G/TBT/N/BRA/844  
 
11 October 2018  
(18-6300) 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: Brazilian Health Regulatory Agency (Anvisa)  
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 different from above:   
National Institute of Metrology, Quality and Technology (INMETRO)  
Telephone: +(55) 21 2563.2918  
Telefax: +(55) 21 2563.5637  
Email: barreirastecnicas@inmet ro.gov.br   
Web-site: www.inmetro.gov.br/barreirastecnicas   
The comments to this Draft Regulation shall be sent to  
http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=29311  
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): Vaccines  
5. Title, number of pages and language(s) of the notified document: Regarding 
procedures related to the commercialization and utilization of influenza vaccines in 2019 
published by the Brazilian official Gazette (1 page(s), in Portuguese)    
6. Description of  content: Resolution -RE, 4 October 2018, regarding procedures related to 
the commercialization and usage of influenza vaccines in 2019.  
This Resolution establishes that the trivalent influenza vaccines used in Brazil from 
February 2019 on must contain, necessarily, a combination of three types of virus strains, 
and must be in accordance with the specifications below:  
- one virus similar to influenza virus A/Michigan/45/2015 (H1N1) pdm09;  
- one virus similar to influenza virus A/Switzerland/8060/2017 (H3N 2); 
- one virus similar to influenza virus B/Colorado/06/2017 (strain B/Victoria/2/87).  
It is recommended that the component A (H3N2) of non -based on eggs vaccines for usage 
on influenza period of 2019 be one type of A/Singapore/INFIMH -16- 0019/2016 virus in 
addition to the others vaccines components described above.  
This Resolution also establishes that the tetravalent influenza vaccines containing two 
types of virus strains influenza B must contain one virus similar to influenza 
B/Phuket/3073/2013 (strain  B/Yamagata/16/88), additionally to the three strains types 
specified above.  G/TBT/N/BRA/844  
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of Human Health  
8. Relevant documents:  (1) Brazilian Official Journal (Diário Oficial da União) Nº193, 
05 October 2018, section 1, page 64; (2) Resolution - RDC nº 61, 3 February 2016; 
Resolution - RDC nº 151, 20 April 2017; (3) Brazilian Official Journal; (4) Not applicable   
9. Proposed date of adoption: On the date of this public ation 
Proposed date of entry into force: On the date of publication  
10. Final date for comments: Not applicable  
11. Texts available from: National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:   
Agency Responsible  
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://portal.anvisa.gov.br/documents/10181/2718376/RE_2714_2018_.pdf/6a3990d4 -
53cf-489f-b944-7e6ddbf4657c