ENFORCEMENT DECREE OF THE ACT ON THE PROMOTION OF COLLECTION, MANAGEMENT, AND UTILIZATION OF PATHOGEN RESOURCES
Presidential Decree No. 27817, Jan. 31, 2017
Amended by Presidential Decree No. 31013, Sep. 11, 2020
Presidential Decree No. 32528, Mar. 8, 2022
| Article 2 (Formulation and Implementation of Comprehensive Pathogen Resource Management Plan) |
| (1) | Where deemed necessary for the formulation of a comprehensive pathogen resource management plan (hereinafter referred to as "comprehensive plan") referred to in Article 5 (1) of the Act on the Promotion of Collection, Management, and Utilization of Pathogen Resources (hereinafter referred to as the "Act") and an annual implementation plan referred to in paragraph (4) of that Article (hereinafter referred to as "implementation plan"), the Commissioner of the Korea Disease Control and Prevention Agency may request that the heads of the relevant central administrative agencies, the heads of local governments, the heads of public institutions prescribed in the Act on the Management of Public Institutions, or healthcare-related corporations, organizations, experts, etc. submit data or opinions, etc. <Amended on Sep. 11, 2020> |
| (2) | Where deemed necessary for the formulation of an implementation plan, the Commissioner of the Korea Disease Control and Prevention Agency may refer such plan to the Pathogen Resource Deliberative Committee established under Article 7 (1) of the Act for deliberation. <Amended on Sep. 11, 2020> |
| (3) | Upon the formulation of a comprehensive plan or an implementation plan, the Commissioner of the Korea Disease Control and Prevention Agency shall publish such plan on the website of the Korea Disease Control and Prevention Agency and shall notify the heads of the relevant central administrative agencies thereof. <Amended on Sep. 11, 2020> |
| Article 3 (Survey of Current Status of Domestic Pathogen Resources) |
| (1) | A survey of the current status of pathogen resources referred to in Article 6 (1) or (2) of the Act (hereinafter referred to as "survey of the current status") shall include the following: <Amended on Sep. 11, 2020> |
| 1. | The collection, management, and utilization of pathogen resources; |
| 2. | The research and development of, and technology development of, pathogen resources; |
| 3. | Specialized personnel, facilities, equipment, etc. related to pathogen resources; |
| 4. | Information systems for pathogen resources, and education, publicity campaigns, etc. therefor; |
| 5. | Other matters deemed particularly necessary by the Commissioner of the Korea Disease Control and Prevention Agency for conducting a survey of the current status of pathogen resources. |
| (2) | A survey of the current status shall be conducted by document investigation and field survey: Provided, That a questionnaire survey, a specimen inspection, an online survey through an information and communication network, or any other similar survey may be conducted concurrently, where deemed necessary by the Commissioner of the Korea Disease Control and Prevention Agency. <Amended on Sep. 11, 2020> |
| (3) | Where deemed necessary for the efficient collection, management, and utilization of pathogen resources, the Commissioner of the Korea Disease Control and Prevention Agency may disclose the results of a survey of the current status. <Amended on Sep. 11, 2020> |
| (4) | Except as provided in paragraphs (1) through (3), details necessary for the scope and methods of a survey of the current status, and the disclosure of the results thereof shall be determined by the Commissioner of the Korea Disease Control and Prevention Agency. <Amended on Sep. 11, 2020> |
| Article 4 (Composition and Operation of Pathogen Resource Deliberative Committee) |
| (1) | The term of office of a commissioned member of the Pathogen Resource Deliberative Committee established under Article 7 (1) of the Act (hereinafter referred to as the “Committee") shall be two years: Provided, That a member who is newly commissioned due to the dismissal of an existing member shall be in office for the remainder of his or her predecessor's term of office. |
| (2) | The Commissioner of the Korea Disease Control and Prevention Agency may remove or dismiss a member of the Committee from office, in any of the following cases: <Amended on Sep. 11, 2020> |
| 1. | Where the member becomes unable to perform his or her duties due to a physical or mental disability; |
| 2. | Where the member commits misconduct in connection with his or her duties; |
| 3. | Where the member is deemed unsuitable as a member due to neglect of duty, injury to dignity, or any other reason; |
| 4. | Where the member voluntarily expresses that it is impracticable to perform his or her duties. |
| (3) | The chairperson of the Committee (hereafter in this Article referred to as “chairperson”) shall represent the Committee and exercise overall control over the business affairs of the Committee. |
| (4) | Where the chairperson is unable to perform his or her duties for any unavoidable cause, a member designated by the chairperson shall act on his or her behalf. |
| (5) | A meeting of the Committee shall be convened at the request of the Commissioner of the Korea Disease Control and Prevention Agency or of at least 1/3 of the members of the Committee or where deemed necessary by the chairperson, and the chairperson shall preside over the meeting. <Amended on Sep. 11, 2020> |
