TBT BSN | Notification

Notification Detail :: G/TBT/N/KOR/1227

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 Safety of Pharmaceuticals, etc.”

Objective

Other (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 Safety of Pharmaceuticals, etc.” are as follows:_x000D_
A. Specification of submission and follow up of Risk Management Plan (Article 4 and 8 of the draft) _x000D_
     To specify the data including legal sources that the person, who already obtained marketing authorization for the product provided with its Risk Management Plan, is required to summit when applying for another marketing authorization for new product or change._x000D_
B. Streamlined process of approval for change  (Article 8) _x000D_
     To provide a legal basis for addressing changes in the medical product item together with approval for or notification of change, in case an application for approval for change in pharmaceutical manufacturing business (import) is submitted due to the change of manufacturer (importer) name or business site._x000D_
C. Specification of subject and items to be disclosed for data protection (newly established Article 21 bis)_x000D_
     To specify the pharmaceuticals subject to data protection to be determined by Ordinance of Prime Minister under  the Pharmaceutical Affairs Act and the items to be disclosed including product name, manufacturer name and protection period_x000D_
D. Specification of the subject for submission of a risk management plan (newly established Article 23 bis)_x000D_
     To specify the product to establish a Risk Management Plan to be determined by Ordinance of Prime Minister under the Pharmaceutical Affairs Act

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/1227

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