CHAPTER I GENERAL PROVISIONS
The purpose of this Act is to contribute to the protection of public safety and health by prescribing matters necessary to promote the development of medical products in response to a crisis and to create a supply base for emergency use in order to quickly overcome a public health crisis.
The terms used in this Act are defined as follows:
| 2. | The term "public health crisis" means a situation where the State needs to respond urgently because people's life or body is or is likely to be seriously harmed by a pandemic of an infectious disease under the Infectious Disease Control and Prevention Act (including an outbreak of an infectious disease that is of significant concern to become a pandemic; hereinafter the same shall apply), by an outbreak of a disease caused by the use, etc. of a biochemical weapon such as anthrax bacillus or toxic chemicals, or by a nuclear material threat, radiation emergency, or radiological disaster, etc. under Article 2 (1) 6 through 8 under the Act on Physical Protection and Radiological Emergency; |
| 3. | The term "medical product in response to a public health crisis" means a medical product that has been designated by the Minister of Food and Drug Safety as a medical product that can be used to diagnose, treat, mitigate, cure, or prevent any of the following diseases or injuries in a public health crisis: |
| (b) | Diseases or injuries caused by the use, etc. of biochemical weapons, such as anthrax bacillus or toxic chemicals; |
| (d) | Diseases or injuries equivalent to those under items (a) through (c) that are recognized by the head of the relevant central administrative agency or the head of the Minister of Food and Drug Safety as likely to cause serious harm to public health; |
| 6. | The term "therapeutic confirmatory trial" means a clinical trial to confirm the safety and effectiveness of a drug; |
| 7. | The term "therapeutic exploratory trial" means a trial to explore therapeutic effectiveness in a patient group to establish a feasible dose and to prepare the trial design, evaluation items, evaluation methods, etc. for a therapeutic confirmatory trial. |
| Article 3 (Responsibilities of the State) |
| (1) | The State shall endeavor to support and promote the development of medical products in response to a public health crisis (hereinafter referred to as "crisis response medical products") and to ensure the smooth and urgent supply of crisis response medical products. |
| (2) | The Minister of Food and Drug Safety shall formulate policy measures such as establishing a relevant system and training specialized personnel to develop a method to promptly predict and evaluate the quality, safety, and effectiveness of crisis response medical products. |
| Article 4 (Relationship to Other Statutes) |
CHAPTER II COMMISSION ON SAFETY CONTROL AND SUPPLY OF MEDICAL PRODUCTS IN RESPONSE TO PUBLIC HEALTH CRISIS
| Article 5 (Commission on Safety Control and Supply of Medical Products in Response to Public Health Crisis) |
| (1) | A Commission on Safety Control and Supply of Medical Products in Response to a Public Health Crisis (hereinafter referred to as the "Commission") shall be established under the control of the Ministry of Food and Drug Safety to deliberate on the following matters and to provide advice regarding the inquiry of the Minister of Food and Drug Safety: |
| 1. | Development of safety control and supply systems for crisis response medical products; |
| 2. | Support for and promotion of the development of crisis response medical products, etc.; |
| 3. | Deliberation and consultation on designation of, revocation of designation of, permission for, revocation of permission for, transfer of, or acquisition, etc. of, crisis response medical products (including preliminary crisis response medical products under Article 6); |
| 4. | Authorization for emergency use of crisis response medical products; |
| 5. | Decision on whether to continue using crisis response medical products based on the report of its adverse effects; |
| 6. | Emergency production or import orders, distribution improvement measures, stockpiling, etc. of crisis response medical products; |
| 7. | Other matters for which the head of the relevant central administrative agency or the Minister of Food and Drug Safety requests deliberation or advice with regard to the development and supply of crisis response medical products. |
| (2) | The Commission shall consist of up to 30 members including one chairperson. |
| (3) | The Vice Minister of Food and Drug Safety shall serve as the chairperson of the Commission; and its members shall be appointed or commissioned by the Minister of Food and Drug Safety, from among public officials belonging to the Senior Executive Service of the relevant central administrative agency prescribed by Presidential Decree and persons with extensive knowledge of and experience in medical products in response to a public health crisis. In such cases, the non-public official members shall constitute the majority of the members. |
| (4) | The Commission may have sectoral subcommittees to efficiently perform its duties. |
| (5) | The deliberation and resolution of a subcommittee shall be reported to the chairperson and be resolved on by the Commission: Provided, That the resolution of a subcommittee may substitute for the resolution of the Commission for matters deemed minor by the chairperson. |
| (6) | Other details necessary for the composition, operation, etc. of the Commission and subcommittees shall be prescribed by Ordinance of the Prime Minister. |
CHAPTER III DESIGNATION OF, PERMISSION FOR, AND SAFETY CONTROL OF PRELIMINARY CRISIS RESPONSE MEDICAL PRODUCTS
SECTION 1 Designation of and Permission for Preliminary Crisis Response Medical Products
| Article 6 (Designation of Preliminary Crisis Response Medical Products) |
| (1) | A person intending to develop a crisis response medical product may file an application to designate such product as a preliminary crisis response medical product with the Minister of Food and Drug Safety; in such cases, the following materials shall be submitted together: |
| 1. | Materials describing a disease or injury targeted by the medical product to be designated and developed as a preliminary crisis response medical product; |
| 2. | Materials on the results of non-clinical trials or the plans or results of clinical trials, etc. that prove that the medical product to be designated and developed as a preliminary crisis response medical product can diagnose, treat, mitigate, cure, or prevent a disease or injury under subparagraph 1. |
| (2) | Where a medical product to be designated and developed as a preliminary crisis response medical product under paragraph (1) is used for the purpose of diagnosis, treatment, etc. of any disease or injury specified in the items of subparagraph 3 of Article 2 and meets the following requirements, the Minister of Food and Drug Safety may designate the medical product as a preliminary crisis response medical product after deliberation by the Commission: |
