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Notification Detail :: G/TBT/N/PHL/303
Main Data
Notification No.
Notification Type
Notifying Member
Date of Notification
Final Date for Comments
Days to Final Date
Title
Guidelines on the Publishing of Package Insert and Patient Information Leaflet of Registered Drug Products in the Food and Drug Administration (FDA) Verification Portal System
Objective
Protection of human health or safety (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 proposed policy aims to provide guidelines to all Marketing Authorization Holders (MAHs) of drug products on the publishing of the package insert and patient information leaflet of registered drug products. This Circular shall also provide the healthcare professionals and consumers with the latest information on drug safety and use, through PI and PIL publication on the FDA Verification Portal System.
Notified Document
1:
File here
2:
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
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