LABORATORY ANIMAL ACT
Act No. 9025, Mar. 28, 2008
Amended by Act No. 9932, Jan. 18, 2010
Act No. 11690, Mar. 23, 2013
Act No. 11987, Jul. 30, 2013
Act No. 14023, Feb. 3, 2016
Act No. 14570, Feb. 8, 2017
Act No. 15278, Dec. 19, 2017
Act No. 15944, Dec. 11, 2018
Act No. 18853, Apr. 26, 2022
Act No. 18969, Jun. 10, 2022
Act No. 19918, Jan. 2, 2024
CHAPTER I GENERAL PROVISIONS
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.
The terms used in this Act are defined 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 management and quality control of foods, functional health foods, medical and pharmaceutical products, non-medical and pharmaceutical products, biomedicines, medical appliances, and cosmetics; |
| 2. | Safety management and quality control of narcotics. |
| Article 4 (Relationship to other statutes) |
The Animal Protection Act shall apply to the use or administration of laboratory animals, except as prescribed by this Act.
| Article 5 (Responsibilities of 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 on Mar. 23, 2013; 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 performing matters provided in paragraph (1) shall be prescribed by Prime Ministerial Decree. <Amended on Jan. 18, 2010; Mar. 23, 2013> |
[Title Amended on Mar. 23, 2013]
CHAPTER II SCIENTIFIC USE OF LABORATORY ANIMALS
| Article 6 (Responsibilities 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 of laboratory animal management committee) |
| (1) | A laboratory animal management committee shall be established and operated in the animal testing facilities in order to secure the ethics, safety, and reliability of animal testing; provided, where the relevant animal testing facility has established an institutional animal care and use committee within the facility as prescribed in Article 51 (1) of the Animal Protection Act (including cases where an institutional animal care and use committee is deemed established under Article 51 (2) of the Animal Protection Act), the composition of which fulfills the requirements specified in paragraphs (2) and (3), the committee shall be deemed a laboratory animal management committee. <Amended on Feb. 3, 2016; Apr. 26, 2022> |
| (2) | Each laboratory animal management committee shall be comprised of not fewer than 4 but not more than 15 members, including 1 chairperson. <Amended on Feb. 3, 2016> |
| (3) | Members shall be commissioned by the operator of animal testing facilities from among any of the following persons, and the chairperson shall be elected by and from among the members: <Added on Feb. 3, 2016; Jan. 2, 2024> |
| 1. | A veterinarian under the Veterinarians Act; |
| 2. | A person who has obtained a doctoral degree in the field of animal testing and has experience in the management of animal testing or in conducting animal testing (including experience acquired before obtaining the doctoral degree); |
| 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 Prime Ministerial Decree. |
| (4) | The following matters shall undergo deliberation by a laboratory animal management committee: <Added on 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. <Added on Feb. 3, 2016; Dec. 19, 2017> |
CHAPTER III ANIMAL TESTING FACILITIES
| Article 8 (Registration of animal testing facilities) |
| (1) | A person who intends to establish an animal testing facility shall file for registration with the Minister of Food and Drug Safety, and the same shall apply where the person intends to modify any registered matter; provided, where a person intends to modify any minor matter prescribed by Prime Ministerial Decree, he or she shall report it to the Minister of Food and Drug Safety. <Amended on Mar. 23, 2013; Jan. 2, 2024> |
| (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 Prime Ministerial Decree. <Amended on Jan. 18, 2010; Mar. 23, 2013> |
| Article 9 (Use 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 on 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 or she shall use laboratory animals meeting the standards prescribed by Prime Ministerial Decree. <Amended on Jan. 18, 2010; Mar. 23, 2013> |
| 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 Prime Ministerial Decree. <Amended on Jan. 18, 2010; Mar. 23, 2013> |
| (2) | Any facility who intends to be designated as an excellent animal testing facility under paragraph (1) shall apply for designation as prescribed by Prime Ministerial Decree. <Amended on Jan. 18, 2010; 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 under paragraph (1). <Amended on Mar. 23, 2013> |
| Article 11 (Guidance and supervision on animal testing facilities) |
