G/TBT/N/KOR/905  
13 July 2020  
(20-4785) 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 
E-mail: intmfds@korea.kr  
Website: www.mfds.go.kr  
3. Notified under Article 2.9.2 [   ], 2.10.1 [   ], 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  in 
the form of transdermal administration" or in forms or packings for retail sale (excl. 
medicaments containing antibiotics, medicaments containing hormones or steroids used as 
hormones, but not containing antibiotics, medicaments containing alkaloids or  derivates 
thereof but not containing hormones or antibiotics and medicaments containing 
provitamins, vitamins or derivates thereof used as vitamins) (HS 300490)  
5. Title, number of pages and language(s) of the notified document:  The draft 
regulation on t he "Review and Approval of Advanced Biological Products" (94 page(s), in 
Korean)  
6. Description of content:  As the Act on the Safety and Support of Advanced Biological 
Products was established, the Regulations on the Review and Approval of Advanced 
Biolog ical Products was enacted to stipulate document requirements and evaluation criteria 
for the approval of advanced biological products.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Adoption of Domestic Law; Protecti on of human health or safety; Other  G/TBT/N/KOR/905  
 
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  8. Relevant documents:   
• MFDS NOTIFICATION No. 2020 -282 (3 July 2020);  
• G/TBT/N/KOR/891 - The enactment of enforcement rules for advanced biological 
products regarding safety and support (27 April 2020).  
9. Proposed date of adoption:  28 August 2020  
Proposed date of entry into force:  28 August 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:   
Technical Barriers to Trade (TBT) Division  
Korean Agency for Technology and Standards (KATS)  
93, Isu -ro, Maengdong -myeon, Eumseong -gun, Chungcheongbuk -do, Republic of Korea, 
27737  
Tel.: (+82) 43 870 5525  
Fax: (+82) 43 870 5682  
E-mail: tbt@korea.kr   
Website: http://www.knowtbt.kr  
https://members.wto.org/crnattachments/2020/TBT/KOR/20_4173_00_x.pdf