  
  
G/TBT/N/BRA/1494  
10 August 2023  
(23-5445) 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 (ICS code(s): 11.120.10)  
5. Title, number of pages and language(s) of the notified document:  Draft resolution 
1179, 20 July 2023; ; (13 page(s), in Portuguese)  
6. Description of content:  This Draft Resolution contains provisions on the sanitary 
requirements for the market authorization of industrialized medicines for human use.  
It is important to highlight that, when the absence or incompleteness of national market 
authorization, andas long as there is no incompatibility, the adoption of guides and 
guidelines by the International Council for Harmonisation of Technical Requirement s for 
Pharmaceuticals  for Human Use ( ICH) 
7. Objective and rationale, including the nature of urgent problems where 
applicable:  The different rules in force that deal with the market authorization of different 
categories of drugs describe, in a non -standa rd way, the administrative requirements 
necessary for granting market authorization, generating asymmetries in relation to the 
documentation that must be presented. Unlike the technical criteria, the criteria that we 
call administrative here are independen t of the specifics of the product and, therefore, 
can be equated. Non -standardization generates different costs for companies in the 
preparation of market authorization dossiers, which may even involve different financial 
costs, as is the case with product s for which a sworn translation of official documents in 
a foreign language is required; Protection of human health or safety  
8. Relevant documents:   G/TBT/N/BRA/1494  
 
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  9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  25 September 2023  
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/10181/6627714/CONSULTA+PUBLICA+N+1179
++DIRE2.pdf/9ea14e78 -f7ea-4f5f-847a-22347d679909  Comment form: 
http://antigo.anvisa.gov.br/pesquisa.anvisa.gov.br/index.php/316543?lang=pt -BR The 
original text was rectified on 24/07/20223. The rectified text is available only in 
Portuguese: https://www.in.gov.br/en/web/dou/ -/retificacao -498166860  
 