TBT BSN | Notification

Notification Detail :: G/TBT/N/KOR/40

Notification No.

Notification Type

Notifying Member

Date of Notification

Final Date for Comments

Days to Final Date

Title

Draft Amendment of "The Regulation on Review of application for manufacturing·importing license of drug·quasi-drug" (2 pages, available in Korean)

Objective

Product Covered

Pharmaceuticals

Document Notification

Link to ePing

HSCODE

ICSCODE

Keywords

Specific Regions

Description

1)	In the case of extraction and fractionation, the solvent should be purified water, ethanol or spirit in principle. When other solvents are used, the documents on safety and efficacy of the solvent should be submitted. 2)	In case ingredients originating from an animal are contained in final products or used in manufacturing process, the name of the animal and the part of the animal should be indicated. Additionally, selecting (originating country, age of ruminants) or processing methods, etc. for preventing transmission of Transmissible Sponge-form Encephalopathy(TSE) should be indicated in the case of using ingredients originating from ruminants. 3)	When finished products are imported in packaged-form or bulk, the manufacturing method should be mentioned. 4)	In case a drug which has been designated as a new drug is listed in the Korean Pharmacopoeia or official compendium which is recognized by KFDA, the designation of new drug can be cancelled.

Notified Document

Link to Notification

EN:File here

FR:File here

ES:File here

Status Active

No	#	Comment By	Title	Comment Date	File

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Notification Detail :: G/TBT/N/KOR/40

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