G/TBT/N/KOR/761  
 
27 April 2018  
(18-2643) 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 Food and Drug safety website www.mfds.go.kr . 
Also available from:  
International Cooperation Office  
Ministry of Food a nd Drug Safety  
187 Osongsaengmyeong2 -ro, Osong -eup, Heungdeok -gu, Cheongju -si, Chungcheongbuk -
do, Republic of Korea 363 -700  
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): Narcotics  
5. Title, number of pages and language(s) of the notified document: Proposed 
amendments to the "Enforcement Regulations of the Narcotics Control Act" (27 page(s), in 
Korean)   
6. Description of content: The proposed amendments seek to:  
- Establish a legal basis in order to include information required to be provided on 
containers/ packaging under the Pharmaceutical Affairs Act in the Enforcement Rules of 
Narcotics Controls Act such as the indication of all ingredients, usage, dosage, dir ection for 
use, warning signs, and prescription drug labels (if applicable).  
 - Specify persons responsible for providing required information of narcotics drugs or 
psychoactive substances on containers and packaging as follows: manufacturers, 
importers, exporters, and users of raw materials thereof.   
 - Establish a legal basis in order to allow the omission of certain information provided on 
containers/packaging of standard preparations or reagents for medical use containing 
narcotic drugs or psychoactive  substances while indicating item codes, generated through 
Narcotics Information Management System, on the containers/packaging thereof.   
7. Objective and rationale, including the nature of urgent problems where 
applicable: Consumer information, labelling  G/TBT/N/KOR/761  
 
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  8. Relevant documents:  MFDS PUBLIC NOTICE No 2018 -088 (9 March 2018)   
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  1 year after the date of adoption  
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, 
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/2018/TBT/KOR/18_2259_00_x.pdf