Article 1(Purpose) #
The purpose of this Decree is to prescribe matters mandated by the Special Act for Promotion of the Development and Emergency Supply of Medical Products in Response to Public Health Crisis and matters necessary for the enforcement thereof.
Article 2(Composition of commission on safety control and supply of medical products in response to public health crisis) #
"Relevant central administrative agency prescribed by Presidential Decree" in the former part of Article 5(3) of the Special Act for Promotion of the Development and Emergency Supply of Medical Products in Response to Public Health Crisis (hereinafter referred to as the "Act") means the following central administrative agencies: <Amended on Oct. 1, 2025; Dec. 30, 2025>
1. Ministry of Finance and Economy;
2. The Ministry of Science and ICT;
3. The Ministry of Foreign Affairs;
4. The Ministry of National Defense;
5. The Ministry of the Interior and Safety;
6. The Ministry of Trade, Industry and Resources;
7. The Ministry of Health and Welfare;
8. The Office for Government Policy Coordination;
9. The Korea Customs Service;
10. The Public Procurement Service;
11. The Korea Disease Control and Prevention Agency;
12. The Nuclear Safety and Security Commission.
Article 3(Necessary measures such as suspension of manufacturing or importation of medical products approved for emergency use) #
Where intending to issue an order to take necessary measures such as suspension of manufacturing or importation under Article 12(5) of the Act, the Minister of Food and Drug Safety shall consider the following matters; in such cases, the opinion of the head of the relevant central administrative agency may be heard or the Commission on Safety Control and Supply of Medical Products in Response to Public Health Crisis under Article 5(1) of the Act (hereinafter referred to as the "Safety Control and Supply Commission") may be consulted:
1. The status of use and effectiveness of medical products for which approval for emergency use under Article 12(1) of the Act (hereinafter referred to as "approval for emergency use") have been granted;
2. The results of implementation of measures, etc. under Articles 13 through 15 of the Act;
3. Whether a medical product for which permission for manufacturing and distributing each item, permission for importing each item, manufacturing permission, import permission, manufacturing certification, or import certification (hereinafter referred to as "permission by item") has been granted can substitute for a medical product for which approval for emergency use has been granted to address a public health crisis.
Article 4(Notification of designation of medical products subject to tracing investigation) #
(1) Where having designated a medical product as a subject of a tracing investigation under the former part of Article 15(1) of the Act, the Minister of Food and Drug Safety shall notify the person who has received approval of a clinical trial plan or permission by item for the medical product or the importer of the medical product (hereinafter referred to as "importer, etc. of medical products subject to tracing investigation") in writing.
(2) Where having designated a medical product as a subject of a tracing investigation under the former part of Article 15(1) of the Act, the Minister of Food and Drug Safety may post the fact on the website of the Ministry of Food and Drug Safety.
(3) Where deeming that a tracing investigation is no longer needed for a medical product subject to tracing investigation and therefore revoking the designation, the Minister of Food and Drug Safety shall notify the importer, etc. of the medical product subject to tracing investigation of the revocation of designation in writing.
(4) Importers, etc. of medical products subject to tracing investigation who are notified of the designation or revocation of designation under paragraph (1) or (3) shall inform medical doctors, dentists, doctors of Korean medicine, pharmacists, and Korean medicine pharmacists who handle such medical products of the details of the notification, future measures to be taken, etc.
(5) Where deeming it necessary for the designation of a medical product subject to tracing investigation or revocation of such designation, the Minister of Food and Drug Safety may seek advice from the Safety Management and Supply Commission.
(6) Except as provided in paragraphs (1) through (5), details necessary for the procedures, methods, etc. for the designation of medical products subject to tracing investigation or revocation of such designation shall be determined and publicly notified by the Minister of Food and Drug Safety.
Article 5(Procedures and methods for tracing investigation) #
(1) For a tracing investigation under Article 15(1) of the Act, the Minister of Food and Drug Safety may require the importer, etc. of medical products subject to tracing investigation to submit a report on the details and results of the tracing investigation within two months from every anniversary of the date the relevant medical products are designated as the subjects of the tracing investigation; provided, the frequency of submissions may be determined otherwise in consideration of the type of the medical products, their characteristics, the degree of safety or risk, and other similar factors.
(2) Except as provided in paragraph (1), details necessary for the procedures, methods, etc. for tracing investigation shall be determined and publicly notified by the Minister of Food and Drug Safety.
