   
  
G/TBT/N/BRA/1154/Add.5  
 
12 August 2021  
(21-6193) Page: 1/1 
Committee on Technical Barriers to Trade  Original: English  
 
 
NOTIFICATION  
Addendum  
The following communication , dated  12 August 2021 , is being circulated at the request of the 
delegation of Brazil . 
 
_______________  
 
 
Title: Amendment of ANVISA Resolution number 483, 19 March, 2021.  
 
Reason for Addendum:  
[  ] Comment period changed - date:   
[  ] Notified measure adopted - date:  
[X] Notified measure published - date: 6 August 2021  
[X] Notified measure enters into force - date: 6 August 2021  
[  ] Text of final measure available from1:  
[  ] Notified measure withdrawn or revoked - date:  
Relevant symbol if measure re -notified:   
[X] Content or scope of notified measure changed  and text available from1: 
https://www.in.gov.br/web/dou/ -/resolucao -de-diretoria -colegiada -rdc-n-531-de-4-de-
agosto -de-2021-336657231  
http://antigo.anvisa.gov.br/documents/10181/6245812/RDC_531_2021_.pdf/8a51929
c-cfff-40d3-88a6-5754dbf913a2  
New deadline for comments (if applicable):   
[  ] Interpretive guidance issued and text available from1:  
[  ] Other:  
 
Description:  ANVISA Resolution number 483, 19 March 2021 - previously notified 
through G/TBT/N/BRA/1154 - which establishes exceptional and temporary technical requirements 
for the import of new medical devices and medicines identified as indispensable for use in heal thcare 
services due to the international public health emergency related to the SARS -CoV-2, was amended 
by Resolution - number 531, 4 August 2021.  
__________  
 
 
 
1 This information can be provided by including a website address, a pdf attachment, or other 
information on where the text of the final /modified  measure and/or interpretive guidance can be obtained.  