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Notification Detail :: G/TBT/N/BRA/1528/Add.1
Main Data
Notification No.
Notification Type
Notifying Member
Date of Notification
Final Date for Comments
Days to Final Date
Title
Draft resolution 1245, 20 March 2024
Objective
Protection of human health or safety (TBT)
Product Covered
Medicaments consisting of two or more constituents mixed together for therapeutic or prophylactic uses, not in measured doses or put up for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3003); 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) (HS code(s): 3004); Medicaments (ICS code(s): 11.120.10)
Document Notification
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HSCODE
3003 - Medicaments consisting of two or more constituents mixed together for therapeutic or prophylactic uses, not in measured doses or put up for retail sale (excl. goods of heading 3002, 3005 or 3006); 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); 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); 3003 - Medicaments consisting of two or more constituents mixed together for therapeutic or prophylactic uses, not in measured doses or put up for retail sale (excl. goods of heading 3002, 3005 or 3006)
ICSCODE
11.120.10 - Medicaments; 11.120.10 - Medicaments
Keywords
Human health; Human health
Specific Regions
Additional Data
Description
Draft resolution 1245, 20 March 2024 - previously notified through G/TBT/N/BRA/1528 - which contains provisions on the validation of bioanalytical methods and analysis of study samples for regulatory submissions of industrialized medicines for human use, was adopted as Resolution 641, 18 November 2024. The final text is available only in Portuguese and can be downloaded at: https://antigo.anvisa.gov.br/documents/10181/3855414/RDC_941_2024_.pdf/fd356c37-661b-4c84-8f20-8e582b4e2f3f
Notified Document
1:
File here
Link to Notification
EN:
File here
Status Active
Active
Inactive
Comment
No
#
Comment By
Title
Comment Date
File
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