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ENFORCEMENT DECREE OF THE BIOTECHNOLOGY SUPPORT ACT

Presidential Decree No. 14731, Jul. 13, 1995

Amended by Presidential Decree No. 16326, May 24, 1999

Presidential Decree No. 17048, Dec. 29, 2000

Presidential Decree No. 17115, Jan. 29, 2001

Presidential Decree No. 18452, jun. 29, 2004

Presidential Decree No. 20740, Feb. 29, 2008

Presidential Decree No. 22075, Mar. 15, 2010

Presidential Decree No. 24423, Mar. 23, 2013

Presidential Decree No. 25751, Nov. 19, 2014

Presidential Decree No. 28210, Jul. 26, 2017

 Article 1 (Purpose)
The purpose of this Decree is to prescribe matters delegated by the Biotechnology Support Act (hereinafter referred to as the "Act") and matters necessary for enforcing said Act. <Amended by Presidential Decree No. 14731, Jul. 13, 1995>
 Article 2 (Basic Plans for Biotechnology Support)
The Minister of Science and ICT shall formulate a basic plan for biotechnology support under Article 4 (2) of the Act every five years, and shall notify the heads of the ministries and agencies concerned thereof as referred to in Article 13 (1) 2 through 7 of the Act. <Amended by Presidential Decree No. 14731, Jul. 13, 1995; Presidential Decree No. 18452, Jun. 29, 2004; Presidential Decree No. 20740, Feb. 29, 2008; Presidential Decree No. 24423, Mar. 23, 2013; Presidential Decree No. 28210, Jul. 26, 2017>
 Article 3 (Establishment of Annual Implementation Plans for Biotechnology Support and Notification of Its Modification)
Where the heads of the ministries and agencies concerned as referred to in Article 13 (1) 2 through 7 of the Act have established an annual implementation plan for the biotechnology support (hereinafter referred to as "implementation plan") under Article 5 (1) of the Act or have modified it, they shall notify the Minister of Science and ICT thereof. <Amended by Presidential Decree No. 14731, Jul. 13, 1995; Presidential Decree No. 18452, Jun. 29, 2004; Presidential Decree No. 20740, Feb. 29, 2008; Presidential Decree No. 24423, Mar. 23, 2013; Presidential Decree No. 28210, Jul. 26, 2017>
 Article 4 (Formulation of Basic Guidelines for Implementation Plans)
The Minister of Science and ICT shall undergo deliberation by the Council for Comprehensive Biotechnology Policy provided for in Article 6 (1) of the Act (hereinafter referred to as the "Council") when the basic guidelines necessary for establishing an implementation plan are formulated under Article 5 (3) of the Act. <Amended by Presidential Decree No. 14731, Jul. 13, 1995; Presidential Decree No. 18452, Jun. 29, 2004; Presidential Decree No. 20740, Feb. 29, 2008; Presidential Decree No. 24423, Mar. 23, 2013; Presidential Decree No. 28210, Jul. 26, 2017>
 Article 5 (Composition of Council)
(1) Deleted. <by Presidential Decree No. 18452, Jun. 29, 2004>
(2) “Central administrative agencies concerned that are prescribed by Presidential Decree" in Article 6 (4) 1 of the Act means the following agencies: <Amended by Presidential Decree No. 18452, Jun. 29, 2004; Presidential Decree No. 20740, Feb. 29, 2008; Presidential Decree No. 22075, Mar. 15, 2010; Presidential Decree No. 24423, Mar. 23, 2013; Presidential Decree No. 25751, Nov. 19, 2014; Presidential Decree No. 28210, Jul. 26, 2017>
1. The Ministry of Strategy and Finance;
2. The Ministry of Education;
3. The Ministry of Science and ICT;
4. The Ministry of Agriculture, Food and Rural Affairs;
5. The Ministry of Trade, Industry and Energy;
6. The Ministry of Health and Welfare;
7. The Ministry of Environment;
8. The Ministry of Oceans and Fisheries.
(3) The members provided for in Article 6 (4) 2 of the Act shall be commissioned by the Minister of Science and ICT; and the terms of office for the commissioned members shall be two years. <Amended by Presidential Decree No. 18452, Jun. 29, 2004; Presidential Decree No. 20740, Feb. 29, 2008; Presidential Decree No. 24423, Mar. 23, 2013; Presidential Decree No. 28210, Jul. 26, 2017>
 Article 6 (Duties of Chairperson of Council)
(1) The chairperson of the Council shall excercise overall control and supervision of Council affairs and convene and preside over meetings.
(2) If the chairperson is prevented from performing his duties, a council member designated by the chairperson of the Council shall act for the chairperson.
 Article 7 (Meetings)
(1) The meetings of the Council shall be divided into regular and special meetings.
(2) Regular meetings shall be convened once a year on a date designated by the Council, and special meetings shall be convened by the chairperson as the occasion arises.
(3) The meetings shall come to order with a majority of all the registered members attending and resolutions shall be adopted by an affirmative vote of a majority of members present.
 Article 8 (Secretary)
(1) One secretary shall be appointed to the Council to handle general affairs of the Council.
(2) The Minister of Science and ICT shall appoint one secretary from among public officials under his/her jurisdiction. <Amended by Presidential Decree No. 18452, Jun. 29, 2004; Presidential Decree No. 20740, Feb. 29, 2008; Presidential Decree No. 24423, Mar. 23, 2013; Presidential Decree No. 28210, Jul. 26, 2017>
