   
  
G/TBT/N/BRA/1154/Add.3  
 
8 June 2021  
(21-4662) Page: 1/1 
Committee on Technical Barriers to Trade  Original: English  
 
NOTIFICATION  
Addendum  
The following communication , dated  8 June 2021 , is being circulated at the request of the delegation 
of Brazil . 
 
_______________  
 
 
Title: Resolution – RDC No. 516, 2 June 2021. Amendment to Collegiate Board Resolution - RDC 
No. 483 of March 19, 2021  
 
Reason for Addendum:  
[  ] Comment period changed - date:   
[  ] Notified measure adopted - date:  
[X] Notified measure published - date: 2 June 2021  
[X] Notified measure enters into force - date: 2 June 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[  ] Notified measure withdrawn or revoked - date:  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/en/web/dou/ -/resolucao -rdc-n-516-de-2-de-junho -de-2021-
323825328  
http://antigo.anvisa.gov.br/documents/10181/6245812/RDC_516_2021_.pdf/cfb3a225
-e012-47a8-8a93-b1e5036b6b8a  
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 the use in healthcare 
services due to the international public health emergency related to the SARS -CoV-2, was amended 
by Resolution – RDC  number 516, 2 June 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.  