Pharmaceuticals

Enforcement Decree of Act on Encouragement of Development and Emergency Distribution of Medical Countermeasures for Public Health Emergency (25 page(s), in Korean)

1) Establishment of Establishment of Committee for Safety Management and Circulation of Medical Countermeasures (MCs) for Public Health Emergency (PHE) (Article 2 of the draft)

Central administrative agency for establishment of Committee for Safety Management and Circulation of Countermeasures (MCs) for Public Health Emergency(PHE), which was designated from the decree, has been designated (10 government departments including Ministry of Economy and Finance)

2) Measure for the medical products granted EUA (Article 3 of the draft)

A decision on the measure such as manufacturing, import prohibition, recall abandonment and discontinuance of use for the medical products obtained EUA following consultation with Committee for Safety Management and Circulation of MCs for PHE shall be allowed

3) Details for implementation of tracking (from Article 4 to 6)

Designation of agencies who are responsible for implementing tracking such as KIDS and NIDS, target, scope, process and method of tracking have been specified

4) Reporting method and details on adverse event concerning medical products to be traced (Article 7 of the draft)

The adverse event shall be reported to KIDS or NIDS within 15 days of recognizing it (within 7 days of recognizing it which leads to death)

5) Registration of administration details and written consent procedure (Article 8 and 9 of the draft)

Procedures for registration of administration details to be traced (by doctor, dentist, pharmacist) and written consent have been specified

6) Procedure for registration of marketing and distribution details (Article 10 of the draft)

Procedures for registration of marketing and distribution of medical products to be traced have been specified

7) Procedure for executive order to manufacture and import (Article 12 of the draft)

Content, procedure and notification method for executive order to manufacture and import of MCs for PHE have been specified

8) Procedure for intervention for MCs distribution (Article 13 of the draft)

Content, procedure and notification method for intervention for MCs distribution have been specified

9) Establishment and operation of MCs for PHE information system (Article 15 of the draft)

MCs for PHE information system infrastructure and operation have been specified

10) Establishment of standards for calculating fines (Article 14 and 18 of the draft)

11) Dealing with personally identifiable information (Article 17 of the draft)

Dealing with personally identifiable information including identification number has been specified