G/TBT/N/BRA/736  
 
18 August 2017  
(17-4434) 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 (A nvisa)  
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 Metr ology, Quality and Technology (INMETRO)  
Telephone: +(55) 21 2563.2765  
Telefax: +(55) 21 2563.5637  
Email: barreirastecnicas@inmetro.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):  Pharmaceutical 
Products  
5. Title, number of pages  and language(s)  of the notified document:  RDC Nº 168, 
8 August  2017 (3 page(s), in Portuguese)    
6. Description of content:  This Resolution provides for the administrative procedure related 
to Anvisa's prior consent for the granti ng of patents for pharmaceutical products and 
processes, regulated by Joint Ordinance ANVISA -INPI nº 01, of 12 April 2017.  
The prior consent procedure will begin with fowarding of the application by INPI to Anvisa, 
pursuant to art. 2 of Joint Ordinance No.  1, of 12 April  2017.  
Upon receipt of patent applications forwarded by INPI, Anvisa will analyze such requests in 
the light of public health and will conclude by consent or non -consent based on a technical 
evaluation by the competent organizational unit wi thin ANVISA.  
The petitions and documents referred to in this Resolution will be received in accordance 
with Anvisa's specific protocol regulation.  
The provisions of this Resolution also apply to current patent applications and those who 
have closed the adm inistrative instance within Anvisa .  
Resolutions RDC - nº 45, of 20 June 2008 and RDC - nº 21, of 10 April 2013 are revoked.  
This Resolution shall enter into force on the date of its publication.  
7. Objective and rationale , including the nature of urgent problems where applicable: 
Protection of Human Health  G/TBT/N/BRA/736  
 
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  8. Relevant documents:   
1) Brazilian Official Journal (Diário Oficial da União), 153, 1 0 August 2017; Section 1, 
p. 52; 2) Resolution RDC 61, 3 February 2016 (Resolução RDC Nº 61, de 3 de fevereiro de 
2016); Law 9.782, 26 January 1999; 3) Brazilian Official Journal; 4) Not stated.   
9. Proposed date of adoption: On the date of its publication  
Proposed date of entry into force: On the date of its publication  
10. Final date for comments:  Not applicable  
11. Texts available from : National enquiry point  [X] or address, telephone and fax 
number s and e mail and website address es, if available , of other body:   
http://portal.anvisa.gov.br/documents/10181/3506177/RDC_168_2017_.pdf/793d53f7 -
2e00-460e-bf21-bedb722ac033