TBT BSN | Notification

Notification Detail :: G/TBT/N/KOR/1185

Notification No.

Notification Type

Notifying Member

Date of Notification

Final Date for Comments

Days to Final Date

Title

Proposed amendments to the “ENFORCEMENT DECREE OF THE PHARMACEUTICAL AFFAIRS ACT”

Objective

Other (TBT)

Product Covered

Pharmaceuticals

Document Notification

Link to ePing

HSCODE

ICSCODE

11.120 - Pharmaceutics

Keywords

Human health

Specific Regions

Description

To implement the revision of the Act without difficulties by establishing specific criteria for the fine in the case of failure to report the reason for expiration of priority marketing authorization, which is responsible by the law, with the revision of  [Pharmaceutical Affairs Act] (Act No, 19652, promulgation Date 16 Aug,2023, Enforcement Date 17, Feb,2024,), which includes that a person who obtained a priority marketing authorization that can market a medicine in priority to the identical medicine by receiving judgement or decision that means the medicine doesn't fall within the invalidity or the scope of patent right shall report it to the Minister of Ministry of Food and Drug Safety when a reason arises to the patent to expire.

Notified Document

1:File here

Link to Notification

EN:File here

Status Active

No	#	Comment By	Title	Comment Date	File

Back

Notification Detail :: G/TBT/N/KOR/1185

Link to ePing

App Settings