Statutes of the Republic of Korea

Article 1 (Purpose)

The purpose of this Act is to contribute to the development of life sciences and improvement in national health by enhancing the ethical standards in and reliability of animal testing through appropriate administration of laboratory animals and animal testing.

Article 2 (Definitions)

The definitions of terms used in this Act shall be as follows:

1.	The term "animal testing" means testing conducted for laboratory animals or the scientific procedure for scientific purposes, such as education, testing, research and production of biological medicines or such;

2.	The term "laboratory animal" means vertebrate used or raised for the purpose of animal testing;

3.	The term "disaster" means infection in humans and animals, occurrence of an infectious disease, exposure to harmful substances and environmental pollution or such, due to animal testing;

4.	The term "animal testing facilities" means facilities prescribed by Presidential Decree, as facilities for conducting animal testing or raising laboratory animals therefor;

5.	The term "laboratory animal production facilities" means facilities producing and raising laboratory animals;

6.	The term "operator" means a person who operates animal testing facilities or laboratory animal production facilities.

Article 3 (Objects of Application)

This Act shall apply to administration of animals used in testing required for any of the following subparagraphs and of animal testing facilities thereof or such:

1.	Development, safety control and quality control of foods, functional health foods, medical and pharmaceutical products, non-medical and pharmaceutical products, biomedicines, medical appliances, and cosmetics;

2.	Safety control and quality control of narcotics.

Article 4 (Relationship with other Acts)

The Animal Protection Act shall apply to the use or administration of laboratory animals, except as prescribed by this Act.

Article 5 (Duties of the Ministry of Food and Drug Safety)

(1)	The Minister of Food and Drug Safety shall carry out matters referred to in the following subparagraphs to achieve the purposes referred to in Article 1: <Amended by Act No. 11690, Mar. 23, 2013; Act No. 14023, Feb. 3, 2016>

1.	Formulation and promotion of policies concerning the use and administration of laboratory animals;

2.	Support for the establishment and operation of animal testing facilities;

3.	Support for the maintenance, conservation and development of laboratory animals in animal testing facilities;

3-2.	Establishment and operation of laboratory animal resources banks (referring to facilities for the preservation of laboratory animal species and the management of resources originated from experimentally induced laboratory animals);

4.	Research support for the improvement in quality of laboratory animals;

5.	Support for the collection and management of information, and education in connection with laboratory animals;

6.	Formulation and promotion of policies concerning the development and approval of methods which can substitute animal testing;

7.	Other matters concerning the use and administration of laboratory animals.

(2)	Matters necessary for carrying out paragraph (1) shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>

Article 6 (Duties of Operator of Animal Testing Facilities)

An operator of animal testing facilities shall carry out matters referred to in the following subparagraphs in order to ensure the safety and reliability of animal testing:

1.	Formulation of guidelines on the scientific use and administration of laboratory animals;

2.	Education of those who carry out and engage in animal testing;

3.	Preferential consideration of methods which can substitute animal testing;

4.	Formulation of plans concerning the appropriate disposal of animal waste left over after testing and the safety of workers.

Article 7 (Establishment, etc. of Laboratory Animal Management Committee)

(1)

A laboratory animal management committee shall be established and managed in animal testing facilities in order to secure the ethics, safety and reliability of animal testing: Provided, That where the relevant animal testing facility has an animal testing ethics committee prescribed in Article 25 of the Animal Protection Act, the organization of which complies with the requirements in paragraphs (2) and (3), the committee shall be deemed a laboratory animal management committee. <Amended by Act No. 14023, Feb. 3, 2016>

(2)	Each laboratory animal management committee shall be comprised of not less than four nor more than 15 members including one chairperson. <Amended by Act No. 14023, Feb. 3, 2016>

(3)	Members of each committee shall be commissioned by the manager of the laboratory animal facility among the following persons, and the chairperson of the committee shall be elected among such members: <Newly Inserted by Act No. 14023, Feb. 3, 2016>

1.	A veterinarian under the Veterinarians Act;

2.	A person who has a doctor's degree in the area of animal testing and has experience in managing animal testing or animal testing affairs;

3.

A person recommended by a corporation prescribed by the Civil Act or by a non-profit, non-governmental organization prescribed by the Assistance for Non-Profit, Non-Governmental Organizations Act among persons who have an abundant knowledge and experience in protecting animals, and has qualifications prescribed by Presidential Decree;

4.	A person who has abundant knowledge and experience in animal testing and who is prescribed by Ordinance of the Prime Minister.

