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ACT ON CORD BLOOD MANAGEMENT AND RESEARCH

Act No. 10130, Mar. 17, 2010

Amended by Act No. 14929, Oct. 24, 2017

CHAPTER I GENERAL PROVISIONS
 Article 1 (Purpose)
The purpose of this Act is to ensure the quality and safety of human cord blood and contribute to the development of medical science and the improvement of national health by prescribing matters necessary for the safe management and transplantation of human cord blood, research with regard thereto, etc.
 Article 2 (Definitions)
The terms used in this Act shall be defined as follows:
1. The term "human cord blood (hereinafter referred to as "cord blood")" means blood stored in the umbilical cord and placenta detached from an infant and woman in childbed who gives birth to the infant;
2. The term "cord blood products" means hematopoietic stem cells made by isolating active ingredients from cord blood collected to use for transplantation, etc. and other products prescribed by Presidential Decree;
3. The term "duties regarding cord blood management" means duties of collecting, testing, and registering, etc, cord blood after being donated or entrusted therewith, or duties of manufacturing, keeping, supplying and controlling the quality of cord blood products;
4. The term "cord blood transplantation" means transplanting cord blood products to patients for the purpose of medical treatment, etc.;
5. The term "cord blood donation" means that a woman in childbed provides cord blood collected in the course of childbirth to a cord blood bank without compensation for the purpose of medical treatment for a disease of a person outside of kinship, or medical research, etc.;
6. The term "entrusting cord blood" means that a woman in childbed entrusts a cord blood bank with cord blood collected in the course of childbirth for a limited period for the purpose of medical treatment of her newborn infant or persons in kinship;
7. The term "cord blood bank" means an institution permitted as prescribed in Article 11 (1), which is either a cord blood bank (hereinafter referred to as "public cord blood bank") managing cord blood donated through cord blood donation (hereinafter referred to as "donated cord blood") or a cord blood bank (hereinafter referred to as "family cord blood bank") managing cord blood entrusted (hereinafter referred to as "family cord blood").
 Article 3 (Respect for Cord Blood Donation)
(1) The affection of a donor of cord blood (hereinafter referred to as "cord blood donor") for neighbors and the spirit of sacrifice shall be respected.
(2) A Cord blood bank may issue an honorary certificate of cord blood donation to the cord blood donors in order to commend them for their. In such cases, no honorary certificate of cord blood donation shall thoughtfulness be provided for a remuneration purpose.
(3) Matters necessary for the issue, etc. of honorary certificate of cord blood donation shall be prescribed by Ordinance of the Ministry of Health and Welfare.
 Article 4 (Responsibilities of the State and Local Governments)
(1) The State and local governments shall endeavor to help the culture of healthy cord blood donation and transfusion take root.
(2) In order to activate cord blood donation and transfusion, the State and local governments shall prepare measures for support related research, publicity, etc.
 Article 5 (Prohibition of Sale and Purchase of Cord Blood, etc.)
(1) No person shall do any of the following act after giving, receiving, or promising to give or receive money, property interests or other considerations:
1. Giving another person's cord blood, cord blood products or other residual products (hereinafter referred to as "cord blood, etc.") to a third person, receiving cord blood, etc. to give them to a third person, or promising to perform such act;
2. Giving his/her cord blood, etc. to another person, receiving another person's cord blood, etc. to transfuse them in himself/herself, or promising to perform such act;
3. Abetting, counseling or aiding the act prescribed in subparagraph 1 or 2.
(2) Whoever becomes aware of violation of paragraph (1) shall not manage or transplant cord blood, etc. relating to such act.
 Article 6 (Cord Blood Committee)
(1) In order to deliberate on the following matters, the Ministry of Health and Welfare shall have the Cord Blood Committee (hereinafter referred to as the "Committee"):
1. Matters concerning the establishment and promotional plan of cord blood management policies;
2. Matters concerning eligibility criteria for cord blood donors and persons intending to be transfused with cord blood (hereinafter referred to as "person who is to be transfused with cord blood");
3. Matters concerning the standards for permission for and operation of cord blood banks;
4. Matters concerning the inspection and evaluation of cord blood banks;
5. Matters concerning the standards for the duties of cord blood management;
6. Matters concerning the operation of the Cord Blood Information Center prescribed in Article 23 (1), and building database, etc.;
7. Matters concerning the support, fostering, etc. of research on cord blood;
8. Other matters that the Minister of Health and Welfare put to deliberation for the management of cord blood.
(2) The Committee shall consist of not more than 15 members, including one chairperson and one vice chairperson.
(3) Members of the Committee shall be appointed or commissioned by the Minister of Health and Welfare from among any of the following persons:
1. Public officials affiliated with the Ministry of Health and Welfare, who are in charge of duties relating to cord blood;
2. Persons recommended by the Korean Medical Association prescribed in Article 28 of the Medical Service Act;
3. Persons recommended by consumer organizations prescribed in Article 2 of the Framework Act on Consumers;
4. Persons who qualified as a lawyer and have engaged in duties relating to medical services for not less than five years;
5. Persons who have abundant knowledge and experience in cord blood.
(4) Other matters necessary for the organization, operation, etc. of the Committee shall be prescribed by Presidential Decree.
