TBT BSN | Notification

Notification Detail :: G/TBT/N/KOR/1218

Notification No.

Notification Type

Notifying Member

Date of Notification

Final Date for Comments

Days to Final Date

Title

Proposed partial amendments to the ”Regulation on the Registration of Drug Substance

Objective

Cost saving and productivity enhancement (TBT)

Product Covered

Medicinal Products, Pharmaceuticals

Document Notification

Link to ePing

HSCODE

ICSCODE

11.120 - Pharmaceutics

Keywords

Human health

Specific Regions

Description

The proposed amendments to the ”Regulation on the Registration of Drug Substance” are as follows:_x000D_
A. to clarify the expert in the medicine and pharmacy who reviewed  translated documents for registration of drug substance and allow English translation of submitted documents written in other foreign languages. (Article 3 of the draft)_x000D_
B. to simplify the requirement for registration of drug substance  by replacing Good Manufacturing Practice (GMP) inspection with submission of a GMP certificate and modify the relevant provisions (Article 4 and 5 of the draft and Annex 2)

Notified Document

1:File here

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/1218

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