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ENFORCEMENT DECREE OF THE PHARMACEUTICAL AFFAIRS ACT

Wholly Amended by Presidential Decree No. 20130, jun. 28, 2007

Amended by Presidential Decree No. 20156, Jul. 3, 2007

Presidential Decree No. 20679, Feb. 29, 2008

Presidential Decree No. 20767, Apr. 10, 2008

Presidential Decree No. 20875, jun. 25, 2008

Presidential Decree No. 21084, Oct. 14, 2008

Presidential Decree No. 22075, Mar. 15, 2010

Presidential Decree No. 23459, Dec. 30, 2011

Presidential Decree No. 23488, Jan. 6, 2012

Presidential Decree No. 23734, Apr. 17, 2012

Presidential Decree No. 23759, May 1, 2012

Presidential Decree No. 23843, jun. 7, 2012

Presidential Decree No. 23886, jun. 27, 2012

Presidential Decree No. 24077, Aug. 31, 2012

Presidential Decree No. 24144, Oct. 22, 2012

Presidential Decree No. 24247, Dec. 21, 2012

Presidential Decree No. 24479, Mar. 23, 2013

Presidential Decree No. 24775, Sep. 26, 2013

Presidential Decree No. 25050, Dec. 30, 2013

Presidential Decree No. 25357, May 21, 2014

Presidential Decree No. 25447, Jul. 7, 2014

Presidential Decree No. 25529, Jul. 28, 2014

Presidential Decree No. 25605, Sep. 11, 2014

Presidential Decree No. 25862, Dec. 16, 2014

Presidential Decree No. 26143, Mar. 13, 2015

Presidential Decree No. 26544, Sep. 22, 2015

Presidential Decree No. 26742, Dec. 22, 2015

Presidential Decree No. 26844, Dec. 31, 2015

Presidential Decree No. 27048, Mar. 22, 2016

Presidential Decree No. 27673, Dec. 13, 2016

 Article 1 (Purpose)
The purpose of this Decree is to prescribe the matters delegated by the Pharmaceutical Affairs Act and the matters necessary for its enforcement.
 Article 2 (Administration of National Examinations for Pharmacists or Herb Pharmacists)
(1) Pursuant to Article 8 (2) of the Pharmaceutical Affairs Act (hereinafter referred to as the "Act"), the Minister of Health and Welfare shall entrust the administration of a national examination for pharmacists or herb pharmacists (hereinafter referred to as "national examination") to the Korea Health Personnel Licensing Examination Institute established under the Korea Health Personnel Licensing Examination Institute Act (hereinafter referred to as "national examination administrative agency"). <Amended by Presidential Decree No. 26742, Dec. 22, 2015>
(2) Where the head of the national examination administrative agency intends to hold a national examination, he/she shall, with prior approval from the Minister of Health and Welfare, publicly announce the date and time, places and subjects of the examination, the deadline for submission of written applications for the examination, and other matters necessary for holding the examination, at least 90 days before the date when the examination is held: Provided, That he/she may publicly announce the places of the examination by no later than 30 days before the examination date after the number of applicants for the examination for each region is determined. <Amended by Presidential Decree No. 20679, Feb. 29, 2008; Presidential Decree No. 22075, Mar. 15, 2010; Presidential Decree No. 23759, May 1, 2012>
 Article 3 (Application, etc. for National Examination)
(1) Any person who intends to apply for a national examination, shall submit to the head of the national examination administrative agency a written application prescribed by the head of the national examination administrative agency.
(2) "Foreign college of pharmacy, accredited by the Minister of Health and Welfare" in Article 3 (2) 2 of the Act means a college equivalent to or higher than those prescribed by Article 3 (2) 1 of the Act with respect to its curriculum or educational system. <Amended by Presidential Decree No. 20679, Feb. 29, 2008; Presidential Decree No. 22075, Mar. 15, 2010>
(3) Any person who submits a written application provided for in paragraph (1) shall pay in cash a fee determined by the head of the national examination administrative agency with approval from the Minister of Health and Welfare. In such cases, the amount and payment method of the fee and other necessary matters shall be publicly announced by the head of the national examination administrative agency pursuant to Article 2. <Amended by Presidential Decree No. 20679, Feb. 29, 2008; Presidential Decree No. 22075, Mar. 15, 2010; Presidential Decree No. 23459, Dec. 30, 2011>
(4) The head of the national examination administrative agency may have a fee referred to in paragraph (3) paid by means of electronic currencies, electronic settlement, etc. through information and communication networks. <Amended by Presidential Decree No. 23459, Dec. 30, 2011>
 Article 4 (Subjects of Examinations)
(1) The national pharmacist examination shall be administered in writing, covering the following subjects, and the details of subjects shall be prescribed by Ordinance of the Ministry of Health and Welfare:
1. Life science in pharmacy;
2. Industrial pharmacy;
3. Clinical pharmacy and pharmacy practice;
4. Regulations concerning health and welfare, and pharmacy.
(2) The national oriental pharmacist examination shall be administered in writing, covering the following subjects and the details of subjects shall be prescribed by Ordinance of the Ministry of Health and Welfare:
1. Basics of oriental pharmacy;
2. Applied oriental pharmacy;
3. Regulations concerning health and welfare, and pharmacy.
[This Article Wholly Amended by Presidential Decree No. 24775, Sep. 26, 2013]
 Article 5 (Decision on Successful Candidate)
Anyone who obtains a score of at least 40% in each subject and whose overall score is a 60% or more in total, shall be considered a successful candidate.
 Article 6 (Announcement of Successful Candidates)
Where the head of the national examination administrative agency decides on the successful candidates of the national examination held under Articles 2 and 5, he/she shall promptly announce the list of the successful candidates.
 Article 7 (Examiners)
In order to give questions for the national examination and mark papers thereof, the head of a national examination management agency shall designate persons of profound learning and experience in pharmacology or related Acts and subordinate statutes as examiners.
 Article 8 (Request for Cooperation to Relevant Agencies, etc.)
The head of a national examination management agency may request the State and local governments, or relevant agencies or organizations for the assistance in examination rooms, examination proctors, etc., if necessary for the smooth administration duties of national examination.
 Article 8-2 (Composition of Each Ethics Committee)
(1) Each Ethics Committee to be established within the Korean Pharmaceutical Association (hereinafter referred to as the "Pharmaceutical Association") and the Association of Korea Oriental Pharmacy (hereinafter referred to as the "Oriental Pharmacy Association") in accordance with Articles 11 (5) and 12 (5) of the Act shall be comprised of 11 members including one chairperson.
(2) The chairperson shall be commissioned by the head of the Pharmaceutical Association or the Oriental Pharmacy Association (hereafter referred to as "each Association" in this Article through Article 8-4) from among the members of each Association.
(3) Members shall be commissioned by the head of each Association from among the following persons and shall include at least four persons who fall under subparagraph 2:
1. A member of each Association who has at least 10 years experience as a pharmacist or 5 years experience as a herb pharmacist;
2. A person who is not a pharmacist or herb pharmacist but has considerable knowledge and experience in law, health care, press, rights and interests of consumers, etc.
(4) The term of office of a member shall be three years, and may be renewed only once.
[This Article Newly Inserted by Presidential Decree No. 23843, Jun. 7, 2012]
 Article 8-3 (Operation of Each Ethics Committee)
(1) Each Ethics Committee shall deliberate and adopts resolutions on the following matters:
1. Matters concerning the request for disposition of qualification suspension under Article 79-2 of the Act;
2. Matters concerning the examination on qualification of, and the disciplinary actions against, members of each Association;
3. Other matters necessary for the establishment of ethics among members, which are prescribed by the articles of incorporation of each Association.
(2) A meeting of each Ethics Committee shall be convened by the chairperson where deemed necessary by the chairperson or where requested by the head of each Association or not less than 1/3 of its incumbent members.
(3) In convening a meeting, the chairperson shall notify each member of the date and time, venue, and agenda of the meeting seven days before the opening of the meeting: Provided, That where an urgent meeting is required or where any extenuating circumstances exist, he/she may notify such matters until the day before the meeting is due.
(4) A meeting of each Ethics Committee shall require the attendance of at least 2/3 of its incumbent members, and the adoption of a resolution shall require the concurrent vote of at least 2/3 of those present: Provided, That the quorum for the matters referred to in paragraph (1) 2 and 3 shall be prescribed otherwise by the articles of incorporation of each Association.
