. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/BRA/487 
18 June 2012  
 (12-3182) 
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 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, Standa rdization and Industrial Quality-INMETRO 
Telephone:  +(55) 21 2563.2821 Telefax:  +(55) 21 2502.6542 Email:  barreirastecnicas@inmetro.gov.br  
Web-site:  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):  Pharmaceutical Excipients 
5. Title, number of pages and language(s) of the notified document:  Draft Resolution nº 31 
24 May 2012 - Establishes Good Manufacturing Practices for Ph armaceutical Excipients 
(14 pages, in Portuguese)     
6. Description of content:  This draft technical resolution establishes Good Manufacturing 
Practices for pharmaceutical exci pients, which must be followed by all manufactures of these 
products. The pharmace utical excipient manufactures must hold authorization to operate, as 
well as the sanitary license, and their activities mu st be subjected to regular inspection by the 
competent health authorities. The manufac turer is responsible for the quality of 
pharmaceutical excipient and also for defi ning control measures, even though production 
operations are outsourced. Due to the variety of  the excipients, some directives of this 
normative may not apply, which mu st be technically justified. 
To the establishments covered by this draft Re solution will be granted a period of 12 (twelve) 
months from its publication to promote the neces sary adjustments to c onform to the technical 
regulations. From the publication of the Resoluti on, the new establishments and those wishing 
to start their activities, must fully meet the re quirements contained therei n, prior to operation. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of Human Health  G/TBT/N/BRA/487 
Page 2  
 
  8. Relevant documents:   Brazilian Offi cial Journal (Diário Ofic ial da União), 28 May 2012; 
Section 1 page 65. Draft Resolution (Consulta Pública) number 31, 24 May 2012, issued by 
the Brazilian Health Regulatory 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 
10. Final date for comments:  4 August 2012 
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:    
National enquiry point 
Agency responsible: Brazilian Health Regulatory Agency - ANVISA 
SIA, Trecho 5, Área Especial 57 
Brasília - DF / Brazil CEP:  71.205-050 Phone.:  55 61 3462-5402 E-mail:  rel@anvisa.gov.br   
Website:  http://portal.anvisa .gov.br/wps/portal/anvisa/home 
http://portal.anvisa.gov.br /wps/wcm/connec t/478966004b68ccec8be49baf8fded4db/Consulta
+P%C3%BAlblica+N%C2%B0+31 +GGIMP.pdf?MOD=AJPERES