ENFORCEMENT DECREE OF THE ACT ON THE ACQUISITION, MANAGEMENT, AND UTILIZATION OF BIOLOGICAL RESEARCH RESOURCES

Article 1(Purpose) #

The purpose of this Decree is to prescribe matters delegated by the Act on the Acquisition, Management, and Utilization of Biological Research Resources and matters necessary for the enforcement thereof.

Article 2(Master plans and implementation plans) #

(1) The Minister of Science and ICT shall formulate a master plan for the management of biological research resources (hereinafter referred to as "master plan") under Article 7(1) of the Act on the Acquisition, Management, and Utilization of Biological Research Resources (hereinafter referred to as the "Act") in the year immediately preceding the commencement year of the master plan. <Amended on Mar. 23, 2013; Jul. 26, 2017>

(2) Following consultations with the heads of related central administrative agencies, the Minister of Science and ICT may prepare a plan specific to the field under his or her jurisdiction under Article 7(3) of the Act and common guidelines for the formulation of annual implementation plans under Article 7(5) of the Act and notify the heads of related central administrative agencies thereof. <Amended on Mar. 23, 2013; Jul. 26, 2017>

(3) The head of each related central administrative agency shall notify the Minister of Science and ICT of a plan specific to the field under his or her jurisdiction under Article 7(3) of the Act by no later than September 30 of the year immediately preceding the commencement year of the relevant master plan. <Amended on Mar. 23, 2013; Jul. 26, 2017>

(4) If necessary for the efficient promotion of the master plan, the Minister of Science and ICT may request the heads of related central administrative agencies to submit implementation plans for the relevant year and the data related to the performance record of the implementation plans of the previous year. <Amended on Mar. 23, 2013; Jul. 26, 2017>

Article 2-2(Investigation of current status of biological research resources) #

(1) The head of each related central administrative agency shall conduct an investigation of current status of biological research resources prescribed in Article 7-2(1) of the Act (hereinafter referred to as "investigation of current status") each year.

(2) The scope of the investigation of current status shall be as follows:

1. Matters concerning the securement, preservation, management, and utilization of biological research resources;

2. Matters concerning the professional human resources, facilities, equipment, and information systems of institutions in possession of biological research resources;

3. Other matters deemed necessary by the heads of the related central administrative agencies for the investigation of current status.

(3) The investigation of current status shall be conducted in writing; provided, where the head of a related central administrative agency deems necessary, it may be conducted in concurrence with on-site investigation.

[This Article Added on Jun. 18, 2019]

Article 3(Standards for designating biological resource centers) #

(1) The minimum standards for designating a biological resource center in which biological research resources can be deposited, registered, and preserved under Article 8(1) of the Act (hereinafter referred to as "biological resource center") shall be as follows: <Amended on Jun. 18, 2019; Aug. 9, 2022>

1. It shall have facilities and equipment capable of receiving deposits and registrations of at least 1,000 items of biological research resources and of preserving and managing them for a long period;

2. It shall secure the following human resources of at least a fifth of the whole human resources (one person, if the total number of human resources is less than five):

a. Persons with at least a master’s degree in the field of biology under the national standard classification system for science and technology under Article 27 of the Framework Act on Science and Technology;

b. Persons with a bachelor's degree in the field of biology under the national standard classification system for science and technology under Article 27 of the Framework Act on Science and Technology, who has at least three years' work experience (including work experience before obtaining a degree) in the related fields, including research institutes;

3. It shall possess computation equipment, backup facilities, and security facilities for operating an information system for biological research resources, and shall secure at least one person in charge of data processing.

(2) The head of a related central administrative agency may, if necessary, prescribe additional standards for designation by Decree of the relevant Ministry other than designation standards referred to in paragraph (1), reflecting the characteristics of biological research resources under his or her jurisdiction, if necessary.

(3) The head of a related central administrative agency may, taking into consideration the expertise of the human resources, facilities, etc., designate a person deemed suitable to perform the duties of a biological resource center under Article 8(2) of the Act as a biological resource center from among persons fulfilling designation standards referred to in paragraphs (1) and (2).

