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BIOETHICS AND SAFETY ACT

Wholly Amended by Act No. 11250, Feb. 1, 2012

Amended by Act No. 11690, Mar. 23, 2013

Act No. 12447, Mar. 18, 2014

Act No. 12844, Nov. 19, 2014

Act No. 13651, Dec. 29, 2015

Act No. 14438, Dec. 20, 2016

Act No. 14839, Jul. 26, 2017

Act No. 15188, Dec. 12, 2017

Act No. 15888, Dec. 11, 2018

Act No. 16372, Apr. 23, 2019

CHAPTER I GENERAL PROVISIONS
 Article 1 (Purpose)
The purpose of this Act is to ensure bioethics and safety, thereby contributing to promoting citizens' health and improving their quality of life by preventing the violation of human dignity and values or the infliction of harm on human body in the course of researching on human beings, human materials, etc. or of handling embryos, genes, etc.
 Article 2 (Definitions)
The definitions of the terms used in this Act are as follows: <Amended by Act No. 13651, Dec. 29, 2015>
1. The term "human subjects research project" means a research project specified by Ordinance of the Minister of Health and Welfare, such as a research project physically involving a human being as a subject or conducted through communication, physical contact, or other means of interaction, and a research project conducted by using information with which individuals can be identified;
2. The term "human subject of research" means a person who is the subject of a human subjects research project;
3. The term "embryo" means a fertilized human ovum or a group of cells divided during a period from the time such ovum is fertilized until the time all organs are embryologically formed;
4. The term "surplus embryo" means an embryo left over after embryos produced as a consequence of in vitro fertilization are used for pregnancy;
5. The term "surplus oocyte" means a human oocyte left over after oocytes are used for in vitro fertilization;
6. The term "somatic-cell nuclear transplantation" means that a human somatic nucleus is transplanted into a human oocyte which is enucleated;
7. The term "parthenogenesis" means a form of reproduction in which a human ovum develops by cell division without being fertilized;
8. The term "somatic-cell cloning embryo" means a group of cells produced by somatic-cell nuclear transplantation;
9. The term "parthenogenic embryo" means a group of cells produced by parthenogenesis;
10. The term "embryonic stem cell line" means a cell line derived from an embryo, somatic-cell cloning embryo, or parthenogenic embryo, which can constantly multiply in culturable conditions and can be divided into various cells;
11. The term "human material" means a component of the human body, such as a tissue, a cell, blood, or body fluid collected or extracted from the human body; or serum, plasma, chromosomes, DNA (Deoxyribonucleic Acid), RNA (Ribonucleic Acid), protein, etc. separated from such component;
12. The term "human materials research project" means a research project on human materials through direct examination and analysis;
13. The term "biobank" means an institution that collects and stores human materials or genetic information, relevant epidemiological information, and clinical information so as to directly use such materials or information or provide them to other persons;
14. The term "genetic information" means information regarding the genetic characteristics of an individual, obtained by analyzing human materials of such individual;
15. The term "genetic test" means a test conducted to obtain genetic information from a human material, for identifying an individual or for preventing, diagnosing, or treating a disease;
16. The term "gene therapy" means a series of procedures to alter genes in the body or to transfer hereditary substances or cells to which hereditary substances are introduced, to the body, for the purpose of preventing or treating a disease;
17. The term "personally identifiable information" means information with which an individual can be identified, such as the name and resident registration number of a human subject of research or the donor of an embryo, oocyte, spermatozoon, or human material (hereinafter referred to as "human subject of research or donor");
18. The term "personal information" means information about an individual, such as personally identifiable information, genetic information, or information about health;
19. The term "anonymization" means the permanent deletion of personally identifiable information or full or partial substitution of personally identifiable information with an identification code given by an institution involved.
 Article 3 (Basic Principles)
(1) No act regulated under this Act shall be conducted in any manner that violates the dignity and values of a human being, and priority shall be given to human rights and welfare of each human subject of research or donor.
(2) Self-determination of each human subject of research or donor shall be respected, and the voluntary consent of a human subject of research or donor shall be supported by sufficient information.
(3) Privacy of each human subject of research or donor shall be protected, and personal information likely to lead to the invasion of privacy shall be protected as confidential information, except where the relevant party consents to disclosure or except as otherwise provided in any other statute.
(4) Full consideration shall be given to the safety of each human subject of research or donor, and risks shall be minimized.
(5) An individual or group in vulnerable conditions shall be specially protected.
(6) International cooperation shall be promoted as necessary to ensure bioethics and safety, and a person conducting such activities shall endeavor to adopt universal norms.
 Article 4 (Scope of Application)
(1) Except as otherwise provided in any other statute, bioethics and safety shall be governed by this Act.
(2) When it is intended to enact or amend any other statute providing for bioethics and safety, endeavors shall be made to ensure that such statute accords with this Act.
 Article 5 (Responsibilities of the State and Local Governments)
(1) The State and local governments shall formulate policies necessary to efficiently address bioethics and safety issues.
(2) The State and local governments shall formulate schemes to provide administrative and financial support to research and activities relating to bioethics and safety.
(3) The State and local governments shall ensure that educational institutions at various levels provide education about bioethics and safety and shall offer support for laying educational foundations, such as developing educational programs.
 Article 6 (Designation of Bioethics Policy Research Centers)
(1) In order to conduct specialized surveys, research, education, etc. with respect to policies on bioethics, the Minister of Health and Welfare may designate, as a bioethics policy research center, an institution, organization, or facility deemed to be capable of conducting such activities.
(2) Matters necessary for the designation, operation, etc. of a bioethics policy research center under paragraph (1) shall be prescribed by Ordinance of the Ministry of Health and Welfare.
CHAPTER II NATIONAL BIOETHICS COMMITTEE AND INSTITUTIONAL REVIEW BOARD
SECTION 1 National Bioethics Committee
 Article 7 (Establishment and Functions of National Bioethics Committee)
(1) In order to deliberate on the following matters regarding bioethics and safety, a National Bioethics Committee (hereinafter referred to as the "National Committee") shall be established as a presidential committee:
1. Establishment of basic national policies on bioethics and safety;
2. Affairs assigned to joint institutional review boards under Article 12 (1) 3;
3. Exemption from the deliberation on a human subjects research project under Article 15 (2);
4. Making and preservation of records and disclosure of information under Article 19 (3);
5. Research permitted to use surplus embryos under Article 29 (1) 3;
6. Categories, subject-matter, and the scope of research under Article 31 (2);
7. Research permitted to use embryonic stem cell lines under Article 35 (1) 3;
8. Exemption from the deliberation on a human materials research project under Article 36 (2);
9. Restrictions on genetic tests under Article 50 (1);
10. Other matters tabled by the chairperson of the National Committee, deemed likely to substantially affect society in connection with bioethics and safety.
(2) The chairperson of the National Committee shall introduce a bill, submitted by at least 1/3 of current members regarding a matter specified in paragraph (1) 1 through 9, to a meeting of the National Committee.
 Article 8 (Composition of National Committee)
(1) The National Committee shall be comprised of at least 16 and not more than 20 members, including one chairperson and one vice chairperson. <Amended by Act No. 11690, Mar. 23, 2013>
(2) The chairperson shall be appointed or commissioned by the President from among members, and the vice chairperson shall be elected by and from among members.
(3) The National Committee shall be comprised of the following members: <Amended by Act No. 11690, Mar. 23, 2013; Act No. 12844, Nov. 19, 2014; Act No. 14839, Jul. 26, 2017>
1. The Minister of Education, the Minister of Science and ICT, the Minister of Justice, the Minister of Trade, Industry and Energy, the Minister of Health and Welfare, and the Minister of Gender Equality and Family;
2. Not more than seven persons commissioned by the President from among persons who have abundant expertise and experience in research on biological science, medical science, or social science;
3. Not more than seven persons commissioned by the President from among representatives of religions, ethics circles, judicial circles, civic groups (referring to nonprofit, non-governmental organizations defined in Article 2 of the Assistance for Non-Profit, Non-Governmental Organizations Act) or women.
(4) Each member specified in paragraph (3) 2 and 3 shall hold office for a term of three years and may be appointed consecutively for further terms: Provided, That the term of office of a member newly commissioned to fill a vacancy shall be the remaining term of his or her predecessor.
(5) The National Committee shall have two secretaries, who are the Minister of Science and ICT and the Minister of Health and Welfare; and the Minister of Health and Welfare shall also serve as senior secretary. <Amended by Act No. 11690, Mar. 23, 2013; Act No. 14839, Jul. 26, 2017>
(6) In order to support the affairs, including the management of administrative affairs, of the National Committee, the Minister of Health and Welfare may designate a specialized institution related to bioethics and safety, so that the institution serves as a secretariat, as prescribed by Ordinance of the Ministry of Health and Welfare. <Newly Inserted by Act No. 12447, Mar. 18, 2014>
 Article 9 (Operation of National Committee)
(1) The National Committee may organize specialized committees for its efficient operation.
(2) The senior secretary shall take charge of administrative affairs of the National Committee.
(3) Meetings and activities of the National Committee shall be independent and open to the public, in principle.
(4) The National Committee may request parties to a case to make an appearance and make oral statements or to submit information. A person so requested shall comply with such request, unless justifiable grounds exist.
(5) Except as provided in this Act, the organization and operation of the National Committee and special committees and other necessary matters shall be prescribed by Presidential Decree.
