The purpose of this Decree is to prescribe matters mandated by the Blood Management Act and matters necessary for the enforcement thereof. <Amended on Jan. 29, 2005>
| Article 2 (Composition of National Blood Donation Promotion Council) |
| (1) | The National Blood Donation Promotion Council established under Article 4-2 (1) of the Blood Management Act (hereinafter referred to as the "Act") (hereinafter referred to as the "National Blood Donation Council") shall be comprised of up to 10 members, including 1 Chairperson. |
| (2) | The Second Vice Minister of Health and Welfare shall serve as the Chairperson of the National Blood Donation Council. |
| (3) | Members of the National Blood Donation Council shall be appointed by the head of any of the following central administrative agencies, from among Grade III public officials of the following central administrative agencies, members in general service of the Senior Executive Service, or public officials equivalent thereto: |
| 1. | The Ministry of Economy and Finance; |
| 2. | The Ministry of Education; |
| 3. | The Ministry of National Defense; |
| 4. | The Ministry of the Interior and Safety; |
| 5. | The Office for Government Policy Coordination; |
| 6. | Other central administrative agencies deemed necessary by the Minister of Health and Welfare. |
[This Article Added on Jun. 15, 2021]
[Previous Article 2 moved to Article 2-3 <Jun. 15, 2021>]
| Article 2-2 (Operation of National Blood Donation Council) |
| (1) | The Chairperson of the National Blood Donation Council shall convene a meeting and preside over the meeting. |
| (2) | A majority of the members of the National Blood Donation Council shall constitute a quorum, and any resolution thereof shall require the concurring vote of a majority of those present. |
| (3) | The National Blood Donation Council shall have 1 executive secretary to conduct its business affairs, who shall be appointed by the Minister of Health and Welfare from among public officials under his or her control. |
| (4) | Except as provided in paragraphs (1) through (3), matters necessary for operating the National Blood Donation Council shall be determined by the Chairperson of the National Blood Donation Council, subject to resolution by the National Blood Donation Council. |
[This Article Added on Jun. 15, 2021]
| Article 2-3 (Encouragement of blood donation) |
| (1) | The Minister of Health and Welfare shall formulate and implement a plan for encouraging blood donation every year in order to ensure appropriateness in adjusting the supply of and demand for blood pursuant to Article 4-3 (3) of the Act. <Amended on Jan. 29, 2005; Feb. 29, 2008; Mar. 15, 2010; Jun. 15, 2021> |
| (2) | Agencies of the State and local governments shall actively cooperate in the encouragement of blood donation under paragraph (1), and the Chairperson of the Korean Red Cross may request public organizations, non-governmental organizations, or blood centers to provide necessary cooperation, such as the encouragement of blood donation, in order to control the supply of and demand for blood. <Amended on Jan. 29, 2005; May 28, 2019> |
| (3) | The Minister of Health and Welfare may set a period to promote blood donation in order to raise citizens' awareness of blood donation and encourage them to donate blood. <Amended on Feb. 29, 2008; Mar. 15, 2010; May 9, 2023> |
| (4) | Deleted. <May 9, 2023> |
[Moved from Article 2 <Jun. 15, 2021>]
| Article 3 (Protection of blood donors) |
Pursuant to Article 4-4 (8) of the Act, a blood center shall take measures to protect blood donors, such as providing them with necessary beverages immediately after blood collection. <Amended on Jan. 29, 2005; Jun. 15, 2021>
| Article 3-2 (Formulation and implementation of plans for supply of and demand for source plasma) |
| (1) | The Minister of Health and Welfare shall formulate a plan for the stable supply of and demand for source plasma (hereafter in this Article referred to as "supply and demand plan") every year to ensure the stable supply of and demand for source plasma pursuant to Article 4-7 of the Act. |
| (2) | If necessary to formulate and implement a supply and demand plan, the Minister of Health and Welfare may request a blood center that supplies source plasma or a manufacturer of plasma derivatives supplied with source plasma to provide relevant data and information. |
| (3) | Except as provided in paragraphs (1) and (2), matters necessary for formulating and implementing a supply and demand plan, such as procedures for formulating a supply and demand plan and the scope of data and information requested by the Minister of Health and Welfare, shall be determined and publicly notified by the Minister of Health and Welfare. |
[This Article Added on May 9, 2023]
| Article 3-3 (Programs for enhancing honorable treatment for blood donors) |
Programs for enhancing honorable treatment for blood donors conducted by the State pursuant to Article 4-8 of the Act shall be as follows: | 1. | Commendation events to award merits to those who contribute to blood donation; |
