TBT BSN | Notification

Notification Detail :: G/TBT/N/BRA/1467/Add.2

Notification No.

Notification Type

Notifying Member

Date of Notification

Final Date for Comments

Days to Final Date

Title

Draft resolution number 1136, 26 December 2022

Objective

Protection of human health or safety (TBT)

Product Covered

Medicaments (ICS code(s): 11.120.10)

Document Notification

Link to ePing

HSCODE

30 - PHARMACEUTICAL PRODUCTS; 30 - PHARMACEUTICAL PRODUCTS

ICSCODE

11.120.10 - Medicaments; 11.120.10 - Medicaments

Keywords

Specific Regions

Description

Draft resolution 1136, 26 December 2022 - previously notified through G/TBT/N/BRA/1467  - which is regarded to a proposal to define the general guidelines for the pilot implementation of the optimized analysis procedure, based on risk criteria, to confirm the suitability of the documentation submitted to Anvisa for marketing authorization and post-marketing authorization changes to medicines., was adopted as Resolution 823, 19 October 2023.The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/documents/10181/6531732/RDC_823_2023_.pdf/097b9a99-6230-4f87-ba03-2c0738c4860f

Notified Document

Link to Notification

EN:File here

FR:File here

ES:File here

Status Active

No	#	Comment By	Title	Comment Date	File

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Notification Detail :: G/TBT/N/BRA/1467/Add.2

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