(4)	Matters necessary for the functions, management, etc. of laboratory animal management committees referred to in paragraph (1) shall be prescribed by Presidential Decree. <Newly Inserted by Act No. 14023, Feb. 3, 2016>

Article 7 (Establishment, etc. of Laboratory Animal Management Committee)

(1)

A laboratory animal management committee shall be established and managed in animal testing facilities in order to secure the ethics, safety and reliability of animal testing: Provided, That where the relevant animal testing facility has an animal testing ethics committee prescribed in Article 25 of the Animal Protection Act, the organization of which complies with the requirements in paragraphs (2) and (3), the committee shall be deemed a laboratory animal management committee. <Amended by Act No. 14023, Feb. 3, 2016>

(2)	Each laboratory animal management committee shall be comprised of not less than four nor more than 15 members including one chairperson. <Amended by Act No. 14023, Feb. 3, 2016>

(3)	Members of each committee shall be commissioned by the manager of the laboratory animal facility among the following persons, and the chairperson of the committee shall be elected among such members: <Newly Inserted by Act No. 14023, Feb. 3, 2016>

1.	A veterinarian under the Veterinarians Act;

2.	A person who has a doctor's degree in the area of animal testing and has experience in managing animal testing or animal testing affairs;

3.

A person recommended by a corporation prescribed by the Civil Act or by a non-profit, non-governmental organization prescribed by the Assistance for Non-Profit, Non-Governmental Organizations Act among persons who have an abundant knowledge and experience in protecting animals, and has qualifications prescribed by Presidential Decree;

4.	A person who has abundant knowledge and experience in animal testing and who is prescribed by Ordinance of the Prime Minister.

(4)	The following matters shall undergo deliberation by a laboratory animal management committee: <Newly Inserted by Act No. 15278, Dec. 19, 2017>

1.	Matters relating to the planning and execution of animal testing;

2.	Operation of animal testing facilities and evaluation thereof;

3.	Matters relating to the appropriateness of animal testing using harmful substances;

4.	Matters relating to raising and managing laboratory animals;

5.	Other matters deemed necessary by the chairperson of the laboratory animal management committee to ensure the ethics, safety and reliability of animal testing.

(5)	Matters necessary for operating laboratory animal management committees referred to in paragraph (1) and others shall be prescribed by Presidential Decree. <Newly Inserted by Act No. 14023, Feb. 3, 2016; Act No. 15278, Dec. 19, 2017>

<<Enforcement Date: June 20, 2018>> Article 7

Article 8 (Registration of Animal Testing Facilities)

(1)	Any person who intends to establish animal testing facilities shall register with the Minister of Food and Drug Safety. The same shall also apply to cases where he/she changes registered matters. <Amended by Act No. 11690, Mar. 23, 2013>

(2)	An administrator (hereinafter referred to as "administrator") who has qualifications prescribed by Presidential Decree shall be assigned to animal testing facilities to administer the relevant facilities and laboratory animals.

(3)	Matters necessary for standards and procedures for registration referred to in paragraph (1) shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>

Article 9 (Use, etc. of Laboratory Animals)

(1)	Where a person uses laboratory animals prescribed by Presidential Decree in animal testing facilities, he/she shall endeavor to preferentially use laboratory animals produced in animal testing facilities or excellent laboratory animal production facilities prescribed in Article 15 (1).

(2)	Where a person intends to use laboratory animals imported from abroad, he/she shall use laboratory animals meeting the standards prescribed by Ordinance of the Prime Minister. <Amended by Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>

Article 9 (Use, etc. of Laboratory Animals)

(1)	Where animal testing facilities use laboratory animals prescribed by Presidential Decree, they shall not come from sources other than the following: <Amended by Act No. 15278, Dec. 19, 2017>

1.	Other animal testing facilities;

2.	Excellent laboratory animal production facilities prescribed in Article 15 (1);

3.	Suppliers of laboratory animals registered under Article 12.

(2)	Where a person intends to use laboratory animals imported from abroad, he/she shall use laboratory animals meeting the standards prescribed by Ordinance of the Prime Minister. <Amended by Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>

<<Enforcement Date: Jun. 20, 2018>> Article 9

Article 10 (Designation of Excellent Animal Testing Facilities)

(1)

