G/TBT/N/KOR/1062  
10 March 2022  
(22-2182) 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, H eungdoek -gu Cheongju -si, 
Chungcheongbuk -do, 363 -700  
Republic of Korea  
Tel: (+82) 43 719 -1564 
Fax: (+82) 43 -719-1550 
Email: wtokfda@korea.kr  
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [   ], 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):  
Pharmaceuticals; PHARMACEUTICAL PRODUCTS (HS 30)  
5. Title, number of pages and language(s) of the notified document:  Proposed 
amendments to The Korean Pharmacopoeia (21 page(s), in Korean)  
6. Description of content:  The purpose of the revision is to secure pharmaceutical quality 
control based on achieved international harmonization of criteria/specification in Korean 
Pharmacopoeia, to improve some criteria/specifications and general tests to the latest 
scientific level with reflecting opinions from the pharmaceutical industries, ultimately, to 
advance criteria/specifications and circ ulate high quality pharmaceuticals.  
A. To improve test's accuracy including accurate calibration and dissolution test (changed 
from fluorometry or ultraviolet -visible spectrophotometry to chromatography (High 
Performance Liquid Chromatography))  
B. To improve process on test solutions and reference solutions based on solubility. To 
utilize spectrometry (Infrared Spectroscopy) and chromatography instead of quantitative 
test 
7. Objective and rationale, including the nature of urgent problems where 
applic able:  To compensate the inadequacies of the current operating system; Other  G/TBT/N/KOR/1062  
 
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  8. Relevant documents:   
Notification No. 2022 -110 by MFDS (February 24, 2022)  
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:   
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, 
369-811 
Tel.: (+82) 43 870 5521 Fax: (+82) 43 870 5682  
E-mail: tbt@kats.go.kr  Website: http://www.knowtbt.kr  
https://members.wto.org/crnattachments/2022/TBT/KOR/22_2076_00_x.pdf