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
Presidential Decree No. 28081, May 29, 2017
Presidential Decree No. 28211, Jul. 26, 2017
Presidential Decree No. 28456, Nov. 28, 2017
Presidential Decree No. 28820, Apr. 24, 2018
Presidential Decree No. 29811, jun. 4, 2019
Presidential Decree No. 29950, Jul. 2, 2019
Presidential Decree No. 29983, Jul. 16, 2019
Presidential Decree No. 30170, Oct. 29, 2019
Presidential Decree No. 30256, Dec. 24, 2019
Presidential Decree No. 30372, Jan. 29, 2020
Presidential Decree No. 30509, Mar. 3, 2020
Presidential Decree No. 30510, Mar. 3, 2020
Presidential Decree No. 30545, Mar. 24, 2020
Presidential Decree No. 31047, Sep. 22, 2020
Presidential Decree No. 31380, Jan. 5, 2021
Presidential Decree No. 31614, Apr. 6, 2021
Presidential Decree No. 31603, Apr. 6, 2021
Presidential Decree No. 32088, Oct. 19, 2021
Presidential Decree No. 33052, Dec. 9, 2022
Presidential Decree No. 33112, Dec. 20, 2022
Presidential Decree No. 33321, Mar. 7, 2023
Presidential Decree No. 33382, Apr. 11, 2023
Presidential Decree No. 33818, Oct. 17, 2023
Presidential Decree No. 34225, Feb. 13, 2024
The purpose of this Decree is to prescribe the matters mandated by the Pharmaceutical Affairs Act and matters necessary for the enforcement thereof.
| Article 1-2 (Events on PharmDay) |
| (2) | When the State and local governments hold commemorative events for the PharmDay under Article 2-2 (2) of the Act, they may select a person or an organization as a meritorious person for the PharmDay, who has rendered distinguished service for the safety of drugs and the development of the pharmaceutical industry, etc. and grant an award thereto. |
[This Article Newly Inserted on Oct. 19, 2021]
| Article 2 (Implementation of National Examination for Pharmacist License and Oriental Medicine Pharmacist License and Preliminary Examination for Pharmacist License) |
| (1) | Pursuant to Article 8 (2) of the Act, the Minister of Health and Welfare shall entrust the administration of national examinations for a pharmacist license and an oriental medicine pharmacist license and preliminary examinations for a pharmacist license (hereinafter referred to as "national examinations, etc.") 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 on Dec. 22, 2015; Jan. 29, 2020; Oct. 19, 2021> |
| (2) | Where the head of the national examination, etc. administrative agency intends to hold a national examination, he or 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 due date for the 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 or 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 on Feb. 29, 2008; Mar. 15, 2010; May 1, 2012; Jan. 29, 2020> |
[Title Amended on Jan 29, 2020]
| Article 3 (Application for National Examination) |
| (1) | A person who intends to take the national examination, etc. shall submit the application form determined by the head of the national examination, etc. administrative agency to the head of the national examination, etc. administrative agency. <Amended on Jan. 29, 2020> |
| (2) | Deleted. <Jan. 29, 2020> |
| (3) | Any person who submits a written application provided 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 on Feb. 29, 2008; Mar. 15, 2010; Dec. 30, 2011; Jan. 29, 2020> |
| (4) | The head of the national examination, etc. 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 on Dec. 30, 2011; Jan. 29, 2020> |
[Title Amended on Jan 29, 2020]
| Article 4 (Examination Subjects) |
| (1) | A national examination for a pharmacist license 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; |
| 3. | Clinical pharmacy and pharmacy practice; |
| 4. | Regulations concerning health and pharmacy. |
| (2) | A national examination for an oriental medicine pharmacist license 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 pharmacy. |
| (3) | Preliminary examination for pharmacists shall be conducted as a written examination for each of the following subjects, and details for each subject shall be prescribed by Ordinance of the Ministry of Health and Welfare: <Newly Inserted on Jan. 29, 2020> |
[This Article Wholly Amended on Sep. 26, 2013]
| Article 5 (Determination of Passing the Exam) |
| (1) | Those who have passed the national examination for a pharmacist license and an oriental medicine pharmacist license shall be those who have scored at least 40 percent of the total score in each subject and at least 60 percent of the total score in all subjects. |
| (2) | Those who have passed the preliminary examination for pharmacists shall be those who have scored at least 60 percent of the full marks in the basic pharmacy course meet the requirements for Korean subjects prescribed by Ordinance of the Ministry of Health and Welfare. |
| (3) | Those who have passed the preliminary examination for a pharmacist license shall be exempted from preliminary examinations for pharmacists for the next national examination for a pharmacist license. |
[This Article Wholly Amended on Jan. 29, 2020]
| Article 6 (Announcement of Successful Candidates) |
Where the head of the national examination, etc. administrative agency decides on the successful candidates of the national examination held under Articles 2 and 5, he or she shall announce the list of the successful candidates, without delay. <Amended on Jan. 29, 2020>
In order to give questions for the national examination, etc. and mark papers thereof, the head of a national examination management agency shall designate persons of profound learning and experience in pharmacology or related statutes or regulations as examiners. <Amended on Jan. 29, 2020>
| Article 8 (Request for Cooperation to Relevant Agencies) |
The head of the national examination management agency may request the State and local governments, or relevant agencies or organizations for the cooperation in examination places, examination proctors, etc., if necessary for the smooth administration of national examinations. <Amended on Jan. 29, 2020>
| Article 8-2 (Composition of Ethics Committee) |
| (1) | The 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 in this Article through Article 8-4, referred to as "each Association") 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 of experience as a pharmacist or five years of experience as an oriental medicine pharmacist; |
| 2. | A person who is not a pharmacist or oriental medicine pharmacist but has much 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 on Jun. 7, 2012]
| Article 8-3 (Operation of Each Ethics Committee) |
| (1) | Each Ethics Committee shall deliberate and resolve on the following matters: <Amended on Apr. 24, 2018> |
| 1. | Matters concerning the request for disposition of license revocation or qualification suspension under the subparagraphs of Article 79-2 (1) 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 ethics of members, which are prescribed by the articles of incorporation of each Association. |
| (2) | A meeting of 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 items of the meeting no later than seven days before the opening of the meeting: Provided, That where an urgent meeting is required or where any unavoidable reason exists, the chairperson may notify such matters by the day before the meeting. |
| (4) | At least 2/3 of the members of the Ethics Committee shall constitute a quorum, and any decision thereof 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 separately prescribed by the articles of association of each Association. |
| (5) | Where the chairperson of the Ethics Committee intends to deliberate and decide on the matters referred to in paragraph (1) 1 or 2, he or she shall give a party to the relevant agenda item an opportunity to state his or her opinion orally or in writing (including electronic documents). |
| (6) | Except as provided in paragraphs (1) through (5), matters necessary for the operation of each Ethics Committee shall be prescribed by the articles of association of each Association. |
[This Article Newly Inserted on Jun. 7, 2012]
| Article 8-4 (Exclusion of Members of Ethics Committee) |
| (1) | A member of the Ethic Committee who falls under any of the following subparagraphs shall be disqualified from deliberations and decisions of the relevant Ethics Committee: |
| 1. | Where he or she becomes a party to the agenda item to be deliberated and decided by the Ethics Committee (hereafter in this Article, referred to as "relevant agenda item"); |
| 2. | Where the member is or was a relative of a party to the relevant agenda item; |
| 3. | Where he or she engages in or has engaged in an institution to which a party to the relevant agenda item belongs in the recent three years. |
| (2) | If there exists any ground for disqualification referred to in paragraph (1) or the circumstances indicate that it would be impracticable to expect fair deliberations and decisions by the Ethics Committee, a party to the relevant agenda item may file a written request for a challenge to the relevant member with the Ethics Committee by stating the reasons therefor. |
| (3) | Upon receipt of the request for the challenge under paragraph (2), the Ethics Committee shall determine whether or not to accept the challenge with the attendance of a majority of all the incumbent members and the concurring vote of a majority of those present. In such cases, the member against whom the request for challenge is filed shall not participate in such decision. |
| (4) | If any member of the Ethics Committee falls under any ground referred to in paragraph (1) or (2), he or she may voluntarily refrain from deliberations and decisions. |
[This Article Newly Inserted on Jun. 7, 2012]
| Article 9 (Authorization for Establishment of Pharmaceutical Association and Oriental Pharmacy Association) |
If the Pharmaceutical Association or the 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 on Feb. 29, 2008; Mar. 15, 2010; Jun. 7, 2012> | 1. | The articles of association; |
| 2. | The detailed statement of assets; |
| 3. | A business plan and a budget of revenues and expenditures; |
| 4. | A resolution of establishment; |
| 5. | Documents regarding the election process for establishment representatives; |
