G/TBT/N/KOR/903  
9 July 2020 
(20-4730) Page: 1/3 
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, 363 -700 - 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:  Draft amendment 
of the "Regulation on Safety of Pharmaceuticals, etc." (17 page(s), in Korean)  
6. Description of content:   
1) Establishment of Criteria for Administrative disposition for where false approval is 
obtained (Proposal [Attachment 8])  
 - A new set of detailed criteria for administrative disposition for where permission or 
approval is obtained by a false or other wrongful method (e.g., revocation of approval).  
2) Reinforcement of criteria for administrative disposition for where pharmaceutical 
manufacturing, test instructions and records are falsely prepared (Proposal 
[Attac hment  8]) 
 - Reinforcement of criteria for administrative disposition for where pharmaceutical 
manufacturing, test instructions and records are not prepared or falsely prepared.  
3) Establishment of criteria for administrative disposition for where national  lot release is 
falsely permitted (Proposal [Attachment 8]).  
 - Establishment of criteria for administrative disposition for where national lot release is 
obtained by a false or other wrongful method (e.g., revocation of approval for the item)  
4) Changes t o the effective date and transitional measures for "enhancement on obligation G/TBT/N/KOR/903  
 
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  of pharmaceutical manufacturers" (Article 4 and 48 of Proposal)  
 - Notification in advance of re -legislation to shorten the effective date and transitional 
measures deadline for the pharmaceutical manufacturing and application of GMP including 
disinfectants for medical devices, which was notified in advance on 18 November 2019.  
5) Improvement of time frame for reporting changes in the registration of Active 
Pharmaceutical Ingredie nt (API) (Article 17 of Proposal)   
 - Improvement of time frame for reporting changes in the registration of Active 
Pharmaceutical Ingredient (API) from the existing deadline "by 31 January every year" to 
"by the end of the month that belongs to the date o f registration every year".  
6) Creation of the basis for exemption of analysis and testing for the person who imports 
national essential drugs (Article 60 of Proposal);  
 - The basis allows to substitute the analysis and testing for the importer with testin g 
report from original manufacturer even where the minister of Ministry of Food and Drug 
Safety recognizes that there will be likely to fail to treat the patients due to the absence of 
alternative pharmaceuticals when national essential drug supply is susp ended.  
7) Subdivisions of criteria for administrative disposition for where the manufacturing and 
testing contract acceptor violates commission/entrustment regulation (Proposal 
[Attachment 8])  
 - Distinguishment on the scope of contract acceptor's commissi on/entrustment and the 
criteria for the administrative disposition for violations of supervision responsibilities so 
that they can be applied to herbal medicines without classification of dosage forms.  
8) Reduction of criteria for administrative dispositio n for where minor changes in 
pharmaceutical approval and notification are not submitted (Proposal [Attachment 8]  
 - Reduction of criteria for administrative disposition for where the changes in 
pharmaceutical approval and notification are not submitted asi de from where approval for 
product change is not obtained.  
9) Subdivision of criteria for administrative disposition for where some of the 
Pharmaceutical Risk Management Plan (RMP) have not been implemented (Proposal 
[Attachment 8]).  
 - If a safety managem ent is not implemented according to the Pharmaceutical Risk 
Management Plan  (RMP), the criteria for the disposition is subdivided, except for unmet 
number of target,  and the criteria for the administrative disposition for where some of 
them are not impleme nted are reduced.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety  
8. Relevant documents:   
• MFDS PUBLIC NOTIFICATION No. 2020 -260 (29 Jun 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  G/TBT/N/KOR/903  
 
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  11. Texts available from:  National 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 5525  
Fax: (+82) 43 870 5682  
Email: tbt@korea.kr   
Website: http://www.knowtbt.kr  
https://members.wto.org/crnattachments/2020/TBT/KOR/20_4133_00_x.pdf