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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:

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 [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): Quasi-drugs

5.

Title, number of pages and language(s) of the notified document: Proposed amendments to the "Regulation on Quasi-Drug Approval, Notification and Review" (36 pages, in Korean)

6.

Description of content: Expand the designation of products containing problematic ingredients regarding safety and efficacy: inhalants and other types of products containing polyhexamethylene guanidine hydrochloride (PHMG), Oligo (2-(2-ethyoxy) ethoxyethylguanidium chloride (PGH), products containing more than 0.05% of Cetylpyridinium chloride (CPC), and products containing dipropylisocinchomeronate.

Adjust the allowed range of use for preservatives in quasi-drug by only allowing the use of methylchloro-isothiazolinone and methylisothia-zolinone for external preparations and under 0.0015%.

For products that are same (in ingredient, specification, dosage, type, efficacy, etc.) as a quasi-drug that has undergone re-evaluation, mandate the submission of safety and efficacy data (clinical, toxicity).

7.

Objective and rationale, including the nature of urgent problems where applicable: For balanced review of quasi-drug products' approval, notification and examination and strengthened safety management.

8.

Relevant documents: MFDS Notification No. 2015-352 (9 November 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_4566_00_x.pdf