CHAPTER II DONATION, ENTRUSTMENT, COLLECTION, ETC. OF CORD BLOOD
 Article 7 (Consent to Donation and Entrustment of Cord Blood)
(1) The heads of cord blood banks shall explain the following matters to women in childbed in an easily understandable manner, and obtain signatures on the donation agreement or entrustment agreement from women in childbed who consent thereto:
1. Matters concerning the purpose of cord blood donation or cord blood entrustment;
2. Matters concerning the methods of collecting cord blood and matters to be attended to;
3. Matters concerning the period and methods of preserving cord blood, expenses for keeping cord blood, etc.;
4. Matters concerning the protection of rights and information of cord blood donors, persons entrusting cord blood (hereinafter referred to as "cord blood entrusters") and their family members;
5. Matters concerning the timing and methods of withdrawing cord blood donation and cord blood entrustment;
6. Other matters prescribed by Ordinance of the Ministry of Health and Welfare concerning consent to cord blood donation and cord blood entrustment.
(2) Women in childbed who consent to donate or entrust cord blood as prescribed in paragraph (1) shall provide information concerning personal history and medical history necessary to confirm the safety of cord blood.
(3) Women in childbed may withdraw consent prescribed in paragraph (1) any time before cord blood is collected.
(4) Matters necessary for cord blood donation consents, cord blood entrustment consents, etc. shall be prescribed by Ordinance of the Ministry of Health and Welfare.
 Article 8 (Matters to Be Observed when Collecting Cord Blood)
(1) Cord blood shall be collected only in cases where women in childbed give consent thereto as prescribed in Article 7 (1).
(2) Cord blood shall be collected in a medical institution prescribed in Article 3 of the Medical Service Act (hereinafter referred to as "medical institution") by a medical practitioner prescribed in Article 2 of the same Act under the supervision of a medical doctor or directly by a medical doctor.
(3) A medical practitioner who is to collect cord blood as prescribed in paragraph (2) shall confirm as to whether the women in childbed have given consent thereto after hearing explanation prescribed in Article 7 (1). and explain them the collecting methods, matters to be attended to, etc., and obtain a signature of consent concerning the collection of cord blood.
(4) A medical practitioner prescribed in paragraph (2) shall collect cord blood in a way that does not incur any damage to the health of the women in childbed and newborn infants.
(5) Where a medical doctor who collects cord blood or supervises the collection of cord blood as prescribed in paragraph (2) confirms that a woman in childbed or a newborn infant has any health problem, such as deformity, infectious disease, genetic disease, etc., he/she shall notify such fact to a cord blood bank.
(6) Other matters necessary for the collection of cord blood, etc. shall be prescribed by Presidential Decree.
 Article 9 (Requirements for Prohibition of Collection, etc. of Cord Blood)
(1) No cord blood shall be collected from a woman in childbed who falls under any of the following subparagraphs, no such cord blood collected therefrom shall be used for supply or transfusion:
1. A woman in childbed infected with an infectious disease inappropriate for transfusion;
2. A woman in childbed whose chromosomes are confirmed to be abnormal in the amniotic fluid test, or who has an abortion or a stillborn baby;
3. A woman in childbed who has a disease, such as a malignant tumor, etc., feared to endanger the life of a person who is to be transfused with cord blood or inflict grievous bodily injury to such person;
4. A woman in childbed who is confirmed to have medical history of a genetic disease likely to spread, through cord blood transfusion, etc. as prescribed in Article 7 (2);
5. A woman in childbed who is judged by a medical doctor in charge of childbirth as inappropriate for the collection of cord blood.
(2) The kinds of infectious diseases, etc. prescribed in the provisions of paragraph (1) 1 through 4 shall be prescribed by Ordinance of the Ministry of Health and Welfare.
 Article 10 (Tests of Cord Blood and Cord Blood Products)
(1) Each cord blood bank shall test whether cord blood and cord blood products are qualified as prescribed by Ordinance of the Ministry of Health and Welfare.
(2) Where a woman in childbed or a newborn infant is confirmed to have a health condition, such as deformity, an infectious disease, or genetic disease, etc. after collecting cord blood, a cord blood bank shall record such fact in the cord blood record prescribed in Article 20 (1).
(3) Where a cord blood entruster entrusts family cord blood for transfusion into himself/herself or kinship, part of the test prescribed by Ordinance of the Ministry of Health and Welfare may be omitted, notwithstanding paragraph (1).
(4) Where cord blood or cord blood products are confirmed to be qualified as a result of test prescribed in paragraph (1), a cord blood bank shall discard such cord blood or cord blood products: Provided, That in cases where such cord blood or cord blood products are used for a purpose prescribed by Presidential Decree, such as medical research, manufacture of medicines, etc., such cord blood or cord blood products shall be allowed not to be discarded.
