   
  
G/TBT/N/BRA/1032/Add.2  
 
26 March 2021  
(21-2526) Page: 1/1 
Committee on Technical Barriers to Trade  Original: English  
 
 
NOTIFICATION  
Addendum  
The following communication , dated  26 March 2021 , is being circulated at the request of the 
delegation of Brazil . 
 
_______________  
 
 
Title: Resolution – RDC number 482, 19 March 2021  
 
Reason for Addendum:  
[  ] Comment period changed - date:   
[  ] Notified measure adopted - date:  
[X] Notified measure published - date: 19 March 2021  
[X] Notified measure enters into force - date: 19 March 2021  
[X] Text of final measure available from1:  
https://www.in.gov.br/web/dou/ -/resolucao -rdc-n-482-de-19-de-marco -de-2021-
309557127  
http://antigo.anvisa.gov.br/documents/10181/5893706/RDC_482_2021_.pdf/12dc0b3
2-f1e3-4489-b913-e57a9354e41a  
[  ] Notified measure withdrawn or revoked - date:  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:  The Resolution – RDC number 392, 26 May 2020 – previously notified through 
G/TBT/N/BRA/1032  – which establishes temporary and extraordinary criteria for the application of 
exceptionalities to specific technical requirement s of the Good Manufacturing and Import Practice of 
Medicinal Products and Active Pharmaceutical Ingredients, due to the international public health 
emergency of the new coronavirus (Covid -19) – was changed by the Resolution – RDC number 482, 
19 March 2021.  This resolution establishes exceptionalities for the use of non -medicinal oxygen 
cylinder, industrial cylinder filling ramps for the filling of medicinal cylinders, and industrial gas filling 
unit for the filling of medicinal gases.  
The final text is avai lable only in Portuguese and can be downloaded at:  
http://antigo.anvisa.gov.br/documents/10181/5893706/RDC_482_2021_.pdf/12dc0b32 -f1e3-
4489-b913-e57a9354e41a  
__________  
 
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.  