| 6. | A letter of acceptance of appointment and a 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 on Jun. 7, 2012>
| 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 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 the Oriental Pharmacy Association intends 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 Advisory Committee) |
The Central Pharmaceutical Affairs Advisory Committee (hereafter in Articles 14-2, 14-3, 15 through 20, 20-2, 21 and 22, referred to as the "Advisory Committee") under Article 18 (1) of the Act shall deliberate on the following matters: <Amended on Feb. 29, 2008; Mar. 15, 2010; Dec. 30, 2011; Mar. 23, 2013; Sep. 11, 2014; Jun. 4, 2019; Jul. 16, 2019> | 1. | Matters concerning the enactment and amendment of the Korean Pharmacopoeia prescribed in Article 51 of the Act; |
| 2. | Matters concerning the standards 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 brought to deliberation by the Minister of Health and Welfare or the Minister of Food and Drug Safety. |
| Article 14 Deleted. <Jun. 4, 2019> |
| Article 14-2 (Dismissal of Members of the Advisory Committee) |
Where a member of the Advisory Committee commissioned pursuant to Article 18 (4) of the Act falls under any of the following subparagraphs, the Minister of Food and Drug Safety may dismiss the member: <Amended on May 29, 2017; Jun. 4, 2019> | 1. | Where the member is unable to perform the duties due to mental or physical disability; |
| 2. | Where the member commits a misdeed in connection with his or her duties; |
| 3. | Where the member is deemed unsuitable as a member due to neglect of duties, injury to dignity, or other causes; |
| 4. | Where the member admits that it is impracticable to voluntarily perform the duties; |
| 5. | Where the member fails to refrain from himself or herself, though he or she falls under any of the subparagraphs of Article 14-3 (1). |
[This Article Newly Inserted on Dec. 31, 2015]
| Article 14-3 (Exclusion of, Challenge to, and Recusal of, Advisory Committee Member) |
| (1) | Any of the following members of the Advisory Committee shall be excluded from deliberation and decision-making by the Advisory Committee: <Amended on Mar. 3, 2020; Oct. 19, 2021> |
| 1. | Where the member or his or her spouse or a person who used to be a spouse is a party to the relevant agenda (including its executives or employees if the party is a corporation, organization, etc.; hereafter in this subparagraph and subparagraph 2 the same shall apply) or a party to the agenda and a joint right holder or in the case of co-obligation; |
| 2. | Where the member is or was a relative of a party to the relevant agenda item; |
| 3. | Where the member has offered any testimony, statement, advice, research, services, or appraisal for the relevant agenda item; |
| 4. | Where the member or the corporation to which the member belongs is or was an agent of a party to the relevant agenda item; |
| 5. | Where a member has served as an executive or employee within the last three years in a corporation or organization that is a party to the relevant agenda; |
| 6. | In other cases where the chairperson of the Advisory Committee (hereinafter referred to as the "chairperson") deems that there is a serious cause that will impede a fair deliberation and resolution by the Advisory Committee, such as where the committee member has a direct interest in the relevant agenda. |
| (2) | If the circumstances indicate that it would be impracticable to expect fair deliberations and decisions of a member, a party may file a request for a challenge to the member with the Advisory Committee by explaining the relevant fact in writing. |
| (3) | Upon receipt of a request for challenge under paragraph (2), the Advisory Committee shall determine whether or not to accept the request by decision. In such cases, the member against whom the request for challenge is filed shall not participate in the decision. |
| (4) | If a member falls under any of the grounds prescribed in the subparagraphs of paragraph (1) or finds himself or herself to be in the circumstances under which it would be impracticable to expect fair deliberations and decisions, he or she shall voluntarily refrain from deliberations and decisions on the relevant agenda item. |
[This Article Newly Inserted on May 29, 2017]
| Article 15 (Duties of Chairpersons) |
| (1) | The chairpersons shall jointly represent the Advisory Committee, and exercise overall control over its affairs. <Amended on Oct. 19, 2021> |
| (2) | The vice chairpersons shall assist the chairpersons, and if the chairpersons are unable to perform the duties due to unavoidable reasons, the vice chairperson designated in advance by the Advisory Committee shall act on behalf of the chairpersons. <Amended on Oct. 19, 2021> |
| Article 16 (Convocation of Meetings) |
| (1) | The chairpersons shall jointly convene a meeting of the Advisory Committee, and preside over the meetings in turn. <Amended on Oct. 19, 2021> |
| (2) | The chairpersons shall convene a meeting of the Advisory Committee without delay when requested by the Minister of Health and Welfare, the Minister of Food and Drug Safety, or a majority of the incumbent members. <Amended on Feb. 29, 2008; Mar. 15, 2010; Mar. 23, 2013> |
| Article 17 (Subcommittees) |
| (1) | The Advisory Committee shall have the subcommittees classified as follows (hereinafter referred to as "subcommittees") for deliberation by field: <Amended on Oct. 19, 2021> |
| 1. | Subcommittee on pharmaceutical system: Deliberation on policies and classification of drugs; |
| 2. | Subcommittee on the standards and specifications of drugs, etc.: Deliberation on standards, specifications, etc. of drugs, etc.; |
| 3. | Subcommittee on the safety and effectiveness of drugs, etc.: Deliberation on the safety and effectiveness of drugs, etc. |
| 4. | Subcommittee on new drugs: Deliberation on new drugs, clinical trials, etc. |
| 5. | Subcommittee on biological drugs: Deliberation on biological drugs (referring to drugs manufactured using those originated from humans or other organisms as raw materials or materials); |
| (2) | The chairperson of a subcommittee shall be elected from among and by its members. <Newly Inserted on Oct. 19, 2021> |
| (3) | In order to efficiently conduct affairs of a subcommittee, sub-subcommittees may be established by specialized area (hereinafter referred to as "sub-subcommittee"). <Newly Inserted on Oct. 19, 2021> |
| (4) | Except as provided in paragraphs (1) through (3), matters related to the organization and operation of the subcommittees and sub-subcommittees shall be determined by the Minister of Food and Drug Safety in consultation with the Minister of Health and Welfare. <Amended on Feb. 29, 2008; Mar. 15, 2010; Mar. 23, 2013; Oct. 19, 2021> |
| (1) | A majority of the members of the Advisory Committee shall constitute a quorum, and any decision thereof shall require the concurring vote of at least 2/3 of those present. |
| (2) | Matters deliberated by the subcommittees or sectional committees shall be deemed decided by the Advisory Committee, except where the chairperson of the Advisory Committee determines that it is necessary for another committee to re-deliberate the matters. |
The chairperson shall without delay report matters deliberated by the Advisory Committee to the Minister of Food and Drug Safety and shall without delay inform the Minister of Health and Welfare of the matters to be brought to deliberation by the Minister of Health and Welfare under subparagraph 6 of Article 13. <Amended on Feb. 29, 2008; Mar. 15, 2010; Mar. 23, 2013>
| Article 20 (Research Committee Members) |
| (1) | Not more than 10 research committee members shall, in advance, be assigned to the Advisory Committee. |
| (2) | The research committee members shall investigate and research in advance matters to be deliberated by the Advisory Committee, following an order from the chairperson. |
| (3) | The research committee members may attend and speak at meetings of the Advisory Committee. |
| (4) | The Advisory Committee shall assign not more than 10 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 much knowledge and experience in pharmaceutical affairs. <Amended on Feb. 29, 2008; Mar. 15, 2010; Mar. 23, 2013> |
| Article 20-2 Deleted. <Oct. 19, 2021> |
| Article 21 (Executive Secretary and Clerks) |
| (1) | One executive secretary and several clerks shall be assigned to the Advisory Committee. |
| (2) | The executive 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 on Feb. 29, 2008; Mar. 15, 2010; Mar. 23, 2013> |
| (3) | The executive secretary shall perform administrative affairs of the Advisory Committee following an order from the chairperson, and clerks shall assist the executive secretary. |
| Article 22 (Allowances and Traveling Expenses) |
The Minister of Food and Drug Safety may pay allowances and traveling expenses to the members of the Advisory Committee, subcommittees, and sectional committees, and research expenses and traveling expenses to the research committee members and researchers, respectively, within the budget. <Amended on Feb. 29, 2008; Mar. 15, 2010; Mar. 23, 2013>
| Article 22-2 (Standards for Facilities of Pharmacies) |
| (1) | A pharmacy shall be equipped with the following facilities under Article 20 (3) of the Act: |
| 2. | A facility for low-temperature storage and sun screen; |
| 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 on Mar. 23, 2013]
| Article 23 (Scope of Direct Dispensing by Physicians or Dentists) |
"Cases prescribed by Presidential Decree" in Article 23 (4) 14 of the Act means any of the following cases: <Amended on Jun. 25, 2008; Oct. 14, 2008; Dec. 30, 2011; Apr. 17, 2012; Jun. 27. 2012; Dec. 21, 2012; Dec. 13, 2016; Dec. 24, 2019; Apr. 6, 2021> | 2. | Where physicians 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 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 officials in the course of performing their duties; |
| 3. | Where physicians or dentists, who serve in medical 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 that Act; |
| 5. | Where physicians or dentists, who serve in a health 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 drugs for patients who are students or teaching staff of the relevant school in the course of performing their duties; |
