G/TBT/N/BRA/1493  
10 August 2023  
(23-5437) 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):  
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 code(s): 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 code(s) : 3004); Pharmaceutics (ICS code(s): 11.120)  
5. Title, number of pages and language(s) of the notified document:  Draft resolution 
1188, 03 August 2023; (5 page(s), in Portuguese)  
6. Description of content:  This Draft Resolution contains provisions on hea lth 
requirements for safety and efficacy for post -marketing registration alterations of 
synthetic and semi -synthetic drugs classified as new or innovative.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  This draft resolution seeks to maintain convergence to international 
standards; 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  G/TBT/N/BRA/1493  
 
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  10. Final date for comments:  28 August 2023; The shorter period for comments is due to 
the search for convergence with international standards, in order to facilitate trade.  
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/10181/6636520/CONSULTA+P%C3%9ABLICA+
N+1188+GGMED.pdf/baa1ed2a -81ed-4b4c-9a28-40384f1811ed  Comment form: 
https://pesquisa.anvisa.gov.br/index.php/559546?lang=pt -BR 
https://members.wto.org/crnattachments/2023/TBT/BRA/23_11630_00_x.pdf