   
  
G/TBT/N/BRA/782/Add.1  
 
22 August 2023  
(23-5629) Page: 1/1 
Committee on Technical Barriers to Trade  Original: English  
 
NOTIFICATION  
Addendum  
The following communication , dated  21 August 2023, is being circulated at the request of the 
delegation of Brazil . 
 
_______________  
 
 
Title:  RDC Nº 204, December 27th, 2017  
 
Reason for Addendum:  
[ ] Comment period changed - date:   
[ ] Notified measure adopted - date:  
[ ] Notified measure published - date:  
[ ] Notified measure enters into force - date:  
[ ] 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[ ] Notified measure withdrawn or revoked - date:  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:  
RDC 811/2023  
http://antigo.anvisa.gov.br/documents/10181/6298833/RDC_811_2023_.pdf/5882959
d-e982-4c7a-8460-042199a9d8bf  
https://members.wto.org/crnattachments/2023/TBT/BRA/modification/23_11930_00_x
.pdf 
New deadli ne for comments (if applicable):   
[ ] Interpretive guidance issued and text available from1:  
[ ] Other:  
 
Description:  RDC Nº 204, December 27th, 2017 - previously notified throughG/TBT/N/BRA/782 - 
which provides for the classification in the priority category, of registration petitions, post registration 
and prior consent in clinical trial of medicines., was changed by Resolution 811, 18 August 2023  
The final text is available only in Portuguese and can be downloaded at:  
http://antigo.anvisa.gov.br/documents/10181/6298833/RDC_811_2023_.pdf/5882959d -e982-
4c7a-8460-042199a9d8bf  
__________  
 
 
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.  