| 6. | Where physicians or dentists, who are health managers under Article 18 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 drugs for patients who are workers of the relevant workplace in the course of performing their duties; |
| Article 24 (Similar Collusive Acts) |
| (1) | "Other acts similar to any of those referred to in subparagraphs 1 through 4, prescribed by Presidential Decree as having the potential for collusion." in Article 24 (2) 5 of the Act means the following acts: <Amended on Jul. 2, 2019> |
| 1. | An act of making dispensing available 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. | An act, performed by a medical institution founder, of making dispensing available only at a specific pharmacy by prescribing the drugs not in the list of prescription drugs under Article 25 of the Act; |
| 3. | An act, performed together by a pharmacy founder and a medical institution founder, of supporting or managing the affairs of purchasing drugs, dispensing drugs, filing applications for the review of the costs of health care benefits, etc. under the National Health Insurance Act; |
| 4. | An act, performed by a medical institution founder, of transmitting the prescription by utilizing a facsimile or computer communications, etc. so as to make dispensing available at a specific pharmacy without any request from the holder of such prescription; |
| 5. | An act, performed by a medical institution founder, of ordering a pharmacist under his or her de facto control and supervision to establish a pharmacy, or of operating a pharmacy actually by controlling or supervising a pharmacist who has established the pharmacy. |
| (2) | The Minister of Health and Welfare, the Special Metropolitan City Mayor, a Metropolitan City Mayor, a Do Governor, or a Special Self-Governing Province Governor (hereinafter referred to as the "Mayor/Do Governor"), or the head of a Si/Gun/Gu (the head of a Gu refers 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 in accordance with the standards determined by the Minister of Health and Welfare in order to prevent any collusive act under Article 24 (2) of the Act, in any of the following cases: <Amended on Feb. 29, 2008; Mar. 15, 2010; 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 child’s spouse, 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 with the same entrance, and it is considered that the relevant pharmacy exclusively induces the prescriptions issued by the relevant medical institution. |
| Article 24-2 (Matters to Be Described in Documents for Access or Inspection by GMP Officers) |
"Matters prescribed by Presidential Decree, such as the period and scope of inspection, persons in charge of inspection, and relevant statutes or regulations" in the latter part of Article 38-4 (2) 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 investigation; |
| 3. | A list of inspection materials, such as data on the manufacturing and quality control of drugs, etc.; |
| 4. | Applicable statutes and regulations for the investigation; |
| 5. | Matters corresponding to those specified in subparagraphs 1 through 4, which are deemed necessary by the Minister of Food and Drug Safety for the relevant inspection. |
[This Article Newly Inserted on Dec. 9, 2022]
[Previous Article 24-2 moved to Article 24-3 <Dec. 9, 2022>]
| Article 24-3 (Entrustment of Affairs related to Registration of Drug Identification Mark) |
| (1) | "Relevant specialized institution prescribed by Presidential Decree" in Article 38-6 (3) of the Act means a corporation designated and publicly notified by the Minister of Food and Drug Safety, among drug-related corporations established with permission from the Minister of Food and Drug Safety, pursuant to Article 32 of the Civil Act. <Amended on Dec. 9, 2022> |
| (2) | Where the Minister of Food and Drug Safety entrusts affairs pursuant to Article 38-6 (3) of the Act, he or she shall publicly notify an entity entrusted with the affairs and the details of such affairs. <Amended on Dec. 9, 2022> |
[This Article Newly Inserted on Sep. 22, 2015]
[Moved from Article 24-2 <Dec. 9, 2022>]
| Article 25 (Examination for Herb Druggists) |
The examination for herb druggists provided 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 herbal drugs and their working-level functions.
| Article 26 (Eligibility Requirements for Examination) |
A person with at least five years of career in handling of herbal drugs at an oriental medical clinic or an herb drugstore, who has graduated from a high school or higher educational institution or who is recognized by the Minister of Education as one with educational attainment equal to or higher than such school shall be entitled to apply for the examination for herb druggists.
[This Article Wholly Amended on Jul. 16, 2019]
| Article 27 (Subjects of Examination and Allotting Percentage) |
The examination for herb druggists shall be classified into a written examination and a practical examination, and the subjects of the examination and allocated examination percentage shall be as follows:
[This Article Wholly Amended on Jul. 2, 2019]
| Article 28 (Public Announcement of Examination) |
Where the Mayor/Do Governor administers the examination for herb druggists, he or she shall publicly announce the date and time, place of the examination, subjects of the examination, deadline for submission of applications, an area where business permission is expected to be granted, the expected number of persons who obtain such permission, and other matters necessary for the examination, no later than 30 days before the examination date.
| Article 29 (Application Form) |
| (1) | A person who intends to apply for the examination for herb druggists shall submit an application form to the Mayor/Do Governor, along with the following documents: <Amended on Oct. 14, 2008> |
| 2. | Documents evidencing educational attainment and career experience under Article 26; |
| 3. | A medical certificate issued by a physician evidencing that an applicant does not fall under the main clause of subparagraph 1 of Article 5 of the Act or a medical certificate issued by a medical specialist evidencing that an applicant falls under the proviso of subparagraph 1 of Article 5 of the Act; |
| 4. | A medical certificate issued by a physician evidencing that an applicant does not fall under subparagraph 3 of Article 5 of the Act; |
| 5. | The 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 on Feb. 29, 2008; Mar. 15, 2010> |
| Article 30 (Determination of Successful Applicants) |
| (1) | After administering the examination for herb druggists, the Mayor/Do Governor shall determine applicants who score at least 60 percent on aggregate in all subjects, as successful applicants within the limit of expected number of those to be granted permission for each area where business permission is 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 expected number of those to be granted permission 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 as successful applicants. |
| (2) | The Mayor/Do Governor shall inform the successful applicants under paragraph (1) of their passing of the examination. |
| Article 31 (Examination Committee Members) |
| (1) | The Mayor/Do Governor shall appoint examination committee members from among persons who have much knowledge and experience in herbal drugs and who have substantial knowledge of statutes and regulations on pharmaceutical affairs and narcotics. |
| (2) | The examination committee under paragraph (1) shall consist of two to five persons per subject. |
| Article 31-2 (Standards for Facilities of Herb Druggists and Drug Wholesalers) |
| (1) | Detailed standards for a business place that an 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 place 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 shall 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 business of selling radioactive isotope under Article 55 of the Nuclear Safety Act. |
| (3) | Notwithstanding the main clause of paragraph (2), a drug wholesaler need not be equipped with a warehouse, if he or 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 Pharmaceutical Affairs Act (Act No. 8365) intends to operate his or her business, he or she shall be equipped with a business place 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 on Mar. 23, 2013]
| Article 32 (Grounds for Retail or Distribution of Drugs by Persons Who Obtained Permission by Item of Drugs) |
"Ground prescribed by Presidential Decree, such as cases for public interests" in Article 47 (1) 2 of the Act means grounds falling under attached Table 1-2. [This Article Wholly Amended on Mar. 22, 2016]
| Article 32-2 (Designation of 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 information on the distribution of drugs (hereinafter referred to as the "Korea Pharmaceutical Information Service") pursuant to Article 47-3 (1) of the Act. <Amended on Mar. 15, 2010; Aug. 31, 2012; May 29, 2017> [This Article Newly Inserted on Oct. 14, 2008]
[Previous Article 32-2 moved to Article 32-5 <Oct. 14, 2008>]
| Article 32-3 (Operation of Korea Pharmaceutical Information Service) |
| (1) | The Korea Pharmaceutical Information Service shall perform the following affairs: <Amended on Mar. 15, 2010; Mar. 22, 2016; May 29, 2017> |
| 1. | Collection, investigation, processing, utilization and provision of drug distribution information; |
| 2. | Formulation and implementation of a basic plan for informatization on the distribution of drugs; |
| 3. | Construction and operation of database of information on the 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 drug standard codes [referring to serial numbers imposed on each drug for identification thereof, which are numbers in 13 figures, including country identification code; identification code of a person who has obtained permission by item of drugs (referring to the person who has obtained permission for manufacturing and distribution of items or filed a notification of manufacturing and distribution of items in accordance with Article 31 (2) or (3) of the Act; hereinafter the same shall apply) or of a person who has filed a notification of import business pursuant to the former part of Article 42 (1) of the Act (hereinafter referred to as "importer"); item code; and verification code]; |