The Minister of Food and Drug Safety may, for the appropriate use and administration of laboratory animals, designate animal testing facilities which have appropriate human resources and facilities, and the operating condition of which is excellent as excellent animal testing facilities. In such cases, matters concerning the standard for designation, change of matters designated or such, shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>

(2)	Any facility who intends to be designated as an excellent animal testing facility pursuant to paragraph (1) shall apply for designation as prescribed by Ordinance of the Prime Minister. <Amended by Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>

(3)	The Minister of Food and Drug Safety may advise the relevant business operator who uses laboratory animals or a person who carries out research services to conduct such business in excellent animal testing facilities designated pursuant to paragraph (1). <Amended by Act No. 11690, Mar. 23, 2013>

Article 11 (Guidance and Supervision on Animal Testing Facilities, etc.)

(1)	Any facility who has registered as animal testing facilities pursuant to Article 8 or has been designated as excellent animal testing facilities pursuant to Article 10 shall be guided and supervised by the Minister of Food and Drug Safety. <Amended by Act No. 11690, Mar. 23, 2013>

(2)	Matters necessary for details, objects, and timing of and standards, etc., for guidance and supervision pursuant to paragraph (1) shall be determined by the Minister of Food and Drug Safety. <Amended by Act No. 11690, Mar. 23, 2013>

Article 12 (Registration of Supplier of Laboratory Animals)

(1)

Any person who intends to engage in business of producing, importing or selling laboratory animals prescribed by Presidential Decree (hereinafter referred to as "supplier of laboratory animals") shall register with the Minister of Food and Drug Safety, as prescribed by Ordinance of the Prime Minister: Provided, That this shall not apply to cases where he/she supplies laboratory animals produced in the process of maintenance or research in animal testing facilities referred to in Article 8. <Amended by Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>

(2)	When a person intends to change any matters registered pursuant to paragraph (1), he/she shall register such change, as prescribed by Ordinance of the Prime Minister. <Amended by Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>

Article 13 (Matters to be Observed by Supplier of Laboratory Animals)

A supplier of laboratory animals shall observe matters referred to in the following subparagraphs to ensure the safety and health of laboratory animals: <Amended by Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>

1.	He/she shall maintain laboratory animal production facilities and laboratory animals so that no harm is caused to health and hygiene and the safety is ensured;

2.	When he/she transports laboratory animals, he/she shall do so by a method suitable to the ecology of such laboratory animals;

3.	Other matters prescribed by Ordinance of the Prime Minister deemed necessary for securing the safety and health care of laboratory animals, as matters equivalent to subparagraphs 1 and 2.

Article 14 (Matters concerning Importation of Laboratory Animals)

The provisions of Articles 32, 34, 35, and 36 of the Act on the Prevention of Contagious Animal Diseases shall apply to the importation and quarantine of laboratory animals.

Article 15 (Designation, etc. of Excellent Laboratory Animal Production Facilities)

(1)

The Minister of Food and Drug Safety may, for the improvement of quality of laboratory animals, designate laboratory animal production facilities which have sufficient human resources and facilities, and the administration condition of which is excellent as excellent laboratory animal production facilities. In such cases, matters concerning criteria for designation, change of any matters designated or such, shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>

(2)	Any person who intends to be designated as excellent laboratory animal production facilities pursuant to paragraph (1) shall apply for designation, as prescribed by Ordinance of the Prime Minister. <Amended by Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>

(3)	No person, other than excellent laboratory animal production facilities designated pursuant to paragraph (1), shall attach a mark of excellent laboratory animal production facilities or any other mark similar thereto to transporting containers or documents or such, or shall publicize such.

Article 16 (Guidance and Supervision on Supplier, etc. of Laboratory Animals)

(1)

Any person who has registered as a supplier of laboratory animals pursuant to Article 12 or has been designated as excellent laboratory animal production facilities pursuant to Article 15 shall be guided and supervised by the Minister of Food and Drug Safety. <Amended by Act No. 11690, Mar. 23, 2013>

(2)	Matters concerning objects, timing of and standards, etc., for guidance and supervision pursuant to paragraph (1) shall be determined by the Minister of Food and Drug Safety. <Amended by Act No. 11690, Mar. 23, 2013>

Article 17 (Education)

(1)	Persons referred to in the following subparagraphs shall receive education on the use, administration, etc., of laboratory animals: <Amended by Act No. 14570, Feb. 8, 2017>

1.	An operator of an animal testing facility;

2.	An administrator prescribed in Article 8 (2);

3.	A supplier of laboratory animals prescribed in Article 12;

4.	A person who conducts animal testing.

(2)

The Minister of Food and Drug Safety shall conduct education prescribed in paragraph (1), and matters necessary for institutions entrusted with education, details of education, the reimbursement of expenses incurred or such, shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>

Article 18 (Prevention of Disasters)

(1)	Where an operator or an administrator of animal testing facilities conducts animal testing using substances or pathogens or such, which may cause any disasters, he/she shall take the necessary measures so as not to do any harm to humans and animals.