| (6) | A majority of the members of the Committee shall constitute a quorum, and any resolution thereof shall require the concurring vote of a majority of those present. |
| (7) | Except as provided in paragraphs (1) through (6), details necessary for the composition, operation, etc. of the Committee shall be determined by the Commissioner of the Korea Disease Control and Prevention Agency. <Amended on Sep. 11, 2020> |
| Article 5 (Composition and Operation of Specialized Committee) |
| (1) | A specialized committee by field established under Article 7 (5) of the Act (hereinafter referred to as "specialized committee") shall be composed of up to 10 members, including one chairperson. |
| (2) | The chairperson and members of each specialized committee shall be appointed or commissioned by the Commissioner of the Korea Disease Control and Prevention Agency. <Amended on Sep. 11, 2020> |
| (3) | A majority of the members of a specialized committee shall constitute a quorum, and any resolution thereof shall require the concurring vote of a majority of those present. |
| (4) | Except as provided in paragraphs (1) through (3), details necessary for the composition, operation, etc. of a specialized committee shall be determined by the Commissioner of the Korea Disease Control and Prevention Agency. <Amended on Sep. 11, 2020> |
| Article 6 (Establishment and Operation of National Culture Collection for Pathogens) |
| (1) | The head of the National Culture Collection for Pathogens established under the former part of Article 8 (1) of the Act (hereinafter referred to as the "National Culture Collection for Pathogens") shall be designated by the Commissioner of the Korea Disease Control and Prevention Agency, from among public officials of the Korea Disease Control and Prevention Agency who are in charge of business affairs regarding pathogen resources. <Amended on Sep. 11, 2020> |
| (2) | Where deemed necessary for performing business affairs, the head of the National Culture Collection for Pathogens may request that the heads of the relevant central administrative agencies, the heads of local governments, the heads of public institutions prescribed in the Act on the Management of Public Institutions, or healthcare-related corporations, organizations, experts, etc. submit data or opinions, etc. |
| (3) | The head of the National Culture Collection for Pathogens shall annually report to the Commissioner of the Korea Disease Control and Prevention Agency on a project operation plan, the current status of project performance, a financial management plan, the details of financial operations, etc., as determined by the Commissioner of the Korea Disease Control and Prevention Agency. <Amended on Sep. 11, 2020> |
| 1. | Research and development of, and technology development of, pathogen resources; |
| 2. | Provision of the results of analyzing and evaluating pathogen resources and the relevant information; |
| 3. | Provision of support in establishing a foundation for the utilization of pathogen resources; |
| 4. | Other matters deemed particularly necessary by the Commissioner of the Korea Disease Control and Prevention Agency for the collection, management, and utilization of pathogen resources. |
| (5) | Except as provided in paragraphs (1) through (3), details necessary for the establishment and operation, etc. of the National Culture Collection for Pathogens shall be determined by the Commissioner of the Korea Disease Control and Prevention Agency. <Amended on Sep. 11, 2020> |
| Article 7 (Designation and Operation of Specialized Pathogen Resource Bank by Field) |
| (1) | The standards for designating a specialized pathogen resource bank by field pursuant to the former part of Article 9 (1) of the Act (hereinafter referred to as "specialized bank") shall be as follows: <Amended on Sep. 11, 2020> |
| 1. | Standards for facilities and equipment: To satisfy all of the following requirements: |
| (b) | Storage facilities to manage at least 1,000 different pathogen resources and related equipment; |
| (d) | Facilities and equipment for the safety management and risk prevention of pathogen resources; |
| (e) | Other facilities and equipment deemed particularly necessary by the Commissioner of the Korea Disease Control and Prevention Agency for the management of pathogen resources; |
| 2. | Standards for personnel: To satisfy all of the following requirements: |
| (a) | At least one specialized person dedicated to business affairs related to pathogen resources, with a master or doctoral degree in a field related to pathogen resources; |
| (b) | At least one person in charge of the safety management of pathogen resources; |
| (c) | At least one person in charge of information systems for pathogen resources; |
| (d) | Other personnel deemed particularly necessary by the Commissioner of the Korea Disease Control and Prevention Agency for the management of pathogen resources. |
| (2) | A person who intends to be designated as a specialized bank pursuant to Article 9 (1) of the Act shall submit an application for designation as a specialized bank (including an application in electronic form) to the Commissioner of the Korea Disease Control and Prevention Agency, along with the following documents (including documents in electronic form): <Amended on Sep. 11, 2020> |