| 5. | Research, education, and public relations on standardization of drug distribution information; |
| 6. | Support of informatization on the distribution of drugs, such as the development and dissemination of programs necessary for the submission of supply details, etc. of drugs under Article 47-3 (2) of the Act; |
| 7. | Other matters recognized necessary by the Minister of Health and Welfare in connection with drug distribution information. |
| (2) | The president of the Korea Pharmaceutical Information Service shall report, to the Minister of Health and Welfare, a business plan for the affairs under paragraph (1), business performance, budget and settlement of accounts of the relevant fiscal year by the deadline classified as follows: <Amended on Mar. 15, 2010> |
| 1. | A business plan 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 require persons who have obtained permission by item of drugs or importers to submit a report on the product information of drugs which they intend to manufacture and distribute or import as determined and publicly notified by the Minister of Health and Welfare. <Amended on Mar. 15, 2010> |
[This Article Newly Inserted on Oct. 14, 2008]
| Article 32-4 (Fees for Providing Drug Distribution Information) |
| (1) | Where the Korea Pharmaceutical Information Service provides the processed information on distribution of drugs at the request of persons who have obtained permission by item of drugs, importers, drug wholesalers, etc. (excluding cases of 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 on Mar. 15, 2010> |
| 1. | Where a State agency or a local government requests to provide drug distribution information in connection with the performance of affairs pursuant to statutes or regulations; |
| 2. | Where a non-profit corporation or a non-profit academic and public organization requests to provide drug distribution information for the purpose of academic research or administrative surveillance; |
| 3. | Where a requester makes a request for providing the information on distribution of the same drugs as that processed according to the same standards in the same year; |
| 4. | Other cases where the Minister of Health and Welfare recognizes that reduction or exemption of fees is necessary for public welfare, etc. |
| (2) | Fees referred to in paragraph (1) shall be determined within the extent of actual expenses in consideration of expenses incurred in processing and providing drug distribution information, expenses incurred in developing programs necessary for the management of drug distribution information, etc. |
| (3) | Fees referred to in paragraph (1) shall be paid in cash (including payment by methods of electronic currencies, electronic settlement, etc. through the information and communications network) to a financial institution or postal service agency designated by the Korea Pharmaceutical Information Service. |
| (4) | Matters necessary for the methods for requesting drug distribution information, and eligibility for and percentage of reduction or exemption of fees under paragraph (1), the specific methods for calculating fees under paragraph (2), etc. shall be determined and publicly notified by the Minister of Health and Welfare. <Amended on Mar. 15, 2010> |
[This Article Newly Inserted on Oct. 14, 2008]
| Article 32-5 (Grounds for Exceptions to Informing of Application for Permission by Item) |
"Cases prescribed by Presidential Decree" in Article 50-4 (1) 4 of the Act (including cases applied 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 an application for permission for manufacturing and distribution or import of items or permission for modification is filed pursuant to Article 31 (2), (3) or (9) or 42 (1) of the Act. <Amended on Sep. 22, 2015> [This Article Newly Inserted on Mar. 13, 2015]
[Previous Article 32-5 moved to Article 32-6 <Mar. 13, 2015>]
| Article 32-6 (Measures to Inform That Drugs Are Illegally Distributed, Arranged for, or Advertised) |
| (1) | "Measures prescribed by Presidential Decree" in the former part, with the exception of the subparagraphs, of Article 61-2 (5) of the Act means measures to require the providers of information and communications services and others under the former part of paragraph (3) of that Article to post the following information on the media, such as the website on which the drugs, etc. under the subparagraphs of Article 61-2 (2) of the Act have been sold, arranged for, or advertised: |
| 1. | A title stating that the measures are specified in Article 61-2 (5) of the Act; |
| 2. | Names of the drugs, etc. specified in the subparagraphs of Article 61-2 (2) of the Act; |
| 3. | The violation (including the specific details of the violation and the applicable statutes and regulations); |
| (2) | The Minister of Food and Drug Safety shall not request measures under paragraph (1) in cases where posts for the sale, arrangement, or advertisement of drugs, etc. specified in the subparagraphs of Article 61-2 (2) of the Act are removed or restricted from access. |
[This Article Newly Inserted on Oct. 17, 2023]
[Previous Article 32-6 moved to Article 32-8 <Oct. 17, 2023>]
| Article 32-7 (Entrustment of Duties of Monitoring of Illegal Sale of Drugs) |
| (1) | "Institution or organization prescribed by Presidential Decree" in Article 61-3 (1) of the Act means any of the following institutions and organizations, which are determined and publicly notified by the Minister of Food and Drug Safety: |
| 4. | Any other institutions or organizations recognized by the Minister of Food and Drug Safety as having the specialized personnel and dedicated organization necessary to perform the monitoring of the illegal sale of drugs and others. |
| (2) | Where entrusting the duties of monitoring of the illegal sale of drugs, etc. pursuant to Article 61-3 (1) of the Act, the Minister of Food and Drug Safety shall publicly notify the entrusted institution or organization and the details of entrusted duties. |
[This Article Newly Inserted on Oct. 17, 2023]
[Previous Article 32-7 moved to Article 32-9 <Oct. 17, 2023>]
| Article 32-8 (Entrustment of Affairs of Deliberation on Advertisement) |
The Minister of Food and Drug Safety shall entrust an incorporated association designated and publicly notified by him or her among incorporated associations established pursuant to Article 67 of the Act with deliberation on advertisement of drugs pursuant to Article 68-2 (2) of the Act. <Amended on Mar. 23, 2013> [This Article Newly Inserted on Apr. 10, 2008]
[Moved from Article 32-6, previous Article 32-8 moved to Article 32-10 <Oct. 17, 2023>]
| Article 32-9 (Organization 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 on 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 resolve on important matters concerning the business affairs of the Institute of Drug Safety and Risk Management. |
| (4) | Except as provided in paragraphs (1) through (3), matters necessary for the organization and operation of the Institute of Drug Safety and Risk Management shall be prescribed by the articles of association. |
[This Article Newly Inserted on Dec. 30, 2011]
[Moved from Article 32-7, previous Article 32-9 moved to Article 32-11 <Oct. 17, 2023>]
| Article 32-10 (For-Profit Projects) |
"For-profit projects prescribed by Presidential Decree" in the provisions, with the exception of the subparagraphs, of Article 68-4 of the Act means any of the following projects: <Amended on Mar. 23, 2013> | 1. | Education and training of a person in charge of the 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 on Dec. 30, 2011]
[Moved from Article 32-8; previous Article 32-10 moved to Article 32-12 <Oct. 17, 2023>]
| Article 32-11 (Approval of Business Plans and Budget Bills) |
| (1) | Where the Institute of Drug Safety and Risk Management intends to obtain approval of its business plan and budget bill pursuant to 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 after decision by the board of directors, before each fiscal year begins: <Amended on Mar. 23, 2013; Jan. 5, 2021> |
| 1. | Statement of estimated financial position; |
| 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 of modification of a business plan and a budget bill pursuant to the latter part of Article 68-6 (2) of the Act, it shall submit a document stating the details of and grounds for modification to the Minister of Food and Drug Safety after decision by the board of directors. <Amended on Mar. 23, 2013> |
[This Article Newly Inserted on Dec. 30, 2011]
[Moved from Article 32-9, previous Article 32-11 moved to Article 32-13 <Oct. 17, 2023>]
| Article 32-12 (Documents for Access or Inspection by Drug Epidemiological Investigators) |
"Matters prescribed by Presidential Decree, such as the period and scope of an investigation, persons in charge of the investigation, and relevant statutes or regulations" in the latter part of Article 68-12 (3) of the Act means the following matters: | 1. | The purpose, period, scope, and details of the investigation; |
| 2. | Names and positions of persons in charge of the investigation; |
| 3. | A list of data that shall be submitted; |
| 4. | Applicable statutes and regulations for the investigation; |
| 5. | Details of administrative dispositions or penalties against a refusal, obstruction, evasion, etc. of the investigation and applicable statutes and regulations; |
| 6. | Matters corresponding to those specified in subparagraphs 1 through 5, which are deemed necessary by the Minister of Food and Drug Safety for the relevant investigation. |
[This Article Newly Inserted on Dec. 13, 2016]
[Moved from Article 32-10, previous Article 32-12 moved to Article 32-14 <Oct. 17, 2023>]
| Article 32-13 (Instructions for Entry, Inspection, and Collection) |
| (1) | "The head of an agency under his or her jurisdiction prescribed by Presidential Decree" in the provisions, with the exception of the subparagraphs, of Article 69 (1) of the Act means the head of a regional food and drug administration. <Newly Inserted on Sep. 22, 2020> |