 Article 9 Deleted. <by Presidential Decree No. 18452, Jun. 29, 2004>
 Article 10 (Hearing of Opinions)
The Council may, if it is deemed necessary, have related public officials or experts with professional knowledge and experience in the field of biotechnology attend meetings of the Council and state their opinions.
<Amended by the Presidential Decree No. 14731, Jul. 13, 1995; Presidential Decree No. 18452, Jun. 29, 2004>
 Article 11 (Allowances)
Expenses or allowances for council members, public officials and experts who attend the meetings of the Council may be paid within the budget: Provided, That this shall not apply if the public officials who are council members attend the meetings directly related with their proper duties. <Amended by Presidential Decree No. 18452, Jun. 29, 2004>
 Article 12 (Support for Joint Research)
To promote joint research for the study of biotechnology, and development of technology among academic circles, research institutes and industries, the Minister of Science and ICT may recommend joint procurement of research equipment and instruments and reagents and joint utilization of research facilities; and may provide the necessary support for such activities. <Amended by Presidential Decree No. 14731, Jul. 13, 1995; Presidential Decree No. 18452, Jun. 29, 2004; Presidential Decree No. 20740, Feb. 29, 2008; Presidential Decree No. 24423, Mar. 23, 2013; Presidential Decree No. 28210, Jul. 26, 2017>
 Article 13 (Support for Manufacture of New Technology Products)
(1) To support the manufacture of new technology products, and to promote the industrialization of biotechnology research results, the Minister of Science and ICT may request the heads of the relevant ministries and agencies to take necessary measures, such as financial assistance and purchase of the products on a priority basis, etc. after undergoing the deliberation of the Council. <Amended by Presidential Decree No. 14731, Jul. 13, 1995; Presidential Decree No. 18452, Jun. 29, 2004; Presidential Decree No. 20740, Feb. 29, 2008; Presidential Decree No. 24423, Mar. 23, 2013; Presidential Decree No. 28210, Jul. 26, 2017>
(2) The heads of the relevant ministries and agencies in receipt of requests as referred to in paragraph (1) will take necessary measures, such as financial assistance, in the absence of special circumstances.
 Article 14 (Formulation of Guidelines for Clinical Testing and Inspection)
(1) In order to establish a system of clinical testing and inspection for biotechnology-related products under the provisions of Article 14 of the Act, the Minister of Agriculture, Food and Rural Affairs, the Minister of Trade, Industry and Energy, the Minister of Health and Welfare, the Minister of Environment and the Minister of Oceans and Fisheries shall formulate and implement guidelines for clinical testing and inspection after undergoing the deliberation of the Council: Provided, That this shall not apply if it is otherwise prescribed by other statutes and regulations. <Amended by the Presidential Decree No. 13870, Mar. 6, 1993; Presidential Decree No. 14446, Dec. 23, 1994; Presidential Decree No. Jul. 13, 1995; Presidential Decree No. 18452, Jun. 29, 2004; Presidential Decree No. 20740, Feb. 29, 2008; Presidential Decree No. 22075, Mar. 15, 2010; Presidential Decree No. 24423, Mar. 23, 2013>
(2) Guidelines for clinical testing and inspection as referred to in paragraph (1) shall include the following matters: Provided, That if there are matters which cannot be covered by such guidelines due to special characteristics of biotechnology-related products, such matters may not be included in the guidelines: <Amended by the Presidential Decree No. 14731, Jul. 13, 1995>
1. Animal tests of commodities produced or manufactured by using genetically modified organisms;
2. Clinical tests of pharmaceuticals produced or manufactured by using genetically modified organisms;
3. Analysis of components, degree of purity and degree of activity of commodities produced or manufactured by using genetically modified organisms;
4. Other necessary matters for clinical tests and inspection of biotechnological products.
 Article 15 (Formulation of Guidelines for Experiments)
(1) Under the provisions of Article 15 of the Act, the Minister of Health and Welfare shall formulate and implement guidelines for experiments to promote the research and industrialization of biotechnology after undergoing the deliberation of the Council. <Amended by Presidential Decree No. 14446, Dec. 23, 1994; Presidential Decree No. Jul. 13, 1995; Presidential Decree No. 20740, Feb. 29, 2008; Presidential Decree No. 22075, Mar. 15, 2010>
(2) The guidelines for experiments as referred to in paragraph (1) shall include the following matters: <Amended by Presidential Decree No. 14731, Jul. 13, 1995>
1. Matters necessary to prevent biological risks such as the method of inhibiting the prevention of dissemination and increase of genetically modified organisms;
