G/TBT/N/KOR/574  
 
15 April 2015  
(15-2022)  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 telephon e 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 ( http://www.mfds.go.kr ) 
Also available from: 
International Cooperation Office Ministry of Food and Drug Safety 187 Osongsaengmyeong2-ro 
Osong-eup, Heungdeok-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 [X], 5.7.1 [ ], other:  
4. Products covered (HS or CCCN where applic able, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable): Pharmaceuticals 
5. Title, number of pages and language(s) of the notified document: Proposed 
amendments to the Pharmaceutical Affairs Act (76 pages, in Korean) 
6. Description of content: The main contents are as (but not restricted to) the following:  
 To establish a legal basis to register foreign drug manufacturing plants and perform 
foreign inspections; 
 A penalty shall be imposed on a manufacturer/importer of 
substandard/spurious/falsely labelled/falsified/counterfeit drugs. The amount of penalty surcharge shall not exceed 5% of th e total amount of production/imports in 
the previous year; 
 The head of a clinical trial institution may apply to the Ministry of Food and Drug 
Safety the assessment of safety and efficacy of off-label uses. The Ministry of Food and Drug Safety shall classify the obtained information by grade and may place a 
restriction on off-label use if the off-label use is inappropriate; 
 Regarding the labelling of quasi-drugs, the name and use-by date of all quasi-drugs 
should be specified. If the information on the container or the packaging of the 
quasi-drug is physically unreadable because it is covered by external containers or 
packaging, the same information should also be indicated on the external containers or packaging. G/TBT/N/KOR/574 
 
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  7. Objective and rationale, including the nature of urgent problems where applicable: 
Protection of human health or safety 
8. Relevant documents:  MFDS Notification No. 2015-110 (10 April 2015) 
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: Nati onal 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 55 20 
https://members. wto.org/crnattachments/2 015/TBT/KOR/15_1610_00_x.pdf