(2)

Where a disaster caused by animal testing facilities and laboratory animal production facilities is deemed detrimental to national health and public good, an operator or an administrator shall take the necessary measures immediately, such as closure, disinfection or such, and then report the results thereof to the Minister of Food and Drug Safety. In such cases, Article 19 of the Act on the Prevention of Contagious Animal Diseases shall apply mutatis mutandis. <Amended by Act No. 11690, Mar. 23, 2013>

(3)

Where a disaster caused by animal testing and laboratory animals is deemed detrimental to national health and public good, an operator or an administrator shall take the necessary measures, such as destruction or such, and then report the results thereof to the Minister of Food and Drug Safety. In such cases, Article 20 of the Act on the Prevention of Contagious Animal Diseases shall apply mutatis mutandis. <Amended by Act No. 11690, Mar. 23, 2013>

Article 19 (Reporting on Use of Biological Harmful Substances)

(1)

Where an operator of animal testing facilities intends to use any biologically harmful substances prescribed by Ordinance of the Prime Minister for animal testing, he/she shall report it in advance to the Minister of Food and Drug Safety. <Amended by Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>

(2)	Matters concerning reporting referred to in paragraph (1) shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>

Article 20 (Waste Matter, such as Carcass)

(1)	Deleted. <by Act No. 14023, Feb. 3, 2016>

(2)

The operator and manager of each animal testing facility or every laboratory animal supplier shall dispose of waste byproducts, such as carcasses of laboratory animals from animal testing facilities and laboratory animal production facilities under the Wastes Control Act: Provided, That the same shall not apply to the supply to laboratory animal resources banks mentioned in Article 5 (1) 3-2. <Amended by Act No. 14023, Feb. 3, 2016>

Article 21 (Records)

Any person who conducts animal testing shall record types of laboratory animals, quantity of animals used, procedures for researches conducted, participants in research as prescribed by Ordinance of the Prime Minister. <Amended by Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>

Article 22 (Reporting on Current Status of Animal Testing)

(1)	The Minister of Food and Drug Safety shall prepare and publish a report on the current status of animal testing each year. <Amended by Act No. 11690, Mar. 23, 2013>

(2)	Matters referred to in the following subparagraphs shall be included in a report on the current status prescribed in paragraph (1): <Amended by Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>

1.	The types and number of laboratory animals used for animal testing;

2.	Disposal of laboratory animals after animal testing;

3.	The types and number of animal testing facilities and laboratory animal production facilities;

4.	Matters concerning guidance and supervision on animal testing facilities prescribed in Article 11;

5.	Matters concerning the use of substances or pathogens causing disasters or such, prescribed in Article 18;

6.	Matters concerning the use of harmful substances prescribed in Article 19;

7.	Matters concerning the cancellation, etc., of designation prescribed in Article 24;

8.	Other matters prescribed by Ordinance of the Prime Minister.

Article 23 (Laboratory Animal Association)

(1)	The Laboratory Animal Association (hereinafter referred to as the "Association") may be established for the promotion of reliability of animal testing and the sound development of the laboratory animal industry.

(2)	The Association shall be a juristic person.

(3)	Any of the following persons may be members of the Association:

1.	A person who has made registration prescribed in Article 8 (1);

2.	An administrator prescribed in Article 8 (2);

3.	A person determined by the articles of association of the Association among those who have knowledge and technology in the field of laboratory animals.

(4)	Where a person intends to establish the Association, he/she shall prepare the articles of association, as prescribed by Presidential Decree and obtain approval for the establishment of the Minister of Food and Drug Safety. <Amended by Act No. 11690, Mar. 23, 2013>

(5)	Matters to be entered in the articles of association and matters necessary for business of the Association shall be prescribed by Presidential Decree.

(6)	The provisions concerning incorporated associations of the Civil Act shall apply mutatis mutandis to matters not prescribed in this Act on the Association.

