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ENFORCEMENT DECREE OF THE LABORATORY ANIMAL ACT

Presidential Decree No. 21370, Mar. 25, 2009

Amended by Presidential Decree No. 22075, Mar. 15, 2010

Presidential Decree No. 22906, Apr. 22, 2011

Presidential Decree No. 23488, Jan. 6, 2012

Presidential Decree No. 23845, jun. 7, 2012

Presidential Decree No. 24454, Mar. 23, 2013

Presidential Decree No. 27125, May 3, 2016

Presidential Decree No. 28928, May 29, 2018

Presidential Decree No. 30513, Mar. 3, 2020

Presidential Decree No. 30652, Apr. 28, 2020

Presidential Decree No. 30979, Aug. 27, 2020

Presidential Decree No. 33112, Dec. 20, 2022

 Article 1 (Purpose)
The purpose of this Decree is to prescribe matters mandated by the Laboratory Animal Act and matters necessary for the enforcement thereof.
 Article 2 (Animal Testing Facilities)
"Facilities prescribed by Presidential Decree" in subparagraph 4 of Article 2 of the Laboratory Animal Act (hereinafter referred to as the "Act") means facilities established and operated by any of the following institutions or organizations: <Amended on Mar. 15, 2010; Jun. 7, 2012; Mar. 23, 2013; Mar. 3, 2020; Apr. 28, 2020; Aug. 27, 2020>
1. An institution or organization which engages in the business of manufacturing, importing, or selling any of the following:
(a) Foods under the Food Sanitation Act;
(b) Health functional foods under the Health Functional Foods Act;
(c) Drugs and quasi-drugs under the Pharmaceutical Affairs Act or advanced biological products under the Act on the Safety of and Support for Advanced Regenerative Medicine and Advanced Biological Products (excluding drugs and quasi-drugs for animals or advanced biological products for animals);
(d) Medical devices under the Medical Devices Act or in vitro diagnostic medical devices under the Act on In Vitro Diagnostic Medical Devices (excluding medical devices for animals and in vitro diagnostic medical devices for animals);
(e) Cosmetics under the Cosmetics Act;
(f) Narcotic drugs under the Narcotics Control Act;
2. Health centers under the Regional Public Health Act;
3. Medical institutions under the Medical Service Act;
4. Public health and environment research institutes under the Public Health and Environment Research Institute Act;
5. Institutions or organizations delegated or entrusted by the Minister of Food and Drug Safety with affairs regarding research into the development, safety control, or quality control of those falling under any item of subparagraph 1;
6. Institutions or organizations that perform animal testing for the purpose of the development, safety control, or quality control of those falling under any item of subparagraph 1.
 Article 3 Deleted. <May 29, 2018>
 Article 4 (Organization of Laboratory Animal Management Committees)
(1) "Person ... has qualifications prescribed by Presidential Decree" in Article 7 (3) 3 of the Act means any of the following persons: <Amended on May 3, 2016>
1. A person who graduates from a school specified in Article 2 of the Higher Education Act or who is deemed to have an equivalent or higher level of such educational attainment;
2. A person who completes educational courses determined and publicly notified by the Minister of Food and Drug Safety.
(2) Deleted. <May 3, 2016>
(3) A laboratory animal management committee established under Article 7 (1) of the Act (hereinafter referred to as "committee") shall have at least one member falling under subparagraphs 1 through 3 of Article 7 (3) of the Act, and the following members shall not work for, and have any interest in, the relevant animal testing facility: <Amended on May 3, 2016; May 29, 2018>
1. At least one member among the members specified in Article 7 (3) 1 and 2 of the Act;
2. A member under Article 7 (3) 3 of the Act.
(4) Each member shall hold office for a term of two years.
(5) No member involved in animal testing subject to deliberation by a committee shall participate in such deliberation on the relevant animal testing.
[Title Amended on May 29, 2018]
 Article 5 (Duties of Chairperson)
(1) The chairperson shall represent the relevant committee and exercise general supervision over its affairs.
(2) Where the chairperson is unable to perform his or her duties due to any unavoidable reason, a member pre-designated by the chairperson shall act on behalf of the chairperson.
 Article 6 (Meetings of Committees)
(1) The chairperson shall convene and preside over meetings of the relevant committee in any of the following cases:
1. Where the operator of an animal testing facility requests a meeting;
2. Where at least 1/3 of the members request a meeting;