Article 4(Procedures for designation of biological resource centers) #

(1) A person who intends to be designated as a biological resource center shall file an application for designation including the following matters with the head of the related central administrative agency:

1. Current state of possession of biological research resources;

2. Current state of possession of facilities, equipment and human resources;

3. Outcomes of projects related to biological research resources and plans therefor;

4. Other matters prescribed and publicly notified by the head of the related central administrative agency for verifying the competence in performance of duties prescribed in the subparagraphs of Article 8(2) of the Act.

(2) The head of a related central administrative agency shall determine whether to make a designation, within 30 days from the receipt of the application under paragraph (1); provided, where any extenuating circumstances exist, the time limit may be extended only once for a fixed period not exceeding 30 days, and in such cases, he or she shall notify the applicant of the reason therefor in writing (including electronic documents).

(3) Upon designating a biological resource center, the head of a related central administrative agency shall issue a certificate of designation to a designated institution and publish the following matters in the Official Gazette:

1. Name and address of a designated institution;

2. Date of designation;

3. Current state of resources being preserved by a designated institution.

(4) Matters necessary for designation procedures for a biological resource center other than those prescribed in paragraphs (1) through (3) shall be prescribed by Decree of the relevant central administrative agency.

Article 4-2(Disclosure of information by biological resource centers) #

(1) The scope of information on biological research resources to be disclosed by biological resource centers pursuant to Article 8(5) of the Act shall be as follows:

1. Lists of biological research resources preserved and managed by biological resource centers and information related thereto;

2. Information on facilities and equipment preserving and managing biological research resources;

3. Information necessary for mutual connections among information systems in such centers' charge, information systems prescribed in Article 10(2)2 of the Act, and the Korean Bio-resource Information System prescribed in Article 11(2)1 of the Act;

4. Other information deemed necessary by the heads of the related central administrative agencies to be disclosed in connection with the securement, preservation, management, and utilization of the biological research resources of the areas in their charge.

(2) Biological resource centers shall disclose information prescribed in paragraph (1) through information systems in such centers' charge prescribed in paragraph (1), information systems prescribed in Article 10(2)2 of the Act, and the Korean Bio-resource Information System prescribed in Article 11(2)1 of the Act.

(3) Except as provided in paragraphs (1) and (2), matters necessary for the disclosure of information by biological resource centers shall be prescribed by Decree of the related central administrative agency.

[This Article Added on Jun. 18, 2019]

Article 5(Methods of deposit and registration) #

(1) A person who intends to deposit and register a biological research resource pursuant to Article 9(1) of the Act shall submit an application for deposit and registration determined by the biological resource center (including an application in electronic form) to the biological resource center along with documents on the actual object of the biological research resource he or she intends to deposit and register and the detailed specifications thereof (including documents in electronic form). In such case, the relevant biological research resource shall be submitted in a condition suitable for depositing and registration. <Amended on Jun. 18, 2019>

(2) Where the outcomes of the examination of the application for deposit and registration under paragraph (1) turn out to be appropriate, the biological resource center shall issue a certificate of deposit and registration to the applicant, and where they turn out to be inappropriate, it shall refuse to accept the application for deposit and registration or notify the applicant to make a supplementation. <Amended on Aug. 13, 2024>

(3) Where a person who has conducted a national research and development project deposits and registers a biological research resource pursuant to the main sentence of Article 9(2) of the Act, he or she shall deposit and register the biological research resource within three months from the date following the date on which the national research and development project ends. In such case, paragraphs (1) and (2) shall apply mutatis mutandis to the methods of the relevant depositing and registration. <Added on Jun. 18, 2019; Aug. 13, 2024>

(4) Notwithstanding paragraph (3), where a person who conducts a national research and development project intends to ensure that the results of deposit and registration of biological research resources are reflected in a stage evaluation under Article 9(3)1 of the Act, he or she may deposit and register biological research resources even during the performance of the relevant project. <Added on Aug. 13, 2024>