| (1) | Any facility who has registered as animal testing facilities under Article 8 or has been designated as excellent animal testing facilities under Article 10 shall be guided and supervised by the Minister of Food and Drug Safety. <Amended on Mar. 23, 2013> |
| (2) | Matters necessary for details, objects, and timing of and standards, etc., for guidance and supervision under paragraph (1) shall be determined by the Minister of Food and Drug Safety. <Amended on Mar. 23, 2013> |
CHAPTER IV SUPPLY OF LABORATORY ANIMALS
| 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 Prime Ministerial Decree; provided, this shall not apply to cases where he or she supplies laboratory animals produced in the process of maintenance or research in animal testing facilities referred to in Article 8. <Amended on Jan. 18, 2010; Mar. 23, 2013> |
| (2) | When a person intends to modify any registered matter under paragraph (1), he or she shall file for registration of modification, as prescribed by Prime Ministerial Decree; provided, if he or she intends to modify minor matters prescribed by Prime Ministerial Decree, he or she shall report thereon to the Minister of Food and Drug Safety. <Amended on Jan. 18, 2010; Mar. 23, 2013; Jan. 2, 2024> |
| Article 13 (Matters to be observed by supplier of laboratory animals) |
A supplier of laboratory animals shall observe the following matters to ensure the safety and health of laboratory animals: <Amended on Jan. 18, 2010; Mar. 23, 2013; Jan. 2, 2024>
| 1. | He or 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 or she transports laboratory animals, he or she shall do so by a method suitable to the ecology of such laboratory animals; |
| 3. | He or she shall report the status of production, import, sale, etc. of laboratory animals to the Minister of Food and Drug Safety, as prescribed by Prime Ministerial Decree; |
| 4. | Other matters equivalent to those under subparagraphs 1 and 2, which are deemed necessary for ensuring the safety and health management of laboratory animals, as prescribed by Prime Ministerial Decree. |
| 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 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 Prime Ministerial Decree. <Amended on Jan. 18, 2010; Mar. 23, 2013> |
| (2) | Any person who intends to be designated as excellent laboratory animal production facilities under paragraph (1) shall apply for designation, as prescribed by Prime Ministerial Decree. <Amended on Jan. 18, 2010; Mar. 23, 2013> |
| (3) | No person, other than excellent laboratory animal production facilities designated under 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 of laboratory animals) |
| (1) | Any person who has registered as a supplier of laboratory animals under Article 12 or has been designated as excellent laboratory animal production facilities under Article 15 shall be guided and supervised by the Minister of Food and Drug Safety. <Amended on Mar. 23, 2013> |
| (2) | Matters concerning objects, timing of and standards, etc., for guidance and supervision under paragraph (1) shall be determined by the Minister of Food and Drug Safety. <Amended on Mar. 23, 2013> |
CHAPTER V SAFETY MANAGEMENT
| (1) | Persons referred to in the following subparagraphs shall receive education on the use, administration, etc., of laboratory animals: <Amended on Feb. 8, 2017> |
| 1. | An operator of an animal testing facility; |
| 2. | An administrator under Article 8 (2); |
| 3. | A supplier of laboratory animals prescribed in Article 12; |
| 4. | Deleted. <Jan. 2, 2024> |
| (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 Prime Ministerial Decree. <Amended on Jan. 18, 2010; 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 or 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 on 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 on 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 Prime Ministerial Decree for animal testing, he or she shall report it in advance to the Minister of Food and Drug Safety. <Amended on Jan. 18, 2010; Mar. 23, 2013> |
| (2) | Matters concerning reporting referred to in paragraph (1) shall be prescribed by Prime Ministerial Decree. <Amended on Jan. 18, 2010; Mar. 23, 2013> |
| Article 20 (Waste matter, such as carcass) |
| (1) | Deleted. <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, the same shall not apply to the supply to laboratory animal resources banks mentioned in Article 5 (1) 3-2. <Amended on Feb. 3, 2016> |
CHAPTER VI DISCLOSURE OF RECORDS AND INFORMATION TO PUBLIC
| Article 21 (Recording and reporting) |
