  
  
G/TBT/N/BRA/1496  
10 August 2023  
(23-5446) 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  
Website: www.inmetro.gov.br/barreirastecnicas  
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  
Pharmaceutics (ICS code(s): 11.120)  
5. Title, number of pages and language(s) of the notified document:  Draft resolution 
1187, 27 July 2023; (8 page(s), in Portuguese)  
6. Description of content:  This Draft Resolut ion establishes the criteria for carrying out 
Forced Degradation Studies on drugs containing synthetic and semi -synthetic active 
pharmaceutical ingredients and defines the parameters for notification, identification and 
qualification of degradation product s in these same products.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  International alignment is sought regarding requirements related to forced 
degradation and degradation products and the removal of scientifically unnecessary or 
disproportionate requirements; Protection of human health or safety  
8. Relevant documents:  - 
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  18 October 2023  G/TBT/N/BRA/1496  
 
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  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  
 
The final text is available only in Portuguese and can be downloaded at:  
Draft: 
http://antigo.anvisa.gov.br/documents/10181/6631540/%281%29CONSULTA+PUBLICA
+N+1187+GQMED.pdf/ 3c746727 -d8f2-4435-abed-9c4bdb13c2ff   
 
Comment form: https://pesquisa.anvisa.gov.br/index.php/576697?lang=pt -BR 
https://members.wto.org/crnattachments/2023/TBT/BRA/23_11633_00_x. pdf 
 