  
  
G/TBT/N/BRA/870/Add.3  
27 August 2019  
(19-5501) Page: 1/1 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
Addendum  
The following communication, dated 26 August 2019, is being circulated at the request of the 
delegation of Brazil .  
 
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Complementary guidelines to the manufacture of biological medicinal substances and products for 
human use  
The draft normative instruction regarding Complementary guidelines to the manufacture of biological 
medicinal substances and products for human use of the draft resolution number 653, 24 May 2019 
– previously notified through G/TBT/N/BRA/870  - was adopted as a final text, published as 
Normative Instruction number 36, 21 August 2019.  
The full text is available only in Portuguese and can be downloaded at:  
http://portal.anvisa.gov.br/documents/10181/5389382/IN_36_2019_.pdf/284462f9 -735d-4077-
9946-7f532c67afe9  
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