| 2. | Support for education on blood donation and public relations activities to encourage blood donation; |
| 3. | Other programs determined by the Minister of Health and Welfare for honorable treatment of blood donors. |
[This Article Added on May 9, 2023]
| Article 4 (Composition of Blood Management Committee) |
| (1) | Deleted. <Jan. 29, 2005> |
| (2) | The Vice Chairperson of the Blood Management Committee under Article 5 of the Act (hereinafter referred to as the "Committee") shall be appointed by the Minister of Health and Welfare from among public officials of Grade III of the Ministry of Health and Welfare, public officials in general service belonging to the Senior Executive Service, or public officials equivalent thereto. <Amended on Jan. 29, 2005; Jun. 12, 2006; Feb. 29, 2008; Mar. 15, 2010> |
| (3) | Members of the Committee shall be appointed or commissioned by the Minister of Health and Welfare from among the following persons: <Added on Jan. 29, 2005; Jun. 12, 2006; Feb. 29, 2008; Mar. 15, 2010> |
| 1. | Public officials of Grade II or III belonging to the relevant administrative agencies or public officials equivalent thereto (including public officials belonging to the Senior Executive Service); |
| 2. | Persons representing persons engaged in blood centers; |
| 4. | Persons representing the press; |
| 5. | Persons qualified as attorneys-at-law; |
| 6. | Persons with extensive knowledge of and experience in blood management work. |
| Article 4-2 (Dismissal and decommissioning of Committee members) |
If a Committee member under the subparagraphs of Article 4 (3) of the Act falls under any of the following cases, the Minister of Health and Welfare may dismiss such member or terminate his or her commission: | 1. | Where the member is unable to perform duties due to a mental or physical disorder; |
| 2. | Where the member commits an irregularity in connection with his or her duties; |
| 3. | Where the member is deemed unsuitable as a member due to neglecting duties, demeaning behavior, or other reasons; |
| 4. | Where the member explicitly states in person that it is impractical for him or her to perform duties. |
[This Article Added on Dec. 31, 2015]
| Article 5 (Operation of Committee) |
| (1) | The Chairperson of the Committee (hereinafter referred to as the "Chairperson") shall represent the Committee and have general supervision and control of the business affairs of the Committee, and the Vice Chairperson shall assist the Chairperson, and if the Chairperson is unable to perform his or her duties due to unavoidable reasons, the Vice Chairperson shall act on behalf of the Chairperson. <Amended on Jan. 29, 2005; Jul. 2, 2019> |
| (2) | The Chairperson shall convene and preside over meetings of the Committee. |
| (3) | Meetings of the Committee shall be convened by the Chairperson upon request by the Minister of Health and Welfare or by at least 1/3 of all incumbent members or when the Chairperson deems it necessary. <Added on Jan. 29, 2005; Feb. 29, 2008; Mar. 15, 2010> |
| (4) | A majority of the members of the Committee shall constitute a quorum, and any resolution thereof shall require the concurring vote of a majority of those present. |
| (5) | The Chairperson may, if deemed necessary, have relevant public officials or experts attend the Committee and hear their opinions. |
| (6) | The Committee shall have 1 executive secretary to handle the administrative affairs of the Committee, and the executive secretary shall be appointed by the Minister of Health and Welfare from among public officials under his or her jurisdiction. <Amended on Feb. 29, 2008; Mar. 15, 2010> |
| (7) | The Chairperson shall, without delay, report the matters deliberated upon by the Committee to the Minister of Health and Welfare without delay. <Amended on Jan. 29, 2005; Feb. 29, 2008; Mar. 15, 2010> |
| (8) | Deleted. <Jan. 29, 2005> |
| Article 5-2 (Subcommittees) |
| (1) | The Committee may establish subcommittees for each specialized field to professionally examine matters to be deliberated on. |
| (2) | A subcommittee shall be comprised of up to 10 members, and the chairperson of a subcommittee shall be elected from among the members of the subcommittee. <Amended on May 9, 2023> |
| (3) | The chairperson of a subcommittee shall report the results of deliberation by the subcommittee to the Committee, and matters deemed minor by the Chairperson among the matters deliberated by the subcommittee shall be deemed to have undergone deliberation by the Committee. |
[This Article Added on Jan. 29, 2005]
| Article 5-3 (Payment of allowances) |
Allowances and travel expenses may be paid to the members and related experts who have attended a meeting of the Committee and a subcommittee within the budget; provided, this shall not apply where a member who is a public official attends in direct connection with the business affairs under his or her jurisdiction.