| (1) | A person who conducts animal testing shall keep records on the types and number of laboratory animals used, the procedures of the research conducted, the persons who participated in the research, and the disposal of laboratory animals after the animal testing. <Amended on Jan. 18, 2010; Mar. 23, 2013; Jan. 2, 2024> |
| (2) | The operator of an animal testing facility shall report to the Minister of Food and Drug Safety the types and number of laboratory animals used in animal testing, and the disposal of such animals after the animal testing. <Added on Jan. 2, 2024> |
| (3) | Matters necessary for the method of keeping records under paragraph (1) and the procedures and methods, etc. for reporting under paragraph (2) shall be prescribed by Prime Ministerial Decree. <Added on Jan. 2, 2024> |
[Title Amended on Jan. 2, 2024]
| 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 on 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 on Jan. 18, 2010; 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 revocation, etc., of designation prescribed in Article 24; |
| 8. | Other matters prescribed by Prime Ministerial Decree. |
CHAPTER VII SUPPLEMENTARY PROVISIONS
| 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 corporation. |
| (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 under 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 or 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 on 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 under paragraph (1), support finance or such. |
| Article 24 (Revocation of designation) |
| (1) | When any person who has registered an animal testing facility under Article 8 or who is registered as a supplier of laboratory animals under Article 12 falls under any of the following subparagraphs, the Minister of Food and Drug Safety may revoke the registration of the relevant facilities or supplier, or suspend the operation of the animal testing facilities or the business operation of a supplier of laboratory animals (including operation of laboratory animal production facilities) for up to 6 months; provided, where the person falls under subparagraph 1, the Minister of Food and Drug Safety shall revoke the registration. <Amended on Mar. 23, 2013; Dec. 19, 2017; Jun. 10, 2022; Jan. 2, 2024> |
| 1. | Where he or 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 no facility exists at the location where an animal testing facility or the supplier of laboratory animals has filed for registration; |
| 4. | Where the operator of an animal testing facility violates the duties under Article 6; |
| 5. | Where he or she fails to comply with the guidance or supervision or fails to meet the standards under Article 11 or 16; |
| 6. | Where he or 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); |
| 7. | Where he or she fails to comply with the matters to be observed by a supplier of laboratory animals under subparagraphs 1 and 2 of Article 13. |
| (2) | When any person whose facilities are designated as excellent animal testing facilities under Article 10 or as excellent laboratory animal production facilities under Article 15 falls under any of the following subparagraphs, the Minister of Food and Drug Safety may revoke such designation or suspend the designation of the relevant facilities for up to 6 months; provided, where the person falls under subparagraph 1, the Minister of Food and Drug Safety shall revoke the designation: <Amended on Mar. 23, 2013; Jun. 10, 2022> |
| 1. | Where he or 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 or she fails to follow guidance and supervision or fails to meet the standard prescribed in Article 11 or 16. |
| (3) | The standards for disposal under paragraphs (1) and (2) shall be prescribed by Prime Ministerial Decree. <Amended on Jan. 18, 2010; Mar. 23, 2013> |
| Article 25 (Grounds for disqualification) |
Any of the following persons may not be an operator or an administrator of animal testing facilities and a supplier of laboratory animals: <Amended on Feb. 3, 2016; Dec. 19, 2017; Jun. 10, 2022>
| 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, 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 or 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 one year has not passed since the person received a disposition to suspend operation of the animal testing facilities or a disposition to suspend business operation as the supplier of laboratory animals or registration under Article 24 (1) thereof was revoked. |
When the Minister of Food and Drug Safety intends to revoke registration, to suspend operation, or to revoke designation of the relevant facilities under Article 24, he or she shall hold a hearing in advance. <Amended on Mar. 23, 2013>
