TBT BSN | Notification

Notification Detail :: G/TBT/N/BRA/955/Add.3

Notification No.

Notification Type

Notifying Member

Date of Notification

Final Date for Comments

Days to Final Date

Title

Draft Resolution number 760

Objective

Protection of human health or safety (TBT)

Product Covered

HS Code(s): 3003; 3004; 3005; 2941 (pharmaceutical products).

Document Notification

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HSCODE

2941 - Antibiotics; 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 in the form of transdermal administration" or in forms or packings for retail sale (excl. goods of heading 3002, 3005 or 3006); 3005 - Wadding, gauze, bandages and the like, e.g. dressings, adhesive plasters, poultices, impregnated or covered with pharmaceutical substances or put up for retail sale for medical, surgical, dental or veterinary purposes; 2941 - Antibiotics; 3005 - Wadding, gauze, bandages and the like, e.g. dressings, adhesive plasters, poultices, impregnated or covered with pharmaceutical substances or put up for retail sale for medical, surgical, dental or veterinary purposes; 3004 - Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses "incl. those in the form of 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 - Pharmaceutics; 11.120 - Pharmaceutics

Keywords

Human health; Human health

Specific Regions

Description

Resolution 742, 10 August 2022  - previously notified through G/TBT/N/BRA/955/Add.1 - which establishes the minimal technical requirements for relative bioavailability and bioequivalence studies that supports dossier of consent for clinical research, market authorization or post-market authorization of medicines, in the terms of this resolution, was changed by Resolution 942, 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_942_2024_.pdf/bf46fb32-1ddb-4ba9-abf4-e6fac15966e2

Notified Document

1:File here

Link to Notification

EN:File here

Status Active

No	#	Comment By	Title	Comment Date	File

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Notification Detail :: G/TBT/N/BRA/955/Add.3

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