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 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, Cheongwon-gun,

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 [ 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): Pharmaceuticals

5.

Title, number of pages and language(s) of the notified document: Draft Amendment of the "Enforcement Decree of the Pharmaceuticals Affairs Act" (10 pages, in Korean)

6.

Description of content:

·                Revised standards that are used in imposing administrative fines/penalty surcharges (the fine corresponding to one-day suspension of business operation is increased, etc).

·                Established the amount of fine that will be imposed to those that haven't received the education program for safety management personnel.

7.

Objective and rationale, including the nature of urgent problems where applicable: Protection of human health or safety

To rationalize the criteria for imposing administrative fines by reflecting the growth of the pharmaceutical industry since related regulations were last revised.

8.

Relevant documents: MFDS NOTIFICATION No. 2014-11 (May 7^th, 2014)

9.

Proposed date of adoption: 

Proposed date of entry into force: 

To be determined

To be determined

10.

Final date for comments: 60 days from date of notification

11.

Text available from:  National enquiry point [X], or address, telephone and fax numbers, e-mail and web-site addresses, if available of the other body:

Technical Barriers to Trade (TBT) Division

Korean Agency for Technology and Standards (KATS)

98 Gyoyukwongil, Gwacheon-si, Gyeonggi-do,

Rep. of Korea 427-716

Tel.:  (+82) 2 509 7254/7255

Fax:  (+82) 2 509 7307

E-mail:  tbt@kats.go.kr

Website:  http://www.knowtbt.kr

http://members.wto.org/crnattachments/2014/tbt/kor/14_2373_00_x.pdf