescribed by Ordinance of the Prime Minister following consultation with the Minister of Health and Welfare: Provided, That where a dispensary of a medical institution, the incorporation of which is permitted by a Mayor/Do Governor pursuant to the Medical Service Act, intends to manufacture medications, it shall report to the relevant Mayor/Do Governor. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
(2) The scope of pharmacy medications and dispensary medications, facilities of dispensaries, and other necessary matters shall be prescribed by Ordinance of the Prime Minister following consultation with the Minister of Health and Welfare. <Amended by Act No. 852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
SECTION 2 Permission, etc. for Importation of Drugs, etc.
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 Article 42 (Permission, etc. for Importation of Drugs, etc.)   print
(1) Any person who intends to import drugs, etc. (hereinafter referred to as "importer") shall obtain permission from or file a report with the Minister of Food and Drug Safety by item, as prescribed by Ordinance of the Prime Minister. The same shall also apply where he/she intends to modify the permitted or reported matters. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
(2) Notwithstanding paragraph (1), the Minister of National Defense or an importer may import a relevant drug, etc. without obtaining permission or filing a report under paragraph (1) in any of the following cases: <Amended by Act No. 10512, Mar. 30, 2011; Act No. 11690, Mar. 23, 2013>
1. Where the Minister of National Defense intends to import drugs, etc, that are not produced domestically for any urgent military purpose following prior consultation with the Minister of Food and Drug Safety on the items and quantity of the drugs, etc.;
2. Where an importer intends to import drug substances to manufacture drugs, etc., or the drugs, etc. prescribed by Ordinance of the Prime Minister, including drugs, etc. for clinical trial.
(3) An importer shall have necessary facilities in compliance with standards for installation prescribed by Presidential Decree.
(4) Articles 31 (7), (10) and (11), 31-2 through 31-5, 31-3, 31-4, 32, 33, 35-2, 36, 37, 37-2, 37-3, 38, and 75 shall apply mutatis mutandis to drugs, etc. that are imported pursuant to paragraph (1) or to an importer thereof. In such cases, "manufacture" or "production" shall be construed as "importation", and "manufacturers or persons who have obtained permission" as "importers" <Amended by Act No. 8643, Oct. 17, 2007; Act No. 10512, Mar. 30, 2011; Act No. 10788, Jun. 7, 2011; Act No. 11118, Dec. 2, 2011; ; Act No. 11421, May 14, 2012>
(5) Matters necessary for the subject-matter, criteria, condition, control, etc. of permission for or reporting on items of imported drugs, etc. under paragraph (1) shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 10512, Mar. 30, 2011; Act No. 11118, Dec. 2, 2011; Act No. 11690, Mar. 23, 2013>
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 Article 43 (International Trade, etc. in Endangered Species of Wild Fauna and Flora)   print
(1) Any person who intends to export, import, or carry into Korea by sea, drugs made from processed goods of animals and plants as prescribed by the Convention on International Trade in Endangered Species of Wild Fauna and Flora, shall obtain permission from the Minister of Food and Drug Safety, as prescribed by Ordinance of the Prime Minister. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
(2) No person shall commit any of the following acts with respect to the horns of rhinoceroses or the bones of tigers, which are processed goods using endangered species of wild animals:
1. Importing or selling the horns of rhinoceros or the bones of tigers, or storing or displaying them for sale;
2. Manufacturing or dispensing drugs using the horns of rhinoceros or the bones of tigers;
3. Selling any drugs manufactured or dispensed using the horns of rhinoceros or the bones of tigers, or storing or displaying them for sale.
SECTION 3 Distribution Business of Drugs, etc.
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 Article 44 (Distribution of Drugs)   print
(1) No person, other than pharmacy founders, (including pharmacists or herb-pharmacists working for a pharmacy; hereafter the same shall apply in Articles 47, 48 and 50) shall sell or obtain drugs for the purpose of sale: Provided, That the same shall not apply where a person who has obtained product licenses of drugs or an importer sells drugs manufactured or imported to a person eligible to manufacture or sell drugs according to this Act. <Amended by Act No. 8643, Oct. 17, 2007>
(2) Notwithstanding the provisions of paragraph (1), any of the following persons may sell or obtain drugs for sale: <Amended by Act No. 11421, May 14, 2012>
1. The Korea Orphan Drug Center established pursuant to Article 91;
1-2. A seller of safe and readily available drugs who has been registered under Article 44-2 (applicable only to the cases where safe and readily available drugs referred to in Article 44-2 (1) are sold);
2. A herb druggist or drug wholesaler who has obtained a license pursuant to Article 45.
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 Article 44-2 (Registration of Sellers of Safe and Readily Available Drugs)   print
(1) A person who intends to sell safe and readily available drugs (referring to drugs which, among over-the-counter drugs, are emergently used mainly for minor symptoms at the sole discretion of patients and are prescribed and publicly notified by the Minister of Health and Welfare within the limit of 20 items taking into consideration the components, side effects, content, dosage form, awareness, purchase availability, etc. of the relevant items; hereinafter the same shall apply) at a place which is not a pharmacy shall file for registration for a seller of safe and readily available drugs with the head of the competent Si/Gun/Gu.
(2) A person who intends to file for registration for a seller of safe and readily available drugs under paragraph (1) shall have a year-round shop that opens 24 hours a day, and shall meet the criteria for registration prescribed by Ordinance of the Ministry of Health and Welfare in consideration of the convenience in use by local residents, the availability of recall of hazardous drugs, etc.
(3) If a seller of safe and readily available drugs intends to alter any matter prescribed by Ordinance of the Ministry of Health and Welfare among the matters registered, he/she shall file for registration to change registration details with the head of the competent Si/Gun/Gu.
(4) Where a seller of safe and readily available drugs discontinues the sale of safe and readily available drugs, or suspends such business or resumes the suspended business, he/she shall file a report thereon with the head of the competent Si/Gun/Gu: Provided, That the same shall not apply if the period of suspension is less than one month.
(5) Matters necessary for filing for registration, filing for registration to change registration details pursuant to paragraphs (1) through (3) and for the methods, procedures, etc. for reporting on the discontinuation, suspension, resumption of the sale, etc. under paragraph (4) shall be prescribed by Ordinance of the Ministry of Health and Welfare.
[This Article Newly Inserted by Act No. 11421, May 14, 2012]
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 Article 44-3 (Education for Sellers of Safe and Readily Available Drugs)   print
(1) A person who intends to file for registration for a seller of safe and readily available drugs under Article 44-2 (1) shall receive education in advance on safety assurance and quality control of safe and readily available drugs.
(2) If deemed necessary to prevent harm to public health, the Minister of Health and Welfare may order a seller of safe and readily available drugs (including his/her employees) to receive education on the safety assurance and quality control of safe and readily available drugs.
(3) In order to provide education referred to in paragraphs (1) and (2), the Minister of Health and Welfare may designate a relevant organization or institution as an education institution.
(4) Matters necessary for the curricula, time, method, procedures, fees, etc. of education under paragraph (1) and (2) and matters necessary for the designation, operation, revocation of designation, etc. of an education institution under paragraph (3) shall be prescribed by Ordinance of the Ministry of Health and Welfare.
[This Article Newly Inserted by Act No. 11421, May 14, 2012]
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 Article 44-4 (Matters to be Observed by Sellers of Safe and Readily Available Drugs)   print
Each seller of safe and readily available drugs shall observe the following matters:
1. He/she shall manage his/her facilities and safe and readily available drugs in a manner that does not impede health and sanitation and the efficacy of drugs;
2. He/she shall thoroughly oversee his/her employees in order to prevent any sanitary incident;
3. He/she shall observe the matters prescribed by Ordinance of the Ministry of Health and Welfare, such as the limit of quantity to sell at one time, age restricted sales, etc.
4. He/she shall observe other matters corresponding to subparagraphs 1 through 3 and prescribed by Ordinance of the Ministry of Health and Welfare.
[This Article Newly Inserted by Act No. 11421, May 14, 2012]
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 Article 44-5 (Application Mutatis Mutandis)   print
(1) Articles 39 (1), 47 (1), 50 (1) and (3), 56 (2), 68-7, 69, 71, 71 (2) shall apply mutatis mutandis to sellers of safe and readily available drugs registered under Article 44-2 (1). In such cases, "pharmacy founder" shall be construed as "seller of safe and readily available drugs registered under Article 44-2 (1)", and "over-the-counter drugs" referred to in Article 50 (3) as "safe and readily available drugs under Article 44-2 (1)".
(2) Article 47-2 (2) shall apply mutatis mutandis to sellers of safe and readily available drugs registered under Article 44-2 (1). In such cases, "pharmacy" shall be construed as "seller of safe and readily available drugs".
[This Article Newly Inserted by Act No. 11421, May 14, 2012]
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 Article 45 (Licenses of Drug Distribution Business)   print
(1) A person who intends to become a herb druggist or drug wholesaler pursuant to Article 44 (2) 2 shall be licensed by the head of a Si/Gun/Gu, as prescribed by Ordinance of the Ministry of Health and Welfare. The same shall apply to the modification of the licensed matters. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 10788, Jun. 7, 2011>
(2) A herb druggist or drug wholesaler who intends to obtain a license pursuant to paragraph (1) shall have the facilities that are classified as follows: <Amended by Act No. 10512, Mar. 30, 2011>
1. In cases of a herb druggist, a business office and other facilities meeting the standards for facilities prescribed by Presidential Decree;
2. In cases of a drug wholesaler, a business office, a warehouse, and other facilities meeting the standards for facilities prescribed by Presidential Decree. In such cases, the size of the warehouse shall be at least 264 square meters: Provided, That where a herb wholesaler handles only imported drugs, reagents, or drug substances, the size of his/her warehouse shall be at least 66 square meters, while where a herb wholesaler handles only herb drugs, high pressure gas for medical purposes, and radiopharmaceuticals, standards for the warehouse sizes shall not be applied.
(3) A license of a herb druggist under paragraph (1) shall be granted to a person who has passed the examination for herb druggists prescribed by Presidential Decree by limiting districts prescribed by Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>
(4) A herb druggist licensed under paragraph (1) may sell herb drugs after mixing them in accordance with a prescription recorded in an established herb book or with a prescription of a herb doctor.
(5) A drug wholesaler licensed under paragraph (1) shall employ a pharmacist to manage the wholesale business, and a herb wholesaler shall employ any of the following persons to manage the herb wholesale business: Provided, That where the drug wholesaler who himself/herself is a pharmacist manages his/her business in person, or the herb wholesaler who falls under any of the following subparagraphs manages his/her business in person, this shall not apply: <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>
1. A pharmacist;
2. A herb pharmacist;
3. A herb druggist;
4. A person who has completed a herb-related course of a college or university accredited by the Minister of Health and Welfare.
(6) Where a drug wholesaler or herb wholesaler intends to employ a person who shall manage the business pursuant to paragraph (5), he/she shall file a report with the head of a Si/Gun/Gu, as prescribed by Ordinance of the Ministry of Health and Welfare. <Newly Inserted by Act No. 10788, Jun. 7, 2011>
(7) Matters necessary for the standards, conditions and management of licenses pursuant to paragraph (1) shall be prescribed by Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 10788, Jun. 7, 2011>
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 Article 46 (Grounds for Disqualification of Licenses of Herb Druggists or Drug Wholesalers)   print
None of the following persons shall be licensed as a herb druggist or drug wholesaler: <Amended by Act No. 10788, Jun. 7, 2011>
1. A person falling under any of subparagraphs of Article 5;
2. A person for whom one year has not passed after his/her license was revoked pursuant to Article 76;
3. A medical institution founder (where the medical institution is a juristic person, the officers and staff thereof) or a pharmacy founder;
4. A person who was declared bankrupt but has not yet been reinstated.
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 Article 47 (Order in Distribution of Drugs, etc.)   print
(1) A pharmacy founder, a person who has obtained product licenses of drugs, an importer, a drug distributor, and other persons entitled to distribute drugs pursuant to this Act shall comply with the matters necessary to establish a distribution system of drugs, etc. and to maintain order in distribution, as prescribed by Presidential Decree. <Amended by Act No. 8643, Oct. 17, 2007; Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
(2) No person who has obtained product licenses of drugs, importer, and drug wholesaler shall offer any money, articles, labor, entertainment or other economic benefits (hereinafter referred to as "economic benefits, etc.") to a pharmacist, herb pharmacist (including persons working for the relevant pharmacy; hereafter the same shall apply in this Article), medical personnel, medical institution founders (including the representative, directors, and other employees of a juristic person) or persons working for a medical institution for the purpose of sales promotion, such as adoption of drugs and inducement of prescription: Provided, That the same shall not apply to the economic benefits, etc. to the extent prescribed by Ordinance of the Ministry of Health and Wealth following consultation with the Minister of Food and Drug Safety, such as provision of samples, support for symposiums, support for clinical trials, product presentation, discount of expenses pursuant to price payment conditions, and post-marketing survey (hereinafter referred to as "provision of samples, etc."). <Newly Inserted by Act No. 10324, May 27, 2010; Act No. 11690, Mar. 23, 2013>
(3) No pharmacist and herb pharmacist shall receive any economic benefits, etc. from a person who has obtained product licenses of drugs, an importer, and a drug wholesaler for the purpose of sales promotion, such as adoption of drugs: Provided That the same shall not apply to the economic benefits, etc. to the extent prescribed by Ordinance of the Ministry of Health and Welfare following consultation with the Minister of Food and Drug Safety, such as provision of samples. <Newly Inserted by Act No. 10324, May 27, 2010; Act No. 11690, Mar. 23, 2013>
(4) No drug wholesaler shall sell drugs, directly or through another drug wholesaler, to a medical institution or pharmacy falling under any of the following subparagraphs with which he/she has a special relationship: Provided, That the same shall not apply to herb drugs: <Newly Inserted by Act No. 10788, Jun. 7, 2011>
1. Where a person who has any of the following special relationships with a drug wholesaler (hereinafter referred to as "related party") is a medical institution founder or a pharmacy founder, the relevant medical institution or pharmacy;
(a) If a drug wholesaler is an individual, his/her relatives within the second degree of consanguinity or affinity (referring to relatives under Article 767 of the Civil Act; hereinafter the same shall apply);
(b) If a drug wholesaler is a juristic person, an executive officer of the relevant juristic person, and their relatives within the second degree of consanguinity or affinity;
(c) If a drug wholesaler is a juristic person, a person who actually controls the relevant juristic person (referring to a person who has contributed or owns the share exceeding 50/100 of the total amount of contributions, the total issued stocks, or the total contributed shares of the relevant juristic person, and a person who exercises a dominant influence over an organization of executive officers or business operation, etc.; hereinafter the same shall apply);
(d) If a related party under item (c) is a juristic person, an executive officer of the relevant juristic person or a person who actually controls the relevant juristic person;
(e) If a related party under items (c) and (d) is an individual, his/her relatives within the second degree of consanguinity or affinity;
(f) A juristic person which actually controls drug wholesalers;
(g) A juristic person actually controlled by a related party under this subparagraph;
(h) An employee of a drug wholesaler or of a related party under this subparagraph (referring to an executive officer in cases of a juristic person, and commercial employees and employees by an employment contract in cases of individuals; hereinafter the same shall apply in this Article);
2. Where a person who has any of the following special relationship with a medical institution founder or a pharmacy founder is a drug wholesaler, the relevant medical institution or pharmacy;
(a) If a medical institution founder or a pharmacy founder is an individual, his/her relatives within the second degree of consanguinity or affinity;
(b) If a medical institution founder is a juristic person, an executive officer of the relevant juristic person, and their relatives within the second degree of consanguinity or affinity;
(c) If a medical institution founder is a juristic person, a person who actually controls the relevant juristic person;
(d) If a related party under item (c) is a juristic person, an executive officer of the relevant juristic person, and a person who actually controls the relevant juristic person;
(e) If a related party under items (c) and (d) is an individual, his/her relatives within the second degree of consanguinity or affinity;
(f) A juristic person which actually controls a corporate medical institution;
(g) A juristic person actually controlled by a related party under this subparagraph;
(h) Employees of a medical institution founder, a pharmacy founder, or a related party under this subparagraph.
