G/TBT/N/KOR/647  
 
1 June 2016  
(16-2935)  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  : 
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) 43719–1564 
Fax: (+82) 43–719–1550 
Email: wtokfda@korea.kr   
3. Notified under Article 2.9.2 [ ], 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): Pharmaceutical 
products 
5. Title, number of pages and language(s) of the notified document: Proposed 
amendments to the Pharmaceutical Affairs Act (65 pages, in Korean) 
6. Description of content: 
 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 medical products. The amount of penalty surcharge shall not exceed 5% of total amount of 
production/imports in the previous year. 
 The head of a clinical trial institution may ask the commissioner of the Ministry of 
Food and Drug Safety for the assessment of safety and efficacy of off – label uses.  
 The name of all quasi – drugs should be specified. And if the information on the 
container or the packaging of the quasi – drug is physically unreadable due to 
being covered by external containers or packaging, the same information should also be indicated on the external containers or packaging. 
7. Objective and rationale, including the nature of urgent problems where applicable: 
 To strengthen safety control of foreign drugs by establishing a legal basis for 
foreign inspections of pharmaceutical manufacturing plants 
 To improve public health and actual effectiveness of administrative disposition by 
imposing a penalty surcharge on a manufacturer/importer of SSFFC, not exceeding 
5% of total amount of production/imports in the previous year 
 To evaluate the safety and efficacy of drugs for off label use in a systemic and 
comprehensive way and enhance its follow – up management 
 To provide accurate information on quasi – drugs to protect consumers G/TBT/N/KOR/647 
 
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  8. Relevant documents:  
 MFDS NOTIFICATION No. 2016–195 (May 23, 2016) 
 This notification is related to G/TBT/N/KOR/574, notified on 15th April 2015, and 
contents of regulation have been relieved comparing to previous one. 
9. Proposed date of adoption: To be determined 
Proposed date of entry into force : To be determined   
10. Final date for comments: 27 May 2016 
11. Texts available from : National enquir y point [ ] 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 
27737, Republic of Korea  Tel.: (+82) 43 870 5525 
Fax: (+82) 43 870 5682 
Email: tbt@kats.go.kr   
Website: http://www.knowtbt.kr   
https://members. wto.org/crnattachments/2 016/TBT/KOR/16_2086_00_x.pdf