[This Article Added on Jan. 29, 2005]
| Article 5-4 (Detailed operational rules) |
Except as provided in this Decree, matters necessary for the operation of the Committee and subcommittees shall be determined by the Chairperson following a resolution by the Committee.
[This Article Added on Jan. 29, 2005]
| Article 5-5 (Notification to persons ineligible to donate blood) |
| (1) | Upon receipt of a request from a person listed on the list of persons ineligible to donate blood pursuant to Article 7-2 (4) of the Act, the Minister of Health and Welfare may notify the relevant matters, such as the grounds for and period of blood donation ban, as prescribed by Ministerial Decree of Health and Welfare. <Amended on Mar. 15, 2010> |
| (2) | In giving a notice under paragraph (1), the Minister of Health and Welfare shall use means such as sealing to make sure that no one other than the person ineligible to donate blood can learn the contents, and shall guide the notified individual not to donate blood during the period of blood donation ban. <Amended on Mar. 15, 2010> |
| (3) | Except as provided in paragraphs (1) and (2), matters necessary for notifying persons ineligible to donate blood shall be prescribed by Ministerial Decree of Health and Welfare. <Amended on Mar. 15, 2010> |
[This Article Added on Jan. 30, 2009]
| Article 6 (Exceptions to disposal of blood unfit for use) |
Blood unfit for use need not be discarded pursuant to the proviso of Article 8 (2) of the Act in any of the following cases: <Amended on Jan. 29, 2005; Jan. 30, 2009; Jun. 30, 2016> | 1. | Where it is used as a raw material for vaccines; |
| 2. | Where it is used for medical research or development of medicines or medical devices; |
| 3. | Where it is used for tests for the quality control of medicines or medical devices, such as blood products, etc. |
| Article 7 (Submission of records) |
The Minister of Health and Welfare may require a blood center to submit records on blood management work under Article 12 (1) of the Act pursuant to Article 13 (1) of the Act. <Amended on Feb. 29, 2008; Mar. 15, 2010>
| Article 7-2 (Review and assessment of blood management work) |
| (1) | The review and assessment under Article 13 (3) of the Act shall be classified into regular and occasional assessments. |
| (2) | A regular assessment shall be conducted every 2 years, and an occasional assessment shall be conducted where it is necessary to verify whether a blood center that has undergone a regular assessment continuously maintains the assessed level based on the results of such assessment. |
| (3) | The standards for review and assessment shall be as follows: |
| 1. | Matters regarding the appropriateness of blood collection process, such as protection of blood donors; |
| 2. | Matters regarding the accuracy of blood tests; |
| 3. | Matters regarding the safety of manufacture, preservation, supply, and quality management of blood products. |
| (4) | The Minister of Health and Welfare may require relevant specialized institutions or organizations to perform part of review and assessment. <Amended on Feb. 29, 2008; Mar. 15, 2010> |
| (5) | Detailed standards for review and assessment under paragraph (3) and other matters necessary for review and assessment shall be determined and publicly notified by the Minister of Health and Welfare. <Amended on Feb. 29, 2008; Mar. 15, 2010> |
[This Article Added on Jan. 29, 2005]
| Article 8 (Use of reserves for return of blood donation) |
“Purposes prescribed by Presidential Decree” in Article 15 (3) 4 of the Act means any of the following purposes: <Amended on Jan. 29, 2005; Jan. 30, 2009> | 1. | Fact-finding surveys and research on specific side effects from blood transfusion; |
| 2. | Support for the computerization of blood management work of blood centers; |
| 3. | Deleted. <Jan. 30, 2009> |
[Title Amended on May 28, 2019]
| Article 9 (Management and operation of reserves for return of blood donation) |
| (1) | The President of the Korean Red Cross entrusted with the raising and management of reserves for return of blood donation (hereinafter referred to as "reserves") pursuant to subparagraph 5 of Article 10 shall operate the reserves as an independent account separately from other accounts of the Korean Red Cross. <Amended on Jan. 30, 2009; May 28, 2019; Sep. 8, 2020> |
| (2) | The President of the Korean Red Cross shall establish a reserve account in a bank under the Banking Act in order to clarify the revenue and expenditure of the reserves. <Amended on Jan. 29, 2005; Nov. 15, 2010; May 28, 2019> |
[Title Amended on May 28, 2019]