(5) Where the chairperson of each Ethics Committee intends to deliberate and adopt a resolution on the matter referred to in paragraph (1) 1 or 2, he/she shall give a party to the relevant agenda an opportunity to state his/her opinion orally or in writing (including electronic message).
(6) Matters necessary for the operation of each Ethics Committee other than those prescribed in paragraph (1) through (5) shall be prescribed by the articles of incorporation of each Association.
[This Article Newly Inserted by Presidential Decree No. 23843, Jun. 7, 2012]
 Article 8-4 (Exclusion, etc. of Members of Each Ethics Committee)
(1) A member of each Ethic Committee who falls under any of the following subparagraphs shall be excluded from the deliberation and resolution of the relevant Ethics Committee:
1. Where he/she becomes a party to the agenda item to be deliberated and adopted by the Ethics Committee (hereafter referred to as "relevant agenda item" in this Article);
2. Where he/she is or was a relative of a party to the relevant agenda item;
3. Where he/she engages in or has engaged in an institution to which a party to the relevant agenda item belongs in recent three years.
(2) If there exists any ground for exclusion referred to in paragraph (1) or any circumstances under which it would be difficult to expect the impartial deliberation and resolution by the Ethics Committee, a party to the relevant agenda item may file a request for a challenge to the relevant member with the Ethics Committee in writing stating the reasons therefor.
(3) Upon receiving the request for the challenge under paragraph (2), the Ethics Committee shall adopt a resolution whether to accept the challenge with the attendance of a majority of all the incumbent members and the consent of a majority of those present. In such cases, the member who is challenged may not participate in the resolution.
(4) If any member of the Ethics Committee falls under any ground referred to in paragraph (1) or (2), he/she may voluntarily refrain from deliberation and resolution.
[This Article Newly Inserted by Presidential Decree No. 23843, Jun. 7, 2012]
 Article 9 (Authorization for Establishment of Pharmaceutical Association and Oriental Pharmacy Association)
If a Pharmaceutical Association or an Oriental Pharmacy Association intends to obtain authorization for establishment under Article 13 (1) of the Act, it shall submit the following documents to the Minister of Health and Welfare: <Amended by Presidential Decree No. 20679, Feb. 29, 2008; Presidential Decree No. 22075, Mar. 15, 2010; Presidential Decree No. 23843, Jun. 7, 2012>
1. Articles of association;
2. Detailed statement of assets;
3. A written business plan and a budget of revenues and expenditures;
4. A resolution of establishment;
5. Detailed documents of election process for establishment representatives;
6. A letter of acceptance of appointment and resume of an executive officer.
 Article 10 (Matters to be Included in Articles of Association)
Matters to be included in the articles of association of the Pharmaceutical Association or the Oriental Pharmacy Association shall be as follows: <Amended by Presidential Decree No. 23843, Jun. 7, 2012>
1. Purposes;
2. Title;
3. Principal office;
4. Matters concerning assets and accounting;
5. Matters concerning appointment of executive officers;
6. Matters concerning qualification and discipline of members;
7. Matters concerning amendments to the articles of association;
8. Matters concerning method of giving public announcement;
9. Matters concerning operation, etc. of the Ethics Committee.
 Article 11 (Application for Authorization for Modification of Articles of Association)
If the Pharmaceutical Association or Oriental Pharmacy Association wishes to obtain authorization for the modification of its articles of association under Article 13 (3) of the Act, it shall submit the following documents:
1. Details of and reasons for modification of its articles of association;
2. Minutes concerning modification of its articles of association;
3. Comparison table of its new and old articles of association, and other reference documents.
 Article 12 (Establishment of Chapters)
The Pharmaceutical Association or the Oriental Pharmacy Association shall establish its chapters in the Special Metropolitan City, Metropolitan Cities, Dos, and the Special Self-Governing Province under Article 14 of the Act within three weeks from the date of registration for establishment.
 Article 13 (Functions of the Central Pharmaceutical Affairs Council)
The Central Pharmaceutical Affairs Council (hereinafter referred to as the "Council" from this Article to Article 22) referred to in Article 18 of the Act shall deliberate on the following matters: <Amended by Presidential Decree No. 20679, Feb. 29, 2008; Presidential Decree No. 22075, Mar. 15, 2010; Presidential Decree No. 23459, Dec. 30, 2011; Presidential Decree No. 24479, Mar. 23, 2013; Presidential Decree No. 25605, Sep. 11, 2014>
1. Matters concerning the enactment and amendment of the Korean Pharmacopoeia prescribed in Article 51 of the Act;
2. Matters concerning the criteria for drugs and quasi-drugs (hereinafter referred to as "drugs, etc") prescribed in Article 52 of the Act;
3. Matters concerning the investigation, research and evaluation of safety and effectiveness of drugs, etc.;
4. Matters concerning the relief of injury from side effects of drugs;
5. Matters concerning the classification of over-the-counter drugs and prescription drugs;
6. Other matters to be presented by the Minister of Health and Welfare or the Minister of Food and Drug Safety for deliberation.
 Article 14 (Organization of the Council)
(1) The Council shall be comprised of not more than 100 members, including one chairperson and two vice chairpersons under Article 18 (2) of the Act.
(2) The Vice Minister of Food and Drug Safety shall serve as the chairperson, and each one public official belonging to the senior civil service corps of the Ministry of Health and Welfare and the Ministry of Food and Drug Safety shall serve as each vice chairperson. <Amended by Presidential Decree No. 24479, Mar. 23, 2013>
(3) Members shall be appointed or commissioned by the Minister of Food and Drug Safety from among public officials in charge of pharmaceutical affairs, or persons recommended by the head of an organization related to pharmaceutical affairs, or persons who have considerable knowledge and experience in pharmaceutical affairs, and the Minister of Health and Welfare may recommend candidates for members. <Amended by Presidential Decree No. 20679, Feb. 29, 2008; Presidential Decree No. 22075, Mar. 15, 2010; Presidential Decree No. 24479, Mar. 23, 2013>
 Article 14-2 (Dismissal of Members of the Council)
Where a member of the Council commissioned pursuant to Article 14 (3) falls under any of the following cases, the Minister of Food and Drug Safety may dismiss the member:
1. Where the member is unable to perform his/her duties due to mental and physical disorder;
2. Where there is a misdeed of the member regarding his/her duties;
3. Where it is deemed that the member is disqualified as a Council member due to negligence to duties, injury to dignity or other causes;
4. Where the member himself/herself express his/her intention that it is difficult to perform his/her duties.
[This Article Newly Inserted by Presidential Decree No. 26844, Dec. 31, 2015]
 Article 15 (Duties of Chairperson, etc.)
(1) The chairperson shall exercise overall control over the affairs of the Council, and represent the Council. <Amended by Presidential Decree No. 23459, Dec. 30, 2011>
(2) Vice chairpersons shall assist the chairperson, and the vice chairperson appointed by the chairperson shall act on behalf of the chairperson where the chairperson is unable to perform his/her duties due to unavoidable reasons.
 Article 16 (Convocation of the Council)
(1) The chairperson shall convene a meeting of the Council and take the chair of the meeting.
(2) The chairperson shall convene a meeting of the Council without delay when requested by the Minister of Health and Welfare, the Minister of Food and Drug Safety, or the majority of the incumbent members. <Amended by Presidential Decree No. 20679, Feb. 29, 2008; Presidential Decree No. 22075, Mar. 15, 2010; Presidential Decree No. 24479, Mar. 23, 2013>
 Article 17 (Subcommittees, etc.)
(1) Subcommittees and sectional committees may be established within the Council if necessary.
(2) Matters relating to organization and administration of the subcommittees and sectional committees under paragraph (1) shall be determined by the Minister of Food and Drug Safety following consultation with the Minister of Health and Welfare. <Amended by Presidential Decree No. 20679, Feb. 29, 2008; Presidential Decree No. 22075, Mar. 15, 2010; Presidential Decree No. 24479, Mar. 23, 2013>
 Article 18 (Proceedings)
(1) Meetings of the Council shall be convened with the attendance of a majority of incumbent members, and shall adopt a resolution with an affirmative vote of at least 2/3 of members present.
(2) Matters discussed by the subcommittees or sectional committees shall be deemed to be decided by the Council, except where the chairperson of the Council decides that it is necessary for another committee to take the matters into reconsideration.
 Article 19 (Reporting)