| 1. | The medical product shall be one of the following items and is intended to be used to diagnose, treat, mitigate, cure, or prevent the relevant disease: |
| (a) | Drugs such as antibiotics, antivirals, antifungals, or vaccines that work against pathogens that have developed resistance to existing drugs; |
| (b) | Drugs such as antibiotics, antivirals, antifungals, or vaccines that work against new or untreated pathogens; |
| (c) | Medical devices that have significantly improved or are expected to improve safety and effectiveness compared to existing medical devices or therapeutic technologies or that are not essentially equivalent thereto in terms of the purpose of use, operating principle, etc.; |
| (d) | Medical products that can diagnose, treat, mitigate, cure, or prevent a disease caused by a pandemic of an infectious disease or the use of a biochemical weapon; |
| (e) | Medical products to protect against radiation or radioactivity; |
| (f) | Medical products similar to those under items (a) through (e) that are determined and publicly notified by the Minister of Food and Drug Safety; |
| 2. | The medical product shall be predicted to diagnose, treat, mitigate, cure, or prevent a disease or injury that is likely to cause serious harm to public health in non-clinical or clinical trials. |
| (3) | The Minister of Food and Drug Safety shall decide whether to make a designation under paragraph (2) within 30 days from the date of receipt of the application under paragraph (1). |
| (4) | Where any of the following cases is applicable to a preliminary crisis response medical product designated under paragraph (2), the Minister of Food and Drug Safety may revoke the designation of such medical product after deliberation by the Commission: Provided, That the designation shall be revoked in the case of subparagraph 1: |
| 1. | Where the designation under paragraph (2) has been obtained by fraud or other improper means; |
| (5) | To revoke the designation of a preliminary crisis response medical product under paragraph (4), a hearing shall be held. |
| (6) | Details necessary for the procedures, methods, etc. of the designation under paragraphs (1) and (2) shall be prescribed by Ordinance of the Prime Minister. |
| Article 7 (Prioritized Review) |
| (1) | The Minister of Food and Drug Safety shall prioritize the review of a preliminary crisis response medical product over the review of other medical products, except for a good cause, in any of the following cases: |
| 1. | Where 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 applied (including an application for change) for the preliminary crisis response medical product; |
| 2. | Where an application for approval of a clinical trial plan (including an application for change) has been filed for the preliminary crisis response medical product. |
| (2) | The deadline for the prioritized review under paragraph (1) and other necessary matters shall be prescribed by Ordinance of the Prime Minister. |
| Article 8 (On-Call Concomitant Review) |
| (1) | Where a person who has obtained the designation of a preliminary crisis response medical product intends to obtain permission by item for that medical product, the person may pre-submit, before filing an application for permission by item, all or part of the documentation required for such application, which is completed at each phase of the development process, to the Minister of Food and Drug Safety at each such phase and may file an application to conduct a review whenever necessary (hereinafter referred to as "on-call concomitant review") with the Minister of Food and Drug Safety. |
| (2) | Where deeming that the application under paragraph (1) is suitable for an on-call concomitant review, the Minister of Food and Drug Safety may approve the application under paragraph (1) after consulting with the applicant regarding the type and scope of documentation to be submitted for the on-call concomitant review, the submission schedule, and the timing of notification of the review results. The same shall apply when intending to change the approved details, such as the type and scope of the documentation submitted. |
| (3) | When an on-call concomitant review is completed for each phase, the Minister of Food and Drug Safety shall notify the applicant of the results of each review of the documentation pre-submitted, in accordance with the timing of notification of the review results agreed upon under paragraph (2); and if the results of the review are deemed sufficient to file an application for permission by item, the Minister shall notify the applicant of such fact. |
| (4) | Where an application for permission by item is filed for a preliminary crisis response medical product for which an on-call concomitant review is completed, the Minister of Food and Drug Safety shall reflect the results of the review notified under paragraph (3) in the decision whether to grant permission by item. |
| (5) | Details necessary for an application for review under paragraph (1), approval or approval for change under paragraph (2), notification of review results under paragraph (3), etc. shall be prescribed by Ordinance of the Prime Minister. |
| Article 9 (Concurrent Review) |
The Minister of Food and Drug Safety may conduct a concurrent review for permission by item in any of the following cases:
| 1. | Where a preliminary crisis response drug and a preliminary crisis response medical device are assembled or combined together; |
| 2. | Where applications are concurrently filed for permission by item for a preliminary crisis response drug and for permission by item for a medical device for diagnosing an indication for the preliminary crisis response drug. |
| Article 10 (Support for Clinical Trials) |
| (1) | Where a person who has obtained the designation of a preliminary crisis response medical product intends to conduct clinical trials (including therapeutic exploratory trials and therapeutic confirmatory trials) or non-clinical trials (hereinafter referred to as "clinical trials, etc."; hereafter in this Article, the same shall apply) on such medical product, the Minister of Food and Drug Safety may provide support for preparation of plans for clinical trials, etc., recruitment of subjects, training of personnel, implementation of international collaborative trials, etc. |
| (2) | To efficiently and promptly conduct clinical trials, etc. for preliminary crisis response medical products and to improve the quality of related information, the Minister of Food and Drug Safety may collect and manage necessary information on the results of clinical trials, etc. in electronic form and may provide support, including providing such information, to persons who intend to conduct clinical trials on preliminary crisis response medical products. |