(7)	The State may, where deemed necessary for the Association to conduct business pursuant to paragraph (1), support finance or such.

Article 24 (Cancellation, etc. of Designation)

(1)

When any person who has registered as animal testing facilities pursuant to Article 8 or as a suppler of laboratory animals pursuant to Article 12 falls under any of the following subparagraphs, the Minister of Food and Drug Safety may cancel registration of the relevant facilities or supplier, or suspend the operation of facilities or business within six months: <Amended by Act No. 11690, Mar. 23, 2013>

1.	Where he/she is found to have registered by fraud or other improper means;

2.	Where a disaster, such as a disease or such which undermines the health of people or public good, has occurred from animal testing facilities or in connection with the supply of laboratory animals;

3.	Where he/she fails to follow guidance and supervision or fails to meet the standard prescribed in Article 11 or 16.

(2)

When any person who is designated as excellent animal testing facilities pursuant to Article 10 or as excellent laboratory animal production facilities pursuant to Article 15 falls under any of the following subparagraphs, the Minister of Food and Drug Safety may cancel such designation or suspend the operation of facilities within six months: <Amended by Act No. 11690, Mar. 23, 2013>

1.	Where he/she is found to have been designated by fraud or other improper means;

2.	Where a disaster, such as a disease or such which undermines the health of people or public good, has occurred from excellent animal testing facilities or excellent laboratory animal production facilities;

3.	Where he/she fails to follow guidance and supervision or fails to meet the standard prescribed in Article 11 or 16.

(3)	The standards for disposal pursuant to paragraphs (1) and (2) shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>

Article 24 (Cancellation, etc. of Designation)

(1)

When any person who has registered as animal testing facilities pursuant to Article 8 or as a suppler of laboratory animals pursuant to Article 12 falls under any of the following subparagraphs, the Minister of Food and Drug Safety may cancel registration of the relevant facilities or supplier, or suspend the operation of facilities or business within six months: <Amended by Act No. 11690, Mar. 23, 2013; Act No. 15278, Dec. 19, 2017>

1.	Where he/she is found to have registered by fraud or other improper means;

2.	Where a disaster, such as a disease or such which undermines the health of people or public good, has occurred from animal testing facilities or in connection with the supply of laboratory animals;

3.	Where he/she fails to follow guidance and supervision or fails to meet the standard prescribed in Article 11 or 16;

4.	Where he/she is supplied with laboratory animals from sources other than other animal testing facilities, excellent laboratory animal production facilities or suppliers of laboratory animals in violation of Article 9 (1).

(2)

When any person who is designated as excellent animal testing facilities pursuant to Article 10 or as excellent laboratory animal production facilities pursuant to Article 15 falls under any of the following subparagraphs, the Minister of Food and Drug Safety may cancel such designation or suspend the operation of facilities within six months: <Amended by Act No. 11690, Mar. 23, 2013>

1.	Where he/she is found to have been designated by fraud or other improper means;

2.	Where a disaster, such as a disease or such which undermines the health of people or public good, has occurred from excellent animal testing facilities or excellent laboratory animal production facilities;

3.	Where he/she fails to follow guidance and supervision or fails to meet the standard prescribed in Article 11 or 16.

(3)	The standards for disposal pursuant to paragraphs (1) and (2) shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>

<<Enforcement Date: Jun. 20, 2018>> Article 24

Article 25 (Grounds for Disqualification)

Any of the following persons shall not be an operator or an administrator of animal testing facilities and a supplier of laboratory animals: <Amended by Act No. 14023, Feb. 3, 2016; Act No. 15278, Dec. 19, 2017>

1.

A mental patient prescribed in subparagraph 1 of Article 3 of the Act on the Improvement of Mental Health and the Support for Welfare Services for Mental Patients: Provided, That this shall not apply to a person deemed appropriate as an operator or an administrator of animal testing facilities by a medical specialist;

2.	A person under adult guardianship or limited guardianship;

3.	An addict of narcotics, hemp or other anti-psychotic drugs;

4.	A person in whose case two years have not passed since his/her imprisonment without labor or heavier punishment was completely executed (including cases where the execution is deemed to have been completed) or exempted by court order, in violation of this Act;

5.	A person who is under the suspension of the execution of imprisonment without labor or heavier punishment by court order, in violation of this Act;

6.	A person in whose case two years have not passed since the suspension of the operation of facilities or the cancellation of registration pursuant to Article 24 (1).

