The purpose of this Decree is to prescribe matters mandated by the Act on the Promotion of Korean Medicine and Pharmaceuticals and matters necessary for the enforcement thereof. <Amended on Jun. 11, 2019>
| Article 2 (Korean medicine and pharmaceutical technology) |
The scope of Korean medicine and pharmaceutical technologies under subparagraph 3 of Article 2 of the Act on the Promotion of Korean Medicine and Pharmaceuticals (hereinafter referred to as the "Act") shall be as specified in the attached Table <Amended on Jun. 11, 2019> [Title Amended on Jun. 11, 2019]
| Article 3 (Notification of comprehensive plans for fostering Korean medicine and pharmaceuticals) |
When a comprehensive plan for fostering Korean medicine and pharmaceuticals under Article 6 of the Act is finalized, the Minister of Health and Welfare shall, without delay, notify the heads of the relevant central administrative agencies and the heads of local governments of the details thereof. <Amended on Feb. 29, 2008; Mar. 15, 2010; Jun. 11, 2019> [Title Amended on Jun. 11, 2019]
| Article 4 (Functions of the Deliberative Committee on the Development of Korean Medicine and Pharmaceuticals) |
The Deliberative Committee on the Development of Korean Medicine and Pharmaceuticals under Article 6 (3) of the Act (hereinafter referred to as the "Committee") shall deliberate on the following matters:<Amended on Feb. 29, 2008; Mar. 15, 2010; Jun. 11, 2019> | 1. | The formulation and change of a comprehensive plan for fostering Korean medicine and pharmaceuticals under Article 6 of the Act; |
| 2. | The formulation of plans to implement major policy measures under Article 7 of the Act; |
| 3. | The standards for formulating regional plans for fostering Korean medicine and pharmaceuticals under Article 8 of the Act; |
| 4. | Research and development of health and medical service industrial technologies using Korean medicine treatment and herbal medicine, supportive policy measures to turn Korean medicine and pharmaceutical technologies and products related to Korean medicine and pharmaceuticals into a health and medical service industry and to strengthen their international competitiveness, and clinical trials and the establishment of verification systems for Korean medicine treatment and products related to Korean medicine and pharmaceuticals under Article 10 of the Act; |
| 5. | Support for the development of Korean medicine industrial complexes and the establishment and modification of plans for the establishment of a Korean medicine industrial complex under article 12 (1) of the Act; |
| 6. | Other matters regarding the fosterage of Korean medicine and pharmaceuticals, which the Minister of Health and Welfare or the chairperson of the Committee refers to the Committee for deliberation. |
| Article 5 (Composition of Committee) |
| (1) | Deleted. <Jun. 11, 2019> |
| (2) | The chairperson shall be elected from among and by its members, and the vice chairperson shall be appointed by the chairperson. |
| (3) | Members shall be appointed or commissioned by the Minister of Health and Welfare from among the following persons: <Amended on Jun. 12, 2006; Feb. 29, 2008; Mar. 15, 2010; Jan. 4, 2011; Mar. 23, 2013; Nov. 19, 2014; Jul. 26, 2017; Jun. 11, 2019> |
| 1. | Persons who have extensive experience or expertise in the fields related to Korean medicine and pharmaceuticals; |
| 2. | An executive officer or employee of a public health organization or consumer organization established under the Civil Act or a special Act; |
| 3. | Public officials of Grade IV or higher under the jurisdiction of the Ministry of Economy and Finance, the Ministry of Science and ICT, the Ministry of the Interior and Safety, the Ministry of the Interior and Safety, the Ministry of Agriculture, Food and Rural Affairs, the Ministry of Trade, Industry and Energy, the Ministry of Health and Welfare, the Ministry of Food and Drug Safety, the Rural Development Administration, the Special Metropolitan City, Metropolitan City, Special Self-Governing City, Do, or Special Self-Governing Province (hereinafter referred to as "City/Do"), or public officials in general service belonging to the Senior Executive Service, who are appointed by the head of the relevant agency. |
| (4) | The term of office of a member shall be 2 years; provided, the term of office of a member who is a public official shall be the period of his or her service. |
| Article 5-2 (Exclusion of, challenge to, or recusal of, members) |
| (1) | If a member of the Committee falls under any of the following subparagraphs, he or she shall be excluded from deliberation by the Committee: |
