G/TBT/N/BRA/1193  
9 June 2021  
(21-4733) 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 2145.3817  
Telefax: +(55) 21 2563.5637  
Email: barreirastecnicas@inmetro.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):  
Medicaments consisting of two or more constituents mixed together for therapeutic or 
prophylactic uses, not in measured doses or put up for retail sale (excl. goods of heading 
3002, 3005 or 3006) (HS 3003); Medicaments consisting of mixed or unmixed products 
for therapeutic or prophylactic uses, put up in measured doses "incl. those for transdermal 
administration" or in forms or packings for retail sale (excl. goods of heading 3002, 3005 
or 3006) (HS 3 004) 
5. Title, number of pages and language(s) of the notified document:   
Draft Resolution No. 1050, 31 May 2021 (4 page(s), in Portuguese)  
Comment form: https://pesquisa.anvisa.go v.br/index.php/551215?lang=pt -BR  
6. Description of content:  Draft resolution of risk assessment and control of potentially 
carcinogenic nitrosamines in medicines for human use.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  In 2018, the world's regulatory agencies became aware of the presence of 
nitrosamines above the levels allowed in drugs, after manufacturers of active 
pharmaceutical inputs in the group of medicines commonly called sartanas issued alerts 
of their possible presence in this class of drugs. Since then, these agencies have promoted 
actions to protect patients' health from exposure to nitrosamines in drugs above 
acceptable levels. Anvisa's initial actions involved inspections in 30 drug manufac turers, 
with 31 health actions carried out. In this sense and so that medicines in the Brazilian 
market do not contain levels of harmful impurities, it is proposed the publication of the 
Guide on nitrosamine control in medicines.; Protection of human healt h or safety  G/TBT/N/BRA/1193  
 
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  8. Relevant documents:  01) Brazilian Official Gazette 103 on 02 June 2021, section 1, 
page 120; 02) Regulatory Impact Analysis (RIA) dispensation motivations  
https://www.in.gov.br/web/dou/ -/consulta -publica -n-1.050 -de-31-de-maio-de-2021-
323567102  
http://antigo.anvisa.gov.br/documents/10181/6279847/Parecer+com+as+motiva%C3
%A7%C3%B5es+de+dispensa+de+AIR.pdf/6574a23e -7418-4dfb-bd74-c9cae143c653  
9. Proposed date of adoption:  To be defined  
Proposed date of entry into force:  To be defined  
10. Final date for comments:  8 July 2021  
11. Texts available from:  National enquiry point [ ] 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://antigo.anvisa.gov.br/documents/10181/6279847/CONSULTA+P%C3%9ABLICA+
N+1050+GIMED.pdf/5c0906c0 -7b02-475e-826e-2a90aefce168