SPECIAL ACT FOR PROMOTION OF THE DEVELOPMENT AND EMERGENCY SUPPLY OF MEDICAL PRODUCTS IN RESPONSE TO PUBLIC HEALTH CRISIS

CHAPTER I GENERAL PROVISIONS

Article 1(Purpose) #

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.

Article 2(Definitions) #

The terms used in this Act are defined as follows:

1. The term "medical product" means a drug (including an advanced biological product under the Act on the Safety of and Support for Advanced Regenerative Medicine and Advanced Biological Products) and a quasi-drug under the Pharmaceutical Affairs Act, and a medical device under the Medical Devices Act (including an in vitro diagnostic medical device under the Act on In Vitro Diagnostic Medical Devices);

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:

(a) Infectious diseases under subparagraph 1 of Article 2 of the Infectious Disease Control and Prevention Act;

(b) Diseases or injuries caused by the use, etc. of biochemical weapons, such as anthrax bacillus or toxic chemicals;

(c) Diseases or injuries caused by a nuclear material threat, radiation emergency, or radiological disaster, etc. under subparagraphs 6 through 8 of Article 2 under the Act on Physical Protection and Radiological Emergency;

SPECIAL ACT FOR PROMOTION OF THE DEVELOPMENT AND EMERGENCY SUPPLY OF MEDICAL PRODUCTS IN RESPONSE TO PUBLIC HEALTH CRISIS

Article 1(Purpose) #

Article 2(Definitions) #

Article 3(Responsibilities of the State) #

Article 4(Relationship to Other Statutes) #

Article 5(Commission on Safety Control and Supply of Medical Products in Response to Public Health Crisis) #

Article 6(Designation of Preliminary Crisis Response Medical Products) #

Article 7(Prioritized Review) #

Article 8(On-Call Concomitant Review) #

Article 9(Concurrent Review) #

Article 10(Support for Clinical Trials) #

Article 11(Conditional Permission by Item) #

Article 12(Approval for Emergency Use) #

Article 12-2(State Compensation for Damage from Side Effects of Drugs Authorized for Emergency Use) #

Article 13(Safe Use Measures) #

Article 14(Reporting Side Effects) #

Article 15(Tracing Investigation and Registration of Details of Use) #

Article 16(Value Assessment of Medical Products and Disclosure Thereof) #

Article 17(Designation and Management of Crisis Response Medical Products) #

Article 18(Emergency Production or Import Orders) #

Article 19(Distribution Improvement Measures) #

Article 20(Special Cases concerning Labeling and Inspection of Crisis Response Medical Products) #

Article 21(Fact-Finding Surveys) #

Article 22(Revocation of Manufacturing Permission and Suspension of Business Operations) #

Article 23(Imposition of Penalty Surcharges) #

Article 24(Support for Research and Development) #

Article 25(Support for International Cooperation) #

Article 26(Free Provision of Crisis Response Medical Products) #

Article 27(Transfer or Acquisition of Preliminary Crisis Response Medical Products) #

Article 28(Fees) #

Article 29(Extension of Effective Period of National Stockpile of Crisis Response Medical Products) #

Article 30(Establishment of Crisis Response Medical Product Information System) #

Article 31(Special Cases concerning Goods Other Than Medical Products) #

Article 32(Penalty Provisions) #

Article 33(Penalty Provisions) #

Article 33-2(Penalty Provisions) #

Article 34(Penalty Provisions) #

Article 35(Joint Penalty Provisions) #

Article 36(Administrative Fines) #