SECTION 2 Institutional Review Boards
 Article 10 (Establishment and Functions of Institutional Review Boards)
(1) Any of the following institutions shall establish an institutional review board (hereinafter referred to as "IRB") so as to ensure bioethics and safety:
1. An educational institution, research institute, hospital, or similar institution, to which a person who conducts a human subjects research project (hereinafter referred to as "human subjects researcher") belongs;
2. An educational institution, research institute, hospital, or similar institution, to which a person who conducts a human materials research project (hereinafter referred to as "human materials researcher") belongs;
3. A medical institution producing embryos designated pursuant to Article 22 (1);
4. An embryo research institute registered pursuant to Article 29 (2);
5. A research institute for somatic-cell cloning embryos, etc. registered pursuant to Article 31 (3);
6. A biobank with permission from the Minister of Health and Welfare under Article 41 (1);
7. Other institutions specified by Ordinance of the Ministry of Health and Welfare as institutions likely to substantially affect society in connection with bioethics and safety.
(2) Notwithstanding paragraph (1), an institution shall be deemed to have an IRB, if it has entered into an agreement with the IRB of any other institution or a joint institutional review board under Article 12 (1), to entrust the affairs assigned to its IRB specified in paragraph (3) and Article 11 (4), as prescribed by Ordinance of the Ministry of Health and Welfare.
(3) An IRB shall take charge of the following affairs:
1. Deliberation on the following matters:
(a) Ethical and scientific validity of a research plan;
(b) Whether consent has been duly obtained from human subjects of research or donors;
(c) Matters regarding the safety of human subjects of research or donors;
(d) Measures for protecting personal information of human subjects of research or donors;
(e) Other matters regarding bioethics and safety in the relevant institution;
2. Inspection and supervision of the progress and outcomes of research projects conducted by the relevant institution;
3. The following activities for bioethics and safety:
(a) Education of researchers and employees of the relevant institution;
(b) Formulation of measures for protecting human subjects of research or donors in a vulnerable position;
(c) Establishment of ethical guidelines for researchers.
(4) An institution that has established an IRB pursuant to paragraph (1) shall file for registration of the IRB with the Minister of Health and Welfare.
(5) Matters necessary for functions of an IRB and the registration under paragraphs (3) and (4) shall be prescribed by Ordinance of the Ministry of Health and Welfare.
 Article 11 (Composition and Operation of IRBs)
(1) An IRB shall be comprised of at least five members, including one chairperson, with mixed gender; and shall include at least one person who has sufficient experience and knowledge to evaluate social and ethical validity and at least one person from outside of the relevant institution.
(2) Members of an IRB shall be commissioned by the head of the relevant institution specified in the subparagraphs of Article 10 (1), and the committee chairperson shall be elected by and from among the members.
(3) No member involved in a case of research, development, or use subject to deliberation shall participate in the deliberation of the relevant case of research, development, or use.
(4) If the head of an institution specified in the subparagraphs of Article 10 (1) discovers that a research project conducted by his or her institution has posed or is likely to pose a grave danger to bioethics or safety, he or she shall convene a meeting of the competent IRB without delay for deliberation and shall report to the Minister of Health and Welfare on the results of the deliberation.
(5) The head of an institution specified in the subparagraphs of Article 10 (1) shall ensure that the competent IRB maintains independence and shall provide administrative and financial support to the committee.
(6) An institution that has two or more IRBs established pursuant to Article 10 (1) may integrate such IRBs for efficient operation, as prescribed by Ordinance of the Ministry of Health and Welfare.
(7) Except as provided in paragraphs (1) through (6), matters necessary for organizing and operating an IRB shall be prescribed by Ordinance of the Ministry of Health and Welfare.
 Article 12 (Designation of Joint Institutional Review Boards and Joint Operation of IRBs)
(1) In order to authorize an IRB established pursuant to Article 10 (1) to conduct the following affairs, the Minister of Health and Welfare may designate such IRB as a joint institutional review board that institutions or researchers may jointly use (hereinafter referred to as "joint IRB"):
1. Affairs entrusted by an institution under an agreement made with the joint IRB pursuant to Article 10 (2);
2. Affairs requested by a human subjects researcher or human materials researcher not affiliated with any educational institution, research institute, hospital, or similar institution;
3. Other affairs specified by Ordinance of the Ministry of Health and Welfare after deliberation by the National Committee.
(2) Where two or more institutions conduct a joint research project and it is found inappropriate for the IRB of each institution involved in the research project to deliberate on the project severally, the institutions involved may select one of their IRBs to authorize it to exclusively deliberate on the research project.
(3) Matters necessary for the designation, functions, and operation of a joint IRB and the joint operation of an IRB under paragraphs (1) and (2) shall be prescribed by Ordinance of the Ministry of Health and Welfare.
 Article 13 (Support to IRBs)
(1) In order to appropriately supervise and support the operation of IRBs, the Minister of Health and Welfare shall take charge of the following affairs:
1. Inspection of IRBs;
2. Education of members of IRBs;
3. Other affairs specified by Ordinance of the Ministry of Health and Welfare as necessary to supervise and support IRBs.
(2) Matters necessary for inspection of IRBs and educational support shall be prescribed by Ordinance of the Ministry of Health and Welfare.
 Article 14 (Evaluation and Accreditation of IRBs)
(1) The Minister of Health and Welfare may evaluate and accredit the organization, operation performance, etc. of each IRB on a regular basis.
(2) The Minister of Health and Welfare may publish the results of accreditation of an IRB under paragraph (1) on a website or by other means.
(3) The head of a central administrative agency may subsidize an institution's budget or take measures to restrict provision of subsidies for research expenses, based on the results of accreditation under paragraph (1).
(4) If an IRB accredited under paragraph (1) falls under any of the following, the Minister of Health and Welfare may revoke its accreditation: Provided, That the Minister of Health and Welfare shall revoke the accreditation in cases falling under subparagraph 1:
1. If an IRB obtains accreditation by fraud or other improper means;
2. If an IRB ceases to meet a standard for accreditation under paragraph (5) because of a significant change in the organization or operation of the IRB.
(5) Matters necessary for the standards for accreditation referred to in paragraph (1) and the period for validity of such accreditation shall be prescribed by Presidential Decree.
CHAPTER III RESEARCH PROJECTS AND PROTECTION OF HUMAN SUBJECTS OF RESEARCH
 Article 15 (Deliberation on Human Subjects Research Projects)
(1) A person who intends to conduct a human subjects research project shall prepare a research plan and submit it for deliberation by the competent IRB before commencing such human subjects research project.
(2) Notwithstanding paragraph (1), a research project may be exempted from deliberation by the competent IRB, if a risk to human subjects of research and the general public is insignificant and the research project meets the standards prescribed by Ordinance of the Ministry of Health and Welfare after deliberation by the National Committee.
 Article 16 (Consent to Human Subjects Research Projects)
(1) A human subjects researcher shall obtain written consent (including consent given in an electronic document; hereinafter the same shall apply) regarding the following matters from human subjects of research before commencing a human subjects research project:
1. The objectives of the human subjects research project;
2. The duration, procedures for, and methods of participation of human subjects of research;
3. Foreseen risks and benefits to human subjects of research;
4. Protection of personal information;
5. Compensation for losses incurred through participation in the research project;
6. Provision of personal information;
7. Withdrawal of consent;
8. Other matters the competent IRB deems necessary.
(2) Notwithstanding paragraph (1), where a research project is to involve a person incapable of, or incompetent for, giving consent as a human subject of research, as specified by Ordinance of the Ministry of Health and Welfare, his or her representative specified in the following shall give written consent thereto. A representative's consent in such cases must not be contrary to the intention of the relevant human subject of research:
1. The legal representative;
2. If no legal representative is appointed, the spouse or a lineal ascendant or descendant shall act as an agent for such person in the abovementioned order; but if there are two or more lineal ascendants or descendants, the representative for such person shall be appointed under agreement by and between such ascendants or descendants, or the oldest person among them shall act as the representative for such person if they fail to reach an agreement.
(3) Notwithstanding paragraph (1), a research project may be exempted from obtaining written consent of a human subject of research, subject to approval from the competent IRB, if the research project satisfies all the following prerequisites. In such cases, a research project shall not be exempted from obtaining written consent of the representative under paragraph (2):
1. If it is deemed that obtaining consent from a human subject of research is impracticable in the course of research or is likely to seriously affect the validity of research;
2. If there is no ground to find that a human subject of research will decline consent or the risk to a human subject of research is very low even if the project is exempted from consent.
(4) A human subjects researcher shall fully explain the matters specified in paragraph (1) to a person having the right to consent before obtaining written consent from him or her pursuant to paragraphs (1) and (2).
 Article 17 (Safety Measures for Human Subjects of Research)
(1) A human subjects researcher shall assess the physical and mental impact of a research project and the research environment on human subjects of research and prepare safety measures before commencing the research project, and if he or she discovers that a research project in progress is likely to cause a serious harm to an individual or society, he or she shall immediately report thereon to the head of the institution, to which he or she belongs, and shall take appropriate measures therefor.
(2) No human subjects researcher shall delay medical treatment necessary to a human subject of research or deprive such person of an opportunity for diagnosis or prevention of a disease in the course of research relating to the diagnosis, treatment, or prevention of a disease.
 Article 18 (Provision of Personal Information)
(1) Where a human subjects researcher obtains written consent from a human subject of research for the provision of such subject's personal information to a third party pursuant to Article 16 (1), the researcher may provide the personal information to a third party, after deliberation thereon by the competent IRB.
(2) Where a human subjects researcher provides personal information about a human subject of research to a third party under paragraph (1), he or she shall anonymize such personal information: Provided, That the foregoing shall not apply where a human subject of research consents to leaving his or her personally identifiable information therein.
