G/TBT/N/BRA/782  
 
11 January 2018  
(18-0281) 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 2563.2765  
Telefax: +(55) 21 2563.5637  
Email: barreirastecnicas@inmet ro.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): 3003 3004: 
Medicaments  
5. Title, number of pages and language(s) of the notified document: RDC Nº 204, 
December 27th, 2017 (6 page(s), in Portuguese)    
6. Description of content: This Resolution provides for the classification in the priority 
category, of registration petitions, post registration and prior consent in clinical trial of 
medicines.  
The criteria and procedures for framing on the priority category applications for 
registration, post -registration and prior consent in clinical trial for drugs are approved 
under the terms of this Resolution.  
In addition to the criteria established in arts. 3 and 4, Anvisa may classify as priority 
requests for registration and post -registr ation of medicines for sale under medical 
prescription, when the risk of market shortages that have an impact on public health is 
configured.  
The classification in the priority category should be made at the moment of the application 
of the petition regard ing registration, post -registration alteration and prior consent in 
clinical trial.  
This resolution establishes the criteria for requests for registration of medicines and 
petitions for prior consent.  
The deadline for final decision regarding the analysis of petitions classified as priority will 
be: 120 (one hundred and twenty) days for drug registration applications and 60 (sixty) G/TBT/N/BRA/78 2 
 
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  days for post -registration petitions.  
In order to be able to apply the criteria set forth in this resolution, the priority peti tion for 
registration, post -registration and prior consent in clinical trial must present all 
documentation required by the current resolution and current regulation, under penalty of 
rejection.  
7. Objective and rationale, including the nature of urgent p roblems where 
applicable: Protection of Human Health  
8. Relevant documents:  (1) Brazilian Official Journal (Diário Oficial da União) Nº. 248, 
28 December 2017, section 1, page 88; (2) Law nº 9.782, 26 January 1999; RDC nº 20, 
de 10 April 2013 (3) Brazilian Official Journal; (4) Not applicable   
9. Proposed date of adoption: On the date of its publication  
Proposed date of entry into force: 60 (sixty) days after the date of its publication, 
12 December 2017.  
10. Final date for comments: Not applicab le 
11. Texts available from: National enquiry point [X] 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: 71.205 -050 
Phone.: +(55) 61 3462.5402  
Website: www.anvisa.gov.br    
http://portal.anvisa.gov.br/documents/10181/2718376/RDC_204_2017_.pdf/b2d4ae64 -
2d91-44e9-ad67-b883c752c094