(5) Matters concerning the discardment, etc. of cord blood or cord blood products prescribed in paragraph (4) shall be recorded in the cord blood management record prescribed in Article 20 (1), as prescribed by Ordinance of the Ministry of Health and Welfare.
(6) Matters necessary for the criteria for disqualification, testing methods, standards for judgment, etc. shall be prescribed by Presidential Decree.
CHAPTER III CORD BLOOD BANKS AND CORD BLOOD MANAGEMENT, ETC.
 Article 11 (Permission, etc. for Cord Blood Banks)
(1) Any entity intending to establish a cord blood bank shall prepare facilities, equipment, manpower, quality management system, etc. prescribed by Presidential Decree and obtain permission from the Minister of Health and Welfare as a public cord blood bank or family cord blood bank. The same shall apply to cases where it intends to modify important matters prescribed by Presidential Decree from among the permitted matters.
(2) Entities that are eligible for permission for a cord blood bank shall be as prescribed in the following subparagraphs:
1. The State or local governments;
2. Medical institutions at general hospital level prescribed in Article 3 (2) 3 of the Medical Service Act or educational foundations possessing such medical institutions;
3. Juristic persons established for the principal purpose of business relating to cord blood;
4. Biological product manufacturers who have obtained permission for items pursuant to Article 31 of the Pharmaceutical Affairs Act.
(3) Where a cord blood bank intends to close, suspend or restart business, it shall report to the Minister of Health and Welfare, as prescribed by Presidential Decree.
(4) Matters necessary for the standards and procedures for granting permission for public cord blood banks and family cord bloods, and for reporting, etc. on business closure, etc. shall be prescribed by Presidential Decree.
 Article 12 (Prohibition of Duties, etc. not Permitted)
No person who is not permitted to establish a cord blood bank prescribed in Article 11 (1) shall engage in the duties of cord blood management: Provided, That this shall not apply to cases where he/she is engaged in the cord blood management prescribed by Presidential Decree, such as medical treatment, medical test and research, etc. in a medical institution or research institution.
 Article 13 (Exchanges of Information among Cord Blood Banks)
A cord blood bank may cooperate with another cord blood bank in collecting, keeping, supplying, etc. cord blood and cord blood products, as prescribed by Ordinance of the Ministry of Health and Welfare: Provided, That in cases of personal information on women in childbed and newborn infants except for the items prescribed by Ordinance of the Ministry of Health and Welfare, they shall not be allowed to exchange or supply such information.
 Article 14 (Entrustment of Duties by Cord Blood Banks)
(1) Cord blood banks may entrust medical institutions prescribed by Ordinance of the Ministry of Health and Welfare with all or part of duties for collection or test among duties of cord blood management.
(2) Pursuant to paragraph (1), no cord blood banks shall entrust the duties of cord blood management to institutions other than the medical institutions prescribed by Ordinance of the Ministry of Health and Welfare.
(3) Matters necessary for the extent of duties to be entrusted, methods of entrusting duties, recording entrusted duties, etc. shall be prescribed by Ordinance of the Ministry of Health and Welfare.
 Article 15 (Matters to Be Observed by Cord Blood Banks)
In order to ensure the safety of cord blood and cord blood products, cord blood banks shall observe the standards prescribed by Ordinance of the Ministry of Health and Welfare concerning the duties of cord blood management to be performed by cord blood banks.
 Article 16 (Discardment, etc. of Family Cord Blood)
(1) Where an entruster of cord blood, his/her family member or his/her bereaved family member requests to discard cord blood and cord blood products, a cord blood bank shall discard the relevant cord blood or cord blood products, as prescribed by Ordinance of the Ministry of Health and Welfare.
(2) Where a period for keeping family cord blood expires, a cord blood bank shall discard the relevant cord blood, as prescribed by Ordinance of the Ministry of Health and Welfare: Provided, That in cases an agreement was made at the time the family cord blood was entrusted or the cord blood entruster, his/her family member or his/her bereaved family member makes a request, the cord blood bank may extend the period for keeping the relevant cord blood products or convert the relevant cord blood products into donated cord blood products, as prescribed by Ordinance of the Ministry of Health and Welfare.
(3) Where family cord blood is converted into donated cord blood as prescribed in the proviso to paragraph (2), it shall meet the requirements necessary for conversion prescribed by Ordinance of the Ministry of Health and Welfare.
 Article 17 (Establishment, etc. of Public Cord Blood Banks)
(1) The State or local governments may establish or designate public cord blood banks performing the following duties:
1. Managing cord blood donation and donated cord blood;
2. Registration of donated cord blood in the database;
3. Evaluating the accuracy of quality, test and management of donated cord blood;
4. Other duties prescribed by Presidential Decree in order to ensure the safety of donated cord blood.
(2) The State or local governments may provide all or part of expenses incurred for business relating to the establishment and operation of public cord blood banks within budgetary limits.
(3) The State or local governments may provide all or part of the expenses incurred for business relating to publicity of cord blood donation and to the donated cord blood within budgetary limits.
(4) Matters necessary for the establishment, designation, etc. of public cord blood banks prescribed in paragraph (1) shall be prescribed by Presidential Decree.