The chairperson shall report matters deliberated by the Council to the Minister of Food and Drug Safety without delay, and shall inform the Minister of Health and Welfare without delay of the matters to be presented by the Minister of Health and Welfare for deliberation under subparagraph 9 of Article 13. <Amended by Presidential Decree No. 20679, Feb. 29, 2008; Presidential Decree No. 22075, Mar. 15, 2010; Presidential Decree No. 24479, Mar. 23, 2013>
 Article 20 (Research Committee Members, etc.)
(1) Ten or less research committee members shall, in advance, be assigned to the Council.
(2) The research committee members shall examine and study in advance matters to be deliberated by the Council, following an order from the chairperson.
(3) The research committee members may attend and speak at meetings of the Council.
(4) The Council shall assign not more than ten researchers to assist the research committee members.
(5) The research committee members and researchers referred to in paragraphs (1) and (4) shall be appointed by the Minister of Food and Drug Safety from among persons who have considerable knowledge and experience in pharmaceutical affairs. <Amended by Presidential Decree No. 20679, Feb. 29, 2008; Presidential Decree No. 22075, Mar. 15, 2010; Presidential Decree No. 24479, Mar. 23, 2013>
 Article 21 (Secretary and Clerks)
(1) One secretary and several clerks shall be assigned to the Council.
(2) The secretary and clerks shall be appointed by the Minister of Food and Drug Safety from among public officials of the Ministry of the Food and Drug Safety. <Amended by Presidential Decree No. 20679, Feb. 29, 2008; Presidential Decree No. 22075, Mar. 15, 2010; Presidential Decree No. 24479, Mar. 23, 2013>
(3) The secretary shall take charge of business affairs of the Council following an order from the chairperson, and clerks shall assist the secretary.
 Article 22 (Remuneration, Traveling Expenses, etc.)
The Minister of Food and Drug Safety may pay remuneration and traveling expenses to the Council members, subcommittee members, and sectional committee members, and research funds and traveling expenses to the research committee members and researchers, respectively, within budgetary limits. <Amended by Presidential Decree No. 20679, Feb. 29, 2008; Presidential Decree No. 22075, Mar. 15, 2010; Presidential Decree No. 24479, Mar. 23, 2013>
 Article 22-2 (Standards for Facilities of Pharmacies)
(1) A pharmacy shall be equipped with the following equipment under Article 20 (3) of the Act:
1. A dispensary;
2. A facility for low-temperature storage and sun screen;
3. A facility for providing tap water or underground water, etc. that satisfies the quality standards for drinking water under Article 5 of the Drinking Water Management Act;
4. Devices necessary for dispensing drugs.
(2) Detailed standards for facilities under paragraph (1) shall be prescribed by Ordinance of the Ministry of Health and Welfare following consultation between the Minister of Health and Welfare and the Minister of Food and Drug Safety.
[This Article Newly Inserted by Presidential Decree No. 24479, Mar. 23, 2013]
 Article 23 (Scope of Direct Dispensing by Doctors or Dentists)
"Cases prescribed by Presidential Decree" in Article 23 (4) 14 of the Act means any of the following cases: <Amended by Presidential Decree No. 20875, Jun. 25, 2008; Presidential Decree No. 21084, Oct. 14, 2008; Presidential Decree No. 23459, Dec. 30, 2011; Presidential Decree No. 23734, Apr. 17, 2012; Presidential Decree No. 23886, Jun. 27. 2012; Presidential Decree No. 24247, Dec. 21, 2012; Presidential Decree No. 27673, Dec. 13, 2016>
1. Where doctors or dentists, who serve in military medical facilities under Article 15 of the Act on the Organization of National Armed Forces, dispense drugs for patients who are soldiers under Article 4 of the same Act in the course of performing their duties;
2. Where doctors or dentists, who serve in the National Police Hospital under Article 31 of the Regulations on the Organization of Office of the National Police Agency and Its Affiliated Agencies, etc., or in the Central Fire Fighter Treatment Center under Article 7 of the Enforcement Decree of the Framework Act on Health, Safety and Welfare of Fire Officials, dispense drugs for patients who are police officers or fire officers in the course of performing their duties;
3. Where doctors or dentists, who serve in medial institutions established and operated by the Korea Workers' Compensation and Welfare Service pursuant to Article 11 (2) of the Industrial Accident Compensation Insurance Act, dispense, in the course of performing their duties, drugs for patients suffering from pneumoconiosis from among persons who had occupational accidents under subparagraph 1 of Article 5 of the same Act;
4. Where doctors or dentists, who serve in the Korea Veterans Hospital established under Article 7 of the Korea Veterans Welfare and Healthcare Corporation Act, dispense drugs for patients for whom the total amount of medical expenses is borne by the State pursuant to the Act on the Honorable Treatment and Support of Persons, etc. of Distinguished Services to the State, the Act on Support for Persons Eligible for Veteran’s Compensation, the Act on Supporting and Establishing on Organization for the Patients Suffering from Exposure to Defoliants, and the Act on the Honorable Treatment of Persons of Distinguished Services to the May 18 Democratization Movement in performing their duties;
5. Where doctors or dentists, who serve in a health care room under Article 3 of the School Health Act (excluding those who serve in a medical institution established in the relevant school under the Medical Service Act), dispense, in the course of performing their duties, drugs for patients who are students or teaching staff members of the relevant school;
6. Where doctors or dentists, who are health managers under Article 16 of the Industrial Safety and Health Act (excluding those who serve in a medical institution established in the relevant workplace under the Medical Service Act), dispense, in the course of performing their duties, drugs for patients who are workers of the relevant workplace;
7. Where doctors or dentists dispense drugs for foreign patients pursuant to Article 27 (3) 2 of the Medical Service Act.
 Article 24 (Similar Collusive Acts)
(1) "Any other act similar to that referred to in subparagraphs 1 through 4 and prescribed by Presidential Decree as having the potential of collusion" in Article 24 (2) 5 of the Act means any of the following acts:
1. The act of making dispensing avaliable only at a specific pharmacy by stating the names, etc. of drugs on a prescription with a symbol or code pursuant to a prearrangement between a pharmacy founder and a medical institution founder;
2. The act, performed by a medical institution founder, of making dispensing avaliable only at a specific pharmacy by prescribing the drugs other than the list of prescription drugs under Article 25 of the Act;
3. The act, performed together by a pharmacy founder and a medical institution founder, of supporting or managing the affairs of drug purchase, drug dispensing, or filing applications for screening the expenses for medical care benefits, etc. under the National Health Insurance Act;
4. The act, performed by a medical institution founder, of transmitting the prescription by utilizing a facsimile or computer communication, etc. so as to make dispensing available at a specific pharmacy, even though there exists no request from the holder of such prescription;
5. The act, performed by a medical institution founder, of ordering a pharmacist subject to his/her de facto control and supervision to establish a pharmacy, or of operating the pharmacy actually by controlling or supervising the pharmacist who has established the pharmacy.
(2) The Minister of Health and Welfare, the Special Metropolitan City Mayor, Metropolitan City Mayors, Do Governors, the Governor of the Special Self-Governing Province (hereinafter referred to as "Mayor/Do Governor"), the head of a Si/Gun/Gu (referring to the head of an autonomous Gu; hereinafter the same shall apply) shall require relevant public officials to conduct an inspection under Article 69 of the Act on a medical institution founder or a pharmacy founder pursuant to the criteria set forth by the Minister of Health and Welfare in any of the following cases to prevent any collusive act under Article 24 (2) of the Act: <Amended by Presidential Decree No. 20679, Feb. 29, 2008; Presidential Decree No. 22075, Mar. 15, 2010; Presidential Decree No. 24479, Mar. 23, 2013>
1. Where it is considered that a medical institution founder (if a medical institution founder is a corporation, including the executive officers of such corporation) and a pharmacy founder have the relationship of spouse, parent, sibling, child, or spouse thereof, and that the relevant pharmacy exclusively induces prescriptions issued by the relevant medical institution;
2. Where a medical institution and a pharmacy are installed in the same building so as to jointly use the entrance, and it is considered that the relevant pharmacy exclusively induces the prescriptions issued by the relevant medical institution.
 Article 24-2 (Entrustment of Duties of Registrating Drug Identification Mark)