3. Other cases deemed necessary by the chairperson.
(2) Any resolution of a meeting of each committee shall require the concurring vote of a majority of its members.
(3) The chairperson shall convene a meeting of the relevant committee at least twice each year and shall prepare the minutes of such meeting and retain them for at least three years.
(4) Except as provided in this Decree, matters necessary for the organization, operation, etc. of a committee shall be determined by the chairperson following its resolution.
 Article 7 (Administrators of Animal Testing Facilities)
(1) A person who establishes an animal testing facility shall appoint as an administrator, pursuant to Article 8 (2) of the Act, a person who has extensive knowledge of and experience in animal testing and holds all of the following qualifications:
1. A person who graduates from a school specified in Article 2 of the Higher Education Act or who is deemed to have an equivalent or higher level of such educational attainment;
2. A person who has experience in managing animal testing or conducting affairs related to animal testing for at least three years.
(2) Where the operator of an animal testing facility who has the qualifications specified in paragraph (1) performs the duties of an administrator under Article 8 (2) of the Act, such operator shall be deemed to have an administrator under Article 8 (2) of the Act.
 Article 8 (Laboratory Animals Subject to Preferential Use)
"Laboratory animals prescribed by Presidential Decree" in Article 9 (1) of the Act means mice, rats, hamsters, gerbils, guinea pigs, rabbits, dogs, pigs, or monkeys.
 Article 9 (Suppliers of Laboratory Animals Subject to Registration)
"Person who intends to engage in the business of producing, importing, or selling laboratory animals prescribed by Presidential Decree” in the main clause of Article 12 (1) of the Act means a person who intends to engage in the business of producing, importing, or selling laboratory animals specified in Article 8 for the purpose of using such animals for animal testing.
 Article 10 (Authorization to Establish Laboratory Animal Association)
A person who intends to obtain authorization to establish a Laboratory Animal Association under Article 23 (4) of the Act (hereinafter referred to as the "Association") shall submit a written application for authorization of such establishment to the Minister of Food and Drug Safety, along with the following documents: <Amended on Mar. 23, 2013>
1. One copy of a document stating the name, address, and profile of a person who intends to obtain authorization of the establishment (in cases of a corporation; the name, articles of incorporation, and location of the main office of the corporation and the name, address, and recent business activities of its representative);
2. One copy of the statement of purposes of the establishment;
3. One copy of the articles of incorporation;
4. One copy of the business plan for the relevant business year after the date its business is scheduled to commence or commences;
5. One copy of the minutes of the inaugural general meeting and the list of names and addresses of persons who intend to be members.
 Article 11 (Matters to Be Entered in Articles of Incorporation and Business Affairs)
(1) The articles of incorporation of the Association shall include the following, pursuant to Article 23 (5) of the Act:
1. Objectives;
2. Name;
3. Location of the office;
4. Matters regarding the qualifications of members;
5. Matters regarding joining of and withdrawal from the Association;
6. Matters regarding the rights and duties of members;
7. Matters regarding membership fees;
8. Matters regarding general meetings;
9. Matters regarding assets and accounting;
10. Matters regarding amendments to the articles of incorporation;
11. Matters regarding business affairs and the execution thereof;
12. Other matters necessary for performing the business affairs of the Association.
(2) The business affairs of the Association under Article 23 (5) of the Act shall be as follows:
1. Research and advice on policies regarding animal testing;
2. Providing information on the use, administration, etc. of laboratory animals;
3. Protecting rights and interests among members;
4. Business affairs entrusted under statutes or regulations;
5. Other business affairs prescribed by the articles of incorporation for the enhancement of reliability of animal testing and the sound development of the laboratory animal industry.
 Article 11-2 (Management of Sensitive Information and Personally Identifiable Information)
