  
  
G/TBT/N/BRA/902  
21 August 2019  
(19-5369) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  BRAZIL   
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
National Institute of Metrology, Quality and Technology (INMETRO)  
Telephone: +(55) 21 2563.2918  
Telefax: +(55) 21 2563.5637  
Email: barreirastecnicas@inmetro.gov.br   
Website: www.inmetro.gov.br/barreirastecnicas  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicat ed if different from above:   
Brazilian Health Regulatory Agency (ANVISA)  
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Biological 
products  
5. Title, number of pages and language(s) of the notified document:  Draft Normative 
Instruction number 686, August 12th, 2019. Published on D.O.U, August 14th, 2019. 
Language(s): Portuguese. Number of pages: 54.  
6. Description of content:  This draft resolution proposes an initiative for the revision of the 
Resolution – RDC number 49, September 20th, 2011, which establishes post -market 
authorization alterations of biological produc ts. 
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of Human Health  
8. Relevant documents:  RDC number 49, September 20th, 2011  
9. Proposed date of adoption:  To be determined after the end of the consultation period.  
Proposed date of entry into force:  120 days after the date of its publication.  
10. Final date for comments:  21 October 2019  G/TBT/N/BRA/902  
 
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  11. Texts available from:  National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
Brazilian Health Regulatory Agency (Anvisa)  
SIA, Trecho 5, Área Especial 57  
Brasília – DF/Brazil  
CEP: 71.205 -050 
Phone.: +(55) 61 3462.5402  
Website: www.anvisa.gov.br  
http://pesquisa.in.gov.br/imprensa/jsp/visualiza/index.jsp?data=14/08/2019&jornal=515&
pagina=73  
 