G/TBT/N/BRA/1155  
26 March 2021  
(21-2498) 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:  The Brazilian Health Regulatory Agency  
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 2563.2840  
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); 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 3 002, 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 for retail sale (excl. goods 
of heading 30 02, 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 484, 19 March 2021. (7 page(s), in Portuguese)  
6. Description of cont ent: This resolution establishes exceptional and temporary 
procedure for the market authorization on an emergency basis of anaesthetics, sedatives, 
neuromuscular blockers, and other hospital medicines used for the maintenance of 
patients' lives use in heal thcare services to tackle the national public health emergency 
related to the outbreak of the new coronavirus (SARS -CoV-2). 
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety  G/TBT/N/BRA/1155  
 
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  8. Relevant documents:  1) Brazilian Official Gazette 53 -C on 19 March 2021, section 1, 
page 2  
https://www.in.gov.br/web/dou/ -/resolucao -rdc-n-484-de-19-de-marco-de-2021-
309501644  
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/10181/6245834/RDC_484_2021_.pdf/442fc93e -
8079-42d9-b45a-cef8ee0f70a1