 Article 19 (Preservation of Records and Disclosure of Information)
(1) A human subjects researcher shall keep and preserve records about matters regarding a human subjects research project.
(2) A human subject of research may request the relevant human subjects researcher to disclose information about him or her, and the human subjects researcher so requested shall disclose relevant information, except in exceptional circumstances.
(3) Further details about the keeping and preservation of records and the disclosure of information under paragraphs (1) and (2) shall be prescribed by Ordinance of the Ministry of Health and Welfare, after deliberation by the National Committee.
CHAPTER IV PRODUCTION OF EMBRYOS AND RESEARCH THEREON
SECTION 1 Protection of Human Dignity and Identity
 Article 20 (Prohibition of Human Cloning)
(1) No person shall implant a somatic-cell cloning embryo or parthenogenic embryo (hereinafter referred to as "somatic-cell cloning embryo, etc.") into a human or animal womb, keep such embryo implanted, or bear a child therefrom.
(2) No person shall induce another person to conduct an act referred to in paragraph (1) or act as a broker for such act.
 Article 21 (Prohibition on Implantation between Different Species)
(1) No person shall implant a human embryo into an animal womb or implant an animal embryo into a human womb.
(2) No person shall engage in the following acts:
1. Fertilizing a human ovum with an animal sperm or an animal ovum with a human sperm: Provided, That medical tests for examining the activity of a human sperm shall be excluded herefrom;
2. Implanting an animal somatic nucleus into a human oocyte which is enucleated or implanting a human somatic nucleus into an animal oocyte which is enucleated;
3. Fusing a human embryo with an animal embryo;
4. Fusing human embryos with different genetic information.
(3) No person shall implant a thing produced from a procedure referred to in any subparagraph of paragraph (2) into a human or animal womb.
SECTION 2 Medical Institutions Producing Embryos
 Article 22 (Designation of Medical Institutions Producing Embryos)
(1) A medical institution that intends to extract and preserve oocytes or spermatozoa or to produce embryos through fertilization for purposes of in vitro fertilization shall be designated as a medical institution producing embryos by the Minister of Health and Welfare.
(2) A medical institution that intends to be designated as a medical institution producing embryos shall secure facilities and human resources, as prescribed by Ordinance of the Ministry of Health and Welfare.
(3) Matters necessary for the standards and procedures for the designation of medical institutions producing embryos shall be prescribed by Ordinance of the Ministry of Health and Welfare.
(4) When a medical institution producing embryos designated under paragraph (1) (hereinafter referred to as "medical institution producing embryos") intends to change an important matter specified by Ordinance of the Ministry of Health and Welfare, it shall report to the Minister of Health and Welfare on such change.
(5) If a medical institution producing embryos suspends or closes its business operations, the head of such medical institution shall report thereon to the Minister of Health and Welfare, as prescribed by Ordinance of the Ministry of Health and Welfare.
(6) When a medical institution producing embryos suspends or closes its business operations, the head of such medical institution shall transfer embryos, reproductive cells, and relevant documents in its custody to the Korea Centers for Disease Control and Prevention or another medical institution producing embryos, as prescribed by Ordinance of the Ministry of Health and Welfare.
 Article 23 (Matters to Be Observed regarding Production of Embryos)
(1) No person shall produce an embryo for any purpose other than pregnancy.
(2) No person shall conduct any of the following acts in producing an embryo:
1. Selecting an ovum and sperm for fertilization with intent to choose a particular sex;
2. Fertilizing with a decedent's ovum or sperm;
3. Fertilizing with a minor's ovum or sperm: Provided, That cases where a married minor attempts to fertilize in order to have a child shall be excluded herefrom.
(3) No person shall provide or use an embryo, oocyte, or spermatozoon for money, an interest in property, or any other consideration; solicit another person to provide or use an embryo, oocyte, or spermatozoon for such consideration; or act as a broker for providing or using an embryo, oocyte, or spermatozoon.
 Article 24 (Consent to Production of Embryos)
(1) When a medical institution producing embryos intends to extract oocytes or spermatozoa in order to produce embryos, it shall obtain written consent to the following matters from the donor of the oocytes or spermatozoa, the person to undergo in vitro fertilization and the spouse, if any, of the donor or the person to undergo IVF: Provided, That if a person involved has a disability, heed shall be given to the person's particular conditions in seeking for consent to such acts:
1. The objectives of producing embryos;
2. The preservation period of embryos, oocytes, or spermatozoa and other matters regarding preservation;
3. Discarding of embryos, oocytes, or spermatozoa;
4. Use of surplus embryos or oocytes for the purpose of research;
5. Alteration to, or withdrawal of, consent;
6. Protection of rights of the person with the right to consent and information about such person and other matters specified by Ordinance of the Ministry of Health and Welfare.
(2) A medical institution producing embryos shall fully explain matters specified in the subparagraphs of paragraph (1) to persons with the right to consent before obtaining written consent pursuant to paragraph (1).
(3) Matters necessary for the form of the written consent specified in paragraph (1) and the preservation of such consent shall be prescribed by Ordinance of the Ministry of Health and Welfare.
 Article 25 (Preservation and Discarding of Embryos)
(1) The period for preservation of embryos shall be five years: Provided, That if the period set by a person with the right to consent is less than five years, embryos shall be preserved only for such period.
(2) Notwithstanding paragraph (1), a person with the right to consent may extend the preservation period beyond five years in cases specified by Ordinance of the Ministry of Health and Welfare, such as an anticancer therapy.
(3) A medical institution producing embryos shall discard embryos that will not be used for the purpose of research under Article 29, among embryos for which the preservation period set under paragraph (1) or (2) ends.
(4) A medical institution producing embryos shall keep and preserve records of details about the discarding of embryos.
(5) The procedures and methods of discarding embryos and matters necessary for keeping and preserving records of details about the discarding of embryos under paragraphs (3) and (4) shall be prescribed by Ordinance of the Ministry of Health and Welfare.
 Article 26 (Provision of Surplus Embryos or Oocytes)
(1) Where a medical institution producing embryos provides surplus embryos necessary for research projects to an embryo research institute with an embryo research plan approved pursuant to Article 30 (1) or offers surplus oocytes to a research institute with a research plan approved regarding somatic-cell cloning embryos, etc. pursuant to Article 31 (4), such provision or offer shall be made free of charge: Provided, That a medical institution producing embryos may request a research institute to which surplus embryos or oocytes are provided, to reimburse it for expenses incurred in preserving and providing such embryos or oocytes, as prescribed by Ordinance of the Ministry of Health and Welfare.
(2) The procedures for providing surplus embryos or oocytes and the calculation of expenses therefor under paragraph (1) and other necessary matters shall be prescribed by Ordinance of the Ministry of Health and Welfare.
(3) A medical institution producing embryos shall report details about the preservation, provision, etc. of surplus embryos or oocytes to the Minister of Health and Welfare, as prescribed by Ordinance of the Ministry of Health and Welfare.
 Article 27 (Protection of Donors of Oocytes)
(1) A medical institution producing embryos shall examine the health of an oocytes donor before it extracts oocytes from her, as prescribed by Ordinance of the Ministry of Health and Welfare.
(2) No medical institution producing embryos shall extract oocytes from a person whose health fails to meet a standard prescribed by Ordinance of the Ministry of Health and Welfare.
(3) No medical institution producing embryos shall extract oocytes from one and the same donor in excess of the frequency specified by Presidential Decree.
(4) A medical institution producing embryos may pay an oocytes donor an amount specified by Ordinance of the Ministry of Health and Welfare for the expense items specified by Ordinance of the Ministry of Health and Welfare, including compensation for the time required for the operation necessary to donate oocytes and for recovery from the operation and travel expenses.
 Article 28 (Matters to Be Observed by Medical Institutions Producing Embryos)
(1) A medical institution producing embryos shall comply with the following: <Amended by Act No. 13651, Dec. 29, 2015>
1. A medical institution producing embryos shall comply with the terms and conditions of the written consent obtained pursuant to Article 24 in handling embryos, oocytes, or spermatozoa;
2. A medical institution producing embryos shall strictly adhere to the Ordinance of the Ministry of Health and Welfare in preserving, handling, discarding, and managing surplus embryos or oocytes;
3. Other rules prescribed by Ordinance of the Ministry of Health and Welfare as necessary to ensure bioethics and safety.
(2) In order to appropriately manage consents, etc. to the production of embryos, etc., the Minister of Health and Welfare shall determine guidelines for the standard operation of medical institutions producing embryos and advise medical institutions producing embryos to comply therewith. <Newly Inserted by Act No. 13651, Dec. 29, 2015>
[Title of This Article Amended by Act No. 13651, Dec. 29, 2015]
SECTION 3 Research on Surplus Embryos
 Article 29 (Research on Surplus Embryos)
(1) A surplus embryo for which the preservation period set under Article 25 ends may be used externally for any of the following purposes of research only before the primitive streak appears during embryonic development:
1. Research for the development of therapies for infertility and technology for contraception;
2. Research on therapies for muscular dystrophy or other rare or incurable diseases specified by Presidential Decree;
3. Research specified by Presidential Decree after deliberation by the National Committee.
(2) A person who intends to conduct research on surplus embryos under paragraph (1) shall secure facilities and human resources specified by Ordinance of the Ministry of Health and Welfare and shall file for registration of the establishment as an embryo research institute with the Minister of Health and Welfare.
(3) If an embryo research institute registered pursuant to paragraph (2) (hereinafter referred to as "embryo research institute") intends to change an important matter specified by Ordinance of the Ministry of Health and Welfare or to close its business operations, it shall report thereon to the Minister of Health and Welfare.