(1) “A relevant specialized institution prescribed by Presidential Decree” in Article 38-2 (3) of the Act means a corporation designated and publicly notified by the Minister of Food and Drug Safety, among drug-related corporations established upon permission of the Minister of Food and Drug Safety, pursuant to Article 32 of the Civil Act.
(2) Where the Minister of Food and Drug Safety entrusts the duties pursuant to Article 38-2 (3) of the Act, he/she shall notify an entity entrusted and the details of duties entrusted.
[This Article Newly Inserted by Presidential Decree No. 26544, Sep. 22, 2015]
 Article 25 (Examination for Herb Druggists)
The examination for herb druggists provided for in Article 45 (3) of the Act shall be administered by the Mayor/Do Governor with regard to the knowledge necessary for the handling of herb drugs and their working-level functions.
 Article 26 (Qualification of Applicants)
A person who has at least five years career experience in handling of herb drugs at a herb doctor's clinic or a herb drugstore and who has graduated from a high school or higher educational institution or who is recognized by the Minister of Education, Science and Technology as one with an educational background at least equivalent to graduation from a high school shall be entitled to apply for the examination for herb druggists shall. <Amended by Presidential Decree No. 21084, Oct. 14, 2008>
 Article 27 (Subjects of Examination and Allotting Percentage, etc.)
The examination for herb druggists shall be classified into a written and practical examination, and the subjects of the examination and allocated examination percentage shall be as follows:
SectionSubjects Percentage
1. Written
examination
(a) Name, nature, use and storing methods of herb drugs which are listed in BON-CHO-KANG-MOK (a botanical list), BANG-YAK HAP-PYON (a comprehensive herb phara-copoeia) and YAK-SUNG-KA (a chant to the nature of a drug) and distinction of poisonous and powerful drugs;45%
(b) Prescription and mixing method listed in accepted herb drug books; 20%
(c) Acts and regulations on pharmaceutics and narcotics.15%
2. Practical
examination
Discrimination ability for 50 or more herbal drug materials and herbal drug chopping. 20%
 Article 28 (Announcement of Examination)
Where a Mayor/Do Governor conducts the examination for herb druggists, he/she publicly announce the date and time, place of the examination, subjects of the examination, deadline for submission of applications, an area where business licenses are expected to be granted, expected number of licensees and other necessary matters relating to the examination, 30 days prior to the examination date.
 Article 29 (Application Form)
(1) A person who intends to apply for the examination for herb druggists shall submit the following documents to the relevant Mayor/Do Governor, along with an application form: <Amended by Presidential Decree No. 21084, Oct. 14, 2008>
1. Resume;
2. Documents verifying educational background and career experience pursuant to Article 26;
3. A medical certificate issued by a doctor verifying that an applicant does not fall under the main sentence of subparagraph 1 of Article 5 of the Act or a medical certificate issued by a medical specialist verifying that an applicant does not fall under the proviso to subparagraph 1 of Article 5 of the Act;
4. A medical certificate issued by a doctor verifying that an applicant does not fall under subparagraph 3 of Article 5 of the Act;
5. Expected place of business and a rough map thereof.
(2) A person who submits an application form under paragraph (1), shall pay a fee, as prescribed by Ordinance of the Ministry of Health and Welfare. <Amended by Presidential Decree No. 20679, Feb. 29, 2008; Presidential Decree No. 22075, Mar. 15, 2010>
 Article 30 (Determination, etc. of Successful Applicants)
(1) After conducting the examination for herb druggists, a Mayor/Do Governor shall choose those applicants whose total score is 60% or more for all subjects, as successful applicants within the limit of expected numbers of licensees to be issued as per the allocated number of licensees for each area where business licenses are expected to be granted as publicly announced under Article 28: Provided, That where there are not less than two persons with a tie score, exceeding the allocated number of licensees for each area where business permission is expected to be granted, the person with a higher score on the written examination shall be chosen, and even where there is a tie score on the written examination, all the persons with a tie score shall be chosen.
(2) A Mayor/Do Governor shall notify the successful applicants under paragraph (1) of their passing of the examination.
 Article 31 (Examination Committee Members)
(1) A Mayor/Do Governor shall appoint examination committee members from among persons who have considerable knowledge and experience in herbal drugs and who have substantial knowledge of Acts and regulations on pharmaceutical affairs and narcotics.
(2) The examination committee under paragraph (1) shall have two to five persons per subject.
 Article 31-2 (Standards for Facilities of Herb Druggists, Drug Wholesalers, etc.)
(1) Detailed standards for a business office that a herb druggist is required to be equipped with under Article 45 (2) 1 of the Act shall be prescribed by Ordinance of the Ministry of Health and Welfare following consultation between the Minister of Health and Welfare and the Minister of Food and Drug Safety.
(2) In accordance with Article 45 (2) 2 of the Act, a drug wholesaler shall be equipped with a business office and a warehouse prescribed by Ordinance of the Ministry of Health and Welfare following consultation between the Minister of Health and Welfare and the Minister of Food and Drug Safety and own assets prescribed by Ordinance of the Ministry of Health and Welfare for the operation, etc. of the relevant facilities: Provided, That a medical high-pressure gas wholesaler shall comply with the standards for facilities for the sales of high-pressure gas under Article 4 (4) of the High-Pressure Gas Safety Control Act, and a radiopharmaceuticals wholesaler shall comply with the standards for facilities for radioisotope sales business under Article 55 (1) of the Nuclear Safety Act.
(3) Notwithstanding the main sentence of paragraph (2), a drug wholesaler may choose not to be equipped with a warehouse, if he/she entrusts the management of distribution, such as storage and delivery, of drugs to another drug wholesaler who meets the requirements prescribed by Ordinance of the Ministry of Health and Welfare.
(4) If a druggist or drug seller referred to in Article 5 of the Addenda to the wholly amended Pharmaceutical Affairs Act (Act No. 8365) intends to operate his/her business, he/she shall be equipped with a business office prescribed by Ordinance of the Ministry of Health and Welfare following consultation between the Minister of Health and Welfare and the Minister of Food and Drug Safety.
[This Article Newly Inserted by Presidential Decree No. 24479, Mar. 23, 2013]
 Article 32 (Grounds for Sale or Retail of Drugs by Persons, etc. who Obtained Marketing Approval)
“For public interests or for other purposes prescribed by Presidential Decree” in Article 47 (1) 2 of the Act means purposes falling under attached Table 1-2.
[This Article Wholly Amended by Presidential Decree No. 27048, Mar. 22, 2016]
 Article 32-2 (Designation of the Korea Pharmaceutical Information Service)
The Minister of Health and Welfare shall designate the Health Insurance Review and Assessment Service under Article 62 of the National Health Insurance Act as an agency managing the distribution information on drugs (hereinafter referred to as the "Korea Pharmaceutical Information Service") pursuant to Article 47-2 (1) of the Act. <Amended by Presidential Decree No. 22075, Mar. 15, 2010; Presidential Decree No. 24077, Aug. 31, 2012>
[This Article Newly Inserted by Presidential Decree No. 21084, Oct. 14, 2008]
 Article 32-3 (Operation of Korea Pharmaceutical Information Service)
(1) The Korea Pharmaceutical Information Service shall perform the following affairs: <Amended by Presidential Decree No. 22075, Mar. 15, 2010; Presidential Decree No. 27048, Mar. 22, 2016>
1. Collection, investigation, processing, utilization and provision of drug distribution information;
2. Formulation and implementation of a basic plan for informatization on distribution of drugs;
3. Construction and operation of database of the information on distribution of drugs;
4. Management of bar codes or RFID tags of drugs determined by the Minister of Health and Welfare, such as a public announcement of standard codes (referring to numbers in 13 figures, including country identification code; identification code of a person who has obtained marketing approval of drugs or of a person who has reported on importation business pursuant to the former part of Article 42 (1) of the Act (hereinafter referred to as “importer”); item code; and verification code as proper codes imposed on each drug for identification thereof) of drugs;
5. Research, education and public relations on standardization of the information on distribution of drugs;
6. Support of informatization on distribution of drugs, such as the development and dissemination of programs necessary for presentation of supply details, etc. of drugs under Article 47-2 (2) of the Act;
7. Other matters recognized necessary by the Minister of Health and Welfare in connection with the information on distribution of drugs.
