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ENFORCEMENT DECREE OF THE SAFETY, MANAGEMENT, ETC. OF HUMAN TISSUE ACT

Wholly Amended by Presidential Decree No. 26062, Jan. 28, 2015

Amended by Presidential Decree No. 26823, Dec. 30, 2015

Presidential Decree No. 26844, Dec. 31, 2015

Presidential Decree No. 27126, May 3, 2016

Presidential Decree No. 27949, Mar. 20, 2017

 Article 1 (Purpose)
The purpose of this Decree is to prescribe matters delegated by the Safety, Management, Etc. of Human Tissue Act and matters necessary for the enforcement thereof.
 Article 2 (Definition of Human Tissue)
“Body parts determined by Presidential Decree” in subparagraph 1 (c) of Article 3 of the Safety, Management, etc. of Human Tissue Act (hereinafter referred to as “Act”) means any of the following:
1. Nerve;
2. Pericardium.
 Article 3 (Organization of Human Tissue Safety and Management Advisory Committee)
(1) A Human Tissue Safety and Management Advisory Committee (hereinafter referred to as the "Committee") referred to in Article 6 (1) of the Act shall be comprised of not more than 15 members, including a chairperson and a vice-chairperson.
(2) The chairperson (hereinafter referred to as the “chairperson”) and the vice-chairperson of the Committee shall be elected from among Committee members.
(3) The Committee members shall be the following persons:
1. A person designated by the head of the affiliated organization, from among general public officials belonging to Grade 3 public officials or to the Senior Civil Service of the Ministry of Health and Welfare and the Ministry of Food and Drug Safety who are in charge of duties regarding human tissue (hereinafter referred to as “tissue”);
2. A person designated by the Minister of Health and Welfare from among persons who have broad knowledge and experience on donation, management and transplant of tissues.
(4) The term of the members referred to in paragraph (3) 2 shall be two years.
 Article 3-2 (Dismissal of Members of Committee)
Where a member referred to in Article 3 (3) 2 falls under any of the following cases, the Minister of Health and Welfare may dismiss such member:
1. If the member is unable to perform any of his/her duties due to a mental or physical disorder;
2. If the member commits any misdeed relevant to any of his/her duties;
3. If the member is found incompetent on the ground of his/her neglecting a duty, loss of dignity, or on any other ground;
4. If a member expresses that it is difficult to perform his/her duties.
[This Article Newly Inserted by Presidential Decree No. 26844, Dec. 31, 2015]
 Article 4 (Operation of Committee)
(1) The chairperson shall represent the Committee and exercise overall control over duties of the Committee.
(2) The chairperson shall convene and chair Committee meetings.
(3) Where the chairperson is unable to perform his/her duties due to extenuating circumstances, the vice-chairperson shall perform such duties on behalf of the chairperson.
(4) In principle, meetings of the Committee shall be held at least annually Provided, That where upon request by the Minister of Health and Welfare or majority of the Committee members or where the chair person deems necessary, the chairperson shall convene a meeting.
(5) A meeting of the Committee shall be held with attendance of majority of incumbent members and resolutions shall be passed with the concurrent votes of majority of the members present.
(6) To handle the duties of the Committee, the Committee shall have one secretary, designated by the Minister of Health and Welfare from among the public officials belonging to the Ministry of Health and Welfare.
(7) In addition to the matters prescribed in paragraphs (1) through (6), matters necessary for operating the Committee shall be determined by the chairperson, following a resolution by the Committee.
 Article 5 (Duties of National Tissue Donation Management Agency)
“Duties prescribed by Presidential Decree” in Article 6-2 (2) 5 of the Act means the following duties:
1. Education and consultation regarding tissue donation;
2. Duties regarding the promotion for spreading tissue donation culture;
3. Other duties deemed necessary by the Minister of Health and Welfare for properly managing tissue donations by the National Tissue Donation Management Agency referred to in Article 6-2 of the Act (hereinafter referred to as the “National Tissue Donation Management Agency”).
 Article 6 (Standard for Designation of Tissue Donation Registry)
A person who intends to be designated as a tissue donation registry pursuant to Article 7-3 (1) of the Act (hereinafter referred to as “registry”) shall prepare the following facilities, human resources and equipment:
1. An office divided separately, necessary for conducting the duties prescribed in Article 7-3 (3) of the Act (only referring to persons other than medical institutions defined in Article 3 of the Medical Service Act (hereinafter referred to as "medical institution"));
2. Human resources necessary for conducting the duties pursuant to Article 7-3 (3) of the Act;
3. Computation equipment necessary for the receipt, registration and notification of completed registration of tissue donors and candidates for tissue donation pursuant to Article 7-3 (3) 1 and 2 of the Act.
