TBT WTO Indonesia
Home
Regulation
Notification
FAQ
Forum
Contact Us
Login
Logout Confirmation
Apakah anda yakin
Notification Detail :: G/TBT/N/KOR/1219
Main Data
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
Reducing trade barriers and facilitating trade (TBT)
Product Covered
Medicinal Products, Pharmaceuticals
Document Notification
Link to ePing
HSCODE
ICSCODE
11.120 - Pharmaceutics
Keywords
Human health
Specific Regions
Additional Data
Description
The proposed amendments to the ”Regulation on Safety of Pharmaceuticals, etc.” are as follows:_x000D_ A. Simplification of submission for Good Manufacturing Practice (GMP) conformity assessment (Article 4, 48-bis of the draft, and attached Form 4) _x000D_ - 11 GMP submission requirements for Marketing Authorization will be simplified into 4 requirements including site master file, and in particular, for an imported API (biological product is excluded), the submission can be replaced with an internationally harmonized GMP certificate._x000D_ B. Simplification of API registration requirement (Article 15, 17 of the draft, attached Form 16 and 17) _x000D_ - Existing API registration requirement, manufacturer ‘s certificate of origin or GMP conformity assessment, will be replaced with an internationally harmonized GMP certificate._x000D_ C. Improvement of verification • inspection for extension of GMP certificate validity (Article 48-quarter of the draft)_x000D_ - A verification • inspection will be improved to extend the GMP certificate validity by verifying or inspecting by means other than on-site inspection, if the Minister of Food and Drug Safety recognizes that, for the reason including no history of significant change within the manufacturing site, as well as no natural disaster.
Notified Document
1:
File here
Link to Notification
EN:
File here
FR:
File here
ES:
File here
Status Active
Active
Inactive
Comment
No
#
Comment By
Title
Comment Date
File
Back
Link to ePing
App Settings
Dark Mode
NEW
Adjust the appearance to reduce glare and give your eyes a break.
Header Inverse
Sidebar Fixed
Sidebar Grid
TBT WTO Indonesia