 Article 30 (Approval of Plans for Research on Embryos)
(1) If an embryo research institute intends to conduct research on surplus embryos, it shall, in advance, submit a plan for research on embryos to the Minister of Health and Welfare for approval. The same shall also apply to the change of an important matter specified by Presidential Decree in the details of the approved plan for research on embryos.
(2) A plan for research on embryos under paragraph (1) shall be accompanied by documents about the results of deliberation by the competent IRB.
(3) Upon receipt of a plan for research on embryos from an embryo research institute that the head of any other central administrative agency subsidizes for research expenses, the Minister of Health and Welfare shall consult thereon with the head of the central administrative agency before determining whether to approve the plan.
(4) The standards and procedures for approval of a plan for research on embryos, documents required therefor, and other necessary matters shall be prescribed by Ordinance of the Ministry of Health and Welfare.
 Article 31 (Research on Somatic-Cell Cloning Embryos)
(1) No person shall engage in somatic-cell nuclear transplantation or parthenogenesis for any purpose other than research on a therapy for a rare or incurable disease under Article 29 (1) 2.
(2) The categories, targets, and scope of research under paragraph (1) shall be prescribed by Presidential Decree after deliberation by the National Committee.
(3) A person who intends to produce, or conduct research on, somatic-cell cloning embryos, etc. shall secure facilities and human resources specified by Ordinance of the Ministry of Health and Welfare and file for registration of the establishment with the Minister of Health and Welfare.
(4) If an institution registered pursuant to paragraph (3) (hereinafter referred to as "research institute for somatic-cell cloning embryos, etc.") intends to produce, or conduct research on, somatic-cell cloning embryos, etc., it shall, in advance, submit a research plan (hereinafter referred to as "plan for research on somatic-cell cloning embryos, etc.") to the Minister of Health and Welfare for approval, as prescribed by Ordinance of the Ministry of Health and Welfare.
(5) Article 30 shall apply mutatis mutandis to approval of a plan for research on somatic-cell cloning embryos, etc. In such cases, "surplus embryos" shall be construed as "somatic-cell cloning embryos, etc.", and "plan for research on embryos" as "plan for research on somatic-cell cloning embryos, etc.", respectively.
 Article 32 (Matters to Be Observed by Embryo Research Institutes)
(1) Where a research project conducted by an embryo research institute or a research institute for somatic-cell cloning embryos, etc. has posed or is likely to pose a grave danger to bioethics or safety, such institute shall discontinue the research project or take other appropriate measures.
(2) Article 25 (3) through (5) shall apply mutatis mutandis where an embryo research institute or a research institute for somatic-cell cloning embryos, etc. intends to disuse surplus embryos or oocytes for the purpose of research after it acquires such embryos or oocytes. In such cases, "embryos" shall be construed as "surplus embryos or oocytes".
(3) Article 28 shall apply mutatis mutandis where an embryo research institute manages surplus embryos or where a research institute for somatic-cell cloning embryos, etc. manages surplus oocytes or somatic-cell cloning embryos, etc.
SECTION 4 Embryonic Stem Cell Lines
 Article 33 (Registration of Embryonic Stem Cell Lines)
(1) A person who establishes or imports embryonic stem cell lines shall either provide such embryonic stem cell lines to a third person pursuant to Article 34 or file for registration of such embryonic stem cell lines with the Minister of Health and Welfare pursuant to Article 35 before using them, as prescribed by Ordinance of the Ministry of Health and Welfare.
(2) If a person who applies for the registration of embryonic stem cell lines has successfully passed a scientific test conducted by the head of any other central administrative agency, the Minister of Health and Welfare shall utilize data from the test in granting the registration under paragraph (1).
(3) The Minister of Health and Welfare may fully or partially subsidize a person who files for registration of embryonic stem cell lines pursuant to paragraph (1) for expenses incurred in testing the embryonic stem cell lines.
 Article 34 (Provision of Embryonic Stem Cell Lines)
(1) If a person who has established an embryonic stem cell line intends to provide it to a third person, he or she shall undertake deliberation by the competent IRB, as prescribed by Ordinance of the Ministry of Health and Welfare.
(2) A person who provides an embryonic stem cell line to a third person pursuant to paragraph (1) shall report the current status of the provided embryonic stem cell line to the Minister of Health and Welfare, as prescribed by Ordinance of the Ministry of Health and Welfare.
(3) An embryonic stem cell line under paragraph (1) shall be provided free of charge: Provided, That a person who provides an embryonic stem cell line may demand the third person to whom it is provided, to reimburse him or her for expenses incurred in preserving and providing the embryonic stem cell line, as prescribed by Ordinance of the Ministry of Health and Welfare.
(4) Matters necessary for providing and reporting embryonic stem cell lines and the method of calculating expenses therefor under paragraphs (1) through (3) shall be prescribed by Ordinance of the Ministry of Health and Welfare.
 Article 35 (Use of Embryonic Stem Cell Lines)
(1) Embryonic stem cell lines registered pursuant to Article 33 (1) may be used externally only for the purpose of conducting the following research projects:
1. Research projects for diagnosis, prevention, or treatment of a disease;
2. Basic research projects on characteristics and division of stem cells;
3. Other research projects specified by Presidential Decree after deliberation by the National Committee.
(2) A person who intends to use an embryonic stem cell line pursuant to paragraph (1) shall submit the relevant research plan to be deliberated on by the competent IRB and shall obtain approval thereof from the head of the relevant institution, as prescribed by Ordinance of the Ministry of Health and Welfare. The same shall also apply to the change of an important matter specified by Presidential Decree in the details of the approved research plan.
(3) A person who has obtained approval of a plan or approval for change of such plan pursuant to paragraph (2) shall report relevant facts to the Minister of Health and Welfare, as prescribed by Ordinance of the Ministry of Health and Welfare.
(4) A person who has obtained approval of a plan pursuant to paragraph (2) shall prepare a plan for the use of the provided embryonic stem cell line and shall submit the plan to the person who has provided the embryonic stem cell line.
(5) The head of the institution who approves a research project pursuant to paragraph (2) shall supervise the person who conducts the research project so as to ensure that the person complies with the relevant plan in conducting the research project.
CHAPTER V HUMAN MATERIALS RESEARCH PROJECTS AND BIOBANKS
SECTION 1 Human Materials Research Projects
 Article 36 (Deliberation on Human Materials Research Projects)
(1) A person who intends to conduct a human materials research project shall undertake deliberation on the relevant research plan by the competent IRB before commencing such research project.
(2) Notwithstanding paragraph (1), where a research project poses an insignificant danger to donors of a human material and to the general public and meets the standards prescribed by Ordinance of the Ministry of Health and Welfare after deliberation by the National Committee, such research project may be exempted from deliberation by the competent IRB.
 Article 37 (Consent to Human Materials Research Projects)
(1) A human materials researcher shall obtain written consent regarding the following matters from donors of a human material before commencing the human materials research project:
1. The objectives of the human materials research project;
2. Protection and management of personal information;
3. Preservation and discarding of human materials;
4. Provisions of human materials and genetic information obtained from human materials (hereinafter referred to as "human materials, etc.");
5. Withdrawal of consent, disposal of human materials if consent is withdrawn, rights of donors of a human material, change of the objectives, and other matters specified by Ordinance of the Ministry of Health and Welfare.
(2) Article 16 (2) shall apply mutatis mutandis to the consent of a representative in cases where the donor of a human material is incapable of, or incompetent for, giving consent. In such cases, “human subject of research” shall be construed as “donor of a human material”. <Newly Inserted by Act No. 15888, Dec. 11, 2018>
(3) Notwithstanding paragraphs (1) and (2), if a human materials researcher conducts research with a human material provided by a person who is not a human materials researcher but extracted the human material, the human materials researcher shall be deemed to have obtained written consent pursuant to paragraph (1) at the time the person who extracted the human material obtained written consent from the donor (including the representative prescribed in Article 16 (2), which applies mutatis mutandis under paragraph (2); hereafter in this Article and Article 38 the same shall apply) of the human material regarding matters specified in paragraph (1). <Amended by Act No. 15888, Dec. 11, 2018>
(4) Article 16 (3) shall apply mutatis mutandis to the exemption of a human materials research project from written consent. In such cases, "human subject of research" shall be construed as "donor of a human material".
(5) A human materials researcher shall fully explain the matters specified in paragraph (1) to the donor of a human material before obtaining written consent under paragraphs (1) and (2) from him or her. <Amended by Act No. 15888, Dec. 11, 2018>
(6) Matters necessary for the form, etc. of the written consent under paragraphs (1) and (2) shall be prescribed by Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 15888, Dec. 11, 2018>
 Article 38 (Provision of Human Materials)
(1) If a human materials researcher has obtained written consent from the donor of a human material regarding the provision of human materials, etc. pursuant to Article 37 (1) and (2), such researcher may provide the human material, etc. to a biobank or another researcher, after deliberation thereon by the competent IRB. <Amended by Act No. 15888, Dec. 11, 2018>
(2) When a human materials researcher provides a human material, etc. to another researcher pursuant to paragraph (1), such researcher shall anonymize the human material, etc.: Provided, That the foregoing shall not apply where the donor of the human material consents to leaving personally identifiable information therein.
(3) A human material, etc. provided pursuant to paragraph (1) shall be offered free of charge: Provided, That an institution to which the human materials researcher belongs may demand the person who conducts a research project with the provided human material, etc. to reimburse it for expenses incurred in preserving and providing the human material, etc., as prescribed by Ordinance of the Ministry of Health and Welfare.