 Article 18 (Management Expenses, etc. for Donated Cord Blood)
(1) Public cord blood banks may pay expenses incurred for duties to medical institutions to which the duties of collecting or testing cord blood is entrusted.
(2) Expenses incurred in managing cord blood and cord blood products provided as prescribed in Article 27 (1) shall be assumed by a person who is transfused with the relevant cord blood products, and the expenses incurred for the management of cord blood and cord blood products provided as prescribed in paragraph (2) of the same Article shall be assumed by a person provided with the relevant cord blood and cord blood products: Provided, That in cases prescribed otherwise by other statutes concerning the expenses to be assumed by a person who is transfused with cord blood and cord blood products, the relevant statutes shall govern.
(3) The calculation of expenses prescribed in paragraphs (1) and (2) shall be as prescribed by the National Health Insurance Act: Provided, That in cases of the calculation of expenses not prescribed by the National Health Insurance Act, such expenses shall be prescribed by Ordinance of the Ministry of Health and Welfare.
(4) Matters necessary for procedures for and methods of providing expenses, etc. shall be prescribed by Ordinance of the Ministry of Health and Welfare.
 Article 19 (Medical Directors)
(1) A cord blood bank shall have one or more persons in charge of medical services (hereinafter referred to as "medical director") who is to take charge of duties of cord blood management, such as test, manufacture, quality control, etc. of cord blood and cord blood products: Provided, That in cases where cord blood products are manufactured and kept in one or more places, each place shall have a separate medical directors.
(2) Medical directors shall observe matters prescribed by Ordinance of the Ministry of Health and Welfare concerning duties of cord blood management, such as guidance and supervision of manpower engaged in duties of cord blood management, management of manufacturing facilities, quality control of cord blood products, etc.
(3) No head of a cord blood bank shall interfere with the performance of duties of cord blood management by a medical director, and where a medical director requests matters necessary for the performance of duties, the heads of cord blood banks shall not reject such request without justifiable reasons.
 Article 20 (Preparation, etc. of Records)
(1) Each cord blood bank shall record matters concerning duties of cord blood management in a book, etc. (hereinafter referred to as "record of cord blood management"), as prescribed by Ordinance of the Ministry of Health and Welfare.
(2) A record of cord blood management may be kept in an electronic document, etc. (hereinafter referred to as "electronic record") attached with a digital signature pursuant to the Digital Signature Act. In such cases, cord blood banks shall be equipped with facilities, equipment, etc. necessary for the safe management and preservation of electronic records.
(3) The record of cord blood management shall be preserved from the date on which cord blood is donated or entrusted until the date on which five years pass from the date it is used or discarded.
(4) Matters necessary for the preservation, etc. of records of cord blood management and electronic records shall be prescribed by Ordinance of the Ministry of Health and Welfare.
 Article 21 (Perusal, etc. of Records)
(1) Where a cord blood entruster makes a request for the perusal of records on the entrustment, transplantation, etc. of cord blood, the head of a family cord blood bank shall allow him/her to peruse such records or deliver a copy to him/her.
(2) Matters necessary for perusal and procedures, extent, etc. of delivery of a copy prescribed in paragraph (1) shall be prescribed by Ordinance of the Ministry of Health and Welfare.
 Article 22 (Transfer of Control, etc. of Cord Blood, etc.)
(1) In any of the following cases, the head of a cord blood bank shall manage cord blood, etc. as prescribed by Ordinance of the Ministry of Health and Welfare, or transfer the control thereof to another cord blood bank:
1. Where he/she closes or suspends business as prescribed in Article 11 (3);
2. Where his/her permission or designation is revoked as prescribed in Article 34 (1);
3. Other cases prescribed by Presidential Decree.
(2) In any of the following cases of paragraph (1), the head of a cord blood bank shall transfer the control of records on cord blood management to the Cord Blood Information Center prescribed in Article 23 (1), as prescribed by Ordinance of the Ministry of Health and Welfare.
(3) Where a cord blood bank relocates cord blood, etc. kept in a permitted place to another place for keeping, or transfers cord blood, etc. to another cord blood bank, it shall report to the Minister of Health and Welfare and the Cord Blood Information Center, respectively, as prescribed by Ordinance of the Ministry of Health and Welfare.
CHAPTER IV TRANSFUSION, ETC. OF CORD BLOOD
 Article 23 (Establishment, etc. of Cord Blood Information Center)
(1) In order to effectively manage donated cord blood, etc., the Minister of Health and Welfare shall establish and operate the Cord Blood Information Center.
(2) Duties of the Cord Blood Information Center shall be as follows:
1. Management and supply of information on donated cord blood;
2. Search for cord blood products appropriate for transfusion, notification thereof and adjustment of supply;
3. Duties concerning the collection and analysis of the result of use, such as cord blood transfusion, and report thereon;
4. Other duties concerning information on cord blood prescribed by Ordinance of the Ministry of Health and Welfare.
(3) The Cord Blood Information Center shall build a database of information on donated cord blood for cord blood transfusion, etc.