| (3) | Details necessary for the support for the preparation of plans for clinical trials, etc., recruitment of subjects, training of personnel, implementation of international collaborative trials, etc. under paragraph (1) and the procedures and methods, etc. for collecting and managing information on clinical trials, etc. under paragraph (2) shall be prescribed by Ordinance of the Prime Minister. |
| Article 11 (Conditional Permission by Item) |
| (1) | For preliminary crisis response drugs that have completed a therapeutic exploratory trial similar in form and purpose to a therapeutic confirmatory trial in terms of the safety and effectiveness of the drug and the nature of the target disease, the Minister of Food and Drug Safety may grant permission by item on the condition that the confirmatory trial data, etc. of the drugs be submitted within a specified period; in such cases, the following data shall be submitted: |
| 1. | Clinical trial data proving that the drugs have clinical effectiveness from a pharmacoepidemiologic, pharmacotherapeutic, or pathophysiologic perspective, etc. or those proving effectiveness with surrogate endpoints that can reasonably predict the clinical effectiveness of the drugs; |
| 2. | Other materials prescribed by Ordinance of the Prime Minister with regard to the safety and effectiveness of the drugs. |
| (2) | For preliminary crisis response medical devices for which it is impractical to obtain the number of subjects for a clinical trial for the indication, the Minister of Food and Drug Safety may grant permission by item on the condition that clinical trial data that can confirm the safety and effectiveness of the medical devices be submitted within a specified period; in such cases, the following data shall be submitted: |
| 1. | Clinical trial data ascertaining that the medical devices have clinical effectiveness, even if the number of subjects is less than that for a statistically valid trial; |
| 2. | Other materials prescribed by Ordinance of the Prime Minister with regard to the safety and effectiveness of the medical devices. |
| (3) | For preliminary crisis response medical products for which it is deemed clear that clinical trials to study their effectiveness against nuclear, biological weapons, etc. cannot be conducted, the Minister of Food and Drug Safety may grant permission by item on the condition that clinical trial data that can confirm the safety and effectiveness of the medical products be submitted within a specified period, if the following data are submitted: |
| (a) | Explanation that the mechanism of action of the relevant drug, including how the drug reduces toxicity, is reasonable in light of pathophysiology, etc.; |
| (b) | Evidence that the results from non-clinical trials on animals are sufficient to predict response in humans; |
| (c) | A clear explanation that the endpoints used in non-clinical trials on animals are related to a benefit, such as increasing survivability of humans; |
| (d) | Evidence demonstrating that pharmacokinetic and pharmacodynamic data in humans or animals are the appropriate dose for use in humans for the relevant drug for which an application has been filed; |
| (e) | Other materials prescribed by Ordinance of the Prime Minister with regard to proving, etc. the safety and effectiveness of the relevant drug; |
| (a) | Explanation that the mechanism of action of the relevant quasi-drug is reasonable in light of the safety and effectiveness in the treatment, mitigation, cure, or prevention of the disease in question; |
| (b) | Evidence that the results from non-clinical trials are sufficient to predict safety and efficacy in humans; |
| (c) | Other materials prescribed by Ordinance of the Prime Minister with regard to proving, etc. the safety and effectiveness of the relevant quasi-drug; |
| (a) | Explanation that the relevant medical device's principle of action is reasonable in light of the safety and effectiveness in the diagnosis, treatment, mitigation, cure, or prevention of the disease in question; |
| (b) | Evidence that the results from non-clinical trials on animals are sufficient to predict safety and effectiveness in humans; |
| (c) | Other materials prescribed by Ordinance of the Prime Minister with regard to proving, etc. the safety and effectiveness of the relevant medical device. |
| (5) | Where a person who has received permission by item for the relevant medical product under paragraphs (1) through (3) fails to fulfill the conditions of the permission, the Minister of Food and Drug Safety shall immediately revoke such permission by item as prescribed by Ordinance of the Prime Minister: Provided, That in cases prescribed by Ordinance of the Prime Minister, such as when it is necessary to ensure treatment opportunities for those to whom the medical product are administered or for those who use the medical product, the Minster may revoke the permission by item after requiring the person to take necessary measures. |
| (6) | Details necessary for the application methods, processing procedures, and materials to be submitted under paragraphs (1) through (5) shall be prescribed by Ordinance of the Prime Minister. |
| Article 12 (Approval for Emergency Use) |
| (1) | In cases where deeming it necessary for responding appropriately to a public health crisis or at the request of the head of the relevant central administrative agency, the Minister of Food and Drug Safety may, after deliberation by the Commission, make any of the following dispositions (hereinafter referred to as "approval for emergency use"): Provided, That deliberation by the Commission may be omitted in urgent cases: |
| 2. | Allowing a manufacturer or importer to manufacture or import and then supply drugs, etc. for which permission by item has already been obtained or a notification by item has already been filed, specifying the use, dose, efficacy, effectiveness, and duration of use that is different from the details of the permission or notification; |
| (2) | To grant approval for emergency use under paragraph (1), the Minister of Food and Drug Safety may request the manufacturer or importer of the relevant medical product or the head of the relevant central administrative agency to submit necessary materials. |
| (3) | Where deeming that approval for emergency use of a medical product in a specific field is necessary to effectively overcome a public health crisis, the Minister of Food and Drug Safety may receive an application for approval for emergency use from the manufacturer or importer of a medical product by publicly announcing the following; in such cases, the manufacturer or importer of the medical product for which an application for emergency use is filed shall submit materials, etc. proving the safety and effectiveness of the medical product as prescribed by Ordinance of the Prime Minister: |
| 1. | The scope of the medical product eligible for approval for emergency use; |