(4) If a human materials researcher provides a human material, etc. to any person or acquires a human material, etc. provided by any person pursuant to paragraph (1), such researcher shall keep and preserve records about the provision of the human material, etc., as prescribed by Ordinance of the Ministry of Health and Welfare.
(5) The methods and procedures for providing human materials, etc., the calculation of expenses therefor, and other necessary matters shall be prescribed by Ordinance of the Ministry of Health and Welfare.
 Article 39 (Preservation and Discarding of Human Materials)
(1) A human materials researcher shall discard a human material, etc. at the lapse of the duration set in the relevant written consent: Provided, That if such researcher receives a request from the donor of the human material, while preserving the human material, etc., to amend the duration of preservation or to discard the human material, etc., the researcher shall comply with such request.
(2) A human materials researcher shall keep and preserve records of details about the discarding of human materials, etc. under paragraph (1), as prescribed by Ordinance of the Ministry of Health and Welfare.
(3) Where a human materials researcher is unable to preserve human materials, etc. due to inevitable circumstances, such researcher shall dispose of, or transfer, the human materials, etc., after deliberation thereon by the competent IRB.
(4) Matters necessary for the preservation, discarding, disposal, or transfer of human materials, etc. shall be prescribed by Ordinance of the Ministry of Health and Welfare.
 Article 40 (Matters to Be Observed by Human Materials Researchers)
Articles 17 and 19 shall apply mutatis mutandis to the safety measures for donors of a human material taken by human materials researchers and the preservation of records and disclosure of information, respectively. In such cases, “human subjects research project” shall be construed as “human materials research project”, and “human subject of research” as “donor of a human material”, respectively.
SECTION 2 Biobanks
 Article 41 (Permission for, and Reporting of, Biobanks)
(1) A person who intends to establish a biobank shall obtain permission therefor from the Minister of Health and Welfare, as prescribed by Presidential Decree: Provided, That the foregoing shall not apply to a State agency that intends to directly establish a biobank.
(2) Notwithstanding paragraph (1), if a person who intends to establish a biobank with approval from the head of a central administrative agency for subsidizing research expenses pursuant to any other statute or regulation reports thereon to the Minister of Health and Welfare after obtaining approval from the head of the central administrative agency for subsidizing research expenses, such person shall be deemed to have obtained permission required under paragraph (1). In such cases, the head of the competent central administrative agency shall consult thereon with the Minister of Health and Welfare in advance.
(3) If a biobank established pursuant to paragraphs (1) and (2) intends to change any important matter specified by Presidential Decree or suspends or closes its business operations, it shall report thereon to the Minister of Health and Welfare.
(4) The standards for facilities and equipment of a biobank, the procedures for permission for, and reporting of, a biobank, and other necessary matters shall be prescribed by Presidential Decree.
 Article 42 (Consent to Extraction of Human Materials)
(1) When a biobank intends to directly extract a human material for a human materials research project or to request a third person to extract a human material for such purpose, it shall obtain written consent regarding the following matters from the donor of the human material, prior to such extraction:
1. The objectives of the human materials research project (only applicable where the biobank directly conducts the human materials research project);
2. Protection and disposal of personal information;
3. The scope of researchers and institutions that are provided with the human material, etc.;
4. Preservation, management, and discarding of the human material, etc.;
5. Withdrawal of consent, disposal of the human material, etc. when consent is withdrawn, rights of the donor of the human material, and other matters specified by Ordinance of the Ministry of Health and Welfare.
(2) A biobank shall fully explain the matters specified in paragraph (1) to the donor of a human material before obtaining written consent pursuant to paragraph (1).
(3) Matters necessary for the form, etc. of the written consent under paragraph (1) shall be prescribed by Ordinance of the Ministry of Health and Welfare.
 Article 42-2 (Provision of Surplus Samples)
(1) Notwithstanding Article 42, a biobank can be provided from a medical institution (referring to any medical institution established under the Medical Service Act; hereafter in this Article the same shall apply) with any human material left over after the medical institution has used for the purpose of treatment or diagnosis (hereinafter referred to as “surplus sample”) only for research purposes in compliance with the manner and procedures provided in paragraphs (2) through (6). In such cases, medical institutions shall not collect any human material in excess of the volume necessary for treatment or diagnosis for the purpose of providing surplus samples.
(2) A medical institution that intends to provide surplus samples for biobanks shall give the donor subject written notice stating the following information before the medical institution collects the human materials it intends to provide. In such cases, the medical institution shall also explain the information referred to in subparagraph 1 orally to the donor subject:
1. The fact that the surplus samples can be provided to biobanks unless the donor subject expresses his or her opposition;
2. The manner and procedures in which the donor subject expresses his or her opposition under subparagraph 1;
3. The method of anonymizing the surplus samples;
4. Matters about the preservation, management, discarding, and use of the surplus samples;
5. Other matters prescribed by Ordinance of the Ministry of Health and Welfare.
(3) In receipt of written notice under paragraph (2), a donor subject who intends to oppose to the provision of surplus samples, shall express his or her opposition in writing form signed or sealed by himself or herself or in other manners prescribed by Ordinance of the Ministry of Health and Welfare. In such cases, a refusal to accept written notice given under paragraph (2) shall be construed as expression of opposition under the former part.
(4) A medical institution shall not provide biobanks with any surplus samples to which the donor subject has expressed his or her opposition under paragraph (3).
(5) A medical institution shall determine the purposes and objects for which surplus samples are provided and the method of anonymizing such surplus samples, and shall obtain approval from its IRB, before providing the surplus samples.
(6) A medical institution shall anonymize surplus samples when it provides such samples for biobanks under paragraph (1).
(7) Provision of surplus samples by medical institutions under paragraph (1) shall be free of charge: Provided, That if any expenses are incurred by a medical institution in preserving and providing surplus samples, the medical institution may request reimbursement of the expenses from biobanks, as prescribed by Ordinance of the Ministry of Health and Welfare.
(8) Upon provision of a surplus sample, a medical institution shall keep and preserve records on the provision of the surplus sample, as prescribed by Ordinance of the Ministry of Health and Welfare.
(9) Article 43 shall apply mutatis mutandis to the provision of surplus samples by biobanks. In such cases, “human material, etc.” shall be construed as “surplus sample”.
(10) The manner and procedures in which written notice shall be given under paragraph (2) and donor subjects shall express their opposition under paragraph (3), the items requiring approval of IRBs and approval procedures under paragraph (5), and other necessary matters shall be prescribed by Ordinance of the Ministry of Health and Welfare.
[This Article Newly Inserted by Act No. 16372, Apr. 23, 2019]
 Article 42-3 (Management of Surplus Samples)
(1) The head of a biobank or its employees shall not use, discard, or damage any surplus samples preserved by the biobank without good cause.
(2) Article 39 shall apply mutatis mutandis to the preservation and discarding of surplus samples by biobanks. In such cases, “human materials researcher” shall be construed as “biobank”, and “human material, etc.” as “surplus sample”.
(3) If a biobank is provided with a surplus sample under Article 42-2 (1), it shall anonymize the surplus sample.
(4) The head of a biobank shall formulate personal information protection guidelines, including schemes for anonymizing surplus samples, as prescribed by Ordinance of the Ministry of Health and Welfare, and shall designate a manager in charge of the management and security of personal information.
[This Article Newly Inserted by Act No. 16372, Apr. 23, 2019]
 Article 43 (Provision of Human Materials)
(1) The head of a biobank shall require a person who intends to acquire a human material, etc. to submit a plan for the use of the human material, etc., and shall examine the plan to determine whether to provide the human material, etc.
(2) Where the head of a biobank provides a human material, etc. to any other person, he or she shall anonymize the human material, etc.: Provided, That the foregoing shall not apply where the donor of a human material consents to leaving his or her personally identifiable information therein.
(3) Where the head of a biobank provides a human material, etc. to any other person, such provision shall be made free of charge: Provided, That the head of a biobank may demand a person who is provided with a human material, etc., to reimburse him or her for expenses incurred in preserving and providing the human material, etc., as prescribed by Ordinance of the Ministry of Health and Welfare.
(4) An IRB shall formulate guidelines necessary to provide human materials, etc. and shall regularly review whether human materials, etc. are provided properly in compliance with the guidelines.
(5) The details of a plan for the use of human materials, etc., the procedures for the submission of such plan, the guidelines to provide human materials, etc., the review by an IRB, and other matters necessary for providing and managing human materials, etc. shall be prescribed by Ordinance of the Ministry of Health and Welfare.
 Article 44 (Matters to Be Observed by Biobanks)
(1) The head or an employee of a biobank shall not use, discard, or destroy human materials, etc. in its custody without good cause.
(2) When a biobank receives human materials, etc. provided pursuant to Article 38 (1) or 53 (1), it shall anonymize the human materials, etc.
(3) Article 39 shall apply mutatis mutandis to the preservation and discarding of human materials, etc. by a biobank.
(4) The head of a biobank shall formulate personal information protection guidelines, including schemes for anonymizing human materials, etc., as prescribed by Ordinance of the Ministry of Health and Welfare, and shall designate a manager in charge of the management and security of personal information.
 Article 45 (Support to Biobanks)
The State or a local government may subsidize a biobank for expenses incurred in operation, within the budget.
CHAPTER VI GENE THERAPY AND TESTING
 Article 46 (Prohibition of Discrimination Based on Genetic Information)
(1) No person shall discriminate against any person on the ground of genetic information in education, employment, promotion, insurance, or any other social activity.
(2) Except as otherwise provided in any other statute, no person shall compel any other person to undergo a genetic test or to submit the results of a genetic test.