(4) Other matters necessary for the establishment and operation of the Cord Blood Information Center shall be prescribed by Presidential Decree.
(5) The Minister of Health and Welfare may entrust the National Organ Transplantation Management Institution prescribed in Article 9 of the Internal Organs, etc. Transplant Act, or relevant specialized organizations, etc. with the operation of the Cord Blood Information Center prescribed in paragraph (1).
 Article 24 (Cooperation, etc. with Cord Blood Information Center)
(1) In order to build and manage the database prescribed in Article 23 (3), the Cord Blood Information Center may request cord blood banks and cord blood transplantation medical institutions prescribed in Article 25 to provide information on cord blood.
(2) A person requested to provide information on cord blood as prescribed in paragraph (1) shall comply with such request except in extenuating circumstances prescribed by Presidential Decree exists.
(3) When a public cord blood bank is donated with donated cord blood, it shall register information prescribed by Ordinance of the Ministry of Health and Welfare with the Cord Blood Information Center.
(4) Matters necessary for the details of information on cord blood to be provided, methods of registration, etc. shall be prescribed by Ordinance of the Ministry of Health and Welfare.
 Article 25 (Medical Institutions for Cord Blood Transfusion)
(1) Only a medical institution that is capable of transplanting bone marrow from among for medical institutions for organ transplantation prescribed in Article 21 (1) of the Internal Organs, etc. Transplant Act shall be a medical institution eligible to perform cord blood transfusion (hereinafter referred to as "medical institution for cord blood transfusion").
(2) Medical institutions other than medical institution for cord blood transfusion prescribed in paragraph (1), shall be allowed to perform cord blood transfusion.
(3) Where any side effect prescribed by Ordinance of the Ministry of Health and Welfare occurs, such as an infection, etc. relating to cord blood and cord blood products, a medical institution for cord blood transfusion shall report without delay to the Minister of Health and Welfare.
(4) Medical institutions for cord blood transfusion shall keep records of matters concerning cord blood transfusion and preserve the records for ten years.
 Article 26 (Request, etc. for Search for Donated Cord Blood Products)
(1) Where a medical institution for cord blood transfusion intends to transfuse a cord blood product, it shall request the Cord Blood Information Center to search for cord blood products appropriate for transfusion as prescribed by Ordinance of the Ministry of Health and Welfare.
(2) The Cord Blood Information Center shall notify without delay the result of search for donated cord blood prescribed in paragraph (1) to the relevant cord blood bank and medical institution for cord blood transfusion, as prescribed by Ordinance of the Ministry of Health and Welfare.
(3) Where a medical institution for cord blood transfusion is provided with donated cord blood as prescribed in Article 27 (1), it shall report to the Cord Blood Information Center.
(4) Other matters necessary to request the search for donated cord blood products, and procedures and details of report shall be prescribed by Ordinance of the Ministry of Health and Welfare.
 Article 27 (Supply of Cord Blood Products)
(1) For cord blood transfusion, cord blood banks shall supply donated cord blood qualified as the result of test prescribed in Article 10 (1) to a medical institution for cord blood transfusion in accordance with the notification of Cord Blood Information Center prescribed in Article 26 (2).
(2) Cord blood banks may supply unqualified cord blood and cord blood products not discarded as prescribed in the proviso to Article 10 (4) only in cases where such unqualified cord blood and cord blood products are used for purposes prescribed by Presidential Decree, such as research, manufacture of medicines, etc., with the approval of the Cord Blood Information Center: Provided, That the unqualified cord blood and cord blood products supplied for the purposes of manufacturing medicines shall be limited to cord blood and cord blood products that are judged unqualified due to capacity deficiency.
(3) Where cord blood banks supply cord blood and cord blood products pursuant to paragraphs (1) and (2), they shall report to the Cord Blood Information Center.
(4) Cord blood banks shall not refuse to supply donated cord blood products prescribed in paragraph (1) to medical institutions for cord blood transfusion without justifiable grounds.
(5) No one shall use, transplant, or administer unqualified cord blood or cord blood products or have them transplanted or administered. <Newly Inserted by Act No. 14949, Oct. 24, 2017>
(6) Other matters necessary for the supply of cord blood and cord blood products, requirements and procedures for approval, details and methods of report, etc. shall be prescribed by Presidential Decree.
 Article 28 (Trans-Boundary Movement, etc. of Cord Blood Products)
(1) Where no cord blood products appropriate for transfusion exist in Korea following a search prescribed in Article 26, the Cord Blood Information Center may request cord blood banks, Cord Blood Information Centers, etc. in foreign countries to search for cord blood products.
(2) Where the Cord Blood Information Center is requested by cord blood banks, Cord Blood Information Centers, etc. in foreign countries to search for cord blood products in Korea, it may notify the result of search.
(3) Where appropriate cord blood products exist within Korea following a search prescribed in paragraph (2), the relevant cord blood bank may supply the relevant cord blood products to an overseas medical institution as prescribed by Ordinance of the Ministry of Health and Welfare with the approval of the Cord Blood Information Center.