| 1. | A document evidencing that the standards for designation specified in the subparagraphs of paragraph (1) are met; |
| 2. | A project operation plan; |
| 3. | A document relating to the current status of pathogen resources held (only applicable to where pathogen resources are held); |
| 4. | A document relating to the current status of the registration of pathogen resources under Article 13 (2) of the Act (only applicable to where such pathogen resources are registered in the Register for Preservation and Management of Pathogen Resources); |
| 5. | A document relating to the results of project activities involving pathogen resources during the recent two years (only applicable to where the results of project activities exist; and where the period of project activities is less than two years, referring to a document relating to the results of project activities during the relevant period); |
| 6. | Articles of incorporation or the corresponding regulations on business operations. |
| (3) | Upon receipt of an application for designation under paragraph (2), where the Commissioner of the Korea Disease Control and Prevention Agency determines whether to grant designation, he or she shall notify the relevant applicant of the determination in writing (including a document in electronic form). <Amended on Sep. 11, 2020> |
| (4) | Upon designating a specialized bank under Article 9 (1) of the Act, the Commissioner of the Korea Disease Control and Prevention Agency shall issue a certificate of designation as a specialized bank to the relevant applicant and publish such designation on the website designated by the Commissioner of the Korea Disease Control and Prevention Agency. <Amended on Sep. 11, 2020> |
| (5) | The head of a specialized bank designated under Article 9 (1) of the Act shall semiannually report to the Commissioner of the Korea Disease Control and Prevention Agency on a project operation plan, project performance results, a fund management plan, the details of fund operations, etc., as determined by the Commissioner of the Korea Disease Control and Prevention Agency. <Amended on Sep. 11, 2020> |
| (6) | Where the Commissioner of the Korea Disease Control and Prevention Agency subsidizes specialized banks pursuant to Article 9 (4) of the Act, he or she may provide differentiated subsidies to the specialized banks, in consideration of the project performance results, etc. of each specialized bank. <Amended on Sep. 11, 2020> |
| (7) | Except as provided in paragraphs (1) through (6), details necessary for the standards for designating a specialized bank, an application for designation as such bank, notification of such designation, reporting on its business affairs, subsidization of a specialized bank, etc. shall be determined and publicly notified by the Commissioner of the Korea Disease Control and Prevention Agency. <Amended on Sep. 11, 2020> |
| Article 8 (Issuance of Corrective Order and Revocation of Designation) |
| (1) | Where the Commissioner of the Korea Disease Control and Prevention Agency issues a corrective order to a specialized bank pursuant to the main clause of Article 10 (1) of the Act, such order shall be issued in writing (including a document in electronic form) specifying the details of violation, the methods and period of correction, matters regarding reporting on corrective measures, etc. <Amended on Sep. 11, 2020> |
| (2) | Where the Commissioner of the Korea Disease Control and Prevention Agency has revoked the designation of a specialized bank pursuant to Article 10 (1) of the Act, he or she shall publish the details of the revocation on the website designated by the Commissioner of the Korea Disease Control and Prevention Agency and shall notify the head of the National Culture Collection for Pathogens of such revocation. <Amended on Sep. 11, 2020> |
| (3) | Where the designation of a specialized bank is revoked pursuant to Article 10 (1) of the Act, the head of the relevant specialized bank shall return the certificate of designation as a specialized bank to the Commissioner of the Korea Disease Control and Prevention Agency within 10 days of such revocation. <Amended on Sep. 11, 2020> |
| (4) | Where the designation of a specialized bank is revoked pursuant to Article 10 (1) of the Act, matters regarding the transfer, disposal, etc. of the pathogen resources collected and managed by the relevant specialized bank shall be determined and publicly notified by the Commissioner of the Korea Disease Control and Prevention Agency. <Amended on Sep. 11, 2020> |
| Article 9 (Standards and Procedures for Depositing Pathogen Resources) |
| 1. | Need for conducting the research and development of the relevant pathogen resources; |
| 2. | Possibility of utilizing the relevant pathogen resources; |
| 3. | Easy preservation, management, etc. of the relevant pathogen resources; |
| 4. | Levels of identity or similarity with the pathogen resources held and managed by the National Culture Collection for Pathogens or a specialized bank. |
| (2) | A person who intends to deposit pathogen resources under Article 12 (1) of the Act shall submit an application for depositing pathogen resources (including an application in electronic form) to the head of the National Culture Collection for Pathogens or the head of a specialized bank, along with the following documents (including documents in electronic form): |
| 1. | A document relating to the names, types, details, etc., of pathogen resources; |