Article 6(Designation of organization to conduct tracing investigation) #
(1) Pursuant to the latter part of Article 15(1) of the Act, the Minister of Food and Drug Safety shall designate an organization to conduct a tracing investigation for each medical product classified as follows: <Amended on Dec. 12, 2023>
1. Drugs: The Korea Institute of Drug Safety and Risk Management under Article 68- 3(1) of the Pharmaceutical Affairs Act (hereinafter referred to as the "Korea Institute of Drug Safety and Risk Management");
2. Medical devices: The National Institute of Medical Device Safety Information under Article 42 of the Medical Devices Act.
(2) Pursuant to the latter part of Article 15(1) of the Act, the Minister of Food and Drug Safety shall entrust the following tasks to the organizations designated under paragraph (1) to conduct a tracing investigation:
1. Receipt of reports on tracing investigation plans under Article 15(2) of the Act;
2. Receipt of adverse event reports under Article 15(3) of the Act and Article 7 of this Decree;
3. Receipt of reports on the details and results of tracing investigations under Article 5.
Article 7(Methods of reporting adverse events) #
(1) Pursuant to Article 15(3) of the Act, the importers, etc. of medical products subject to tracing investigation shall report the occurrence of an adverse event and the investigation and analysis plan therefor to the Minister of Food and Drug Safety in any of the following cases by the deadlines specified as follows:
1. In cases of a fatal or life-threatening adverse event: Within seven days from the date of learning of such event;
2. In cases of any other serious adverse event: Within 15 days from the date of learning of such event.
(2) Within six months from the date of reporting the investigation and analysis plan for an adverse event under paragraph (1), the importers, etc. of medical products subject to tracing investigation shall report the results of the investigation and analysis of the adverse event to the Minister of Food and Drug Safety, including the following; provided, any unavoidable cause makes it impossible to complete the investigation and analysis within that period, the deadline for reporting the results of the adverse event investigation and analysis may be extended by up to three months with approval from the Minister of Food and Drug Safety:
1. The type and details of the adverse event;
2. The cause of the adverse event;
3. The correlation between the relevant medical product and the adverse event;
4. Countermeasures against the adverse event;
5. National and international literature on the adverse event;
6. Other matters deemed necessary by the Minister of Food and Drug Safety, which correspond to those specified in subparagraphs 1 through 5.
(3) Except as provided in paragraphs (1) and (2), details necessary for the methods, procedures, etc. for reporting adverse events shall be determined and publicly notified by the Minister of Food and Drug Safety.
Article 8(Consent to registration of details of use) #
(1) A medical doctor, dentist, or pharmacist who handles a medical product subject to tracing investigation shall obtain the consent of a person to use the product in such a way that the person signs a consent form containing the following, in order to register the personal information of the person and details of use as prescribed in Article 15(4) of the Act:
1. Matters concerning the use of the medical product subject to tracing investigation;
2. Matters concerning the registration of the personal information of the person to use the product and details of use;
3. Matters concerning the protection and provision of personal information;
4. Matters concerning the withdrawal of consent;
5. Other matters that are equivalent to those under subparagraphs 1 through 4 and are determined and publicly notified by the Minister of Food and Drug Safety.
(2) Notwithstanding paragraph (1), if a person to use the product is a minor, a mentally defective person, or a mentally weak person, the consent of the person and the person's legal representative (if there is no legal representative, it shall be in the order of the spouse, lineal ascendant, lineal descendant, and sibling; but if there are multiple persons of the same rank, it shall be determined by consultation, and if no consultation is achieved, the elderly person shall become the representative) shall be obtained; provided, the consent of the person may be omitted if the person is unable to give it due to lack of mental capacity, etc.
(3) A medical doctor, dentist, or pharmacist who intends to obtain consent under paragraphs (1) and (2) shall fully explain each of the matters under the subparagraphs of paragraph (1) to a person to use the product and the person's legal representative before obtaining their consent.
Article 9(Registration of Details of Use) #
(1) The personal information of a person to use the product and the details of use under Article 15(4) of the Act shall be registered within seven days from the date of use of the relevant medical product subject to tracing investigation.
(2) The sale and supply details of a medical product subject to tracing investigation under Article 15(5) of the Act shall be registered each time the medical product is sold or supplied.