The Minister of Food and Drug Safety shall manage information on health under Article 23 of the Personal Information Protection Act (limited to the affairs under subparagraphs 1 and 2), information that constitutes criminal history records under subparagraph 2 of Article 18 of the Enforcement Decree of that Act (limited to the affairs under subparagraphs 1 and 2), or data containing resident registration numbers under subparagraph 1 of Article 19 of that Decree, if unavoidable to perform the following affairs: <Amended on Mar. 23, 2013; Dec. 20, 2022>
1. Affairs regarding the registration of animal testing facilities under Article 8 of the Act;
2. Affairs regarding the registration of suppliers of laboratory animals under Article 12 of the Act;
3. Affairs regarding administrative dispositions under Article 24 of the Act;
4. Affairs regarding hearings under Article 26 of the Act;
5. Affairs regarding the imposition and collection of penalty surcharges under Article 28 of the Act.
[This Article Newly Inserted on Jan. 6, 2012]
 Article 12 (Standards for Calculating Penalty Surcharges)
The standards for calculating penalty surcharges under Article 28 (1) of the Act shall be as specified in attached Table 1.
 Article 12-2 (Dispositions against Defaulters of Penalty Surcharges)
(1) Where a person obligated to pay a penalty surcharge under Article 28 (1) of the Act fails to pay it by the payment deadline, the Minister of Drug and Food Safety shall issue a written reminder within 15 days after the payment deadline under the main clause of paragraph (5) of that Article. In such cases, the payment deadline shall be within 10 days from the date the written reminder is issued.
(2) Where a person who has failed to pay a penalty surcharge fails to pay it again by the payment deadline under the latter part of paragraph (1) even though he or she receives a written reminder under that paragraph, the Minister of Food and Drug Safety shall revoke the imposition of the penalty surcharge and shall suspend his or her business operations or collect it in the same manner as delinquent national taxes.
(3) Where the imposition of a penalty surcharge is to be revoked and business operations are to be suspended under paragraph (2), the details thereof shall be notified in writing to a person subject to such disposition, and such notice shall specify matters necessary for suspending business operations, such as the grounds for changing the disposition and the period of suspension of business operations.
[This Article Newly Inserted on May 3, 2016]
 Article 13 (Standards for Imposing Administrative Fines)
The standards for imposing administrative fines under Article 33 (1) and (2) of the Act shall be as specified in attached Table 2. <Amended on Mar. 3, 2020>
[This Article Wholly Amended on Apr. 22, 2011]
ADDENDUM <Presidential Decree No. 21370, Mar. 25, 2009>
This Decree shall enter into force on March 29, 2009.
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. 22906, Apr. 22, 2011>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation.
Article 2 Omitted.
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.)
Article 2 Omitted.
ADDENDA <Presidential Decree No. 23845, Jun. 7, 2012>
Article 1 (Enforcement Date)
This Decree shall enter into force on June 8, 2012.
Articles 2 through 4 Omitted.
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 4 Omitted.
ADDENDUM <Presidential Decree No. 27125, May 3, 2016>
This Decree shall enter into force on May 4, 2016.
ADDENDUM <Presidential Decree No. 28928, May 29, 2018>
This Decree shall enter into force on June 20, 2018.
ADDENDA <Presidential Decree No. 30513, Mar. 3, 2020>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation.
Article 2 (Transitional Measures concerning Standards for Calculating Penalty Surcharges)
(1) Notwithstanding the amended provisions of subparagraph 1 (f) of attached Table 1, the application of the standards for calculating penalty surcharges to violations committed before this Decree enters into force shall be governed by the previous provisions.
(2) Notwithstanding the amended provisions of subparagraph 1 (d) of attached Table 2, the application of the standards for calculating penalty surcharges to violations committed before this Decree enters into force shall be governed by the previous provisions.
ADDENDA <Presidential Decree No. 30652, Apr. 28, 2020>
Article 1 (Enforcement Date)
This Decree shall enter into force on May 1, 2020.
Articles 2 and 3 Omitted.
ADDENDA <Presidential Decree No. 30979, Aug. 27, 2020>
Article 1 (Enforcement Date)
This Decree shall enter into force on August 28, 2020.
Articles 2 through 4 Omitted.
ADDENDUM <Presidential Decree No. 33112, Dec. 20, 2022>
This Decree shall enter into force on the date of its promulgation.