   
  
G/TBT/N/BRA/870/Add.27  
 
7 December 2021  
(21-9181) Page: 1/1 
Committee on Technical Barriers to Trade  Original: English  
 
 
NOTIFICATION  
  Addendum  
The following communication , dated  6 December 2021 , is being circulated at the request of the 
delegation of Brazil . 
 
_______________  
 
 
Title: Resolution – RDC number 301, 21 August 2019  
 
Reason for Addendum:  
[  ] Comment period changed - date:   
[  ] Notified measure adopted - date:  
[  ] Notified measure published - date:  
[X] Notified measure enters into force - date: 1 December 2021  
[X] Text of final measure available from1: 
http://antigo.anvisa.gov.br/documents/10181/6359266/RDC_580_2021_.pdf/e949883
2-cfe6-43f3-b175-0986c6bc5d5c  
[  ] Notified measure withdrawn or revoked - date:  
Relevant symbol if measure re -notified:   
[  ] Content or scope of notified measure changed  and text available from1:  
New deadline for comments (if applicable):   
[  ] Interpretive guidance issued and text available from1:  
[  ] Other:  
 
Description:  Resolution – RDC number 301, 21 August 2019 - previously notified through  
G/TBT/N/BRA/870/Add.1 - which establishes  Good Practice Guidelines for the Manufacture of 
Medicines, was changed Resolution – RDC number 580, 26 November 2021.    
The final text is available only in Portuguese and can be downloaded at:   
http://antigo.anvisa.gov.br/documents/10181/6359266/RDC_580_2021_.pdf/e949883 2-cfe6-
43f3-b175-0986c6bc5d5c  
__________  
 
 
 
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.  