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 Article 47-2 (Designation and Operation of Korea Pharmaceutical Information Service)   print
(1) The Minister of Health and Welfare may designate a specialized institution or organization as an institution for information control of distribution of drugs (hereinafter referred to as the "Korea Pharmaceutical Information Service"), as prescribed by Presidential Decree, for collection, investigation, processing, utilization and provision of information on distribution of drugs, such as manufacture, importation, supply and details of use of drugs and require it to perform such affairs. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>
(2) Where a person who has obtained product licenses of drugs, an importer, or a drug wholesaler has supplied medical institutions, pharmacies, and drug wholesalers with drugs, he/she shall submit details of such supply to the Korea Pharmaceutical Information Service, as prescribed by Ordinance of the Ministry of Health and Welfare: Provided, That the submission of details of supply may be omitted when he/she has supplied drugs in a manner that details of supply can be confirmed, as prescribed by Ordinance of the Ministry of Health and Welfare.
(3) The Korea Pharmaceutical Information Service may request the State, local governments, and other public organizations, etc. to provide necessary data for efficient control of information on distribution of drugs, and the State, local governments, and other public organizations, etc. upon receipt of requests shall comply with such requests, except in extenuating circumstances. In such cases, such data provided to the Korea Pharmaceutical Information Service shall be utilized free of royalties, fees, etc.
(4) The Minister of Health and Welfare and the Minister of Food and Drug Safety may order the president of the Korea Pharmaceutical Information Service to report the current status of management and distribution of drugs. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
(5) The Minister of Health and Welfare may fully or partially subsidize expenses incurred in operation of the Korea Pharmaceutical information Service. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>
(6) Matters necessary for operation, etc. of the Korea Pharmaceutical Information Service shall be prescribed by Presidential Decree.
[This Article Newly Inserted by Act No. 8643, Oct. 17, 2007]
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 Article 48 (Prohibition of Sale of Unsealed Drugs)   print
No person shall remove the seal on a container or package of drugs affixed by a manufacturer of the drugs, etc., a person who has product licenses, or an importer pursuant to Article 63 for the purpose of sales of such drugs: Provided, That the same shall not apply in any of the following cases: <Amended by Act No. 8643, Oct. 17, 2007; Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>
1. Where a pharmacy founder dispenses and sells drugs according to prescriptions made by a doctor, dentist, or herb doctor, or pursuant to the provisos to Article 23 (3) and (6) or to Article 4 of the Addenda of the amended Pharmaceutical Affairs Act (Act No. 4731);
2. Where a pharmacy founder sells prepared herb drugs after opening them;
3. Where a person designated by the Minister of Health and Welfare opens and sells drugs within the scope prescribed by Ordinance of the Ministry of Health and Welfare.
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 Article 49 (Restrictions on Products for Sale by Drug Sellers)   print
No drug seller shall sell drugs, other than those designated separately by the Minister of Health and Welfare, nor store or display them for sale. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>
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 Article 50 (Distribution of Drugs)   print
(1) No pharmacy founder or drug distributor shall sell drugs at a place, other than his/her pharmacy or shop: Provided, That the same shall not apply where approval therefor is obtained from the head of a Si/Gun/Gu.
(2) No pharmacy founder shall sell any prescription drugs without prescriptions issued by a doctor or dentist: Provided, That the same shall not apply where prescription drugs are sold to any person who has established a veterinary hospital in accordance with the Veterinarians Act, as prescribed by Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>
(3) A pharmacy founder may sell over-the-counter drugs without prescriptions issued by a doctor or a dentist.
(4) Where a pharmacy founder deems it necessary to sell over-the-counter drugs, he/she may provide medication counselling.
CHAPTER VI HANDLING OF DRUGS, ETC.
SECTION 1 Standards and Product Testing
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 Article 51 (Korean Pharmacopoeia)   print
(1) In order to ensure the appropriateness in the nature, state, quality, and storing method of drugs, etc., and similar matters, the Minister of Food and Drug Safety shall enact the Korean Pharmacopoeia following deliberation by the Central Pharmaceutical Affairs Council, and shall announce it publicly. <Amended by Act No. 10788, Jun. 7, 2011; Act No. 11690, Mar. 23, 2013>
(2) The Korean Pharmacopoeia shall consist of Parts I and II: drug substances that are frequently used and the primary preparations shall be mainly listed in Part I, and the mixed preparations of drugs and the drugs, etc. not listed in Part I shall be mainly listed in Part II. <Amended by Act No. 10788, Jun. 7, 2011>
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 Article 52 (Standards for Drugs, etc.)   print
(1) With regard to biological preparations and drugs which are not listed in the Korean Pharmacopoeia, the Minister of Food and Drug Safety may, after consultation with the Central Pharmaceutical Affairs Council, determine the nature, state, quality and storing methods, and other necessary standards therefor. <Amended by Act No. 10788, Jun. 7, 2011; Act No. 11690, Mar. 23, 2013>
(2) Where the Minister of Food and Drug Safety deems it necessary to prevent any danger or harm to the public health and sanitation, he/she may, after consultation with the Central Pharmaceutical Affairs Council, determine the manufacturing method, nature, efficacy, quality, and storing method of quasi-drugs and other necessary standards therefor. <Amended by Act No. 11690, Mar. 23, 2013>
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 Article 53 (Drugs under National Lot Release)   print
(1) A person who intends to sell or to display, keep, or store, for sale, the drugs prescribed by Ordinance of the Prime Minister, among the following drugs, shall obtain lot release approval from the Minister of Food and Drug Safety after the data on manufacturing and quality control of the drugs is examined and inspected: <Amended by Act No. 11690, Mar. 23, 2013>
1. Biologically prepared drugs;
2. Drugs liable to be changed or spoiled in quality;
3. Other preparation of drugs deemed necessary by the Minister of Food and Drug Safety.
(2) Matters necessary for the procedures and methods for lot release approval under paragraph (1) and other necessary matters shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 11690, Mar. 23, 2013>
[This Article Wholly Amended by Act No. 10788, Jun. 7, 2011]
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 Article 54 (Radiopharmaceuticals)   print
The Minister of Food and Drug Safety may determine matters necessary for manufacturing and importation of radiopharmaceuticals after consultation with the Minister of Science, ICT and Future Planning. <Amended by Act No. 10788, Jun. 7, 2011; Act No. 11690, Mar. 23, 2013>
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 Article 55 (Addictive and Habit-forming Drugs)   print
Matters necessary for the manufacturing and management of drugs that might affect the human body and thus lead to addiction or habit-forming, shall be prescribed by a separate Act.
SECTION 2 Handling of Drugs
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 Article 56 (Labelling of Drug Containers, etc.)   print
(1) A person who has obtained product licenses of drugs and an importer shall indicate the following information on the containers or packages of drugs: Provided, That in cases of the containers or packages prescribed by Ordinance of the Prime Minister, some of the following information may be omitted or only some of the following information may be indicated, as prescribed by Ordinance of the Prime Minister: <Amended by Act No. 11421, May 14, 2012; Act No. 11690, Mar. 23, 2013>
1. Trade name and address of a person who has obtained product licenses of drugs or an importer (in cases of contract manufacturing business, trade name and address of a factory shall be included);
2. Name (as for drugs listed in the Korean Pharmacopoeia, the names provided for in such Pharmacopoeia, and as for other drugs, general names);
3. Manufacturing number and effective period or time-limit for use;
4. Weight, capacity, or number of articles;
5. Mandatory information in labels of containers or packages prescribed by the Korean Pharmacopoeia;
6. As for drugs, the standards for which are determined under Article 52 (1), the storing methods and mandatory information in labels of the containers or packages of such drugs in accordance with such standards;
7. As for drugs not listed in the Korean Pharmacopoeia, names of active ingredients (if general names exist, such names shall be indicated) and quantity (if active ingredients are not clear, the essence thereof and outline of manufacturing methods shall be indicated);
8. Letters of "prescription drug" or "over-the-counter drug" (in cases of safe and readily available drugs, letters of "over-the-counter (safe and readily available) drugs);
9. Information provided for in subparagraphs 1 through 3 of Article 58;
10. Other information prescribed by Ordinance of the Prime Minister.
(2) A person who sells drugs directly to consumers, such as a pharmacy founder, shall indicate prices of drugs on the containers or packages of such drugs, as prescribed by the Minister of Health and Welfare.
[This Article Wholly Amended by Act No. 10788, Jun. 7, 2011]
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 Article 57 (Labelling of Outside Packages)   print
If information listed in subparagraphs of Articles 56 (1) and 56 (2), which have been indicated on the immediate container or package of drugs, are not visible because it is obstructed by the outside container or package, such information shall also be indicated on the outside container or package. <Amended by Act No. 10788, Jun. 7, 2011>
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 Article 58 (Information in Package Inserts)   print
The following information shall be indicated in package inserts for drugs: <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 10788, Jun. 7, 2011; Act No. 11690, Mar. 23, 2013>
1. Directions, doses, and other precautions necessary for use or handling;
2. As for drugs listed in the Korean Pharmacopoeia, mandatory information in package inserts for drugs or labels of containers or packages of drugs provided for in the Korean Pharmacopoeia;
3. As for drugs, the standards for which are determined under Article 52 (1), mandatory information in package inserts for drugs or labels of containers or packages of drugs in accordance with such standards;
4. Other information prescribed by Ordinance of the Prime Minister.
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 Article 59 (Precautions in Indications)   print
Information provided for in Articles 56 though 58 shall be indicated on places which are more easily seen than other letters, news articles, pictures or designs, and such information shall be indicated precisely in easy and understandable terms, as prescribed by Ordinance of the Prime Minister. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
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 Article 60 (Information Prohibited from being Indicated)   print
Any of the following information shall not be indicated in package inserts for drugs or labels of containers or packages of drugs: <Amended by Act No. 8643, Oct. 17, 2007>
1. False or misleading information with regard to the relevant drug;
2. Efficacy or effectiveness which has not been permitted or reported pursuant to Article 31 (2) and (3) or 41 (1);
3. Direction, dosage or period of use which is dangerous to public health and sanitation,
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 Article 61 (Prohibition of Distribution, etc.)   print
(1) No one shall sell, or store or display the followings drugs for sale: <Amended by Act No. 8643, Oct. 17, 2007; Act No. 10788, Jun. 7, 2011>
1. Drugs in violation of Articles 56 through 60 or fake drugs;
2. Drugs manufactured or imported in violation of Articles 31 (2) and (3), 41 (1), 42 (1) and (3), and 43 (1).
(2) No one shall indicate information that leads to misunderstandings about medical efficacy, effectiveness, etc. in containers, packages, or package inserts for articles, other than drugs, shall advertise such information, or shall sell, store or display for sale, articles in which such information is indicated or advertised.
