. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/BRA/439 
20 July 2011  
 (11-3621) 
Committee on Technical Barriers to Trade Original:   English 
  
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6 
 
1. Notifying Member:  BRAZIL  
If applicable, name of local governme nt involved (Article 3.2 and 7.2):     
2. Agency responsible:  Brazilian Health Surveillance 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, Standa rdization and Industrial Quality-INMETRO 
Telephone:  +(55) 21 2563.2821 Telefax:  +(55) 21 2563.5637 Email:  mailto:barreirastecnicas@inmetro.gov.br  
Website:  http://www.inmetro.gov.br/barreirastecnicas  
3. Notified under Article 2.9.2 [ X ], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other:   
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable):  Medicines 
5. Title, number of pages and language(s) of the notified document:  Draft Resolution nº 33, 
28 June 2011 – Establishes the requirements to va lidate bioanalytical methods used in studies 
with the purpose of medicines regi stration and post-registration (8 pages, in Portuguese).     
6. Description of content:  This draft technical resolution es tablishes requireme nts to validate 
bioanalytical methods used in studies with the purpose of medicines registration and post-
registration in Brazil.  
This resolution aims to establish minimum requirements to validate bioanalytical methods 
used in studies for medicines registra tion and post-registration at Anvisa. 
It will revoke the section "bioanalytical method s" in the annex of resolution RE 899, 9 May 
2003 and letter "d" of item 2 in the an nex of resolution RE 1170, 19 April 2006. 
The Resolution will enter into force 180 (one  hundred and eighty)days after its publication. 
Thus, it will be granted a period of 180 (one hundr ed and eighty days) after the publication of 
the Resolution for laboratories to adequate. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of Human Health  G/TBT/N/BRA/439 
Page 2  
 
  8. Relevant documents:   Brazilian Offici al Journal (Diário Oficial da União), June 30th 2011; 
Section 1 page 39. Draft Resolution (Consulta P ública) number 33, June 28th 2011, issued by 
Brazilian Sanitary Surveillance Agency – A nvisa; When adopted, it will be published at 
Brazilian Official Journal.  Available in Portuguese. 
9. Proposed date of adoption:   
Proposed date of entry into force:    To be determined after the end of the 
consultation period.  180 days after the publication of the Resolution. 
10. Final date for comments:  30 August 2011 
11. Text available from:  National enquiry point [X], or address, telephone and fax 
numbers, e-mail and web-site addres ses, if available of the other body:    
Agency responsible 
Brazilian Health Regulatory Agency - ANVISA 
SIA, Trecho 5, Área Especial 57 
Brasília – DF / Brazil CEP:  71.205-050 Tel.:  55 61 3462-5402 E-mail:  mailto:rel@anvisa.gov.br   
Website:  http://www.anvisa.gov.br  
"http://portal.anvisa.gov.br/wps/wcm/ connect/85773780476b92afb476b65c9a854df2/CP_N_
33_COBIO.pdf?MOD=AJPERES "