(1) Reasons for Proposal

Due to the enactment of the “Special Act for Promotion of the Development and Emergency Supply of Medical Products in Response to Public Health Crisis” so as to rapidly overcome a public health crisis (Act No. 17922, promulgated on March 9, 2021, enforced on March 9, 2021),the Act aims to set forth matters entrusted under the Act and other matters necessary for its implementation, such as the composition of the safety management and supply committee for medical products in response to public health crises, and measures for medical products approved for emergency use. 

(2) Major Provisions

A. Method of reporting abnormal cases of medical products under the follow-up survey (Article 6 Paragraph 2, Article 7 Paragraphs 1 and 2)

B. Registration of details of medical products subject to follow-up survey (Article 9 paragraph 1 and Article 10 Paragraph 1)

C. Emergency production/import order procedures (Article 12 Paragraphs 2 and 3)

D. Procedural measures to improve distribution (Article 13 Paragraphs 3 and 4)

E. Composition of the safety management and supply committee for medical products in response to public health crises (Article 2)

F. Regulations on the measures for medical products approved for emergency use (Article 3)

G. Detailed regulations on the implementation of follow-up surveys (Articles 4 through 6)

H. Registration of sales and supply details of medical products subject to follow-up surveys (Article 10)

I. Establishment of the standards for calculating penalty surcharges (Article 14)

J. Matters on the establishment and operation of a medical product information system in response to crises (Article 15)

K. Administrative regulations on processing sensitive information and unique identifiers (Article 17)

L. Standards for imposing administrative fines (Article 18)