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 Article 62 (Prohibition of Manufacturing, etc.)   print
No one shall sell any of the following drugs nor shall manufacture, import, store, or display them for sales purposes: <Amended by Act No. 8643, Oct. 17, 2007; Act No. 10788, Jun. 7, 2011; Act No. 11690, Mar. 23, 2013>
1. Drugs which are listed in the Korean Pharmacopoeia, but whose nature, efficacy or quality does not meet standards specified in the Korean Pharmacopoeia;
2. Drugs which are licensed or reported under Articles 31 (2) and (3) and 41 (1), but whose ingredients or quantities (if active ingredients are not clear, the essence thereof or outline of manufacturing methods) are different from contents as licensed or reported;
3. Drugs the standards for which are determined under Article 52 (1), but which do not meet such standards;
4. Drugs, all or some of which are made from unclean, or degenerated or spoiled materials;
5. Drugs which are tainted or deemed to have been tainted by germs that may cause a disease;
6. Drugs to which alien substances are mixed or adhered;
7. Drugs in which tar pigment other than that determined by the Minister of Food and Drug Safety is used;
8. Drugs which are manufactured under unsanitary circumstances that might cause harm to public health and sanitation, or which are manufactured at a place where the manufacturing equipment fails to meet the standards prescribed by Presidential Decree;
9. Drugs which are deemed to cause harm to the public health and sanitation, due to unsanitary containers or packages;
10. Drugs whose containers or packages might make users misunderstand the method of using them;
11. Drugs falling under Article 76 (1) 4.
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 Article 63 (Sealing)   print
If a manufacturer of drugs, a person who has obtained product licenses of drugs, or an importer sells drugs manufactured or imported by himself/herself, he/she shall seal the containers or packages of such drugs, as prescribed by Ordinance of the Prime Minister: Provided, That this shall not apply where he/she sells them to a manufacturer of drugs, or a person who has obtained product licenses of drugs. <Amended by Act No. 8643, Oct. 17, 2007; Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
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 Article 64 (Safety Containers or Packages, etc.)   print
(1) Where a person who has obtained product licenses of drugs or an importer sells drugs manufactured or imported by him/herself, he/she shall use safety containers or packages in order to prevent the accidents of drugs by children due to misuses: Provided, That the same shall not apply where they are sold to drug manufacturers or persons who have obtained product licenses of drugs. <Amended by Act No. 8643, Oct. 17, 2007>
(2) The scope of products for which safety containers or packages shall be used and the criteria, etc. for safety containers or packages shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
SECTION 3 Quasi-Drugs
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 Article 65 (Labelling of Containers, etc. of Quasi-Drugs)   print
(1) A manufacturer and importer of quasi-drugs shall indicate the following information in the containers, packages, or package inserts (if any) for quasi-drugs: Provided, That in cases of the containers or packages designated by Ordinance of the Prime Minister, only the names of quasi-drugs and the trade names of manufacturers or importers may be stated: <Amended by Act No. 11690, Mar. 23, 2013>
1. Names of quasi-drugs (excluding products under subparagraph 7 (a) of Article 2);
2. Trade name and address of a manufacturer or importer;
3. Capacity or weight (capacity, weight, or number, in cases of products under subparagraph 7 (a) of Article 2);
4. Manufacturing number and date (referring to the period of use, instead of the manufacturing number and date, in cases of products under subparagraph 7 (b) of Article 2);
5. Names of major ingredients (excluding products under subparagraph 7 (a) of Article 2);
6. For products, the standards for which are determined under Article 52 (2), the storing methods and mandatory information in containers or packages under such standards;
7. The letter "quasi-drug";
8. Other information prescribed by Ordinance of the Prime Minister.
(2) A person who sells quasi-drugs directly to consumers, such as a pharmacy founder, shall indicate prices of quasi-drugs on their containers or packages, as prescribed by the Minister of Health and Welfare.
[This Article Wholly Amended by Act No. 10788, Jun. 7, 2011]
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 Article 65-2 (Precautions in Indications)   print
Information provided for in Article 65 shall be indicated on places which are more easily seen thant other letters, articles, pictures or designs, and such information shall be indicated precisely in easy and understandable terms, as prescribed by Ordinance of the Prime Minister. <Amended by Act No. 11690, Mar. 23, 2013>
[This Article Newly Inserted by Act No. 11251, Feb. 1, 2012]
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 Article 66 (Application Mutatis Mutandis)   print
The provisions of Articles 60 through 63 (Articles 60 through 62 in cases of products falling under subparagraph 7 (a) of Article 2 among quasi-drugs) shall apply mutatis mutandis to quasi-drugs. In such cases, "drugs" shall be construed as "quasi-drugs", and "Article 31 (2) and (3)" as "Article 31 (4)". <Amended by Act No. 11251, Feb. 1, 2012>
SECTION 4 Pharmaceutical Organizations
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 Article 67 (Organization)   print
Manufacturers of drugs, etc., persons who have obtained product licenses, importers, or drug distributors may form an incorporated association, respectively in order to secure independent activities and common interests and to contribute to the improvement of the national public health. <Amended by Act No. 8643, Oct. 17, 2007>
SECTION 5 Advertisement of Drugs, etc.
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 Article 68 (Prohibition of Exaggerated Advertisement, etc.)   print
(1) Names, manufacturing methods, efficacy, or performance of drugs, etc. shall not be advertised falsely or exaggeratedly.
(2) No news article shall be used for drugs to make people misunderstand that doctors, dentists, herb doctors, veterinarians or other persons guarantee the efficacy or performance of drugs, etc.
(3) No efficacy or performance of drugs, etc. shall be advertised by suggestive news articles, photographs, designs and other suggestive methods.
(4) No documents or designs which suggest induced abortion shall be used with respect to drugs.
(5) Names, manufacturing methods, efficacy or performance of drugs, etc. shall not be advertised without obtaining a license or submitting a report, under Article 31 (2) and (3) or 42 (1). <Amended by Act No. 8643, Oct. 17, 2007>
(6) Matters necessary for the scope of advertisement of drugs and other necessary matters shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
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 Article 68-2 (Deliberation of Advertisement)   print
(1) Where a manufacturer of drugs, a person who has obtained product licenses of drugs, or an importer intends to advertise drugs manufactured or imported by himself/herself, he/she shall undergo deliberation by the Minister of Food and Drug Safety, as prescribed by Ordinance of the Prime Minister. <Amended by Act No. 11690, Mar. 23, 2013>
(2) The Minister of Food and Drug Safety may entrust an association incorporated pursuant to Article 67 with affairs concerning deliberation on advertisement of drugs under paragraph (1). <Amended by Act No. 11690, Mar. 23, 2013>
(3) Procedure for and method of deliberation on advertisement under paragraph (1) and matters necessary for raising an objection against the results of deliberation, altering the details of deliberation, and indicting the results of deliberation shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 10788, Jun. 7, 2011; Act No. 11690, Mar. 23, 2013>
[This Article Newly Inserted by Act No. 8643, Oct. 17, 2007]
SECTION 6 Korea Institute of Drug Safety and Risk Management
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 Article 68-3 (Establishment)   print
(1) The Korea Institute of Drug Safety and Risk Management (hereinafter referred to as the '"Institute of Drug Safety and Risk Management") shall be established to efficiently and systematically perform the duties of collecting, managing, analyzing, assessing, and supplying a variety of information on drug safety, such as side effects caused by drugs, etc., information on product license, and information on product notification (hereinafter referred to as "drug safety information").
(2) The Institute of Drug Safety and Risk Management shall be a juristic person.
(3) The provisions concerning incorporated foundations under the Civil Act shall apply mutatis mutandis to the Institute of Drug Safety and Risk Management, except as prescribed by this Act.
(4) Other matters necessary for the organization and operation of the Institute of Drug Safety and Risk Management shall be prescribed by Presidential Decree.
[This Article Newly Inserted by Act No. 10788, Jun. 7, 2011]
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 Article 68-4 (Business)   print
The Institute of Drug Safety and Risk Management shall perform any of the following business entrusted by the Minister of Food and Drug Safety pursuant to Article 84 and profit-making business prescribed by Presidential Decree with regard to drug safety information: <Amended by Act No. 11690, Mar. 23, 2013>
1. Investigating and identifying causal relationships of side effects of drugs, such as pharmaceutical accidents;
2. Establishing a drug safety information management system to collect and manage drug safety information;
3. Collecting, analyzing, assessing, managing, and supplying drug safety information;
4. Conducting investigation, research, education, and publicity aimed at developing and utilizing drug safety information.
[This Article Newly Inserted by Act No. 10788, Jun. 7, 2011]
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 Article 68-5 (Financial Resources for Operation)   print
The Institute of Drug Safety and Risk Management shall be operated by contributions from the Government and persons, other than the Government, and other gains.
[This Article Newly Inserted by Act No. 10788, Jun. 7, 2011]
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 Article 68-6 (Submission, etc. of Business Plans)   print
(1) The business year of the Institute of Drug Safety and Risk Management shall coincide with the fiscal year of the Government.
(2) The Institute of Drug Safety and Risk Management shall prepare a business plan and budget bill for each fiscal year, as prescribed by Presidential Decree, and obtain approval from the Minister of Food and Drug Safety. The same shall apply to revisions to such business plan and budget bill. <Amended by Act No. 11690, Mar. 23, 2013>
[This Article Newly Inserted by Act No. 10788, Jun. 7, 2011]
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 Article 68-7 (Requests for Provision of Data)   print
(1) If deemed necessary for performing the duties, such as collection and assessment of drug safety information, the president of the Institute of Drug Safety and Risk Management may require an institution or any of the following persons to provide data regarding drug safety information:
1. The State or a local government;
2. A public institution or public organization;
3. A research institute;
4. A pharmacy founder or a medical institution founder;
5. A person who may handle drugs in accordance with this Act, including a manufacturer of drugs, etc., a person who has obtained product licenses of drugs, an importer, or a drug distributor.
(2) An institution or a person who has received a request under paragraph (1) shall comply with such request, except in extenuating circumstances.
[This Article Newly Inserted by Act No. 10788, Jun. 7, 2011]
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 Article 68-8 (Reporting Side Effects, etc.)   print
(1) Where a manufacturer of drugs, etc., a person who has obtained product licenses of drugs, an importer, or a drug wholesaler becomes aware of an adverse event suspected of having been caused by drugs, etc. such as a disease, disability, death, or other event relating to the safety and effectiveness of other drugs, etc. prescribed by Ordinance of the Prime Minister, he/she shall report thereon to the president of the Institute of Drug Safety and Risk Management, as prescribed by the Minister of Food and Drug Safety. <Amended by Act No. 11690, Mar. 23, 2013>
(2) Where a pharmacy founder and a medical institution founder becomes aware of an adverse event suspected of having been caused by drugs, etc. such as a serious disease, disability, and death prescribed by Ordinance of the Prime Minister, he/she shall report thereon to the president of the Institute of Drug Safety and Risk Management, as prescribed by the Minister of Food and Drug Safety. <Amended by Act No. 11690, Mar. 23, 2013>
(3) The president of the Institute of Drug Safety and Risk Management shall report to the Minister of Food and Drug Safety the matters on which he/she has received a report under paragraphs (1) and (2), as prescribed by the Minister of Food and Drug Safety. <Amended by Act No. 11690, Mar. 23, 2013>
[This Article Newly Inserted by Act No. 10788, Jun. 7, 2011]
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 Article 68-9 (Duty of Confidentiality)   print
No person who is or was an executive or employee of the Institute of Drug Safety and Risk Management shall divulge any confidential information he/she has become aware of in the course of performing his/her duties.
[This Article Newly Inserted by Act No. 10788, Jun. 7, 2011]
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 Article 68-10 (Prohibition against Use of Similar Names)   print
Any person, other than the Institute of Drug Safety and Risk Management, shall be prohibited from using the name “the Institute of Drug Safety and Risk Management” or any other similar name.
[This Article Newly Inserted by Act No. 10788, Jun. 7, 2011]
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 Article 68-11 (Establishment of Deliberative Council on Side Effects of Drugs)   print
(1) In order to deliberate on matters of judging side effects and hazards of drugs, such as pharmaceutical accidents, and identifying causes thereof, the Deliberative Council on Side Effects of Drugs (hereinafter referred to as the "Deliberative Council") shall be established under the control of the Ministry of Food and Drug Safety. <Amended by Act No. 11690, Mar. 23, 2013>
(2) The Deliberative Council shall be comprised of 10 to 15 members, including one chairperson, and the chairperson shall be elected from among its members.
(3) The members shall be appointed or commissioned by the Minister of Food and Drug Safety, as prescribed by Presidential Decree, and one person each from among those falling under each subparagraph shall be included: <Amended by Act No. 11690, Mar. 23, 2013>
1. A person with expertise in public health care and drugs;
2. A person recommended by a non-profit, non-governmental organization under Article 2 of the Assistance for Non-Profit, Non-Governmental Organizations Act;
3. An expert under the Medical Service Act and forensic medicine who is qualified as a judge, prosecutor, or lawyer;
4. A public official of a relevant central administration agency prescribed by Presidential Decree.
(4) The Deliberative Council shall deliberate on the following matters:
1. Matters on side effects and possible harm of drugs, etc.;
2. Matters on identifying the causal relationship of side effects of drugs, etc.
(5) The Deliberative Council may establish a specialized committee under its control to have the committee deliberate on matters prescribed in the subparagraphs of paragraph (4) in a professional point of view.
(6) Matters necessary for the organization and operation of the Deliberative Council and the specialized committee and other necessary matters shall be prescribed by Presidential Decree.
[This Article Newly Inserted by Act No. 10788, Jun. 7, 2011]
CHAPTER VII SUPERVISION
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 Article 69 (Reporting, Inspection, etc.)   print
(1) The Minister of Health and Welfare, the Minister of Food and Drug Safety, a Mayor/Do Governor, or the head of a Si/Gun/Gu may issue an order as follows: <Amended by Act No. 8643, Oct. 17, 2007; Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 10788, Jun. 7, 2011; Act No. 11690, Mar. 23, 2013>
1. Directing that pharmacy founders, medical institution founders, manufacturers of drugs, etc., persons who have obtained product licenses of drugs, importers, distributors, persons who have obtained approval for protocols of clinical trials or biological equivalence tests, clinical trial institutions, biological equivalence test institutions, non-clinical trial institutions, quality inspection institutions under Article 73 (1), and other persons engaged in the business of handling drugs, etc. shall submit necessary documents or other data;
2. Directing that the relevant public officials shall visit pharmacies, medical institutions, factories, warehouses, shops or offices that manufacture, store or handle drugs, etc., clinical trial institutions, biological equivalence test institutions, non-clinical trial institutions, quality inspection institutions under Article 73 (1), places where drugs, etc. are handled for clinical trials or biological equivalence tests, or other places where drugs, etc. are handled for business to inspect the relevant facilities, relevant books and documents or other articles, or to inquire of the relevant persons;
3. Collecting drugs, etc. which are suspected to fall under Article 71 (1) or samples necessary for quality test in a minimum quantity to the extent necessary for such test.