| Article 27 (Guidance and supervision) |
| (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 Article 11 and 16. <Amended on Mar. 23, 2013> |
| (2) | A public official who performs an investigation under paragraph (1) shall carry identification indicating his or her authority and present it to interested persons. |
| Article 28 (Penalty surcharges) |
| (1) | Where an operator of the facilities falls under Article 24 (1), the Minister of Food and Drug Safety may impose a penalty surcharge not exceeding 100 million won in lieu of the suspension of operation of the relevant facilities. <Amended on Mar. 23, 2013; Dec. 11, 2018; Jun. 10, 2022> |
| (2) | Matters necessary for an amount of a penalty surcharge according to degree, etc., of an offense for which the penalty surcharge is imposed under 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 on Mar. 23, 2013; Feb. 3, 2016> |
| 1. | Personal information of the taxpayer; |
| 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 or she has any justifiable ground contrary thereto. <Added on Feb. 3, 2016> |
| (5) | Where a person obliged to pay a penalty surcharge under paragraph (1) fails to do so by the deadline for payment, the Minister of Food and Drug Safety shall either revoke the disposition to impose a penalty surcharge under paragraph (1) as prescribed by Presidential Decree and issue a disposition to suspend operation under Article 24 (1), or collect the penalty surcharge in the same manner as delinquent national taxes; provided, if it is not possible to render a disposition to suspend operation prescribed in Article 24 (1) due to business closure, etc., the Minister shall collect the penalty surcharge in the same manner as delinquent national taxes. <Added on Feb. 3, 2016; Jun. 10, 2022> |
| (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: <Added on 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 revoking the decision to extend deadline for payment or installment payment: <Added on 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 Prime Ministerial Decree. <Added on Feb. 8, 2017> |
Any of the following persons shall pay a fee as prescribed by Prime Ministerial Decree: <Amended on Jan. 18, 2010; 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) |
A person who fails to file for registration or registration of modification in violation of the main clause of Article 12 (1) or (2) shall be punished by a fine not exceeding 5 million won. <Amended on Jan. 2, 2024>
| 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 on Dec. 19, 2017]
| 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, 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 on Jul. 30, 2013>
| Article 33 (Administrative fines) |
| (1) | Any of the following persons shall be subject to an administrative fine not exceeding 3 million won: <Amended on 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 1 million won: <Amended on Feb. 8, 2017; Dec. 19, 2017; Jan. 2, 2024> |
| 1. | A person who fails to file for registration or registration of modification or to file a report on change under Article 8; |
| 1-2. | A person who fails to file a report on change under the proviso of Article 12 (2); |
| 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 under Article 18 (2) and (3) or 19 (1) or has made a false report. |
| 5. | A person who fails to file a report under subparagraph 3 of Article 13 or Article 21 (2) or files 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 on Mar. 23, 2013; Dec. 19, 2017> |
| (4) | Deleted. <Mar. 23, 2013> |
| (5) | Deleted. <Mar. 23, 2013> |
ADDENDA <Act No. 9025, Mar. 28, 2008>
| (1) | (Enforcement Date) This Act shall enter into force one year after the date of its promulgation. |
| (2) | (Transitional measures concerning operator of animal testing facilities) Any person who establishes or operates animal testing facilities as at the time this Act enters into force shall be deemed an operator under this Act. In such cases, he or she shall make registration under Article 8 within one year after this Act enters into force. |
| (3) | (Transitional measures concerning supplier of laboratory animals) Any person who supplies laboratory animals as at the time this Act enters into force shall be deemed a supplier of laboratory animals. In such cases, he or she shall make registration under Article 12 within one year after this Act enters into force. |
ADDENDA <Act No. 9932, Jan. 18, 2010>
Article 1 (Enforcement date)
This Act shall enter into force two months after the date of its promulgation. (Proviso Omitted.)
Articles 2 through 5 Omitted.
