   
  
G/TBT/N/BRA/1069  
 
2 September 2020  
(20-5966) 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 f rom above:   
National Institute of Metrology, Quality and Technology (INMETRO)  
Telephone: +(55) 21 2145.3817  
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):  
Provitamins and vitamins, natural or reproduced by synthesis (including natural 
concentrates), derivatives thereof used primarily as vitamins, and intermixtures of the 
foregoing, whether or not in any solvent (HS 29 36); Hormones, natural or reproduced by 
synthesis; derivatives thereof, used primarily as hormones; other steroids used primarily 
as hormones (HS 2937); Pharmaceutical products (HS 30)  
5. Title, number of pages and language(s) of the notified document:  Draft Normative 
Instruction number 877, 23 July, 2020 (2 page(s), in Portuguese)  
6. Description of content:  This draft normative instruction establishes the list of medical 
devices selected to economic monitoring by Anvisa.  
Comment form:  http://formsus.data sus.gov.br/site/formulario.php?id_aplicacao=58342  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety  
8. Relevant documents:   
1) Brazilian Official Gazette 144 on 29 July 2020, section 1, page 71 2) RIA report  
https://www.in.gov.br/web/dou/ -/consulta -publica -n-877-de-23-de-julho-de-2020-
269154981  
http://portal.anvisa.gov.br/documents/10181/4247877/Re lat%C3%B3rio+de+AIR+sob
re+Monitoramento+Econ%C3%B4mico+de+Produtos+para+Sa%C3%BAde+no+Brasil.
pdf/2f9b1ce3 -ae07-46c2-a2d6-503ccdf4c4eb  G/TBT/N/BRA/1069  
 
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  9. Proposed date of adoption:  To be determined after the end of the consultation period  
Proposed date of entry into force:  To be determined after the end of the consultation 
period  
10. Final date for comments:  5 October 2020  
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://portal.anvisa.gov.br/documents/10181/4247877/CONSULTA+P%C3%9ABLICA+
N+877+GECOR.pdf/d61f9281 -0f24-4850-82c0-ea97ea1bab6d  
 