   
  
G/TBT/N/BRA/841/Add.1  
 
11 August 2020  
(20-5509) Page: 1/1 
Committee on Technical Barriers to Trade  Original: English  
 
NOTIFICATION  
Addendum  
The following communication , dated  6 August 2020 , is being circulated at the request of the 
delegation of Brazil . 
 
_______________  
 
 
Title: Good Pharmacovigilance Practices to be watched by all the registration holder of medicine for 
human use  
 
Reason for Addendum:  
[  ] Comment period changed - date:   
[X] Notified measure adopted - date: 22 July 2020  
[  ] Notified measure published - date:  
[  ] Notified measure enters into force - date:  
[X] Text of final measure available from1:  
http://portal.anvisa.gov.br/documents/10181/ 4858873/RDC_406_2020_.pdf/c62cdded
-e779-4021-858d-852edbd90178  
[  ] Notified measure withdrawn or revoked - date:  
Relevant symbol if measure re -notified:   
[  ] Content or scope of notified measure changed  
New deadline for comments (if applicable):   
[  ] Interpretive guidance issued and text available from1:  
[  ] Other:  
 
Description:  The Draft Resolution number 551, 3 September 2018 – previously notified through 
G/TBT/N/BRA/841 – which establishes the Good Pharmacovigilance Practices to be watched by all 
the registration holder of medicine for human use, was adopted as Resolution – RDC number 406, 
22 July 2020.  
 
__________  
 
 
 
1 This information can be provided by including a website address, a pdf attachment, or other 
information on where the text of the final measure and/or interpretive guidance can be obtained.  