   
  
G/TBT/N/BRA/870/Add.28  
 
6 December 2021  
(21-9182) 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: Normative Instruction number 35, 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/IN_109_2021_.pdf/16c9c2d3 -
d346-4317-be12-301824a95a5b  
[  ] Notified measure withdrawn or revoked - date:  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 Normative Instruction number 35, 21 August 2019 - previously notified through 
G/TBT/N/BRA/870/Add.2 - which establishes Complementary guidelines to the manufacture of sterile 
medicinal products, was changed by Normative Instruction number 109, 26 Novem ber  2021.  
The final text is available only in Portuguese and can be downloaded at:   
 
http://antigo.anvisa.gov.br/documents/10181/6359 266/IN_109_2021_.pdf/16c9c2d3 -d346-4317-
be12-301824a95a5b  
__________  
 
 
 
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.  