(3) No medical institution shall include genetic information in medical records, therapy records, etc. provided to any person other than the patient himself or herself pursuant to Article 21 (3) of the Medical Service Act: Provided, That the foregoing shall not apply where another medical institution requests to provide such records for the purpose of diagnosis or treatment of the same disease as the disease of the patient involved and measures for protecting personal information are taken. <Amended by Act No. 14438, Dec. 20, 2016>
 Article 47 (Gene Therapies)
(1) Research on a gene therapy that falls into a series of procedures to alter genes in the body may be conducted only in cases that meet both of the following conditions: <Amended by Act No. 13651, Dec. 29, 2015>
1. Research on a therapy for a hereditary disease, Acquired Immune Deficiency Syndrome (AIDS), or any other disease that threatens one's life or causes a severe disability;
2. Research on a therapy where there is no applicable therapy at present or the effect of a gene therapy is expected to be significantly better than other therapies.
(2) Research on a gene therapy that falls into a series of procedures to transfer hereditary substances or cells to which hereditary substances are introduced, to the body may be conducted only when falling under either subparagraph 1 or 2 of paragraph (1). <Newly Inserted by Act No. 13651, Dec. 29, 2015>
(3) No gene therapy shall be applied to an embryo, ovum, sperm, or fetus. <Amended by Act No. 13651, Dec. 29, 2015>
 Article 48 (Gene Therapy Institutions)
(1) A medical institution that intends to apply a gene therapy shall file a report thereon to the Minister of Health and Welfare. The same shall also apply where such institution intends to change an important matter specified by Presidential Decree.
(2) A medical institution that has filed a report on its business with the Minister of Health and Welfare pursuant to paragraph (1) (hereinafter referred to as "gene therapy institution") shall, in advance, explain the following to each patient to whom it intends to apply a gene therapy and shall obtain written consent thereto:
1. The objectives of the therapy;
2. Expected results and side-effects of the therapy;
3. Other matters prescribed by Ordinance of the Ministry of Health and Welfare.
(3) The conditions and procedures for filing a report of gene therapy institutions, the form of the written consent, and other necessary matters shall be prescribed by Ordinance of the Ministry of Health and Welfare.
 Article 49 (Genetic Testing Institutions)
(1) A person who intends to conduct genetic tests shall secure such facilities, human resources, etc. required depending on genetic test items as prescribed by Ordinance of the Ministry of Health and Welfare and shall file a report on his or her business with the Minister of Health and Welfare: Provided, That the foregoing shall not apply to a State agency that intends to conduct genetic tests.
(2) A change to any important matter specified by Presidential Decree, among matters reported pursuant to paragraph (1), shall be also reported.
(3) The Minister of Health and Welfare may require a genetic testing institution that has filed a report on its business pursuant to paragraph (1) (hereinafter referred to as "genetic testing institution") to undergo the evaluation of the accuracy of genetic tests, as prescribed by Ordinance of the Ministry of Health and Welfare, and may disclose the results thereof to the public.
(4) Where a genetic testing institution intends to suspend or close its business operations of genetic testing, it shall file a report thereon with the Minister of Health and Welfare, as prescribed by Ordinance of the Ministry of Health and Welfare.
(5) Where a genetic testing institution has filed a report on its business closure with the head of the competent tax office pursuant to Article 8 of the Value-Added Tax Act or where the head of the competent tax office has canceled the business registration of a genetic testing institution, the Minister of Health and Welfare may ex officio delete records of the reporting of the genetic testing institution. <Amended by Act No. 15188, Dec. 12, 2017>
(6) Where necessary to delete the reported matters ex officio under paragraph (5), the Minister of Health and Welfare may request the head of the competent tax office to furnish information on whether the genetic testing institution has closed its business operations. In this case, the head of the competent tax office in receipt of the request shall provide the requested information in accordance with Article 36 (1) of the Electronic Government Act. <Newly Inserted by Act No. 15188, Dec. 12, 2017>
 Article 50 (Restrictions on Genetic Tests)
(1) No genetic testing institution shall conduct any genetic test for physical appearance or character which has no reliable scientific proof and is likely to mislead the testee, or other genetic tests specified by Presidential Decree after deliberation by the National Committee.
(2) A genetic testing institution may conduct a genetic test for an embryo or fetus only for diagnosing muscular dystrophy or other hereditary diseases specified by Presidential Decree.
(3) No genetic testing institution, other than a medical institution, shall conduct a genetic test in connection with the prevention, diagnosis, or treatment of a disease except in the following cases: <Amended by Act No. 13651, Dec. 29, 2015>
1. Where it is requested by a medical institution;
2. Where it conducts a genetic test related to the prevention of a disease, which is deemed necessary by the Minister of Health and Welfare.
(4) No genetic testing institution shall make a misrepresentation or an exaggerated advertisement regarding genetic tests. The standards and procedures for judgment on misrepresentation or exaggerated advertisement and other necessary matters shall be prescribed by Ordinance of the Ministry of Health and Welfare.
 Article 51 (Consent to Genetic Testing)
(1) When a genetic testing institution intends to collect a material to be used for a genetic test on a testee or to request a third person to collect such material from a testee, it shall obtain written consent from the testee regarding the following, before collecting the material for testing: Provided, That if a testee has a disability, heed shall be given to the person's particular conditions in seeking for consent:
1. The objectives of the genetic test;
2. Management of the material for testing;
3. Withdrawal of consent, the protection of rights and information of the testee, and other matters specified by Ordinance of the Ministry of Health and Welfare.
(2) If a genetic testing institution intends to provide a material for testing to a human material researcher or a biobank, it shall obtain written consent from the testee regarding the following in addition to the consent under paragraph (1):
1. Protection and disposal of personal information;
2. Preservation, management, and discarding of the material for testing;
3. Provision of the material for testing;
4. Withdrawal of consent, disposal of the material for testing when consent is withdrawn, rights of the testee, and other matters specified by Ordinance of the Ministry of Health and Welfare.
(3) When any person, other than a genetic testing institution, collects a material for testing and requests a genetic testing institution to conduct a genetic test thereon, he or she shall present written consent obtained from the testee to the genetic testing institution pursuant to paragraph (1) and shall take measures for protecting personal information, as prescribed by Ordinance of the Ministry of Health and Welfare.
(4) Article 16 (2) shall apply mutatis mutandis to consent by an agent where a testee is incompetent or quasi-incompetent to consent. In such cases, "human subject of research" shall be construed as "testee", and "research project" as "testing", respectively.
(5) Consent is not required for genetic testing in either of the following cases:
1. Where it is urgently or specially required to identify a corpse or an unconscious person;
2. Where it is provided in any other statute.
(6) A person who intends to obtain written consent pursuant to paragraphs (1) through (4) shall, in advance, give sufficient explanation the objectives and methods of the genetic test and the expected results and significance of the genetic test, to the testee or his or her legal representative.
(7) The method for consenting to a genetic test, the exemption from consent, and other necessary matters shall be prescribed by Ordinance of the Ministry of Health and Welfare.
 Article 52 (Preservation of Records and Disclosure of Information)
(1) A genetic testing institution shall record and preserve the following documents, as prescribed by Ordinance of the Ministry of Health and Welfare:
1. A written consent under Article 51;
2. Reports on the results of genetic tests;
3. Records about the provision of materials for testing under Article 53 (2).
(2) Where a testee or his or her legal representative requests a genetic testing institution to allow him or her to inspect the records specified in paragraph (1) or to issue copies of such records, the genetic testing institution shall comply with such request.
(3) Matters necessary for the procedures for applying for the inspection of records or the issuance of copies under paragraph (2), the form of such application, etc. shall be prescribed by Ordinance of the Ministry of Health and Welfare.
 Article 53 (Provision and Discarding of Materials for Testing)
(1) Where a genetic testing institution obtains written consent to the provision of a material for testing from a testee under Article 51 (2), such institution may provide the material for testing to a human material researcher or biobank.
(2) Article 38 (2) through (5) shall apply mutatis mutandis to the provision of materials for testing under paragraph (1). In such cases, "human materials, etc." shall be construed as "materials for testing", and "donor of a human material" as "testee", respectively.
(3) Except materials for testing to be provided under paragraph (1), a genetic testing institution shall discard materials for testing after it obtains the result of a genetic test.
(4) A genetic testing institution shall keep and preserve records of the details about the discarding of materials for testing.
(5) Where a genetic testing institution is unable to preserve materials for testing due to suspension or closure of its business operations or other inevitable circumstances, such institution shall dispose of materials for testing or transfer such materials to any other person, as prescribed by Ordinance of the Ministry of Health and Welfare.
(6) Matters necessary for the discarding of materials for testing, the keeping and preservation of records of discarding, the disposal or transfer of materials for testing shall be prescribed by Ordinance of the Ministry of Health and Welfare.
CHAPTER VII SUPERVISION
 Article 54 (Reporting and Inspection)
(1) Where deemed necessary to ensure bioethics and safety, the Minister of Health and Welfare may order an institution specified in the subparagraphs of Article 10 (1) or a genetic testing institution (hereinafter referred to as "institution subject to supervision") or an employee of any of such institutions to submit a report or data necessary for enforcing this Act, as prescribed by Ordinance of the Ministry of Health and Welfare; and may order any of such institutions to discontinue research projects or the use of outcomes of research projects or may take other necessary measures, if bioethics or safety is or is likely to be in grave danger.
(2) Where deemed necessary to ascertain compliance with the provisions of this Act or a violation of any provision of this Act, the Minister of Health and Welfare may authorize a relevant public official to enter an institution subject to supervision or its office to inspect its facilities, equipment, relevant accounting books or documents, or other articles or to inquire of interested persons; and may collect the minimum quantity of samples necessary for testing. In such cases, a public official shall carry an identification certificate indicating his or her authority and present it to interested persons.