| 2. | Other matters determined by the Minister of Food and Drug Safety to be necessary, such as the requirements for approval for emergency use and duration of the approval. |
| (4) | The Minister of Food and Drug Safety may order the manufacturer or importer of a medical product approved for emergency use under paragraph (1) to take measures under Articles 13 through 15. |
| (5) | The Minister of Food and Drug Safety may order the manufacturer or importer of a medical product approved for emergency use, the founder of a medical institution, etc. to take such necessary measures as suspension of manufacturing or importation, recall and disposal, or suspension of use, as prescribed by Presidential Decree, in any of the following cases: Provided, That in cases falling under subparagraph 2, such measures as suspension of manufacturing or importation, recall and disposal, or suspension of use shall be taken: |
| 1. | Where the public health crisis has ended; |
| 2. | Where the medical product is recognized as causing or likely to cause significant damage to public health or as having or likely to have a fatal effect on public health; |
| 3. | Where the person who manufactures or imports the medical product fails to implement measures or fulfill obligations under this Act. |
| (6) | Where a person who has received approval for emergency use under paragraph (1) files an application for permission by item as prescribed by Ordinance of the Prime Minister, the Minister of Food and Drug Safety may grant permission by item on the condition that the evidence of the safety and effectiveness of the relevant medical product, such as the results of use of the medical product or clinical trial data be submitted within a specified period. |
| (7) | The Minister of Food and Drug Safety may apply Articles 7 through 9 to a medical product for which an application for permission by item has been filed under paragraph (6). |
| (8) | Articles 11 (4) and (5) and 13 through 16 shall apply mutatis mutandis to a medical product for which permission by item has been granted or a person who has received such permission by item pursuant to paragraph (6). |
| (9) | The details necessary for the dispositions under paragraph (1), the application process and scope of materials to be submitted under paragraph (3), the measures under paragraph (5), the processing procedures under paragraph (6), and other similar matters shall be prescribed by Ordinance of the Prime Minister. |
| Article 12-2 (State Compensation for Damage from Side Effects of Drugs Authorized for Emergency Use) |
| (1) | Where a person who has used a drug authorized for emergency use pursuant to Article 12 (1) becomes ill, becomes disabled, or dies as a result of a side effect of such drug, the State shall pay compensation under the following subparagraphs: |
| 2. | Lump-sum compensation for disability; |
| 3. | Lump-sum compensation for death; |
| (2) | The Minister of Food and Drug Safety may entrust part of the business affairs related to the payment of compensation under paragraph (1) to the Korea Institute of Drug Safety and Risk Management (hereinafter referred to as the "Korea Institute of Drug Safety and Risk Management") under Article 68-3 (1) of the Pharmaceutical Affairs Act. |
| (3) | Articles 86-3 through 86-8 of the Pharmaceutical Affairs Act shall apply mutatis mutandis to the payment of compensation under paragraph (1). In such cases, "benefits for relief of injury" shall be construed as "compensation", and "deposit them in the charges account as earnings" shall be construed as "revert to the National Treasury". |
[This Article Newly Inserted on Mar. 28, 2023]
SECTION 2 Safety Control and Evaluation of Medical Products
| Article 13 (Safe Use Measures) |
| (1) | A person who has received permission by item for a medical product under Article 11 shall conduct an investigation, etc. on the safe use measures and usage performance of the medical product and report the results to the Minister of Food and Drug Safety, as prescribed by Ordinance of the Prime Minister. |
| (2) | Where necessary based on the results of an investigation, etc. of safe use measures and usage performance under paragraph (1), the Minister of Food and Drug Safety may order a person who has received permission by item for the relevant medical product to take additional measures to ensure safe use. |
| (3) | Where a person who has received permission by item for a medical product fails to comply with an order to take measures under paragraph (2), the Minister of Food and Drug Safety may order the person to recall and dispose of the relevant medical product or to take other necessary measures. |
| (4) | Where a person who has received an order under paragraph (3) fails to comply with the order, the Minister of Food and Drug Safety may authorize a relevant public official to recall and dispose of the relevant medical product or to take other necessary measures. |
| (5) | Where ordering a person who has received permission by item for a medical product to recall and dispose of the medical product in circulation or to take other necessary measures under paragraph (3), the Minister of Food and Drug Safety may order the person to publish the fact. |
| (6) | Details necessary for orders for recall, disposal, other measures, and publication, etc. under paragraphs (3) through (5) shall be prescribed by Ordinance of the Prime Minister. |
| Article 14 (Reporting Side Effects) |
| (1) | Upon learning of any harmful cases such as illness, disability, death, and other cases related to the safety and effectiveness of the medical products prescribed by Ordinance of the Prime Minister, which are suspected to be caused by a medical product for which permission by item has been granted under Article 11, any of the following persons shall report to the head of the Korea Institute of Drug Safety and Risk Management or the head of the National Institute of Medical Device Safety Information (hereinafter referred to as "National Institute of Medical Device Safety Information") under Article 42 (1) of the Medical Devices Act: <Amended on March 28, 2023> |
| 1. | A person who has received permission by item for a medical product under Article 11; |
| (2) | Upon receiving a report under paragraph (1), the president of the Korea Institute of Drug Safety and Risk Management or the president of the National Institute of Medical Device Safety Information shall analyze the causal relationship between the side effects, etc. and the relevant medical product, the level of harm, etc. and shall report the results to the Minister of Food and Drug Safety. |
| (3) | Where the results reported under paragraph (2) show that the relevant medical product is deemed likely to cause significant harm to the public, the Minister of Food and Drug Safety shall determine whether the medical product may continue to be used after deliberation by the Commission. In such cases, where deciding to suspend the use of the relevant medical product, the Minister of Food and Drug Safety shall take necessary measures without delay, such as revocation of the permission by item for the medical product, suspension of sale, or recall and disposal orders. |