| 2. | A document relating to the clinical and biological characteristics of pathogen resources; |
| 3. | A document relating to epidemiological information, etc. on pathogen resources; |
| (3) | Upon receipt of an application for depositing pathogen resources under paragraph (2), where the head of the National Culture Collection for Pathogens or the head of a specialized bank determines whether to receive such resources, he or she shall notify the relevant applicant of the determination in writing (including a document in electronic form). |
| (4) | The head of the National Culture Collection for Pathogens or the head of a specialized bank shall conclude a business agreement with a depositor to deposit the relevant pathogen resources, where the pathogen resources are deposited therein pursuant to Article 12 (1) of the Act, as determined by the Commissioner of the Korea Disease Control and Prevention Agency. <Amended on Sep. 11, 2020> |
| (5) | Where a person who implements a national research and development project relating to pathogen resources pursuant to the main clause of Article 12 (2) of the Act deposits the pathogen resources, he or she shall do so within three months from the day after the last day of the project. In such cases, paragraphs (2) and (4) shall apply mutatis mutandis to the methods and procedures for depositing the relevant pathogen resources. |
| (6) | "Causes prescribed by Presidential Decree ..., such as where other statutes prescribe that special protection is required" in the proviso of Article 12 (2) of the Act means the following: |
| 1. | Where other statutes prescribe that special protection is required; |
| 2. | Where it is necessary to restrict the relevant pathogen resources from being deposited, for filing a patent application; |
| 3. | Where it is substantially impracticable to prevent the leakage of personal information due to the characteristics of the relevant pathogen resources; |
| 4. | Where the preservation and management of the relevant pathogen resources is not appropriate in light of the types, characteristics, forms, etc. of the pathogen resources. |
| (7) | Except as provided in paragraphs (1) through (5), details necessary for the standards, methods, procedures, etc. for depositing pathogen resources shall be determined and publicly notified by the Commissioner of the Korea Disease Control and Prevention Agency. <Amended on Sep. 11, 2020> |
| Article 10 (Standards and Procedures for Approving Distribution of Pathogen Resources) |
| (1) | The standards for approving the distribution of pathogen resources or for approving the modification of the distribution thereof under Article 14 (1) of the Act and the main clause of paragraph (3) of that Article shall be as follows: <Amended on Sep. 11, 2020> |
| 1. | Not to have grounds for restricting approval for the distribution of pathogen resources under the subparagraphs of Article 14 (2) of the Act; |
| 2. | To ensure that there is no hindrance to protecting the rights of persons to the relevant pathogen resources; |
| 3. | To have appropriate personnel, facilities, and equipment for managing and utilizing the relevant pathogen resources; |
| 4. | To meet other standards determined and publicly notified by the Commissioner of the Korea Disease Control and Prevention Agency, in consideration of the purpose of distributing pathogen resources, the volume of distribution, the clinical characteristics of such pathogen resources, etc. |
| (2) | A person who intends to obtain approval for the distribution of pathogen resources pursuant to Article 14 (1) of the Act shall submit an application for the distribution of pathogen resources (including an application in electronic form) to the Commissioner of the Korea Disease Control and Prevention Agency, along with the following documents (including documents in electronic form): <Amended on Sep. 11, 2020> |
| 1. | A document evidencing that the standards for distribution specified in the subparagraphs of paragraph (1) are met; |
| 2. | A plan for managing and utilizing pathogen resources subject to distribution. |
| (3) | Upon receipt of an application for the distribution under paragraph (2), where the Commissioner of the Korea Disease Control and Prevention Agency determines whether to grant approval, he or she shall notify the relevant applicant of the determination in writing (including a document in electronic form). In such cases, where the Commissioner of the Korea Disease Control and Prevention Agency determines to approve the distribution, he or she may designate a bank to distribute the relevant pathogen resources from among the National Culture Collection for Pathogens or specialized banks and may notify the applicant thereof. <Amended on Sep. 11, 2020> |
| (4) | A person who has obtained approval for the distribution of pathogen resources pursuant to Article 14 (1) of the Act shall conclude a business agreement on the distribution thereof with the National Culture Collection for Pathogens or a specialized bank that distributes the relevant pathogen resources, as determined by the Commissioner of the Korea Disease Control and Prevention Agency. <Amended on Sep. 11, 2020> |