(4) The heads of cord blood banks and the heads of medical institutions for cord blood transfusion who supply cord blood products or are supplied with cord blood products from or to foreign countries shall report the result thereof to the Cord Blood Information Center as prescribed by Ordinance of the Ministry of Health and Welfare.
(5) The head of Cord Blood Information Center shall report matters concerning trans-boundary movement, etc. prescribed in paragraph (4) to the Minister of Health and Welfare.
(6) Matters necessary for trans-boundary supply of cord blood products, requirements and procedures for approval, details and methods of reporting, etc. shall be prescribed by Presidential Decree.
 Article 29 (Cord Blood Research Institutions)
(1) Institutions that are supplied with unqualified cord blood, etc. from cord blood banks as prescribed in Article 27 (2) and conduct research on cord blood prescribed by Presidential Decree (hereinafter referred to as "cord blood research institution") shall endeavor to develop medical science and improve national health.
(2) Cord blood research institutions shall handle cord blood, etc. remaining after research is suspended or terminated as prescribed by Ordinance of the Ministry of Health and Welfare.
CHAPTER V SUPERVISION
 Article 30 (Guidance, Supervision, etc.)
(1) For the quality control and enhancement of the safety of cord blood and cord blood products, the Minister of Health and Welfare shall guide and supervise duties managed by cord blood banks, medical institutions for cord blood transfusion and Cord Blood Information Center, may order them to report as necessary or submit data as prescribed by Presidential Decree.
(2) If deemed necessary, the Minister of Health and Welfare may have relevant public officials enter the relevant offices, places of business or other necessary places of cord blood banks, medical institutions for cord blood transfusion and Cord Blood Information Center to examine documents, papers or other articles or to query interested persons.
(3) Where an examination is to be made as prescribed in paragraph (2), persons to be examined shall be notified of the date, purpose and details of the examination, etc. by not later than five days before such examination begins: Provided, That in cases of an emergency or attainment of the purpose of examination is deemed impossible due to destruction of evidence, etc. if examination is notified in advance, this shall not apply.
(4) Public officials who enter such places and make examinations as prescribed in paragraph (2) shall carry a certificate indicating their authority and present it to interested persons.
(5) Persons requested to comply with orders, examinations, etc. as prescribed in paragraph (1) and (2) shall comply with such request expect in extenuating circumstances.
 Article 31 (Inspection, etc. of Cord Blood Banks)
(1) For the quality control and enhancement of the safety of cord blood and cord blood products, the Minister of Health and Welfare shall inspect and evaluate the duties of cord blood banks concerning cord blood management regularly every two years, as prescribed by Ordinance of the Ministry of Health and Welfare, and shall announce the outcomes thereof. <Amended by Act No. 14929, Oct. 24, 2017>
(2) Where cord blood banks are requested for inspection and evaluation prescribed in paragraph (1), they shall comply with such request expect in extenuating circumstances.
(3) Matters necessary for the standards for inspection and evaluation, announcement of outcomes, etc. shall be prescribed by Ordinance of the Ministry of Health and Welfare.
 Article 32 (Corrective Orders)
Where the head of a cord blood bank or the head or any employee of a medical institution for cord blood transfusion fall under any of the following subparagraphs, the Minister of Health and Welfare may order the head of the cord blood bank or medical institution for cord blood transfusion to correct such violations, specifying a period:
1. Where he/she fails to supply cord blood information, in violation of Article 24 (2);
2. Where he/she fails to make a report to the Cord Blood Information Center, in violation of Article 28 (4);
3. Where he/she refuses, obstructs or evades inspection and evaluation prescribed in Article 31;
4. Where he/she violates matters prescribed by Ordinance of the Ministry of Health and Welfare concerning the management of cord blood and cord blood products.
 Article 33 (Suspension of Duties)
Where any cord blood bank, medical institution or medical institution for cord blood transfusion falls under any of the following subparagraphs, the Minister of Health and Welfare may suspend the performance of the duties of cord blood management, specifying a period of not more than one year as prescribed by Ordinance of the Ministry of Health and Welfare: <Amended by Act No. 14929, Oct. 24, 2017>
1. Where he/she fails to record health problems of women in childbed or newborn infants, in violation of Article 10 (2);
2. Where he/she fails to observe matters to be observed by cord blood banks, in violation of Article 15;
3. Where family cord blood is not discarded, in violation of Article 16 (1) and (2);
4. Where he/she compels a person who is transfused with the relevant cord blood products to bear expenses, other than management expenses, in violation of Article 18 (2);
5. Where he/she fails to record or preserve cord blood management record, in violation of Article 20;
6. Where he/she relocates cord blood, etc. from a permitted place to another place for keeping, or fails to report that cord blood, etc. is transferred to other cord blood banks, in violation of Article 22 (3);
6-2. Where he/she provides unqualified cord blood or cord blood products, in violation of Article 27 (2);
7. Where he/she fails to comply with an order to report duties, to submit documents, etc. or they reject examinations, in violation of Article 30 (5);
8. Where he/she fails to comply with corrective orders prescribed in Article 32.
 Article 34 (Revocation of Permission, etc.)
