  
  
G/TBT/N/BRA/1386  
25 May 2022  
(22-4019) 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 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  
Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of two or 
more constituents which have been mixed together for therapeutic or prophylac tic uses, 
not put up in measured doses or in forms or packings for retail sale. (HS code(s): 3003); 
Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or 
unmixed products for therapeutic or prophylactic uses, put up in measu red doses 
(including those in the form of transdermal administration systems) or in forms or 
packings for retail sale. (HS code(s): 3004)  
5. Title, number of pages and language(s) of the notified document:  Resolution 
number 688, 13 May 2022; (9 page(s), i n Portuguese)  
6. Description of content:  This Resolution contains provisions on the procedures and 
requirements for the maintenance of authorizations already granted and for new requests 
for temporary authorization for emergency use (AUE), on an experimen tal basis, of 
medicines and vaccines against Covid -19 to face the SARS -CoV-2 pandemic .  
The evaluation and authorization procedure through the EAU will only apply to new 
vaccines, provided that they are indicated by the Brazilian Ministry of Health as necessary 
to support the vaccination program in Brazil.  
For the purposes of this Resolution, it considers a listed regulatory authority to be the 
World Health Organization, regulatory authorities founding members and permanent 
members of the International Council for Harmonisation of Technical Requirements for 
Pharmaceuticals for Human Use (ICH) and the Regulatory Agency for Medicines and 
Health Products of the United Kingdom. Kingdom (MHRA).  G/TBT/N/BRA/1386  
 
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  7. Objective and rationale, including the nature of urgent probl ems where 
applicable:  Protection of human health or safety  
8. Relevant documents:   
- 
9. Proposed date of adoption:  18 May 2022  
Proposed date of entry into force:  18 May 2022  
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   
 
The final text is available only in Portuguese and can be downloaded at:  
http://antigo.anvisa.gov.br/documents/10181/6134216/RDC_688_2022_.pdf/22f4f571 -
e98d-49e6-9df7-9a39efe392e0  
 