G/TBT/N/BRA/757  
 
24 November 2017  
(17-6419) 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 2840 
Telefax: +(55) 21 2563  5637 
Email: barreirastecnicas@inmet ro.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): 
HS CODE:  98041000  
5. Title, number of pages and language(s) of the notified document: Draft 
Resolution  416, 8 November 2017 (Consulta Pública N° 416, de 8 de novembro de 2017) 
(12 page(s), in Portuguese)   
6. Description of content: This Draft Resolution defines the procedures and regulatory 
requirements for the reporting of clinical trials with Products Advanced Research Therapies 
in Brazil, including the Clinical Development Dossier (DDCTA), to be submitted to Anvisa 
for consent purposes.  
This Resolution DOES NOT APPLY to:  
I - clinical trials with the drugs referred to in Resolution RDC No. 9 of February 2, 2015 and 
their updates; and  
II - to post -marketing clinical trials (phase IV)  
This Resolution is applicable to clinical trials for the purpose of proving safety and efficacy, 
with Products of Advanced Research Therapies that can be registered and that will have  
their clinical development in Brazil.  
7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of Human Health  
8. Relevant documents:  (1) Brazilian Official Journal (Diá rio Oficial da União Nº 215), 
9 December 2017; Section 1 page 60. (2) Draft Resolution n° 416, 8 December 2017, 
Resolution RDC  63, 25 November 2011; Resolution RDC 172, 12 September 2017; 
(3) Brazilian Official Journal. Available in Portuguese;(4) Not stated.   G/TBT/N/BRA/757  
 
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  9. Proposed date of adoption:  To be determined after the end of consultation period  
Proposed date of entry into force:  To be determined after the end of consultation 
period  
10. Final date for comments: 15 December 2017  
11. Texts available from: National enquiry point [  ] 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: 7 1.205 -050 
Phone.: +(55) 61 3462 5402 
Website: www.anvisa.gov.br  
http://portal.anvisa.gov.br/docum ents/10181/3428326/CONSULTA+PUBLICA+N+416+GS
TCO.pdf/21c3011c -a7b2-483e-9a3c-1d02766c67fd