Article 26 (Hearings)

When the Minister of Food and Drug Safety intends to cancel registration, to suspend operation, or to cancel designation of the relevant facilities pursuant to Article 24, he/she shall hold a hearing in advance. <Amended by Act No. 11690, Mar. 23, 2013>

Article 27 (Guidance and Supervision, etc.)

(1)	The Minister of Food and Drug Safety may have the relevant public official perform a field investigation or request the presentation of necessary materials for guidance and supervision prescribed in Articles 11 and 16. <Amended by Act No. 11690, Mar. 23, 2013>

(2)	A public official who performs an investigation pursuant to paragraph (1) shall carry identification indicating his/her authority and present it to interested persons.

Article 28 (Penalty Surcharges)

(1)	Where an operator of facilities falls under Article 24, the Minister of Food and Drug Safety may impose a penalty surcharge not exceeding 50 million won in lieu of the suspension of operation of the relevant facilities. <Amended by Act No. 11690, Mar. 23, 2013>

(2)	Matters necessary for an amount of a penalty surcharge according to degree, etc., of an offense for which the penalty surcharge is imposed pursuant to paragraph (1) shall be prescribed by Presidential Decree.

(3)	The Minister of Food and Drug Safety may, if necessary for the imposition of a penalty surcharge, request the head of the competent tax office to provide taxation information in a document containing the following matters: <Amended by Act No. 11690, Mar. 23, 2013; Act No. 14023, Feb. 3, 2016>

1.	Personal information of the taxpayer;

2.	Purpose of use;

3.	Sales amount which is the basis for the imposition of a penalty surcharge.

(4)	Any person who receives a request under paragraph (3) shall comply therewith unless he/she has any justifiable ground contrary thereto. <Newly Inserted by Act No. 14023, Feb. 3, 2016>

(5)

Where a person obliged to pay a penalty surcharge mentioned in paragraph (1) fails to do so by the deadline for payment, the Minister of Food and Drug Safety shall either cancel disposition imposing a penalty surcharge prescribed in paragraph (1) as prescribed by Presidential Decree and make disposition suspending business operations prescribed in Article 24 (1) or (2) or collect the penalty surcharge in the same manner as delinquent national taxes: Provided, That where it is not possible to make disposition suspending business operations prescribed in Article 24 (1) or (2) due to business closure, etc., the Minister shall collect the penalty surcharge in the same manner as delinquent national taxes. <Newly Inserted by Act No. 14023, Feb. 3, 2016>

(6)

Where the Minister of Food and Drug Safety recognizes that a person hit with a penalty surcharge under paragraph (1) has difficulties in paying the penalty surcharge in a lump sum on any of the following grounds, the Minister may extend the deadline for payment or allow installment payment within the scope of twelve months: <Newly Inserted by Act No. 14570, Feb. 8, 2017>

1.	Where a person hit with a penalty surcharge suffers from a substantial property loss due to a disaster, etc.;

2.	Where a person hit with a penalty surcharge is expected to undergo substantial difficulty financially due to the lump sum payment of the penalty surcharge;

3.	Where a person hit with a penalty surcharge has grounds equivalent to those in subparagraph 1 or 2;

(7)

Where a person obliged to pay a penalty surcharge for whom the deadline for payment is extended or installment payment is allowed under paragraph (6) falls under any of the following cases, the Minister of Food and Drug Safety may collect the penalty surcharge in a lump sum by cancelling the decision to extend deadline for payment or installment payment: <Newly Inserted by Act No. 14570, Feb. 8, 2017>

1.	Where a person obliged to pay a penalty surcharge fails to pay the penalty surcharge for which installment payment is determined, within the deadline for its payment;

2.

Where it is recognized that the entire amount or remaining amount of a penalty surcharge cannot be collected, for the person obliged to pay the penalty surcharge is subject to compulsory execution or the commencement of auction, declares bankruptcy or the dissolution of a corporation, or is subject to the disposition of national or local taxes in arrears;

3.	Where a person obliged to pay a penalty surcharge has grounds equivalent to those in subparagraph 1 or 2.

(8)	Matters necessary for the extension of deadline for payment, installment payment, etc. of penalty surcharges prescribed in paragraphs (6) and (7) shall be prescribed by Ordinance of the Prime Minister. <Newly Inserted by Act No. 14570, Feb. 8, 2017>

Article 29 (Fees)

Any of the following persons shall pay a fee as prescribed by Ordinance of the Prime Minister: <Amended by Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>

1.	A person who intends to make registration prescribed in Article 8 or to receive designation prescribed in Article 10;

2.	A person who intends to make registration prescribed in Article 12 or to receive designation prescribed in Article 15.

