G/TBT/N/BRA/1110  
22 December 2020  
(20-9278) 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 [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 
for human medicine (HS 300220)  
5. Title, number of pages and language(s) of the notified document:  Resolution 
number 444, 10 Decembe r 2020. (5 page(s), in Portuguese)  
6. Description of content:  This resolution establishes temporary authorization of 
emergency use, experimentally, of COVID -19 vaccines in light of the Public Health 
Emergency of National Concern due to the new coronavirus  (SARS -CoV-2) pandemic.   
7. Objective and rationale, including the nature of urgent problems where 
applicable:  As there is no provision in the existing regulations on the emergency use of 
medicines or vaccines in cases of public health emergency and that  there is an urgent 
and unmet need for vaccines for COVID -19, it is evident the need for the preparation of 
a Draft OF DRC by ANVISA that establishes minimum criteria for temporary authorization 
for emergency use of vaccines for the prevention of COVID -19 , with the objective of 
ensuring minimum requirements for safety, quality and efficacy, based even on the proper 
monitoring of these vaccines in the country. The authorization for emergency use will 
facilitate the availability and use of vaccines for COVID -19, allowing the use of vaccines 
not yet registered, but that meet minimum quality, safety and efficacy requirements.; 
Protection of human health or safety  
8. Relevant documents:   
1) Brazilian Official Gazette 236 -A on 10 December 2020, section 1 Extra A, page 1.  
https://www.in.gov.br/web/dou/ -/resolucao -de-diretoria -colegiada -rdc-n-444-de-10-de-
dezembro -de-2020-293481443  G/TBT/N/BRA/1110  
 
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  9. Proposed date of adoption:  On the day of its publication  
Proposed date of entry into force:  On the day of its publication  
10. Final date for comments:  Not applicable  
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/10181/6134216/RDC_444_2020_.pdf/f23f3e74 -
e0da-4672-ac53-d24ffeb24a85