  
  
G/TBT/N/BRA/918  
3 October 2019  
(19-6386) 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:   
National Institute of Metrology, Quality and Technology (INMETRO)  
Telephone: +(55) 21 2563.2918  
Telefax: +(55) 21 2563.5637  
Email: barreirastecnicas@inmetro.gov.br   
Web-site: www.inmetro.gov.br/barreirastecnicas  
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 differ ent from above:   
Brazilian Health Regulatory Agency (ANVISA)  
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):  HS 
Code(s): 300210, 30029010 (blood plasma and blood derivates ) 
5. Title, number of pages and language(s) of the notified document:   
Draft resolution number 727, 25 September 2019. Comment form: 
http://formsus.datasus.g ov.br/site/formulario.php?id_aplicacao=50589  (17 page(s), in 
Portuguese)  
6. Description of content:  This draft resolution establishes the technical requirements of 
good practice for obtaining, processing, distribution, and use of surplus from blood banks 
that supply blood plasma as processing material for blood derivates manufacture.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health.  
8. Relevant documents:   
(1) Brazilian Official Journal (Diário Oficial da União) 191, 02  October 2019, section 1, 
page 802; (2) Not applied; (3) Brazilian Official Journal; (4) Not applied  
9. Proposed date of adoption:  To be determined after the end of the consultation period.  
Proposed date of entry i nto force:  To be determined after the end of the consultation 
period.  
10. Final date for comments:  9 December 2019  G/TBT/N/BRA/918  
 
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  11. Texts available from:  National enquiry point [X] 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/10181/5648805/SEI_ANVISA+ -+0748935+ -
+Consulta+P%C3%BAblica+N%C2%B0+727.pd f/57c0b964 -c4d9-4cfe-be53-
967334f35240  
http://pesquisa.in.gov.br/imprensa/jsp/visualiza/index.jsp?data=02/10/2019&jornal=5
15&pagina=802  
 