| Article 10 (Entrustment of business affairs) |
The Minister of Health and Welfare shall entrust the following business affairs to the President of the Korean Red Cross pursuant to Article 17 (2) of the Act: | 1. | Preparing, managing, and notifying lists of persons ineligible to donate blood prescribed in Article 7-2 (1) and (4) of the Act; |
| 2. | Receiving, maintaining, and managing reports on blood donors and their blood tests under Article 8 (6) and (7) of the Act; |
| 4. | Receiving reserves for return of blood donation under Article 15 (1) of the Act; |
| 5. | Creating and managing reserves under Article 15 (2) of the Act. |
[This Article Wholly Amended on Sep. 8, 2020]
| Article 10-2 (Processing of sensitive information and personally identifiable information) |
| (1) | The Minister of Health and Welfare (including persons entrusted with the business affairs of the Minister of Health and Welfare pursuant to Article 10) or a blood center may process information on health and sexual life under Article 23 (1) of the Personal Information Protection Act, information constituting criminal history records under subparagraph 2 of Article 18 of the Enforcement Decree of that Act, and data containing resident registration numbers or alien registration numbers under subparagraph 1 or 4 of Article 19 of the Enforcement Decree of that Act, if inevitable to perform the following business affairs: <Amended on May 28, 2019; Sep. 8, 2020; Dec. 1, 2020> |
| 1. | Business affairs regarding blood management and the opening of blood centers under Article 6 of the Act; |
| 2. | Business affairs regarding identification, medical examinations, etc. of blood donors under Article 7 of the Act; |
| 3. | Business affairs regarding the management of persons ineligible to donate blood under Article 7-2 of the Act; |
| 4. | Business affairs regarding securing the safety of blood under Article 8 of the Act; |
| 5. | Business affairs regarding measures, etc. to be taken in case of a blood accident under Article 8-2 of the Act; |
| 6. | Business affairs regarding measures against specific side effects from blood transfusions under Article 10 of the Act; |
| 7. | Business affairs regarding compensation for specific side effects from blood transfusion and side effects from blood collection under Article 10-2 of the Act; |
| 8. | Business affairs regarding the preparation, etc. of records on blood management work under Article 12 of the Act; |
| 9. | Business affairs regarding the preparation, etc. of electronic records on blood management work under Article 12-2 of the Act; |
| 10. | Business affairs regarding quality management inspections, etc. under Article 13 of the Act; |
| 11. | Business affairs regarding the issuance of blood donor cards, compensation, etc. under Article 14 of the Act; |
| 12. | Business affairs regarding the revocation, etc. of permission for opening a blood center under Article 17-3 of the Act. |
| (2) | The Special Metropolitan City Mayor, a Metropolitan City Mayor, a Special Self-Governing City Mayor, a Do Governor, or a Special Self-Governing Province Governor may process data containing information on health and sexual life under Article 23 (1) of the Personal Information Protection Act, information constituting criminal history records under subparagraph 2 of Article 18 of the Enforcement Decree of the Personal Information Protection Act, and data containing resident registration numbers or alien registration numbers under subparagraph 1 or 4 of Article 19 of the Enforcement Decree of that Act, if inevitable to conduct business affairs regarding receipt and notification of reports on the occurrence of specific side effects from blood transfusions under Article 10 (1) and (2) of the Act. <Added on Sep. 8, 2020> |
[This Article Added on Jan. 6, 2012]
| Article 10-3 (Re-examination of regulation) |
The Minister of Health and Welfare shall review the validity of the criteria for the imposition of administrative fines under Article 11 and the Appendix once every 3 years from January 1, 2014 (referring to the period that ends on the day before January 1 of every 3rd year) and shall take measures for improvement, etc. [This Article Added on Dec. 30, 2013]
| Article 11 (Criteria for imposition of administrative fines) |
The criteria for the imposition of administrative fines under Article 23 (1) of the Act shall be as specified in the Appendix. [This Article Wholly Amended on Jan. 30, 2009]
ADDENDUM <Presidential Decree No. 16241, Apr. 9, 1999>
This Decree shall enter into force on the date of its promulgation.
