   
  
G/TBT/N/BRA/871  
 
6 June 2019  
(19-3895) 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 2563.2918  
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 commen ts 
regarding the notification shall be indicated if different 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 Codes:  2941; 30.  
5. Title, number of pages and language(s) of the notified document:  Resolution - 
RDC number 283, 17 May 2019. Published on D.O.U, 22 May 2019, pages 61-62. 
(5 page(s), in Portuguese)  
6. Description of content:  This resolution establishes technical requirements for 
investigation, control and elimination of nitrosamines potentially carcinogenic in active 
pharmaceutical ingredients (IFA) which are angiot ensin II receptor antagonists; and is 
applied to companies that manufacture, import and fractionate active pharmaceutical 
ingredients (IFA).  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of Human Health  
8. Relevant documents:   
• Resolution - RDC number 166, 24 July 2017.  
9. Proposed date of adoption:  22 May 2019  
Proposed date of entry into force:  22 May 2019  
10. Final date for comments:  Not applied  G/TBT/N/BRA/871  
 
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  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/10181/5504465/RDC_283_2019_.pdf/7edb15 8b
-6069-4a56-a2f1-874cbefbc248  
 