| 1. | Where the member, or his or her spouse or his or her former spouse is a party to the relevant agenda (if the party is a corporation, organization, etc., its executive officer or employee shall be included; hereinafter the same shall apply), or is holding any right or obligation jointly with a party whose case is on the agenda; |
| 2. | Where the member is a relative or former relative of a party to the agenda; |
| 3. | Where the member has offered any testimony, statement, advice, research, services, or appraisal for the relevant agenda; |
| 4. | Where the member or the corporation to which the member belongs is or was an agent of a party to the relevant agenda; |
| 5. | Where a member has served as an executive officer or employee within the last 3 years in a corporation or organization that is a party to the relevant agenda. |
| (2) | If a member falls under the grounds for exclusion under paragraph (1) or if it is impracticable to expect a fair deliberation from the member, a party may file an application for challenge to the member with the Committee, and the Committee shall decide whether to accept the challenge by resolution. In such cases, the member subject to the application for challenge shall not participate in the resolution. |
| (3) | Where the member falls under the grounds for exclusion pursuant to the subparagraphs of paragraph (1), he or she shall recuse himself or herself from deliberation the relevant agenda. |
[This Article Newly Inserted on Jun. 11, 2019]
[Previous Article 5-2 moved to Article 5-3 <Jun. 11, 2019>]
| Article 5-3 (Dismissal or removal of Committee member) |
If a Committee member falls under any of the following subparagraphs, the Minister of Health and Welfare may dismiss or remove the relevant member: <Amended on Jun. 11, 2019>
| 1. | Where he or she becomes unable to perform his or her duties due to a mental or physical disability; |
| 2. | Where he or she engages in any misconduct in connection with his or her duties; |
| 3. | Where the member is deemed unfit as a member due to neglect of duties, injury to dignity, or other causes; |
| 4. | Where he or she fails to recuse himself or herself from deliberating on the relevant agenda although he or she falls under any subparagraph of Article 5-2 (1); |
| 5. | Where the member himself or herself indicates it is impracticable for him or her to perform his or her duties. |
[This Article Newly Inserted on May 10, 2016]
[Moved from Article 5-2 <Jun. 11, 2019>]
| Article 6 (Duties of chairperson) |
| (1) | The chairperson shall represent the Committee and have general supervision and control of its business affairs. |
| (2) | The vice chairperson shall assist the chairperson, and if the chairperson is unable to perform his or her duties due to unavoidable circumstances, the vice chairperson shall act on behalf of the chairperson. |
| (3) | The Committee may have an executive secretary to handle the business affairs of the Committee, and the executive secretary shall be appointed by the chairperson from among public officials affiliated with the Ministry of Health and Welfare. <Amended on Feb. 29, 2008; Mar. 15, 2010> |
| Article 7 (Meetings of Committee) |
| (1) | The chairperson shall convene and preside over meetings of the Committee. |
| (2) | A majority of the members of the Committee shall constitute a quorum, and any resolution thereof shall require the concurring votes of a majority of those present. |
| (3) | Allowances and travel expenses may be paid to members who attend a meeting of the Committee within the budget; provided, this shall not apply where a member who is a public official attends a meeting in direct connection with his or her duties. <Amended on Jun. 11, 2019> |
| Article 8 (Detailed guidelines for operation) |
Except as provided in this Decree, matters necessary for the operation of the Committee shall be determined by the chairperson following a resolution by the Committee. <Amended on Jun. 11, 2019>
| Article 9 (Subcommittees) |
| (1) | The Committee may establish subcommittees for each specialized field of Korean medicine and pharmaceuticals to efficiently perform its business affairs. |
| (2) | Matters resolved by a subcommittee shall be reported to the chairperson and submitted to the Committee for deliberation; provided, with respect to matters deemed minor by the chairperson, the resolution of the Committee may be substituted by a resolution of the subcommittee. |
| Article 10 (Plan to develop Korean medicine industrial complex) |
| (1) | A person who intends to develop a Korean medicine industrial complex under Article 12 (1) of the Act (hereinafter referred to as "project operator") shall submit a plan to develop a Korean medicine industrial complex, including the following matters, to the Minister of Health and Welfare via 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. The same shall also apply to any amendment to such plan: <Amended on Feb. 29, 2008; Mar. 15, 2010; Jun. 11, 2019> |
