G/TBT/N/KOR/921  
23 September 2020  
(20-6455) 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:   
International Cooperation Office  
Ministry of Food and Drug Safety  
187 Osongsaengmyeong2 -ro, Osong -eup, Heungdeok -gu Cheongju -si, 
Chungcheongbuk -do, 28159  
Republic of Korea  
Tel: (+82) 43 719 -1564 
Fax: (+82) 43 -719-1550 
Email: intmfds@korea.kr  
Website: www.mfds.go.kr   
3. Notified under Article 2.9.2 [   ], 2.10.1 [X], 5.6.2 [   ], 5.7.1 [X], other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Advanced 
Biological Products (HS: 3004 -90-9900); Medicaments consisting of mixed or unmixed 
products for therapeutic or prophylactic purposes, put up in measured doses "incl. those 
for tr ansdermal administration" or in forms or packings for retail sale (excl. containing 
antibiotics, hormones or steroids used as hormones, alkaloids, provitamins, vitamins, 
their derivatives or antimalarial active principles) (HS 300490)  
5. Title, number of pages and language(s) of the notified document:  The draft 
regulation on the Approval of Advanced Biopharmaceuticals and the Safety about 
Advanced Biological Products (37 page(s), in Korean)  
6. Description of content:  Republic of Korea is proposing the reg ulation on the "Approval 
of Advanced Biopharmaceuticals and the Safety about Advanced Biological Products". The 
main contents  are: 
As the Act on the Safety and Support of Advanced Biological Products was established, 
the regulations on the approval of adva nced biopharmaceuticals and the regulation on 
safety about biological products was enacted to stipulate document requirements and 
evaluation criteria.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety  G/TBT/N/KOR/921  
 
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  8. Relevant documents:   
Ministry of Food and Drug Safety Public Notice No.2020 -378 (31 August 2020)  
9. Proposed date of adoption:  7 September 2020  
Proposed date of entry into force:  7 September 2020  
10. Final date for comments:  20 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/2020/TBT/KOR/20_5693_00_x.pdf