G/TBT/N/KOR/914  
1 September 2020  
(20-5951) 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:   
International Cooperation Office  
Ministry of Food and Drug Safety  
187 Osongsaengmyeong2 -ro, Osong -eup, Heungdoek -gu Cheongju -si, 
Chungcheongbuk -do, 28159  
Republic of Korea  
Tel: (+82) 43 719 -1564 
Fax: (+82) 43 -719-1550 
Email: intmfds@korea.kr  
Website: www.mfds.go.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):  
Pharmaceuticals  
5. Title, number of pages and language(s) of the notified document:  Revision of the 
'Pharmaceutical Affairs Act' (7 page(s), in Korean)  G/TBT/N/KOR/914  
 
- 2 - 
 
  6. Description of content:  1) Cla rification of review criteria for registration of 
pharmaceutical patent list (Article 50 -2, paragraph 6)  
- The requirements for registration of the current patent list are limited to basic 
information such as the presence or absence of patent applications and direct relevance 
to approval matters, thus, specific review criteria for the patent for subject to be 
registered, proofs of direct relevance will be established by delegating it to the sub -
regulations.  
2) Introduction of provision for restricting the deletion of registration of patent list related 
marketing exclusivity (Article 50 -3, paragraph 5)  
- Where the patent challenge for a registered patent is succeeded and the exclusive 
marketing approval is granted, the system shall be supplem ented and operated by 
enabling the registration to be maintained for the period of marketing exclusivity even if 
the registered patentee requests to delete the registered patent.  
3) Clarification of the scope of the same product that the marketing is preve nted according 
to marketing exclusivity (Article 50 -9, paragraph 1)  
- The scope of the marketing prevention of the same pharmaceutical product according 
to the exclusive marketing approval shall be defined by clarifying the pharmaceutical 
which product app roval is granted after the application date of exclusive marketing 
approval.  
4) Exemption from payment of the registration fee where the deletion of the registration 
of the patent list related to exclusive marketing approval is restricted (Article 82 -2, 
paragraph 1)   
- Where the deletion of the registration is restricted for the period of marketing 
exclusivity, the patent registrant's obligation shall be exempt even if the patent registrant 
requests to delete the registration pursuant to Article 50 -3, parag raph 5.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety  
8. Relevant documents:   
MFDS PUBLIC NOTICE No.2020 -359 (20 August 2020)  
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 [X] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
Korea WTO TBT Enquiry Point  
Technical Barriers to Trade (TBT) Division  
Korean Agency for Technology and Standards (KATS)  
93 Isu -ro Maengdong -myeon Eumseong -gun 
Chungchungbuk -do  
27737  
+(82) 43 870 5525  
+(82) 43 870 5682 (Fax)  
tbt@korea.kr  
http://www.knowtbt.kr  
https://members.wto.org/crnattachments/2020/TBT/KOR/20_5225_00_x. pdf