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 of 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

Heungdoek-gu Cheongju-si, Chungcheongbuk-do, 363-700

Republic of Korea

Tel: (+82) 43 719-1564

Fax: (+82) 43-719-1550

Email: wtokfda@korea.kr

3.

Notified under Article 2.9.2 [ ], 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): Human tissue

5.

Title, number of pages and language(s) of the notified document: Regulations on Safety of Human Tissue (10 pages, in Korean)

6.

Description of content:

·                Provides disposal procedures at tissue banks for tissues assessed to be unsuitable for transplantation according to relevant tests

·                Strengthens provisions that tissue banks need to comply with (prohibit the distribution of tissue to persons who are not affiliated to tissue banks or transplant hospitals)

·                Establishes a deadline for the reporting of major changes of tissue banks

·                Establishes a legal basis for the re-issuing of tissue bank establishment permits and import approval certificates

·                Establishes administrative measures for cases where import tissue management status data are not prepared and displayed for review, and where recall and discard orders are not followed through

7.

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

8.

Relevant documents: MFDS Notification No. 2015-242 (28 July 2015)

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

11.

Texts available from: National enquiry point [ ] 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

E-mail: tbt@kats.go.kr

Website: http://www.knowtbt.kr

https://members.wto.org/crnattachments/2015/TBT/KOR/15_3051_00_x.pdf