| (2) | "Matters prescribed by Presidential Decree, such as the period and scope of an investigation, persons in charge of the investigation, and related statutes and regulations" in Article 69 (2) of the Act means the following: <Amended on Sep. 22, 2020; Oct. 17, 2023> |
| 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 on Dec. 13, 2016]
[Title Amended on Sep. 22, 2020]
[Moved from Article 32-11 <Oct. 17, 2023>]
| Article 32-14 (Informing Relevant Agencies) |
"Head of the relevant central administrative agency prescribed by Presidential Decree" in the provisions, with the exception of the subparagraphs, Article 69-2 of the Act means 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 on Mar. 13, 2015]
[Moved from Article 32-12 <Oct. 17, 2023>]
| Article 33 (Standards for Calculation of Penalty Surcharges Imposed in Lieu of Disposition of Business Suspension) |
The amount of penalty surcharges under Article 81 (2) of the Act shall be calculated based on the standards prescribed in attached Table 2 according to the standards for the disposition of business suspension classified as follows, taking into consideration the types, degree, etc. of violations: <Amended on Feb. 29, 2008; Mar. 15, 2010; Mar. 23, 2013> | 1. | In cases of imposition of a penalty surcharge on a manufacturer of drugs, etc., a person who has obtained permission by item, or an importer: The standards 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 standards prescribed by Ordinance of the Ministry of Health and Welfare. |
[Title Amended on Jun. 4, 2019]
| Article 34 (Procedures for Imposition and Collection of Penalty Surcharges Imposed in Lieu of Disposition of Business Suspension) |
| (1) | If the Minister of Food and Drug Safety, the Mayor/Do Governor, or the head of a Si/Gun/Gu intends to impose a penalty surcharge under Article 81 of the Act, he or she shall give written information of the payment thereof, stating the type of violation and the amount of penalty surcharge. <Amended on Mar. 23, 2013> |
| (2) | Procedures for collecting penalty surcharges shall be subject to the following classification: <Amended on Mar. 23, 2013> |
| 1. | In cases of imposition of a penalty surcharge on a manufacturer of drugs, etc., a person who has obtained permission by item, 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. |
[Title Amended on Jun. 4, 2019]
| Article 34-2 (Disposition to Defaulters of Penalty Surcharges Imposed in Lieu of Disposition of Business Suspension) |
| (1) | When a person fails to pay a penalty surcharge by the deadline for payment, the Minister of Food and Drug Safety, the Mayor/Do Governor, the head of a Si/Gun/Gu shall issue a demand for payment within 15 days after the elapse of the deadline for payment pursuant to the main clause of Article 81 (4) of the Act. In such cases, a new deadline for payment shall be within 10 days after the demand for payment is issued. <Amended on Mar. 23, 2013> |
| (2) | If a person who fails to pay a penalty surcharge pursuant to paragraph (1) fails to pay it by the relevant payment deadline even after receipt of a demand for payment, a disposition to impose penalty surcharges shall be revoked and a disposition to suspend business shall be imposed: Provided, That where he or she falls under the proviso of Article 81 (4) of the Act, the penalty surcharge shall be collected in the same manner as delinquent national taxes are collected or pursuant to Act on the Collection of Local Administrative Penalty Charges. <Amended on Sep. 11, 2014; Mar. 24, 2020> |
| (3) | Where a disposition to suspend business is imposed after the revocation of the disposition to impose a penalty surcharge pursuant to the main clause of paragraph (2), a person subject to the disposition shall be given written information, stating matters necessary for the disposition of business suspension, including grounds for the change of the disposition and a period for the suspension of business. <Amended on Sep. 11, 2014> |
[This Article Newly Inserted on Jul. 3, 2007]
[Title Amended on Jun. 4, 2019]
| Article 34-3 (Standards for Imposing Penalty Surcharges for Manufacturing of Hazardous Drugs) |
| (1) | The amount of a penalty surcharge imposed under Article 81-2 (1) of the Act shall be twice the amount calculated by multiplying the sales volume of the relevant item by the sales price. In such cases, if the sales prices fluctuate during a sales period, the amount of a penalty surcharge shall be calculated by aggregating the sales prices for each period of sales price fluctuation. |
| (2) | The sales volume under paragraph (1) shall be the amount calculated by subtracting the amount actually unsold for reasons of recovery, return, inspection, etc. from the delivery volume during the sales period. |
| (3) | The Minister of Food and Drug Safety may reduce the amount of penalty surcharges within the scope of 1/2 of penalty surcharges calculated pursuant to paragraph (1), in consideration of matters referred to in the subparagraphs of Article 81-2 (2) of the Act. |
[This Article Wholly Amended on Oct. 19, 2021]
| Article 34-4 (Imposition and Payment of Penalty Surcharges for Manufacturing of Hazardous Drugs) |
| (1) | Where the Minister of Food and Drug Safety intends to impose a penalty surcharge under Article 81-2 (1) of the Act, he or she shall give written information of the payment thereof, specifying the type of offense and the amount of penalty surcharge. |
| (2) | A person informed pursuant to paragraph (1) (hereinafter referred to as "person liable to pay a penalty surcharge") shall pay the penalty surcharge to the receiving agency designated by the Minister of Food and Drug Safety within 60 days from the date of receiving the information. |
| (3) | The receiving agency upon receipt of the penalty surcharge under paragraph (2) shall issue a receipt to the payer and inform without delay the Minister of Food and Drug Safety of the fact of receiving the penalty surcharge. |
| (4) | Except as provided in paragraphs (1) through (3), matters necessary for imposing and paying penalty surcharges shall be prescribed by Ordinance of the Prime Minister. |
[This Article Newly Inserted on Jun. 4, 2019]
[Previous Article 34-4 moved to Article 34-8 <Jun. 4, 2019>]
| Article 34-5 (Extension of Deadline for Payment of Penalty Surcharges for Manufacturing of Hazardous Drugs, and Installment Payment) |
If the Minister of Food and Drug Safety extends the deadline for payment of a penalty surcharge under Article 81-2 (1) of the Act or allows the payment of a penalty surcharge in installments pursuant to the proviso of Article 29 of the Framework Act on the Administration, the deadline for payment shall not exceed one year from the day following the deadline for payment, and the interval between installments shall be within three months, and the number of installment payments shall not exceed three times. [This Article Wholly Amended on Dec. 12, 2023]
| Article 34-6 (Demand for Payment of Penalty Surcharges for Manufacturing of Hazardous Drugs) |
| (1) | If a person liable to pay a penalty surcharge fails to pay the penalty surcharge by the deadline for payment, the Minister of Food and Drug Safety shall issue a demand notice within 10 days from the date on which the deadline for payment pursuant to Article 81-2 (5) of the Act (referring to the deadline for payment in a lump sum, where the deadline for payment of a penalty surcharge is extended or the installment payments of a penalty surcharge is permitted pursuant to Article 34-5 (1) and the penalty surcharge is collected in a lump sum pursuant to Article 7 (3) of the Enforcement Decree of the Framework Act on the Administration) has passed pursuant to Article 81-2 (5) of the Act. <Amended on Dec. 12, 2023> |
| (2) | In cases of issuing a demand for payment under paragraph (1), the deadline for payment of the penalty surcharge in arrears shall be within 10 days from the date of issuing the demand for payment. |
[This Article Newly Inserted on Jun. 4, 2019]
[Previous Article 34-6 moved to Article 34-10 <Jun. 4, 2019>]
| Article 34-7 (Publication of Violations) |
| (1) | "Information ... , which is prescribed by Presidential Decree" in Article 81-3 (1) of the Act means the following matters: |
| 1. | The title "Publication of Violations of the Pharmaceutical Affairs Act"; |
| 2. | Names of drugs, etc. for which dispositions are finalized; |
| 3. | Type of business, name, location, and the name of the representative of, persons subject to dispositions; |
| 4. | Details of violations and the statutes or regulations the persons in question violated; |
| 5. | Details of dispositions, and date and duration of dispositions. |
| (2) | Where the Minister of Food and Drug Safety publishes matters specified in the subparagraphs of paragraph (1) of this Article pursuant to Article 81-3 (1) of the Act, he or she shall post a notice on the website of the Ministry of Food and Drug Safety for a period of up to five years, as determined and publicly notified by the Minister of Food and Drug Safety. |
[This Article Newly Inserted on Dec. 9, 2022]
[Previous Article 34-7 moved to Article 34-8 <Dec. 9, 2022>]
| Article 34-8 (Designation 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. | The 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) | A 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, an application for designation prescribed by Ordinance of the Ministry of Health and Welfare or by Ordinance of the Prime Minister, along with the documents prescribed by Ordinance of the Ministry of Health and Welfare or by Ordinance of the Prime Minister. |
| (3) | The standards for designating a professional training institution shall be as follows: |
| 1. | The courses and curricula of education and training shall be appropriate; |
| 2. | Appropriate personnel, facilities and equipment for conducting education and training shall be secured; |
| 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 or she shall issue a certificate of designation prescribed by Ordinance of the Ministry of Health and Welfare or Ordinance of the Prime Minister and publicly announce such fact on the website of the Ministry of Health and Welfare or the Ministry of Food and Drug Safety. |
