  
  
G/TBT/N/BRA/932  
5 November 2019  
(19-7475) 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   
Web-site: 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 indicated if differ ent 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):  HS 
Code(s): 30022000 (Vaccines)  
5. Title, number of pages and language(s) of the notified document:  Resolution – RE 
number 3076, October 31st, 2019 (1 page(s), in Portuguese)  
6. Description of content:  This resolution establishes the technical requirements for the 
influenza vaccines commercialization from February 2020. The influenza trivalent vaccine 
must contain, necessarily, three types of combined virus strains, and be according to 
specifications described below:  
- a virus similar to influenza A/Brisbane/02/2018 (H1N1)pdm09 virus;  
- a virus similar to virus influenza A/South Australia/34/2019 (H3N2 ) virus; and  
- a virus similar to virus influenza B/Washington/02/2019 (strain B/Victoria) virus.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of Human Health  
8. Relevant documents:   
• Resolution – RE number 2735, October 2nd, 2019  
9. Proposed date of adoption:  In the date of its publication  
Proposed date of entry into force:  In the date of its publication  G/TBT/N/BRA/932  
 
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  10. Final date for comments:  Not applied.  
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=01/11/2019&jornal=5
15&pagina=148  
 