| (5) | A person who intends to obtain approval for, or to file a report on, the modification of distribution pursuant to Article 14 (3) of the Act shall submit an application for the modification of distribution (including an application in electronic form) to the Commissioner of the Korea Disease Control and Prevention Agency, along with the following documents (including documents in electronic form); in such cases, the former part of paragraph (3) and paragraph (4) shall apply mutatis mutandis to the methods and procedures for approving the modification of distribution: <Amended on Sep. 11, 2020> |
| 1. | A statement of causes for modifying the approved matters on distribution; |
| 2. | A document evidencing the modification of the approved matters on distribution; |
| 3. | A plan for managing and utilizing pathogen resources following the modification of the approved matters on distribution; |
| 4. | A document evidencing that the standards specified in paragraph (1) are met (only applicable to approval for the modification of distribution). |
| (6) | "Minor matters prescribed by Presidential Decree, such as the period of research" in the proviso of Article 14 (3) of the Act means any of the following: |
| 1. | The period of research on pathogen resources; |
| 2. | The address or contact information of a person who has obtained approval for distribution; |
| 3. | The representative of a person who has obtained approval for distribution (only applicable to an institution, corporation, or organization that has its own representative); |
| 4. | A person in charge of the safety management of pathogen resources. |
| (7) | Except as provided in paragraphs (1) through (5), details necessary for the standards for approving the distribution of pathogen resources or for approving the modification of the distribution thereof, the procedures and methods for approving the distribution of pathogen resources, the procedures and methods for modifying the distribution thereof, and similar matters shall be determined and publicly notified by the Commissioner of the Korea Disease Control and Prevention Agency. <Amended on Sep. 11, 2020> |
| Article 11 (Revocation of Approval for Distribution and Issuance of Disposal Order) |
| (1) | Where the Commissioner of the Korea Disease Control and Prevention Agency has revoked approval for the distribution of pathogen resources or approval for the modification of the distribution thereof pursuant to Article 15 (1) of the Act, he or she shall notify such revocation to the head of the National Culture Collection for Pathogens or a specialized bank that has distributed the relevant pathogen resources. <Amended on Sep. 11, 2020> |
| (2) | Where the Commissioner of the Korea Disease Control and Prevention Agency issues an order to dispose of pathogen resources pursuant to Article 15 (1) of the Act, such order shall be issued in writing (including a document in electronic form) specifying the pathogen resources subject to disposal, the methods and period of disposal, and other similar information. <Amended on Sep. 11, 2020> |
| (3) | A person, in receipt of an order to dispose of pathogen resources pursuant to Article 15 (1) of the Act, shall report to the Commissioner of the Korea Disease Control and Prevention Agency on the results of disposing of the pathogen resources within 10 days from the day after the expiry of the disposal period under paragraph (2). <Amended on Sep. 11, 2020> |
| Article 12 (Standards and Procedures for Approving Outbound Transfer) |
| (1) | The standards for approving the outbound transfer of pathogen resources or for approving the modification of the outbound transfer thereof under the main clauses of Article 16 (1) and (4) of the Act shall be as follows: |
| 2. | To ensure that there is no hindrance to protecting the rights of persons to the relevant pathogen resources; |
| 3. | Not to be pathogen resources whose outbound transfer is prohibited in accordance with international conventions or international agreements. |
| (2) | A person who intends to obtain approval for outbound transfer pursuant to the main clause of Article 16 (1) of the Act shall submit an application for approval for the outbound transfer of pathogen resources (including an application in electronic form) to the Commissioner of the Korea Disease Control and Prevention Agency, along with the following documents (including documents in electronic form): <Amended on Sep. 11, 2020> |
| 1. | A document evidencing that the standards for approval specified in the subparagraphs of paragraph (1) are met; |
| 2. | A document relating to the names, types, characteristics, etc. of pathogen resources subject to outbound transfer; |
| 3. | A plan for managing and utilizing pathogen resources subject to outbound transfer. |
| (3) | Upon receipt of an application for the outbound transfer of pathogen resources under paragraph (2), where the Commissioner of the Korea Disease Control and Prevention Agency determines whether to grant approval, he or she shall notify the relevant applicant of the determination in writing (including a document in electronic form). <Amended on Sep. 11, 2020> |
| (4) | Where the Commissioner of the Korea Disease Control and Prevention Agency has granted approval for the outbound transfer of pathogen resources pursuant to the main clause of Article 16 (1) of the Act, and where the relevant pathogen resources have been approved for distribution pursuant to Article 14 (1) of the Act, he or she shall notify such approval to the head of the National Culture Collection for Pathogens or a specialized bank that has distributed such pathogen resources. <Amended on Sep. 11, 2020> |