| (4) | Details necessary for the procedures and methods for reporting side effects under paragraph (1), the procedures and methods for reporting under paragraph (2), and the measures including revocation of permission under paragraph (3) shall be prescribed by Ordinance of the Prime Minister. |
| Article 15 (Tracing Investigation and Registration of Details of Use) |
| (1) | The Minister of Food and Drug Safety may designate a medical product for which permission by item has been granted under Article 11 and for which it is deemed necessary to ascertain whether an adverse event occurs for a certain period of time after use as a subject of a tracing investigation and may conduct a tracing investigation for a specified period necessary for such investigation. In such cases, the Minister of Food and Drug Safety may designate an organization to conduct a tracing investigation as prescribed by Presidential Decree and entrust all or part of the tasks. |
| (2) | A person who has received approval of a clinical trial plan or permission by item for a medical product designated as a subject of a tracing investigation under paragraph (1) or an importer of such medical product (hereinafter referred to as "person who has received permission by item for a medical product subject to a tracing investigation, etc."; hereafter in this Article, the same shall apply) shall formulate a tracing investigation plan as prescribed by Ordinance of the Prime Minister and report it to the Minister of Food and Drug Safety. |
| (3) | Where a person who has received permission by item for a medical product subject to a tracing investigation, etc. learns that a serious adverse event has occurred to a person who used the medical product while conducting a tracing investigation in accordance with a tracing investigation plan, he or she shall investigate, analyze, and report it to the Minister of Food and Drug Safety. |
| (4) | A medical doctor, dentist, or pharmacist who handles a medical product subject to a tracing investigation under paragraph (1) shall, with the consent of a person to use the product, register the personal information of the person to use it and the details of use with an institution designated by the Minister of Food and Drug Safety. |
| (5) | A person who has received permission by item for a medical product subject to a tracing investigation, etc. shall register the details of the sale and supply of the relevant medical product with an institution designated by the Minister of Food and Drug Safety. |
| (6) | The Minister of Food and Drug Safety may provide subsidies to cover all or part of the expenses incurred in conducting a tracing investigation under paragraphs (2) and (3) and filing for registration under paragraphs (4) and (5) within the budget. |
| (7) | Where necessary based on the results of a tracing investigation, etc., the Minister of Food and Drug Safety may take measures necessary for public health on a person who has received permission by item for a medical product subject to a tracing investigation, etc., 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. |
| (8) | Matters necessary for the designation of medical products subject to tracing investigations under paragraph (1), the scope, procedures, and methods of tracing investigations, the methods of reporting adverse events under paragraph (3), the procedures for consent and methods of registration under paragraph (4), the methods of registration under paragraph (5), etc. shall be prescribed by Presidential Decree. |
| Article 16 (Value Assessment of Medical Products and Disclosure Thereof) |
| (1) | Where the Minister of Food and Drug Safety approves a medical product under Article 11, he or she may assess the following and publicly announce the results on the website, etc.: |
| 1. | The impact of the medical product on patients, including its therapeutic effectiveness; |
| 2. | The overall preventive and therapeutic value of the medical product, regarding its safety and effectiveness. |
| (2) | Where necessary for the value assessment of a medical product under paragraph (1), the Minister of Food and Drug Safety may request cooperation from the head of the relevant central administrative agency or relevant public institution. |
| (3) | Details necessary for the period of and the procedures and methods for public announcement under paragraph (1) shall be prescribed by Ordinance of the Prime Minister. |
CHAPTER IV DESIGNATION, MANAGEMENT, AND SUPPLY MANAGEMENT OF CRISIS RESPONSE MEDICAL PRODUCTS
| Article 17 (Designation and Management of Crisis Response Medical Products) |
| (2) | Notwithstanding paragraph (1), any of the following medical products shall be deemed to be designated as a crisis response medical product under paragraph (1): |
| 1. | A medical product that has been designated as a preliminary crisis response medical product under Article 6 and for which permission by item has been granted; |
| 2. | A medical product that has been approved for emergency use under Article 12 or for which permission by item has been granted after having been approved for emergency use. |
| (3) | In cases of designation as a crisis response medical product under paragraph (1) or in cases of being deemed to be designated as a crisis response medical product under paragraph (2), the Minister of Food and Drug Safety shall publicly announce such designation without delay and shall notify a person who manufactures, imports, or sells the medical product of the designation, management plan, etc. |
| (4) | The Minister of Food and Drug Safety may revoke the designation of a crisis response medical product after deliberation by the Commission in any of the following cases: |
| 1. | Where the public health crisis has ended or is clearly expected to end; |
| 2. | Where it is deemed unnecessary to separately manage the medical product in case of a public health crisis due to changes in supply and demand conditions, etc. |
| (5) | Details necessary for the methods and procedures for designation of crisis response medical products under paragraph (1), the content and methods of public announcement and notification under paragraph (3), and the revocation of designation under paragraph (4) shall be prescribed by Ordinance of the Prime Minister. |
| Article 18 (Emergency Production or Import Orders) |
| (1) | Where deeming it necessary for responding effectively to a public health crisis, or at the request of the head of the relevant central administrative agency, the Minister of Food and Drug Safety may, after deliberation by the Commission, issue an order to produce or import crisis response medical products designated under Article 17 (hereinafter referred to as "emergency production or import order") to any of the following persons (hereinafter referred to as "producers, etc."): |