(5) "Grounds prescribed by Presidential Decree" in the proviso of Article 9(2) of the Act means the following: <Amended on Jun. 18, 2019; Aug. 13, 2024>

1. Where it is difficult to prevent the divulgence of personal information because the biological research resources are originated from the human body;

2. Where the biological research resources are likely to harm public health, the ecosystem, etc.;

3. Where the biological research resources are designated by other statutes, international agreements, or treaties as those requiring special protection;

Article 5-2(Applications for sale) #

(1) A person who intends to purchase a biological research resource from a biological resource center or from a competent authority prescribed in Article 10(1) of the Act (hereinafter referred to as "competent authority") shall submit an application for sale (including an application in electronic form) determined by the relevant biological resource center or competent authority pursuant to the main sentence of Article 9-2 of the Act, with the exception of its subparagraphs, to the biological resource center or to the competent authority.

(2) "Matters prescribed by Presidential Decree" in subparagraph 2 of Article 9-2 of the Act means any of the following cases:

1. Where the head of a related central administrative agency deems necessary to restrict sale for the protection of personal information;

2. Where the head of a related central administrative agency deems likely to harm public health, the ecosystem, etc.;

3. In cases of biological research resources designated by an international agreement or treaty as those requiring special protection;

4. In cases of biological research resources for which the depositors request to temporarily restrict sale for patent application.

(3) Except as provided in paragraphs (1) and (2), matters necessary for applications for the sale of biological research resources shall be prescribed by Decree of the related central administrative agency.

[This Article Added on Jun. 18, 2019]

Article 5-3(Standards and procedures for approving shipment to other countries) #

(1) Standards for approving shipment to other countries prescribed in the main sentence of Article 9-3(2) of the Act, with the exception of its subparagraphs, shall be as follows:

1. The securement, preservation, management, and utilization of domestic biological research resources shall not be disrupted;

2. Such shipment shall not be against the will of the holder of a right to the relevant biological research resource, nor infringe the right of such holder;

3. It shall not be a biological research resource of which shipment to other countries is prohibited by other statutes, international agreements, or treaties;

4. It shall not be a biological research resource that is likely to inflict a loss to the State when shipped to other countries.

(2) A person who intends to obtain approval for shipment to other countries pursuant to the main sentence of Article 9-3(2) of the Act, with the exception of its subparagraphs, shall submit an application for approval for the shipment of biological research resources to other countries (including an application in electronic form) to the Minister of Science and ICT along with the following:

1. Documents evidencing compliance with the standards for approval prescribed in the subparagraphs of paragraph (1);

2. Documents on the names, types, characteristics, etc. of biological research resources to be shipped to other countries;

3. A plan for managing and utilizing the biological research resources to be shipped to other countries;

4. A copy of the agreement to share benefits from domestic genetic resources, etc. prescribed in Article 11 of the Act on Access to and Utilization of Genetic Resources and Benefit-Sharing (hereinafter referred to as "mutual agreement conditions") (limited to where a Korean biological research resource provider and a foreign user conclude an agreement on mutual agreement conditions).

(3) Where the Minister of Science and ICT deems necessary to supplement the details of an application submitted pursuant to paragraph (2), he or she may request the relevant applicant to supplement them by fixing a considerable period required for the supplementation. In such case, no period required for supplementation shall be included in the calculation of the period prescribed in paragraph (4).

(4) Where the Minister of Science and ICT receives an application prescribed in paragraph (2), he or she shall examine if the application is in compliance with the standards for approving shipment to other countries prescribed in paragraph (1), and inform the applicant of approval or disapproval in writing (including in electronic form) within 30 days from the date he or she receives the application after consulting with the heads of the related central administrative agencies; provided, where there exists any unavoidable cause, the period may be extended once within the scope of 30 days.