 Article 7 (Priority Order, etc. for Distributing Tissues)
(1) The priority order for distributing tissues pursuant to Article 12 of the Act shall be as follows:
1. Recovered tissues shall be distributed in priority to medical institutions which urgently required to transplant tissues for the treatment of patients;
2. Tissues other than those distributed pursuant to subparagraph 1 shall be distributed to tissue banks or medical institutions that perform tissue transplantation (hereinafter referred to as "tissue transplant hospital"), in light of the purpose of transplantation, treatment effects, suitability of transplantation, etc.
(2) The detailed standards of the priority order for distributing tissues pursuant to paragraph (1) shall be determined and publicly announced by the Minister of Health and Welfare.
(3) The head of a tissue bank which distributes tissues pursuant to paragraph (1) shall report the result, etc. of tissue distribution to the head of the National Tissue Donation Management Agency, as prescribed by the Minister of Health and Welfare.
 Article 8 (Authorization Standards for Tissue Banks)
The standards of facilities, equipment, and human resources, quality control system, etc. which shall be equipped by a person who intends to establish a tissue bank shall be as provided for in attached Table 1.
 Article 9 (Renewal of Authorization for Tissue Banks)
(1) A tissue bank which intends to obtain renewal of authorization pursuant to Article 14 (1) of the Act shall submit to the Minister of Food and Drug Safety, an application for renewal of authorization for a tissue bank (including electronic documents) by not later than 60 days before the expiration date of the authorization attaching the following documents (including electronic documents), as prescribed by Ordinance of the Prime Minister:
1. The original certificate of authorization for the establishment of the tissue bank;
2. Documents regarding the status of facilities, equipment, and human resources, quality control system, etc. of the tissue bank;
3. Documents regarding the performance record of tissue processing or import for the previous three years.
(2) Upon receipt of an application for renewal of authorization for a tissue bank pursuant to paragraph (1), the Minister of Food and Drug Safety shall verify whether the standards of facilities, equipment, and human resources, quality control system, etc. of the relevant tissue bank meet the standards prescribed in attached Table 1 and the performance record of tissue processing or import for the previous three years, and when he/she deems it necessary to renew the authorization, he/she shall state the matters of renewal of authorization in the certificate of authorization for the establishment of tissue bank and issue it to the relevant tissue bank.
 Article 10 (Designation Standards for Tissue Donation Support Institutions)
The facilities, equipment and human resources which a person who intends to be designated as a tissue support institution pursuant to Article 16-2 (4) of the Act (hereinafter referred to as “tissue support institution”) shall be equipped with shall be as provided for in attached Table 2.
 Article 11 (Subjects for Duties of Confidentiality)
“Persons prescribed by Presidential Decree” in Article 22 (1) of the Act means any of the following persons:
1. The head of the National Tissue Donation Management Agency and a person who conducts the duties referred to in Article 6-2 (2) of the Act in the National Tissue Donation Management Agency;
2. The head of a registry and a person who conducts the duties referred to in Article 7-3 (3) of the Act in the registry (including the head of an organ transplantation registry conducting the duties of the registries pursuant to paragraph (4) 1 of the same Article and persons conducting such duties);
3. The head of a tissue bank and a person who conducts the duties pursuant to Article 13 (3) of the Act in the tissue bank (including persons who conduct the duties of the registries pursuant to Article 7-3 (4) 2 of the Act);
4. The head of a tissue support institution and a person who conducts the duties pursuant to Article 16-2 (1) of the Act in the tissue support institution (including persons who conduct the duties of the registries pursuant to Article 7-3 (4) 3 of the Act);
5. Any of the following persons, who works in a tissue transplant hospital:
(a) A physician or dentist who conducts tissue transplantation, and other persons who participates in transplantation surgery;
(b) A person who keeps or manages the record regarding tissue transplantation;
(c) A person who participates in the physical examination of a person who intends to be subject to the tissue transplantation;
6. A person who works in a medical institution, etc. which is consigned a blood test, etc. from a tissue bank, and participates in a blood test, etc. of a tissue donor, etc.;
7. A person who participates in the establishment, management, operation of a computer network system that manages information on the donation, management, transplantation, etc. of tissues pursuant to Article 27 (3) of the Act;
8. Other persons determined and publicly announced by the Minister of Health and Welfare or the Minister of Food and Drug Safety, who participates in the duties regarding the donation, management and transplantation, etc. of tissues.