(2) The president of the Korea Pharmaceutical Information Service shall report, to the Minister of Health and Welfare, a business program, business showings, budget and settlement of accounts of the relevant fiscal year on the affairs under paragraph (1) by the deadline classified as follows: <Amended by Presidential Decree No. 22075, Mar. 15, 2010>
1. A business program and budget of the relevant fiscal year: Not later than the commencement of the relevant fiscal year;
2. Business performance and settlement of accounts of the relevant fiscal year: Not later than the end of February of the following fiscal year.
(3) If necessary for the management of bar codes or RFID tags of drugs under paragraph (1) 4, the president of the Korea Pharmaceutical Information Service may request persons who have obtained marketing approval or importers to report the drug information which they intend to manufacture for sale or import as determined and announced by the Minister of Health and Welfare. <Amended by Presidential Decree No. 22075, Mar. 15, 2010>
[This Article Newly Inserted by Presidential Decree No. 21084, Oct. 14, 2008]
 Article 32-4 (Fees for Furnishing Information on Distribution of Drugs)
(1) Where the Korea Pharmaceutical Information Service furnishes the processed information on distribution of drugs at the request of persons who have obtained marketing approval, importers, drug wholesalers or such (excluding disclosure to the public under subparagraph 2 of Article 2 of the Official Information Disclosure Act), it may receive fees from the relevant requester: Provided, That in any of the following cases, fees may be reduced or exempted: <Amended by Presidential Decree No. 22075, Mar. 15, 2010>
1. Where a State agency or a local government requests to furnish the information on distribution of drugs in connection with its performance of affairs pursuant to Acts and subordinate statutes;
2. Where a non-profit corporation or a non-profit academic and public organization requests to furnish the information on distribution of drugs for the purpose of academic research or administrative surveillance;
3. Where a requester makes a request for furnishing the information on distribution of the same drugs as that processed according to the same standard in the same year;
4. Where the Minister of Health and Welfare recognizes reduction or exemption of fees necessary for public welfare.
(2) Fees referred to in paragraph (1) shall be determined within the extent of actual expenses in consideration of expenses incurred in processing and furnishing the information on distribution of drugs, expenses incurred in developing programs necessary for the management of the information on distribution of drugs or such.
(3) Fees referred to in paragraph (1) shall be paid in cash (including payment by methods of electronic currency and electronic settlement, etc. by making use of information and communication network) to financial institutions or communications agency designated by the president of the Korea Pharmaceutical Information Service.
(4) Matters necessary for a method of requesting the information on distribution of drugs, eligibility for reduction or exemption of fees and percentage of reduction or exemption under paragraph (1), and a specific method of calculating fees under paragraph (2) shall be determined and announced by the Minister of Health and Welfare. <Amended by Presidential Decree No. 22075, Mar. 15, 2010>
[This Article Newly Inserted by Presidential Decree No. 21084, Oct. 14, 2008]
 Article 32-5 (Grounds for Exceptions to Notification of Application for Marketing Approval, Etc.)
“Cases prescribed by Presidential Decree” in Article 50-4 (1) 4 of the Act (including cases to which relevant provisions apply mutatis mutandis under Article 42 (5) of the Act) means cases where the registered patent information regarding medical usage referred to in Article 50-2 (4) 1 (d) of the Act is not relevant to the efficacy nor effectiveness of the drug for which approval or revised approval for manufacturing or marketing or importation is applied pursuant to Article 31 (2), (3) or (9) or 42 (1) of the Act. <Amended by Presidential Decree No. 26544, Sep. 22, 2015>
[This Article Newly Inserted by Presidential Decree No. 26143, Mar. 13, 2015]
 Article 32-6 (Entrustment of Deliberation Affairs on Advertisements)
The Minister of Food and Drug Safety shall entrust an incorporated association designated and announced by him/her among incorporated associations established pursuant to Article 67 of the Act with deliberation on advertisements of medical and pharmaceutical products pursuant to Article 68-2 (2) of the Act. <Amended by Presidential Decree No. 24479, Mar. 23, 2013>
[This Article Newly Inserted by Presidential Decree No. 20767, Apr. 10, 2008]
 Article 32-7 (Organizational Structure and Operation of the Korea Institute of Drug Safety and Risk Management)
(1) Directors and auditors, including the president, shall be appointed as executive officers for the Korea Institute of Drug Safety and Risk Management established under Article 68-3 of the Act (hereinafter referred to as the "Institute of Drug Safety and Risk Management").
(2) The president of the Institute of Drug Safety and Risk Management shall be appointed by the Minister of Food and Drug Safety, as prescribed by the articles of association. <Amended by Presidential Decree No. 24479, Mar. 23, 2013>
(3) A board of directors shall be established within the Institute of Drug Safety and Risk Management in order to deliberate, and adopt a resolution, on important matters concerning business affairs of the Institute of Drug Safety and Risk Management.
(4) Matters necessary for organizing and operating the Institute of Drug Safety and Risk Management, except as provided for in paragraphs (1) through (3), shall be prescribed by the articles of association.
[This Article Newly Inserted by Presidential Decree No. 23459, Dec. 30, 2011]
 Article 32-8 (For-Profit Projects)
“For-profit projects prescribed by Presidential Decree" in Article 68-4 of the Act means any of the following projects: <Amended by Presidential Decree No. 24479, Mar. 23, 2013>
1. Education and training of a person in charge of business affairs concerning drug safety information;
2. Production and distribution of publications, etc. related to drug safety information;
3. Other projects approved by the Minister of Food and Drug Safety to attain the establishment purposes of the Institute of Drug Safety and Risk Management.
[This Article Newly Inserted by Presidential Decree No. 23459, Dec. 30, 2011]
 Article 32-9 (Approval for Business Plans and Budget Bills)
(1) Where the Institute of Drug Safety and Risk Management intends to obtain approval for its business plan and budget bill as prescribed in the former part of Article 68-6 (2) of the Act, it shall submit the budget bill accompanied by a business plan for the following year and the following documents to the Minister of Food and Drug Safety before each fiscal year begins after resolution by the board of directors: <Amended by Presidential Decree No. 24479, Mar. 23, 2013>
1. An estimated balance sheet;
2. An estimated profit and loss statement;
3. A plan for revenue and expenditure.
(2) Where the Institute of Drug Safety and Risk Management intends to obtain approval for its revised business plan and budget bill as prescribed in the latter part of Article 68-6 (2) of the Act, it shall submit a document stating the details and grounds of revisions to the Minister of Food and Drug Safety after resolution by the board of directors. <Amended by Presidential Decree No. 24479, Mar. 23, 2013>
[This Article Newly Inserted by Presidential Decree No. 23459, Dec. 30, 2011]
 Article 32-10 (Documents for Access or Inspection by Drug Epidemiological Investigators)
"Matters prescribed by Presidential Decree such as the period of inspection, scope of inspection, persons in charge of inspection and relevant statutes“ in the latter part of Article 68-12 (3) of the Act means the following matters:
1. Purpose, period, scope, and details of the inspection;
2. Names and positions of persons in charge of the inspection;
3. List of data that shall be submitted;
4. Basis statutes of the inspection;
5. Details and basis statutes of administrative dispositions or penal provisions against a refusal, interruption, evasion, etc. of the inspection;
6. Matters similar to subparagraphs 1 through 5, which are deemed necessary by the Minister of Food and Drug Safety for the relevant inspection.
[This Article Newly Inserted by Presidential Decree No. 27673, Dec. 13, 2016]
 Article 32-11 (Documents for Access or Inspection by Relevant Public Officials)
"Matters prescribed by Presidential Decree such as the period of inspection, scope of inspection, persons in charge of inspection and relevant statutes“ in Article 69 (2) of the Act means the following matters:
1. Matters under subparagraphs 1 through 5 of Article 32-10;
2. Matters corresponding to those falling under subparagraph 1, which are deemed necessary by the Minister of Health and Welfare or the Minister of Food and Drug Safety for the relevant inspection.
[This Article Newly Inserted by Presidential Decree No. 27673, Dec. 13, 2016]
 Article 32-12 (Notification to Relevant Agency)
“The head of the relevant central administrative agency prescribed by Presidential Decree” in Article 69-2 of the Act means any of the following persons:
1. The Minister of Health and Welfare;
2. The Chairperson of the Fair Trade Commission;
3. The Commissioner of the Korean Intellectual Property Office.
[This Article Newly Inserted by Presidential Decree No. 26143, Mar. 13, 2015]
 Article 33 (Guidelines for Calculation of Penalty Surcharges)
The amount of penalty surcharges under Article 81 (2) of the Act shall be calculated based on attached Table 2 according to the criteria of the disposition of business suspension classified as follows, taking into consideration categories, degree, etc. of offenses: <Amended by Presidential Decree No. 20679, Feb. 29, 2008; Presidential Decree No. 22075, Mar. 15, 2010; Presidential Decree No. 24479, Mar. 23, 2013>
1. In cases of imposition of a penalty surcharge on a manufacturer of drugs, etc., a person who has obtained marketing approval, or an importer: The criteria prescribed by Ordinance of the Prime Minister;
2. In cases of imposition of a penalty surcharge on a pharmacy founder or a drug distributor: The criteria prescribed by Ordinance of the Ministry of Health and Welfare.
 Article 34 (Procedures for Imposition of Penalty Surcharges and Collection thereof)
(1) If the Minister of Food and Drug Safety, a Mayor/Do Governor, or the head of a Si/Gun/Gu intends to impose any penalty surcharge under Article 81 of the Act, he/she shall provide a written payment notice, expressing the category of the offense and amount of the relevant penalty surcharge. <Amended by Presidential Decree No. 24479, Mar. 23, 2013>
(2) Procedures for collecting penalty surcharges shall be subject to the following classification: <Amended by Presidential Decree No. 24479, Mar. 23, 2013>
1. In cases of imposition of a penalty surcharge on a manufacturer of drugs, etc., a person who has obtained marketing approval, or an importer: The procedures for collection prescribed by Ordinance of the Prime Minister;
2. In cases of imposition of a penalty surcharge on a pharmacy founder or a drug distributor: The procedures for collection prescribed by Ordinance of the Ministry of Health and Welfare.
 Article 34-2 (Disposition to Defaulters of Penalty Surcharges)
(1) When a person liable to pay a penalty surcharge fails to pay it by the relevant payment deadline, the Minister of Food and Drug Safety, a Mayor/Do Governor, the head of a Si/Gun/Gu shall issue a reminder within 15 days after the deadline pursuant to the main sentence of Article 81 (4) of the Act expires. In such cases, a new deadline for payment shall be within 10 days from the date the reminder is issued. <Amended by Presidential Decree No. 24479, Mar. 23, 2013>
(2) If a defaulter fails to pay a penalty surcharge by the relevant payment deadline even after he/she receives a reminder issued pursuant to paragraph (1), a disposition for imposition of penalty surcharges shall be revoked and disposition of suspension of business shall be imposed on him/her: Provided, That where he/she falls under the proviso to Article 81 (4) of the Act, the penalty surcharge shall be collected in the same manner as national taxes in arrears or in accordance with the Act on the Collection, etc. of Local Non-Tax Revenue. <Amended by Presidential Decree No. 25605, Sep. 11, 2014>
(3) Where a disposition to suspend business after revoking the disposition of imposition of a penalty surcharge is intended pursuant to the main sentence of paragraph (2), a person subject to the disposition shall be given written notice specifying matters necessary for the disposition of business suspension, including grounds for altering the disposition, a period for disposition for suspension of business, etc. <Amended by Presidential Decree No. 25605, Sep. 11, 2014>
[This Article Newly Inserted by Presidential Decree No. 20156, Jul. 3, 2007]
 Article 34-3 (Designation, etc. of Professional Training Institution)
(1) The Minister of Health and Welfare and the Minister of Food and Drug Safety may designate any of the following institutions or organizations as a professional training institution pursuant to Article 83-2 (2) of the Act (hereinafter referred to as “professional training institution”):
1. Institute of Drug Safety and Risk Management;
2. Corporations established pursuant to Article 67 of the Act;
3. Universities and colleges where drug-related departments or majors are established, among universities and colleges defined in subparagraph 1 of Article 2 of the Higher Education Act;
4. Other institutions or organizations established to perform duties relevant to drugs or health.
(2) Each person, who intends to be designated as a professional training institution pursuant to paragraph (1), shall submit, to the Minister of Health and Welfare or the Minister of Food and Drug Safety, a designation application prescribed by Ordinance of the Ministry of Health and Welfare or by Ordinance of the Prime Minister, by attaching the documents prescribed by Ordinance of the Ministry of Health and Welfare or by Ordinance of the Prime Minister.
(3) The standard of designating a professional training institution shall be as follows:
1. The procedure and curricula of education and training shall be appropriate;
2. Appropriate personnel and facilities and equipment for conducting education and training shall be arranged;
3. The plan for raising operational funds shall be reasonable.
(4) Where the Minister of Health and Welfare or the Minister of Food and Drug Safety designates a professional training institution, he/she shall issue a designation certificate prescribed by Ordinance of the Ministry of Health and Welfare or Ordinance of the Prime Minister, and post it on the website of the Ministry of Health and Welfare or the Ministry of Food and Drug Safety for the public.
(5) Expenses to be subsidized to a professional training institution pursuant to Article 83-2 (3) of the Act shall be as follows:
1. Lecture fees and allowances;
2. Expenses for producing teaching materials and expenses for purchasing tools for practicing;
3. Expenses for field practice;
4. Other expenses deemed necessary for professional training.
[This Article Newly Inserted by Presidential Decree No. 26544, Sep. 22, 2015]
 Article 35 (Delegation and Entrustment of Affairs)
(1) Pursuant to Article 84 (2) of the Act, the Minister of Food and Drug Safety shall delegate the following authority to the head of each regional food and drug administration: <Amended by Presidential Decree No. 24479, Mar. 23, 2013; Presidential Decree No. 26544, Sep. 22, 2015>
1. Approval or revised approval for manufacturing and marketing drugs, approval or revised approval for importing drugs by product, and acceptance of a report or revised report on importation business under Article 31 (2), (9) or 42 (1) of the Act (limited to the items that need verification of equivalence of drugs);
2. Acceptance of a report on an import manager or report on the closure of business, etc. by an importer under Article 36 (3) and 40 of the Act, to which Article 42 (5) of the Act applies mutatis mutandis;
3. Imposition or collection of administrative fines under Article 98 (1) 4-3 of the Act.
(2) Deleted. <by Presidential Decree No. 24479, Mar. 23, 2013>
(3) The Minister of Health and Welfare shall entrust the following affairs to the Pharmaceutical Association or the Oriental Pharmacy Association pursuant to Article 16 (2) of the Act: <Amended by Presidential Decree No. 20679, Feb. 29, 2008; Presidential Decree No. 22075, Mar. 15, 2010; Presidential Decree No. 23459, Dec. 30, 2011>
1. Receiving reports on pharmacists or herb pharmacists under Article 7 of the Act;
2. Training and education of pharmacists or herb pharmacists under Article 15 of the Act;
3. Reviewing pharmacists' or herb pharmacists' ethics under Article 16 (2) of the Act;
4. Inspecting and verifying a sale price indication at drug stores under subparagraph 10 of Article 56 of the Act.
 Article 36 (Special Cases concerning Animal Drugs, etc.)
In applying Articles 33, 34 and 39 to animal drugs, etc. referred to in Article 85 of the Act, the "Minister of Health and Welfare" or "Minister of Food and Drug Safety" in the same Articles shall be construed as "the Minister of Agriculture, Food and Rural Affairs or the Minister of Oceans and Fisheries", and "Ordinance of the Prime Minister" or "Ordinance of the Ministry of Health and Welfare" as "Ordinance of the Ministry of Agriculture, Food and Rural Affairs or Ordinance of the Ministry of Oceans and Fisheries". <Amended by Presidential Decree No. 20679, Feb. 29, 2008; Presidential Decree No. 22075, Mar. 15, 2010; Presidential Decree No. 24479, Mar. 23, 2013>
 Article 36-2 (Field Survey Documents for Inspection and Evaluation of Damage from Side Effects of Drugs)
“Matters prescribed by Presidential Decree such as the period of inspection, scope of inspection, persons in charge of inspection and relevant statutes” in the latter part of Article 86-6 (3) of the Act means matters under each subparagraph of Article 32-10.
[This Article Newly Inserted by Presidential Decree No. 27673, Dec. 13, 2016]
 Article 37 (Procedures for Paying Bounty)
(1) Any supervisory agency or investigative agency which has received a report or information of the violation of related Acts and subordinate statutes under Article 90 of the Act, shall notify the head of the competent Si/Gun/Gu of the outline of such violation.
