. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/BRA/471 
24 February 2012  
 (12-1068) 
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, Standard ization and Industrial Quality - INMETRO 
Telephone:  +(55) 21 2563.2821 Telefax:  +(55) 21 2502.6542 Email:  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 12 
30 January 2012 - Establishes rules for medi cine labelling (27 pages, Portuguese). 
6. Description of content:  This draft technical re gulation establishes dire ctives for medicine 
labelling. It aims to upgrade th e content of medicines labels  registered at ANVISA and 
commercialized in Brazil, guaranteeing the acces s to safe and adequate information for the 
rational use of medicines. This draft technical regulation applies to all medicines registered at 
ANVISA and commercialized in Brazil. Co mpanies must notify labelling compliance, 
according to the provisions of this draft te chnical regulation, and commercialize medicines 
with the new labels within 180 (one hundred eighty) days from the publication of the draft 
technical regulation as a Resolution. It revok es articles 4 and 5 of "Portaria nº 802" 
8 October 1998; Resolution RDC nº 9 2 Janua ry 2001; Resolution RDC nº 333 19 November 
2003, except item 3 of the annex referring to commercial names; articles 188, 189 and 190 of 
Resolution RDC nº 48 6 October 2009.  
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of Human Health  G/TBT/N/BRA/471 
Page 2  
 
  8. Relevant documents:   Brazilian Official J ournal (Diário Oficial da  União), 31 January 2012; 
Section 1, page 55. Draft Resolution (Consulta  Pública) number 12 30 January 2012, issued 
by the Brazilian Health Regulat ory Agency - Anvisa; When a dopted, 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:  31 March 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://www.anvisa.gov.br/  
http://portal.anvisa.gov.br/w ps/wcm/connect/595c9e0049f e823f9bb4bbaa19e2217c/Consulta
+P%C3%BAblica+n%C2%B0+12 +GGMED.pdf?MOD=AJPERES