 Article 12 (Investigation of Registries, etc.)
An investigation referred to in Article 23 (2) of the Act shall be conducted by the following inspection and verification against registries, tissue donation support institutions, tissue banks and tissue transplant hospitals:
1. Inspection and verification of details of the records which are to be maintained according to the Act;
2. Inspection of storage, management status, etc. of tissues;
3. Verification of qualifications of the facilities and equipment, etc. of registries, tissue donation support institutions, and tissue banks;
4. Inspection of matters deemed necessary by the Minister of Health and Welfare or the Minister of Food and Drug Safety regarding donation, management, transplantation, etc. of tissues.
 Article 13 (Transfer of Data)
(1) The head of a tissue bank that ceases operation or whose authorization is revoked shall transfer the data maintained under Article 20 of the Act to the Minister of Food and Drug Safety pursuant to Article 26 (3) of the Act, within the following relevant period:
1. Where the operation ceased pursuant to Article 26 (1) of the Act: Within one month from the date the operation ceased;
2. Where the authorization is revoked pursuant to Article 25 of the Act: Within one month from the date the authorization is revoked.
(2) The head of a registry or tissue donation support institution which intends to cease operation or cease to perform duties or whose designation is revoked shall transfer the data regarding the implementation of duties pursuant to Article 7-3 (3) or Article 16-2 (1) of the Act to the Minister of Health and Welfare, within the following relevant period:
1. Where the institution ceases operation or ceases performing duties pursuant to Article 26 (2) of the Act: Within one month from date it intends to cease operation or cease performing duties;
2. Where the designation of the institution is revoked pursuant to Article 25 of the Act: Within one month from the date the designation is revoked.
 Article 14 (Establishment and Management of Computer Network System)
(1) The Minister of Health and Welfare shall establish, operate and manage a computer network system pursuant to Article 27 (3) of the Act to conduct the following duties:
1. Computerization of the information on tissue donors and candidates for tissue donation notified by the registry pursuant to Article 7-3 (3) 1 and 2 of the Act;
2. Computerization of the information on tissue distribution pursuant to Article 12 of the Act;
3. Investigation and research on tissue donation and preparation of information and statistics thereof;
4. Computerization of other information on tissue donation and management of tissue distribution.
(2) The Minister of Food and Drug Safety shall establish, operate and manage a computer network system pursuant to Article 27 (3) of the Act to conduct the following duties:
1. Computerization of information on tissue donors notified by a registry pursuant to Article 7-3 (3) 1 of the Act;
2. Computerization of the duties of reporting and management regarding destruction of tissue pursuant to Article 10 (4) of the Act;
3. Computerization of the duties of reporting and management regarding donation, management and transplant of tissues pursuant to Article 19 (1) of the Act;
4. Computerization of the duties of reporting and management regarding the findings, side effects, etc. discovered in follow-up inspection pursuant to Article 19 (3) of the Act;
5. Production, analysis and provision of statistics regarding donation, management and transplant of tissues;
6. Computerization of other information on tissue banks and safety management of tissues.
(3) The Minister of Health and Welfare and the Minister of Food and Drug Safety shall mutually cooperate in using the computer network systems and information sharing pursuant to paragraphs (1) and (2).
 Article 15 (Delegation of Authorization)
The Minister of Food and Drug Safety shall delegate the following authority to the head of a Regional Office of Food and Drug Safety pursuant to Article 28 of the Act:
1. Orders to and investigations of tissue banks pursuant to Article 23 (1) and (2) of the Act;
2. Administrative dispositions issued pursuant to Article 25 (1) and (3) of the Act.
 Article 16 (Management of Sensitive Information and Personally Identifiable Information)
(1) The Minister of Health and Welfare and the Minister of Food and Drug Safety may manage information regarding health prescribed in Article 23 of the Personal Information Protection Act and genetic information prescribed in subparagraph 1 of Article 18 of the Enforcement Decree of the same Act (hereinafter referred to as health information, etc.) and data including resident registration numbers prescribed in subparagraph 1 of Article 19 of the Enforcement Decree of the same Act (hereafter referred to as “resident registration numbers” in this Article), if it is essential to conduct the following affairs:
1. Affairs regarding the management of completed registration of tissue donors notified by a registry pursuant to Article 7-3 (3) 1 of the Act;
2. Affairs regarding the management of results of tissue transplant reported pursuant to Article 19 (1) of the Act and the latter part of Article 19 (2) of the Act;
3. Affairs regarding orders and inspection, etc. referred to in Article 23 (1) and (2) of the Act;
4. Affairs regarding the management of data transferred by the head of a tissue bank, a registry and a tissue donation support institution pursuant to Article 26 (3) and (4) of the Act.
