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Notification Detail :: G/TBT/N/KOR/1232
Main Data
Notification No.
Notification Type
Notifying Member
Date of Notification
Final Date for Comments
Days to Final Date
Title
Proposed amendments to the “Enforcement Rule of the Safety and Support of the Advanced Biopahrmaceutical Products”
Objective
Other (TBT)
Product Covered
Advanced biopharmaceutical products
Document Notification
Link to ePing
HSCODE
ICSCODE
11.120 - Pharmaceutics
Keywords
Human health
Specific Regions
Additional Data
Description
The Ministry of Food and Drug Safety of the Republic of Korea intends to amend the Enforcement Rule of the Safety and Support of the Advanced Biopharmaceutical Products to include the following:_x000D_ - Establishment of fee standards for the application for approval of new drugs among advanced biopharmaceutical products_x000D_ - Raising fees of customized technical documents review by the field of newly developed drugs in compliance with approval_x000D_ - Establishment of standards for reducing fees of newly developed drugs
Notified Document
1:
File here
Link to Notification
EN:
File here
FR:
File here
ES:
File here
Status Active
Active
Inactive
Comment
No
#
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Title
Comment Date
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