G/TBT/N/BRA/814  
 
31 May 2018  
(18-3260) 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 2563.2765  
Telefax: +(55) 21 2563.5637  
Email: barreirastecnicas@inmet ro.gov.br   
Web-site: www.inmetro.gov.br/barreirastecnicas  
The comments to this Draft Regulation shall be sent to  
http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=33294  
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): Improve 
knowledge of existing, emerging and innovative technologies, subsidizing the processes of 
evaluation of technologies and production of regulations in Sanitary Surveillance  
5. Title, number of pages and language(s) of the notified document: Public call 
number 2, 21 May 2018 - Portuguese.   
6. Description of content: This Public Call aims to promote a collaborative environment 
between the Anvisa, industry, academic -scientific community and third sector in the search 
to increase the safety and effectiveness of products and services to be made available to 
the Brazilian population; improve knowledge of existing, emerging and innovative 
technologies, subsidizing the processes of evaluation of technologies and production of 
regulations in Sanitary Surveillance; Improve critical thinking and proble m solving by 
better understanding difficulties, challenges and regulatory needs in the development cycle 
of innovative and emerging technologies; establish transparent and universal criteria and 
procedures for partnerships with the various actors involved and interested in the 
evaluation of technologies and the production of regulations in Health Surveillance;  
The main themes are: Regulation and Registration of Health Products; Regulation of Blood, 
Tissues, Cells and Organs; Regulation and Registration of F ood Products; Regulation of 
Agrochemicals; Regulation of Technologies in Health Services; Monitoring of Products 
subject to Health Surveillance and Emergency Information Management in Health 
Surveillance  
7. Objective and rationale, including the nature of  urgent problems where 
applicable: Protection of Human Health  G/TBT/N/BRA/814  
 
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  8. Relevant documents:  Nota Técnica n ° 67/2015/CGNOR/DENOP/SEGEP/MP; Resolução 
ANVISA da Diretoria Colegiada - RDC n ° 2, de 15 de janeiro de 2007; Instrução Normativa 
ANVISA n ° 15, de 13 de abr il de 2017; Consulta Pública Nº485/2018 .  
9. Proposed date of adoption:  Not applicable  
Proposed date of entry into force:  Not applicable  
10. Final date for comments: Not stated  
11. Texts available from: National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:   
Agency Responsible  
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://www.imprensanacional.gov.br/web/guest/materia/ -
/asset_publisher/Kujrw0TZC2Mb/content/id/15358016/do3 -2018-05-22-aviso-de-
chamamento -publico -n-2-de-21-de-maio-de-2018-15358012