| (5) | Expenses to be subsidized to a professional training institution pursuant to Article 83-2 (3) of the Act shall be as follows: <Amended on May 29, 2017> |
| 1. | Lecture fees and allowances; |
| 2. | Expenses for producing teaching materials and expenses for purchasing tools for practice; |
| 3. | Expenses for field practice; |
| 4. | Other expenses deemed necessary to train professional personnel. |
[This Article Newly Inserted on Sep. 22, 2015]
[Moved from Article 34-7; previous Article 34-8 moved to Article 34-9 <Dec. 9, 2022>]
| Article 34-9 (Functions of Council for Stable Supply of National Essential Drugs) |
The Council for Stable Supply of National Essential Drugs (hereinafter referred to as the "Council") under Article 83-4 (3) of the Act shall consult on the following: <Amended on Oct. 17, 2023> | 1. | Designation of national essential drugs and cancellation of the designation; |
| 2. | Business affairs under the subparagraphs of Article 83-4 (1) of the Act. |
[This Article Newly Inserted on May 29, 2017]
[Moved from Article 34-8; previous Article 34-9 moved to Article 34-10 <Dec. 9, 2022>]
| Article 34-10 (Organization of Council) |
| (1) | The Council shall be comprised of not more than 20 members, including one chairperson. |
| (2) | The Vice Minister of Food and Drug Safety shall serve as the chairperson of the Council. |
| (3) | The members of the Council shall be appointed by the head of a relevant agency from among members in general service of the Senior Executive Service belonging to the Ministry of Education, the Ministry of National Defense, the Ministry of the Interior and Safety, the Ministry of Patriots and Veterans Affairs, the Ministry of Health and Welfare, the Ministry of Employment and Labor, the Office for Government Policy Coordination, the Ministry of Food and Drug Safety, the Korea Disease Control and Prevention Agency, and the Nuclear Safety and Security Commission. <Amended on Jul. 26, 2017; Nov. 28, 2017; Oct. 19, 2021; Apr. 11, 2023> |
[This Article Newly Inserted on May 29, 2017]
[Moved from Article 34-9; previous Article 34-10 moved to Article 34-11 <Dec. 9, 2022>]
| Article 34-11 (Operation of Council) |
| (1) | The chairperson shall represent the Council and exercise general supervision over its business affairs. |
| (2) | If the chairperson is unable to perform the duties due to any unavoidable reasons, the member pre-designated by the chairperson shall act on behalf of the chairperson. |
| (3) | A regular meeting of the Council shall be held once a year; and a special meeting shall be convened when the chairperson deems it necessary or at the request of at least 1/3 of the members. |
| (4) | Where the chairperson intends to hold a meeting, the chairperson shall inform each member of the date and time, place, and agenda item of the meeting not later than seven days prior to the date of holding the meeting: Provided, That where it is required to urgently hold a meeting or there exists any other unavoidable reason, he or she may give such information not later than the day before the meeting. |
| (5) | A majority of the members of the Council shall constitute a quorum, and any decision thereof shall require the concurrent vote of a majority of those present. |
| (6) | If necessary for efficient consultation, the chairperson may have a person related to the agenda item or an expert in the relevant field attend and speak at a meeting. |
[This Article Newly Inserted on May 29, 2017]
[Moved from Article 34-10; previous Article 34-11 moved to Article 34-12 <Dec. 9, 2022>]
| Article 34-12 (Working Committee and Subcommittees) |
| (1) | A working committee and subcommittees may be established in the Council if necessary to efficiently perform the Council’s affairs. |
| (2) | Matters necessary for the organization and operation of the working committee and subcommittees shall be determined by the Minister of Food and Drug Safety. |
[This Article Newly Inserted on May 29, 2017]
[Moved from Article 34-11; previous Article 34-12 moved to Article 34-13 <Dec. 9, 2022>]
| Article 34-13 (Executive Secretary) |
| (1) | The Council and the working committee, respectively shall have one executive secretary to deal with the administrative affairs thereof. |
| (2) | An executive secretary shall be designated by the Minister of Food and Drug Safety from among the public officials of the Ministry of Food and Drug Safety. |
[This Article Newly Inserted on May 29, 2017]
[Moved from Article 34-12; previous Article 34-13 moved to Article 34-14 <Dec. 9, 2022>]
| Article 34-14 (Allowances) |
Allowances, travel expenses, and other necessary expenses may be paid to relevant experts attending meetings of the Council, the working committee, and subcommittees, within the budget.
[This Article Newly Inserted on May 29, 2017]
[Moved from Article 34-13 <Dec. 9, 2022>]
| Article 34-15 (Entrustment of Consumer Education and Publicity Work) |
| (1) | "Institution or organization prescribed by Presidential Decree" in Article 83-8 (2) of the Act means an institution or organization determined and publicly notified by the Minister of Food and Drug Safety, among the following institutions or organizations: |
| 2. | Other institutions or organizations recognized by the Minister of Food and Drug Safety as having expertise in drugs, etc. |
| (2) | Where entrusting education and publicity work pursuant to Article 83-8 (2) of the Act, the Minister of Food and Drug Safety shall publicly notify the entrusted institution or organization and the details of the entrusted work. |
[This Article Newly Inserted on Oct. 17, 2023]
| Article 35 (Delegation and Entrustment of Authority and 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 a regional office of food and drug safety: <Amended on Mar. 23, 2013; Sep. 22, 2015; Apr. 24, 2018; Jun. 4, 2019; Dec. 9, 2022> |
| 1. | Permission for manufacturing and distribution of items, permission for modification, and permission for renewal; permission for import of each item, permission for modification, and permission for renewal; and acceptance of a notification of import business or a notification of modification, with regard to drugs (limited to the items that need the verification of equivalence of drugs), under Article 31 (2) and (9), 31-5 (3) (including cases applied mutatis mutandis under Article 42 (5) of the Act), or 42 (1) of the Act; |
| 2. | Acceptance of a notification of manufacturing and distribution, notification of modification, or notification of renewal, and acceptance of a notification of import of each item, notification of modification, or notification of renewal, with regard to drugs (excluding drug substances determined and publicly notified by the Minister of Food and Drug Safety), under Article 31 (2) and (9), 31-5 (3) (including cases applied mutatis mutandis under Article 42 (5) of the Act), or 42 (1) of the Act; |
| 2-2. | Permission conditioned on the establishment of facilities under Article 35 (1) of the Act (excluding permission conditioned on the establishment of facilities regarding items which do not need the verification of drug equivalence) |
| 2-3. | Certification of Good Manufacturing Practice (GMP) compliance under Article 38-2 (1) of the Act and modified certification of GMP compliance under paragraph (2) of that Article; |
| 2-4. | Verification and Inspection of GMP compliance under Article 38-3 (1) of the Act; |
| 2-5. | Extension of the term of validity for the certification of GMP compliance under Article 38-3 (2) of the Act; |
| 2-6. | Necessary measures such as revocation of the certification of GMP compliance and issuing a corrective order, under Article 38-3 (3) of the Act; |
| 2-7. | Allowance of production and sale of drugs, etc. whose certification of GMP compliance is revoked under Article 38-3 (4) of the Act; |
| 3. | Acceptance of a notification of an import manager or a notification of business closure, etc. by an importer under Article 36 (3) or 40 of the Act applied mutatis mutandis pursuant to Article 42 (5) of the Act; |
| 3-2. | Imposition or collection of a penalty surcharge on or from a drug manufacturer, a person who has obtained permission by item, or an importer, and disposition on delinquency under Article 81-2 of the Act; |
| 4. | Imposition or collection of administrative fines under Article 98 (1) 4-3 of the Act. |
| (2) | Pursuant to Article 84 (5) of the Act, the Minister of Food and Drug Safety shall entrust the task of receiving reports on the production performance of drugs, etc. under Article 38 (2) of the Act to an organization determined and publicly notified by the Minister of Food and Drug Safety from among the associations under Article 67 of the Act. <Newly Inserted on Oct. 17, 2023> |
| (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 on Feb. 29, 2008; Mar. 15, 2010; Dec. 30, 2011; Apr. 6, 2021> |
| 1. | Affairs related to acceptance of reports on employment status of pharmacists or oriental medicine pharmacists under Article 7 (1) of the Act; |
| 2. | Affairs of training and education of pharmacists or oriental medicine pharmacists under Article 15 of the Act; |
| 3. | Affairs of examination of pharmacists' or oriental medicine pharmacists' ethics under Article 16 (2) of the Act; |
| 4. | Affairs to investigate and confirm the indication of the selling price of a pharmacy under Article 56 (2) of the Act. |
[Title Amended on Apr. 6, 2021]
| Article 36 (Special Cases concerning Animal Drugs) |
In applying Articles 33, 34, 38-2 and 39 to animal drugs, etc. referred to in Article 85 of the Act, the "Minister of Health and Welfare" or the "Minister of Food and Drug Safety" in those 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 on Feb. 29, 2008; Mar. 15, 2010; Mar. 23, 2013; Nov. 28, 2017>
| Article 36-2 (Field Survey Documents for Investigation and Evaluation of Injury from Side Effects of Drugs) |
"Matters prescribed by Presidential Decree, such as the period and scope of an investigation, persons in charge of investigation, and relevant statutes or regulations" in the latter part of Article 86-6 (3) of the Act means matters under the subparagraphs of Article 32-12. <Amended on Oct. 17, 2023> [This Article Newly Inserted on Dec. 13, 2016]
