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1.
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Notifying Member: Republic of Korea
If applicable, name of local government
involved (Article 3.2 and 7.2):
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2.
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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
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3.
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Notified under Article 2.9.2 [ X ],
2.10.1 [ ], 5.6.2 [ X ],
5.7.1 [ ], other:
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4.
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Products covered (HS or CCCN where
applicable, otherwise national tariff
heading. ICS numbers may be provided in addition, where
applicable): Pharmaceuticals
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5.
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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)
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6.
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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.
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7.
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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.
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8.
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Relevant documents: MFDS NOTIFICATION No. 2014-11 (May 7th,
2014)
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9.
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Proposed date of adoption:
Proposed date of entry into force:
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To be
determined
To be
determined
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10.
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Final date for comments: 60 days from date of
notification
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11.
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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
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