G/TBT/N/KOR/552
5 February 2015 
(15-0772)  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 [   ], 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  
Regulation on Good Manufacturing Practice for Medicinal Products (229 pages, in Korean)     
6. Description of content: Content of this draft regulation is as follows:  
• Detailed guidelines and principles of good manufacturing practice for medicinal 
product are defined and mandated. Annexes from 1 to 16 to this regulation are equivalent to the annexes of the PIC/S GMP Guide (except for Annexe 4, 5, 16 and 
20 which are outside the jurisdiction of MFDS or are not required by PIC/S); 
• For GMP Certificate of GMP Compliance of a Manufacturer, the effective period for an 
initial certificate is 3 years from the date of issue and for subsequent certificates, 
and its effective period is also 3 years from the GMP inspection date. It is defined 
that if there are any changes within the effe ctive period of the certificate issued, the 
existing period will st ill remain effective; 
• Peritoneal Dialysis Solutions/Agents, Irrigations, Ophthalmic Solutions, Ophthalmic 
Ointments, and Sterile API are added to th e subject to evaluation of GMP compliance 
of a manufacturer for approval of medicinal products even though GMP certificate is within effective period. 
7. Objective and rationale, including the nature of urgent problems where applicable: 
Protection of human health or safety and harmonizing with international GMP standards  G/TBT/N/KOR/552 
 
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  8. Relevant documents:  MFDS Notification No. 2015-35 (30 January 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 date of 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 
https://members. wto.org/crnattachments/2 015/TBT/KOR/15_0657_00_x.PDF