G/TBT/N/KOR/1048  
17 December 2021  
(21-9458) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  REPUBLIC OF KOREA   
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:  Ministry of Food and Drug Safety  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
Documents are available from the Ministry of Food and Drug safety website 
(www.mfds.go.kr ).  
Also available from:  
International Cooperation Office  
Ministry of Food and Drug Safety  
187 Osongsaengmyeong2 -ro, Osong -eup, Heungdoek -gu Cheongju -si, 
Chungcheongbuk -do, 28159  
Republic of Korea  
Tel: (+82) 43 719 -1564 
Fax: (+82) 43 -719-1550 
Email: intmfds@korea.kr  
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [X], 5.7.1 [   ], other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  
Quasi -drugs (HS code 3808.94 -0000), Quasi -drugs (HS code 9619.99 -1090); (HS: 3808, 
9619)  
5. Title,  number of pages and language(s) of the notified document:  Proposed 
amendments to the "Regulation on Quasi -drug Approval, Notification and Review" 
(16 page(s), in Korean)  
6. Description of content:  The "Regulation on Quasi -drug Approval, Notification and 
Review" is being amended by the Ministry of Food and Drug Safety (MFDS) as follows:  
A. For external disinfectants containing benzalconium chloride, spraying is being excluded 
from the instructions for use.  
B. External disinfectants that use direct containers in the form of packets or stopper -
mounted pouches are required to be indicated in packaging units that exceed 200 mL.  
C. Products used for hygienic treatment of postpartum haemorrhage or lochia 
(postpart um vaginal discharge) have been additionally designated as quasi -drugs 
(enforcement date: 1 Oct. 2021); accordingly, the scope of safety and effectiveness 
review data that need to be submitted for these products is to be defined.  G/TBT/N/KOR/1048  
 
- 2 - 
 
  7. Objective and rational e, including the nature of urgent problems where 
applicable:  Consumer information, labelling; Protection of human health or safety  
8. Relevant documents:   
• MFDS NOTIFICATION No. 2021 -572, 10 December  2021 
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  60 days from notification  
11. Texts available from:  National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
Korea WTO TBT Enquiry Point  
Technical Barriers to Trade (TBT) Division  
Korean Agency for Technology and Standards (KATS)  
93 Isu -ro Maengdong -myeon Eumseong -gun 
Chungchungbuk -do  
27737  
+(82) 43 870 5525  
+(82) 43 870 5682 (Fax)  
tbt@korea.kr  
http://www.knowtbt.kr  
https://members.wto.org/crnattachments/2021/TBT/KOR/21_7892_00_x. pdf