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[Press Release, Sept. 16] Easy to file an objection against injury from adverse drug reaction
  • Registration Date 2020-10-07
  • Hit 285
[Press Release, Sept. 16 / Unofficial translation]



Easy to file an objection against injury from adverse drug reaction
- A Legislative Notice of the revision of ENFORCEMENT DECREE FOR REGULATIONS ON RELIEF OF INJURY FROM ADVERSE DRUG REACTION



□ The Ministry of Food and Drug Safety (MFDS, Minister Lee Eui-Kyung) announced to make a legislative notice of the revision of ENFORCEMENT DECREE FOR REGULATIONS ON RELIEF OF INJURY FROM ADVERSE DRUG REACTION to strengthen the right of a claimer of the relief of injury from adverse drug reaction.
* Relief system for adverse drug reactions: In case when non-fault injury like death, disorder, and disease occur despite the normal use of drugs, patients and the family of the deceased is reimbursed of temporary compensation payment for death and disorder, funeral expenses, and medical expenses.


□ The revision is to improve the system for the claimers to file an objection to the director of Korea Institute of Drug Safety & Risk Management (KIDS) in person if there’s an objection against the results of the relief for adverse drug reactions.

○ Until now, claimers could raise an objection only through administrative appeal system. Through the revision, the claimers can exercise their rights more easily.


□ The MFDS stated that the expansion of relief for adverse drug reactions is expected through the revision, and the Ministry will further improve the “Relief system for adverse drug reactions” to function as a safety net which can provide benefits to Korean citizens.

○ For more information about the revision, please visit the MFDS webpage (www.mfds.go.kr) or Law Making Center webpage (opinion.lawmaking.go.kr).
※ Relief for adverse drug reactions : Consultation and registration available via Korea Institute of Drug Safety & Risk Management webpage (drugsafe.or.kr) or phone call (1644-6223).
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