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Notification Detail :: G/TBT/N/RUS/143
Main Data
Notification No.
Notification Type
Notifying Member
Date of Notification
Final Date for Comments
Days to Final Date
Title
Draft amendments to the Rules for Conducting Bioequivalence Studies of Medicines in the Eurasian Economic UnionĀ
Objective
Protection of human health or safety (TBT)
Product Covered
3004 (Medicinal products)
Document Notification
Link to ePing
HSCODE
3004 - Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses "incl. those for transdermal administration" or in forms or packings for retail sale (excl. goods of heading 3002, 3005 or 3006)
ICSCODE
11.120 - Pharmaceutics
Keywords
Human health
Specific Regions
Additional Data
Description
The draft decision envisages the updating of:a unified approach to the selection of a reference medicine;requirements for a biovaver based on a biopharmaceutical classification system taking into account 5 years of law enforcement practice, international experience and changes in bioequivalence research technologies for biovaver medicines
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
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Link to ePing
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