TBT BSN | Notification

Notification Detail :: G/TBT/N/BRA/1376/Add.2

Notification No.

Notification Type

Notifying Member

Date of Notification

Final Date for Comments

Days to Final Date

Title

Resolution – RDC number 621, 09 March 2022

Objective

Protection of human health or safety (TBT)

Product Covered

HS (3003-3004) - Medicaments

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); 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); 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

Description

Resolution – RDC number 621, 09 March 2022 - previously notified through G/TBT/N/BRA/1376- which contains provisions on petitions for license requests, license renewals, post-qualification modifications, testing outsourcing, suspensions and cancellations  of Pharmaceutical Equivalence Centers, was revoked by Resolution 927, 20 September 2024. The final text is available only in Portuguese and can be downloaded at: https://antigo.anvisa.gov.br/documents/10181/6874029/RDC_927_2024_.pdf/63167a0c-94c3-48ea-b226-035dbad5b698

Notified Document

Link to Notification

EN:File here

FR:File here

ES:File here

Status Active

No	#	Comment By	Title	Comment Date	File

Back

Notification Detail :: G/TBT/N/BRA/1376/Add.2

Link to ePing

App Settings