(2) The head of a Si/Gun/Gu in receipt of a notification under paragraph (1) may pay the bounty within budgetary limits in cases where an adjudication of the court concerning the relevant case is final and conclusive.
(3) The bounty under paragraph (2) shall not exceed 10/100 of the amount of a fine sentenced for the said case (where sentenced to imprisonment, the maximum amount of fines under the relevant applied penal provisions).
 Article 38 (Operation. etc. of the Korea Orphan Drug Center)
(1) The Chairperson of the Korea Orphan Drug Center under Article 91 of the Act (hereinafter referred to as the "Center") shall submit the project plans and the budget of revenues and expenses for the following year to the Minister of Food and Drug Safety by not later than April 30 of each business year. <Amended by Presidential Decree No. 24479, Mar. 23, 2013>
(2) Where it is intended to change the important details of the business plans and the budget of revenues and expenses under paragraph (1), the documents clarifying the details of and reasons for relevant changes shall be submitted to the Minister of Food and Drug Safety. <Amended by Presidential Decree No. 24479, Mar. 23, 2013>
(3) The Minister of Food and Drug Safety may, if deemed necessary, request the Chairperson of the Center to submit data concerning the following matters where he/she has received the project plans and the budget of revenues and expenses for the following year under paragraph (1): <Amended by Presidential Decree No. 24479, Mar. 23, 2013>
1. Matters concerning the projects under the subparagraphs of Article 92 (1) of the Act;
2. Matters concerning the details of financial assistance under Article 92 (2) of the Act.
 Article 38-2 (Handling of Sensitive Information and Personally Identifiable Information)
The Minister of Health and Welfare (including a person to whom the Minister of Health and Welfare has delegated his/her business affairs pursuant to Article 35), the Minister of Food and Drug Safety, a Mayor/Do Governor or the head of a Si/Gun/Gu (where the relevant authority has been delegated or entrusted, including a person to whom such authority has been delegated or entrusted), or the national examination administrative agency may handle the information on health under Article 23 of the Personal Information Protection Act, the information corresponding to the criminal history record under subparagraph 2 of Article 18 of the Presidential Decree of the said Act, and data containing resident registration numbers and foreigner registration numbers prescribed in subparagraph 1 or 4 of Article 19 of the said Decree, if such handling is inevitable to perform any of the following affairs: <Amended by Presidential Decree No. 24144, Oct. 22, 2012; Presidential Decree No. 24479, Mar. 23, 2013; Presidential Decree No. 26544, Sep. 22, 2015>
1. Affairs concerning registration of a pharmacist's or herb pharmacist's license, and issuance and re-issuance of a certificate of such licence under Article 6 of the Act;
2. Affairs concerning reports by pharmacists or herb pharmacists under Article 7 of the Act;
3. Affairs concerning national examinations for pharmacists or herb pharmacists under Article 8 of the Act;
4. Affairs concerning verification of the qualifications for applying for national examinations for pharmacists or herb pharmacists under Article 9 of the Act;
5. Affairs concerning registration for the establishment or alteration of pharmacies under Article 20 of the Act;
6. Affairs concerning filing reports on the discontinuation, suspension, or resumption of business under Article 22 of the Act;
7. Affairs concerning permission for the business of manufacturing drugs, reports on the business of contract manufacturing of drugs, reports on the business of manufacturing quasi-drugs, and permission for and reports on changes thereto under Article 31 of the Act;
8. Affairs concerning conditional permission for the business of manufacturing drugs under Article 35 of the Act;
9. Affairs concerning recall of drugs, etc. under Article 39 of the Act;
10. Affairs concerning filing reports on discontinuance, suspension and resumption of business under Article 40 of the Act;
11. Affairs concerning filing reports on manufacturing pharmacy medication and dispensary medication under Article 41 of the Act;
11-2. Affairs concerning filing reports on importation business of drugs, etc. or revised reports thereof under Article 42 (1) of the Act;
11-3. Affairs concerning registration of sellers of safe and readily available drugs and alteration registration under Article 44-2 of the Act;
12. Affairs concerning licenses, etc. of herb druggists or drug wholesalers under Article 45 of the Act;
13. Affairs concerning orders issued under Article 69 of the Act;
14. Affairs concerning administrative dispositions under Articles 70 through 76 and 76-3 of the Act;
15. Affairs concerning hearings under Article 77 of the Act;
16. Affairs concerning appointment of pharmaceutical inspectors under Article 78 of the Act;
17. Affairs concerning revocation of a pharmacist's or a herb pharmacist's license and suspension of qualification as a pharmacist or herb pharmacist under Article 79 of the Act;
18. Affairs concerning renewal of a certificate of license, permit, registration, etc. under Article 80 of the Act;
19. Affairs concerning imposition and collection of penalty surcharges under Article 81 of the Act;
20. Affairs concerning succession to the status of a manufacturer, etc. under Article 89 of the Act;
21. Affairs concerning payment of a bounty under Article 90 of the Act;
22. Affairs concerning issuance of a druggist's license under Article 5 of the Addenda of the wholly amended Pharmaceutical Affairs Act (Act No. 8365).
[This Article Newly Inserted by Presidential Decree No. 23488, Jan. 6, 2012]
 Article 38-3 (Review of Regulations)
The Minister of Health and Welfare shall review the appropriateness of the following matters every three years (referring to a period by every third anniversary from the base date) on the basis of following base date and take improvement measures, etc.:
1. Standards for facilities of pharmacies prescribed in Article 22-2: January 1, 2014;
2. Standards for facilities of herb druggists, drug wholesalers, etc., prescribed in Article 31-2: January 1, 2014;
3. Standards for imposition of administrative fines prescribed in Article 39 (1) and attached Table 3: January 1, 2014.
[This Article Newly Inserted by Presidential Decree No. 25050, Dec. 30, 2013]
 Article 39 (Imposition and Collection of Administrative Fines)
(1) The guidelines for imposing administrative fines referred to in Article 97-2 (1) of the Act shall be as listed in attached Table 2-2. <Newly Inserted by Presidential Decree No. 26143, Mar. 13, 2015>
(2) The guidelines for imposing administrative fines referred to in Article 98 (1) of the Act shall be as listed in attached Table 3. <Amended by Presidential Decree No. 26143, Mar. 13, 2015>
(3) Deleted. <by Presidential Decree No. 27673, Dec. 13, 2016>
[This Article Wholly Amended by Presidential Decree No. 21084, Oct. 14, 2008]
ADDENDA
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation.
Article 2 (Herb Preparation Examination)
(1) The Minister of Health and Welfare shall hold a herb preparation examination as referred to in the subparagraphs of Article 9 (1) of the Addenda of the Act, and put the management of the examination under the charge of the national examination administrative agency pursuant to Article 2. In such cases, the national examination administrative agency shall formulate a basic plan concerning the designation of the examination committee members and making questions for the examination, etc. and shall carry out the plan.
(2) The Minister of Health and Welfare shall hold a herb preparation examination not less than once a year.
(3) The herb preparation examination shall be divided into a written examination and a practical examination, and the examination subjects shall be as follows:
SectionSubject
1.Written examination Herbal drugs;
Prescriptions;
Guide book for the preparation of herbal drugs.
2.Practical examination Ability to distinguish 50 or more herbal drug materials.
(4) When the head of the national examination administrative agency intends to hold a herb preparation examination, he/she shall, with prior approval of the Minister of Health and Welfare, announce the date and time, place and examination subjects, deadline for the submission of application for examination, and other matters necessary for the examination by not later than thirty days before the examination. <Amended by Act No. 23759, May 1, 2012>
(5) The head of the national examination administrative agency may, when deemed necessary for the smooth performance of the management of the duties of herb preparation examination, request the Mayor/Do Governor for cooperation, such as assistance in examination rooms, deliver of applications, proctors of examination, etc.
(6) A person who wishes to apply for the herb preparation examination shall submit the following documents along with an application form:
1. A person who falls under Article 9 (1) 1 of the Addenda of the Act shall submit a copy of a pharmacist license;
2. A person who falls under Article 9 (1) 2 of the Addenda of the Act shall submit documents to certify that he/she has completed the courses relating to herbal drugs and a copy of pharmacist license.