Article 30 (Penalty Provisions)

Any person who has failed to make registration or to register a change, in violation of Article 12 (1) or (2) shall be punished by a fine not exceeding five million won.

Article 31 (Penalty Provisions)

Any person who has refused, evaded or interfered with a field investigation without good cause, or has failed to comply with a request for presentation of materials pursuant to Article 27 (1), or has presented false materials shall be punished by a fine not exceeding two million won.

Article 31 (Penalty Provisions)

Any of the following persons shall be subject to an administrative fine not exceeding two million won:

1.	A person supplied with laboratory animals from sources other than other animal laboratory facilities, excellent laboratory animal production facilities or suppliers of laboratory animals, in violation of Article 9 (1);

2.	A person who has refused, evaded or interfered with a field investigation prescribed in Article 27 (1) without good cause, or who fails to comply with a request for presentation of materials, or has presented false materials.

[This Article Wholly Amended by Act No. 15278, Dec. 19, 2017]

<<Enforcement Date: Jun. 20, 2018>> Article 31

Article 32 (Joint Penalty Provisions)

Where the representative of a juristic person or an agent or employee of, or other persons employed by, the juristic person or an individual commits any offense falling under Article 31 with regard to the business affairs of the juristic person or individual, the juristic person or individual shall, in addition to punishing the violators accordingly, be subject to a fine referred to in the relevant provisions. Provided, That this shall not apply where the juristic person or individual has not been negligent in paying due attention to and exercising supervision of the relevant duties in order to prevent such offense. <Amended by Act No. 11987, Jul. 30, 2013>

Article 33 (Administrative Fines)

(1)	Any of the following persons shall be punished by an administrative fine not exceeding one million won: <Amended by Act No. 14570, Feb. 8, 2017>

1.	A person who has failed to make registration pursuant to Article 8;

2.	A person who has attached a mark of excellent laboratory animal production facilities or any other mark similar thereto or has publicized it, in violation of Article 15 (3);

3.	A person who operated animal testing facilities, an administrator or a supplier of laboratory animals, who has not received education, in violation of Article 17 (1);

4.	A person who has failed to file a report pursuant to Article 18 (2) and (3) or 19 (1) or has made a false report.

(2)	Administrative fines prescribed in paragraph (1) shall be imposed and collected by the Minister of Food and Drug Safety, as prescribed by Presidential Decree. <Amended by Act No. 11690, Mar. 23, 2013>

(3)	through (5) Deleted. <by Act No. 11690, Mar. 23, 2013>

Article 33 (Administrative Fines)

(1)	Any of the following persons shall be subject to an administrative fine not exceeding three million won: <Newly Inserted by Act No. 15278, Dec. 19, 2017>

1.	An operator or administrator of animal testing facilities who fails to establish and operate a laboratory animal management committee, in violation of Article 7 (1);

2.	An operator or administrator of animal testing facilities who fails to undergo deliberation by the laboratory animal management committee, in violation of Article 7 (4).

(2)	Any of the following persons shall be subject to an administrative fine not exceeding one million won: <Amended by Act No. 14570, Feb. 8, 2017; Act No. 15278, Dec. 19, 2017>

1.	A person who fails to make registration pursuant to Article 8;

2.	A person who has attached a mark of excellent laboratory animal production facilities or any other mark similar thereto or has publicized it, in violation of Article 15 (3);

3.	A person who operated animal testing facilities, an administrator or a supplier of laboratory animals, who has not received education, in violation of Article 17 (1);

4.	A person who fails to file a report pursuant to Article 18 (2) and (3) or 19 (1) or has made a false report.

(3)	Administrative fines prescribed in paragraphs (1) and (2) shall be imposed and collected by the Minister of Food and Drug Safety, as prescribed by Presidential Decree. <Amended by Act No. 11690, Mar. 23, 2013; Act No. 15278, Dec. 19, 2017>

(4)	and (5) Deleted. <by Act No. 11690, Mar. 23, 2013>

<<Enforcement Date: Jun. 20, 2018>> Article 33

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LABORATORY ANIMAL ACT