2. Matters necessary to prevent the occurrence of ethical problems such as the prohibition of genetic modification of human genes, etc. which may cause effects detrimental to the dignity of human beings.
 Article 16 (Designation and Operation of Organization in Charge of Nurturing Basic Medical Science)
(1) Any organization in charge of nurturing the basic medical science provided for in Article 17 (1) of the Act shall be designated by the Minister of Science and ICT and the Minister of Health and Welfare after they consult thereabout. <Amended by Presidential Decree No. 20740, Feb. 29, 2008; Presidential Decree No. 22075, Mar. 15, 2010; Presidential Decree No. 24423, Mar. 23, 2013; Presidential Decree No. 28210, Jul. 26, 2017>
(2) Every organization in charge of nurturing the basic medical science shall perform the following work:
1. Undertaking and managing projects for nurturing the basic medical science;
2. Assistance in academic and research activities in the field of the basic medical science.
[This Article Wholly Amended by Presidential Decree No. 18452, Jun. 29, 2004]
 Article 17 through 22 Deleted. <by Presidential Decree No. 18452, Jun. 29, 2004>
 Article 23 (Shipment Prior to Acceptance of Import Declaration)
(1) Items that may be allowed to be shipped prior to the acceptance of an import declaration thereon under Article 19 (2) of the Act shall be the following items, which are recognized by the Minister of Science and ICT: <Amended by Presidential Decree No. 28210, Jul. 26, 2017>
1. Biochemical reagents;
2. Radioactive substances reagents;
3. Microbial bacteria colony and cell colony of plants and animals;
4. Genetic substances;
5. Enzyme products;
6. Biotechnology-related products corresponding to those as referred to in subparagraphs 1 through 5.
(2) A person who intends to import any item falling under each subparagraph of paragraph (1) in accordance with the procedures for the shipment prior to the acceptance of an import declaration shall submit documents containing a statement of names and volumes of the relevant items, reasons for the necessity of the shipment prior to the acceptance of an import declaration and other matters to the Minister of Science and ICT. <Amended by Presidential Decree No. 28210, Jul. 26, 2017>
(3) Where the Minister of Science and ICT in receipt of the documents under paragraph (2) deems it necessary to ship the relevant items into Korea before an import declaration is accepted after reviewing the details of the documents, he/she shall request the head of a competent customs office to approve the shipment of the relevant items prior to the acceptance of an import declaration pursuant to Article 252 of the Customs Act. In such cases, the head of the competent customs office shall approve the shipment prior to the acceptance of an import declaration in the absence of special circumstances. <Amended by Presidential Decree No. 28210, Jul. 26, 2017>
[This Article Wholly Amended by Presidential Decree No. 24423, Mar. 23, 2013]
ADDENDUM
This Decree shall enter into force on the date of its promulgation.
ADDENDA <Presidential Decree No. 13282, Feb. 1, 1991>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation.
Articles 2 through 5 Omitted.
ADDENDA <Presidential Decree No. 13870, Mar. 6, 1993>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation.
Articles 2 through 4 Omitted.
ADDENDA <Presidential Decree No. 14438, Dec. 23, 1994>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation.
Articles 2 through 5 Omitted.
ADDENDA <Presidential Decree No. 14446, Dec. 23, 1994>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation. (Proviso Omitted.)
Articles 2 and 3 Omitted.
ADDENDUM <Presidential Decree No. 14731, Jul. 13, 1995>
This Decree shall enter into force on the date of its promulgation.
ADDENDA <Presidential Decree No. 16326, May 24, 1999>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation.
Articles 2 through 4 Omitted.
ADDENDA <Presidential Decree No. 17048, Dec. 29, 2000>
Article 1 (Enforcement Date)
This Decree shall enter into force on January 1, 2001.
Articles 2 through 8 Omitted.
ADDENDA <Presidential Decree No. 17115, Jan. 29, 2001>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation.
Articles 2 through 5 Omitted.
ADDENDUM <Presidential Decree No. 18452, Jun. 29, 2004>
This Decree shall enter into force on July 1, 2004.
ADDENDA <Presidential Decree No. 20740, Feb. 29, 2008>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation.
Articles 2 through 7 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.
ADDENDA <Presidential Decree No. 24423, Mar. 23, 2013>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation. (Proviso Omitted.)
Articles 2 through 7 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 the amendments to the Presidential Decrees to be amended pursuant to Article 5 of the Addenda, which were promulgated before this Decree enters into force but the enforcement dates of which have yet to arrive, shall enter into force on the enforcement date of the relevant Presidential Decree.
Articles 2 through 5 Omitted.
ADDENDA <Presidential Decree No. 28210, Jul. 26, 2017>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation.
Articles 2 through 6 Omitted.