  
  
G/TBT/N/BRA/955  
9 January 2020  
(20-0203) 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 2563.2840  
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 differe nt from above:   
The Brazilian Health Regulatory Agency  
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): 3003; 3004; 3005; 2941 (pharmaceutical products).  
5. Title, number of pages and language(s) of the notified document:   
Draft Resolution number 760, December 27th, 2019. Number of pages: 38; 
Language(s): Portuguese Draft: Comment 
form: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao =52824  
6. Description of content:  This Draft Resolution establishes the minimal technical 
requirements for relative bioavailability and bioequivalence studies that supports dossier 
of consent for clinical research,  market authorization or post -market auth orization of 
medicines, in the terms of this resolution.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health.  
8. Relevant documents:   
Impact Assessment Report  
9. Proposed date of adoption:  365 days after the date of  its publication.  
Proposed date of entry into force:  365 days after the date of its publication.  
10. Final date for comments:  7 April 2020  G/TBT/N/BRA/955  
 
- 2 - 
 
  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/10181/5740831/C onsulta+P%C3%BAblica+n%C
2%BA+760 -2019.pdf/e7555e7d -f87d-4190-bb10-82ec5fd13e61  
 