(7) Successful applicants shall be those who have made a 40% or more score in each individual subject and 60% or more of total score on all subjects in the examination.
(8) The Minister of Health and Welfare shall deliver a herb preparation license, as stipulated by the Ordinance of the Ministry of Health and Welfare, to the successful applicants of the herb preparation examination.
(9) A person who submits an application pursuant to paragraph (6) shall pay in cash a fee as the head of the national examination administrative agency has determined with the approval of the Minister of Health and Welfare. In such cases, the amount and payment method of the fee and other necessary matters shall be announced by the head of the national examination administrative agency.
ADDENDUM <Presidential Decree No. 20156, Jul. 3, 2007>
This Decree shall enter into force on July 4, 2007.
ADDENDA <Presidential Decree No. 20679, Feb. 29, 2008>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation.
Articles 2 through 9 Omitted.
ADDENDUM <Presidential Decree No. 20767, Apr. 10, 2008>
This Decree shall enter into force on April 18, 2008.
ADDENDA <Presidential Decree No. 20875, Jun. 25, 2008>
Article 1 (Enforcement Date)
This Decree shall enter into force on July 1, 2008.
Articles 2 through 15 Omitted.
ADDENDUM <Presidential Decree No. 21084, Oct. 14, 2008>
This Decree shall enter into force on October 18, 2008.
ADDENDA <Presidential Decree No. 22075, Mar. 15, 2010>
Article 1 (Enforcement Date)
This Decree shall enter into force on March 19, 2010. (Proviso Omitted.)
Article 2 Omitted.
ADDENDUM <Presidential Decree No. 23459, Dec. 30, 2011>
This Decree shall enter into force on the date of its promulgation.
ADDENDA <Presidential Decree No. 23488, Jan. 6, 2012>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation. (Proviso Omitted.)
Article 2 Omitted.
ADDENDA <Presidential Decree No. 23734, Apr. 17, 2012>
Article 1 (Enforcement Date)
This Decree shall enter into force on April 18, 2012. (Proviso Omitted.)
Articles 2 and 3 Omitted.
ADDENDA <Presidential Decree No. 23759, May 1, 2012>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation. (Proviso Omitted.)
Article 2 (Application Examples concerning Notification of Examinations)
Matters on amending the deadline of a public announcement on examinations, etc. under this Decree shall apply, starting with an examination held after January 1, 2013.
ADDENDUM <Presidential Decree No. 23843, Jun. 7, 2012>
This Decree shall enter into force on June 8, 2012: Provided, That the amended provisions of subparagraph 6 of attached Table 3 shall enter into force on August 2, 2012.
ADDENDA <Presidential Decree No. 23886, Jun. 27, 2012>
Article 1 (Enforcement Date)
This Decree shall enter into force on July 1, 2012.
Article 2 Omitted.
ADDENDA <Presidential Decree No. 24077, Aug. 31, 2012>
Article 1 (Enforcement Date)
This Decree shall enter into force on September 1, 2012. (Proviso Omitted.)
Articles 2 through 9 Omitted.
ADDENDUM <Presidential Decree No. 24144, Oct. 22, 2012>
This Decree shall enter into force on November 15, 2012.
ADDENDA <Presidential Decree No. 24247, Dec. 21, 2012>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation.
Articles 2 and 3 Omitted.
ADDENDA <Presidential Decree No. 24479, Mar. 23, 2013>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation.
Article 2 (Enforcement Date of Partially Amended Pharmaceutical Affairs Act)
"Date prescribed by the Presidential Decree" in Article 1 (2) of the Addenda to the wholly amended Government Organization Act (Act No. 11690) means the date of promulgation of this Decree.
Article 3 (Transitional Measures concerning Members, etc. of the Central Pharmaceutical Affairs Council)
(1) Members of the Central Pharmaceutical Affairs Council appointed or commissioned by the Minister of Health and Welfare under the previous provisions as at the time this Decree enters into force shall be deemed to have been appointed or commissioned by the Minister of Food and Drug Safety in accordance with the amended provisions of Article 14 (3).
(2) Research committee members and researchers appointed by the Minister of Health and Welfare under the previous provisions as at the time this Decree enters into force shall be deemed to have been appointed by the Minister of Food and Drug Safety in accordance with the amended provisions of Article 20 (5).
Article 4 (Transitional Measures concerning Standards for Facilities of Pharmacies, etc.)
A person who is equipped with facilities for a pharmacy or distribution business, etc. under the previous Decree on Facility Standards for Pharmacies, Manufacturing Business, Importers and Distribution Business of Drugs, etc. as at the time this Decree enters into force shall be deemed to have satisfied the standards under the amended provisions of Article 22-2 or 31-2.
Article 5 (Transitional Measures concerning Inspection on Similar Collusive Acts)
Any similar collusive act that is under the inspection by the Commissioner of the Korea Food and Drug Administration under the previous provisions as at the time this Decree enters into force may be continuously inspected by the Minister of Food and Drug Safety notwithstanding the amended provisions of Article 24 (2), and upon completing the relevant inspection, the Minister of Food and Drug Safety shall report the results thereof to the Minister of Health and Welfare without delay.
Article 6 (Transitional Measures concerning Licenses or Revised Licenses of Manufacturing and Selling Drugs or Permission and Revised Permission for Importing Drugs)
Written applications for licenses or revised licenses of manufacturing or selling drugs by product or permission or revised permission for importing drugs by product submitted to the Korea Food and Drug Administration under the previous provisions as at the time this Decree enters into force shall be deemed to have been submitted to the regional food and drug administration having jurisdiction over each applicant's domicile.
Article 7 Omitted.
ADDENDA <Presidential Decree No. 24775, Sep. 26, 2013>
Article 1 (Enforcement Date)
This Decree shall enter into force on January 1, 2015.
Article 2 (Applicability concerning Change of Subjects of National Examinations)
The amended provisions of Article 4 shall begin to apply to any examination administered after this Decree enters into force.
Article 3 (Transitional Measures concerning Change of Subjects of National Pharmacist Examinations)
Until February 29, 2016, the national pharmacist examination may be administered, pursuant to previous Article 4 (1), to persons who entered a Korean university to major in pharmaceutics before January 1, 2009, notwithstanding the amended provisions of Article 4 (1).
ADDENDUM <Presidential Decree No. 25050, Dec. 30, 2013>
This Decree shall enter into force on January 1, 2014. (Proviso Omitted.)
ADDENDA <Presidential Decree No. 25357, May 21, 2014>
Article 1 (Enforcement Date)
This Decree shall enter into force on August 7, 2014.
Article 2 Omitted.
ADDENDUM <Presidential Decree No. 25447, Jul. 7, 2014>
This Decree shall enter into force on the date of its promulgation.
ADDENDA <Presidential Decree No. 25529, Jul. 28, 2014>
Article 1 (Enforcement Date)
This Decree shall enter into force on July 31, 2014.
Articles 2 and 3 Omitted.
ADDENDA <Presidential Decree No. 25605, Sep. 11, 2014>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation: Provided, That the amended provisons of attached Table 3 shall enter into force on September 19, 2014.
Article 2 (Applicability concerning Disposition to Defaulters of Penalty Surcharges)
The amended provisions of Article 34-2 (2) shall apply even to a person who fails to pay a penalty surcharge within a deadline for payment even after receiving a reminder before this Decree enters into force.
Article 3 (Transitional Measures concerning Standards for Calculation of Penalty Surcharges)
Notwithstanding the amended provisions of attached Table 2, previous provisions shall apply to the imposition of a penalty surcharge on a violation committed before this Decree enters into force.
ADDENDA <Presidential Decree No. 25862, Dec. 16, 2014>
Article 1 (Enforcement Date)
This Decree shall enter into force on December 19, 2014.
Articles 2 through 4 Omitted.
ADDENDUM <Presidential Decree No. 26143, Mar. 13, 2015>
This Decree shall enter into force on March 15, 2015.
ADDENDUM <Presidential Decree No. 26544, Sep. 22, 2015>
This Decree shall enter into force on September 29, 2015.
ADDENDA <Presidential Decree No. 26742, Dec. 22, 2015>
Article 1 (Enforcement Date)
This Decree shall enter into force on December 23, 2015.
Article 2 Omitted.
ADDENDUM <Presidential Decree No. 26844, Dec. 31, 2015>
This Decree shall enter into force on the date of its promulgation.
ADDENDUM <Presidential Decree No. 27048, Mar. 22, 2016>
This Decree shall enter into force on March 30, 2016.
ADDENDA <Presidential Decree No. 27673, Dec. 13, 2016>
Article 1 (Enforcement Date)
This Decree shall enter into force on December 30, 2016.
Article 2 (Transitional Measures concerning Criteria for Imposition of Administrative Fines)
No disposition of imposing administrative fines against violation before this Decree enters into force shall be included in the calculation of the number of violation under the amended provision of the attached Table 3.