| 1. | Cultivating medicinal herbs; |
| 2. | Processing and manufacturing herbal medicines or herbal preparation; |
| 3. | Distributing and selling herbal medicines; |
| 4. | Developing products related to Korean medicine and pharmaceuticals; |
| 5. | Installing and operating Korean medicine and pharmaceutical research facilities; |
| 6. | Raising and securing financial resources to develop Korean medicine industrial complexes; |
| 7. | Measures to revitalize the local economy by creating a Korean medicine industrial complex; |
| 8. | Other matters necessary for developing Korean medicine industrial complexes. |
| (2) | Upon receipt of a plan to develop a Korean medicine industrial complex pursuant to paragraph (1), the Minister of Health and Welfare shall determine whether to provide support after deliberation by the Committee and notify the project operator of the results thereof. In such cases, he or she shall hear the opinions of the Minister of Agriculture, Food and Rural Affairs on matters regarding the cultivation of medicinal herbs. <Amended on Feb. 29, 2008; Mar. 15, 2010; Mar. 23, 2013; Jun. 11, 2019> |
| (3) | If the Minister of Health and Welfare provides support for the creation of a Korean medicine industrial complex, he or she shall preferentially support the Korean medicine industrial complex where the cultivation of medicinal herbs, the manufacturing and distribution of herbal medicines, and Korean medicine and pharmaceutical research facilities are inter-connected to enable the development of high-value-added products related to Korean medicine and pharmaceuticals. <Amended on Feb. 29, 2008; Mar. 15, 2010> |
| Article 11 (Operation of National Institute for Korean Medicine Development) |
| (1) | The National Institute of Korean Medicine Development established under Article 13 (1) of the Act (hereinafter referred to as the "Institute") may request cooperation from relevant institutions, organizations, etc., such as provision of data, if necessary to perform the business affairs prescribed in the subparagraphs of paragraph (5) of that Article. |
| (2) | The Institute shall submit its business performance records for the relevant year, a business plan for the following year, etc. to the Minister of Health and Welfare, and the Minister of Health and Welfare shall notify the Minister of Agriculture, Food and Rural Affairs of matters concerning the cultivation of medicinal herbs from the business performance records and business plan submitted by the Institute. |
[This Article Wholly Amended on Jun. 11, 2019]
| Article 12 (Request for and Decision on Contributions) |
| (1) | If the Institute intends to receive contributions under Article 13 (6) of the Act, it shall submit to the Minister of Health and Welfare a budget request for contributions for the following year along with the following documents by April 30 every year: |
| 1. | The business plan for the following year; |
| 2. | The estimated statement of financial position and the estimated income statement for the following year; |
| 3. | Other documents necessary to clarify the details of the budget request for contributions. |
| (2) | If the Minister of Health and Welfare deems the details of a budget request for contributions under paragraph (1) reasonable, he or she shall reflect such details in the budget. |
| (3) | If the budget for contributions under paragraph (2) is finalized, the Minister of Health and Welfare shall notify the Institute thereof. |
| (4) | If the Institute intends to receive contributions finalized and notified pursuant to paragraph (3), it shall submit an application for payment of contributions to the Minister of Health and Welfare, along with a business plan and a budget execution plan for the relevant year. In such cases, if the Minister of Health and Welfare deems that the business plan and budget execution plan are reasonable, he or she shall pay the contributions. |
| (5) | In receipt of contributions, the Institute shall establish and manage a separate account and use them for the purposes specified in the business plan and budget execution plan. |
| (6) | If the Institute uses contributions for any purpose other than those specified in its business plan and budget execution plan, the Minister of Health and Welfare shall recover the amount equivalent thereto. |
| (7) | If the Institute receives contributions pursuant to paragraph (4), it shall report to the Minister of Health and Welfare the business performance records and the results of budget execution. |
[This Article Wholly Amended on Jun. 11, 2019]
| Article 13 (Good Practices for Herbal Medicines) |
