  
  
G/TBT/N/BRA/1136  
15 February 2021  
(21-1250) 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 2145.3817  
Telefax: +(55) 21 2563.5637  
Email: barreirastecnicas@inmetro.gov.br   
Web-site: www.inmetro.gov.br/barreirastecnicas  
3. Notified under Article 2.9.2 [   ], 2.10.1 [X], 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 
for human medicine (HS 300220)  
5. Title, number of pages and language(s) of the notified document:  Resolution – 
RDC number 465, 9 February 2021. (4 page(s), in Portuguese)  
6. Description of  content:  This Resolution establishes the exemption of market 
authorization and emergency use authorization and the procedure for the import and 
monitoring of Covid -19 vaccines acquired by the Ministry of Health within the scope of 
The Global Alliance for Vaccines and Immunization Covid -19 (Covax Facility) for the 
tackling the Public Health Emergency of National Concern related to the new coronavirus 
pandemic (SARS -CoV-2). 
7. Objective and rationale, including the nature of urgent problems where 
applicable : Public health emergency of national importance due to the outbreak of the 
new coronavirus (SARS -CoV-2); Protection of human health or safety  
8. Relevant documents:  1) Brazilian Official Gazette 27 -A on 09 February 2021, section 1 
Extra A, page 1.  
https://www.in.gov.br/web/dou/ -/resolucao -rdc-n-465-de-9-de-fevereiro -de-2021-
303002180  
9. Proposed date of adoption:  In the date of its publication  
Prop osed date of entry into force:  9 February 2021  
10. Final date for comments:  Not applied  G/TBT/N/BRA/1136  
 
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  11. Texts available from:  National enquiry point [ ] 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://antigo.anvisa.gov.br/documents/10181/6226224/RDC_465_2021_.pdf/ffc79c3d -
7872-44df-ae8c-96f40094af7a  
https://www.in.gov.br/web/dou/ -/resolucao -rdc-n-465-de-9-de-fevereiro -de-2021-
303002180  
 