(3) The head of the organization with which the details of use, etc. have been registered under paragraphs (1) and (2) may request the relevant medical doctor, dentist, pharmacist, and importer, etc. that handles the medical product subject to tracing investigation to correct or supplement the registration if there are any omissions or errors, etc. in the registered matters.
Article 10(Measures necessary for public health) #
"Measures necessary for public health ... as prescribed by Presidential Decree, such as suspending clinical trials, suspending the manufacture, importation, or sale of the relevant medical product, or ordering its recall and disposal" in Article 15(7) of the Act means the following measures:
1. An order to suspend a clinical trial that is a condition of permission by item under Article 11 or 12(6) of the Act;
2. An order to change a tracing investigation plan under Article 15(2) of the Act;
3. An order to suspend manufacturing, importing, or selling the medical product;
4. An order to recall and dispose of the medical product;
5. An order to provide necessary safety information to the users of the medical product or to medical doctors, dentists, doctors of Korean medicine, pharmacists, and Korean medicine pharmacists;
6. An order to change the intended use, efficacy and effectiveness (performance), dosage, directions for use, precautions for use of the medical product, or any other similar information;
7. Other measures which are equivalent to the measures under subparagraphs 1 through 6 and are deemed necessary by the Minister of Food and Drug Safety for public health.
Article 10-2(Classification management of medical products in response to crisis) #
(1) The head of a central administrative agency responsible for stockpiling and managing medical products responding to public health crisis may stockpile the relevant medical products responding to public health crisis by classifying them by product, item, or other standards prescribed by the head of the central administrative agency pursuant to Article 17-2(1) of the Act, or manage them by monitoring the supply and demand situation thereof.
(2) Where the Minister of Food and Drug Safety deems it necessary to effectively respond to a public health crisis situation effectively or at the request of the head of a relevant central administrative agency, he or she may request the Safety Management and Supply Commission to deliberate on matters concerning the stockpiling and management of medical products in response to public health crisis separately.
(3) The Minister of Food and Drug Safety may notify the head of the relevant central administrative agency of the results of deliberation under paragraph (2) and request the head of the relevant central administrative agency to take necessary measures. Upon receipt of such request, the head of the relevant central administrative agency shall comply therewith, except in extenuating circumstances.
[This Article Added on Aug. 6, 2024]
Article 11(Emergency production or import orders) #
(1) Where issuing an emergency production or import order under Article 18(1) of the Act (hereinafter referred to as "emergency production or import order") for medical products in response to public health crisis, the Minister of Food and Drug Safety shall notify any person specified in the subparagraphs of that paragraph of the subject of the emergency production or import order and its details, period, causes, etc. in writing; provided, where individual notification is deemed impracticable, such as when urgent action is required, notification may be provided by posting the relevant information on the website of the Ministry of Food and Drug Safety or in the Official Gazette.
(2) A person who receives an emergency production or import order shall formulate a production or import plan for the relevant medical product as determined by the Minister of Food and Drug Safety and shall submit it to the Minister of Food and Drug Safety.
(3) A person who receives an emergency production or import order shall report the results of the production or import based on the production or import plan formulated under paragraph (2).
(4) A person seeking financial and administrative support for the implementation of an emergency production or import order as prescribed in Article 18 (4) of the Act shall submit the reasons for the application for support and related materials to the Minister of Food and Drug Safety.
(5) Where revoking the emergency production or import order under Article 18(5) of the Act, the Minister of Food and Drug Safety shall notify the person who received the emergency production or import order in writing; provided, where individual notification is deemed impracticable, such as when urgent action is required, notification may be provided by posting the relevant information on the website of the Ministry of Food and Drug Safety or in the Official Gazette.
(6) Except as provided in paragraphs (1) through (5), details necessary for the procedures, methods, etc. for emergency production or import orders shall be determined and publicly notified by the Minister of Food and Drug Safety.
Article 12(Distribution improvement measures) #
(1) Pursuant to Article 19 of the Act, the Minister of Food and Drug Safety may take the following distribution improvement measures:
1. Instructions on the sales process, such as verifying a purchaser's age, gender, and health status;
2. Instructions on the terms of the sale, such as the amount sold, the price, or the period or place of sale;
3. Instructions on the method of transportation and storage and improvement of facilities and equipment;
4. Instructions on import and export controls;
5. Instructions on shipments and quantities of shipments to outlets designated by the Minister of Food and Drug Safety;
6. Other instructions that the Minister of Food and Drug Safety deems necessary to improve the distribution of medical products in response to public health crisis.