| (1) | The Minister of Health and Welfare may determine and publicly notify Good Agricultural Practices, Good Supply Practices, and Good Manufacturing Practices for Medicinal Herbs (hereinafter referred to as "Good Practices for Medicinal Herbs"), including the following matters, pursuant to Article 14 (1) of the Act. In such cases, in determining Good Agricultural Practices for Medicinal Herbs, he or she shall hear the opinion of the Minister of Agriculture, Food and Rural Affairs in advance: <Amended on Feb. 29, 2008; Mar. 15, 2010; Mar. 23, 2013> |
| 1. | Specifications and standards of good medicinal herbs or herbal medicines; |
| 2. | Matters to be observed in the process of cultivating, manufacturing, and distributing good herbal medicines; |
| 3. | Quality control standards for good medicinal herbs and herbal medicines. |
| (2) | The Minister of Health and Welfare may provide necessary support to a person who cultivates, manufactures, or distributes medicinal herbs in conformity with Good Practices for Medicinal Herbs, in consultation with the heads of the relevant administrative agencies. <Amended on Feb. 29, 2008; Mar. 15, 2010> |
[Moving from Article 14; Previous Article 13 Deleted <Jun. 11, 2019>]
| Article 14 (Use of medicinal herbs in conformity with Good Practices for Herbal Medicines) |
| (1) | Pursuant to Article 14 (2) of the Act, the Minister of Health and Welfare may require drug manufacturers and Korean medicine institutions using medicinal herbs or herbal medicines in conformity with the Good Practices for Herbal Medicines to indicate the details thereof. <Amended on Feb. 29, 2008; Mar. 15, 2010> |
| (2) | Matters necessary for the method of indication, etc. under paragraph (1) shall be determined and publicly notified by the Minister of Health and Welfare. <Amended on Feb. 29, 2008; Mar. 15, 2010> |
[Moved from Article 15; previous Article 14 to Article 13 <Jun. 11, 2019>]
| Article 15 Deleted. <Mar. 3, 2020> |
[Previous Article 16 moved to Article 15 <Jun. 11, 2019>]
ADDENDA <Presidential Decree No. 18513, Aug. 7, 2004>
| (1) | (Enforcement date) This Decree shall enter into force on August 7, 2004. |
| (2) | (Applicability to comprehensive plans for fostering Korean medicine and pharmaceuticals) The first comprehensive plan for fostering Korean medicine and pharmaceuticals to be formulated pursuant to Article 3 shall apply from January 1, 2006 to December 31, 2010. |
ADDENDA <Presidential Decree No. 19513, Jun. 12, 2006>
Article 1 (Enforcement date)
This Decree shall enter into force on July 1, 2006.
Articles 2 through 5 Omitted.
ADDENDA <Presidential Decree No. 20679, Feb. 29, 2008>
Article 1 (Enforcement date)
This Decree shall enter into force on the date of its promulgation.
Articles 2 through 10 Omitted.
ADDENDA <Presidential Decree No. 22075, Mar. 15, 2010>
Article 1 (Enforcement date)
This Decree shall enter into force on March 19, 2010. (Proviso Omitted.)
Article 2 Omitted.
ADDENDUM <Presidential Decree No. 22612, Jan. 4, 2011>
This Decree shall enter into force on the date of its promulgation.
ADDENDA <Presidential Decree No. 24454, Mar. 23, 2013>
Article 1 (Enforcement date)
This Decree shall enter into force on the date of its promulgation. (Proviso Omitted.)
Articles 2 through 5 Omitted.
ADDENDUM <Presidential Decree No. 25050, Dec. 30, 2013>
This Decree shall enter into force on January 1, 2014. (Proviso Omitted.)
ADDENDA <Presidential Decree No. 25751, Nov. 19, 2014>
Article 1 (Enforcement date)
This Decree shall enter into force on the date of its promulgation: Provided, That among the Presidential Decrees amended pursuant to Article 5 of the Addenda, the provisions amending the Presidential Decrees the enforcement dates of which have not yet arrived shall enter into force on the dates on which the relevant Presidential Decrees enter into force, respectively. Articles 2 through 5 Omitted.
ADDENDUM <Presidential Decree No. 27129, May 10, 2016>
This Decree shall enter into force on the date of its promulgation.
ADDENDA <Presidential Decree No. 28211, Jul. 26, 2017>
Article 1 (Enforcement date)
This Decree shall enter into force on the date of its promulgation: Provided, That among the Presidential Decrees amended pursuant to Article 8 of the Addenda, the provisions amending the Presidential Decrees the enforcement dates of which have not yet arrived shall enter into force on the dates on which the relevant Presidential Decrees enter into force, respectively. Articles 2 through 8 Omitted.
ADDENDUM <Presidential Decree No. 29837, Jun. 11, 2019>
This Decree shall enter into force on June 12, 2019.
ADDENDUM <Presidential Decree No. 30509, Mar. 3, 2020>
This Decree shall enter into force on the date of its promulgation.