(1) Where a cord blood bank falls under any of the following subparagraphs, the Minister of Health and Welfare may revoke permission or designation: Provided, That in cases under subparagraph 1, he/she shall revoke such permission:
1. Where it obtains permission or permission for modification prescribed in Article 11 by deceit or fraudulent means;
2. Where it becomes disqualified for facilities, equipment, manpower or quality control system, etc. prescribed in Article 11 (1);
3. Where it violates corrective orders prescribed in Article 32 on not less than two occasions;
4. Where it continues business during the period of suspension of business after being issued disposition of suspension of duties prescribed in Article 33.
(2) Detailed standards for revocation of permission for or designation of a cord blood bank shall be prescribed by Ordinance of the Ministry of Health and Welfare.
 Article 35 (Hearings)
Where the Minister of Health and Welfare intends to issue any of the following dispositions, he/she shall hold a hearing:
1. Suspension of business prescribed in Article 33;
2. Revocation of permission or designation prescribed in Article 34.
CHAPTER VI SUPPLEMENTARY PROVISIONS
 Article 36 (Prohibition of Use of Similar Names)
No person who is not permitted to operate a cord blood bank prescribed in Article 11 (1) shall be allowed to use the name of cord blood bank or similar names.
 Article 37 (Prohibition of False or Exaggerated Advertisement)
(1) No person shall place any false advertisement or exaggerated advertisement with the contents not recognized medically concerning the procedures of keeping cord blood, effects of cord blood transfusion, etc.
(2) Matters necessary for the contents, extent. etc. of a false or exaggerated advertisement prescribed in paragraph (1) shall be prescribed by Ordinance of the Ministry of Health and Welfare.
 Article 38 (Prohibition of Disclosure of Confidential Information)
(1) A person who is or has been engaged in a cord blood bank or Cord Blood Information Center or in the duties of cord blood management shall not disclose or make public of another person's confidential information that he/she has learned in the course of duties.
(2) A person who is engaged in the research of cord blood, etc. shall not use information on cord blood, etc. provided for research for a purpose other than research.
(3) Where a cord blood bank supplies cord blood, etc. to a cord blood research institution for research, it shall delete all personal information of the relevant women in childbed or newborn infant except for the items prescribed by Ordinance of the Ministry of Health and Welfare.
 Article 39 (Commissioning, Entrusting, etc. Authority)
(1) Authority of the Minister of Health and Welfare pursuant to this Act may be partially commissioned to the director of the Center for Disease Control, Special Metropolitan City Mayor, Metropolitan City Mayors, Do Governors, the Governor of Special Self-Governing Province (hereinafter referred to as "Mayor/Do Governor"), as prescribed by Presidential Decree.
(2) The Minister of Health and Welfare may commission or entrust duties concerning the guidance and supervision of cord blood banks prescribed in Article 30 and the inspection, etc. prescribed in Article 31, as prescribed by Presidential Decree.
CHAPTER VII PENALTY PROVISIONS
 Article 40 (Penalty Provisions)
(1) Any of the following persons shall be punished by imprisonment with labor for not more than five years or by a fine not exceeding 50 million won: <Amended by Act No. 14929, Oct. 24, 2017>
1. A person who promises to give and receive cord blood, etc., or abets, counsels or aids such acts, in violation of Article 5 (1);
2. A person who collects cord blood without obtaining consent from women in childbed, in violation of Article 8 (1);
3. A person who entrusts the duties of cord blood management to an institution other than the entrusted institution, in violation of Article 14 (2);
(2) Any of the following persons shall be punished by imprisonment with labor for not more than three years or by a fine not exceeding 30 million won: <Amended by Act No. 14929, Oct. 24, 2017>
1. A person who manages or transfuses cord blood, etc., in violation of Article 5 (2);
1-2. A person who provides unqualified cord blood or cord blood products, in violation of Article 27 (2);
2. A person who discloses or makes public of another person's personal information, in violation of Article 38 (1);
3. A person who uses cord blood, etc. for a purpose other than research, in violation of Article 38 (2).
(3) Any of the following persons shall be punished by imprisonment with labor for not more than two years or by a fine not exceeding 20 million won: <Amended by Act No. 14929, Oct. 24, 2017>
1. A person who collects, supplies or transfuses cord blood, in violation of Article 9 (1);
2. A person who performs the duties of cord blood management without obtaining permission, in violation of Article 11 (1) or the main sentence of Article 12;
3. A person who fails to observe matters to be observed, in violation of Article 15;
4. A person who fails to manage cord blood, etc. or transfer the control thereof, in violation of Article 22 (1);
5. A person who transfuses cord blood, in violation of Article 25 (2);
6. A person who fails to report or falsely report the supply of cord blood and cord blood products, in violation of Article 27 (3);
7. A person who places a false or exaggerated advertisement, in violation of Article 37 (1).
(4) Any of the following persons shall be punished by imprisonment with labor for not more than one year or by a fine not exceeding one million won: <Amended by Act No. 14929, Oct. 24, 2017>
1. A person who fails to perform the duties of safety management of cord blood products, in violation of Article 19;
2. A person who uses, transplants, or administers unqualified cord blood or cord blood products or has them transplanted or administered, in violation of Article 27 (5).