(2) Any public official who performs an inspection under paragraph (1) shall carry with him/her a certificate indicating such authority and produce it to the relevant persons.
(3) The authority and the scope of duties of pertinent public officials and other necessary matters under paragraph (2) shall be prescribed by Ordinance of the Prime Minister following consultation with the Minister of Health and Welfare. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
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 Article 70 (Order, etc. to Commence Business)   print
(1) If it is recognized that drug manufacturers, persons who have obtained product licenses of drugs, pharmacy founders, or drug distributors cause or are likely to cause remarkable impediment in the purchase of drugs through joint suspension of production and sale of drugs, or collective suspension or closure of business, the Minister of Health and Welfare, the Minister of Food and Drug Safety, a Mayor/Do Governor, or the head of a Si/Gun/Gu may order them to commence production of drugs or restart their business. <Amended by Act No. 8643, Oct. 17, 2007; Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
(2) No drug manufacturer, person who has obtained product license of drugs, pharmacy founder, or drug distributor shall refuse an order granted under paragraph (1) without justifiable grounds. <Amended by Act No. 8643, Oct. 17, 2007>
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 Article 71 (Order, etc. of Abandonment)   print
(1) The Minister of Food and Drug Safety, a Mayor/Do Governor, or the head of a Si/Gun/Gu may order persons who have obtained product licenses of drugs, quasi-drug manufacturers, importers or distributors of drugs, etc., pharmacy founders, medical institution founders, or other persons prescribed by Ordinance of the Prime Minister among persons eligible to sell or handle drugs pursuant to this Act or other Acts to abandon the drugs, etc. which have been sold, stored, displayed, manufactured, or imported in violation of Articles 53 (1), 61 (including cases to which relevant provisions apply mutatis mutandis under Article 66), and 62 (including cases to which relevant provisions apply mutatis mutandis under Article 66) or bad drugs, etc. or raw materials and materials thereof, etc. in a manner that prevents hazards to public health or to take other necessary measures. <Amended by Act No. 8643, Oct. 17, 2007; Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 201>
(2) When any drug, etc. actually harms or is likely to harm public health, the Minister of Food and Drug Safety, a Mayor/Do Governor, or the head of a Si/Gun/Gu may order persons who have obtained product licenses of drugs, quasi-drug manufacturers, importers or distributors of drugs, etc., pharmacy founders, medical institution founders, or other persons prescribed by Ordinance of the Prime Minister among persons eligible to sell or handle drugs pursuant to this Act or other Acts, to recall and abandon such drug, etc. under distribution or to take other necessary measures. <Amended by Act No. 8643, Oct. 17, 2007; Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 201>
(3) Where any person upon receipt of an order pursuant to paragraph (1) or (2) fails to comply with such order, or in cases of emergency for public health, the Minister of Food and Drug Safety, a Mayor/Do Governor, or the head of a Si/Gun/Gu may require relevant public officials to recall and abandon the relevant drug, etc., or to make other necessary disposals. <Amended by Act No. 11690, Mar. 23, 2013>
(4) The provisions of Article 69 (2) shall apply mutatis mutandis to paragraph (2).
(5) Necessary matters concerning the ranking of harms and standards for appraisal of drugs, etc., recall and abandonment of drugs, etc. and other measures under paragraph (2) shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 201>
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 Article 72 (Announcement of Recall, etc. of Drugs, etc.)   print
(1) When the Minister of Food and Drug Safety receives a report on a plan for recall of drugs, etc. pursuant to the latter part of Article 39 (1), he/she may order persons who have obtained product licenses of drugs, quasi-drug manufacturers, or importers of drugs, etc. to publicly announce the recall plan: Provided, That he/she shall order a public announcement if the use of a relevant drug, etc. causes harms prescribed by Ordinance of the Prime Minister, such as a serious side effect impossible to cure completely and a side effect temporarily or medically possible to cure completely. <Amended by Act No. 8643, Oct. 17, 2007; Act No. 11251, Feb. 1, 2012; Act No. 11690, Mar. 23, 2013>>
(2) Where the Minister of Food and Drug Safety, a Mayor/Do Governor, or the head of a Si/Gun/Gu has issued an order to recall and abandon drugs, etc. under distribution, or to take other necessary measures pursuant to Article 71 (2), he/she shall order persons who have product licenses of drugs, quasi-drug manufacturers, importers or distributors of drugs, etc., pharmacy founders, medical institution founders, or other persons prescribed by Ordinance of the Prime Minister from among persons eligible to sell or handle drugs pursuant to this Act or other Acts, to publicly announce such fact. <Amended by Act No. 8643, Oct. 17, 2007; Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
(3) A person upon receipt of an order for public announcement under paragraphs (1) and (2) shall make a public announcement by any of the following methods, depending upon the ranking of harms under Article 71 (5): <Newly Inserted by Act No. 11251, Feb. 1, 2012>
1. Broadcasting, daily newspaper, or its equivalents;
2. Medical or pharmaceutical journal or its equivalents;
3. The relevant firm’s website or its equivalents;
(4) Matters necessary for a public announcement referred to in paragraphs (1) through (3) shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 11251, Feb. 1, 2012; Act No. 11690, Mar. 23, 2013>
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 Article 73 (Order of Inspection and Quality Inspection Institutions)   print
(1) The Minister of Food and Drug Safety or a Mayor/Do Governor may order manufacturers of drugs, etc., persons who have obtained product licenses of drugs, or importers to undergo an inspection of drugs, etc., which have been manufactured or imported, or which have been product-licensed or product-notified, by a quality inspection institution designated by the Minister of Food and Drug Safety or the Mayor/Do Governor (hereinafter referred to as "quality inspection institution"). <Amended by Act No. 11690, Mar. 23, 2013>
(2) The Minister of Food and Drug Safety or a Mayor/Do Governor shall designate an institution equipped with facilities and experts necessary for inspection referred to in paragraph (1) as the quality inspection institution. <Amended by Act No. 11690, Mar. 23, 2013>
(3) Where the quality inspection institution has conducted an inspection referred to in paragraph (1), it shall prepare and issue the quality inspection results, keep records on such inspection and observe other matters prescribed by Ordinance of the Prime Minister. <Amended by Act No. 11690, Mar. 23, 2013>
(4) Matters necessary for the designation requirements, procedures, methods, etc. for a quality inspection institution, except as prescribed in paragraphs (1) through (3), shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 11690, Mar. 23, 2013>
[This Article Wholly Amended by Act No. 10788, Jun. 7, 2011]
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 Article 73-2 (Effective Period for Designation of Quality Inspection Institution)   print
(1) The effective period for designating a quality inspection institution pursuant to Article 73 (2) shall be three years from the date on which it is designated.
(2) The effective period referred to in paragraph (1) may be extended by up to one year only once, as prescribed by Ordinance of the Prime Minister. <Amended by Act No. 11690, Mar. 23, 2013>
(3) A quality inspection institution, the effective period for which expires pursuant to paragraphs (1) and (2) and which satisfies the designation requirements for a quality inspection institution under Article 73 (4), may be re-designated as such in accordance with the same Article.
[This Article Newly Inserted by Act No. 10788, Jun. 7, 2011]
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 Article 73-3 (Education of Inspectors)   print
(1) The representative and inspectors of a quality inspection institution shall receive education concerning the methods of quality inspection, etc. each year.
(2) Matters concerning an institution which provides education on the inspection methods, etc. under paragraph (1), the curricula of education, and other necessary matters shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 11690, Mar. 23, 2013>
[This Article Newly Inserted by Act No. 10788, Jun. 7, 2011]
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 Article 74 (Order for Improvement)   print
If any facility ceases to meet the standards for facilities under Articles 20 (3), 31 (1) and (4), 34-2 (2), 34-3 (2), 42 (3), 45 (2) and 73 (2) or any facility has become worn out, squalid or damaged, so that there is an apprehension that the drugs, etc. which have been manufactured by using such facility would fall under any of subparagraphs of Article 62 (including cases to which relevant provisions apply mutatis mutandis under Article 66), the Minister of Food and Drug Safety, the Mayor/Do Governor, or the head of a Si/Gun/Gu may order pharmacy founders, manufacturers of drugs, etc., persons who have obtained product licenses of drugs, importers, distributors, clinical trial institutions, biological equivalence test institutions, non-clinical trial institutions, or quality inspection institutions to improve such facility or may order them to fully or partially suspend the use of such facility until the completion of improvement. <Amended by Act No. 8643, Oct. 17, 2007; Act No. 10788, Jun. 7, 2011; Act No. 11690, Mar. 23, 2013>
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 Article 75 (Order to Change Managers, etc.)   print
If a manager of a manufacturing business of drugs, etc. or a manager of a pharmacy violates this Act or an order issued pursuant to this Act, or if the manager is considered inappropriate as a manager, the Minister of Food and Drug Safety may order the relevant manufacturer to change the manager of the manufacturing business, and the head of a Si/Gun/Gu may order the pharmacy founder to change the manager of the pharmacy. <Amended by Act No. 11690, Mar. 23, 2013>
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 Article 76 (Revocation of Permission, Suspension of Business, etc.)   print
(1) If a manufacturer of drugs, etc. or a person who has obtained product licenses of drugs, a person who has filed for registration of drug substances, an importer, a person who has obtained approval for protocols of clinical trials or biological equivalence tests, a pharmacy founder, or a drug distributor falls under any of the following subparagraphs, the Minister of Food and Drug Safety, as for a manufacturer of drugs, etc. or a person who has obtained product licenses of drugs, a person who has registered drug substances, or an importer, a person who has obtained approval for protocols of clinical trials or biological equivalence tests, and the head of a Si/Gun/Gu, as for a pharmacy founder or a drug distributor, may, respectively, revoke permission, approval, and registration; close a contract manufacturing business office and a factory (limited to cases where reports have been submitted pursuant to Article 31 (4); hereafter the same shall apply in subparagraph 1 of Article 77); issue an order to prohibit from manufacturing or importing licensed products; or issue an order to fully or partially suspend the relevant business for a period of up to one year: Provided, That in cases falling under subparagraph 4, if the relevant business entity is not responsible and if it is deemed possible to attain the purposes of licenses or notification by modifying the components, prescription, etc. of the relevant drugs, an order may be issued to modify such components or prescription only. <Amended by Act No. 8643, Oct. 17, 2007; Act No. 10324, May 27, 2010; Act No. 10512, Mar. 30, 2011; Act No. 10788, Jun. 7, 2011; Act No. 11251, Feb. 1, 2012; Act No. 11690, Mar. 23, 2013; Act No. 12074, Aug. 13, 2013>
1. Where he/she falls under any of subparagraphs 1 through 4 of Article 5;
2. Where it turns out that he/she falls under any subparagraph of Article 20 (5), or under Article 31 (8) 2;
2-2. Where he/she, by fraudulent or other deceptive means, files for registration of drug substances under Article 31-2 (1) and (3) (including cases to which relevant provisions apply mutatis mutandis under Article 42 (4)), files for registration to change the registered details thereof, or reports changes thereto;
2-3. Where he/she fails to file for registration to change registered details of, or to report changes in, drug substances under Article 31-2 (3) (including cases to which relevant provisions apply mutatis mutandis under Article 42 (4));
3. Where he/she violates this Act or any order issued under this Act;
4. Where he/she manufactures, imports, or sells drugs, etc. which harm or are likely to harm the national public health, or drugs, etc. which are regarded as having no efficacy;
5. Where he/she fails to recall or take measures necessary to recall, or fails to report, or falsely reports a recall plan pursuant to Article 39 (1);
5-2. Where he/she offers any economic benefits, etc. in violation of Article 47 (2);
5-3. Where he/she violates an order under Articles 71 (1) and (2) and 72 (1) and (2);
6. Where a pharmacy founder has received a disposition of suspension of the qualifications as a pharmacist or herb pharmacist under Article 79 (2).
(2) Where facilities of a person under paragraph (1), do not meet the standards for facilities provided for in Articles 20 (3), 31 (1) and (4), 42 (3) and 45 (2), the same as in paragraph (1) shall apply thereto. <Amended by Act No. 8643, Oct. 17, 2007>
(3) Among the administrative dispositions under paragraphs (1) and (2), the criteria for administrative dispositions, including the revocation of permission, report, registration, and approval, and the suspension of business against a manufacturer of drugs, etc., a person who has obtained product licenses of drugs, a person who has filed for registration of drug substances, an importer, and a person who has obtained approval for protocols of clinical trials or biological equivalence tests shall be prescribed by Ordinance of the Prime Minister, and the criteria for administrative dispositions, including the revocation of licenses, registration, and permission, suspension, etc. of qualification or business of a pharmacist, a herb pharmacist, a pharmacy founder, or a drug distributor shall be prescribed by Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
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 Article 76-2 (Revocation, etc. of Designation)   print
(1) If a clinical trial institution, biological equivalence test institution, non-clinical trial institution, or quality inspection institution referred to in Article 34-2, 34-3, or 73 (hereinafter referred to as "inspection institution, etc.") falls under any of the following subparagraphs, the Minister of Food and Drug Safety or the head of a Si/Gun/Gu may revoke the designation of such institution, or may order suspension of business for up to nine months: Provided, That in cases falling under subparagraphs 1, 2 (limited to cases of intention or serious negligence), and 5, he/she shall revoke the designation of such institution: <Amended by Act No. 11690, Mar. 23, 2013>
1. Where designation has been made by fraudulent or other deceptive means;
2. Where the clinical trial results, biological equivalence test results, non-clinical trial results, or quality inspection results under Article 34-2 (3), 34-3 (3), or 73 (3) have been falsely prepared or issued;
3. Where designation requirements referred to in Article 34-2 (2) and (4), 34-3 (2) and (4), or 73 (2) and (4) have not been satisfied:
4. Where matters to be observed referred to in Article 34-2 (3), 34-3 (3), or 73 (3) have not been observed;
5. Where business has been performed during a business suspension period.
(2) No person whose designation has been revoked pursuant to paragraph (1) shall be re-designated within two years from the date on which the designation is revoked.
