G/TBT/N/BRA/1449  
26 September 2022  
(22-7202) 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 prophylactic 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 measured 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:  Draft resolution 
number 1115, 15 September 2022; (3 page(s), in Portuguese)  
6. Description of content:  This Draft Resolution proposes to establish a special procedure 
for the approval of clinical trials, certification of good manufacturing practices, and market 
authorization of new drugs for the treatment, diagnosis or prevention of rare diseases.  
The text of this draft resolution was rectified.  
The rectified text is available only in Portuguese at:  
https://www.in.gov.br/en/web/dou/ -/retificacao -431296155  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Suspending the obligation to hold a pre -submission meeting exclusively for 
clinical trial consent.; Protection of human health or safety  G/TBT/N/BRA/1449  
 
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  8. Relevant documents:   
 
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  12 October 2022  
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:  
Draft: 
http://antigo.anvisa.gov.br/documents/10181/6491463/%281%29CONSULTA+P%C3%
9ABLICA+N+1115+DIRE2.pdf/2fc6a739 -1b81-4aa0-a177-1818422101f3  Comment 
form: https://pesquisa.anvisa.gov.br/index.php/531375?newtest=Y&lang=pt -BR