| (5) | A person who intends to obtain approval for, or to file a report on, the modification of outbound transfer pursuant to Article 16 (4) of the Act shall submit an application for the modification of outbound transfer (including an application in electronic form) to the Commissioner of the Korea Disease Control and Prevention Agency, along with the following documents (including documents in electronic form); in such cases, paragraphs (3) and (4) shall apply mutatis mutandis to the methods and procedures for approving the modification of outbound transfer: <Amended on Sep. 11, 2020> |
| 1. | A statement of causes for modifying the approved matters on outbound transfer; |
| 2. | A document evidencing the modification of the approved matters on outbound transfer; |
| 3. | A plan for managing and utilizing pathogen resources following the modification of the approved matters on outbound transfer; |
| 4. | A document evidencing that the standards specified in paragraph (1) are met (only applicable to approval for the modification of outbound transfer). |
| (6) | "Minor matters prescribed by Presidential Decree, such as the period of research" in the proviso of Article 16 (4) of the Act means any of the following: |
| 1. | The period of research on pathogen resources; |
| 2. | The period of the outbound transfer of pathogen resources; |
| 3. | The address or contact information of a person who has obtained approval for outbound transfer; |
| 4. | The representative of a person who has obtained approval for outbound transfer (only applicable to an institution, corporation, or organization that has its own representative). |
| (7) | Except as provided in paragraphs (1) through (5), details necessary for the standards for approving the outbound transfer of pathogen resources or for approving the modification of the outbound transfer thereof, the procedures and methods for approving the outbound transfer of pathogen resources, the procedures and methods for modifying the outbound transfer thereof, and similar matters shall be determined and publicly notified by the Commissioner of the Korea Disease Control and Prevention Agency. <Amended on Sep. 11, 2020> |
| Article 13 (Procedures for Reporting on Outbound Transfer) |
| (1) | A person who intends to transfer any pathogen resources not included in the list of pathogen resources subject to approval for outbound transfer from the Republic of Korea pursuant to the main clause of Article 16 (2) of the Act shall submit a report on the outbound transfer of the pathogen resources (including a report in electronic form) to the Commissioner of the Korea Disease Control and Prevention Agency, along with the following documents (including documents in electronic form): <Amended on Sep. 11, 2020> |
| 1. | A document relating to the names, types, characteristics, etc. of pathogen resources subject to outbound transfer; |
| 2. | A plan for managing and utilizing pathogen resources subject to outbound transfer. |
| (2) | "Cases prescribed by Presidential Decree, such as transfer for academic purposes" in the proviso of Article 16 (2) of the Act means any of the following: <Amended on Sep. 11, 2020> |
| 1. | Where pathogen resources are transferred from the Republic of Korea in accordance with international conventions, international agreements, etc.; |
| 2. | Where pathogen resources are transferred from the Republic of Korea for academic or research purposes in accordance with academic conventions, etc. between educational institutions or research institutes recognized by the Commissioner of the Korea Disease Control and Prevention Agency. |
| Article 14 (Revocation of Approval for Outbound Transfer and Issuance of Disposal Order) |
| (1) | Where the Commissioner of the Korea Disease Control and Prevention Agency has revoked approval for the outbound transfer of pathogen resources whose distribution was approved under Article 17 (1) of the Act or approval for the modification of the outbound transfer thereof, he or she shall notify such revocation to the head of the National Culture Collection for Pathogens or a specialized bank that has distributed the relevant pathogen resources. <Amended on Sep. 11, 2020> |
| (2) | Where the Commissioner of the Korea Disease Control and Prevention Agency issues an order to dispose of pathogen resources pursuant to Article 17 (1) of the Act, such order shall be issued in writing (including a document in electronic form) specifying the pathogen resources subject to disposal, the methods and period of disposal, and other similar information. <Amended on Sep. 11, 2020> |
| (3) | A person, in receipt of an order to dispose of pathogen resources pursuant to Article 17 (1) of the Act, shall report to the Commissioner of the Korea Disease Control and Prevention Agency on the results of disposing of the pathogen resources within 10 days from the day after the expiry of the disposal period under paragraph (2). <Amended on Sep. 11, 2020> |
| Article 15 (Procedures and Methods for Acquiring Pathogen Resources by Foreigners) |