(3) The criteria for administrative dispositions under paragraph (1) shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 11690, Mar. 23, 2013>
[This Article Newly Inserted by Act No. 10788, Jun. 7, 2011]
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 Article 76-3 (Revocation of Registration of Sellers of Safe and Readily Available Drugs)   print
(1) The head of a Si/Gun/Gu may revoke the registration of a seller of safe and readily available drugs in any of the following cases: Provided, That he/she shall revoke the registration in cases falling under any of subparagraphs 1 and 3 through 6:
1. Where he/she has filed for registration by fraudulent or deceptive means;
2. Where he/she fails to recall, or take measures to recall, drugs, in violation of the former part of Article 39 (1);
3. Where he/she fails to meet the criteria for registration referred to in Article 44-2 (2);
4. Where he/she fails to file for registration to change registered details, in violation of Article 44-2 (3), or has filed for such registration by fraudulent or deceptive means;
5. Where he/she fails to receive education, in violation of Article 44-3 (1);
6. Where he/she fails to observe the matters to be observed by sellers of safe and readily available drugs, in violation of Article 44-4 (applicable only to cases where such violations are committed at least three times a year);
7. Where he/she fails to abide by matters necessary to establish a distribution system and to maintain order in distribution, in violation of Article 47 (1);
8. Where he/she sells drugs at a non-designated place, in violation of Article 50 (1);
9. Where he/she fails to comply with the order to submit necessary documents or other data as prescribed in Article 69 (1) 1 or rejects, interferes with, or evades the visit, inspection, inquiry, collection conducted under Article 69 (1) 2 or 3;
10. Where he/she fails to comply with an order of abandonment, etc. issued under Article 71 (1) or an order for recall and abandonment issued under paragraph Article 71 (2), or rejects, interferes with, or evades the measures taken for recall, abandonment, etc. under Article 71 (3);
11. Where he/she fails to comply with the order to make public announcement as prescribed in Article 72 (2).
(2) A person whose registration has been revoked under paragraph (1) shall be prohibited from being re-registered as a seller of safe and readily available drugs within one year from the date on which his/her registration was revoked under paragraph (1).
[This Article Newly Inserted by Act No. 11421, May 14, 2012]
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 Article 77 (Hearings)   print
The Minister of Health and Welfare, the Minister of Food and Drug Safety, a Mayor/Do Governor or the head of a Si/Gun/Gu who intends to take any of the following dispositions shall hold a hearing: <Amended by Act No. 8643, Oct. 17, 2007; Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 10788, Jun. 7, 2011; Act No. 11421, May 14, 2012; Act No. 11690, Mar. 23, 2013>
1. Revocation of permission, approval and registration, or closure of a contract manufacturing business office and a factory, or issuing orders to prohibit from manufacturing or importing products under Article 76;
1-2. Revocation of registration under Article 76-3;
2. Revocation of designation under Article 76-2 (1);
3. Revocation of a license under Article 79 (1) or (2).
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 Article 78 (Pharmaceutical Inspectors)   print
(1) Pharmaceutical inspectors shall be assigned to the Ministry of Health and Welfare, the Ministry of Food and Drug Safety, Cities/Dos, Sis/Guns/Gus (referring to autonomous Gus of the Special Metropolitan City and Metropolitan Cities) in order to perform the duties of pertinent public officials under Articles 69 (1) and 71 (2). <Amended by Act No. 11690, Mar. 23, 2013>
(2) Pharmaceutical inspectors shall be appointed by the Minister of Health and Welfare, the Minister of Food and Drug Safety, Mayors/Do Governors or the heads of Sis/Guns/Gus from among public officials belonging to the Ministry of Health and Welfare, the Ministry of Food and Drug Safety, Cities/Dos or Sis/Guns/Gus. <Amended by Act No. 11690, Mar. 23, 2013>
(3) Matters necessary for qualification, appointment, etc. of pharmaceutical inspectors shall be prescribed by Ordinance of the Prime Minister following consultation with the Minister of Health and Welfare. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
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 Article 79 (Revocation, etc. of Pharmacist's or Herb Pharmacist's Licenses)   print
(1) If a pharmacist or herb pharmacist falls under any of subparagraphs 1 through 4 of Article 5, the Minister of Health and Welfare shall revoke his/her license. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>
(2) If a pharmacist or herb pharmacist falls under any of the following subparagraphs, the Minister of Health and Welfare may revoke his/her license or order the suspension of qualification as a pharmacist or herb pharmacist, by up to one year: <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>
1. When he/she violates the statutes concerning pharmaceutical affairs or violates the criteria for ethics prescribed by Ordinance of the Ministry of Health and Welfare;
2. When he/she forges or alters relevant documents or demands drug expenses by fraudulent or deceptive means.
(3) Where a pharmacist or herb pharmacist falls under any of the following subparagraphs, the Minister of Health and Welfare may order the suspension of qualification as a pharmacist or herb pharmacist by up to one year: <Newly Inserted by Act No. 9123, Jun. 13, 2008; ; Act No. 9932, Jan. 18, 2010; Act No. 10324, May 27, 2010>
1. Where he/she has been employed by a person disqualified as a pharmacy founder and performs affairs of a pharmacist or herb pharmacist;
2. Where he/she receives any economic benefit, etc. in violation of Article 47 (3).
(4) Even though a pharmacist's or herb pharmacist's license is revoked under paragraphs (1) and (2), if a ground for the revocation ceases to exist, the Minister of Health and Welfare may regrant the license, as prescribed by Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>
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 Article 79-2 (Pharmaceutical Association and Oriental Pharmacy Association's   print
Requests, etc. for Disposition of Qualification Suspension)
If a pharmacist or herb pharmacist violates the criteria for ethics under Article 79 (2) 1, the head of the Pharmaceutical Association or the Oriental Pharmacy Association may request the Minister of Health and Welfare to suspend qualification of such pharmacist or herb pharmacist, after deliberation and resolution by the Ethics Committee of the Pharmaceutical Association or that of the Oriental Pharmacy Association.
[This Article Newly Inserted by Act No. 10788, Jun. 7, 2011]
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 Article 80 (Renewal of Certificates of License, Permission, Registration, etc.)   print
A person who has obtained a pharmacist's license or a herb pharmacist's license, a person who has registered opening of a pharmacy, a seller of safe and readily available drugs, or a person who has obtained permission for distribution of drugs shall, as prescribed by Ordinance of the Ministry of Health and Welfare; and a person who has obtained permission for the business of manufacturing drugs, etc. or has reported on the business of contract manufacturing shall, as prescribed by Ordinance of the Prime Minister, renew his/her certificate of license, permit, registration, etc.
[This Article Wholly Amended by Act No. 11690, Mar. 23, 2013]
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 Article 81 (Disposition of Penalty Surcharges)   print
(1) If a manufacturer of drugs, etc., a person who has obtained product licenses of drugs, an importer, a pharmacy founder, or a drug distributor is subject to the disposition of business suspension under Article 76, the Minister of Food and Drug Safety, a Mayor/Do Governor or the head of a Si/Gun/Gu may impose a penalty surcharge not exceeding 200 million won (50 million for a pharmacy founder or herb druggist) in lieu of such disposition as prescribed by Presidential Decree. In such cases, if a pharmacy founder who has been ordered to suspend qualification as a pharmacist or herb pharmacist under Article 79 (2) 2 comes to be subject to the disposition of business suspension under Article 76 (1) 5, the penalty surcharge replacing it shall be imposed less than three times. <Amended by Act No. 8643, Oct. 17, 2007; Act No. 10788, Jun. 7, 2011; Act No. 11690, Mar. 23, 2013>
(2) The amount of penalty surcharges according to categories, degree, etc. of offenses that penalty surcharges imposed on pursuant to paragraph (1) and other necessary matters shall be prescribed by Presidential Decree.
(3) When necessary for the collection of penalty surcharges, the Minister of Food and Drug Safety, the Mayor/Do Governor or the head of a Si/Gun/Gu, may request the head of the competent tax office to provide taxation information by submitting documents stating the following matters: <Amended by Act No. 11690, Mar. 23, 2013>
1. Personal information on tax payers;
2. Purpose of use;
3. Data on sales, which serves as a standard for the imposition of penalty surcharges.
(4) If a person who has to pay the penalty surcharge pursuant to paragraph (1) fails to pay it within the time limit of payment, the Minister of Food and Drug Safety, a Mayor/Do Governor or the head of a Si/Gun/Gu shall revoke the disposition of imposition of penalty surcharge under paragraph (1), and shall take a disposition of business suspension pursuant to Article 76 (1) or (2), or shall collect it in the same manner as delinquent national or local taxes are collected as prescribed by Presidential Decree: Provided, That when it is impossible to take a disposition of business suspension pursuant to Article 76 (1) or (2) due to closedown, etc. pursuant to Article 40, the penalty surcharge shall be collected in the same manner as delinquent national or local taxes are collected. <Amended by Act No. 11690, Mar. 23, 2013>
(5) The amount collected as a penalty surcharge under paragraphs (1) and (4) shall revert to the State or local government to which the collecting agency belongs.
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 Article 82 (Fees)   print
(1) Any of the following persons shall pay a fee as determined by Ordinance of the Ministry of Health and Welfare. The same shall also apply to the modification of matters prescribed by Ordinance of the Ministry of Health and Welfare, such as licenses, registration, and permission:
1. A person who intends to obtain the license of a pharmacist or herb pharmacist under Article 3 or 4;
2. A person who intends to file for registration for establishment of a pharmacy under Article 20;
3. A person who intends to file for registration for a seller of safe and readily available drugs under Article 44-2;
4. A person who intends to obtain permission for drug distribution business under Article 45;
5. A person who intends to apply for the provision of information on distribution of drugs;
6. A person who intends to apply for the national examination for pharmacists, etc.;
7. A person who requests other matters prescribed by Ordinance of the Ministry of Health and Welfare.
(2) In connection with the affairs under the jurisdiction of the Ministry of Food and Drug Safety, any of the following persons shall pay a fee as prescribed by Ordinance of the Prime Minister. The same shall also apply to permission, renewal, registration, report, or approval, or the modification of the matters prescribed by Ordinance of the Prime Minister:
1. A person who intends to apply for permission, renewal, registration, report, approval, designation, or a preliminary examination;
2. A person who intends to determine standards for new products;
3. A person who requests other matters prescribed by Ordinance of the Prime Minister.
[This Article Wholly Amended by Act No. 11690, Mar. 23, 2013]
CHAPTER VIII SUPPLEMENTARY PROVISIONS
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 Article 83 (Subsidization from National Treasury)   print
The Minister of Health and Welfare and the Minister of Food and Drug Safety may, as prescribed by Presidential Decree, subsidize research funds for the manufacturers of drugs, etc. who have contributed to exportation, or for institutions, etc. that contribute to the national health by carrying out research projects on the safety of drugs, etc. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
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 Article 84 (Delegation and Entrustment of Authority)   print
(1) The Minister of Health and Welfare may delegate part of his/her authority under this Act to the Director of the Korea Centers for Disease Control and Prevention or Mayors/Do Governors, as prescribed by Presidential Decree.
(2) The Minister of Food and Drug Safety may delegate part of his/her authority under this Act to the heads of the regional food and drug administrations, the Director General of the National Institute of Food and Drug Safety Evaluation or Mayors/Do Governors, as prescribed by Presidential Decree.
(3) The Minister of Food and Drug Safety and Mayors/Do Governors may delegate part of their authority under this Act to the heads of Sis/Guns/Gus or the heads of public health clinics, as prescribed by Presidential Decree.
(4) The heads of Sis/Guns/Gus may delegate part of their authority under this Act to the heads of public health clinics, as prescribed by Presidential Decree.
(5) The Minister of Health and Welfare and the Minister of Food and Drug Safety may entrust an organization or the Institute of Drug Safety and Risk Management under Article 67 with some of pharmaceutical affairs under this Act, as prescribed by Presidential Decree.
[This Article Wholly Amended by Act No. 11690, Mar. 23, 2013]
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 Article 85 (Special Cases concerning Drugs, etc. for Animals)   print
(1) Drugs or quasi-drugs, the purpose of which is to be used exclusively for animals, under the jurisdiction of the Minister of Health and Welfare or the Minister of Food and Drug Safety under this Act, shall be controlled by the Minister of Agriculture, Food and Rural Affairs or the Minister of Oceans and Fisheries, and "Minister of Health and Welfare" or "Minister of Food and Drug Safety" in the corresponding provisions of this Act shall be construed as "Minister of Agriculture, Food and Rural Affairs" or "Minister of Oceans and Fisheries", and "Ordinance of the Ministry of Health and Welfare" or "Ordinance of the Prime Minister" shall be construed as "Ordinance of the Ministry of Agriculture, Food and Rural Affairs" or "Ordinance of the Ministry of Oceans and Fisheries". In such cases, when the Minister of Agriculture, Food and Rural Affairs issues Ordinance of the Ministry of Agriculture, Food and Rural Affairs" or the Minister of Oceans and Fisheries issues Ordinance of the Ministry of Oceans and Fisheries, he/she shall consult with the Minister of Health and Welfare or the Minister of Food and Drug Safety. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 10788, Jun. 7, 2011; Act No. 11690, Mar. 23, 2013>
(2) With respect to drugs for animals used for the treatment or prevention of animal's diseases, and designated as ones that may stay in an animal's body and inflict danger or injury to human health, the Minister of Agriculture, Food and Rural Affairs or the Minister of Oceans and Fisheries may determine standards for use of animal drugs, such as animals for which such drugs are used, direction, dosage, and the period banning its use. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 11690, Mar. 23, 2013>
(3) Any person who intends to use animal drugs, the usage standards for which have been determined under paragraph (2), shall observe such standards: Provided, That where he/she uses them in accordance with the treatment or prescription of a veterinarian or a certified marine disease manager, he/she may choose not to observe such standards.