Article 5-4(Revocation of approval for shipment to other countries) #

(1) A person whose approval for shipment to other countries or approval for the change of shipment to other countries is revoked pursuant to Article 9-4(1) of the Act shall return the relevant biological research resource within 30 days from the date he or she is notified of the revocation of the approval; provided, this shall not apply where the Minister of Science and ICT recognizes that there exists any unavoidable cause that makes the return of the biological research resource impossible, such as destruction or damage.

(2) A person who has returned a biological research resource pursuant to the main sentence of paragraph (1) shall submit a document evidencing the fact of the return to the Minister of Science and ICT within 10 days from the date he or she has returned the biological research resource.

[This Article Added on Jun. 18, 2019]

Article 6(Standards for designation of competent authority) #

(1) The head of a related central administrative agency may designate an entity suitable for performing duties prescribed in the subparagraphs of Article 10(1) of the Act as a competent authority from among entities satisfying the following criteria:

1. It shall fulfill standards for designation of a biological resource center prescribed in Article 3;

2. It shall secure an exclusive organization capable of performing the duties prescribed in Article 10(1) of the Act and at least three personnel exclusively therefor;

3. It shall have an information system for exchange of information among biological resource centers;

4. It shall formulate a management plan and a project plan of biological resource centers.

(2) Upon designating a competent authority, the head of a related central administrative agency shall issue a certificate of the designation of a competent authority to the relevant institution and publish the designation in the Official Gazette. <Amended on Jun. 18, 2019>

(3) To encourage the exchange of information among biological resource centers, competent authorities may organize a council of biological resource centers. <Added on Jun. 18, 2019>

(4) In order to operate competent authorities in an efficient manner, including through technical cooperation, exchange of information, and linkage for the management of biological resource centers, competent authorities may organize a council of competent authorities.

(5) The Government may fully or partially subsidize expenses incurred in operating the council of biological resource centers prescribed in paragraph (3) and the council of competent authorities prescribed in paragraph (4). <Amended on Mar. 23, 2013; Jul. 26, 2017; Jun. 18, 2019>

(6) Except as provided in paragraphs (1) through (5), matters necessary for the designation and operation of competent authorities shall be prescribed by Decree of the related central administrative agency. <Amended on Jun. 18, 2019>

Article 7(Standards for designation of information centers of biological research resources) #

(1) An entity which intends to be designated as an information center of biological research resources under Article 10(2) of the Act (hereinafter referred to as "information center of biological research resources") shall fulfill the following minimum standards: <Amended on Aug. 9, 2022>

1. It shall be equipped with a computer room having computer servers, network facilities, backup facilities, and security facilities;

2. It shall secure the following personnel of at least a tenth of the whole human resources (one person, if the total number of human resources is less than 10):

a. Persons with a master’s or higher degree in the field of computer science or biology under the national standard classification system for science and technology under Article 27 of the Framework Act on Science and Technology;

b. Persons with a bachelor's degree in the field of computer science or in the field of biology under the national standard classification system for science and technology under Article 27 of the Framework Act on Science and Technology, who has at least three years' work experience (including work experience before obtaining a degree) in the related fields, including research institutes;

(2) The head of a related central administrative agency may, if necessary, prescribe additional standards for designation by Decree of the relevant Ministry other than designation standards referred to in paragraph (1), reflecting the characteristics of biological research resources under his or her jurisdiction, if necessary.

(3) The head of a related central administrative agency may, taking into consideration the human resources, facilities, outcomes of related projects and other expertise of an entity, designate an entity deemed suitable to perform the duties of an information center of biological research resources as an information center of biological research resources from among entities fulfilling designation standards referred to in paragraphs (1) and (2).

Article 8(Procedures for designation of information center of biological research resources) #

(1) An entity which intends to be designated as an information center of biological research resources shall file an application for the designation including the following matters with the head of the related central administrative agency:

1. Current state of possession of facilities and human resources;

2. Current state of construction of an information system;

3. Outcomes of projects related to the management of information on biological research resources, and plans therefor;

4. Other matters prescribed and publicly notified by the head of the related central administrative agency for verifying the competence in performance of duties prescribed in the subparagraphs of Article 10(2) of the Act.