(3) An institution subject to supervision or its employees shall comply with an order issued, an inspection conducted, or an inquiry made under paragraph (1) or (2), except in extenuating circumstances.
 Article 55 (Orders for Discarding or Improvement)
(1) The Minister of Health and Welfare may order an institution subject to supervision or any of its employees and a person who files for registration of, provides, or uses an embryonic stem cell line pursuant to Articles 33 through 35, to discard the following materials. In such cases, Articles 25 (5), 39 (4), and 53 (6) shall apply mutatis mutandis to the procedures and methods for the discarding:
1. An embryo, somatic-cell cloning embryo, embryonic stem cell line, or oocytes extracted, produced, preserved, used for research, or provided in violation of Articles 22 (1) through (3), 23, 24 (1), 25 (3) (including cases to which the aforesaid paragraph shall apply mutatis mutandis pursuant to Article 32 (2)), 26 (1), 27 (1) through (3), 29 (1) and (2), 30 (1) through (3), 31 (1), (3), and (4), 33 (1), 34 (1) and (3), and 35 (2);
2. A material for testing or a human material collected, preserved, or provided in violation of Articles 39 (1), 41 (1), 43 (2), 49 (1), 50 (1) through (3), 51 (1), (2), and (4), and 53 (1) through (3).
(2) Where it is deemed that an institution subject to supervision fails to meet the standards prescribed in Article 22 (2), 29 (2), 31 (3), or 41 (4) for facilities, human resources, etc. and therefore has posed or is likely to pose a grave danger to bioethics or safety if it conducts research, collection, preservation, or production of embryos, the Minister of Health and Welfare may order such institution to improve its facilities or to prohibit the use of all or part of its facilities.
 Article 56 (Revocation of Registration and Suspension of Operation)
(1) In any of the following cases, the Minister of Health and Welfare may revoke the designation or registration of, or permission granted to, an institution subject to supervision; or may order such institution to completely or partially suspend its operation for a specified period not exceeding one year: <Amended by Act No. 16372, Apr. 23, 2019>
1. Where an institution subject to supervision violates Articles 10 (1) (excluding where an institution falls under subparagraphs 1 and 2 of the aforesaid paragraph), 20, 21, 22 (1) through (3), 23, 24 (1) and (2), 25 (3) and (4) (including cases to which the aforesaid paragraph shall apply mutatis mutandis pursuant to Article 32 (2)), 26 (1) and (3), 27 (1) through (3), 28 (including cases to which the aforesaid Article shall apply mutatis mutandis pursuant to Article 32 (3)), 29 (2), 30 (1), 31 (1), 32 (1), 42-3 (1), 43 (2), and 44 (1); the latter part of Article 48 (1); Articles 48 (2), 50, 51 (1) through (4), 52 (1) and (2), and 53 (2) through (5);
2. Where an institution subject to supervision fails to comply with an order issued under Article 54 (1) or 55;
3. Where an institution subject to supervision fails to cooperate in an inspection conducted, an inquiry made, or collection conducted under Article 54 (2).
(2) Detailed guidelines for administrative dispositions under paragraph (1) shall be prescribed by Ordinance of the Ministry of Health and Welfare, taking into consideration the type and gravity of each violation.
 Article 57 (Hearings)
Where the Minister of Health and Welfare intends to revoke the designation or registration of, or permission granted to, an institution under Article 56, he or she shall hold a hearing.
 Article 58 (Penalty Surcharges)
(1) If the Minister of Health and Welfare discovers that an institution subject to supervision falls under any of the following and therefore he or she shall order it to suspend its operation, but suspending its operation is likely to cause severe inconvenience to users of its business or undermine public interests; the Minister may impose a penalty surcharge not exceeding 200 million won upon such institution in lieu of suspending its operation, as prescribed by Presidential Decree:
1. If an institution subject to supervision violates Articles 22 (1) through (3), 24 (1) and (2), 25 (3) and (4) (including cases to which the aforesaid paragraph shall apply mutatis mutandis pursuant to Article 32 (2)), and 27 (1) through (3);
2. If an institution subject to supervision violates any rule prescribed in Article 28 (including cases to which the aforesaid Article shall apply mutatis mutandis pursuant to Article 32 (3)) or 32 (1);
3. If an institution subject to supervision fails to comply with an order issued under Article 54 (1) or 55;
4. If an institution subject to supervision fails to cooperate in an inspection conducted, an inquiry made, or collection conducted under Article 54 (2).
(2) The amount of a penalty surcharge to be imposed under paragraph (1), based on the type and degree of each violation, shall be prescribed by Ordinance of the Ministry of Health and Welfare.
(3) If a person obligated to pay a penalty surcharge imposed under paragraph (1) fails to pay it by the payment deadline, such penalty surcharge shall be collected in the same manner as delinquent national taxes are collected.
 Article 59 (Fees)
The Minister of Health and Welfare may require a person who intends to obtain designation, permission, registration, or approval; files a report; or intends to modify the details of any of the aforesaid acts in accordance with this Act, to pay fees, as prescribed by Ordinance of the Ministry of Health and Welfare.
CHAPTER VIII SUPPLEMENTARY PROVISIONS
 Article 60 (Subsidies from National Treasury)
In order to develop and support research projects and education that can contribute to securing bioethics and safety in accordance with this Act, the Minister of Health and Welfare may fully or partially subsidize a relevant organization or institution or their employees for expenses incurred in such projects or education, as prescribed by Presidential Decree.
 Article 61 (Delegation and Entrustment)
(1) The Minister of Health and Welfare may delegate part of his or her authority vested under this Act to the head of an affiliated agency, as prescribed by Presidential Decree.
(2) The Minister of Health and Welfare may partially entrust any of the following affairs to a related specialized institution or organization, as prescribed by Presidential Decree:
1. Education of members of an IRB under Article 13 (1) 2;
2. Evaluation and accreditation of an IRB under Article 14;
3. Evaluation of the accuracy of genetic tests under Article 49 (3).
(3) Where the Minister of Health and Welfare entrusts affairs to a related specialized institution or organization pursuant to paragraph (2), he or she may subsidize such institution or organization for necessary budgetary funding.
(4) Matters necessary for the provision of subsidies of a related specialized institution or organization under paragraph (2) for its budget, the recouping of subsidies, the ban on provision of subsidies, etc. shall be prescribed by Presidential Decree.
 Article 62 (Legal Fiction as Public Officials for Purposes of Penalty Provisions)
The executive officers and employees of an institution or organization that engages in affairs entrusted by the Minister of Health and Welfare pursuant to Article 61 shall be deemed public officials for the purposes of applying Articles 129 through 132 of the Criminal Act.
 Article 63 (Prohibition of Divulgence of Confidential Information)
An institution subject to supervision or an employee or former employee of such institution shall neither divulge personal information or other confidential information that such institution or such employee has learned in the course of conducting duties nor use such information without authorization.
CHAPTER IX PENALTY PROVISIONS
 Article 64 (Penalty Provisions)
(1) Any person who implants a somatic-cell cloning embryo to a womb, keeps such embryo implanted, or bears a child therefrom, in violation of Article 20 (1), shall be punished by imprisonment with labor for not more than 10 years.
(2) Any person who attempts to commit a crime specified in paragraph (1) shall also be punished.
 Article 65 (Penalty Provisions)
(1) Any person who implants a human embryo into an animal womb or implants an animal embryo into a human womb, in violation of Article 21 (1), or any person who implants a thing produced by conducting an act referred to in any subparagraph of Article 21 (2) into a human or animal womb, in violation of Article 21 (3), shall be punished by imprisonment with labor for not more than five years.
(2) Any person who attempts to commit a crime specified in paragraph (1) shall also be punished.
 Article 66 (Penalty Provisions)
(1) Any of the following persons shall be punished by imprisonment with labor for not more than three years:
1. A person who solicits another person to implant a somatic-cell cloning embryo into a womb, to keep such embryo implanted, or to bear a child therefrom or who acts as a broker for such act, in violation of Article 20 (2);
2. A person who conducts an act specified in any subparagraph of Article 21 (2);
3. A person who produces an embryo for any purpose other than pregnancy, in violation of Article 23 (1);
4. A person who provides or uses an embryo, oocyte, or spermatozoon for money, an interest in property, or any other consideration; solicits another person to conduct such act; acts as a broker for conducting such act, in violation of Article 23 (3);
5. A person who engages in somatic-cell nuclear transplantation or parthenogenesis for any purpose other than research on a therapy for a rare or incurable disease, in violation of Article 31 (1);
6. A person who divulges confidential information or uses confidential information without authorization, in violation of Article 63.
(2) Any person who uses a surplus embryo, in violation of Article 29 (1), shall be punished by imprisonment with labor for not more than three years or by a fine not exceeding 50 million won.
(3) Any person who attempts to commit a crime specified in paragraph (1) 1 or 2 shall also be punished.
 Article 67 (Penalty Provisions)
(1) Any of the following persons shall be punished by imprisonment with labor for not more than two years or by a fine not exceeding 30 million won: <Amended by Act No. 13651, Dec. 29, 2015>
1. A person who conducts an act specified in any subparagraph of Article 23 (2) in producing an embryo;
2. A person who extracts oocytes or spermatozoa without written consent, in violation of Article 24 (1);
3. A person who fails to examine the health of a oocytes donor, in violation of Article 27 (1), or who extracts oocytes, in violation of Article 27 (2) or (3);
4. A person who discriminates against another person on the ground of genetic information; compels another person to undergo a genetic test or to submit the results of a genetic test; or leaves genetic information in records, etc. provided to any person other than the patient, in violation of Article 46 (1) through (3);
5. A person who conducts research projects on a gene therapy or practices a gene therapy, in violation of Article 47 (1) through (3);
6. A person who conducts a genetic test, in violation of Article 50 (1) through (3);
7. A person who fails to comply with an order issued for discarding or improvement under Article 55.
(2) Any person who fails to transfer embryos or reproductive cells, in violation of Article 22 (6), shall be punished by imprisonment with labor for not more than two years or by a fine not exceeding 10 million won.
