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1
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Notifying Member
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Republic of Korea
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2
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Title of new legislation/procedure
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'Regulations
on the Safety of Human Tissues'
(Subordinate
legislation of 'Safety, management, etc. of human tissue act')
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3
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Date of Publication
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4 December 2019
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4
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Date of entry into force
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4 December 2019
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5
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Website link/Official publication of the new
regulation/procedure
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Korean Law Information Center https://law.go.kr/LSW/eng/engMain.do?eventGubun=060124
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6
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Have you attached a copy of the regulation (PDF)
to the Secretariat
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[X] Yes. (Please attach a copy of
the regulation to the notification.)
[ ] No.
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7
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Type of notification
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[ ] (a) New licensing regulation/procedure[2];
(please answer question 8 to 14)
[X] (b) Changes to a regulation/procedure which has
been previously notified in document: (please answer question
15 and 16)
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8
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List of products subject to licensing
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9
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Nature of licensing
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Automatic: [ ]
Non-Automatic: [ ]
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10
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Administrative purpose/measure being implemented
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(a)
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Protect public morals;
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(b)
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Protect human, animal or plant life and health; protect environment;
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(c)
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Collect trade statistics or market surveillance;
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(d)
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Protection of patents, trademarks and copyrights, and the prevention
of deceptive practices;
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(e)
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Pursue obligations under the UN Charter and other international
treaties (i.e. CITES, Basel Convention, Rotterdam
Convention, UNSC Resolutions etc.)
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(f)
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Quota (including TRQ) administration;
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(g)
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Regulate imports of arms, ammunition or fissionable materials and
safeguard national security;
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11
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Administrative body(ies) for
submission of applications
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12
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Contact point for information on eligibility
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13
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Expected duration of licensing procedure
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14
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A
summary of the notification in one of the WTO official languages
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15
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In
the case of 7(b), please indicate the type of new change(s)
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(a)
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Termination
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(b)
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Suspension
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(c)
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Modification of specific details in
existing
procedures:
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Product coverage;
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Administrative purpose;
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Automatic or Non-automatic;
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Duration of licensing;
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Change the nature of quantity/value
restriction;
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Eligibility of applicants;
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Contact information on eligibility;
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Administrative body(ies) for submission of
application;
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Documentation requirements (including
application form);
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Period for Application;
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Administrative body(ies) to issue licence;
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Processing time for issuing licence;
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Licence fee/administrative charge;
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Deposit/advance payment and relevant
conditions;
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Appeal regulations/procedures;
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Validity of licence;
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Other conditions of licence (extension,
transferability, penalty of non-use etc.);
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Foreign exchange requirements;
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Other: __________ (please
specify).
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16
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Please
elaborate the changes in detail (in one of the official WTO languages)
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Registration and Modification of Exporting
Country Manufacturing Establishments for Human Tissue Imports
When the head of a tissue bank intends to import
human tissues, the exporting country's manufacturing establishment must be
registered with the Ministry of Food and Drug Safety submitting a foreign
manufacturer registration application form accompanied by a copy of the
establishment authorization of the tissue bank and a copy of the certificate
of import authorization for human tissues.
For amendments to existing registration, the tissue bank shall submit
the foreign manufacturer registration amendment application with supporting
documentation evidencing the relevant changes.
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