TBT BSN | Notification

Notification Detail :: G/TBT/N/KOR/32

Notification No.

Notification Type

Notifying Member

Date of Notification

Final Date for Comments

Days to Final Date

Title

Amendment of "Pharmaceutical law enforcement regulation" 58 pages, in Korean)

Objective

Product Covered

Pharmaceuticals

Document Notification

Link to ePing

HSCODE

ICSCODE

Keywords

Specific Regions

Description

When applying for approval of manufacture or importation of a pharmaceutical product, the following documents should be submitted. 1.	Gene combinant medicine, cell culture medicine, biological product, cell treatment remedy & gene treatment remedy:  documents to prove it compatible with GMP & biological GMP 2.	Raw medicine for listing-up 	-	documents on facilities for manufacture & quality control; 	-	document on physio-chemical properties and stability; 	-	document to prove it compatible with GMP or equal (or over) to GMP; 	-	document on certificate of analysis on raw medicine. Re-examination can be exempted when: 3.	The number of subject pool for surveillance is too small to satisfy the requirement for re-examination.

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/32

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