(2) The head of the National Tissue Donation Management Agency may manage health information, etc. and data including resident registration numbers, if it is essential to conduct the following affairs:
1. Affairs regarding the registration and management of tissue donors and candidates for tissue donation pursuant to Article 6-2 (2) 1 of the Act;
2. Affairs regarding the decision of registration and notification, etc. of tissue donors and candidates for tissue donation pursuant to Article 7-2 (2) of the Act;
3. Affairs regarding the management of completed registration of tissue donors notified by a registry pursuant to Article 7-3 (3) 1 of the Act.
(3) The head of a tissue bank may manage health information, etc. and data including resident registration numbers, if it is essential to conduct the following affairs:
1. Affairs regarding a consent to donate tissues pursuant to Article 7 (1) of the Act;
2. Affairs regarding a consent to recover tissues pursuant to Article 8 (1) and (2) of the Act;
3. Affairs regarding the request to inspect the medical history and record of administered medicines of tissue donors pursuant to Article 10 (2) of the Act;
4. Affairs regarding the management of the results of tissue transplantation notified pursuant to the former part of Article 19 (2) of the Act.
(4) The head of a registry may manage health information, etc. and data including resident registration numbers, if it is essential to conduct the following affairs:
1. Affairs regarding the registration of tissue donors and candidates for tissue donation pursuant to Article 7-2 (1) of the Act;
2. Affairs regarding the receipt, registration and notification of completed registration of tissue donors and candidates for tissue donation pursuant to Article 7-3 (3) 1 and 2 of the Act.
(5) The head of a tissue donation support institution may manage health information, etc. and data including resident registration numbers, if it is essential to conduct the following affairs:
1. Affairs regarding locating tissue donors pursuant to Article 16-2 (1) 1 of the Act;
2. Affairs regarding support for tissue donors and their bereaved family members pursuant to Article 16-2 (1) 3 of the Act;
3. Affairs regarding the request to inspect the medical history and record of administered medicines of tissue donors pursuant to Article 16-2 (5) of the Act.
 Article 17 (Re-Examination of Regulations)
(1) The Minister of Health and Welfare and the Minister of Food and Drug Safety shall examine the standards for imposing administrative fines pursuant to Article 18 and attached Table 3 on a three-yearly basis (referring to a period until January 1 of the base date of the year by every third anniversary) based on January 1, 2015, and take measures, such as improvements. <Amended by Presidential Decree No. 26823, Dec. 30, 2015>
(2) The Minister of Food and Drug Safety shall examine the appropriateness of the renewal of authorization of a tissue bank pursuant to Article 9 on a three-yearly basis (referring to a period until January 1 of the base date of the year by every third anniversary) based on January 1, 2016, and take measures, such as improvements. <Newly Inserted by Presidential Decree No. 26823, Dec. 30, 2015>
 Article 18 (Criteria for Imposition of Administrative Fines)
Criteria for imposition of administrative fines under Article 37 of the Act shall be as listed in attached Table 3.
ADDENDA
Article 1 (Enforcement Date)
This Decree shall enter into force on January 29, 2015.
Article 2 (Relation with other Acts and Subordinate Statutes)
Any citation of the former Enforcement Decree of the Safety, Management, etc. of Human Tissue Act or of any provision thereof, in an statute in force as at the time this Decree enters into force, shall be deemed a citation of this Decree or of the relevant provision of this Decree in lieu of the former provision, if such relevant provisions exist herein.
ADDENDUM <Presidential Decree No. 26823, Dec. 30, 2015>
This Decree shall enter into force on January 1, 2016.
ADDENDUM <Presidential Decree No. 26844, Dec. 31, 2015>
This Decree shall enter into force on the date of its promulgation.
ADDENDUM <Presidential Decree No. 27126, May 3, 2016>
This Decree shall enter into force on May 5, 2016.
ADDENDUM <Presidential Decree No. 27949, Mar. 20, 2017>
This Decree shall enter into force on the date of its promulgation.