G/TBT/N/BRA/1149  
19 March 2021  
(21-2331) 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):  
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 for retail sale (excl. goods of heading 3002, 3005 
or 3006) (HS 3 004); 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 
prepar ations 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 475, 10 March 2021. (9 page(s), in Portuguese)  
6. Description of content:  This resolution es tablishes the procedure and technical 
requirements for the application for temporary market authorization on an emergency 
basis of medicines and vaccines for Covid -19 in experimental character to tackle the 
national public health emergency related to the o utbreak of the new coronavirus 
(SARS -CoV-2) G/TBT/N/BRA/1149  
 
- 2 - 
 
  7. Objective and rationale, including the nature of urgent problems where 
applicable:  Anvisa  has prepared RDC No. 444/20, as well as Guide No. 42/2020, which 
both deal with regulating the Temporary Authorization for Emergency Use of Vaccines. 
Still, the National Congress enacted Provisional Measure No. 1,026/2021, adding aspects 
to the Brazilian legal framework, with a direct impact on the regulatory framework then 
in force in the country. With the imposition of the sanction of The Conversion Bill No. 
1/2021, coming from the Provisional Measure, it is necessary to advance in the regulation 
of the matter so that there is no normative vacuum that imposes additional challenges to 
the confrontation of the Pandemic.; Protection of human health or safety  
8. Relevant documents:  1) Brazilian Official Gazette 47 -A on 11 March 2021, section 1, 
page 1; 2) Le gal Opinion - Exemption from Public Consultation and RIA  
https://www.in.gov.br/web/dou/ -/resolucao -rdc-n-475-de-10-de-marco -de-2021-
307999666  
http://antigo.anvisa.gov.br/documents/10181/6134216/Parecer+ -
+Dispensa+de+AIR+e+CP/ac784dea -a8c6-4f45-bac2-e907fbd4be12  
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/10181/6134216/RDC_475_2021_.pdf/a9edad40
-f6de-4d2d-891b-be84e4ee4171