  
  
G/TBT/N/BRA/784 /Add.1  
19 July 2019  
(19-4809) Page: 1/1 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
Addendum  
The following communication, dated 19 July 2019, is being circulated at the request of the delegation 
of Brazil .  
 
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The Resolution - RDC nº 293, 15 July 2019, changes article 19 of the RDC n ° 205, 28 December 
2017, notified through G/TBT/N/BRA/784 – that establishes special procedure for approval of clinical 
trials, good manufacturing practices certification and registration of new medicines for treatment, 
diagnosis or prevention of rare disea ses. 
From: "The companies that submit a requirement of market authorization for new medicines 
according to the criteria of this resolution must submit the dossier for definition of maximum price 
concomitant with the protocol of the solicitation of market a uthorization"  
To: "The companies that submit a requirement of market authorization for new medicines according 
to the criteria of this resolution will have a deadline of 30 days to submit the dossier for definition 
of maximum price from the first business day after the publication of the market authorization of 
the medicine".  
This resolution enters into force in the date its publication.    
The full text is available only in Portuguese and be downloaded at:  
http://pesquisa.in.gov.br/imprensa/jsp/visualiza/index.jsp?jornal=515&pagina=41&data=17/07/2
019  
http://portal.anvisa.gov.br/documents/10181/5457360/RDC_293_2019_.pdf/8c805184 -fb4a-
47dc-9c0f-a24312de2779  
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