(4) Notwithstanding Article 44, a person who has established a veterinary hospital as prescribed by the Veterinarians Act, may sell animal drugs used for the treatment of animals to any person who rears them, or may purchase animal drugs for the purpose of treating animals from any pharmacy founder under the proviso to Article 50 (2). In such cases, a person who has established a veterinary hospital shall prepare and retain sale and purchase records, as prescribed by Ordinance of the Ministry of Agriculture, Food and Rural Affairs or Ordinance of the Ministry of Oceans and Fisheries. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 11690, Mar. 23, 2013>
(5) Notwithstanding Article 44, a person who has established a marine disease management office prescribed by the Aquatic Life Disease Control Act may sell drugs to be used for the treatment of marine life to any person who cultivates such marine life.
(6) No person who has obtained permission for a wholesaler of drugs for animals under this Act shall distribute any of the following drugs for animals, which are determined and publicly notified by the Minister of Agriculture, Food and Rural Affairs or the Minister of Oceans and Fisheries, without a prescription of a veterinarian or a certified marine disease manager: Provided, That the same shall not apply to cases where such drugs are distributed among a founder of a veterinary hospital, a founder of a marine disease management office, a pharmacy founder, or a wholesaler of drugs for animals: <Newly Inserted by Act No. 11251, Feb. 1, 2012; Act No. 11690, Mar. 23, 2013>
1. Drugs for animals which are likely to do harm to human and animal health if misused or abused;
2. Drugs for animals which require expertise of a veterinarian or a certified marine disease manager;
3. Drugs for animals deemed likely to cause disorder in light of their dosage form and pharmacological actions.
(7) A founder of a pharmacy may sell drugs for animals falling under any of the subparagraphs of paragraph (6) without a prescription of a veterinarian or a certified marine disease manager: Provided, That the same shall not apply to any of the following drugs for animals prescribed by the Minister of Agriculture, Food and Rural Affairs or the Minister of Oceans and Fisheries: <Newly Inserted by Act No. 11251, Feb. 1, 2012; Act No. 11690, Mar. 23, 2013>
1. An antibiotic substance preparation for injection;
2. A biological preparation for injection.
(8) Notwithstanding paragraphs (6) and (7), a person who sells drugs for animals pursuant to this Act may sell drugs for animals falling under the subparagraphs of paragraph (6) without a prescription of a veterinarian or a certified marine disease manager, if he/she falls under any of the following cases. In such cases, methods for sale, the management of records and the scope of purchasers, matters to be observed, and other necessary matters shall be prescribed by Ordinance of the Ministry of Agriculture Food and Rural Affairs or Ordinance of the Ministry of Oceans and Fisheries: <Newly Inserted by Act No. 11251, Feb. 1, 2012; Act No. 11690, Mar. 23, 2013>
1. Where such drugs are sold to a livestock farmer or a fishing household cultivating marine life in an island or a secluded area determined by the Minister of Agriculture, Food and Rural Affairs or the Minister of Oceans and Fisheries:
2. Where the use of drugs for animals has been ordered by the Minister of Agriculture, Food and Rural Affairs or the Minister of Oceans and Fisheries, a Mayor/Do Governor, or the head of a Si/Gun/Gu for purposes of emergent quarantine pursuant to Article 15 of the Act on the Prevention of Contagious Animal Diseases or Article 13 of the Aquatic Life Disease Control Act.
(9) A person who sells drugs for animals pursuant to this Act shall observe matters prescribed by Ordinance of the Ministry of Agriculture Food and Rural Affairs or Ordinance of the Ministry of Oceans and Fisheries to establish the distribution system and to maintain order in sales of drugs for animals, such as prohibition against an act of collusion, designation of sales places, and management of records. <Newly Inserted by Act No. 11251, Feb. 1, 2012; Act No. 11690, Mar. 23, 2013>
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 Article 86 (Projects for Relief of Injury from Side Effects of Drugs)   print
(1) An organization comprised of drug manufacturers, persons who have obtained product licenses of drugs, or importers shall conduct research projects to support the improvement of safety of drugs and the development of new drugs, so as to relieve any harm caused by the side effects of drugs. <Amended by Act No. 8643, Oct. 17, 2007>
(2) Drug manufacturers, persons who have obtained product licenses of drugs, or importers shall bear expenses incurred in relation to projects under paragraph (1). <Amended by Act No. 8643, Oct. 17, 2007>
(3) For the purposes of projects referred to in paragraph (1), the Government may provide a subsidy within budgetary limits.
(4) Matters necessary for projects referred to in paragraph (1) shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
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 Article 87 (Preventing Leakage of Confidential Information)   print
(1) Neither pharmacist nor herb pharmacist shall leak other person's confidential information which he/she has become aware of while dispensing and selling drugs, except as otherwise provided for in this Act or other Acts and subordinate statutes.
(2) No person who has become aware of trade secrets of a person who has obtained product licenses of drugs, an importer, a drug wholesaler, etc. in the course of performing business shall leak the trade secrets to third parties or use them for other purposes than the business purposes. <Newly Inserted by Act No. 8643, Oct. 17, 2007>
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 Article 88 (Protection of Materials Submitted)   print
(1) With respect to data submitted pursuant to Articles 31, 31-2, 32 through 34, 35-2, or 42, when a person who has submitted such data files a written request for protection of them, the Minister of Food and Drug Safety shall not disclose such data: Provided, That where the Minister of Food and Drug Safety deems it necessary to disclose such data for public interest, he/she may disclose it. <Amended by Act No. 10788, Jun. 7, 2011; Act No. 11690, Mar. 23, 2013>
(2) No person who has perused or examined the submitted date, the protection of which is requested under paragraph (1), shall disclose the details of such data that he/she has become aware of.
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 Article 89 (Succession to Status, etc. of Manufacturers, etc.)   print
(1) When a manufacturer of drugs, etc., a person who has obtained product licenses of drugs, a person who has filed a report on contract manufacturing business, a drug distributer (excluding herb druggists), or a person who was designated as an inspection institution, etc. (hereafter referred to as "manufacturer, etc." in this Article and Article 89-2) dies or a merger of corporate manufacturers, etc. takes place, the successor, transferee, corporation surviving such merger, or corporation incorporated by such merger shall succeed to the status of the manufacturer, etc.: Provided, That the same shall not apply to cases where such transferee, such corporation surviving the merger or such corporation incorporated by the merger falls under any of the following cases: <Amended by Act No. 8643, Oct. 17, 2007; Act No. 10512, Mar. 30, 2011; Act No. 10788, Jun. 7, 2011>
1. A manufacturer of drugs, etc., a person who has obtained product licenses of drugs, or a person who has filed a report on contract manufacturing business: Where he/she falls under any of subparagraphs of Article 31 (8);
2. A drug distributor: Where he/she falls under any of subparagraphs of Article 46.
(2) Where a manufacturer of drugs, etc., a person who has obtained product licenses of drugs, a person who has filed a report on contract manufacturing business, or an importer has transferred his/her business of drugs, etc. for which permission has been obtained or a report has been filed depending on manufactured items or imported items pursuant to Articles 31 (2) through (4) or 42 (1), another manufacturer, person who has obtained product licenses of drugs, person who has filed a report on contract manufacturing business, or importer who takes over such business shall succeed to the status of the previous manufacturer, person who obtained product licenses of drugs, person who filed a report on contract manufacturing business, or importer with respect to permission for and report on the relevant items. <Amended by Act No. 10788, Jun. 7, 2011>
(3) A person who has succeeded to the status of a manufacturer, etc. pursuant to paragraphs (1) and (2) shall file a report with the Minister of Food and Drug Safety (referring to the head of a Si/Gun/Gu in cases of a drug distributor) within one month from the date of succession, as classified in the following subparagraphs: Provided, That where a successor who succeeded to the status of a manufacturer, etc. pursuant to paragraph (1) falls under any subparagraph of paragraph (1), he/she shall transfer such status to another person within six months from the date when succession commenced: <Amended by Act No. 8643, Oct. 17, 2007; Act No. 10788, Jun. 7, 2011; Act No. 11251, Feb. 1, 2012; Act No. 11690, Mar. 23, 2013>
1. A person who has succeeded to the status of a manufacturer of drugs, etc., a person who obtained product licenses of drugs, or a person who reported on contract manufacturing business: To comply with the provisions of Ordinance of the Prime Minister;
2. A person who has succeeded to the status of a drug distributor: To comply with the provisions of Ordinance of the Ministry of Health and Welfare.
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 Article 89-2 (Succession to Effects of Dispositions of Administrative Sanctions)   print
Where the status has been succeeded pursuant to Article 89, effects of the administrative dispositions on the previous manufacturer, etc. and importer shall be succeeded by a transferee, a corporation surviving a merger, or a corporation newly established after a merger for one year from the date on which such disposition took place, and where the procedures for administrative disposition are underway, the procedures for disposition of administrative sanctions may proceed for the transferee, the corporation surviving a merger, the corporation newly established after a merger: Provided, That where a new manufacturer, etc. (excluding the succession of the status by inheritance) and an importer succeed to business, the same shall not apply, unless he/she is aware of such disposition or violation.
[This Article Newly Inserted by Act No. 10788, Jun. 7, 2011]
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 Article 90 (Bounty)   print
A bounty may be paid to any person who has whistle-blown or tipped off the fact of violating the provisions of Article 23, 24 (1) and (2), 26 (1), 27 (1) and (3), or 50 (1) (including cases to which relevant provisions apply mutatis mutandis under Article 44-5 (1)) and (2) to any supervisory agency or any investigative agency as prescribed by Presidential Decree. <Amended by Act No. 11421, May 14, 2012>
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 Article 91 (Establishment of Korea Orphan Drug Center)   print
(1) The Korea Orphan Drug Center (hereinafter referred to as the "Center") shall be established to perform the work of providing information with respect to drugs which have the rare subject of their application and are required to be urgently imported because of the lack of their substitute drugs and other drugs used to treat rare diseases (hereinafter referred to as "orphan drugs, etc.") and supplying (including the duties of preparation and dosage of drugs; hereinafter the same shall apply) such drugs.
(2) The Center shall be a corporation.
(3) The provisions governing a juridical foundation of the Civil Act shall apply mutatis mutandis to the Center, except as otherwise provided for in this Act.
(4) Necessary matters concerning the operation, etc. of the Center established under paragraph (1) shall be prescribed by Presidential Decree.
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 Article 92 (Projects of Center)   print
(1) The Center shall conduct the following projects: <Amended by Act No. 11690, Mar. 23, 2013>
1. Collecting information pertaining to orphan drugs, etc. and building a computer network;
2. Supplying orphan drugs, etc.; in such cases, the president of the Center shall install a dispensary in the Center, designate a pharmacist from among the staff of the Center and have him/her take charge of such project;
3. Other projects related to orphan drugs, etc., that are approved by the Minister of Food and Drug Safety.
(2) Where the Minister of Food and Drug Safety deems it necessary for the Center to implement projects specified in paragraph (1), he/she may provide the Center with financial assistance, etc. <Amended by Act No. 11690, Mar. 23, 2013>
CHAPTER IX PENALTY PROVISIONS
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 Article 93 (Penalty Provisions)   print
(1) A person who falls under any of the following subparagraphs shall be punished by imprisonment with labor for not more than five years, or by a fine not exceeding twenty million won: <Amended by Act No. 8643, Oct. 17, 2007>
1. A person who lends his/her license to third persons, in violation of Article 6 (3);
2. A person who establishes a pharmacy, in violation of Article 20 (1);
3. A person who violates Article 23 (1);
4. A person who fails to obtain product licenses of drugs or to file product notification, in violation of Article 31 (1) through (4);
5. A person who fails to obtain permission, to make reporting, to obtain permission for modification, or to make reporting of modification, in violation of Article 42 (1);
6. A person who violates Article 43;
7. A person who violates Article 44 (1);
8. A person who sells drugs without obtaining a license pursuant to Article 44 (2) 2;
9. A person who violates Article 53 (1);
10. A person who violates Article 61 (including cases to which relevant provisions apply mutatis mutandis under Article 66).
(2) As for the punishment under paragraph (1), imprisonment with labor and a fine may be imposed concurrently.
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 Article 94 (Penalty Provisions)   print
(1) Any of the following persons shall be punished by imprisonment with labor for not more than three years, or by a fine not exceeding ten million won: Provided, That any person who violates Article 87 (1) may be prosecuted only when a criminal complaint is filed against him/her: <Amended by Act No. 8643, Oct. 17, 2007; Act No. 10788, Jun. 7, 2011; Act No. 11251, Feb. 1, 2012; Act No. 11421, May 14, 2012>
1. A person who violates Article 3 (3) or 4 (3);
2. A person who commits an act of collusion, in violation of Article 24 (2);
3. A person who violates Article 34 (1) or (3) 2 through 4, or a person who violates an order under Article 34 (6);
4. A person who violates Article 37 (3) (including cases to which relevant provisions apply mutatis mutandis under Article 42 (4));
5. A person who violates Article 45 (5);
6. A person who sells drugs after removing the seal of a container or package, in violation of the main sentence of Article 48;
7. A person who sells, stores, or displays drugs, in violation of Article 49;
8. A person who violates Article 50 (1) (including cases to which relevant provisions apply mutatis mutandis under Article 44-5 (1));
9. A person who sells, manufactures, imports, stores, or displays drugs, in violation of Article 62 (including cases to which relevant provisions mutatis mutandis under Article 66);
9-2. A person who divulge confidential information, in violation of Article 68-9;
10. A person who refuses an order to manufacture drugs or an order to start work without good cause, in violation of Article 70 (2);
11. A person who violates an order pursuant to Articles 71 (1) and (2) (including cases to which relevant provisions apply mutatis mutandis under Article 44-5 (1)) and 72 (1) and (2) (including cases to which relevant provisions apply under Article 44-5 (1)), or refuses, obstructs or evades the recall and abandonment of articles and carried out by relevant public officials pursuant to Article 71 (3) (including cases to which relevant provisions apply mutatis mutandis under Article 44-5 (1)), and other necessary dispositions;
12. A person who violates Article 87 or 88 (2).
(2) As for the punishment under paragraph (1), imprisonment with labor and a fine may be imposed concurrently.