| (1) | A foreigner (referring to a person with a foreign nationality, a corporation established under foreign statutes, or a foreign government) or an international organization (hereinafter referred to as "foreigner, etc.") that intends to obtain permission to acquire pathogen resources pursuant to the main clause of Article 18 (1) of the Act shall submit an application for permission to acquire pathogen resources (including an application in electronic form) to the Commissioner of the Korea Disease Control and Prevention Agency, along with the following documents (including documents in electronic form): <Amended on Sep. 11, 2020> |
| 1. | A document relating to the names, types, characteristics, etc. of pathogen resources subject to acquisition; |
| 2. | A plan for managing and utilizing pathogen resources subject to acquisition; |
| 3. | A document relating to facilities, equipment, personnel, etc. for managing pathogen resources. |
| (2) | Where deemed necessary for permitting a foreigner, etc. to acquire pathogen resources, he or she may request that the heads of the relevant central administrative agencies, the heads of local governments, the heads of public institutions prescribed in the Act on the Management of Public Institutions, or healthcare-related corporations, organizations, experts, etc. submit data or opinions. <Amended on Sep. 11, 2020> |
| (3) | Upon receipt of an application for permission to acquire pathogen resources filed by a foreigner, etc. pursuant to paragraph (1), where the Commissioner of the Korea Disease Control and Prevention Agency determines whether to grant permission, he or she shall notify the relevant applicant of the determination in writing (including a document in electronic form). <Amended on Sep. 11, 2020> |
| (4) | Where the Commissioner of the Korea Disease Control and Prevention Agency grants permission to acquire pathogen resources pursuant to the main clause of Article 18 (1) of the Act, he or she may attach conditions, such as the permission period, the purpose of acquisition, the pathogen resources subject to acquisition, and the scope of utilization. <Amended on Sep. 11, 2020> |
| (5) | A foreigner, etc. who have obtained permission to acquire pathogen resources pursuant to the main clause of Article 18 (1) of the Act shall semiannually implement the obligations specified in the subparagraphs of Article 18 (2) of the Act, as determined by the Commissioner of the Korea Disease Control and Prevention Agency: Provided, That where the purpose of permission is attained or the permission period expires, the foreigner, etc. shall complete the implementation of his or her obligations within three months from the day following the date of such attainment or expiration. <Amended on Sep. 11, 2020> |
| (6) | Except as provided in paragraphs (1) through (5), details necessary for the procedures, methods, etc. for permitting a foreigner, etc. to acquire pathogen resources, for attaching conditions, and for implementing obligations shall be determined and publicly notified by the Commissioner of the Korea Disease Control and Prevention Agency. <Amended on Sep. 11, 2020> |
| Article 16 (Standards for Safety Management of Pathogen Resources) |
| 1. | To conduct regular examinations of facilities and equipment related to pathogen resources on an annual basis and to keep the documents that contain the examination results for five years; |
| 2. | To build and operate a facility to store pathogen resources for the safety management thereof; |
| 3. | To prepare and keep a facility and equipment management register in which the lists, details, functions, etc. of facilities and equipment related to pathogen resources are determined; |
| 4. | To designate and manage a person responsible for the safety management of pathogen resources. |
| Article 17 (Support for Technology Development of Pathogen Resources and Promotion of Utilization Thereof) |
| (1) | In supporting academic circles, research institutes, enterprises, etc. pursuant to Article 20 (1) of the Act, the Commissioner of the Korea Disease Control and Prevention Agency may provide differentiated support, in consideration of the results, outcomes, etc. of the technology development of pathogen resources and the promotion of the utilization thereof. <Amended on Sep. 11, 2020> |
| 1. | Development of specialized human resources for the technology development of pathogen resources; |
| 2. | Provision of information on pathogen resources and exchange of the relevant technologies; |
| 3. | International cooperation and exchange for the technology development of pathogen resources; |
| 4. | Other matters deemed particularly necessary by the Commissioner of the Korea Disease Control and Prevention Agency for the technology development of pathogen resources and the promotion of the utilization thereof. |
| Article 18 (Operation of Pathogen Resource Information System) |
Where deemed necessary for the efficient operation of a pathogen resource information system under the former part of Article 21 (1) of the Act, the Commissioner of the Korea Disease Control and Prevention Agency may establish and implement the standards for evaluating and improving the relevant information system. <Amended on Sep. 11, 2020>
| Article 19 (Development of Specialized Human Resources) |
| (1) | The Commissioner of the Korea Disease Control and Prevention Agency shall formulate and implement a mid- to long-term promotion plan for developing, educating, and training specialized human resources under Article 22 (1) of the Act. <Amended on Sep. 11, 2020> |
