G/TBT/N/BRA/731  
 
8 August 2017  
(17-4287) 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=33367  
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 30  Pharmaceutical 
products  
5. Title, number of pages  and language(s)  of the notified document:  Draft Technical 
Resolution n. 372, 2 August 2017 (7 page(s), in Portuguese)   
6. Description of content:  This Draft Resolution provides for the classification in the priority 
category, of registration petitions, post -registration and prior consent in clinical research of 
medications.  
The criteria and procedures for framing an application for registration, post -registration 
and prior consent in clinical research for drugs in the priority category are stablished under 
the terms of this Resolution, according to public relevanc e, in order to guarantee or 
expand access to pharmaceutical assistance,.  
ANVISA may classify as priority the requests for registration and post -registration of 
medicines for sale under medical prescription, which are under risk of market shortages 
that hav e an impact on public health.  
Medications prioritized and registered according to the criteria of this Resolution should be 
marketed within a period of up to 120 days from the date of publication of the registration. 
New drugs in the priority category, as a result of the criteria established in this Resolution, 
will have a period of 30 days to submit the price proposal to ANVISA, counted from the 
first business day after the protocol of the priority petition.  
The classification in the priority category shou ld be done at the moment of the protocol of 
the petition (registration, post registration alteration and previous consent in clinical 
research), which will be the object of prioritization.  G/TBT/N/BRA/731  
 
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  The deadline for final decision regarding the analysis of registrat ion and post -registration 
requests for medicines classified as priority will be:  
I - 120 days for applications for registration of medication;  
II - 60 days for post -registration requests.  
In order to apply the criteria set forth in this Resolution, the pri ority petition for 
registration, post -registration and prior consent in clinical drug research must be 
instructed with all documentation required by current legislation and regulations.  
7. Objective and rationale , including the nature of urgent problems w here applicable: 
Protection of Human Health  
8. Relevant documents:  (1) Brazilian Official Journal (Diár io Oficial da União) Nº 148, 
3 August 2017, section 1, page 112; (2) Law 9.782, 26 Ja nuary 1999 (Lei nº 9.782, de 
26 de janeiro de 1999); (3) Brazilian Official Journal; (4) Not stated.  
9. Proposed date of adoption:  To be determined after the end of the consultation period.  
Proposed date of entry into force:  On the date of its publication.    
10. Final date for comments:  8 October 2017  
11. Texts availab le from : National enquiry point  [ ] or address, telephone and fax 
number s and e mail and website address es, 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://portal.anvisa.gov.br/documents/10181/3488774/CONSULTA+PUBLICA+N+372+GG
MED_integra.pdf/7867770b -68c6-4b18-b61a-646552948b19