| (2) | Producers, etc. who receive an order under paragraph (1) shall comply with such order in the absence of good cause. |
| (3) | Where consultation, etc. among countries is necessary due to the shortage of raw materials used for the emergency production of medical products or the shortage of imported goods referred to in paragraph (1), the Minister of Food and Drug Safety may request the heads of the relevant central administrative agencies to take necessary measures pursuant to the relevant statutes and regulations. In such cases, the heads of the relevant central administrative agencies shall cooperate with such request in the absence of good cause. |
| (4) | Where deeming it necessary for fulfilling the order under paragraph (1), the Minister of Food and Drug Safety may provide financial and administrative support to producers, etc. |
| (5) | Where the reason for continuing the order under paragraph (1) has ceased to exist or is clearly expected to cease to exist, the Minister of Food and Drug Safety shall revoke the order without delay. |
| (6) | Details necessary for the procedures and methods for the emergency production or import orders under paragraphs (1) through (5) shall be prescribed by Presidential Decree. |
| Article 19 (Distribution Improvement Measures) |
| (1) | In cases where it is deemed that the supply of crisis response medical products designated due to a public health crisis is significantly disrupted or at the request of the head of the relevant central administrative agency, the Minister of Food and Drug Safety may, after deliberation by the Commission, take distribution improvement measures as necessary on the medical products subject to the measures and on their sales outlets, sales procedures, sales volume, sales conditions, etc.; in such cases, the following persons shall comply therewith in the absence of good cause: |
| 5. | A person equivalent to those under subparagraphs 1 through 4, as determined by the Minister of Food and Drug Safety. |
| (2) | Where the measures under paragraph (1) are related to the price stability policy, the Minister of Food and Drug Safety shall consult with the Minister of Economy and Finance in advance. |
| (3) | Where necessary for the distribution improvement measures for medical products under paragraph (1), the Minister of Food and Drug Safety may request cooperation from the head of the relevant central administrative agency. In such cases, the head of the relevant central administrative agency shall comply therewith unless there are special reasons. |
| (4) | Where the reason for continuing the measures under paragraph (1) has ceased to exist or is clearly expected to cease to exist, the Minister of Food and Drug Safety shall revoke the measure without delay. |
| (5) | Details necessary for the sales procedures, the standards for sales conditions, etc., the scope of improvement measures, the revocation of the measures, etc. under paragraphs (1) through (4) shall be prescribed by Presidential Decree. |
| Article 20 (Special Cases concerning Labeling and Inspection of Crisis Response Medical Products) |
| (1) | Where deeming it necessary for supplying crisis response medical products urgently in a public health crisis, the Minister of Food and Drug Safety may exempt the following crisis response medical products from the application of all or part of the provisions specified in each relevant subparagraph, as determined by the Minister of Food and Drug Safety: |
| (2) | Where the Minister of Food and Drug Safety decides not to apply the specified provisions on the labeling of crisis response medical products as prescribed in paragraph (1), key information such as the product name, manufacturing number, and the use-by date of the crisis response medical products shall be indicated on the containers and packaging, and other necessary information shall be provided electronically, as determined by the Minister of Food and Drug Safety. In such cases, such indication may be provided in a foreign language on the containers or packaging. |
| (3) | Where the Minister of Food and Drug Safety decides not to apply the provisions on import management for the importer of crisis response medical products as prescribed in paragraph (1), the relevant importer shall be required to ensure the quality of the crisis response medical products by ascertaining the quality inspection results of overseas manufacturing places, etc. as determined by the Minister of Food and Drug Safety. |
| Article 21 (Fact-Finding Surveys) |
| (1) | The Minister of Food and Drug Safety may investigate the manufacture, import, sale, use, etc. of crisis response medical products to ensure the quality and safety of such products. |
| (2) | The Minister of Food and Drug Safety may investigate the inventory, supply management, etc. of crisis response medical products to ensure a smooth supply of such products. |
| (3) | Where necessary for investigations under paragraphs (1) and (2), the Minister of Food and Drug Safety may require a person who has received permission by item for a crisis response medical product, a person who has received approval of a clinical trial plan for a crisis response medical product, or an importer or distributor of a crisis response medical product to submit relevant materials, to express opinions, or to conduct any similar acts. In such cases, a person requested to submit materials, to express opinions, or to conduct any similar acts shall comply therewith in the absence of good cause. |
| (4) | Matters necessary for the scope of, and methods and procedures for, investigations under paragraphs (1) through (3) shall be prescribed by Ordinance of the Prime Minister. |
| Article 22 (Revocation of Manufacturing Permission and Suspension of Business Operations) |
| (1) | Where any of the following cases is applicable to a person who has received permission by item for a crisis response medical product under this Act, the Minister of Food and Drug Safety shall revoke permission by item for the crisis response medical product: |
| 1. | Where the person has received permission by item for the crisis response medical product under Article 11 or 12 (6) by fraud or other improper means; |
| 2. | Where the person violates an order under Article 13 (2) or (3); |
| 3. | Where the person intentionally fails to report a side effect, etc. in violation of Article 14 (1); |
| 4. | Where the person intentionally fails to report a serious adverse event in violation of Article 15 (3); |
| 5. | Where the person continues business operations during the business suspension period under paragraph (2). |
