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Notification Detail :: G/TBT/N/PHL/308
Main Data
Notification No.
Notification Type
Notifying Member
Date of Notification
Final Date for Comments
Days to Final Date
Title
Application Process and Requirements for Post-Approval Changes of Biological Products Adopting the World Health Organization Guidelines for Changes to Approved Vaccines and Biotherapeutic Products for Human Use
Objective
Other (TBT)
Product Covered
Pharmaceutics (ICS code(s): 11.120)
Document Notification
Link to ePing
HSCODE
ICSCODE
11.120 - Pharmaceutics
Keywords
Human health
Specific Regions
Additional Data
Description
The objectives of this Circular are:1. To promulgate the revised requirements in instituting post-approval changes to registered biological products, incorporating the WHO and country-specific requirements; and_x000D_ 2. To provide the application process for post-approval changes.
Notified Document
1:
File here
2:
File here
3:
File here
4:
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
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