G/TBT/N/KOR/759  
 
23 April 2018  
(18-2519) 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, Heungdoek -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 applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable): Biological 
Products  
5. Title, number of pages and language(s) of the notified document: Proposed 
amendments to the " Regulation on Approval and  Review of Biological Products." 
(31 page(s), in Korean)   
6. Description of content:  
 Whereas the products with the same strength of act ive ingredients, dosage form 
and route of administration for each unit dose are approved as one product, 
orphan drugs can be approved as separate products.  
 Domestic pharmaceutical companies may manufacture drugs using contract -
manufacturing in overseas man ufacturing facilities, which are established or whose 
shares are largely held by the domestic pharmaceutical companies. Importers of 
pharmaceuticals may also entrust part of the manufacturing process of import 
products to domestic manufacturers.  
 If pharmac eutical companies change strains of the approved influenza vaccines, 
the products should be reviewed in order to ensure safety and efficacy.  
 The approved ph armaceuticals described as "in -house packaging units" or G/TBT/N/KOR/759  
 
- 2 - 
 
  "manufacturer’s packaging units"  did not in dicate the specific packaging unit 
information under the current regulation . As a result, consumers couldn' t check the 
dosage or the total number of drugs in circulation. Under the amended regulation, 
however, more detailed packaging unit information of ap proved drugs will be 
provided.  
 The amended regulation provides bases that can be used to subject orphan drugs 
to re-examination upon consent of the applicant company.  
 Please refer to the attached document for information on other revisions to the 
Regulation.  
7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of human health or safety; Protection of consumer health  
8. Relevant documents:  MFDS N otification  No. 2018 -145 (6 April 2018)   
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 [  ] 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 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_2134_00_x.pdf