| (2) | Where any of the following cases is applicable to a person who has received permission by item for a crisis response medical product under this Act, a person who has received approval of a clinical trial plan for a crisis response medical product, or an importer or distributor of a crisis response medical product (including repairers and lessors under the Medical Devices Act in cases of medical devices), the Minister of Food and Drug Safety may revoke the permission by item for the crisis response medical product or order the business suspension of manufacturing, importing, and selling such medical product for a period of up to one year: |
| 1. | Where the person fails to report a side effect, etc. in violation of Article 14 (1); |
| 2. | Where the person fails to report a serious adverse event in violation of Article 15 (3); |
| 3. | Where the person refuses to submit relevant materials or to express opinions without good cause in violation of Article 21 (3); |
| 4. | Where the person fails to comply with an order to take measures under this Act, such as suspension of sale of the relevant medical product or its recall and disposal. |
| (3) | Detailed standards for the revocation of permission by item, etc., the business suspension, etc. of manufacture, importation, and sale under paragraphs (1) and (2) shall be prescribed by Ordinance of the Prime Minister, taking into consideration the type, severity, etc. of the relevant violation. |
| Article 23 (Imposition of Penalty Surcharges) |
| (1) | Where the suspension of business operations is to be ordered under Article 22, but there is a risk of severe inconvenience to persons using the crisis response medical products or harm to the public interest, the Minister of Food and Drug Safety may impose a penalty surcharge not exceeding one billion won in lieu of such suspension as prescribed by Presidential Decree. |
CHAPTER VI SUPPLEMENTARY PROVISIONS
| Article 24 (Support for Research and Development) |
| (1) | The State may provide support for the research and development of crisis response medical products, such as assisting persons researching and developing crisis response medical products in conducting non-clinical or clinical trials or providing necessary research materials. |
| (2) | The procedures and methods for research and development support under paragraph (1) and other necessary matters shall be prescribed by Ordinance of the Prime Minister. |
| Article 25 (Support for International Cooperation) |
| (1) | In order to promote the development of crisis response medical products, the Minister of Food and Drug Safety may cooperate with international organizations to provide necessary support to a person who intends to develop crisis response medical products, such as providing domestic and foreign relevant information, conducting international exchange of relevant technologies and personnel, or conducting international joint research and development. |
| (2) | Where necessary for providing support under paragraph (1), the Minister of Food and Drug Safety may request cooperation from the head of the relevant central administrative agency or relevant public institution. |
| Article 26 (Free Provision of Crisis Response Medical Products) |
| (1) | A person who has received permission by item for a crisis response medical product may provide it free of charge to a person who needs it. |
| (2) | A person who intends to provide free medical products under paragraph (1) shall obtain approval of the Minister of Food and Drug Safety with a free provision plan, etc. attached, as prescribed by Ordinance of the Prime Minister. |
| (3) | Where having granted approval under paragraph (2), the Minister of Food and Drug Safety may request cooperation on supply-related matters from the Korea Center for Rare and Essential Drugs under Article 91 (1) of the Pharmaceutical Affairs Act or the Korea Medical Device Safety Information Center. In such cases, the relevant institution shall comply therewith except in exceptional circumstances. |
| (4) | A person who has completed the free provision of medical products under paragraph (1) shall report the results of such free provision and other matters prescribed by Ordinance of the Prime Minister to the Minister of Food and Drug Safety. |
| (5) | Details necessary for the request for cooperation under paragraph (3), the procedures for reporting under paragraph (4), etc. shall be prescribed by Ordinance of the Prime Minister. |
| Article 27 (Transfer or Acquisition of Preliminary Crisis Response Medical Products) |
| (1) | A person who has obtained the designation of a preliminary crisis response medical product under Article 6 may transfer the status of designation. In such cases, the person who intends to transfer such designation shall prepare materials prescribed by Ordinance of the Prime Minister, such as information on another person to acquire the designation, and shall file an application with the Minister of Food and Drug Safety. |
| (2) | Upon receiving an application under paragraph (1), the Minister of Food and Drug Safety may approve the transfer after deliberation by the Commission, if he or she determines that the transferee has sufficient capacity to develop medical products. |
| (3) | Details necessary for the procedures and methods for transfer and acquisition under paragraphs (1) and (2) shall be prescribed by Ordinance of the Prime Minister. |
Any of the following persons shall pay fees prescribed by Ordinance of the Prime Minister:
| 1. | A person who intends to obtain approval for an on-call concomitant review or approval for change under Article 8 (2); |
| 2. | A person who intends to obtain permission by item for a medical product under Article 11 or 12 (6). |
| Article 29 (Extension of Effective Period of National Stockpile of Crisis Response Medical Products) |
| (1) | Where deeming it necessary to extend the effective period of crisis response medical products stockpiled under statutes, the head of the relevant central administrative agency may request an extension of the effective period from the Minister of Food and Drug Safety. |
| (2) | Matters necessary for the types and targets of crisis response medical products whose effective period can be requested to be extended under paragraph (1), the procedures for requesting the extension of the effective period, and the storage conditions, methods, standards, etc. shall be prescribed by Ordinance of the Prime Minister. |
| Article 30 (Establishment of Crisis Response Medical Product Information System) |
| (1) | In order to efficiently promote distribution improvement measures under Article 19 and to manage the supply of crisis response medical products, the Minister of Food and Drug Safety may establish and operate an information system. |
| (2) | In order to efficiently promote the establishment and operation of the information system under paragraph (1), the Minister of Food and Drug Safety may request the heads of relevant central administrative agencies and manufacturers, importers, distributors, etc. of crisis response medical products to submit information necessary for distribution management, such as production, shipment, and sales volumes and sales history. In such cases, a person receiving such request shall comply therewith in the absence of good cause. |