(2) The head of a related central administrative agency shall determine whether to make the designation, within 30 days from the receipt of the application under paragraph (1); provided, where any extenuating circumstances exist, the time limit may be extended only once for a fixed period not exceeding 30 days, and in such cases, he or she shall notify the applicant of the reason therefor in writing (including electronic documents).

(3) Upon designating an information center of biological research resources, the head of a related central administrative agency shall issue a certificate of designation to a designated institution and publish the following matters in the Official Gazette:

1. Name and address of a designated institution;

2. Date of designation;

3. Current state of resources being preserved by a designated institution.

(4) Matters necessary for designation, other than those prescribed in paragraphs (1) through (3), shall be prescribed by Decree of the relevant central administrative agency.

Article 9(Standards for designation of the national information center of biological research resources) #

(1) The Minister of Science and ICT may designate an entity deemed appropriate for performing the duties prescribed in the subparagraphs of Article 11(2) of the Act as the National Information Center of Biological Research Resources under Article 11(1) of the Act (hereinafter referred to as the "National Information Center of Biological Research Resources") from among entities satisfying the following criteria: <Amended on Mar. 23, 2013; Jul. 26, 2017>

1. It shall fulfill standards for designation of an information center of biological research resources prescribed in Article 7;

2. It shall have continuously performed duties related to the information on biological research resources for the recent three years.

(2) Upon designating the National Information Center of Biological Research Resources, the Minister of Science and ICT shall issue a certificate of the designation to a designated institution and publish the designation in the Official Gazette. <Amended on Mar. 23, 2013; Jul. 26, 2017>

(3) Matters necessary for procedures, etc. for designation of National Information Center of Biological Research Resources, other than those prescribed in paragraphs (1) and (2), shall be prescribed by Decree of the Minister of Science and ICT. <Amended on Mar. 23, 2013; Jul. 26, 2017>

Article 10(Cancellation of designation) #

(1) Standards for cancellation of designation, etc. under Article 12 of the Act, shall be as specified in Appendix 1. <Amended on Jun. 18, 2019>

(2) Where designation is cancelled in accordance with standards for disposition specified in Appendix 1, the relevant biological resource center, competent authority, bioinformation center, or the Korean Bioinformation Center shall return the certificate of designation respectively to the head of the related central administrative agency or the Minister of Science and ICT. <Amended on Mar. 23, 2013; Jul. 26, 2017; Jun. 18, 2019>

(3) The head of the related central administrative agency or the Minister of Science and ICT shall respectively publish the name of the biological resource center, competent authority, bioinformation center, or the Korean Bioinformation Center, the designation of which has been cancelled, and a reason for cancellation in the Official Gazette. <Amended on Mar. 23, 2013; Jul. 26, 2017>

Article 11(Preservation and management of biological research resources following cancellation of designation and suspension of project) #

(1) Biological research resources deposited and registered after designation was made, among those preserved and managed by a biological resource center, competent authority, bioinformation center, or the Korean Bioinformation Center, the designation of which has been cancelled or the project of which has been suspended under Article 12 of the Act, shall be managed by institutions classified as follows: <Amended on Mar. 23, 2013; Jul. 26, 2017>

1. If an institution, the designation of which has been cancelled or the project of which has been suspended, is a biological resource center, competent authority, or bioinformation center: An institution to be designated by the related central administrative agency;

2. If an institution, the designation of which has been cancelled or the project of which has been suspended, is the Korean Bioinformation Center: An institution to be designated by the Minister of Science and ICT.

