G/TBT/N/BRA/1528  
27 March 2024  
(24-3461) 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 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); Medicaments (ICS code(s): 11.120.10)  
5. Title, number of pages and language(s) of the notified document:  Draft resolution 
1245, 20 March 2024; (5 page(s), in Portuguese)  
6. Description of content:  This Draft Resolution contains provisions on the  validation of 
bioanalytical methods and analysis of study samples for regulatory submissions of 
industrialized medicines for human use.  
The bioanalytical method used to quantify the drug in matrix  biological must be described 
in detail, and Guide nº XX, of XX2024, which deals with the validation of bioanalytical 
methods and sample analysis  study (ICH M10 - Bioanalytical method validation and study 
sample analysis /ICHM10 - validation of bioanalytical methods and analysis of study 
samples), and its  updates. 
7. Objective and rationale, including the nature of urgent problems where 
applicable:  This draft resolution aims to: update current regulations on Validation of 
bioanalytical methods; add updated tests for chromatographic and LBA bioanalytical 
metho ds to the standard; and implement Guide adopted by ICH, as a member of the 
institution.; Protection of human health or safety  G/TBT/N/BRA/1528  
 
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  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:  15 May 2024  
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/10181/3855414/CONSULTA+P%C3%9ABLICA+
N%C2%BA+1245+DIRE2.pdf/c 926d52e -08a6-4327-b90c-1a5b2420de63  Comment 
form: https://pesquisa.anvisa.gov.br/index.php/335465?lang=pt -BR The comment form 
link will be available only on 01 April 2024  
https://members.wto.org/crnattachments/2024/TBT/BRA/24_02293_00_x.pdf