  
  
G/TBT/N/BRA/1503  
19 September 2023  
(23-6216) 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 (ICS code(s): 11.120.10)  
5. Title, number of pages and language(s) of the notified document:  Draft resolution 
1204, 14 September 2023; (5 page(s), in Portuguese)  
6. Description of content:  This Draft R esolution contains provisions on the health 
requirements relating to non -clinical safety studies for the market authorization of 
industrialized medicines for human use.  
The non -clinical studies of medication safety of this draft resolution must follow guidelines 
from The International Council for Harmonisation of Technical Requirements for 
Pharmaceuticals for Human Use (ICH)  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  This draft resolution aims to mainta in convergence with international 
standards.; Protection of human health or safety  
8. Relevant documents:  - 
 
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  G/TBT/N/BRA/1503  
 
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  10. Final date for comments:  6 November 2023  
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/10181/6654999/CONSULTA+P%C3%9ABLICA+
N+1204+GGMED.pdf/f2ee27e8 -8e79-44c7-992c-2042453a4ce5  Comment form: 
https://pesquisa.anvisa.gov.br/index.php/591814?lang=pt -BR The comment form link is 
going to be available on 22 September 2023.  
https://members.wto.org/crnattachments/2023/TBT/BRA/23_12452_00_x.pdf  
 