| (3) | The Minister of Food and Drug Safety may utilize the information system under paragraph (1) by electronically linking it with the following information systems; in such cases, the information that can be collected through the linkage shall be limited to information necessary for distribution management, such as production, shipment, and sales volumes and sales history of crisis response medical products: |
| 4. | Any other information system prescribed by Presidential Decree. |
| (4) | The Minister of Food and Drug Safety may entrust business affairs necessary for the maintenance and management of information systems under paragraph (1) to the Korea Institute of Drug Safety and Risk Management. In such cases, the Minister of Food and Drug Safety may provide subsidies to cover all or part of the expenses incurred in maintaining and managing the information systems. <Newly Inserted on Mar. 28, 2023> |
| (5) | Matters necessary for the establishment and operation of an information system under paragraphs (1), (2), and (4), a request for provision of necessary information, entrustment, etc. shall be prescribed by Presidential Decree. <Amended on March 28, 2023> |
| Article 31 (Special Cases concerning Goods Other Than Medical Products) |
| (1) | Where deeming that special measures need to be taken on goods used in conjunction with crisis response medical products in a public health crisis, the Minister of Food and Drug Safety may take necessary measures under Articles 18, 19, and 30 on the goods after consultation with the head of the central administrative agency in charge of the goods and subsequent deliberation by the Commission. |
| (2) | Matters necessary for the consultation with the head of the central administrative agency under paragraph (1) shall be prescribed by Presidential Decree. |
CHAPTER VII PENALTY PROVISIONS
| Article 32 (Penalty Provisions) |
| (1) | A person who obtains permission by item for a medical product under Article 11 or 12 (6) by fraud or other improper means shall be punished by imprisonment with labor for up to seven years or by a fine not exceeding 70 million won. |
| (2) | Imprisonment with labor and fines prescribed in paragraph (1) may be imposed concurrently. |
| Article 33 (Penalty Provisions) |
| (1) | Any of the following persons shall be punished by imprisonment with labor for up to two years or by a fine not exceeding 50 million won: |
| 1. | A person who receives an emergency production or import order under Article 18 (1) and fails to comply therewith without good cause; |
| 2. | A person who fails to comply with the distribution improvement measures under Article 19 (1) without good cause. |
| (2) | Imprisonment with labor and fines prescribed in paragraph (1) may be imposed concurrently. |
| Article 33-2 (Penalty Provisions) |
| (2) | Imprisonment with labor and fines prescribed in paragraph (1) may be imposed concurrently. |
[This Article Newly Inserted on Mar. 28, 2023]
| Article 34 (Penalty Provisions) |
Any of the following persons shall be punished by a fine not exceeding two million won: <Amended on March 28, 2023>
| 2. | A person who refuses or evades a request to submit data or to state an opinion under Article 21 (3). |
| Article 35 (Joint Penalty Provisions) |
If the representative of a corporation or an agent or employee of, or any other person employed by, the corporation or an individual commits any violations described in Articles 32 through 34 in conducting the business affairs of the corporation or individual, the corporation or individual shall be punished by a fine prescribed in the relevant Article in addition to punishing the violators accordingly: Provided, That the foregoing shall not apply if the corporation or individual has not neglected to exercise due care and supervision over the relevant business affairs to prevent the violations.
| Article 36 (Administrative Fines) |
| (1) | Any of the following persons shall be subject to an administrative fine not exceeding 10 million won: |
| 1. | A person who fails to report the results of the investigation on the safe use measures and usage performance to the Minister of Food and Drug Safety in violation of Article 13 (1); |
| 2. | A person who fails to report a harmful case suspected to be caused by a crisis response medical product to the president of the Korea Institute of Drug Safety and Risk Management or the president of the National Institute of Medical Device Safety Information in violation of Article 14 (1); |
| 3. | A person who fails to register the details of the use or the sale and supply of crisis response medical products in violation of Article 15 (4) or (5); |
| 4. | A person who fails to submit information necessary for distribution management without good cause in violation of Article 30 (2). |
| (2) | Any of the following persons shall be subject to an administrative fine not exceeding one million won: <Newly Inserted on Mar. 28, 2023> |
| (3) | Administrative fines prescribed in paragraphs (1) and (2) shall be imposed and collected by the Minister of Food and Drug Safety, as prescribed by Presidential Decree. <Amended on March 28, 2023> |
ADDENDA <Act No. 17922, Mar. 9, 2021>
Article 1 (Enforcement Date)
This Act shall enter into force on the date of its promulgation.
Article 2 (Preparatory Actions Such as Support for Designation of Crisis Response Medical Products)
The Minister of Food and Drug Safety may take preparatory actions, such as providing necessary information and administrative and technical support, even before the enforcement of this Act, so that crisis response medical products can be designated quickly.
Article 3 (Preparatory Actions to Establish Crisis Response Medical Product Information System)
The Minister of Food and Drug Safety may make necessary preparations for the establishment of an information system for crisis response medical products under Article 30 before the enforcement of this Act. In such cases, necessary cooperation may be requested from the head of the relevant central administrative agency or a person producing or handling such products. Article 4 (Applicability to Special Cases concerning Labeling and Inspection)
Article 20 shall also apply to crisis response medical products for which permission by item have been granted and which are in the process of being introduced into supply as at the time this Act enters into force.
Article 5 Omitted.
ADDENDA <No. 19321, Mar. 28, 2023>
Article 1 (Enforcement Date)
This Act shall enter into force on the date of its promulgation.
Article 2 (Applicability to State Compensation for Damage from Side Effects of Drugs Authorized for Emergency Use)
The amended provisions of Article 12-2 shall also apply to side effects from drugs authorized for emergency use that occurred before this Act enters into force.