G/TBT/N/BRA/1150  
19 March 2021  
(21-2326) 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):  Antibiotics 
(HS 2941); Vaccines for human medicine (HS 300220); Medicaments consisting of two 
or more constituents mixed together for therapeutic or prophylactic uses, not in measured 
doses or put up for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS 3003); 
Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic 
uses, put up in measured doses "incl. those for transdermal administration" or in forms 
or packings f or retail sale (excl. goods of heading 3002, 3005 or 3006) (HS 3004); 
Wadding, gauze, bandages and the like, e.g. dressings, adhesive plasters, poultices, 
impregnated or covered with pharmaceutical substances or put up for retail sale for 
medical, surgical , dental or veterinary purposes (HS 3005); Pharmaceutical preparations 
and products of subheadings 3006.10.10 to 3006.60.90 (HS 3006)  
5. Title, number of pages and language(s) of the notified document:  Resolution – 
RDC number 476, 10 March 2021. (12 page( s), in Portuguese)  
6. Description of content:  This resolution establishes the procedure and technical 
requirements for the submission of temporary and exceptional market authorization 
application for the import and distribution of medicines and vaccines f or Covid -19 to tackle 
the national public health emergency related to the outbreak of the new coronavirus 
(SARS -CoV-2) in accordance with the Law number 14.124, 10 March 2021.  
7. Objective and rationale, including the nature of urgent problems where 
appli cable:  Protection of human health or safety  G/TBT/N/BRA/1150  
 
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  8. Relevant documents:  1) Brazilian Official Gazette 47 -A on 11 March 2021, section 1, 
page 2; 2) Law No. 14124, 10 March 2021.  
https://www.in.gov.br/web/dou/ -/resolucao -rdc-n-476-de-10-de-marco -de-2021-
307999746  
http://www.planalto.gov.br/ccivil_03/_ato2019 -2022/2021/lei/L14124.htm  
9. Proposed date of adoption:  In the date of its publication  
Proposed date of entry into force:  In the date of its publication  
10. Final date for comments:  Not applied  
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/10181/6240597/RDC_476_2021_COMP.pdf/6c0
77803 -fc71-4120-90a7-73c609156e76