(2) The Minister of Food and Drug Safety may determine the details of the distribution improvement measures under paragraph (1) differently depending on the suppliers and purchasers of medical products in response to public health crisis, taking into consideration the capacity of supplying the medical products in response to public health crisis, the extent of damage caused by the public health crisis situation, etc.
(3) The Minister of Food and Drug Safety shall consult with the head of the relevant central administrative agency when intending to take the distribution improvement measures under paragraph (1).
(4) Where taking the distribution improvement measures under paragraph (1), the Minister of Food and Drug Safety shall notify the person subject to the measures in writing of the target, details, period, reason, etc. of the distribution improvement measures; provided, where individual notification is deemed impracticable, such as when urgent action is required, notification may be provided by posting the relevant information on the website of the Ministry of Food and Drug Safety or in the Official Gazette.
(5) A person subject to the distribution improvement measures under paragraph (1) shall report the results of the distribution improvement measures for the relevant medical product in response to public health crisis as determined by the Minister of Food and Drug Safety.
(6) Where revoking distribution improvement measures under Article 19(4) of the Act, the Minister of Food and Drug Safety shall notify the person subject to the distribution improvement measures under paragraph (1) in writing; provided, where individual notification is deemed impracticable, such as when urgent action is required, notification may be provided by posting the relevant information on the website of the Ministry of Food and Drug Safety or in the Official Gazette.
Article 13(Criteria for calculating penalty surcharges) #
The criteria for imposing penalty surcharges under Article 23(1) of the Act shall be as specified in Appendix 1.
Article 14(Information system for medical products in response to public health crisis) #
(1) A request for the submission of information under Article 30(2) of the Act shall be made in a document containing the following; provided, where individual notification is deemed impracticable, such as when urgent action is required, notification may be provided by posting the relevant information on the website of the Ministry of Food and Drug Safety or in the Official Gazette:
1. The scope of the information requested;
2. The submission methods and deadline;
3. Other matters for the distribution management that are deemed necessary by the Minister of Food and Drug Safety.
(2) "Information system prescribed by Presidential Decree" in Article 30(3) 4 of the Act means the integrated management system of disaster management resources under Article 46 of the Act on the Management, etc. of Disaster Management Resources. <Amended on Jan. 9, 2024>
(3) Pursuant to the former part of Article 30(4) of the Act, the Minister of Food and Drug Safety shall entrust the Korea Institute of Drug Safety and Risk Management with business affairs necessary for maintaining and managing the crisis response medical product information system under paragraph (1) of that Article (hereinafter referred to as "information system"). <Added on Dec. 12, 2023>
Article 15(Consultation on goods other than medical products) #
Where intending to consult with the head of a central administrative agency under Article 31(1) of the Act, the Minister of Food and Drug Safety shall take the following into consideration:
1. The scope of the targeted goods and need for action;
2. An action plan for the targeted goods and post-action management plan;
3. The provisions of the statutes and regulations regarding the targeted goods.
Article 16(Processing personally identifiable information) #
The Minister of Food and Drug Safety (where the relevant authority is delegated or entrusted, including persons delegated or entrusted with such authority) may manage data containing resident registration numbers or alien registration numbers specified in subparagraph 1 or 4 of Article 19 of the Enforcement Decree of the Personal Information Protection Act, if unavoidable to perform the following business affairs: <Amended on Dec. 12, 2023>
1. Business affairs regarding measures for safe use, etc. under Article 13 of the Act;
2. Business affairs regarding reporting on side effects, etc. under Article 14 of the Act;
3. Business affairs regarding tracing investigations and registration of details of use under Article 15 of the Act;
4. Business affairs regarding fact-finding surveys under Article 21 of the Act;
5. Business affairs regarding the revocation of permission by item and the suspension of manufacturing, import, or sale under Article 22 of the Act;
6. Business affairs regarding the imposition and collection of penalty surcharges under Article 23 of the Act;
7. Business affairs regarding the transfer and acquisition of the status of designation of preliminary crisis response medical products under Article 27 of the Act;
8. Business affairs regarding the establishment and operation of an information system under Article 30 of the Act.
Article 17(Criteria for imposition of administrative fines) #
The standards for imposing administrative fines under Article 36 (1) of the Act shall be as specified in Appendix 2.