G/TBT/N/BRA/1538  
14 May 2024  
(24-3748) 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 [  ], 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 mea sured 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 administra tion" or in forms or packings for retail sale (excl. goods of heading 
3002, 3005 or 3006) (HS code(s): 3004)  
5. Title, number of pages and language(s) of the notified document:  Draft resolution 
1253, 06 May 2024; (4 page(s), in Portuguese)  
6. Description  of content:  This Draft Resolution contains provisions on Inspection Guide 
for Bioavailability/Bioequivalence Centers for Medicines.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  This draft regulation seeks to give the opportunity to regulated sector give 
an opinion on the items in the inspection route that are removed to those inspection 
centers bioequivalence that intend to conduct only pharmacodynamic studies of 
vasoconstriction and also to give companies the  opportunity to express their opinion on 
the topic.; Protection of human health or safety  
8. Relevant documents:   
- G/TBT/N/BRA/1538  
 
- 2 - 
 
  9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  28 July 2024; The short period for comments is due to human 
health protection reasons.  
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: 
https://antigo.anvisa.gov.br/documents/10181/3676755/CONSULTA+P%C3%9ABLICA
+N%C2%BA+1253+GGMED.pdf /f416a7c2 -885a-4c20-ace0-ac2b882edf1d  Comment 
form: https://pesquisa.anvisa.gov.br/index.php/843756?lang=pt -BR 
https://members.wto.org/crnattachments/2024/TBT/BRA/24_03205_00_x.pdf