| (2) | Where necessary for formulating and implementing a mid-to long-term promotion plan under paragraph (1), the Commissioner of the Korea Disease Control and Prevention Agency may request that healthcare-related institutions, corporations, organizations, specialists, etc. provide necessary cooperation. <Amended on Sep. 11, 2020> |
| Article 20 (Annual Report) |
Where deemed necessary for preparing a report under Article 24 (1) of the Act, the Commissioner of the Korea Disease Control and Prevention Agency may request that the heads of the relevant central administrative agencies, the heads of local governments, the heads of public institutions prescribed in the Act on the Management of Public Institutions, or healthcare-related corporations, organizations, experts, etc. provide necessary cooperation, such as the submission of data or opinions. <Amended on Sep. 11, 2020>
| Article 21 (Delegation of Authority) |
The Commissioner of the Korea Disease Control and Prevention Agency shall delegate the following authority to the Deputy Minister of the Korea National Institute of Health, pursuant to Article 28 (1) of the Act: <Amended on Sep. 11, 2020> | 1. | Conducting a survey of the current status of pathogen resources, preparing a list of pathogen resources, and requesting cooperation from the relevant Ministries and institutions pursuant to Article 6 of the Act; |
| 3. | Establishing and operating the National Culture Collection for Pathogens pursuant to Article 8 of the Act; |
| 5. | Revoking the designation of a specialized bank and issuing a corrective order pursuant to Article 10 of the Act; |
| 7. | Analyzing and evaluating pathogen resources, registering pathogen resources in the Register for Preservation and Management of Pathogen Resources, managing pathogen resources, and disclosing the results of analyzing and evaluating pathogen resources and the registered information pursuant to Article 13 of the Act; |
| 8. | Approving the distribution of pathogen resources and the modification of the distribution thereof, and reporting on the modification of the distribution thereof pursuant to Article 14 of the Act; |
| 9. | Revoking approval for distribution or approval for the modification of distribution, and issuing an order to dispose of pathogen resources pursuant to Article 15 of the Act; |
| 10. | Preparing a list of pathogen resources subject to approval for outbound transfer, consulting for the preparation of a list of pathogen resources subject to approval for outbound transfer, and designating and publicly notifying pathogen resources subject to approval for outbound transfer pursuant to Article 16 (1) and (5) of the Act; |
| 12. | Revoking approval for outbound transfer or approval for the modification of outbound transfer, and issuing an order to dispose of pathogen resources pursuant to Article 17 of the Act; |
| 13. | Permitting foreigners, etc. to acquire pathogen resources and managing the implementation of their obligations pursuant to Article 18 of the Act; |
| 16. | Establishing and operating a pathogen resource information system, requesting the submission of data for the establishment and operation of the relevant information system, and taking measures to ensure information security regarding pathogen resources pursuant to Article 21 of the Act; |
| Article 21-2 (Re-Examination of Regulation) |
The Commissioner of the Korea Disease Control and Prevention Agency shall examine the appropriateness of the following matters every three years from January 1, 2022 (referring to the period that ends on the day before January 1 of every third year) and shall take measures, such as making improvements:
| 1. | The standards for designating a specialized pathogen resource bank by field under Article 7 (1); |
| 2. | The procedures and methods for issuing a corrective order and for revoking designation under Article 8; |
| 3. | The standards, procedures, and methods for approving the distribution of pathogen resources, for approving the modification of the distribution thereof, and for reporting on the modification of the distribution thereof under Article 10; |
| 4. | The procedures and methods for revoking approval for the distribution of pathogen resources and approval for the modification of the distribution thereof, and for issuing an order to dispose of pathogen resources under Article 11; |
| 5. | The standards, procedures, and methods for approving the outbound transfer of pathogen resources, for approving the modification of the outbound transfer thereof, and for reporting on the modification of the outbound transfer thereof under Article 12; |
| 6. | The procedures and methods for revoking approval for the outbound transfer of pathogen resources and approval for the modification of the outbound transfer thereof, and for issuing an order to dispose of pathogen resources under Article 14; |
| 7. | The standards for the safety management of pathogen resources under Article 16. |
[This Article Newly Inserted on Mar. 8, 2022]
| Article 22 (Standards for Imposing Administrative Fines) |
ADDENDUM <Presidential Decree No. 27817, Jan. 31, 2017>
This Decree shall enter into force on February 4, 2017.
ADDENDA <Presidential Decree No. 31013, Sep. 11, 2020>
Article 1 (Enforcement Date)
This Decree shall enter into force on September 12, 2020.
Articles 2 and 3 Omitted.
ADDENDUM <Presidential Decree No. 32528, Mar. 8, 2022>
This Decree shall enter into force on the date of its promulgation.