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 Article 94-2 (Penalty Provisions)   print
A person who violates Article 47 (2) and (3) shall be punished by imprisonment with labor for not more than two years or by a fine not exceeding thirty million won. In such cases, any economic benefit, etc. acquired shall be confiscated or where it is impossible to confiscate such economy benefit, etc., a value equivalent thereto shall be collected.
[This Article Newly Inserted by Act No. 10324, May 27, 2010]
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 Article 95 (Penalty Provisions)   print
(1) Any of the following persons shall be punished by imprisonment with labor for not more than one year or by a fine not exceeding three million won: <Amended by Act No. 8558, Jul. 27, 2007; Act No. 8643, Oct. 17, 2007; Act No. 10324, May 27, 2010; Act No. 10788, Jun. 7, 2011; Act No. 11251, Feb. 1, 2012; Act No. 11421, May 14, 2012>
1. A person who fails to file for registration for establishment, in violation of Article 20 (2);
2. A person who violates Article 21 (1) and (2);
3. A person who violates Article 23 (2), (3), (4), (6), and (7);
4. A person who refuses to dispense drugs without good cause, in violation of Article 24 (1);
5. A person who dispenses drugs, in violation of Article 26 (1);
6. A person who violates Article 27 (1), (3), and (4);
6-2. A person who falsely prepares or issues clinical trial results, biological equivalence test results, non-clinical trial results, or quality inspection results under Article 34-2 (3), 34-3 (3), or 73 (3);
7. A person who fails to perform affairs of safety control, in violation of Article 36 (including cases to which relevant provisions apply mutatis mutandis under Article 42 (4)), 37 (2) (including cases to which relevant provisions apply mutatis mutandis under Article 42 (4)) or 37-3 (1) (including cases to which relevant provisions apply mutatis mutandis under Article 42 (4));
8. A person who violates Article 47 (1) (including cases to which relevant provisions apply mutatis mutandis under Article 44-5 (1)) or (4), or 85 (9);
9. A person who sells prescription drugs, in violation of Article 50 (2);
10. A person who violates Article 60, 64 (1), or 68.
11. A person who sells drugs for animals without a prescription, in violation of Article 85 (6) and (7);
(2) As for the punishment under paragraph (1), imprisonment with labor and a fine may be imposed concurrently.
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 Article 95-2 (Penalty Provisions)   print
A person who violates Article 26 (2) shall be punished by a fine not exceeding three million won.
[This Article Newly Inserted by Act No. 8558, Jul. 27, 2007]
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 Article 96 (Penalty Provisions)   print
Any of the following persons shall be punished by a fine not exceeding two million won: Provided, That with regard to a person who violates Article 30 (2), the violation may be prosecuted only if a criminal complaint is filed against him/her: <Amended by Act No. 8643, Oct. 17, 2007; Act No. 10788, Jun. 7, 2011; Act No. 11251, Feb. 1, 2012; Act No. 11421, May 14, 2012>
1. A person who violates Article 24 (3);
2. A person who violates Articles 28, 29, or 30 (1) and (2);
3. A person who violates Articles 37 (1), 37-3 (2), or 38 (1);
4. A person who violates Articles 56 (1), 57, 58, 63 (including cases to which relevant provisions mutatis mutandis under Article 66), or 65 (1);
5. A person who refuses, obstructs, or evades inspection, inquiry, collection, etc. by relevant public officials under Article 69 (1) (including cases to which relevant provisions apply mutatis mutandis under Article 44-5 (1));
6. A person who violates an order of reporting, public announcement, inspection, repair, change, etc. under Articles 69 (1) (including cases to which relevant provisions apply mutatis mutandis under Article 44-5 (1)), 72 (3) and (4), 73, 74, and 75.
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 Article 97 (Joint Penalty Provisions)   print
Where the representative of a juristic person, or any agent, employee, or any other person employed by a juristic person or an individual commits an offense described in Article 93, 94, 94-2, 95, 95-2, or 96 in connection with business affairs of the juristic person or the individual, in addition to the punishment of such person, the juristic person or the individual shall be punished by a fine under each relevant Article: Provided, That where such juristic person or individual has not been negligent in providing due attention and supervision concerning the relevant duties to prevent such offense, this shall not apply.
[This Article Wholly Amended by Act No. 10788, Jun. 7, 2011]
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 Article 98 (Administrative Fines)   print
(1) Any of the following persons shall be punished by an administrative fine not exceeding one million won: <Amended by Act No. 8643, Oct. 17, 2007; Act No. 10788, Jun. 7, 2011; Act No. 11421, May 14, 2012>
1. A person who fails to submit the details of a pharmacist or herb pharmacist, in violation of Article 7;
2. A person who fails to receive training and education prescribed in Article 15;
3. A person who fails to observe matters necessary for the management of a pharmacy, in violation of Article 21 (3);
4. A person who fails to report the discontinuance, etc. of business, in violation of Article 22 or 40;
4-2. A person who fails to receive education, in violation of Articles 37-2 (including cases to which relevant provisions apply mutatis mutandis under Article 42 (4)) and 73-3 (1);
5. A person who fails to report production performance, import performance, etc. of drugs, etc., in violation of Article 38 (2) (including cases to which relevant provisions apply mutatis mutandis under Article 42 (4));
6. Deleted; <by Act No. 11251, Feb. 1, 2012>
6-2. A person who fails to report the manufacturing, etc. of pharmacy medication or dispensary medication, in violation of Article 41 (1);
6-3. A person who fails to report on discontinuation, suspension, or resume of business, in violation of the main sentence of Article 44-2 (4);
6-4. A person who fails to receive education, in violation of an order issued under Article 44-3 (2);
7. A person who fails to abide by the matters to be observed by sellers of safe and readily available drugs, in violation of Article 44-4;
7-2. A person who fails to submit the details of supply of drugs, in violation of Article 47-2 (2) (including cases to which relevant provisions apply mutatis mutandis under Article 44-5 (2));
7-3. A person who fails to indicate prices of drugs on the containers or packages of drugs, in violation of Article 56 (2) (including cases to which relevant provisions apply mutatis mutandis under Article 44-5 (1)) or 65 (2);
7-4. A person who fails to report on an adverse event, in violation of Article 68-8;
7-5. A person who uses the name “the Institute of Drug Safety and Risk Management” or a other similar name, in violation of Article 68-10;
8. Deleted; <by Act No. 11251, Feb. 1, 2012>
9. A person who fails to renew a certificate of license, permission, or registration, in violation of Article 80;
10. A person who fails to observe standards for use of animal drugs, in violation of Article 85 (3).
(2) Administrative fines under paragraph (1) shall be imposed and collected by the Minister of Health and Welfare, the Minister of Food and Drug Safety, Mayors/Do Governors or the heads of Sis/Guns/Gus, as prescribed by Presidential Decree. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 10788, Jun. 7, 2011; Act No. 11690, Mar. 23, 2013>
(3) through (5) Deleted. <by Act No. 10788, Jun. 7, 2011>
ADDENDA
Article 1 (Enforcement Date)
This Act shall enter into force on the date of its promulgation: Provided, That the amended provisions of Article 81 shall enter into force on July 4, 2007.
Article 2 (Transitional Measures concerning Enforcement Date)
The previous provisions of Article 71-3 that corresponds to the amended provisions of Article 81 shall apply until the latter enters into force pursuant to the proviso to Article 1 of this Addenda.
Article 3 (Applicability concerning Disposition of Imposition of Penalty Surcharges)
The amended provision of Article 81 (4) shall apply, beginning with a person who receives disposition of penalty surcharges determined on or after July 4, 2007, the enforcement date of the amended Pharmaceutical Affairs Act (Act No. 8201).
Article 4 (Transitional Measures concerning Drugs, etc. for Family Planning)
The amended provisions of Articles 44, 50 and 68 (4) shall not apply to articles selected by the Minister of Health and Welfare, from among drugs for family planning. And notwithstanding the amended provisions of Articles 44 and 50, those designated by the Minister of Health and Welfare may be allowed to present or sell only articles designated by the Minister of Health and Welfare as stipulated by the Ordinance of the Ministry of Health and Welfare regarding the presentation and sale of drugs in the train, airplane or other places designated by the Minister of Health and Welfare.
Article 5 (Transitional Measures concerning Druggists, etc.)
Druggists (referring to the drug dealers under previous statutes) who have obtained a license pursuant to the previous statutes as of January 13, 1971, the enforcement date of the amended Pharmaceutical Affairs Act (Act No. 2279), and drug sellers shall be subject to the previous statutes.
Article 6 (Transitional Measures concerning Herb Druggists)
Those who have been granted the permission for herb dealers as of January 13, 1971, the enforcement date of the amended Pharmaceutical Affairs Act ( Act No. 2279) shall be deemed herb druggists pursuant to this Act.
Article 7 (Transitional Measures concerning Areas Permitted for Herb Dealers)
Those who have left the permitted area due to war or other natural calamities from among the herb dealers as of January 13, 1971, the enforcement date of the amended Pharmaceutical Affairs Act (Act No. 2279) and those who have left the permitted area before March 3, 1967, the enforcement date of the amended Pharmaceutical Affairs Act (Act No. 1910) may designate the place of residence as a permitted area only if they obtain permission from the Seoul Special Metropolitan City Mayor, Busan Metropolitan City Mayor, or Do Governor who has the jurisdiction of the place of residence concerned.
Article 8 (Transitional Measures concerning Dispensing by Herb Doctors and Veterinarians)
Where a herb doctor dispenses herbs and herb medications in person which he/she uses for treatment, or a veterinarian dispenses animal drugs in person which he/she uses for treatment, he/she may dispenses them notwithstanding the amended provisions of Article 23 (1) and (2).
Article 9 (Transitional Measures concerning Herb Dispensing by Pharmacists)
Those who fall under any of the following subparagraphs may dispense herbs by applying mutatis mutandis the amended provisions of Article 23 (6), notwithstanding the amended provisions of Article 23 (1):
1. Person who has a pharmacist license or who has not obtained a pharmacist license after graduating from a college majoring in pharmacology as at the time the amendment to Pharmaceutical Affairs Act (Act No. 4731) entered into force, who has passed the herbal medicine dispensing examination prescribed by Presidential Decree within 2 years from the date of enforcement of the same Act: Provided, That the herbal medicine dispensing examination shall be taken after obtaining a pharmacist license;
2. Person who was attending a college majoring in pharmacology as at the time the amended Pharmaceutical Affairs Act (Act No. 4731) entered into force, who completed the herb related course stipulated by the Ordinance of the Ministry of Health and Welfare and has succeeded in the herbal medicine dispensing examination prescribed by Presidential Decree within 2 years after the graduation: Provided, That the herbal medicine dispensing examination shall be taken after obtaining a pharmacist license.
Article 10 (Transitional Measures concerning Sale of Prescription Drugs by Druggists)
Druggists in operation as of July 1, 2000, the enforcement date of the amended Pharmaceutical Affairs Act (Act No. 6153) shall not sell prescription drugs in an area other than the area designated by the Minister of Health and Welfare pursuant to the amended provisions of Article 23 (5) as an area where there is no medical institution or pharmacy.
Article 11 (Transitional Measures concerning Substitute Dispensing)
The amended provisions of Article 27 shall enter into force 30 days after the list of local prescription drugs or list of prescription drugs by each medical institution has been supplied (where the list of prescription drugs has been coordinated pursuant to Article 25 (4), the date of such coordination) pursuant to Article 25 (2) to a relevant Si/Gun/Gu branch of the Pharmaceutical Association by a branch, etc. of the Medical Association.
Article 12 (Transitional Measures concerning the Korea Orphan Drug Center)
The Korea Orphan Drug Center, a juridical foundation founded pursuant to Article 32 of the Civil Act as at the time of August 14, 2001, the enforcement date of the amended Pharmaceutical Affairs Act (Act No. 6511), shall be deemed the Korea Orphan Drug Center established pursuant to the amended provisions of Article 91.
Article 13 (Special Cases concerning Granting Herb Pharmacist License)
Those who have completed 95 credits of herbal medicine related subjects stipulated in Article 3-2 of the amended Enforcement Decree of the Pharmaceutical Affairs Act (No. 14319) as conferred under Article 3-2 (2) of the amended Pharmaceutical Affairs Act (Act No. 7376) in a college and have succeeded in the national examination for herb pharmacists from among those falling under any of the following subparagraphs shall be granted a herb pharmacist's license notwithstanding the amended provisions of Article 4 (2):
1. Those who have been attending a college majoring in pharmacology (limited to a department other than the herb drug department) as of March 6, 1997, who entered the college in 1996 school year or before;
2. Those who have completed a college majoring in pharmacology as of March 6, 1997; or
3. Those who were attending a college other than a college majoring in pharmacology as of March 6, 1997, who entered the college in 1996 or before, and who have finished the college other than a college majoring in pharmacology.
Article 14 (Transitional Measures concerning Person who Received Bachelor's Degree in Pharmacology)
Those who have completed oriental pharmacy courses and have obtained a bachelor's degree in pharmacology as at the time the amended Pharmaceutical Affairs Act (Act No. 7635) entered into force shall be deemed those who have obtained a bachelor's degree in oriental pharmacy pursuant to the amended provision of Article 4.
Article 15 (Transitional Measures concerning Qualification for Applying for National Examinations for Pharmacists and Herb Pharmacists)
Those who have the qualification for applying for the National Examinations for Pharmacists and Herb Pharmacists shall be deemed to have the qualification for application pursuant to this Act.
Article 16 (Transitional Measures concerning the Korean Pharmaceutical Association, etc.)
The Korean Pharmaceutical Association, the Association of Korea Oriental Pharmacy, and chapters or branches thereof which all are established under the previous provisions at the time this Act enters into force, shall be deemed to have been established and set up pursuant to this Act.
Article 17 (Transitional Measures concerning License)
Those who have received the pharmacist's license or herb pharmacist's license pursuant to the previous provisions at the time when this Act enters into force shall be deemed to have received license pursuant to this Act.