(2) An institution to which the management authority is transferred under paragraph (1) shall consult in advance respectively with the biological resource center, competent authority, bioinformation center, or the Korean Bioinformation Center, the designation of which has been canceled or the project of which has been suspended, on procedures for preservation and management. <Amended on Jun. 18, 2019>

Article 12(Disclosure of information on biological research resources) #

(1) In order to facilitate the distribution of information on biological research resources under Article 18(1) of the Act, the head of a related central administrative agency shall establish a database of information on biological research resources and extensively disclose it so that it can be utilized by related research institutes, industry, academia, etc.

(2) The Minister of Science and ICT shall ensure that information on biological research resources shall be provided in an integrated manner in linkage with the database referred to in paragraph (1). <Amended on Mar. 23, 2013; Jul. 26, 2017>

(3) For the purpose of Article 18(2) of the Act, the Minister of Science and ICT shall implement the standardization work of information on biological research resources. <Amended on Mar. 23, 2013; Jul. 26, 2017>

(4) The head of a related central administrative agency may entrust a competent authority with the establishment of a database of information referred to in paragraph (1) and the disclosure thereof.

Article 13(Statistical research and issuance of statistical publications) #

(1) Forms and method of research necessary for the issuance of statistical publications related to biological research resources under Article 19 of the Act and other necessary matters under Article 19 of the Act shall be prescribed by the Minister of Science and ICT following consultations with the heads of related central administrative agencies and the Minister of Data and Statistics. <Amended by Presidential Decree No. 24423, Mar. 23, 2013; Presidential Decree No. 28210, Jul. 26, 2017; Oct. 1, 2025>

(2) Subjects of statistical research for preparation of the statistical publications related to biological research resources shall be as follows: <Amended on Mar. 23, 2013; Jul. 26, 2017; Jun. 18, 2019>

1. Matters concerning the current status of possession of biological research resources;

2. Matters concerning institutions in possession of biological research resources;

3. Matters concerning human resources and equipment of institutions in possession of biological research resources;

4. Matters concerning the international trend related to biological research resources;

5. Matters concerning policies and systems related to biological research resources;

6. Matters concerning the current status of the shipment of biological research resources to other countries;

7. Other matters necessary for the preparation of statistical publications, which are prescribed by the Minister of Science and ICT.

Article 14(Entrustment of affairs) #

(1) Pursuant to Article 21(2) of the Act, the Minister of Science and ICT shall entrust the Korean Bioinformation Center with the following affairs: <Amended on Mar. 23, 2013; Jul. 26, 2017>

1. Overall management of information on biological research resources under Article 5(2) of the Act;

2. Standardization for distribution of information on biological research resources under Article 18(2) of the Act;

3. Issuance of statistical publications under Article 19 of the Act.

(2) Pursuant to Article 21(2) of the Act, the Minister of Science and ICT shall entrust the competent authorities designated by the Minister of Science and ICT with the following affairs: <Added on Jun. 18, 2019>

1. The following affairs concerning approval for shipment to other countries prescribed in Article 9-3 of the Act (including approval for change; hereafter in this paragraph the same shall apply):

a. Review on the preparation of lists of objects subject to approval for shipment to other countries prescribed in Article 9-3(1) of the Act;

b. Receipt of applications prescribed in Article 5-3(2) and (6);

c. Requests to supplement applications prescribed in Article 5-3(3) (including cases to which Article 5-3(3) applies mutatis mutandis in paragraph (6) of the same Article);

d. Review on compliance or non-compliance with standards for approval prescribed in Article 5-3(4) (including cases to which Article 5-3(4) applies mutatis mutandis in paragraph (6) of the same Article) and notification of approval or disapproval;

e. Receipt of reports prescribed in Article 5-3(9);

2. The following affairs concerning the revocation of approval for shipment to other countries prescribed in Article 9-4 of the Act:

a. Notification of the revocation of approval for shipment to other countries prescribed in Article 9-4(1) of the Act;

b. Receipt of documents evidencing the fact of return prescribed in Article 5-4(2).

Article 15(Standards for imposing administrative fines) #

Standards for imposing administrative fines prescribed in Article 27(1) of the Act shall be as specified in Appendix 2.

[This Article Added on Jun. 18, 2019]