| Article 37 (Procedures for Paying Monetary Awards) |
| (1) | Any supervisory agency or investigative agency upon receipt of a report or accusation of the fact of violating related statutes or regulations under Article 90 of the Act shall inform the head of the competent Si/Gun/Gu of the outline of such violation. |
| (2) | The head of a Si/Gun/Gu informed under paragraph (1) may grant a monetary award within the budget, where an adjudication of the court or an administrative fine relating to the relevant case becomes final and conclusive. <Amended on Oct. 19, 2021> |
| (3) | The monetary award under paragraph (2) shall not exceed 10/100 of the amount of a fine imposed (where a punishment of an imprisonment with labor is sentenced, the maximum amount of fines under the relevant penalty provisions applied) for the case or an administrative fine imposed therefor. <Amended on Oct. 19, 2021> |
| Article 37-2 (Operation of Vaccine Center for Assisting Safety and Technology) |
| (1) | The head of the Vaccine Center for Assisting Safety and Technology (hereinafter referred to as "vaccine center") under Article 90-2 of the Act (hereinafter referred to as the "head of the vaccine center") shall be appointed by the Minister of Food and Drug Safety, as prescribed by the articles of association. |
| (2) | The head of the vaccine center shall submit a business plan and a budget bill of revenues and expenditures for the following year to the Minister of Food and Drug Safety through a resolution by the board of directors, before the commencement of each fiscal year. The same shall also apply to any modification of the plan and the bill. |
| (3) | If necessary for implementing the programs specified in Article 90-3 (1) of the Act, the head of the vaccine center may request relevant central administrative agencies, relevant private institutions, organizations, or research institutes, etc. to dispatch public officials, executive officers or employees, or researchers belonging thereto. |
| (4) | Except as provided in paragraphs (1) through (3), detailed matters necessary for the operation of the vaccine center and similar shall be prescribed by the articles of association. |
[This Article Newly Inserted on Oct. 19, 2021]
| Article 37-3 (Affairs of Vaccine Center) |
"Affairs prescribed by Presidential Decree" in Article 90-3 (1) 6 of the Act means the following affairs: | 1. | Establishment, maintenance, and management of distribution of vaccine cell lines; |
| 2. | Support for the improvement of the analytical capabilities of clinical trial sample analysis institutions under Article 34-2 (2) of the Act; |
| 3. | Other affairs the Minister of Food and Drug Safety deems necessary to achieve the purposes of the establishment of the vaccine center. |
[This Article Newly Inserted on Oct. 19, 2021]
| Article 38 (Operation of the Korea Orphan and Essential Drug Center) |
| (1) | The chairperson of the Korea Orphan and Essential Drug Center under Article 91 of the Act (hereinafter referred to as the "Center") shall submit a business plan and a budget of revenues and expenses for the following year to the Minister of Food and Drug Safety not later than April 30 of each business year. <Amended on Mar. 23, 2013; May 29, 2017> |
| (2) | Where the important matters of the business plan and the budget of revenues and expenses under paragraph (1) are modified, the documents stating the details of and reasons for such modification shall be submitted to the Minister of Food and Drug Safety. <Amended on Mar. 23, 2013> |
| (3) | Upon receipt of the business plan and the budget of revenues and expenses for the following year under paragraph (1), the Minister of Food and Drug Safety may, if deemed necessary, request the chairperson of the Center to submit data concerning the following matters: <Amended on 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. |
[Title Amended on May. 29, 2017]
| Article 38-2 (Management 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 entrusted his or her affairs pursuant to Article 35), the Minister of Food and Drug Safety (including a person to whom the relevant authority has been delegated or entrusted under that Article), the head of a regional food and drug safety office, a Mayor/Do Governor or the head of a Si/Gun/Gu, or the national examination, etc. administrative agency (including a person to whom the relevant authority has been delegated or entrusted where the relevant authority is delegated or entrusted) may manage information on health under Article 23 of the Personal Information Protection Act, information corresponding to criminal history records under subparagraph 2 of Article 18 of the Enforcement Decree of that Act, and data containing resident registration numbers and alien registration numbers prescribed in subparagraph 1 or 4 of Article 19 of that Decree, if unavoidable to perform the following administrative affairs: Provided, That in cases of administrative affairs specified in subparagraphs 2, 5, 6, 9, 11, 11-3, 15, 16, 19, and 21, the relevant person shall not manage information on health referred to in Article 23 of the Personal Information Protection Act, and information about criminal history records referred to in subparagraph 2 of Article 18 of the Enforcement Decree of that Act: <Amended on Oct. 22, 2012; Mar. 23, 2013; Sep. 22, 2015; May 29, 2017; Nov. 28, 2017; Jan. 29, 2020; Mar. 3, 2020; Sep. 22, 2020; Apr. 6, 2021; Dec. 9, 2022; Dec. 20, 2022> | 1. | Administrative affairs relating to registration of a pharmacist or oriental medicine pharmacist license, and issuance and re-issuance thereof under Article 6 of the Act; |
| 2. | Administrative affairs relating to reporting on employment status of pharmacists or oriental pharmacists under Article 7 (1) of the Act; |
| 3. | Administrative affairs relating to national examination for a pharmacist license and an oriental medicine pharmacist license and preliminary examination for a pharmacist license under Article 8 of the Act; |
| 4. | Administrative affairs relating to verification of eligibility requirements for national examination for a pharmacist license and an oriental medicine pharmacist license and preliminary examination for a pharmacist license under Article 9 of the Act; |
| 5. | Administrative affairs relating to registration of establishment of pharmacies or registration of modification thereof under Article 20 of the Act; |
| 6. | Administrative affairs relating to notifications of business closure, suspension, or resumption of pharmacies under Article 22 of the Act; |
| 7. | Administrative affairs relating to permission for drug manufacturing business, notifications of contract manufacturing and distribution business of drugs, notifications of quasi-drug manufacturing business, and permission for and notifications of modification thereof under Article 31 of the Act; |
| 8. | Administrative affairs relating to conditional permission for drug manufacturing business under Article 35 of the Act; |
| 8-2. | Administrative affairs relating to notifications of manufacturing managers of drugs, etc. under Article 36 of the Act (including import managers applied mutatis mutandis under Article 42 (5) of the Act); |
| 9. | Administrative affairs relating to recall of drugs, etc. under Article 39 of the Act; |
| 10. | Administrative affairs relating to the report on closure, suspension, re-opening of business, or change of manufacturing manager under Article 40 of the Act (including affairs applied mutatis mutandis to importers pursuant to Article 42 (5) of the Act); |
| 11. | Administrative affairs relating to notifications of manufacturing of pharmacy medications and dispensary medications under Article 41 of the Act; |
| 11-2. | Administrative affairs relating to notifications of import business of drugs, etc. or notifications of modification thereof under Article 42 (1) of the Act; |
| 11-3. | Administrative affairs relating to registration of a distributor of safe and readily available drugs and registration of modification thereof under Article 44-2 of the Act; |
| 12. | Administrative affairs relating to permission, etc. for herb druggists or drug wholesalers under Article 45 of the Act; |
| 13. | Administrative affairs relating to directions given under Article 69 of the Act; |
| 14. | Administrative affairs relating to administrative dispositions under Articles 70 through 76 of the Act and Article 76-3 (including affairs under Article 75 of the Act applied mutatis mutandis to importers pursuant to Article 42 (5) of the Act); |
| 15. | Administrative affairs relating to hearings under Article 77 of the Act; |
| 16. | Administrative affairs relating to appointment of pharmaceutical inspectors under Article 78 of the Act; |
| 17. | Administrative affairs relating to revocation of a pharmacist or oriental medicine pharmacist license and suspension of qualifications as a pharmacist or oriental medicine pharmacist under Article 79 of the Act; |
| 18. | Administrative affairs relating to renewal of a license, permit, certificate of registration, etc. under Article 80 of the Act; |
| 19. | Administrative affairs relating to the imposition and collection of penalty surcharges under Articles 81 and 81-2 of the Act; |
| 20. | Administrative affairs relating to succession to the status of a manufacturer, etc. under Article 89 of the Act; |
| 21. | Administrative affairs relating to payment of a monetary award under Article 90 of the Act; |
[This Article Newly Inserted on Jan. 6, 2012]
| Article 38-3 Deleted. <Mar. 7, 2023> |
| Article 39 (Imposition and Collection of Administrative Fines) |
| (1) | The standards for imposing administrative fines referred to in Article 97-2 (1) of the Act shall be as listed in attached Table 3. <Newly Inserted by Mar. 13, 2015; Jun. 4, 2019> |
| (2) | The criteria for imposing administrative fines referred to in Articles 97-3 (1) and 98 (1) of the Act shall be as listed in attached Table 3. <Amended on Mar. 13, 2015; Oct. 17, 2023> |
| (3) | Deleted. <Dec. 13, 2016> |
[This Article Wholly Amended on Oct. 14, 2008]
ADDENDA <Presidential Decree No. 20130, Jun. 28, 2007>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation.