ADDENDA <Act No. 11690, Mar. 23, 2013>
Article 1 (Enforcement date)
| (1) | This Act shall enter into force on the date of its promulgation. |
Articles 2 through 7 Omitted.
ADDENDUM <Act No. 11987, Jul. 30, 2013>
This Act shall enter into force on the date of its promulgation.
ADDENDA <Act No. 14023, Feb. 3, 2016>
Article 1 (Enforcement date)
This Act shall enter into force on the date of its promulgation; provided, the amended provisions of Article 28 (5) shall enter into force three months after its promulgation.
Article 2 (Transitional measures concerning incompetents)
Notwithstanding the amended provisions of subparagraph 2 of Article 25, persons for whom the effect of the sentence of incompetency or quasi-incompetency is maintained under Article 2 of Addenda of the partially amended Civil Act (Act No. 10429) shall be governed by the former provisions.
ADDENDA <Act No. 14570, Feb. 8, 2017>
Article 1 (Enforcement date)
This Act shall enter into force 6 months after its promulgation.
Article 2 (Applicability to installment payment of penalty surcharges)
The amended provisions of Article 28 (6) shall apply starting from cases where a penalty surcharge is imposed under Article 28 (1) after this Act enters into force.
Article 3 (Transitional measures concerning education on use, management of laboratory animals)
The manager of each animal testing facility registered under Article 8 (1) at the time this Act enters into force shall receive education prescribed in Article 17 (1) within one year from the date on which this Act enters into force.
ADDENDUM <Act No. 15278, Dec. 19, 2017>
This Act shall enter into force six months after the date of its promulgation; provided, the amended provisions of subparagraphs 1 and 3 of Article 25 shall enter into force on the date of its promulgation.
ADDENDA <Act No. 15944, Dec. 11, 2018>
Article 1 (Enforcement date)
This Act shall enter into force three months after the date of its promulgation.
Article 2 (Transitional measures concerning imposition of penalty surcharges)
The previous provisions shall apply to the imposition of penalty surcharges for violations committed before this Act enters into force.
ADDENDA <Act No. 18853, Apr. 26, 2022>
Article 1 (Enforcement date)
This Act shall enter into force one year after the date of its promulgation. (Proviso Omitted.)
Articles 2 through 27 Omitted.
ADDENDA <Act No. 18969, Jun. 10, 2022>
Article 1 (Enforcement date)
This Act shall enter into force six months after the date of its promulgation; provided, the amended provisions of subparagraph 6 of Article 25 (limited to the provisions relating to the period of disqualification) shall enter into force on the date of its promulgation.
Article 2 (Applicability to grounds for disqualification)
The amended provisions of subparagraph 6 of Article 25 (limited to the provisions relating to the period of disqualification) shall also apply to persons who receive administrative dispositions before the enforcement date under the proviso of Article 1 of the Addenda.
Article 3 (Transitional measures concerning administrative dispositions and penalty surcharges)
Notwithstanding the amended provisions of Article 24 (1), provisions, with the exception of the subparagraphs, of paragraph (2) of that Article, and Article 28 (1) and (5), the previous provisions shall apply to cases where administrative dispositions are imposed or penalty surcharges are imposed and collected for violations committed before this Act enters into force.
ADDENDA <Act No. 19918, Jan. 2, 2024>
Article 1 (Enforcement date)
This Act shall enter into force 6 months after its promulgation.
Article 2 (Applicability to reports on changes in animal testing facilities)
The amended provisions of the proviso of Article 8 (1) shall begin to apply to modifications made after this Act enters into force.
Article 3 (Applicability to reports on changes to supplier of laboratory animals)
The amended provisions of the proviso of Article 12 (2) shall begin to apply modifications made after this Act enters into force.
Article 4 (Transitional measures concerning administrative dispositions and administrative fines)
Notwithstanding the amended provisions of Articles 24 (1) 3, 4, and 7 and 33 (2) 1, 1-2, and 5, the previous provisions shall apply where an administrative disposition is made or an administrative fine is imposed and collected for a violation committed before this Act enters into force.