. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/BRA/432 
30 May 2011  
 (11-2709) 
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 Surve illance 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 
E-mail:  barreirastecnicas@inmetro.gov.br
 
Website:  http://www.inmetro.gov.br/barreirastecnicas  
3. Notified under Article 2.9.2 [   ], 2.10.1 [   ], 5.6.2 [ X ], 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):  Phytotherapic medicines 
5. Title, number of pages and language(s) of the notified document:  Draft Resolution nº 14, 
March 16th  2011 - It establishes requirements to change, include, su spend, reactivate and 
cancel phytotherapic medicines (34 pages, in Portuguese). 
6. Description of content:  This draft technical re gulation establishes requ irements to change, 
include, suspend, reactivate and cancel phytotherapic medicines already registered at Anvisa.  
This draft resolution aims to classify post registration modifications of phytotherapic 
medicines and establishes the documentation and laboratorial tests required by Anvisa.  
It applies to all phytotherapic medicines that are already registered at Anvisa.  
Anvisa's decisions about the po st registration requests will be published in the Brazilian 
Official Journal (Diári o Oficial da União), or in anothe r institutional publication, when 
applicable. 
Anvisa's recommendations for pos t registration of phytotherapic medicines will be available 
on Anvisa´s website.  
This draft resolution will revoke Re solution RE nº 91 March 16th 2004. G/TBT/N/BRA/432 
Page 2  
 
  7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of Human Health  
8. Relevant documents:   Brazilian Official Journal (Diá rio Oficial da União), March 21th  
2011; Section 1 page 66. Draft Resolution (Cons ulta Pública) number 14, March 16th 2011,  
issued by Brazilian Sanitary  Surveillance Agency  - Anvisa; When adopted, it will be 
published in the Brazilian Official J ournal. Available in Portuguese.   
9. Proposed date of adoption: 
   
Proposed date of entry into force:    To be determined after the end of the 
consultation period 
On the date of adoption 
10. Final date for comments:  12 June 2011 
11. Text available from: National enquiry point [X], or address, telephone and fax numbers, 
e-mail and web-site addresses, 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:  rel@anvisa.gov.br
 
Website:  http://www.anvisa.gov.br  
Text can be downloaded at: 
"http://portal.anvisa.gov.br/wps/wcm/co nnect/9c0fdf804637d1a885cebf0ce2062da6/CP+N
%C2%BA+14+GGMED.pdf?MOD=AJPERES "