ADDENDUM <Presidential Decree No. 18312, Mar. 17, 2004>
This Decree shall enter into force on the date of its promulgation.
ADDENDUM <Presidential Decree No. 18692, Jan. 29, 2005>
This Decree shall enter into force on January 30, 2005.
ADDENDA <Presidential Decree No. 19513, Jun. 12, 2006>
Article 1 (Enforcement date)
This Decree shall enter into force on July 1, 2006.
ADDENDA <Presidential Decree No. 20679, Feb. 29, 2008>
Article 1 (Enforcement date)
This Decree shall enter into force on the date of its promulgation.
ADDENDUM <Presidential Decree No. 21284, Jan. 30, 2009>
This Decree shall enter into force on March 29, 2009; provided, the amended provisions of Article 5-5, Article 10 (2) 1, and subparagraph 1 of the Appendix shall enter into force on the date of its promulgation.
ADDENDA <Presidential Decree No. 22075, Mar. 15, 2010>
Article 1 (Enforcement date)
This Decree shall enter into force on March 19, 2010. (Proviso Omitted.)
ADDENDA <Presidential Decree No. 22493, Nov. 15, 2010>
Article 1 (Enforcement date)
This Decree shall enter into force on November 18, 2010.
ADDENDA <Presidential Decree No. 23488, Jan. 6, 2012>
Article 1 (Enforcement date)
This Decree shall enter into force on the date of its promulgation. (Proviso Omitted.)
ADDENDUM <Presidential Decree No. 25050, Dec. 30, 2013>
This Decree shall enter into force on January 1, 2014. (Proviso Omitted)
ADDENDUM <Presidential Decree No. 26844, Dec. 31, 2015>
This Decree shall enter into force on the date of its promulgation.
ADDENDA <Presidential Decree No. 27299, Jun. 30, 2016>
Article 1 (Enforcement date)
This Decree shall enter into force on July 1, 2016. (Proviso Omitted.)
ADDENDUM <Presidential Decree No. 29794, May 28, 2019>
This Decree shall enter into force on the date of its promulgation.
ADDENDUM <Presidential Decree No. 29950, Jul. 2, 2019>
This Decree shall enter into force on the date of its promulgation. (Proviso Omitted.)
ADDENDUM <Presidential Decree No. 30993, Sep. 8, 2020>
This Decree shall enter into force on January 1, 2021.
ADDENDUM <Presidential Decree No. 31209, Dec. 1, 2020>
This Decree shall enter into force on December 4, 2020; provided, the amended provisions of Article 10-2 (1) 12 shall enter into force on January 1, 2021.
ADDENDUM <Presidential Decree No. 31775, Jun. 15, 2021>
This Decree shall enter into force on June 30, 2021.
ADDENDA <Presidential Decree No. 33454, May 9, 2023>
Article 1 (Enforcement date)
This Decree shall enter into force on June 22, 2023.
Article 2 (Applicability to formulation of plans for supply of and demand for source plasma)
The amended provisions of Article 3-2 (1) shall begin to apply to supply and demand plans formulated in 2024.