Article 2 (Herbal Drug Dispensation Examination)
| (1) | The Minister of Health and Welfare shall administer an herbal drug dispensation examination as referred to in the subparagraphs of Article 9 (1) of the Addenda to the Act, and require the national examination administrative agency under Article 2 to manage such examination. 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 implement the plan. <Amended on Jan. 29, 2020> |
| (2) | The Minister of Health and Welfare shall administer an herbal drug dispensation examination not less than once a year. |
| (3) | The herbal drug dispensation examination shall be divided into a written examination and a practical examination, and the examination subjects shall be as follows: |
| (4) | Where the head of the national examination, etc. administrative agency intends to hold an herbal drug dispensation examination, he or 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 due date for the 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 or 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 on May 1, 2012; Jan. 29, 2020> |
| (5) | The head of the national examination management agency may request the State and local governments, or relevant agencies or organizations for the cooperation in examination places, the distribution of application forms, examination proctors, etc., if necessary for the smooth administration of herbal drug dispensation examinations. <Amended on Jan. 29, 2020> |
| (6) | A person who intends to apply for an herbal drug dispensation examination shall submit an application, along with the following documents: <Amended on Jan. 29, 2020> |
| 1. | A person falling under Article 9 (1) 1 of the Addenda of the Act, a copy of a pharmacist's license; |
| 2. | A person falling under Article 9 (1) 2 of the Addenda of the Act shall have documents certifying that he or she has completed courses relevant to herbal drugs and a copy of his or her pharmacist's license. |
| (1) | Those who have passed the herbal drug dispensation examination shall be those who have scored at least 40 percent of the total score in each subject and at least 60 percent of the total score in all subjects. <Amended on Jan. 29, 2020> |
| (8) | The Minister of Health and Welfare shall issue a certificate of qualification for herbal drug dispensation to a person who has passed the herbal drug dispensation examination, as prescribed by Ordinance of the Ministry of Health and Welfare. <Amended on Jan. 29, 2020> |
| (9) | Any person who submits a written application provided in paragraph (6) 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. <Amended on Jan. 29, 2020> |
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.)
Article 2 Omitted.
Article 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 (Applicability to Public Announcement of Examinations)
Matters on the amendment of the deadline for a public announcement of examinations, etc. under this Decree shall begin to apply to an examination administered 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.
Article 2 Omitted.
Article 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) Article 3 (Transitional Measures concerning Members of the Central Pharmaceutical Affairs Advisory Committee)
| (1) | Members of the Central Pharmaceutical Affairs Advisory Committee 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 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 of the Central Pharmaceutical Affairs Advisory Committee appointed by the Minister of Health and Welfare under the previous provisions as at the time this Decree enters into force shall be deemed 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)
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 Inspections 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 inform the Minister of Health and Welfare of the results thereof without delay. Article 6 (Transitional Measures concerning Permission for Manufacturing and Distribution or Import of Items, and Permission of Modification)
Applications for permission for manufacturing and distribution of items or permission for modification thereof or for permission for import of each item or permission for modification thereof submitted to the Korea Food and Drug Administration under the previous provisions as at the time this Decree enters into force shall be deemed submitted to a regional office of food and drug safety having jurisdiction over each applicant's domicile pursuant to this Decree.
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 to Change of Subjects of National Examinations)
The amended provisions of Article 4 shall begin to apply to examinations administered after this Decree enters into force. Article 3 (Transitional Measures concerning Change of Subjects of National Examinations for Pharmacist License)
Notwithstanding the amended provisions of Article 4 (1), national examinations for a pharmacist license may be administered not later than February 29, 2016 pursuant to the previous Article 4 (1), regarding persons who entered a domestic university to major in pharmaceutics before January 1, 2009.
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.
Article 2 Omitted.
Article 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 provisions of attached Table 3 shall enter into force on September 19, 2014.
Article 2 (Applicability to Disposition on Defaulters of Penalty Surcharges)
The amended provisions of Article 34-2 (2) shall also apply to a person who fails to pay a penalty surcharge within a deadline for payment even after receiving a demand for payment 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, the 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 Standards for Imposition of Administrative Fines)
No disposition of imposing administrative fines for any violation committed before this Decree enters into force shall be included in the calculation of the number of violations under the amended provisions of attached Table 3.
ADDENDUM <Presidential Decree No. 28081, May 29, 2017>
This Decree shall enter into force on the date of its promulgation: Provided, That the amended provisions of Articles 32-2, 32-3 (1) 6, and 34-4 through 34-9 shall enter into force on June 3, 2017.
ADDENDA <Presidential Decree No. 28211, Jul. 26, 2017>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation: Provided, That the amendments to the Presidential Decrees, which were promulgated before this Act enters into force but whose enforcement dates have not yet arrived, among the Presidential Decrees amended by Article 8 of the Addenda, shall enter into force on the enforcement dates of the respective Presidential Decrees. Articles 2 through 8 Omitted.
ADDENDUM <Presidential Decree No. 28456, Nov. 28, 2017>
This Decree shall enter into force on the date of its promulgation: Provided, That the amended provisions of Article 38-2 and subparagraph 2 of attached Table 3 shall enter into force on December 3, 2017.
ADDENDA <Presidential Decree No. 28820, Apr. 24, 2018>
Article 1 (Enforcement Date)
This Decree shall enter into force on April 25, 2018: Provided, That the amended provisions of subparagraph 2 (g) and (h) of attached Table 3 shall enter into force on October 25, 2018.
Article 2 (Applicability to Delegation of Authority)
The amended provisions of Article 35 (1) 1 and 2 shall also apply where an application for renewal of permission for manufacturing and distribution of items or of permission for import of each item, or an application for renewal of a notification of manufacturing and distribution of items or of a notification of import of each item, is filed before this Decree enters into force. Article 3 Omitted.
ADDENDUM <Presidential Decree No. 29811, Jun. 4, 2019>
This Decree shall enter into force on December 12, 2019: Provided, That the amended provisions of subparagraph 2 (w) and (x) of attached Table 3 shall enter into force on June 12, 2019, and the amended provisions of Articles 13, 14, 14-2 and 20-2 on July 16, 2019.
ADDENDUM <Presidential Decree No. 29950, Jul. 2, 2019>
This Decree shall enter into force on the date of its promulgation. (Proviso Omitted.)
ADDENDUM <Presidential Decree No. 29983, Jul. 16, 2019>
ADDENDA <Presidential Decree No. 30170, Oct. 29, 2019>
Article 1 (Enforcement Date)
This Decree shall enter into force on November 1, 2019.
Article 2 Omitted.
Article 3 Omitted.
ADDENDA <Presidential Decree No. 30256, Dec. 24, 2019>
Article 1 (Enforcement Date)
This Decree shall enter into force on January 16, 2020. (Proviso Omitted.)
Articles 2 through 33 Omitted.
ADDENDUM <Presidential Decree No. 30372, Jan. 29, 2020>
This Decree shall enter into force on February 9, 2020.
ADDENDUM <Presidential Decree No. 30509, Mar. 3, 2020>
This Decree shall enter into force on the date of its promulgation.
ADDENDUM <Presidential Decree No. 30510, Mar. 3, 2020>
This Decree shall enter into force on the date of its promulgation.
ADDENDA <Presidential Decree No. 30545, Mar. 24, 2020>
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. 31047, Sep. 22, 2020>
Article 1 (Enforcement Date)
This Decree shall enter into force on October 8, 2020.
Article 2 Omitted.
ADDENDUM <Presidential Decree No. 31380, Jan. 5, 2021>
This Decree shall enter into force on the date of its promulgation. (Proviso Omitted.)
ADDENDUM <Presidential Decree No. 31603, Apr. 6, 2021>
This Decree shall enter into force on April 8, 2021.
ADDENDA <Presidential Decree No. 31614, Apr. 6, 2021>
Article 1 (Enforcement Date)
This Decree shall enter into force on April 6, 2021.
Article 2 Omitted.
Article 3 Omitted.
ADDENDA <Presidential Decree No. 32088, Oct. 19, 2021>
This Decree shall enter into force on January 21, 2022: Provided, That the following amended provisions shall enter into force on the dates classified as follows:
| 1. | The amended provisions of Articles 1-2, 2, and 34-9: Promulgation date; |
| 2. | The amended provisions of Articles 37-2 and 37-3: October 21, 2021; |
| 3. | The amended provisions of subparagraph 2 (u) of attached Table 3: July 21, 2022; |
| 4. | The amended provisions of subparagraph 2 (w) of attached Table 3: July 21, 2024. |
ADDENDUM <Presidential Decree No. 33052, Dec. 9, 2022>
This Decree shall enter into force on December 11, 2022
ADDENDUM <Presidential Decree No. 33112, Dec. 20, 2022>
This Decree shall enter into force on the date of its promulgation.
ADDENDUM <Presidential Decree No. 33321, Mar. 7, 2023>
This Decree shall enter into force on the date of its promulgation.
ADDENDA <Presidential Decree No. 33382, Apr. 11, 2023>
Article 1 (Enforcement Date)
This Decree shall enter into force on June 5, 2023.
Articles 2 through 5 Omitted.
ADDENDA <Presidential Decree No. 33818, Oct. 17, 2023>
This Decree shall enter into force on October 19, 2023: Provided, That the following amended provisions shall enter into force on the dates classified as follows:
| 1. | The amended provisions of Articles 34-9 and 35 (2): On the date of promulgation. |
| 3. | The amended provisions of subparagraph 2 (r) of attached Table 3: October 19, 2024. |
ADDENDUM <Presidential Decree No. 33913, Dec. 12, 2023>
This Decree shall enter into force on the date of its promulgation.
ADDENDUM <Presidential Decree No. 34225, Feb. 13, 2024>
This Decree shall enter into force on February 17, 2024: Provided, That the amended provisions of subparagraph 2 of attached Table 3 of the Enforcement Decree of the Pharmaceutical Affairs Act of Presidential Decree No. 33818 shall enter into force on July 21, 2024.