. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/BRA/469 
7 February 2012  
 (12-0746) 
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, Quality and Technology - 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):  Medicines 
5. Title, number of pages and language(s) of the notified document:  Draft Resolution nº 10 
23 January 2012 - Establishes crit eria for inclusion and exclus ion of products from Anvisa´s 
List of Reference Medicines (6  pages, Portuguese).     
6. Description of content:  This draft technical regulation esta blishes criteria for inclusion and 
exclusion of products in Anvisa´s  List of Reference Medicines.  
Anvisa´s List of Reference Medicines will be available at Anvisa´s webpage with periodic 
updates after they enter into force of this Resolution. 
The criteria set forth in this Resolution apply to  medicines registered at Anvisa with proven 
safety and efficacy though clinical trials, whic h may be indicated by Anvisa for inclusion in 
the List of Reference Medicines. 
The pharmaceutical products are not subject to inclusion in the List of Reference Medicines in 
the following categories: specific medicines;  herbal medicines; dynamised medicines; 
biological medicines; simplified  notification medicines; medica l gases; radiopharmaceuticals; 
or radiological contrast.   
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of Human Health  G/TBT/N/BRA/469 
Page 2  
 
  8. Relevant documents:   Brazilian Official J ournal (Diário Oficial da  União), 25 January 2012; 
Section 1, page 44. Draft Resolution (Consulta  Pública) number 10 23 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:  26 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:   www.anvisa.gov.br 
http://portal.anvisa.gov.br/w ps/wcm/connect/c66bc80049ec1 dc992e7bbaa19e2217c/Consulta
+P%C3%BAblica+n%C2%B0+10 +GGMED.pdf?MOD=AJPERES