(5) Money or property interests, and other benefits in return that have been given or received in cases under paragraph (1) 1 or (2) 1 shall be confiscated: Provided, That where confiscation is impossible, an amount equivalent to such amount shall be collected as a penalty surcharge.
 Article 41 (Suspension of Qualifications to Be Imposed Concurrently)
Where a person is punished by imprisonment with labor for a limited term as prescribed in Article 40, his/her qualification may be concurrently suspended for not more than ten years.
 Article 42 (Joint Penalty Provisions)
If the representative of a corporation, or an agent or employee of, or other persons employed by, the corporation or an individual commits any violations described in Article 40 (1) through (4) in connection with the business affairs of the corporation or individual, not only such violator shall be punished, but also the corporation or individual shall be subjec to a fine prescribed in the relevant Article: Provided, That this shall not apply where such corporation or individual has not been negligent in giving due attention and supervision concerning the relevant business affairs to prevent such violation.
 Article 43 (Administrative Fines)
(1) Any of the following persons shall be subject to an administrative fine not exceeding ten million won:
1. A person who fails to explain matters concerning consent, in violation of Article 7 (1);
2. A person who fails to observe matters to be observed when cord blood is collected, in violation of Article 8 (2), (3) and (4);
3. A person who fails to discard cord blood and cord blood products, in violation of the main sentence of Article 10 (4), Article 16 (1) and the main sentence of paragraph (2) of the same Article;
4. A person who compels another person who is transfused with the relevant cord blood products to bear expenses other than management expenses for cord blood and cord blood products, in violation of Article 18 (2);
5. A person who fails to register information on cord blood with the Cord Blood Information Center, in violation of Article 24 (3);
6. A person who uses the name of cord blood bank or similar names, in violation of Article 36;
7. A person who fails to delete personal information on women in childbed or newborn infants, in violation of Article 38 (3).
(2) Any of the following persons shall be subject to an administrative fine not exceeding five million won:
1. A person who fails to record matters concerning health problems, or discard, etc., in violation of Article 10 (2) and (5);
2. A person who fails to record or preserve cord blood management record, in violation of Article 20;
3. A person who fails to allow perusal or deliver a copy, in violation of Article 21;
4. A person who fails to report the movement, keeping or transfer of cord blood, etc., in violation of Article 22 (3);
5. A person who fails to report side effects relating to cord blood and cord blood products, in violation of Article 25 (3);
6. A person who fails to record or preserve matters concerning cord blood transfusion, in violation of Article 25 (4);
7. A person who fails to handle cord blood, etc. remaining after research is suspended or terminated, in violation of Article 29 (2);
8. A person who fails to take corrective orders pursuant to Article 32.
(3) Any of the following persons shall be subject to an administrative fine not exceeding three million won:
1. A person who fails to report the closure, suspension or restart of business, in violation of Article 11 (3);
2. A person who fails to transfer the control of cord blood management record to the Cord Blood Information Center, in violation of Article 22 (2);
3. A person who fails to comply with an order of report on duties, submission of documents, etc., or rejects examinations, in violation of Article 30 (5).
(4) Administrative fines prescribed in the provisions of paragraphs (1) through (3) shall be imposed and collected by the Minister of Health and Welfare or Mayors/Do Governors, as prescribed by Presidential Decree.
ADDENDA
Article 1 (Enforcement Date)
This Act shall enter into force on July 1, 2011.
Article 2 (Transitional Measures concerning Cord Blood Banks)
(1) Cord blood banks already established as at the time this Act enters into force shall be deemed cord blood banks pursuant to this Act; however, they shall again obtain permission for cord blood bank as prescribed in Article 11 within three months after this Act enters into force.
(2) Where an existing cord blood bank closes business without obtaining permission pursuant to this Act, a cord blood bank established or designated by the State or local governments as prescribed in Article 17 (1) may take over normal cord blood and cord blood products among donated cord blood and donated cord blood products kept by the existing cord blood banks after paying expenses.
Article 3 (Transitional Measures concerning Registration of Information on Donated Cord Blood)
Persons who keep donated cord blood or donated cord blood products pursuant to this Act as at the time this Act enters into force shall again register information on such donated cord blood or donated cord blood products with the Cord Blood Information Center as prescribed in Article 24 (3) within three months from the date this Act enters into force.
Article 4 (Transitional Measures concerning Family Cord Blood, etc.)
Cord blood for which a contract is concluded at the expense of the entruster, such as family cord blood, etc. already being kept by a cord blood bank as at the time this Act enters into force shall be governed by the contract concluded as at the time the entruster of cord blood entrusted such cord blood bank with cord blood. In such cases, such cord blood shall be deemed family cord blood pursuant to this Act.
ADDENDUM <Act No. 14929, Oct. 24, 2017>
This Act shall enter into force on three months after the date of its promulgation.