G/TBT/N/BRA/1499  
11 September 2023  
(23-5994) 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):  Medical 
equipment (ICS code(s): 11.040)  
5. Title, number of pages and language(s) of the notified document:  Draft resolution 
1201, 01 September 2023; (7 page(s), in Portuguese)  
6. Description of content:  This Draf t Resolution contains provisions on the criteria for 
acceptance of toxicological evaluations of Technical Products for registration purposes 
resulting from decisions by the Equivalent Foreign Regulatory Authority (AREE).  
For the purposes of adopting the optimized analysis procedure, the following will be 
considered following AREE:  
I - European Food Safety Authority – European Food Safety Authority (EFSA);  
II - North American Environmental Protection Agency - United States Environmental 
Protec tion Agency (EPA);  
III - Australian Pesticides and Veterinary Medicines Authority -Australian Pesticides and 
Veterinary Medicines Authority (APVMA);  
IV – Ministry of Health of Canada – Health Canada Pest Management Regulatory Agency 
(PMRA);  
V - Ministry of  Health, Labor and Welfare of Japan - Ministry of Health, Labor and Welfare 
of Japan (MHLW) or Ministry of Agriculture, Forestry and Fisheries of Japan - Ministry of 
Agriculture, Forestry and Fisheries of Japan (JMAFF).  G/TBT/N/BRA/1499  
 
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  7. Objective and rationale, includi ng the nature of urgent problems where 
applicable:  This draft resolution is expected to strengthen the regulatory capacity of the 
Anvisa, through toxicological analysis work for registration purposes through the analogy 
process, or that is, optimized analy sis, or even the performance of collaborative work. 
What will make it possible to use Anvisa's resources in a more strategic way, contributing 
to the qualification of the staff and consequently with the institutional strengthening of 
the Agency, allowing a n increase in the effectiveness of the work carried out and a better 
delivery to society.; 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  
10. Final date for comments:  9 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/10181/6649855/CONSULTA+P%C3%9ABLICA+
N+1201+GGTOX.pdf/f6fdd5ea -b0c6-4757-8788-1f300b2056ca  Comment form: 
https://pesquisa.anvisa.gov.br/index.php/771261?lang=pt -BR The comment form link 
will be available only on 11 September 2023.  
https://members.wto.org/crnattachments/2023/TBT/BRA/23_12 218_00_x.pdf