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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 [ ],
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: Revised Decree of
the "Regulation on Safety of Pharmaceuticals" (29 pages, in Korean)
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6.
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Description of content:
·
Newly establish
that pharmaceutical manufacturing sites must be in conformity with
manufacturing and quality control standards. They will be issued with a
certificate (from the Minister of MFDS or, Commissioners of Regional KFDA)
that confirms the above, which is valid for 3 years. When manufacturing sites
with a valid certificate apply for drug approval, the certificate may replace
evaluation data on pharmaceutical manufacturing and quality control.
·
Revise that
when drugs under National Batch Release are used as drug substance to
manufacture pharmaceutical products, the quality evaluation process may be streamlined.
If examination result reports from the manufacturer, and a document which certifies
that the drug is under National Batch Release are submitted, only
verification tests and visual inspection may be conducted.
·
Newly establish
regulations that provide the basis for an administrative measure when those
with drug approval and importers do not comply with Good Supply Practice.
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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 mitigate
burden on companies by ensuring the distribution and manufacture of safe pharmaceutical
products through strengthened quality control and streamlining of approval
process.
·
To mitigate
burden on companies by streamlining the quality evaluation process when drugs
under National Batch Release are used as drug substance.
·
To secure the safety
and quality of pharmaceutical products by imposing administrative measures
when requirements of Good Supply Practice are not met.
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8.
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Relevant documents: MFDS NOTIFICATION No. 2014-114 (7 May 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_2374_00_x.pdf
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