Article 18 (Transitional Measures concerning Disposition, such as Permission)
Where permission has been obtained from the Minister of Health and Welfare, the Commissioner of the Korea Food and Drug Administration, Mayor/Do Governor, the head of a Si/Gun/Gu, or registration or reporting is
made, or application for permission, registration, etc. is made with a competent agency at the time this Act enters into force, it shall be deemed to have been obtained or made pursuant to this Act.
Article 19 (General Transitional Measures concerning Disposition, etc.)
Acts by administrative agencies or acts towards administrative agencies pursuant to the previous provisions at the time this Act enters into force shall be deemed the acts by administrative agencies or acts towards administrative agencies pursuant to this Act.
Article 20 (Transitional Measures concerning Penalty Provisions and Administrative Fines)
When applying a penalty provision or an administrative fine provision to an act committed before this Act enters into force, the previous provision shall govern.
Article 21 Omitted.
Article 22 (Relationship with Other Statutes)
Where the previous Pharmaceutical Affairs Act or a provision thereof is cited by other statutes as at the time this Act enters into force, this Act or a corresponding provision of this Act shall be deemed to have been cited in place of the previous provision if the corresponding provision exists in this Act.
ADDENDA <Act No. 8558, Jul. 27, 2007>
(1) (Enforcement Date) This Act shall enter into force six months after the date of its promulgation.
(2) (Applicability concerning Confirmation of Suspect Matters of Prescription) The amended provisions of Article 26 (2) concerning confirmation of suspect matters of a prescription shall apply beginning from the first prescription written after this Act enters into force.
ADDENDA <Act No. 8643, Oct. 17, 2007>
(1) (Enforcement Date) This Act shall enter into force six months after the date of its promulgation: Provided, That matters concerning the Korea Pharmaceutical Information Service shall enter into force one year after the date of its promulgation.
(2) (Transitional Measures concerning Notification, Disposition, Order, and On-going Activities) Notifications, dispositions, orders, and other acts of administrative agencies or various applications, reports, and other acts to administrative agencies under the previous Pharmaceutical Affairs Act at the time this Act enters into force shall be deemed acts administrative agencies or acts to administrative agencies under this Act corresponding thereto.
(3) (Transitional Measures concerning Penalty Provisions) The offences violated the previous Pharmaceutical Affairs Act at the time this Act enters into force shall be governed by the previous Pharmaceutical Affairs Act in applying penalty provisions or administrative fine provisions.
ADDENDA <Act No. 8723, Dec. 21, 2007>
Article 1 (Enforcement Date)
This Act shall enter into force six months after the date of its promulgation.
Articles 2 through 4 Omitted.
Article 5 (Relationship with Other Statutes)
Where the previous Juvenile Reformatory Act or a provision thereof is cited by any other statute as at the time this Act enters into force, this Act or a corresponding provision of this Act shall be deemed cited in place of the previous provision if the corresponding provision exists in this Act.
ADDENDA <Act No. 8728, Dec. 21, 2007>
Article 1 (Enforcement Date)
This Act shall enter into force one year after the date of its promulgation.
Articles 2 through 6 Omitted.
ADDENDA <Act No. 8852, Feb. 29, 2008>
Article 1 (Enforcement Date)
This Act shall enter into force on the date of its promulgation. (Proviso Omitted.)
Articles 2 through 7 Omitted.
ADDENDUM <Act No. 9123, Jun. 13, 2008>
This Act shall enter into force six months after the date of its promulgation.
ADDENDA <Act No. 9819, Nov. 2, 2009>
Article 1 (Enforcement Date)
This Act shall enter into force six months after the date of its promulgation.
Articles 2 through 6 Omitted.
ADDENDA <Act No. 9847, Dec. 29, 2009>
Article 1 (Enforcement Date)
This Act shall enter into force one year after the date of its promulgation.
Articles 2 through 22 Omitted.
ADDENDA <Act No. 9932, Jan. 18, 2010>
Article 1 (Enforcement Date)
This Act shall enter into force two months after the date of its promulgation. (Proviso Omitted.)
Articles 2 through 5 Omitted.
ADDENDUM <Act No. 10324, May 27, 2010>
This Act shall enter into force six months after the date of its promulgation.
ADDENDA <Act No. 10512, Mar. 30, 2011>
Article 1 (Enforcement Date)
This Act shall enter into force one year after the date of its promulgation: Provided, That the amended provisions of Articles 19, 23 (4), 30 (1), 31 (6), (8) and (11), and 42 (2) shall enter into force on the date of its promulgation.
Article 2 (Applicability to Products, etc. with Drugs, etc. and Medical Devices Combined)
The amended provisions of Article 31 (7) (including cases to which relevant provisions apply mutatis mutandis pursuant to the amended provisions of Article 42 (4)) shall apply, starting with the first application for permission for items or the first report on items filed after this Act enters into force.
Article 3 (Applicability to Submission of Test Results, etc.)
The amended provisions of Article 31 (10) 1 and 2 (including cases to which relevant provisions mutatis mutandis pursuant to the amended provisions of Article 42 (4)) shall apply, starting with the first application for permission for items or the first report on items filed after this Act enters into force.
Article 4 (Transitional Measures concerning Drug Substances Subject to Reporting)
A drug substance, a report on which was filed with the Commissioner of the Korea Food and Drug Administration pursuant to the previous provisions as at the time this Act enters into force, shall be deemed registered pursuant to the amended provisions of Article 31 (2) (including cases which are applied mutatis mutandis pursuant to the amended provisions of Article 42 (4)).
Article 5 (Transitional Measures concerning Drug Wholesalers who Obtained Previous Permission)
A person who has obtained permission for drug wholesalers pursuant to the previous provisions as at the time this Act enters into force shall be deemed obtained permission pursuant to the amended provisions of Article 45: Provided, That he/she shall have facilities prescribed in the amended provisions of Article 45 within two years from the date on which this Act enters into force.
Article 6 Omitted.
ADDENDA <Act No. 10788, Jun. 7, 2011>
Article 1 (Enforcement Date)
(1) This Act shall enter into force one year after the date of its promulgation.
(2) Notwithstanding the provisions of paragraph (1), the amended provisions of subparagraphs 15 through 17 of Article 2, Articles 14 (1), 36 (3), 37, 37-3, 38 (1), 39 (3), 45, 54, 56, 57, 61 (1) 2, 65 (excluding paragraphs (1) 4 and (2)), 68-2 (3), 82, 85 (1), 88 (1), 89, 89-2, 94 (1) 4, 95 (1) (excluding subparagraphs 6-2 and 8), 96, 97, 98 (1) 7-3 and 98 (2) through (5) shall enter into force on the date of its promulgation.
(3) Notwithstanding paragraph (1), the amended provisions of Articles 21 (3) 4, 68-3 through 68-11, 84 (2), 94 (1) 9-2, 98 (1) 7-4 and 7-5 shall enter into force six months after the date of its promulgation: Provided, That Article 2 of this Addenda shall enter into force on the date of its promulgation.
Article 2 (Preparation for Establishment of Institute of Drug Safety and Risk Management)
(1) The Commissioner of the Korea Food and Drug Administration shall appoint no more than 10 establishment members within 30 days from the date on which this Act enters into force to have them take charge of affairs on the establishment of the Institute of Drug Safety and Risk Management and on the appointment of directors and auditors as at the time of its establishment.
(2) The establishment members shall prepare the articles of association of the Institute of Drug Safety and Risk Management and obtain authorization from the Commissioner of the Korea Food and Drug Administration.
(3) The president of the Institute of Drug Safety and Risk Management as at the time of its establishment shall be appointed by the Commissioner of the Korea Food and Drug Administration.
(4) Where the establishment members have obtained authorization under paragraph (2), they shall make an establishment registration of the Institute of Drug Safety and Risk Management without delay and then transfer its affairs to the president of the Institute of Drug Safety and Risk Management.
(5) Where the transfer of affairs referred to in paragraph (4) is completed, the establishment members shall be deemed dismissed.
(6) Expenses, etc. necessary for preparing the establishment of the Institute of Drug Safety and Risk Management shall be covered by the State.
Article 3 (Applicability to Approval, etc. for Clinical Tests, etc.)
The amended provisions of Article 34 (1) shall apply, starting with the first person who applies for approval for a protocol of a clinical trial or biological equivalence test using drugs, etc. after this Act enters into force.
Article 4 (Applicability to Matters to be Stated on Containers, etc.)
The amended provisions of Article 65 (1) 4 shall apply, starting with the quasi-drug first manufactured or imported on or after this Act enters into force.
Article 5 (Applicability concerning Fees)
The amended provisions of Article 82 shall apply, starting with the first application for approval for a protocol on a clinical trial or biological equivalence test and the first designation of a non-clinical trial institution, etc.
Article 6 (Transitional Measures concerning Designation of Clinical Trial Institutions, etc.)
(1) A clinical trial institution designated by the Commissioner of the Korea Food and Drug Administration pursuant to the previous provisions as at the time this Act enters into force shall be deemed a clinical trial institution designated by the Commissioner of the Korea Food and Drug Administration pursuant to the amended provisions of Article 34-2 (1).
(2) A person designated by the Commissioner of the Korea Food and Drug Administration or Mayor/Do Governor pursuant to the previous provisions of Article 73 shall be deemed a quality inspection institution designated by the Commissioner of the Korea Food and Drug Administration or Mayor/Do Governor pursuant to the amended provisions of Article 73 (1).
Article 7 (Transitional Measures concerning Korean Pharmacopoeia)
The Korean Pharmacopoeia publicly notified as at the time this Act enters into force shall be deemed publicly notified as the Pharmacopoeia of the Republic of Korea under the amended provisions of Article 51.
Article 8 (Transitional Measures concerning State-Authorized Drugs)
A drug authorized by the Commissioner of the Korea Food and Drug Administration pursuant to the previous provisions of Article 53 as at the time this Act enters into force shall be deemed a drug, for which lot release was granted by the Commissioner of the Korea Food and Drug Administration pursuant to the amended provisions of Article 53.
Article 9 (Transitional Measures concerning Penalty Provisions)
The acts committed before this Act enters into force shall be governed by the previous provisions in applying penalty provisions or administrative fine provisions.
Article 10 Omitted.
Article 11 (Relationship with Other Statutes)
Where the provisions of the previous Pharmaceutical Affairs Act are cited by other statutes as at the time this Act enters into force, corresponding provisions of this Act shall be deemed cited in lieu of the previous provisions if corresponding provisions exist in this Act.
ADDENDUM <Act No. 11118, Dec. 2, 2011>
This Act enters into force on the date on which the Free Trade Agreement between the Republic of Korea and the United States of America and Exchange of Letters related to the Free Trade Agreement between the Republic of Korea and the United States of America takes effect: Provided, That the amended provisions of subparagraph 4 of Article 5 shall enter into force on the date of its promulgation, while the amended provisions in the former part of Article 42 (4) of the amended Pharmaceutical Affairs Act (Act No. 10512) shall enter into force on March 31, 2012.
ADDENDA <Act No. 11141, Dec. 31, 2011>
Article 1 (Enforcement Date)
This Act shall enter into force on September 1, 2012. (Proviso Omitted.)
Articles 2 through 22 Omitted.
ADDENDA <Act No. 11251, Feb. 1, 2012>
Article 1 (Enforcement Date)
(1) This Act shall enter into force on the date of its promulgation.
(2) Notwithstanding the provisions of paragraph (1), the amended provisions of Articles 65-2, 72, 76, 94, 96, and 98 (1) 6 shall enter into force six months after the date of its promulgation.
(3) Notwithstanding the provisions of paragraph (1), the amended provisions of Article 85 and the amended provisions of Article 95 of the partial amendment of the Pharmaceutical Affairs Act (Act No. 10788) shall enter into force 18 months after the date of its promulgation.
Article 2 (Transitional Measures concerning Matters to be Indicated on Containers, or Packages and in Package Inserts of Quasi-Drugs)
Matters which are indicated on containers, packages or package inserts of quasi-drugs (including marks) pursuant to the previous provisions as at the time the amended provisions of Article 65-2 enter into force may be continuously used on containers, packages or package inserts of relevant quasi-drugs, until two years after the date on which the same amended provisions enter into force, notwithstanding the same amended provisions.
Article 3 (Transitional Measures concerning Penalty Provisions and Administrative Fines)
Any acts committed before this Act enters into force shall be governed by the previous provisions in applying penalty provisions or administrative fine provisions.
ADDENDA <Act No. 11421, May 14, 2012>
Article 1 (Enforcement Date)
This Act shall enter into force six months after the date of its promulgation: Provided, That the amended provisions of Article 31-5 and the former part of Article 42 (4) shall enter into force on January 1, 2013, and the amended provisions of Article 95 (1) 8 of the amended Pharmaceutical Affairs Act (Act No. 11251) shall enter into force on August 2, 2013.
Article 2 (Special Cases concerning Period of Validity of Product Licenses or Product Notification)
Notwithstanding the amended provisions of Article 31-5 (1) (including cases to which relevant provisions apply mutatis mutandis under the amended provisions of the former part of Article 42 (4)), the period of validity of product licenses or product notification of the drugs which is product licensed or product notified before January 1, 2013 and a drug the re-examination period of which expired before January 1, 2013 shall be extended to the date prescribed and publicly notified by the Minister of Food and Drug Safety within the scope from January 1, 2018 to December 31, 2023. <Amended by Act No. 11690, Mar. 23, 2013>
ADDENDA <Act No. 11690, Mar. 23, 2013>
Article 1 (Enforcement Date)
(1) This Act shall enter into force on the date of its promulgation.
(2) Omitted.
Articles 2 through 7 Omitted.
ADDENDA <Act No. 12074, Aug. 13, 2013>
Article 1 (Enforcement Date)
This Act shall enter into force on the date of its promulgation.
Article 2 (Applicability concerning Suspension of Business)
The amended provisions of Article 76 (1) shall also apply to cases where any administrative disposition is granted with respect to any violation occurred before this Act enters into force.