 Article 68 (Penalty Provisions)
Any of the following persons shall be punished by imprisonment with labor for not more than one year or by a fine not exceeding 20 million won: <Amended by Act No. 16372, Apr. 23, 2019>
1. A person who extracts and preserves oocytes or spermatozoa or produces embryos therefrom through fertilization without being designated as a medical institution producing embryos, in violation of Article 22 (1) through (3);
2. A person who fails to discard embryos, in violation of Article 25 (3) (including cases to which the aforesaid paragraph shall apply mutatis mutandis pursuant to Article 32 (2));
3. A person who provides surplus embryos or oocytes for consideration, in violation of Article 26 (1);
4. A person who fails to report relevant details to the Minister of Health and Welfare, in violation of Article 26 (3);
5. A person who conducts research projects on surplus embryos without filing for registration of the establishment as an embryo research institute, in violation of Article 29 (2);
6. A person who conducts research projects on embryos without obtaining approval of the relevant plan therefor, in violation of Article 30 (1) (including cases to which the aforesaid paragraph shall apply mutatis mutandis pursuant to Article 31 (5));
7. A person who produces, or conducts research projects on, somatic-cell cloning embryos, etc. without filing for registration of the establishment with the Minister of Health and Welfare, in violation of Article 31 (3);
8. A person who establishes a biobank without permission, in violation of Article 41 (1);
9. A person who directly collects a human material or requests another person to collect a human material, without written consent, in violation of Article 42 (1);
9-2. A person who provides a biobank with any surplus sample without giving the donor subject written notice required under Article 42-2 (2);
9-3. A person who provides a biobank with a surplus sample collected from a donor subject who expressed his or her opposition, in violation of Article 42-2 (4);
10. A person who makes a misrepresentation or an exaggerated advertisement regarding genetic tests, in violation of Article 50 (4);
11. A person who collects a material to be used for a genetic test without written consent to the genetic test, in violation of Article 51 (1), (2), or (4), or a person who requests a genetic testing institution to conduct a genetic test without presenting written consent or without taking measures for protecting personal information, in violation of Article 51 (3).
 Article 69 (Joint Penalty Provisions)
(1) If the representative of a corporation or an agent, employee, or worker of a corporation or individual commits an offense specified in any provision of Articles 64 through 66 in the course of business of the corporation or individual, not only shall such an offender be punished accordingly, but the corporation or individual also shall be punished by a fine not exceeding 50 million won: Provided, That the foregoing shall not apply where the corporation or individual has not neglected due care and supervision over the business to prevent such offense.
(2) If the representative of a corporation or an agent, employee, or worker of a corporation or individual commits an offense specified in Article 67 or 68 in the course of business of the corporation or individual, not only shall such an offender be punished accordingly, but the corporation or individual also shall be punished by a fine specified in the relevant Article: Provided, That the foregoing shall not apply where the corporation or individual has not neglected due care and supervision over the business to prevent such offense.
 Article 70 (Administrative Fines)
(1) Any of the following persons shall be subject to an administrative fine not exceeding five million won: <Amended by Act No. 16372, Apr. 23, 2019>
1. A person who fails to establish an IRB, in violation of Article 10 (1);
2. A person who provides or uses an embryonic stem cell line without filing for registration, in violation of Article 33 (1);
3. A person who uses an embryonic stem cell line, in violation of Article 35 (1);
4. A person who provides a human material, etc. to any other researcher without anonymizing the human material, etc., in violation of Article 38 (2);
5. A person who fails to discard, dispose of, or transfer a human material as referred to in the main clause of Article 39 (1) or Article 39 (3) (including cases to which any of the aforesaid paragraphs shall apply mutatis mutandis pursuant to Article 42-3 (2) and Article 44 (3));
6. A person who fails to report his or her establishment as required in Article 41 (2);
6-2. A person who provides a surplus sample for a biobank without anonymizing the surplus sample, in violation of Article 42-2 (6);
6-3. A person who provides a surplus sample for any other person without anonymizing the surplus sample, in violation of Article 42-2 (9);
6-4. A person who fails to formulate personal information protection guidelines, including schemes for anonymizing surplus samples or fails to designate a manager in charge of the management and security of personal information, in violation of Article 42-3 (4);
7. A person who fails to formulate personal information protection guidelines, including schemes for anonymizing human materials, etc., or fails to designate a manager in charge of the management and security of personal information, in violation of Article 44 (4);
8. A person who practices a gene therapy without filing a report thereon, in violation of Article 48 (1);
9. A person who fails to file a report pursuant to the main clause of Article 49 (1);
10. An institution subject to supervision or its employee that fails to comply with an order issued, an inspection conducted, or an inquiry, etc. made by the Minister of Health and Welfare, without good cause, in violation of Article 54 (3).
(2) Any of the following persons shall be subject to an administrative fine not exceeding three million won:
1. A person who fails to file a report with the Minister of Health and Welfare, in violation of Article 22 (4) or (5) or 29 (3);
2. A person who fails to transfer relevant documents, in violation of Article 22 (6).
(3) Any of the following persons shall be subject to an administrative fine not exceeding two million won: <Amended by Act No. 16372, Apr. 23, 2019>
1. A person who fails to file for registration with the Minister of Health and Welfare, in violation of Article 10 (4);
2. A person who fails to file a report with the Minister of Health and Welfare, in violation of Article 11 (4);
3. A person who provides an embryonic stem cell line for consideration, in violation of Article 34 (3);
4. A person who provides a human material, etc. for consideration, in violation of Article 38 (3);
5. A person who fails to file a report as required under Article 41 (3);
5-2. A person who provides a surplus sample for consideration, in violation of Article 42-2 (7);
6. A person who fails to file a report as required under Article 49 (2) or (4).
(4) Administrative fines specified in paragraphs (1) through (3) shall be imposed and collected by the Minister of Health and Welfare, as prescribed by Presidential Decree.
ADDENDA <Act No. 11250, Feb. 1, 2012>
Article 1 (Enforcement Date)
This Act shall enter into force one year after the date of its promulgation.
Article 2 (Transitional Measures concerning Consent to Human Materials Research Projects)
Human materials that have been already used in human materials research projects, other than research projects on genes, before this Act enters into force, may be continuously used in such research projects without written consent otherwise required under Article 37 (1): Provided, That the foregoing shall not apply where such human materials are provided to any third person.
Article 3 (Transitional Measures concerning Permission for Biobanks)
A gene bank with permission granted under the previous provisions before this Act enters into force shall be construed as a biobank with permission granted under this Act.
Article 4 (Transitional Measures concerning Administrative Dispositions)
The previous provisions shall apply to administrative dispositions (including the imposition of penalty surcharges) to be taken against violations committed before this Act enters into force.
Article 5 (Transitional Measures concerning Administrative Fines)
The previous provisions shall apply to administrative fines to be imposed for violations committed before this Act enters into force.
Article 6 Omitted.
Article 7 (Relationship to Other Statutes)
A citation of any provision of the previous Bioethics and Safety Act by any other statute in force as at the time this Act enters into force shall be construed as a citation of the relevant provision of this Act in lieu of the previous provision, if this Act contains such relevant provision.
ADDENDA <Act No. 11690, Mar. 23, 2013>
Article 1 (Enforcement Date)
(1) This Act shall enter into force on the date of its promulgation.
(2) Omitted.
Articles 2 through 7 Omitted.
ADDENDUM <Act No. 12447, Mar. 18, 2014>
This Act shall enter into force three months after the date of its promulgation.
ADDENDA <Act No. 12844, Nov. 19, 2014>
Article 1 (Enforcement Date)
This Act shall enter into force on the date of its promulgation: Provided, That the amendments to the statutes to be amended pursuant to Article 6 of the Addenda, which were promulgated before this Act enters into force but the enforcement dates of which have yet to arrive, shall enter into force on the enforcement date of the relevant statute.
Articles 2 through 7 Omitted.
ADDENDUM <Act No. 13651, Dec. 29, 2015>
This Act shall enter into force on the date of its promulgation: Provided, That the amended provisions of Articles 28 (2) and 50 (3) 2 shall enter into force six months after the date of the promulgation.
ADDENDA <Act No. 14438, Dec. 20, 2016>
Article 1 (Enforcement Date)
This Act shall enter into force on the date of its promulgation. (Proviso Omitted.)
Articles 2 through 5 Omitted.
ADDENDA <Act No. 14839, Jul. 26, 2017>
Article 1 (Enforcement Date)
(1) This Act shall enter into on the date of its promulgation: Provided, That the amendments to the statutes to be amended pursuant to Article 5 of the Addenda, which were promulgated before this Act enters into force but the enforcement dates of which have yet to arrive, shall enter into force on the enforcement date of the relevant statute.
Articles 2 through 6 Omitted.
ADDENDUM <Act No. 15188, Dec. 12, 2017>
This Act shall enter into force on the date of its promulgation.
ADDENDUM <Act No. 15888, Dec. 11, 2018>
This Act shall enter into force three months after the date of its promulgation.
ADDENDUM <Act No. 16372, Apr. 23, 2019>
This Act shall enter into force six months after the date of its promulgation.